Medicure - 500 Beiträge pro Seite

[cristrader]

Medicure --> nach Aeterna Zentaris und YM Biosciences die nächste Biotech-Granate aus Kanada!

WKN: 157786
AMEX: MCU
TSX: MPH (MPH.TO)

Webseite: www.medicure.com http://www.medicure.com

Aktueller Kurs: 1,35 €

Nach Abschluss einer aktuell laufenden Finanzierungsrunde (Ausgabe von max. 7.750.000 Aktien zum Ausgabepreis von 1,33 US $) sind 79.782.160 Aktien auf dem Markt. Das ergibt eine Marktkapitalisierung von 107,7 Mio US $.
http://www.sedar.com/csfsprod/data63/filings/00869872/000000…






Annual Report 2005
http://www.medicure.com/pdfs/Medicure_AR_05.pdf


Pipeline:



Medicure hat seine Medikamentenkandidaten bisher noch nicht verpartnert. Der Anfang 2006 zu erwartende Phase III Start der beiden Leadmedikamente MC-1 und MC-4232 wird sicherlich zusammen mit einem neuen Partner durchgeführt.


MC-1

MC-1 LEAD PRODUCT

MC-1 is a powerful cardioprotective drug that in both preclinical and clinical studies has shown potential for treating various forms of cadiovascular disease. The properties of this protective, naturally-occurring molecule were discovered by internationally acclaimed researcher, Naranjan S. Dhalla, Ph.D., Distinguished Professor and Director, Institute of Cardiovascular Sciences, St. Boniface General Hospital Research Centre, Faculty of Medicine, University of Manitoba. MC-1 stands to be a major first-to-market product in a new class of cardioprotective drugs for the treatment of acute cardiovascular events incuding; coronary artery bypass graft surgery ( CABG), acute coronary syndrome (ACS), and angioplasty.

The U.S. Food and Drug Administration (FDA) recently granted MC-1 Fast Track designation as a treatment to reduce cardiovascular and cerebrovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions (angioplasty) , CABG surgery and acute coronary syndrome.


EFFICACY
Medicure had one of the most significant clinical announcements in its history, with the positive clinical results in the Phase II MEND-CABG study. The MEND-CABG study was a double blind, parallel group, randomized, placebo-controlled study in 901 patients who underwent CABG surgery. The objective of the MEND-CABG study was to demonstrate a reduction in the composite of death, non-fatal myocardial infarction (heart attack), and non-fatal stroke up to post operative day (POD) 30 with MC-1 versus placebo. The results showed that the 250 mg dose of MC-1 had a statistically significant reduction in the composite of events driven by a 46.9% reduction in non-fatal heart attacks (peak CK-MB greater than or equal to100ng/ml).

Medicure has also completed a Phase II study with MC-1 in angioplasty patients called MEND-1. The study showed that MC-1 had a statistically significant reduction versus placebo in the cardiac enzyme CK-MB (measured as area under the curve CK-MB).

Based on the positive results in both MEND-CABG and MEND-1, Medicure is planning for Phase III development with MC-1


SAFETY
Phase I clinical studies have demonstrated MC-1`s high degree of safety for human use as initially predicted in extensive GLP preclinical toxicology testing. The MEND-1 study further confirmed the tolerability of MC-1 in angioplasty patients. Safety data is currently being compiled from MEND-CABG and will be reported early in 2006. The promising safety profile of this naturally occuring molecule will inspire the confidence of physicians treating patients with cardiovascular diseases.



CLINICAL DEVELOPMENT


Preclinical: Confirm effect and determine bioavailability and safety in animals. Completed 2000

Phase I: Evaluate safety and bioavailability in human volunteers. Completed 2001


Phase II: Positive results from MEND-1 clinical trial in patients undergoing angioplasty. Completed 2003


Phase II: Commence MEND CABG clinical trial in patients undergoing coronary artery bypass surgery. Trial commenced April 2004

Phase II: Enrollment of 901 patients. Completed July 2005

Phase II: Positive Post Operative Day (POD 30) results from the MEND-CABG study reported. Completed December 2005

Hier die News zu den Phase II-Ergebnissen:

December 5, 2005

MEDICURE REPORTS POSITIVE RESULTS FROM PHASE II MEND-CABG STUDY

MC-1 Demonstrates Statistically Significant Reduction in Post-CABG Heart Attacks
Conference Call Today at 8:00AM Eastern
NEW YORK , New York ­ (December 5, 2005)

NEW YORK, New York – (December 5, 2005) Medicure Inc. (TSX:MPH; Amex: MCU), a cardiovascular drug discovery and development company is pleased to report positive results with its FDA Fast Tracked cardioprotective product, MC-1, in the Phase II MEND-CABG study. The MEND-CABG study is a double blind, parallel group, randomized, placebo-controlled study in 901 patients who underwent coronary artery bypass graft (CABG) surgery. Based on the positive results, the Company plans to move forward with a pivotal Phase III clinical development program for MC-1.

The MEND-CABG Study Results:

The MEND-CABG results demonstrate the positive clinical effects of MC-1

The 250 mg dose of MC-1 had a 37.2% reduction in the composite of death, non-fatal myocardial infarction (peak CK-MB ³ 100ng/ml), and non-fatal stroke versus placebo (p=0.028).
The reduction in the composite endpoint was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction (peak CK-MB ³ 100ng/ml) with the 250 mg of MC-1 versus placebo (p=0.008).
The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of death, non-fatal myocardial infarction (peak CK-MB ³ 50ng/ml), and non-fatal stroke versus placebo (p=0.312).
The 250 mg dose of MC-1 had a 78.7% reduction in physician diagnosed myocardial infarctions with the 250 mg of MC-1 versus placebo (p=0.0065).
Greater efficacy was demonstrated with the 250 mg dose than the 750 mg dose of MC-1.
The study protocol definition of myocardial infarction included peak CK-MB ³ 50ng/ml. This conservative measure of myocardial infarction was selected to increase the powering of the study. An analysis was also performed with a definition of myocardial infarction as peak CK-MB ³ 100ng/ml. This definition of myocardial infarction has been used in recent Phase III clinical studies in CABG patients.

The Principal Investigator for MEND-CABG, Dr. Jean-Claude Tardif, Director of the Research Centre, Montreal Heart Institute, commented, “The statistically significant reduction in myocardial infarctions defined as peak CK-MB ³ 100ng/ml of 46.9% with MC-1 is impressive for this high risk patient population . The results clearly suggest that patients treated with MC-1 experienced clinically meaningful reductions in the composite endpoint, driven by a pronounced reduction in non-fatal myocardial infarctions, which comprise the majority of events after CABG surgery.”

“The strong efficacy signal observed with MC-1 in MEND-CABG, highlighted by the statistically significant reduction in heart attacks, have exceeded our expectations, and clearly warrant advancing MC-1 into pivotal Phase III development,” commented Medicure’s President and CEO, Albert D. Friesen, PhD. “The recent FDA Fast Track designation for MC-1 combined with the positive results in MEND-CABG, have positioned Medicure at the forefront of cardioprotective therapeutic development. The results also provide us with the necessary information to design the Phase III study, including the dosing and endpoints. We now plan on meeting with the FDA to discuss these results and develop the Phase III program. Furthermore, we expect these results to accelerate our ongoing discussions with potential partners.”

David Kandzari, MD, Assistant Professor of Interventional Cardiology and Genomic Sciences, Duke Clinical Research Institute, and Principal Investigator for the US MEND-CABG sites added, “While bypass surgery has brought a significant improvement in the management of coronary artery disease, post operative mortality and morbidity remain significant complications of this procedure. To date cardiologists and surgeons have had limited therapeutic options to mitigate this risk. The promising clinical results seen with MC-1, first in the angioplasty setting of the MEND-1 study and now in the setting of bypass surgery, suggest that MC-1 could represent a major therapeutic breakthrough in the treatment of acute ischemia and ischemic reperfusion injury.”

About the MEND-CABG Study

The MEND-CABG trial was designed to evaluate the cardioprotective and neuroprotective effects of MC-1 in high-risk coronary artery disease patients undergoing CABG surgery. The trial enrolled 901 patients at 42 investigational sites throughout Canada and the United States. The study is a double blind, parallel group, randomized, placebo-controlled study in 901 patients who underwent coronary artery bypass graft (CABG) surgery. The primary endpoint of MEND-CABG is a reduction in the composite of death, non-fatal myocardial infarction (heart attacks), and non-fatal stroke up to post operative day (POD) 30. To assess the efficacy, the event incidence in each of two dose groups - 250 mg and 750 mg per day - was compared to the incidence level in the placebo group.

Secondary efficacy endpoints include evaluating the effect of MC-1 at postoperative day 90 (POD 90) on the same composite of events, as well as the individual components of the composite (i.e. vascular death, non-fatal heart attack and stroke) at POD 4, 30, and 90. Other secondary endpoints being measured during the trial include; cardiac tissue damage as determined by CK-MB and neurological function. Safety and tolerability will also be assessed and reported at the end of the study. Upon completion of POD 90, the complete results from the MEND-CABG study will be presented in future scientific publications and presentations.

About MC-1

MC-1 is a naturally occurring small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1’s cardioprotective properties have now been demonstrated in the Phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the Phase II MEND-CABG study in patients undergoing CABG surgery.




MC-4232

MC-4232 COMBINATION PRODUCT
"The data from MATCHED demonstrate the unique properties of MC-4232, including its antihypertensive, hypoglycemic, and lipid lowering effects. We are now substantially closer to commercialization of a product that today has no comparable competitor – a product that offers a wide range of complimentary benefits for the growing diabetic hypertensive population." ­ Albert D. Friesen, PhD, Medicure`s President & Chief Executive Officer

Medicure`s first combination product is MC-4232, a drug that combines the cardioprotective benefit of MC-1 with an ACE inhibitor, lisinopril,for the treatment of diabetic patients with hypertension. As the incidence of diabetes continues to increase so to does the number of diabetic patients with hypertension. Current statistics show that approximately 75% of diabetics have hypertension, and less than 20% are chieving target blood pressure levels. Medicure developed MC-4232 to address the emerging problem of diabetes and hypertension.

Medicure recently announced positive results from the Phase II MATCHED study (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics), evaluating the effects of MC-4232 in patients with coexisting diabetes and hypertension. The Company is pleased to report that MC-4232 met primary blood pressure and metabolic endpoints in the MATCHED study, demonstrating the products antihypertensive, hypoglycemic, and lipid lowering properties. Based on these positive results, the Company plans to move forward with a pivotal Phase III clinical development program for MC-4232.

DIABETES / HYPERTENSION

Medical Problems
Potential Benefits of MC-4232

High blood pressure (hypertension)
Blood pressure reduction

High blood sugars (hyperglycemia)
Blood sugar/Glucose control

Elevated lipids
Lipid lowering

Increased risk of heart attacks/stroke
Cardioprotective properties

Multiple medications
Combo therapy in one drug

Hier die News zu den Phase II-Ergebnissen: September 14 , 2005

MEDICURE MEETS PRIMARY ENDPOINTS IN PHASE II DIABETIC HYPERTENSION STUDY

Conference Call Today at 10:30 AM Eastern to Discuss Positive MATCHED Results

WINNIPEG, Manitoba ­ (September 14, 2005)

WINNIPEG , Manitoba – (September 14, 2005) Medicure Inc. (TSX:MPH; Amex: MCU), a cardiovascular drug discovery and development company, is pleased to announce that MC-4232 met primary blood pressure and metabolic endpoints in the Phase II MATCHED study. The study evaluated MC-4232, a combination of MC-1 and the ACE inhibitor, lisinopril, in the treatment of coexisting diabetes and hypertension. Based on these results, the Company plans to move forward with a pivotal Phase III clinical development program for MC-4232.

“The MATCHED trial has exceeded our expectations, demonstrating the outstanding clinical benefits of MC-4232,” commented Medicure’s President and CEO, Albert D. Friesen, PhD. “We believe the evidence presents a unique development opportunity, advancing a novel product with combined blood pressure and multiple metabolic benefits for a patient population in desperate need for improved treatment in both areas. We are now advancing MC-4232 into Phase III pivotal studies and these results set the stage for the development of other cardiovascular combination products.”

Results from Blood Pressure Endpoints:

The results of MATCHED demonstrate the positive clinical effects of MC-4232 on primary and secondary blood pressure endpoints, including both systolic and diastolic measurements:

The 300mg/20mg (MC-1/lisinopril) dose of MC-4232 had a statistically significant reduction of 12.0 mmHg (p<0.0001) from baseline over 8 weeks on the primary endpoint of mean daytime ambulatory systolic blood pressure (MDASBP).
The 300mg/20mg dose of MC-4232 reduced MDASBP by 12.0 mmHg over 8 weeks as compared to a 7.5 mmHg reduction with lisinopril alone, equating to an additional 4.5 mmHg (p=0.13) reduction, demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.
In the secondary endpoint of reduction in mean daytime ambulatory diastolic blood pressure (MDADBP), the 300mg/20mg dose of MC-4232 reduced MDADBP by 7.5 mmHg over 8 weeks as compared to a 4.1 mmHg reduction with lisinopril alone, equating to an additional 3.4 mmHg (p=0.06) reduction, again demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.
Results from Metabolic Endpoints:

The results of MATCHED also demonstrated the positive clinical effects of MC-4232 on primary and secondary metabolic endpoints, including glycemic control as measured by fasting serum glucose and glycated hemoglobin (HbA1c), as well as lipid control, after 16 weeks of treatment.

The 300mg/20mg dose had a statistically significant reduction of 1.45 mmol/L (p=0.026) versus placebo on the primary endpoint of fasting serum glucose.
In those patients with HbA1c greater than the prespecified level of 8.0%, the 300mg/20mg dose had an absolute reduction of 0.63% (p=0.27) compared to placebo. This exceeds the regulatory requirements in HbA1c reduction of ≥0.40% for antidiabetic therapeutics. The majority of the patients in the study were well controlled with current antidiabetic therapy, with less than 19% exceeding 8.0% HbA1c.
In those patients with elevated triglycerides (>1.7mmol/L), the 300mg/20mg dose of MC-4232 provided a statistically significant reduction of triglyceride levels by .70 mmol/L (p=0.04) versus baseline.
On all key metabolic and blood pressure endpoints the 300mg/20mg and 1000mg/20mg doses of MC-4232 demonstrated comparable clinical efficacy. The study results also demonstrated that MC-4232 was safe and well tolerated at all dose levels.

The Principal Investigator of the MATCHED study, Yves Lacourcière MD, FRCP, FACP, added, “While medical guidelines recommend stringent blood pressure targets for diabetic patients, such as those studied in the MATCHED trial, achieving and maintaining these targets has proven to be extremely difficult. Although all classes of antihypertensive agents are effective at lowering blood pressure in diabetic patients, treatment has been further complicated by the fact that some major classes have been shown to have deleterious effects on glycemic control. The results from MATCHED demonstrate that MC-4232 not only provides clinically important blood pressure reduction beyond that of lisinopril alone, but also improves upon the glycemic and lipid control offered by current therapies. Based on this data, I believe MC-4232 could be an innovative new treatment that in addition to significant blood pressure reduction also offers metabolic benefits to patients with coexisting diabetes and hypertension.”

The MATCHED study ( MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) was designed as a Phase II trial to determine the optimal dose and endpoint for Phase III development of MC-4232. MATCHED was a randomized, parallel group, cross-over, double-blind, placebo-controlled comparison of 100, 300 or 1000 mg of MC-1 alone and in combination with 20 mg of lisinopril. The study results are based on a population of 120 patients with coexisting type II diabetes and hypertension from 12 sites across Canada. In order to minimize the carry-over effects of lisinopril, all patients were randomized in two different treatment sequences. Patients randomized in the first treatment sequence received an 8-week treatment with MC-4232 (20 mg of lisinopril and MC-1) or placebo and then an 8-week treatment with MC-1 alone or placebo. Patients randomized in the second treatment sequence received an 8-week treatment with MC-1 alone or placebo and then an 8-week treatment with MC-4232 or placebo. In each treatment sequence, all patients were randomized to MC-1 at one of the three prespecified dosages.

This trial was conducted under the guidance and direction of the internationally recognized hypertension specialist, Yves Lacourcière, MD, FRCP, FACP, Director of the Hypertension Research Unit, Centre Hospitalier de l`Université Laval Sainte-Foy, Québec. Dr. Lacourcière, one of North America`s foremost experts in management of hypertension in difficult to treat patient groups, led a group of specialist investigators who enrolled patients at sites across Canada. Dr. Lacourcière has led numerous important hypertension studies and serves as a scientific advisor to several leading pharmaceutical companies.



Medicure wird in Kürze zwei Medikamente mit Blockbuster-Potential in Phase III haben. Nach den überzeugenden Phase-II-Daten ist das Risiko von negativen Pipeline-News zumindest mittelfristig sehr begrenzt.

Medicure hat alle Voraussetzungen zu einem der Highflyer der nächsten Jahre zu werden!



Grüße cristrader

[cristrader]

Hallo, ich wünsche allen ein frohes und erfolgreiches Neues Jahr 2006!


Es lohnt sich auf jeden Fall mal einen genaueren Blick auf Medicure zu werfen.

Company Fact Sheet:
http://www.medicure.com/pdfs/factsheet.pdf

Besonders interessant:
"The positive results from MEND-CABG are the most
impressive reported to date in this high risk patient population."


Kurz aufgeführt nochmal die Chance die sich hier bietet:

-Medicure hat mit MC-1 und MC-4232 zwei Blockbuster-Medikamente im Milliardenmarkt Diabetis/Bluthochdruck/Herzleiden unmittelbar vor Phase III-Start

-möglicher Marktzulassung im Jahr 2008

-Sowohl MC-1 als auch MC-4232 schlossen die Phase II-Tests vor kurzem mit mehr als überzeugenden Erfolg ab

-keiner der Medikamentenkandidaten ist bisher verpartnert.

-Medicure wird die umfangreichen Phase-III-Studien nur mit einem Partner durchführen können, deshalb steht ein grosser Deal unmittelbar bevor.

-Marktkapitalisierung nur 108 Mio US $


Wieviel Wert ist ein Phase-III-Medikament mit Blockbusterpotential? Weniger als 50 Mio US$?


Grüße cristrader

[BrauchGeld]

Hallo Cristrader

Du hälst Medicure für unterbewertet ,dann schau Dir mal Neuren Pharma an .

Thread: Neuren Pharma---Pfizer ist auch dabei

Medicure ist natürlich auch ein gutes Unternehmen aber ich denke Neuren wird 2006 besser performen.
Die nächsten 1-2 Quartale sind entscheidend für Neuren.

Kurs:1,56 C$ ---- Medicure
Kurs:0,53 A$----- Neuren Pharma

Hab mal den aktuellen kurs fest gehalten zum vergleich.

[cristrader]

@BrauchGeld

Neuren ist eine tolle Aktie. Ebenso gut gefällt mir auch Starpharma aus Down Under. Leider habe ich bisher schlechte Erfahrungen mit der Handelbarkeit australischer Aktien bei der DAB Bank gemacht. Es kommt mitunter vor das ich erst 2-3 Tage später erfahre ob ich die Aktie nun gekauft habe oder nicht. Außerdem ist das Handelsvolumen noch recht gering. Das Handelsvolumen hat mich aber leider auch davon abgehalten seinerzeit Medicure zu 0,60 € zu kaufen.


Ob sich Neuren besser entwickelt als Medicure muss man erst abwarten. Bei Medicure erwarte ich in Kürze einen Kurssprung infolge eines Deals mit einem Big-Pharma.

Persönlich erwarte ich die Bekanntgabe eines Deals bereits in den nächsten Wochen. Medicure kann nicht mehr lange Warten mit einem Deal. Es ist absolut notwendig das die Phase-III-Planungen (Studiendetails etc.) zusammen mit dem zukünftigen Partner durchgeführt werden um einen künftigen Markteintritt nicht zu verzögern.

Meine aktuellen Favoriten sind zurzeit folgende Werte:

Absolute Nr. 1:
YM Biosciences

Nr.2:
Medicure

Nr.3
Aeterna Zentaris (z.Z. nur minimal investiert)
absolute risikoloser Value-Wert (lässt sich mit einem Kurssprung hoffentlich noch etwas Zeit )

Nr.4
Starpharma (SPL.AX) (z.Z. nicht mehr investiert)
insbesondere die Beteiligung an Dendritic Nanotechnologies sollte mehr Wert sein als die aktuelle Marktkapitalisierung

Ansonsten gefällt mir auch noch Burcon NutraScience recht gut. Mit Burcon und auch Neuren muss ich mich allerdings erst noch intensiver vertraut machen bevor ich einsteige.


Welche Werte hast du momentan im Depot?

Grüße cristrader

[cristrader]

Hallo!

Neben den beiden Leadmedikamenten MC-1 und MC-4232 besitzt MCU weitere sehr vielversprechende Programme. Besonders MC-45308 scheint gigantisches Potential zu besitzen!


MC-4262 ---> Phase 1 complete

MC-4262 COMBINATION PRODUCT
Medicure recently initiated the development program for its second combination product, MC-4262, a drug combining MC-1 and an Angiotensin Receptor Blocker (ARB), one of the world`s ten largest pharmaceutical drug classes by revenue. The patented new product, is being developed for use in the treatment of hypertension in patients whose condition is complicated with metabolic syndrome resulting in increased cardiovascular risk.

Metabolic syndrome is a cluster of disorders that include obesity, high blood pressure, elevated blood sugar and hyperlipidemia. The American Heart Association estimates that approximately one-quarter of adults in the United States, close to 50 million people, have this condition.


Sales of Angiotensin Receptor Blockers (ARB`s) and ARB combination products in the United States was approximately USD$3.5 billion in 2003 - representing a growth of over 20% compared to 2002 (IMS data), making it the fastest growing class of antihypertensive medication. These products are a part of the first-line of therapy for hypertension and are used extensively in metabolic syndrome. Based upon MC-1 data, the MC-4262 product will be uniquely positioned to compete with other ARB`s by adding to their benefits cardioprotection as well as improved control of other disorders faced by the rapidly growing population of metabolic syndrome patients.


The Company is expanding its combination development program to include an ARB combination, as well as the MC-4232 ACE combination, in response to both the encouraging experience with MC-1 and the interest expressed by clinicians and the market.





MC-45308 ­ PRECLINICAL CANDIDATE

"This has the potential to be a major discovery in the field of antithrombotic therapy. Our preliminary biochemical results suggest potential for MC-45308, which has a unique property that demonstrates a dual anti-platelet and anti-coagulant effect." ­ Jawed Fareed, MD, Professor, Departments of Pathology and Pharmacology, Loyola University Stritch School of Medicine, Maywood, Ill.

Independent Research results have shown significant potential for Medicure`s newest drug, MC-45308, in preventing blood clots. The compound has shown a unique property that demonstrates simultaneous anti-platelet and anti-coagulant effects, which could make MC-45308 a major player in the management strategy of cardiovascular diseases such as Myocardial Infarction (MI), stroke, Pulmonary Emboli (PE) and Peripheral Arterial Disease (PAD). A drug of this type currently is non-existent within the antithrombotic marketplace.


The combined U.S. market for antiplatelets and anticoagulants is projected to grow rapidly from an estimated USD$3 billion in 2000 to USD$6.7 billion in 2008.


To advance the development of MC-45308, a novel and composition of matter patented drug from Medicure`s antithrombotic library, the Company has entered into a research agreement with Dr. Jawed Fareed, Professor, Departments of Pathology and Pharmacology, Loyola University Stritch School of Medicine, Maywood, Ill.


Dr. Fareed`s laboratory is conducting in vivo pre-clinical efficacy studies with MC-45308, which was selected from a larger library of Medicure compounds based on test results from studies conducted in his laboratory at Loyola University.


MC-45308 is structurally different from Medicure`s lead compound MC-1, and is the only agent that addresses each of the three thrombotic cascades, namely antithrombin effects, protease generation inhibition and anti-platelet effects. Other known clinical agents, such as direct thrombin inhibitors and low-molecular weight heparin are not known to have effects across all three cascades, nor have these compounds shown any anti-platelet effects.





About Antithrombotics
Antithrombotics are drugs that prevent blood factors (platelets and fibrin) from aggregating or clotting and subsequently blocking blood flow. These blockages cause thrombosis, or the formation of blood clots within an artery or vein, and represent the leading cause of various acute cardiovascular problems, including stroke, pulmonary embolism and heart attacks. Formation of the clot is driven by acceleration in the coagulation and platelet activation coupled with a reduced fibrinolyisis capability. In order to address this, at-risk patients increasingly receive anti-platelet and/or anticoagulant therapy.

February 28, 2005
MEDICURE REPORTS POSITIVE PRECLINICAL RESULTS FOR NOVEL ANTITHROMBOTIC, MC-45308
http://www.medicure.com/news/2005/press_feb28_2005.html

The preclinical studies demonstrated that MC-45308 has simultaneous anti-platelet and anti-coagulant effects. A drug of this type does not currently exist within the antithrombotic marketplace. The results also suggest that MC-45308 may be a more effective therapeutic for treatment of thrombotic disorders than existing clinically approved agents. "MC-45308 has the potential to be the first in a new class of drugs, a dual-acting agent that provides both anticoagulant and antiplatelet activity,"


"Antithrombotic drug development is a major part of our drug discovery activities due in part to the large market opportunity and the recognized need for novel products that can improve upon the limitations of existing therapeutics," stated Albert D. Friesen, PhD, Medicure`s President and CEO. "Given that MC-45308 performed comparably or better than clinically approved therapeutics in these studies further underscores its potential to be a major drug in the management strategy of cardiovascular diseases such as myocardial infarction, stroke, pulmonary emboli and peripheral arterial disease."







MC-5422 PRECLINICAL CANDIDATE

MC-5422 PRECLINICAL CANDIDATE
Another area of focus being undertaken is the design and synthesis of tenable MC-1 mimetics to address ischemic and reperfusion injury. The lead molecule in Medicure¹s library of novel anti-ischemics is MC-5422, a novel agent that has displayed potent capabilities of reducing damage from ischemic reperfusion injury. The Company is currently conducting preclinical studies of MC-5422 with a view to future clinical testing.

Independent and internal studies using the preclinical ischemic reperfusion in vivo model have shown the potential of Medicure`s anti-ischemics program to provide new cardioprotective agents. Results in an independent study involving intravenous administration of 25 mg/kg of MC-5422 are shown below. MC-5422 was shown to significantly reduce infarct size after ischemia (25 min) followed by reperfusion (120 min). Infarct size is reported as a percentage of the area at risk (AR).

Preliminary toxicology studies carried out on this lead candidate have demonstrated its safety, supporting further study and development of the product.



Grüße cristrader

[cristrader]

Hallo!

January 4, 2006

MEDICURE ANNOUNCES CLOSING OF $12 MILLION BOUGHT DEAL FINANCING

UNDERWRITERS` OPTION FULLY EXERCISED

WINNIPEG, Manitoba­ (January 4, 2006)

Not for distribution to U.S. news wire services or dissemination in the United States.

WINNIPEG, Manitoba– (January 4, 2006) Medicure Inc. (TSX:MPH; Amex: MCU), today announced the closing of the previously announced bought deal financing with a syndicate of underwriters led by Blackmont Capital Inc. and including National Bank Financial Inc., for 6,500,000 common shares of Medicure at $1.55 per share. The underwriters have also fully exercised their 1,250,000 common share option for a total purchase of 7,750,000 common shares. With the exercise of the underwriters’ option, the gross proceeds realized by the Company are approximately CDN$12 million.

Proceeds of the offering will be used towards the funding of the Company`s MC-1 and MC-4232 products into pivotal Phase III development, the continued development of its preclinical compounds, including MC-45308, and for general corporate purposes.

The securities offered were not registered under the Securities Act of 1933, as amended (the "Securities Act") and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful.

About Medicure Inc.

Medicure Inc. is a cardiovascular drug discovery and development Company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The Company`s solid position in this field is supported by the following attributes:

Cardiovascular focused pipeline: a global market of over US $70 billion
Two drugs - MC-1 & MC-4232 - advancing to Phase III development
Four positive Phase II trials completed
FDA Fast Track designation for MC-1
Unique products addressing major, inadequately served markets
Dual action antithrombotic, MC-45308, with positive preclinical results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule, anti-ischemics, and antithrombotics towards human clinical studies.



Grüße cristrader

[cristrader]

Hallo!

Heutiger Einstieg wäre günstiger gewesen!

Was mich jetzt aber aufmuntert ist folgendes:

http://de.today.reuters.com/news/newsArticle.aspx?type=compa…

Bayer erwirbt Rechte an Phase-III-Medikament von Nuvelo

"Mit dieser Phase-III-Substanz haben wir die Möglichkeit, unser Hämatologie- und Herzkreislauf-Geschäft maßgeblich zu verstärken", erklärte der Chef der Bayer-Pharmasparte, Wolfgang Plischke, am Donnerstag. Das Abkommen umfasse eine Entwicklungs- und Vermarktungsvereinbarung für das Medikament mit dem Namen Alfimeprase. Nuvelo erhalte eine Einmalzahlung von 50 Millionen Dollar sowie erfolgsabhängige sogenannte Meilensteinzahlungen von bis zu 385 Millionen Dollar. "Wir sind davon überzeugt, dass Alfimeprase das Potenzial hat, die Behandlung von Patienten mit thrombotischen Erkrankungen positiv zu beeinflussen," erklärte Plischke.

Die Leverkusener erhalten die weltweiten Vermarktungsrechte für das Medikament außerhalb der USA. Nuvelo bekommt dafür Lizenzgebühren von 15 bis 37,5 Prozent vom Umsatz. Das Abkommen sieht ferner vor, dass Bayer 40 Prozent der weltweiten Entwicklungskosten für das Phase-III-Mittel übernimmt. Für die klinische Entwicklung ist Nuvelo verantwortlich.



Diese Meldung verdeutlicht nicht nur das Potential von MCU´s präklinischen Antithrombosemittel MC-45308 sondern zeigt vor allen Dingen die Größenordnung von möglichen Partnerschaftdeals bezüglich der beiden Phase-III-Leadmedikamente MC-1 und MC4232.! Man bedenke Bayer bezahlt diese Summen nur für die Rechte ausserhalb der USA!!!

Nuvelo (NUVO) hat aktuell bei einem Kurs von 12,50 eine Marktkapitalisierung von 530 Mio US $. MCU nur von ca. 100 Mio US $!



Wenn ich die Pipelines beider Unternehmen vergleiche bin ich mir nicht sicher ob überhaupt ein Bewertungsunterschied gerechtfertigt ist!


Grüße cristrader

[cristrader]

Gute News!

January 5, 2006

MEDICURE ANNOUNCES EXPANSION OF ANTITHROMBOTIC PROGRAM

WINNIPEG, Manitoba­ (January 5, 2006)

WINNIPEG, Manitoba– (January 5, 2006) Medicure Inc. (TSX:MPH; Amex: MCU), a cardiovascular drug discovery and development company, is pleased to announce the expansion of its antithrombotic research collaboration with Jawed Fareed, PhD, Professor, Departments of Pathology and Pharmacology, Loyola University Stritch School of Medicine, Maywood, Ill. Medicure’s antithrombotic agents have demonstrated a unique dual antiplatelet/anticoagulant mechanism of action , indicating potential in the management of life-threatening and debilitating cardiovascular and cerebrovascular diseases such as myocardial infarction (MI), stroke, pulmonary emboli (PE) and peripheral arterial disease (PAD). The expanded collaboration with Dr. Fareed will involve a number of new preclinical studies, with the objective of advancing a lead clinical candidate into human studies.

“We have been very pleased with the preclinical results from our antithrombotic program,” commented Albert D. Friesen, PhD, Medicure’s President and CEO. “The safety to efficacy profile of Medicure’s antithrombotic agents, including our lead product MC-45308, has attracted significant international scientific attention, and warrants the expansion and acceleration of our antithrombotic program in association with Loyola.”

“MC-45308’s dual antiplatelet/anticoagulant mechanism of action is a breakthrough in thrombosis, and represents a new paradigm in the field of antithrombotic therapy,“ commented Dr. Fareed. “The unique mechanism of action of MC-45308 gives it potential for a wide variety of clinical indications, including the treatment of both cardiovascular and cerebrovascular disorders.”

About MC-45308

Medicure’s lead product in its antithrombotic program is MC-45308, a novel dual acting antithrombotic, with demonstrated preclinical antiplatelet and anticoagulant efficacy. MC-45308 is one of the only known agents that demonstrates this dual antithrombotic effect. Antithrombotics are drugs that prevent blood components (platelets and coagulation factors) from clotting and aggregating. The clotting and aggregation impede blood flow causing thrombosis, or the formation of blood clots within an artery or vein, and represent the leading cause of various acute vascular problems, including stroke, pulmonary embolism and heart attacks. Formation of the clot is driven by acceleration in blood coagulation and platelet activation coupled with a reduced fibrinolytic capability. In order to address this, high risk patients increasingly receive antiplatelet and/or anticoagulant therapy.

About Jawed Fareed, PhD

Jawed Fareed is Professor of Pathology and Pharmacology and Director of the Hemostasis and Thrombosis Research Laboratories at Loyola University Medical Center, Chicago, IL. Dr. Fareed`s main research interest is the development of novel anticoagulant and antithrombotic drugs. He is recognized for his role in the preclinical development and initiating the first clinical trials of low-molecular-weight heparin and antithrombin agents in acute coronary syndromes. In addition, he has authored and co-authored more than 400 publications in this area.

Dr. Fareed`s professional affiliations include membership on the expert panel on biologicals for the World Health Organization, and fellowships of the American Heart Association, the American College of Angiology, and the Indian College of Interventional Cardiology. He also is currently President of the South Asian Society of Atherosclerosis. Together with Professor Hans Klaus Breddin, Dr. Fareed founded the International Institute of Blood and Vascular Disorders, Frankfurt, Germany, of which he is currently the Associate Director.


Grüße cristrader

[cristrader]

Auszug aus Interview mit The Wallstreet Transcript!

Company Interview Excerpt
ALBERT FRIESEN - MEDICURE INC (MCU)
Full article published: 1/9/2006


TWST: What is Medicure?
Dr. Friesen: Medicure is focused on developing cardiovascular drugs for unmet medical needs. Our main product in development is known as MC-1, a novel cardioprotective drug focused on reducing damage to the heart after acute ischemic events, such as heart attacks, and ischemic reperfusion injury caused by cardiac interventions, like bypass surgery and angioplasty. A second product in development is MC-4232, a combination of MC-1 with an ACE inhibitor, to improve hypertensive and metabolic control in diabetic patients. So our focus is on cardiovascular drug development ` discovering novel therapeutics and then developing them through the various clinical stages and eventually developing relationships with pharmaceutical companies to market them.

TWST: Give us an idea of what the actual products or technologies are today. What does that pipeline look like?
Dr. Friesen: I`d describe three products. First, our cardioprotective drug MC-1 ` it`s a naturally occurring small molecule, that protects heart muscle cells during ischemic events. We recently announced positive results in our large Phase II MEND-CABG study, demonstrating that MC-1 reduced the combined incidence of death, heart attacks and stroke in high-risk patients undergoing coronary artery bypass graft (CABG) surgery. Previous to this study, we had completed an earlier Phase II study also showing MC-1 to be cardioprotective in patients undergoing angioplasty. The second product, as I mentioned, is MC-4232, and it is used to treat diabetics with hypertension. We`ve shown in Phase II studies that not only is MC-4232 antihypertensive, but it also reduces fasting serum glucose and hemoglobin A1C, which is a measure of diabetes control, as well as reducing triglycerides. Our third product, MC-45308, is in preclinical development. MC-45308 is a unique dual acting antithrombotic, which inhibits both thrombin as well as plated aggregation. So both MC-1 and MC-4232 have demonstrated positive Phase II results and are now transitioning to Phase III, and our antithrombotic product MC-45308 will hopefully be transitioning to Phase I in the near future.


Grüße cristrader

[cristrader]

Hallo!

Medicure Announces Financial Results for Fiscal Second Quarter 2006

WINNIPEG, MANITOBA, Jan 10, 2006 (CCNMatthews via COMTEX) -- Medicure Inc. (TSX:MPH)(AMEX: MCU), a cardiovascular drug discovery and development company, today reported the results of operations for the three and six month periods ended November 30, 2005. All amounts referenced herein are in Canadian dollars unless otherwise noted.
As at November 30, 2005, the Company had cash and cash equivalents totaling $3,586,000 compared with $7,591,000 at the previous year-end. Subsequent to November 30, 2005, the Company strengthened its cash position by raising gross proceeds of $12,013,000 (before share issuance costs of approximately $1,096,000) with a syndicate of underwriters led by Blackmont Capital Inc. and including National Bank Financial Inc. A total of 7,750,000 common shares of Medicure were issued at $1.55 per share. The financing increased the Company`s cash and cash equivalents to $13,756,000 at January 4, 2006.

Research and development expenditures for the second quarter of fiscal 2006 were $3,010,000 as compared to $3,068,000 for the same quarter in fiscal 2005. The year-to-date research and development expenditures are $6,307,000 compared to $5,272,000 for the six month period ended November 30, 2004. The increase in expenditures for the six month period ended November 30, 2005, as compared to the same period in fiscal 2005, is due mainly to the clinical development costs of the Phase II Coronary Artery Bypass Graft (CABG) trial, MEND-CABG.

The MEND-CABG study is a placebo controlled, double-blinded study that evaluated the cardioprotective and neuroprotective properties of the Company`s drug, MC-1. The trial enrolled 901 patients at 42 cardiac centres in Canada and the US and is managed by Montreal Heart Institute and Duke Clinical Research Institute (DCRI). Subsequent to the end of the quarter, Medicure announced positive post operative day (POD) 30 results from MEND-CABG, demonstrating MC-1`s cardioprotective efficacy versus placebo. Patients were also followed up to POD 90, which was 60 days after their last drug treatment. The results of this follow up are expected in the second half of fiscal 2006. For the three and six month periods ended November 30, 2005, total expenditures for the MEND-CABG trial were $1,792,000 and $4,230,000 respectively, as compared to $1,868,000 and $3,226,000 for the three and six months ended November 30, 2004.

The increase in research and development expenditures was also due to the clinical development program of MC-4232, a combination of MC-1 and the ACE inhibitor, lisinopril. As part of the Phase II clinical development of MC-4232, the Company recently completed and announced positive results from the Phase II MATCHED study in patients with coexisting diabetes and hypertension. The study demonstrated the positive clinical effects of MC-4232 on certain primary and secondary blood pressure and metabolic endpoints, including fasting serum glucose, HbA1c and triglycerides. For the three and six months ended November 30, 2005, total expenditures for the MATCHED study were $208,000 and $462,000 respectively, as compared to $480,000 and $703,000, for the three and six month periods ended November 30, 2004.

Research and development expenses are expected to decrease in the remainder of fiscal 2006 as compared to fiscal 2005. This decrease in expenditures is expected to result from reduced clinical activity during fiscal 2006 as compared to fiscal 2005, as the MATCHED study is complete and MEND-CABG will be complete following the reporting of POD 90 results. The Company expects a significant decline in clinical expenditures until the initiation of Phase III studies.

"During the second quarter of fiscal 2006 and in the days that followed, Medicure achieved two of the most significant milestones in our Company`s history with the announcement of positive results from the Phase II MEND-CABG and MATCHED studies," commented Medicure`s President and CEO, Albert D. Friesen, PhD. "Based on the positive clinical results in both studies, we now have two drugs, MC-1 and MC-4232, with significant market potential, advancing into Phase III studies. Our focus for the remainder of the fiscal year now turns towards planning the Phase III studies and advancing ongoing partnering negotiations."

Interest and other income for the second quarter of fiscal 2006 were $35,000 as compared to $97,000 for the same quarter in fiscal 2005. The year-to-date interest and other income is $72,000 compared to $203,000 for the six month period ended November 30, 2004. The decrease in interest and other income for the current quarter and the six month period as compared to the same periods in fiscal 2005 is the result of lower cash and cash equivalents balance as compared to the same periods in fiscal 2005. The Company anticipates that investment income will continue to fluctuate in relation to cash and short term investment balances and interest yields.

General and administrative expenditures for the second quarter of fiscal 2006 totaled $636,000, compared to $569,000 for the same quarter in fiscal 2005. The year-to-date general and administrative expenditures are $1,173,000 compared to $1,074,000 for the six month period ended November 30, 2004. The overall increase in costs is primarily driven by an increase in business development costs and stock-based compensation expense. The Company expects slightly higher levels of general and administrative activities for the remainder of the fiscal year ending May 31, 2006 as compared to the same period in fiscal 2005.

The financial results for the three-month period ended November 30, 2005 reflect a consolidated net loss from operations of $3,538,000 or $0.05 per share, compared to $3,627,000 or $0.05 per share for the three-month period ended November 30, 2004. The year-to-date net loss from operations was $7,410,000 or $0.11 per share, compared to $6,242,000 or $0.09 per share, for the six month period ended November 30, 2004. As discussed above, the consolidated net loss resulted mainly from the Company`s investment in the clinical development programs of MC-1 and MC-4232.

An expanded version of Management`s Discussion and Analysis and the financial statements for the three and six month period ended November 30, 2005 is accessible on Medicure`s website at www.medicure.com.

Corporate Highlights for the Quarter

The following are significant events which occurred since the last quarterly report:

- The Company announced positive results from the Phase II MEND-CABG study. The study results showed that MC-1 had a statistically significant reduction in the composite of death, non-fatal myocardial infarctions (peak CK-MB greater than or equal to 100ng/ml), and non-fatal strokes versus placebo in patients undergoing coronary artery bypass graft surgery.

- The Company announced positive results from the Phase II MATCHED study with MC-4232. In the study, MC-4232 met certain primary blood pressure and metabolic endpoints.

- The Company announced that MC-1 received FDA Fast Track designation as a treatment to reduce cardiovascular and cerebrovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions, coronary artery bypass graft surgery and acute coronary syndrome.

- The Company announced the appointment of Peter Quick, former President and CEO of Quick & Reilly, Inc., to its Board of Directors. Quick & Reilly, Inc. was one of the first and largest discount brokerage firms in the United States, before being acquired by Bank of America. Mr. Quick was most recently President of the American Stock Exchange (Amex) from July 2000 through to April 2005.

- The Company announced that A. Michael Lincoff, MD, of the Cleveland Clinic has joined its Scientific Advisory Board (SAB). Dr. Lincoff is an interventional cardiologist in the Cleveland Clinic Department of Cardiovascular Medicine and a staff cardiologist in the Joseph J. Jacobs Center for Thrombosis and Vascular Biology, Department of Molecular Cardiology at the Cleveland Clinic Research Institute

- The Company successfully closed a bought deal financing with a syndicate of underwriters led by Blackmont Capital Inc. and including National Bank Financial Inc., issuing 7,750,000 common shares of Medicure at $1.55 per share for gross proceeds of $12,013,000.

About Medicure Inc.

Medicure Inc. is a cardiovascular drug discovery and development Company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The Company`s solid position in this field is supported by the following attributes:

Cardiovascular focused pipeline: a global market of over US $70 billion

- Two drugs - MC-1 & MC-4232 - in advanced clinical development

- FDA Fast Track designation for MC-1

- Four positive Phase II trials completed

- Unique products addressing major, inadequately served markets

- Dual action antithrombotic, MC-45308, with positive preclinical results

Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.



Genauere Infos hier:
http://www.medicure.com/pdfs/quarter_Nov_2005.pdf


Grüße cristrader

[cristrader]

Hallo!

Neues Börsenspiel von Kanadas grösster Tageszeitung Globe and Mail "My One and Only stock-picking contest."

http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/L…


Our house player this year, Kim Parlee, co-host of Stars & Dogs on Report on Business Television, has chosen Winnipeg-based Medicure Inc. (MPH-TSX).

The reason: "Fabulous pharma," Ms. Parlee says. "It`s a bit of a flyer, but with a number of big blockbuster drugs coming off patent next year, the big pharma`s are looking for ways to boost their prospects. Medicure`s heart drugs may be on their radar. Plus Medicure has raised some money, has a successful Phase 2 study of its heart drug MC-1, and is expecting more study results in the first quarter." The stock opened the year at $1.56.


Grüße cristrader

[cristrader]

Chartanalysen:





Grüße cristrader

[cristrader]

Hallo!

MEDICURE TO PRESENT AT BIO CEO & INVESTOR CONFERENCE

WINNIPEG, Manitoba­ (February 9, 2006)

WINNIPEG, Manitoba– (February 9, 2006) Medicure Inc. (TSX:MPH; Amex: MCU), a cardiovascular drug discovery and development company, today announced that it will be presenting at the upcoming BIO CEO & Investor Conference. BIO CEO will be held on February 14 th & 15 th, 2006 at the Waldorf Astoria Hotel in New York City.

Medicure’s President & CEO, Albert D. Friesen PhD, has been invited to participate and present in a Diabetes Focus Session panel titled “ New Hope for Diabetes Patients”. The Focus Session will be held Tuesday, February 14, 2006 at 4:00PM Eastern in the East Foyer room. The panel, consisting of leading biotechnology and pharmaceutical executives, will discuss clinical and therapeutic developments in the area of diabetes. Dr. Friesen will focus on Medicure’s novel combination product MC-4232 and its role in treating the multiple risk factors in patients with diabetes.

Dr. Friesen will also be delivering a corporate presentation on Wednesday, February 15, 2006 at 3:30PM Eastern in the Park Avenue Suite Center/North room. The presentation will be webcast live and archived on the Medicure website at www.medicure.com.

The 8th Annual BIO CEO & Investor Conference will provide a forum where senior biotechnology executives, institutional investors, industry analysts, venture capitalists, investment bankers and other industry experts will have the opportunity to shape the future investment landscape of the biotechnology industry. Hosted by the Biotechnology Industry Organization (BIO), the largest industry organization focused exclusively on biotechnology, the BIO CEO & Investor Conference will feature issue-oriented plenary sessions, educational sessions focused on hot technologies, therapeutics and key business issues, company presentations, one-on-one meetings, and networking opportunities.

About Medicure Inc.

Medicure Inc. is a cardiovascular drug discovery and development Company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The Company`s solid position in this field is supported by the following attributes:

Cardiovascular focused pipeline: a global market of over US $70 billion
Two drugs - MC-1 & MC-4232 - advancing to Phase III development
Four positive Phase II trials completed
FDA Fast Track designation for MC-1
Unique products addressing major, inadequately served markets
Dual action antithrombotic, MC-45308, with positive preclinical results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule, anti-ischemics, and antithrombotics towards human clinical studies.



Grüße cristrader

[cristrader]

Hallo!

Auf der Bio Ceo & Investor Konferenz gab es wenig Neues.

Hier die wichtigsten Aussagen aus der Präsentation Stockhouse Message Board)

Also, many confirmations:

1) MC1 partnering , should cost 35+ million $ but probably partner will pay large portion of it. MC4232 will cost much less, i.e. 15 million $ approx.

2) MC4232 : go at it alone (that`s what I was told all along and makes sense since how do you share proprietary info on MC1 which is used in both products, between two different companies!)

3) POD90 released in April

4) MC45308 - very good results so far from Dr. ... who did various tests so far. Dual action and very good demand for that product

5) phase III`s will all start this year, and MC4232 soon (IMHO) while MC1 anywhere from June-Dec. They will have partner before starting p3 on MC1.

6) 250 mg is the exact dosage. Confirm

7) market cap still way too low....liked his joke about "then again, all CEO`s say this , but I must say it, we are too low...." hint hint

8) excellent strenght and no unknows. All Scamshank garbage about doing all on their own is garbage. This was clear and NOW I don`t have to call every month to get an update. As long as they follow this route, we are going to fly believe me. I`m IN and will add tomorrow. My housing shorts are good but not as MPH.


Overall, now I think I know what will happen. It`s too obvious. They will announce POD90 in April, but also partnership in March-April probably slightly before IMO. Then we will be in the 3$+ range approx.

Then you might see a share issuance, but not that dilutive, they only need about 5 million shares at 3$. Should not affect share price.

Then, they have multiple products MC45308 + MC4232 + MC1 + other combination product derived from MC1 + phase III results which should be excellent (from the doc himself!).

Conclusion, when compared to ALXN, with a 1.2 billion US $ market cap...... and us at 100 million US $ market cap, you do the maths.

We should go up substantially and even when deal announced, I will probably not sell since it will pull back but then more institutions will want to join the party due to many uncertainties removed, the partnership and cash aspect being the largest ones.



Grüße cristrader

[solarblase]

Wirklich Interessanter Wert. Mal schauen ob man ein paar Stücke bekommt. Der Handel in Deutschland ist ja wirklich sehr gering. Aber kann sich ja schnell ändern

[cristrader]

@solarblase

Das Risiko ist seit den super Phase II-Ergebnissen völlig raus aus dem Wert. Jetzt gilt es nur auf die Verkündung der Partnerschaft zu warten! Wie die Kursreaktion dann ausfällt hängt natürlich von den Konditionen des Deal ab.

Medicure ist hier noch ziemlich unbekannt. An der AMEX lässt sich der Wert mittlerweile recht gut handeln. Die deutschen Regionalbörsen passen ihre Bid/Ask-Spannen recht genau der Amex an, so das du keine Probleme haben wirst!
Ich denke das der Wert die nächsten Wochen noch seitwärts läuft und noch genügend Zeit zum Einstieg besteht!


Grüße cristrader

[cristrader]

Das passt ja wie die Faust aufs Auge!

UPDATE 1-Reuters Summit-Myogen CEO targets deal this year
Myogen says PAH drug trial shows promise
BOSTON, Feb 23 (Reuters) - Myogen Inc. (MYOG.O: Quote, Profile, Research) aims to acquire either a product or a company within its specialty of cardiovascular disease by the end of the year, its chief executive said on Thursday.

"We have a goal to try and get something done this year," Bill Freytag told the Reuters Biotechnology Summit in Boston.

"Let`s make sure we`re not suggesting that it necessarily has to be a company. It could be a product, a clinical-stage or even a commercial product."

Freytag said Myogen was interested in buying experimental drugs in late Phase 2 or Phase 3 development, which is generally considered late stage.

"The most likely candidate ... would be a small biotech company with one product that is undercapitalized and is looking for help," Freytag said. "The likelihood of finding something that meets our needs is probably richer there."

Myogen is currently developing a drug for hypertension in patients who have failed to reach their blood pressure goal on three or more medicines, and one for a serious condition in which blood pressure in the arteries near the lungs rises to dangerous levels.

Freytag said Myogen would be interested in acquiring medicines that address conditions such as heart failure and acute cardiovascular disease.

He said the company would probably not chase a first-line hypertension treatment, which requires a massive sales force to compete with large pharmaceutical companies such as Pfizer Inc.(PFE.N: Quote, Profile, Research) or Novartis AG (NOVN.VX: Quote, Profile, Research).

"We are a company that has an expertise in cardiovascular disease," Freytag said. "We`ll probably stay in cardiovascular. It`s a huge space."

Grüße cristrader

[cristrader]

[KnigRollo]

was lachst du ? gibt es zum anstieg auch ne meldung

und deine ym läuft ja ebenfalls gut.. respekt...:-)


was ist deiner meinung nach, das aussichtsreichste medikament bei der ym versus medicure.. wo lauern deiner meinng nach mehr chancen versus risiko.. ??

grüße Rollo

[cristrader]

@knigrollo

Warum ich lache? Ich warte seit Wochen auf den charttechnischen Ausbruch. Ausserdem erlebt mein Depot heute zumindest vom Wert her den grössten Sprung meiner Börsenlaufbahn!

Da bei Medicure in den nächsten Monaten keine wirklich relevanten Testergebnisse anstehen ist das Risiko minimal. Beide Leadmedikamente MC-1 und MC4232 haben Blockbuster Potential. Im Moment ist Warten auf die Verkündung der Partnerschaft angesagt. Am Tag der Verkündung erwarte ich mindestens eine Kursverdopplung. Partnerschaftsdeals vergleichbarer Medikamente übersteigen die Marktkapitalisierung MCU´s bei weitem!

Bei YMI erwarte ich "vor" den Tesmilifene Phase III-Ergebnissen im Juni/Juli`06 ein Antesten der 10US $-Marke. Von den Ergebnissen hängt der Kursverlauf natürlich entscheidend ab. Das YMI mit Nimotuzumab und Aerolef zwei weitere Late-Stage-Medikamente besitzt reduziert natürlich das Risiko. YMI wird in ca. 1 Monat auf der AACR-Konferenz genaue Daten zum Wirkmechanismus von Tesmilifene bekanntgeben. Im Prinzip bei allen Krebsmedikamenten und Krebsbehandlungen lässt der Behandlungserfolg nach Anfangserfolgen durch zunehmende Resistenz von Zellen ab. Das bisher vermutete Mode of Action von Tesmilifene geht davon aus das Tesmilifene seine Wirkung vor allen Dingen gegen die resistenten Zellen(multi-drug resistant (MDR+) ) ausspielt. Es gibt bisher kein Medikament auf dem Markt das speziell diese resistenten Zellen angreift. Bei positiven Studienergebnissen und Bestätigung dieses Wirkprinzips ist das Potential gigantisch!


Grüße cristrader

[cristrader]

Hallo!

Sehr überzeugendes Interview von Präsident und CEO Friesen auf ROBTV!

http://www.robtv.com/shows/past_archive.tv?day=wed

Besoners die Einschätzung der Marktkapitalisierung nach Phase III-Start gefällt mir!

Phase II-Biotechs: ca. 150 Mio
-->Phase III-Biotechs : 750 Mio - 2 Mrd. $!

Grüße cristrader!

[cristrader]

Hallo!

Das Kurzinterview im RobTV hat ein riesiges Kaufvolumen an TSX und Amex ausgelöst. Der als eher konservativ bekannte CEO Friesen hat mit seiner Prognose 750 Mio bis 2 Mrd $ Marktkapitalisierung nach Beginn der beiden Phase III-Studien in 2006, d.h. immerhin eine verfünf- bis verzehnfachung der aktuellen Bewertung, vielleicht den Stein ins Rollen gebracht!

Mich wundert das geringe Interesse an Medicure hier im Board. Medicure wird in wenigen Monaten zwei Phase III-Medikamente in der Pipeline haben und steht kurz vor einer großen Partnerschaft. Der CEO Friesen hat bestätigt sich in Verhandlungen mit mehreren der Top Ten Big Pharmas zu befinden. Die Größenordnung des bevorstehenden Deals lässt sich kaum einschätzen da das Marktpotential sowohl bei MC-1 als auch bei MC-4232 riesig sind. Der CEO gibt an das MC-1 bei bis zu 3 Mio. Patienten im Jahr und MC-4232 bei bis zu 15 Mio. Patienten Anwendung finden kann. Je mehr ich mich mit dieser Story befasse desto überzeugter werde ich.

Nur um nochmal zu verdeutlichen um was es sich bei MC-1 handelt. MC-1 ist ein natürlich vorkommender Metabolit von Vitamin B6, eines von drei Molekülen das im Zusammenspiel von Vitamin B6 und Enzymen im Körper entsteht. MC-1 ist also im Prinzip die konzentrierte Form der "herzschonenden" Wirkung von Vitamin B6, welches selbst in hohen Dosen keine (kaum) Nebenwirkungen ausweist.


Das Potential von MCU ist bei den riesigen Märkten gigantisch nur wo ist das Risiko? Die nächsten wirklich relevanten Testergebnisse sind erst mit Abschluss der beiden Phase III-Studien in 2008 zu erwarten. Das kein Partner für die Phase III gefunden wird? Diese abgeschlossen Phase II-Ergebnisse machen dies mehr als unwahrscheinlich.

Mit anderen Worten: Eine absolute Traumaktie!


Ich neige mitunter dazu meine Investments zu sehr mit rosaroter Brille zu sehen. Übersehe ich etwas? Welche Risiken sehr ihr bzw. was hindert euch an einem Investment in Medicure?



Grüße cristrader

[cristrader]

Hier noch eine super Chartanalyse!

http://stockcharts.com/def/servlet/Favorites.CServlet?obj=ID…


Grüße cristrader

[toothstone]

@ chris:
danke für den schönen thread!
Bin seit freitag dabei, ymi gefällt mir auch prächtig und bei hbx konnten wir ja sehen, welches potential möglich ist.

[cristrader]

@toothstone

Danke, schön das du dabei bist!

Zurzeit läuft es mit meinen Werten YMI und MCU fast zu gut um wahr zu sein!

YMI hat heute auf neuem Alltimehigh auf Schlußkursbasis und MCU auf neuem 52 Wochenhoch geschlossen!

Bei beiden Werten sehe ich noch enormes Potential, wobei ich das Risiko bei YMI deutlich höher als bei MCU einschätze. Bei YMI ist in den nächsten Wochen und Monaten ein Newsfeuerwerk überfällig! Ich bin mir sicher wir werden noch vor Verkündung der Tesmilifene Phase III-Daten (Juni-August) die 10 $ antesten. Besonders der R&D-Tag am 5.April mit einer Präsentation von Nimotuzumab wird riesige Aufmerksamkeit auf sich ziehen. Dr. Leornard Saltz
vom Memorial Sloan-Kettering Cancer Center, New York einer der bekanntesten Krebswissenschaftler der USA und insbesondere bekannt durch die Durchführung der Erbitux-Studien wird als Hauptredner agieren. Welche Aufmerksamkeit wird es bringen wenn einer der maßgeblichen Entwickler von Erbitux ausgerechnet den Konkurrenten Nimotuzumab heraushebt! Nichts desto trotz ab Juni stehen die Tesmilifene Phase III-Daten an mit dem entsprechenden Risiko.

Bei Medicure entfällt auf absehbare Zeit das Risiko eines typischen Biotechs. Es gilt vorerst im Prinzip zu warten bis eine Partnerschaft mit einem der Top-Ten Big Pharma unter Dach und Fach ist oder vorher zu einem Schnäppchenpreis übernommen wird!
Beides wird sich positiv auf den Kurs auswirken!

Medicure ist bisher noch völlig unbekannt. Es gibt bisher nicht einen vernünftigen Researchreport zu kaufen. Wenn MCU erst mal in den Focus der Instis gerät wie es zurzeit mit YMI geschieht sind Kurse zwischen 5-10 $ nur eine Frage der Zeit!

Grüße cristrader

[cristrader]

Gut für Medicure!

Alexion Updates Previously Announced Phase III Results for PRIMO-CABG2 Study
Monday March 13, 3:00 pm ET
- Results Presented at American College of Cardiology -


CHESHIRE, Conn., March 13 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN - News) today updated results from its Phase III PRIMO-CABG2 clinical trial with pexelizumab at the American College of Cardiology. As previously announced on November 25, 2005, the results show that the drug reduced the primary endpoint, but did not meet the pre-specified threshold for statistical significance. The PRIMO-CABG2 trial enrolled moderate-to-high risk coronary artery bypass graft (CABG) surgery patients and was sponsored jointly by Alexion and Procter and Gamble Pharmaceuticals.
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Peter K. Smith M.D., Professor and Chief of Thoracic Surgery, Duke University Medical Center presented the updated results. Pexelizumab reduced the primary endpoint of the combined incidence of death or nonfatal myocardial infarction (heart attack) through postoperative day 30 (POD 30) following CABG surgery (placebo=16.3% vs. pexelizumab=15.2%, 7% relative reduction, p=0.20). Mortality through POD 30 was reduced from 4.6% in the placebo group to 3.8% (17% relative reduction) in the pexelizumab group (p=0.18). Myocardial infarction through POD 30 was reduced modestly with pexelizumab (placebo=13.3% vs. pexelizumab=12.6%, 5% relative reduction, p=0.31). Additionally, pexelizumab appeared to be well tolerated with an adverse event profile comparable to placebo.

In addition to the results from PRIMO-CABG2, Dr. Smith presented the updated results of a pooled mortality analysis that was performed across five placebo controlled trials conducted with pexelizumab in patients undergoing either CABG surgery or in patients experiencing an acute myocardial infarction treated with either thrombolytic therapy or percutaneous intervention (PCI). These analyses showed that in the 9,233 patient ITT cohort, pexelizumab significantly reduced mortality through 30 days (placebo=4.3% vs pexelizumab=3.3%, relative reduction=24%, p=0.009).

Pexelizumab, a terminal complement inhibitor, is a monoclonal antibody fragment that inhibits complement-mediated tissue damage. The Phase III trial titled Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery 2 (PRIMO-CABG2), included 4,254 patients and was conducted at 249 U.S. and international study sites.

"The PRIMO-CABG2 study did not replicate the significant reduction in myocardial infarction that was observed previously in PRIMO-CABG1 and therefore did not achieve statistical significance for the co-primary endpoint of death or myocardial infarction through POD 30," said Dr. Smith. "However, we continue to be encouraged by the consistent mortality benefit observed in the overall PRIMO-CABG program that appears to extend across all acute cardiovascular trials performed with pexelizumab to date."

"As originally announced in November 2005, we are disappointed that pexelizumab did not achieve the primary efficacy endpoint in PRIMO-CABG2 of reducing death or heart attack," said Dr. Scott A. Rollins, Senior Vice President of Drug Development at Alexion. "However, pexelizumab continues to be associated with a reduction in overall mortality across cardiac indications, as compared to placebo. We currently await the completion and subsequent analysis of the ongoing APEX-AMI trial that we expect to conclude enrollment in the near future. We expect that the results of the APEX trial will assist in determining the future of pexelizumab therapy in acute cardiovascular disease."

As announced in late January, the APEX-AMI trial has enrolled over 5,000 patients at more than 300 U.S. and international study sites. Enrollment in the APEX-AMI trial is continuing.


Grüße cristrader

[toothstone]

Guten Morgen Cris,
danke weiterhin für die infos,
die letzte handelsstunde war ja sehr positiv.
ymi ist übrigens im aktionär mit kursziel 35$.
meine größte position ist ugne, hier kommt in den nächsten tagen das 10k und das 10q, im letzten quartal hatten sie einen gewinn von 10c zwecks milestones, im 4. quartal wird spekuliert, wie hoch dieser allein durch das seit august sich im handel befindliche medikament fortical (salmom calcitonin) sein wird. falls nicht viel passieren wird, werde ich sicher noch umschichten in beide werte, hoffentlich sind sie nicht schon zu weit weg gelaufen. ist halt auch mal wieder ein problem, der steuerfreiheit, die wäre bei mir im juli.
ugne hat auch einige andere hormonpräparate, pth, sollte auch bald phase3 mit milestones kommen und börsenwechsel.
nachdem ich bei hana leider zu früh raus bin, verliere ich lieber ein paar prozent bei ymi und mcu, aber gehe sicher dann sehr, sehr long.

[cristrader]

Hallo toothstone!

Ugne (Unigene) war mir bisher völlig unbekannt. Sieht auf dem ersten Blick recht vielversprechend aus! Die Spekufrist würde ich auf jeden Fall abwarten. Meine YMI laufen auch erst Anfang/Mitte Juni aus der Spekufrist, bis dahin ist ein Verkauf ausgeschlossen.

YMI Kursziel 35 €?
Bei Tesmilifene-Zulassung absolut realistisch, allerdings ist das Risiko nicht so gering wie es die erste Phase III-Studie erwarten lässt. Vielleicht ist es die bessere Strategie kurz vor den entscheidenen News auszusteigen und bei Erfolg zu dann höheren Kursen wieder einzusteigen.


Medicure läuft heute auch wieder super! Nur im Vergleich zu YMI befindet sich MCU noch tief in der Versenkung. Wenn MCU erst ab Kursen oberhalb 3-4$ entdeckt wird kann ich aber auch gut damit leben!

Medicure nimmt aktuell an dieser Konferenz teil:
American College of Cardiology Annual Scientific Session, Atlanta 11-14.03.06

Vielleicht kommen heute noch einige Infos!


Grüße cristrader

[toothstone]

Morgen Cristrader,

die 2$- Marke war wohl doch noch ein kleiner Widerstand, oft ja auch psychologisch.
Ich kann gut damit leben, 2-3mal abzuprallen.
Ymi läuft ja riesig.
Ugne bringt am Freitag die zahlen mit einem CC, das stimmt mich sehr positiv, vielleicht kommt es zum Amexwechsel, vor allem der Ausblick ist wichtig, fortical hat nach 6 Monaten einen Marktanteil von über 20% und die Konkurrenz strauchelt.
Auf einen angenehmen Börsen-und Arbeitstag!

[cristrader]

Hallo!

Hier ein sehr informativer Artikel vom September´05 im Vorfeld der Phase II-Ergebnisse von MC-4232 und MC-1.

http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/L…

BIOTECHNOLOGY

Medicure future hangs on key drug`s lab results
Positive outcome would pave way for partnership
LEONARD ZEHR

BIOTECHNOLOGY REPORTER

There will be howls of joy or buckets of tears coming out of drug developer Medicure Inc. over the next few weeks.

The Winnipeg-based company has completed two mid-stage clinical trials with its MC-1 flagship drug and is set to release those results by mid-September and late October. And without enough money in the bank to continue large-scale testing on its own, the company needs a positive outcome to pave the way for a corporate partnership with a drug company to finish development.

Success here could target cardiovascular markets in the billions of dollars, either with MC-1 on its own or in combination with other heart drugs. So far, the company has invested $25-million in developing the drug.

"I`m not superstitious but we`ve been very fortunate developing MC-1 so far," said Medicure president and chief executive officer Albert Friesen, who is known as the founding father of biotechnology in Manitoba.

Medicure and MC-1 trace their roots to a business lunch in Winnipeg nine years ago. As a trained chemist and CEO of Novopharm Biotech Inc. at the time, Mr. Friesen recalls how impressed he was with University of Manitoba professor Naranjan Dhalla`s drug discovery.

"What hit me was the beauty of the molecule, how safe it is and the huge opportunity in cardiovascular disease," he recalls. Mr. Dhalla is now chief scientific officer of Medicure.

Mr. Friesen`s claim to fame, however, precedes founding Novopharm, which is now Viventia Biotech Inc. In 1969, he was the first employee of the Winnipeg Rh Institute, which pioneered development of the WinRho drug to protect newborns from anemia, heart failure and brain damage associated with Rh disease.

The drug was approved by Health Canada in 1980. WinRho is also used to treat a clotting disorder known as ITP.

Mr. Friesen also began WinRho`s approval process with the U.S. Food and Drug Administration until the institute was acquired in a hostile takeover by Toronto-based Apotex Inc. and became Cangene Inc.

"MC-1 was a chance to take an idea all the way to the marketplace again," he said.

MC-1 is what`s called a metabolite of vitamin B6, one of three chemical compounds left over from reactions between the vitamin and enzymes in the body. The metabolite binds naturally with the protein albumin, circulates in the blood and is slowly released in the heart and other organs.

What impresses analysts about MC-1 is that it is a new drug class, with the potential to reduce damage to heart tissue.

"Our belief is that Medicure may be able to build a business solely on using MC-1 in combination with other therapies," National Bank Financial analyst André Uddin said in a recent research report.

After posting positive results in an earlier mid-stage study with patients undergoing an angioplasty procedure, Medicure combined MC-1 with an angiotensin-converting enzyme (ACE) inhibitor, which is used to treat high blood pressure. The combined therapy, known as MC-4232, was then used to test 120 diabetic patients with hypertension to see if it would reduce blood pressure, triglycerides and blood glucose levels. Those study results are set to be released in the next few weeks.

Medicure has at least three other combination drugs in early research for heart disease.

In late October, the company will learn how MC-1 performed on its own with 900 patients undergoing coronary bypass surgery. The Phase II study is not designed to show statistical significance, which could make investors skittish, but rather a trend toward reducing heart attacks and strokes in the first 30 days after surgery.

"If we can show a reduction of 15 to 25 per cent in clinical events, it would be a home run," Mr. Friesen said. "If we succeed, I believe we have a high probability to repeat in a pivotal Phase III study."

(Wie ja jetzt bekannt war die "reduction of clinical events 46,9%!!! )


He said Medicure is in "active discussions" to team up with a large drug company specializing in cardiovascular disease and mid-sized specialty drug companies to take MC-1 into late-stage clinical testing, which could require several thousand patients.

"When I started Medicure, I thought it would take 10 to 13 years to develop MC-1 and we`re still on schedule."



Grüße cristrader

[toothstone]

Hi,
die klein Verschnaufpause stört mich gar nicht, ist wohl gesund. Wann hat Friesen mit Mc-1 begonnen? Schöne Woche allen Investierten!

[toothstone]

Morgen cris,

hast gestern und vorgestern die 2 dicken blöcke nachbörslich gesehen, kann wohl nicht schlecht sein, war wohl so eine art gapschluß, daytrader wieder raus, heute geht es sicher wieder aufwärts. aber es zählt ja eh bloß das stay long.

[cristrader]

Hallo toothstone,

der Kursverlauf ist momentan traumhaft! Jede Konsolidierung ist nach kürzester Zeit bereits vorbei!

Es ist klar das die Daytrader den Kurs machen. Nur deren Problem ist das die Longs vor dem Partnerschaftsdeal nicht nur keine Stücke rausrücken sondern jede Korrektur zur weiteren Aufstockung nutzen. Die Folge davon ist: ein Hoch jagd das nächste!


Grüße cristrader

[toothstone]

Hört sich nicht schlecht an, nachdem wir ein bißchen rauf- und runter geshaked wurden.
http://www.quote.com/qc/news/story.aspx?symbols=AMEX:MCU&sto…

Positive studienergebnisse lassen hoffen.

[cristrader]

Medicure Reports Positive POD 90 Results From The MEND-CABG Study
Thursday April 6, 8:55 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Apr 6, 2006 -- MC-1 TREATMENT EFFECT MAINTAINED AT 90 DAYS POST OPERATIVELY
Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company is pleased to report positive post operative day (POD) 90 results with its lead cardioprotective product, MC-1, from the Phase II MEND-CABG study. The MEND-CABG study was a double blind, parallel group, randomized, placebo-controlled study in 902 patients who underwent coronary artery bypass graft (CABG) surgery.

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The primary endpoint of MEND-CABG was the reduction in the composite of cardiovascular death, non-fatal myocardial infarction (heart attack), and non-fatal stroke up to POD 30. Positive POD 30 results were announced in December 2005. In addition to the POD 30 analysis, the study protocol included following study patients for 90 days post operatively (POD 90) for further safety and efficacy analysis.

The MEND-CABG Study Results:

The MEND-CABG POD 90 results further demonstrated the positive clinical effects of MC-1:

- The clinical results reported at POD 30 with MC-1, as noted below, were maintained throughout the follow up period.

- The safety analysis demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups.

The MEND-CABG POD 30 results released in December 2005 demonstrated the positive clinical effects of MC-1:

- The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028).

- The reduction in the composite endpoint was driven by a substantial decrease in the incidence of non-fatal myocardial infarction, most notably a 46.9% reduction in non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg of MC-1 versus placebo (p equals 0.008).

- The 250 mg dose of MC-1 had a 14.0% reduction in the primary endpoint composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 50ng/ml), and non-fatal stroke versus placebo (p equals 0.312).

Medicure plans to present the detailed results from MEND-CABG, including the POD 90 analysis, at an upcoming scientific symposium.

"The maintenance of the clinical reductions at POD 90 further supports MC-1's ability to significantly reduce heart attacks in this high risk patient population and clearly warrant advancing MC-1 into pivotal Phase III development," commented Medicure's President and CEO, Albert D. Friesen, PhD. "These results suggest that MC-1 could represent a major therapeutic breakthrough in the treatment of acute ischemia and ischemic reperfusion injury. We will meet with the FDA to discuss these results and develop the Phase III program, which we anticipate commencing in the second half of 2006."

About the MEND-CABG Study

The MEND-CABG trial was designed to evaluate the cardioprotective and neuroprotective effects of MC-1 in high-risk coronary artery disease patients undergoing CABG surgery. The trial enrolled 902 patients at 42 investigational sites throughout Canada and the United States. The study was a double blind, parallel group, randomized, placebo-controlled study in patients who underwent coronary artery bypass graft (CABG) surgery. Study patients received placebo or MC-1 (250 mg or 750 mg) on the day of surgery and for 30 days post operatively (POD 30). The primary endpoint of MEND-CABG was a reduction in the composite of cardiovascular death, non-fatal myocardial infarction (heart attacks), and non-fatal stroke up to POD 30. Study patients were followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.

About MC-1

MC-1 is a naturally occurring small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have now been demonstrated in the Phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the Phase II MEND-CABG study in patients undergoing CABG surgery.

[cristrader]

Tolle News!


Medicure Reports on MEND-CABG End of Phase II Meeting With the FDA
Wednesday April 12, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Apr 12, 2006 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced that based on the positive Phase II MEND-CABG study and a recent End of Phase II meeting with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a single confirmatory Phase III study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft (CABG) surgery. MC-1 has received a Fast Track designation from the FDA.
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Based on the End of Phase II meeting, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction (primary definition peak CK-MB greater than or equal to 100ng/ml) at post operative day (POD) 30 as the primary endpoint for the Phase III study. Initiation of this study is targeted for the second half of calendar 2006.

"We are extremely pleased with the outcome of the End of Phase II meeting with the FDA. A single confirmatory study provides Medicure the most efficient and affordable path for MC-1's Phase III development, and is a valuable asset in our partnership negotiations," commented Medicure's President and CEO, Albert D. Friesen, PhD. "MC-1 has the opportunity to be the first product indicated to reduce cardiovascular events associated with ischemia and/or ischemic reperfusion injury in CABG patients, targeting a significant unmet medical need. We look forward to working with the FDA in expediting the development of MC-1."

MC-1 is a small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function. MC-1's cardioprotective properties have been demonstrated in the Phase II MEND-1 study in patients undergoing percutaneous coronary interventions and the Phase II MEND-CABG study in patients undergoing CABG surgery.

Grüße cristrader

[toothstone]

Hi chris,
nach dem auf und up, schöne konsolidierung sollte es jetzt doch aufwärts gehen. Jetzt noch eine Bekanntgabe eines vernünftigen Partners, dann booooosh.

[cristrader]

Medicure Announces Financial Results for Fiscal Third Quarter 2006
Thursday April 13, 4:30 pm ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Apr 13, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today reported the results of operations for the three and nine month periods ended February 28, 2006. All amounts referenced herein are in Canadian dollars unless otherwise noted.
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As at February 28, 2006, the Company had cash and cash equivalents totaling $12,171,000 compared with $7,591,000 at the previous year-end. During the quarter the Company strengthened its cash position by raising gross proceeds of $12,013,000 (before share issuance costs of approximately $1,155,000) with a syndicate of underwriters led by Blackmont Capital Inc. and including National Bank Financial Inc. A total of 7,750,000 common shares of Medicure were issued at $1.55 per share. The total number of common shares issued and outstanding at February 28, 2006 was 79,920,493.

Research and development expenditures for the third quarter of fiscal 2006 were $1,881,000 as compared to $3,918,000 for the same quarter in fiscal 2005. The year-to-date research and development expenditures are $8,188,000 compared to $9,190,000 for the nine month period ended February 28, 2005. As expected, research and development expenditures for the nine months ended February 28, 2006 were lower as compared to the same period in fiscal 2005 due to the decline in patient enrollment and clinical activities in the Phase II MEND-CABG trial with MC-1 and the Phase II MATCHED study with MC-4232.

"During the third quarter of fiscal 2006, Medicure reported positive Phase II results with our FDA Fast Tracked cardioprotective product, MC-1, in the MEND-CABG study," commented Medicure's President and CEO, Albert D. Friesen, PhD. "The positive MEND-CABG results positions Medicure as a leader in the development of acute cardioprotective therapeutics. We will build on our current clinical momentum as we make the important transition into Phase III clinical development."

The MEND-CABG study was a placebo controlled, double-blinded study that evaluated the cardioprotective and neuroprotective properties of the Company's lead product, MC-1. The trial enrolled 901 patients at 42 cardiac centres in Canada and the U.S. and is managed by Montreal Heart Institute and Duke Clinical Research Institute (DCRI). The Company reported positive top-line results up to post-operative day (POD) 30 in December 2005. Patients were also followed up to POD 90, which was 60 days after their last drug treatment. The treatment effect at POD 30 with MC-1 was maintained throughout the follow up period. The safety analysis from MEND-CABG also demonstrated MC-1 was safe and well tolerated. For the three and nine months ended February 28, 2006, total expenditures for the MC-1 MEND-CABG project were $789,000 and $5,586,000 respectively, as compared to $2,733,000 and $6,094,000 for both the three and nine months ended February 28, 2005. The Company plans on initiating a Phase III study in patients undergoing CABG surgery in the first half of fiscal 2007.

The MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) study evaluated MC-4232, a combination of MC-1 and the ACE inhibitor linisopril, in 120 patients with coexisting diabetes and hypertension. MATCHED was a randomized, parallel group, cross-over, double-blind, placebo-controlled comparison of 100, 300 or 1000 mg of MC-1 alone and in combination with 20 mg of lisinopril. The Company reported positive blood pressure and metabolic results from MATCHED in September 2005. For the three and nine months ended February 28, 2006, total expenditures for the MC-4232 MATCHED project were $491,000 and $947,000 respectively, as compared to $631,000 and $1,400,000 for the three and nine months ended February 28, 2005.

Research and development expenditures are expected to decrease for the remainder of fiscal 2006 as compared to fiscal 2005. This decrease in expenditures is expected to result from reduced clinical activity during fiscal 2006 as compared to fiscal 2005, as the MATCHED study is complete and MEND-CABG will be complete following the reporting of POD 90 results. The Company expects a significant decline in clinical expenditures until the initiation of Phase III studies. The Company plans on initiating one or more Phase III trials in the first half of fiscal 2007.

Interest and other income for the third quarter of fiscal 2006 were $61,000 as compared to $130,000 for the same quarter in fiscal 2005. The year-to-date interest and other income is $133,000 compared to $334,000 for the nine month period ended February 28, 2005. The decrease in interest and other income for the current quarter is the result of a lower cash and cash equivalents balance as compared to the same period of the prior fiscal year. The Company anticipates that investment income will continue to fluctuate in relation to cash, short term investment balances and interest yields.

General and administrative expenditures for the third quarter of fiscal 2006 totaled $861,000, compared to $555,000 for the same quarter in fiscal 2005. The year-to-date general and administrative expenditures are $2,035,000 compared to $1,629,000 for the nine month period ended February 28, 2005. The overall increase in costs for the three and nine month periods ended February 28, 2006 as compared to the same periods in fiscal 2005 were driven by an increase in business development costs and stock-based compensation expense. The Company expects slightly higher levels of general and administrative activities for the remainder of the fiscal year ending May 31, 2006 as compared to the same period in fiscal 2005.

The financial results for the three-month period ended February 28, 2006 reflect a consolidated net loss from operations of $2,718,000 or $0.04 per share, compared to $3,820,000 or $0.06 per share for the three-month period ended February 28, 2005. The year-to-date net loss from operations was $10,128,000 or $0.14 per share, compared to $10,062,000 or $0.15 per share, for the nine month period ended February 28, 2005. As discussed above, the consolidated net loss resulted mainly from the Company's investment in the clinical development programs of MC-1 and MC-4232.

An expanded version of Management's Discussion and Analysis and the financial statements for the three and nine month period ended February 28, 2006 is accessible on Medicure's website at www.medicure.com.

Corporate Highlights for the Quarter

The following are significant events which occurred during the third quarter of fiscal 2006:

- The Company announced positive results from the Phase II MEND-CABG study. Top-line POD 30 results showed that MC-1 had a statistically significant reduction in the composite of cardiovascular death, non-fatal myocardial infarctions (peak CK-MB greater than or equal to 100ng/ml), and non-fatal strokes versus placebo in patients undergoing coronary artery bypass graft surgery. Subsequent to the end of the quarter, the Company announced that MC-1's treatment effect at POD 30 was maintained throughout the follow up period up to POD 90. The safety analysis from MEND-CABG also demonstrated that MC-1 was safe and well tolerated.

- The Company successfully closed a bought deal financing with a syndicate of underwriters led by Blackmont Capital Inc. and including National Bank Financial Inc., issuing 7,750,000 common shares of Medicure at $1.55 per share for gross proceeds of $12,013,000.

- The Company announced that A. Michael Lincoff, MD, of the Cleveland Clinic has joined its Scientific Advisory Board (SAB). Dr. Lincoff is an interventional cardiologist in the Cleveland Clinic Department of Cardiovascular Medicine and a staff cardiologist in the Joseph J. Jacobs Center for Thrombosis and Vascular Biology, Department of Molecular Cardiology at the Cleveland Clinic Research Institute.

- The Company announced the expansion of its antithrombotic research collaboration with Jawed Fareed, PhD, Professor, Departments of Pathology and Pharmacology, Loyola University Stritch School of Medicine, Maywood, Ill. Medicure's antithrombotic agents have demonstrated a unique dual antiplatelet/anticoagulant mechanism of action indicating potential in the management of life-threatening and debilitating cardiovascular and cerebrovascular diseases such as myocardial infarction (MI), stroke, pulmonary emboli (PE) and peripheral arterial disease (PAD).

- Subsequent to the end of the quarter, the Company announced that based on the positive Phase II MEND-CABG study and a recent End of Phase II meeting with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a single confirmatory Phase III study to gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft (CABG) surgery.

- In addition, the Company added additional intellectual property by acquiring several U.S. and European patents from a third party for purinoceptor antagonists and adenosine receptor antagonists for the treatment of ischemic reperfusion injury. Terms of the agreement included a fee US$500,000.

[cristrader]

Antwort auf Beitrag Nr.: 21.203.010 von cristrader am 14.04.06 15:05:45

http://www.medicure.com/pdfs/quarter_Feb_2006.pdf

Hört sich einfach nur gut an!

Message to Shareholders, April 2006
Chairman’s Message to Shareholders
During the third quarter of fiscal 2006, Medicure delivered the most important clinical results in its history by
reporting positive results with its FDA Fast Tracked cardioprotective product, MC-1, in the Phase II MEND-CABG
study. The MEND-CABG study results have placed Medicure at the forefront of drug development for acute
cardioprotective products. The reaction from the scientific, financial, and pharmaceutical communities has been
extremely positive. We are now making the important transition with MC-1 from Phase II to Phase III, as we move
closer to our objective of successfully commercializing novel cardiovascular products. I am pleased to share our
successes from the past quarter with you, as well as my excitement of what lies ahead.
Positive Phase II MEND-CABG Results
We were very pleased to report positive results from the Phase II MEND-CABG study during this quarter. The
MEND-CABG study was a double blind, parallel group, randomized, placebo-controlled study in 901 patients who
underwent coronary artery bypass graft (CABG) surgery. The objective of the MEND-CABG study was to
demonstrate a reduction in the composite of cardiovascular death, non-fatal myocardial infarction (heart attack), and
non-fatal stroke up to post operative day (POD) 30 with MC-1 versus placebo. The results showed that the 250 mg
dose of MC-1 had a statistically significant reduction in the composite of events driven by a remarkable 46.9%
reduction in non-fatal heart attacks (peak CK-MB ³100ng/ml). Subsequent to the end of the quarter, we were
pleased to announce that the treatment effect at POD 30 with MC-1 was maintained throughout the follow up period
(POD 90). The safety analysis from MEND-CABG also demonstrated that MC-1 was safe and well tolerated. The
positive results from MEND-CABG are the most impressive reported to date in this high-risk patient population and
could represent a revolutionary treatment option for patients undergoing bypass surgery. We were also pleased to
report that based on the positive Phase II MEND-CABG study and a recent End of Phase II meeting with the U.S.
Food and Drug Administration (FDA), the Company plans to proceed with a single confirmatory Phase III study to
gain approval for MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft
(CABG) surgery. A single confirmatory study provides Medicure the most efficient and affordable path for MC-1’s
Phase III development, and is a valuable asset in our partnership negotiations.
Increased Cash Position with Bought Deal Financing
The release of the positive MEND-CABG results led to a significant increase in institutional interest in Medicure,
which resulted in a bought deal financing with a syndicate of underwriters led by Blackmont Capital Inc. and
including National Bank Financial Inc. for 6,500,000 common shares of Medicure at $1.55 per share. The
underwriters also fully exercised their 1,250,000 common share option for a total purchase of 7,750,000 common
shares. With the exercise of the underwriters’ option, the gross proceeds realized by the Company were
approximately $12 million. The financing strengthened our cash position, increased our institutional ownership and
enhanced our negotiating position with potential pharmaceutical partners.
New Addition to the Scientific Advisory Board
During the quarter we announced a significant new appointment to our Scientific Advisory Board (SAB), with the
addition of A. Michael Lincoff, MD, of the Cleveland Clinic. Dr. Lincoff is an interventional cardiologist in the
Cleveland Clinic Department of Cardiovascular Medicine and a staff cardiologist in the Joseph J. Jacobs Center for
Thrombosis and Vascular Biology, Department of Molecular Cardiology at the Cleveland Clinic Research Institute.
Dr. Lincoff’s experience as an interventional cardiology will be a significant asset to the Company as we progress in
the development of MC-1.
Expansion of Antithrombotic Program
We were also pleased during the quarter to announce the expansion of our antithrombotic research collaboration
with Jawed Fareed, PhD, Professor, Departments of Pathology and Pharmacology, Loyola University Stritch School
of Medicine, Maywood, Ill. Medicure’s antithrombotic agents have demonstrated a unique dual
antiplatelet/anticoagulant mechanism of action indicating potential in the management of life-threatening and
debilitating cardiovascular and cerebrovascular diseases such as myocardial infarction (MI), stroke, pulmonary
emboli (PE) and peripheral arterial disease (PAD). The expanded collaboration with Dr. Fareed will involve a
number of new preclinical studies, with the objective of advancing a lead clinical candidate into human studies.
- 3 -
Outlook
I strongly believe that the next twelve months will be an incredibly exciting and rewarding period for Medicure and
all of its stakeholders including patients, physicians, investors and employees. The MEND-CABG results have
firmly placed Medicure as leaders in the development of acute cardioprotective therapeutics. The success of
MEND-CABG has drawn wide attention from potential pharmaceutical partners, and we spent a substantial part of
this quarter meeting and negotiating with interested companies. We continue to be optimistic that we will secure a
partnering agreement for the Phase III clinical development and commercialization of MC-1.
The successful completion of two positive Phase II studies during this fiscal year has also gathered significant
attention from the capital markets. Institutional investor interest in Medicure has increased substantially. A
significant focus during the quarter was meeting with new and existing institutional investors to provide updates on
the Company’s recent clinical progress. Our investor outreach was effective in attracting new institutional investors
and increasing our overall institutional shareholder base in the United States, Europe and Canada. We believe this
trend towards greater institutional ownership will continue as Medicure transitions into Phase III clinical
development. History has demonstrated the transition to Phase III as the point at which most biotech companies are
rewarded with the most significant appreciation in their valuations.
I want to take this opportunity to thank all of our dedicated shareholders for their continued support of Medicure. I
would also like to acknowledge the commitment of our employees who share Medicure’s vision to discover and
develop novel cardiovascular medicines. I look forward to sharing our progress with you throughout the year.
Yours sincerely,
Albert D. Friesen, Ph.D
Chairman, President and Chief Executive Officer

[cristrader]

'Huge news' for Medicure Inc.
U.S. puts firm's MC-1 drug on fast track
Thu Apr 13 2006 By Larry Kusch

A Winnipeg drug development company is receiving fast-track approval from the U.S. government for a product that promises to significantly reduce the death rate in heart-bypass surgery patients.
"It's huge news for us," said Dawson Reimer, vice-president of operations for Medicure Inc.
He said potential sales for the drug, known as MC-1, could total hundreds of millions of dollars annually.

Albert Friesen, the company's president and CEO, said the U.S. Food and Drug Administration (FDA) decided this week it will require only one more field trial for the heart drug before it is approved.

If that field trial goes well, the drug will likely be ready for market by the end of 2008, a jubilant Friesen said yesterday.

He said the FDA is fast-tracking MC-1 because it is unique and shows so much promise for saving lives. "We (showed) a 37 per cent reduction in heart attacks and deaths in the first 30 days (following bypass surgery). So it's very significant," he said.

"There's nothing on the market that does this at the present time."

The speedy approval promised by the U.S. government means only one -- and not two -- field trials will be needed in Phase 3 of the product's approval process.

As well, the FDA has committed to review and approve the drug for market within six months of the completion of the final field trial, assuming it is successful, Friesen said.

Normally the approval process takes 12 to 16 months after the research is completed, he said.

"It (the fast-track process) does save us time and a significant amount of money."

Reimer said Medicure has yet to sign a partnership agreement with a pharmaceutical firm to market the product.

He said the company wants to build as much value as it can into MC-1 and a sister drug it has in development before signing a deal. "While we've looked at and have considered potential deals and offers, we have been waiting for the right one and continue to work on that," Reimer said.

"Completing clinical trials to show that the drugs work, which we have done, is huge in terms of increasing the value before (signing with) a partner," he said.

Potential sales for MC-1 are huge.

Reimer said annual sales for its use in reducing heart damage for coronary-bypass surgery patients alone is "north of $200 million."

However, the drug could also be used to treat acute coronary syndromes, which include heart attacks. Potential sales there are in the neighbourhood of $600 million a year, he said.

The company also has high hopes for another heart drug, MC-4232, which would be used for patients who suffer from both hypertension and diabetes.

The latter is also in the approval process, but not quite as close to market as MC-1.

Medicure Inc. is a cardiovascular drug development company that trades on the Toronto Stock Exchange (TSX:MPH).

None of its drugs is yet on the market.

[e-mail]



Grüße cristrader

[toothstone]

Danke Chris,
hab am Donnerstag nochmal nachgelegt, die Käufe haben sehr professionell ausgeschaut, ist mir vorher bei ugne und hana, inzwischen hbx und hnab (nasdaq) aufgefallen von 2 auf 11$.

[cristrader]

Hallo Toothstone, frohe Ostern!

Schaut man sich die Entwicklung der Biotechs in den letzten Jahren an ist immer mehr mit einer kräftigen Korrektur zu rechnen. In der jetzigen Phase erscheint mir Medicure völlig einzigartig. Das typische Risiko eines Biotechs "das Scheitern eines Medikamentenkandidaten" ist zumindestens bis 2008 nicht gegeben. Die Entscheidung der FDA das nur eine "single confirmatory Phase III study" nötig zur Zulassung ist spart MCU nicht nur jede Menge Geld und Zeit sondern erhöht die Wahrscheinlichkeit der Zulassung enorm. Meinen ganzen Recherchen und Infos zufolge wäre bei einem etwas ausgeklügelterem Phase II-Studiendesign u.a. bezüglich der Endpunkte bereits nach Phase II eine Zulassung möglich gewesen.
MCU ist noch völlig unentdeckt gut daran zu sehen das noch keinerlei Researchreporte verfügbar sind. Die bevorstehende Partnerschaft mit Big Pharma wird dies definitiv ändern. Ich bin zwar schon bis über beide Ohren investiert werde aber weiterhin jeden Rücksetzer zur Aufstockung nutzen.

Grüße cristrader

[toothstone]

Danke, hoffe daß dein ostern auch schön war!
Ein bißchen mehr hätte ich nach diesen feinen news schon erwartet, aber eine schöne konsolidierung bei 1,8 1,9 ist auch fein.
Die absicherung nach unten sehe ich auch als ganz wichtig. am besten wär 12 monate liegen lassen und dann erst wider schauen, aber das macht ja keinen spaß.

[cristrader]

Hallo!

Leider wenig erfreuliche News mit einer weiteren Kapitalerhöhung!
Man muss sich die Frage stellen wieso das Management ohne akuten Finanzbedarf zwei Kapitalerhöhungen durchführt kurz vor einer möglichen MC-1 Partnerschaft mit einem Big Pharma!

Das lässt natürlich viel Raum für Spekulationen.

-die mögliche Partnerschaft steht wohl frühestens Ende Sommer/Anfang Herbst bevor

-das Management scheint wohl den Mund etwas zu voll genommen zu haben mit dem angeblich so grossen Interesse von Big Pharma

-CEO und Präsident sieht kurz- bis mittelfristige Marktkapitalisierung bei 750 Mio bis 2 Millarden $ und verscherbelt ein Fünftel des Unternehmenswertes für 25 Mio? Wie passt das zusammen?

-Sinn macht diese Kapitalerhöhung eigentlich nur wenn man beabsichtigt die Phase III-Studien der beiden Leadmedikamente alleine durchzuführen.

-teuer erkaufte Coverage in US und Europa auf Kosten der Shareholder



Medicure Raises US$25 Million in Private Placement
Friday May 5, 7:21 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 5, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced that it has entered into Securities Purchase Agreements (the "Agreements") with U.S. and European institutional investors raising total gross proceeds of approximately US$25 million. Under terms of the Agreements, Medicure intends to issue approximately 16 million common shares at a price of US$1.60, together with warrants, to purchase approximately 4 million additional common shares. The warrants have a five year term and an exercise price of US$2.10. The private placement is expected to close in the next several days and is subject to the approval of the Toronto Stock Exchange and the American Stock Exchange and other customary closing conditions.
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Proceeds of the private placement will be used to help fund the ongoing development of Medicure's lead clinical products, MC-1 and MC-4232 as well as for general corporate purposes.

Deutsche Bank Securities Inc. acted as the lead placement agent and Needham & Company, LLC, GMP Securities L.P. and Versant Partners Inc. served as co-placement agents for the transaction.

"We were extremely pleased with the degree of U.S. institutional interest exhibited in this placement, and are delighted to welcome a number of new high quality investors as Medicure shareholders," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We remain committed to advancing our partnership discussions for the development of MC-1. The proceeds of this financing provides us with the flexibility to proceed with the single Phase III MEND-CABG study with MC-1."

The securities offered were not registered under the Securities Act but were sold to institutional accredited investors on a private-placement basis pursuant to the exemption from registration contained in Regulation D under the Securities Act. Medicure Inc. has agreed to qualify the resale of the common shares issued under the private placement by filing a prospectus in certain provinces of Canada and to register such securities under the Securities Act of 1933, as amended (the "Securities Act").

This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful.

About Medicure Inc.

Medicure Inc. is a cardiovascular drug discovery and development company focused on developing effective therapeutics for unmet needs in the field of cardiovascular medicine, the largest pharmaceutical market sector. The Company's solid position in this field is supported by the following attributes:

- Cardiovascular focused pipeline: a global market of over US $70 billion

- Two drugs - MC-1 & MC-4232 - in late stage clinical development

- Four positive Phase II trials completed

- FDA Fast Track designation for MC-1

- Unique products addressing major, inadequately served markets

- Dual action antithrombotic, MC-45308, with positive preclinical results

Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.


Grüße cristrader

[toothstone]

Ich sehe es nicht ganz so negativ.
Wenn ich dieses private placement mit anderer aktien vergleiche und hier der investor 5% unter kurs immerhin zahlt, ist das niedrig. die dilution wird auch gering gehalten. wichtig ist, daß dieser investor nicht gleich wieder alles schmeißt, sondern auch sehr long ist. und mcu alle möglichkeiten selbst in der hand hat, besser zum pokern.

[cristrader]

Antwort auf Beitrag Nr.: 21.472.164 von toothstone am 08.05.06 12:13:19

@toothstone

Ich erwarte keinen negativen Kursverlauf. Vielmehr werden die neuen Investoren MCU´s Story einer breiteren Öffentlichkeit public machen. Nichts desto trotz wird das langfristige Kurspotential um ein Fünftel reduziert. Mich ärgert insbesonders das die Kapitalerhöhung nicht erst nach Bekanntgabe der Partnerschaft zu wesentlich höheren Kursen stattfindet!

Grüße cristrader

[toothstone]

Wie nahe vermutest du eine partnerschaft?
Finanzielle probleme sind jetzt wohl komplett ausgeschloßen.
Vielleicht ist der neue investor wichtig für die partnerschaft, nur meine vermutung. oder mcu will wirklich erst in oder nach phase 3 partner.
Hab den ceo von prtx gehört live in münchen, die machen es sehr interessant: sie versuchen für eine art der thrompozytopenie(autoimmunerkrankung), eine art fast track zu kriegen. Bis zu diesem zeitpunkt alles selber zu vermarkten, um dann im viel größeren rheuma-markt ganz schnell dicke partner zu haben.
Kannst ja auch mal dd machen.
Immer diese watchlist mit soviel interessanten werten.

[cristrader]

Hallo toothstone!

Nach der Kapitalerhöhung bin ich etwas vorsichtiger mit meinen Prognosen. Generell bin ich der Meinung das die Phase III-Planungen unbedingt zusammen mit dem künftigen Partner durchgeführt werden sollten. Deshalb war ich bisher davon überzeugt das die Partnerschaft-News noch im 1.HJ 2006 kommt. Nach der Kapitalerhöhung glaube ich eher das die Partnerschaft und auch die Phase III-Starts noch länger (Spätsommer) auf sich warten lassen. Im nächster Zeit stehen einige Konferenzen an vielleicht gibt ja was Neues.


Mit Protalex habe ich mich noch nicht beschäftigt. Bin allerdings gegenüber OTC-Werten auch eher skeptisch eingestellt. Wenn ich Zeit finde schaue ich mir mal den Thread an.


Grüße cristrader

[toothstone]

Hast wohl recht, sowohl mit phase 3 als auch mit otc.
Aber das potential nach unten ist bei mcu eigentlich so gering, deswegen bleib ich long.

[cristrader]

Hallo!

Habe mir zwar insgeheim eine etwas kräftigere Korrektur des Biotech-Sentiments gewünscht, aber das meine Werte MCU und YMI derart in Mitleidenschaft gezogen wurden habe ich so nicht erwartet!

Nun genau diese Volatilität im Biotechsektor macht diese Branche ja gerade so interessant!

Anfang der Woche gab es eine Präsentation mit Slides auf der Rodman&Renshaw Konferenz
http://wsw.com/webcast/rrshq8/mcu/

Hier einige Äußerungen von CEO und Präsident Bert Friesen:

MC-1:


Indikation CABG Surgery:

- bisher keine vernünftige Behandlungsmöglichkeit
- am weitesten fortgeschrittenes Medikament
- 500.000 Behandlungen/Patienten pro Jahr in USA/ weltweit 1 Millionen
-erzielbarer Preis pro Patient: 500-600 $
-Start Phase III: 2 HJ. 2006

[cristrader]

Antwort auf Beitrag Nr.: 21.647.955 von cristrader am 18.05.06 19:21:31

weiter gehts

MC-1 - Accute Cornary Disease

-Jährliche Behandlungen: 1.5 Millionen/ weltweit 3 Mio
-Start Phase III Anfang 2007


Gesamtmarktpotential für MC-1 in CABG und ACD:
-4 Millionen Patienten jährlich
-bei 500 $ Behandlungskosten ergibt das ein Marktpotential von ca. 2 Milliarden $.
Als erstes verfügbare Medikament auf dem Markt wird sich MCU sicher einen gehörigen Batzen vom Kuchen abschneiden!

zudem:
-Patentschutz bis Jahr 2025
-in Kürze Verhandlungen mit europäischen Zulassungsbehörden



MC-4232 (Kombination MC-1 + ACE Inhibitor, Lisinopril)
-Diabetic Hypertension
alleine in USA 12 Mio Patienten mit unzureichender Behandlung!
-Start Phase III Ende 2006/Anfang 2007


weitere Aussagen:

-sehr fortgeschrittene Verhandlungen mit einem Partner
-Partnerschaft bis Ende 2007
-US Coverage in Kürze

Also kein Grund zur Panik
Sollte sich die Medicure-Story planmäßig entwickeln sehe ich in fünf Jahren Kurse zwischen 50-100$


Grüße cristrader

[toothstone]

Guten Morgen cris,

mcu ist ja gar nicht so arg betroffen von der korrektur, ymi dagegen schon. sind wohl überall gewinne mitgenommen worden und dann kommen halt wiedr die margin calls.
Aber die story stimmt, wie du schön berichtet hast und das ist das wichtigste.

[cristrader]

Medicure Presents Matched Results at the 21st Annual Meeting of the American Society of Hypertension
Wednesday May 17, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 17, 2006 -- NEW CLINICAL DATA PRESENTED
Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced data from two poster presentations on the Phase II MATCHED study at the 21st Annual Meeting of the American Society of Hypertension (ASH). The posters were presented by the study's principal investigator, Dr. Yves Lacourciere, Director of the Hypertension Research Unit, Centre Hospitalier de l'Universite Laval Sainte-Foy, Quebec.



Data presented from the poster titled "The Combination of MC-1 and Lisinopril Has Beneficial Effects on Carbohydrate and Lipid Metabolism in Hypertensives with Type 2 Diabetes Mellitus" included previously released metabolic results as well as new lipid results from MATCHED:

- The 300mg/20mg (MC-1/lisinopril) dose of MC-4232 had a reduction in fasting serum glucose of 1.45 mmol/L (p equals 0.026) versus placebo.

- In patients with elevated baseline triglycerides (greater than 1.7mmol/L), the 300mg/20mg dose of MC-4232 had a reduction of 0.7 mmol/L (p equals 0.040) versus baseline.

- In patients with elevated baseline LDL (greater than or equal to 2.6 mmol/L), the 300mg/20mg dose of MC-4232 had a reduction of 0.4 mmol/L (p equals 0.045) versus baseline.

"We were very pleased to be able to present the MATCHED data at ASH," commented Medicure's President and CEO, Albert D. Friesen, PhD. "The additional lipid data presented at the conference further demonstrates MC-4232's clinical efficacy in an important cardiovascular endpoint. This data further supports our strategy for the broad application of MC-1 for chronic use in combination with existing cardiovascular and metabolic products including ACE inhibitors (MC-4232), ARBs (MC-4262) and others future products."

Data presented from the poster titled "Evaluation of the Antihypertensive Effects of MC-1 Alone and in Combination with Lisinopril on Ambulatory BP in Hypertensive Patients with Type 2 Diabetes Mellitus" included the previously released hypertension results from MATCHED:

- The 300mg/20mg dose of MC-4232 had a reduction in mean daytime ambulatory systolic blood pressure (MDASBP) of 12.0 mmHg (p less than 0.0001) from baseline after 8 weeks of therapy as compared to 7.5 mmHg with 20mg lisinopril monotherapy, equating to an additional 4.5 mmHg reduction (p equals 0.130).

- The 300mg/20mg dose of MC-4232 had a reduction in mean daytime ambulatory diastolic blood pressure (MDADBP) of 7.5 mmHg (p less than 0.0001) from baseline after 8 weeks of therapy as compared to a 4.1 mmHg reduction with 20mg lisinopril monotherapy, equating to an additional 3.4 mmHg reduction (p equals 0.060).

Medicure completed the Phase II MATCHED study (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) in September 2005. MATCHED was a randomized, parallel group, cross-over, double-blind, placebo-controlled comparison of 100, 300 or 1000 mg of MC-1 alone and in combination with 20 mg of lisinopril. The study results are based on a population of 120 patients with coexisting type II diabetes and hypertension from 12 sites across Canada. The trial was conducted under the guidance and direction of the internationally recognized hypertension specialist, Yves Lacourciere, MD, FRCP, FACP, Director of the Hypertension Research Unit, Centre Hospitalier de l'Universite Laval Sainte-Foy, Quebec

Grüße cristrader!

[cristrader]

Hallo Leute!

Lasst euch von den Kurskapriolen nicht verrückt machen! Medicure wird der Überflieger der nächsten Jahre!

Medicure to Present Matched Results at the American Diabetes Association's 66th Annual Scientific Sessions
Thursday May 25, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 25, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced a poster outlining new findings from the Phase II MATCHED study with MC-4232 has been accepted for presentation at ADA 2006. The American Diabetes Association (ADA) Annual Scientific Session is being held in Washington, DC, June 9-13, 2006. The ADA is the largest U.S. organization dedicated exclusively to diabetes research, information and advocacy.




Dr. Lacourciere, Director of the Hypertension Research Unit, Centre Hospitalier de l'Universite Laval Sainte-Foy, Quebec will present the poster describing the antihypertensive and metabolic effects of MC-4232. The abstract titled "Novel combination of MC-1 and lisinopril lowers blood pressure and CRP levels and improves metabolic function in hypertensive diabetic patients" will be presented at 12:00 PM Eastern on Sunday, June 11, 2006.

Medicure completed the Phase II MATCHED study (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) in September 2005. The study results demonstrated that MC-4232 had a statistically significant reduction in both primary blood pressure and metabolic endpoints.


Grüße cristrader

[cristrader]

Hallo!

Heute Präsentation bei der 66. American Diabetes Association:
http://scientificsessions.diabetes.org/index.cfm?fuseaction=…

Novel Combination of MC-1 and Lisinopril Lowers Blood Pressure and CRP Levels and Improves Metabolic Function in Hypertensive Diabetic Patients
Year: 2006
Abstract Number: 512-P


Authors:

YVES LACOURCIÈRE, JEAN LEFEBVRE, LUC POIRIER, NANCY STEWART, MARJORIE ZETTLER.


Institutions:

Quebec, QC, Canada; Winnipeg, MB, Canada.


Results:

The objective of this cross-over, double-blind, phase II pilot study was to assess the blood pressure (BP) and C-reactive protein (CRP) lowering effects as well as the effects on metabolic parameters of MC-4232, a combination of MC-1 (pyridoxal 5'-phosphate) and the ACE-inhibitor lisinopril (L) in hypertensives with type 2 diabetes mellitus (DM).
A total of 160 patients (pts) with mean daytime ambulatory systolic BP (MDASBP) ≥135 mmHg were randomized into one of 2 treatment sequences. In sequence 1, pts received an 8-wk treatment with MC-4232 (L20mg + MC-1 100, 300 or 1000mg) or placebo, followed by an 8-wk treatment with placebo or MC-1 alone. In sequence 2, pts received the alternate treatment.

The 300/20mg dose of MC-4232 induced a placebo-subtracted 12.0 mmHg decrease in MDASBP (p<0.0001) from baseline vs. 3.1 mmHg with MC-1 and vs. 7.5 mmHg with L monotherapies. Overall MC-4232 (300/20mg) reduced fasting glucose (GLU) by 1.45 mM (p=0.026) vs placebo and by 4.1 mM (p=0.05) in pts with baseline GLU ≥ 10 mM. Pts with HbA1C>8.0% at baseline had an absolute reduction of 0.63% (p=0.27) vs placebo. The overall reduction in total-cholesterol was 0.18 mM (p=0.27) but it was greater (0.91 mM;-15%; p=0.02) in pts with a baseline level ≥5.2 mM. The overall decrease in LDL-cholesterol was 0.27 mM vs placebo (p=0.095) but it was greater (0.41 mM;-12%; p=0.04) in pts with baseline level ≥2.6 mM. In patients with triglycerides >1.7mM at baseline, a reduction of 0.70 mM (p=0.04) vs. baseline was observed. CRP levels were reduced by 1.0 mg/L (-35% vs. baseline, p=0.009).

The results of this pilot study shows that in addition to BP lowering effects, MC-4232 300/20mg improved metabolic function and decreased CRP levels in hypertensive pts with DM. The results of this novel combination may have relevant clinical implications for these pts and those with metabolic syndrome. However, this needs to be confirmed by longer term treatment studies in larger populations.



Time & Room:

Presentation: 6/11 - 12:00:00 PM-02:00:00 PM
Reception: 6/11 - 06:30:00 PM-07:30:00 PM
Poster Hall (WCC-Hall C)


Category:

Clinical Therapeutics/New Technology


Subgroup:

Pharmacologic Treatment of Diabetes or its Complications



Grüße cristrader

[cristrader]

Hallo Leute!

Heutige News bestätigt nur das riesige Potential von MC-1 und MC-4232 hat allerdings keine positive Auswirkungen auf den Kurs.

Das große Problem zurzeit ist das fehlende Volumen. Es ist momentan leider nicht möglich größere Stückzahlen zu ordern ohne den Kurs kräftig nach oben zu treiben. Das hindert sicherlich viele Instis in den Wert einzusteigen. Bisher ist Medicure einfach noch absolut unbekannt. Das Management hat baldige US Coverage angekündigt vielleicht startet Needham (neben der Deutschen Bank ja Hauptbeteiligter der letzten Kaptalerhöhung) nach seiner Konferenz am Donnerstag MCU´s Coverage. Vor den richtig grossen News gibt es in Kürze möglicherweise noch News von den Europäischen Behörden bezüglich möglicher Zulassungsstudien. Mein Aktiendepot besteht mittlerweile zwar schon zu 60% aus Medicure warte allerdings noch auf die Gelegenheit nochmals kräftig aufzustocken!(dann müssten allerdings meine steuerfreien YMI dran glauben )


Medicure Presents New Matched Results at the American Diabetes Association's 66th Annual Scientific Sessions
Monday June 12, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Jun 12, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced that additional positive results from the Phase II MATCHED study were presented at the American Diabetes Association (ADA) Annual Scientific Session in Washington, DC. The study results demonstrated that MC-4232, a combination of MC-1 and the ACE Inhibitor, lisinopril (300mg/20mg) had a statistically significant 1.03mg/L (p equals 0.006) reduction in C-Reactive Protein (CRP) versus baseline. CRP is an important biomarker of inflammation, and is known to be highly predictive of cardiovascular risk. A reduction in CRP versus baseline was a predefined secondary endpoint of the MATCHED study.
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"The reduction in CRP adds to the growing evidence of MC-4232's unique cardiovascular and metabolic benefits, and specifically MC-1's novel cardioprotective properties," commented Medicure's President and CEO, Albert D. Friesen, PhD. "It well known that CRP is a strong indicator of cardiovascular events. As such, we view the positive effect on CRP in MATCHED as being highly supportive for the acute application of MC-1 in CABG surgery and acute coronary syndrome."

The MATCHED study (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) was a 16 week randomized, parallel group, cross-over, double-blind, placebo-controlled comparison of 100, 300 or 1000 mg of MC-1 alone and in combination with 20 mg of lisinopril. The study results are based on a population of 120 patients with coexisting type II diabetes and hypertension from 12 sites across Canada. Medicure completed the Phase II MATCHED study in September 2005. The study results demonstrated that MC-4232 had a statistically significant reduction in both primary blood pressure and metabolic endpoints.

About Medicure Inc.

Grüße cristrader

[cristrader]

Hallo Leute!

Ich habe meine Position in MCU in den letzten Wochen und Monaten deutlich ausgebaut. Laut Unternehmensangaben ist der Phase III-Start für MC-1 im Herbst geplant. Die Partnerschaft mit einem Big Pharma soll möglichst noch vor dem Start der Phase III abgeschlossen werden.


Ich bin mir nicht ganz sicher wie ich die gestrige News bewerten soll. Vielleicht hilft sie ja zumindest Medicure in den USA etwas bekannter zu machen.


Medicure Acquires U.S. Rights to Aggrastat'R' from MGI PHARMA, INC.
Wednesday August 9, 7:00 am ET


Merck & Co., Inc. Acquires Right of First Refusal for MC-1/ AGGRASTAT'R' Combination Product


WINNIPEG, MANITOBA--(MARKET WIRE)--Aug 9, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that the Company has acquired the exclusive U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride) from MGI PHARMA, INC. AGGRASTAT®, a glycoprotein (GP) IIb/IIIa inhibitor, is used for the treatment of acute coronary syndrome (ACS) including unstable angina and non-Q-wave myocardial infarction.
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Developed by Merck & Co., Inc., AGGRASTAT® was launched in the U.S. in 1998, and is currently available in 82 countries worldwide. Merck continues to market AGGRASTAT® outside the U.S., including Europe where 2005 sales for AGGRASTAT® were approximately US$88 million. Merck sold the U.S. rights to AGGRASTAT® to Guilford Pharmaceuticals Inc. in 2003, which was subsequently acquired by MGI PHARMA in 2005. Total U.S. sales for the GP IIb/IIIa inhibitor class in 2005 were in excess of US$450 million, of which AGGRASTAT® sales comprised US$10.9 million.

"The acquisition of AGGRASTAT® fits strategically with Medicure's goal of building a world class cardiovascular business from drug discovery through to commercialization," commented Medicure's President and CEO, Albert D. Friesen, PhD. "This acquisition enables us to build an acute cardiovascular sales team that will support our immediate needs for AGGRASTAT® and also our future needs for MC-1, our lead clinical product."

Under the terms of the agreement Medicure will pay MGI PHARMA US$19 million plus the purchase of existing inventory, and will make certain royalty payments to Merck based on net sales of AGGRASTAT® in the U.S. To finance the acquisition, the Company entered into a senior secured term loan totaling US$15.84 million, repayable over 42 months, with a syndicate of lenders, led by Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., and including Silicon Valley Bank and Oxford Finance Corporation.

In addition, Merck has acquired the non-North American right of first refusal on future product opportunities combining MC-1 with AGGRASTAT®. MC-1, Medicure's lead cardioprotective product, is expected to begin a pivotal Phase III study later this year as a treatment to reduce ischemic reperfusion injury in patients undergoing coronary artery bypass graft (CABG) surgery.

"We believe that the participation of these experienced financial institutions represents a significant endorsement of this strategic acquisition and Medicure's portfolio of cardiovascular products," continued Dr. Friesen. "In addition, this acquisition further increases the value of MC-1. We see a market opportunity in combining AGGRASTAT® with MC-1 for specific cardiovascular applications, and will continue to advance partnering discussions related to this product opportunity. Furthermore the right of first refusal is exclusively focused on the combination of MC-1 and AGGRASTAT® and in no way restricts our ability to develop and partner MC-1 or any other MC-1 combination product."

Pierre Theroux, MD, Professor of Medicine at the University of Montreal and Cardiologist at the Montreal Heart Institute stated, "I had the privilege to lead the PRISM-PLUS trial, which was the first large trial ever done to test the efficacy of upfront use of a GP IIb/IIIa inhibitor in a high-risk ACS population. The trial demonstrated that tirofiban (AGGRASTAT®) added to standard therapy reduced the incidence of death and myocardial infarction at 48 hours (66% reduction), 7 days (43% reduction) and 30 days (30% reduction). Importantly, the observed benefits applied to medically managed patients and to patients referred for percutaneous intervention (PCI) or CABG surgery as well. The current ACC/AHA guidelines also give a strong recommendation for the use of GP IIb/IIIa inhibitors for high-risk PCI."

"There are a number of significant benefits to Medicure resulting from this acquisition," commented Medicure's Vice President, Market and Business Development, Moray Merchant. "AGGRASTAT® gives the Company immediate revenues; it is a product with considerable sales growth potential given its lack of sustained sales support for the past several years; and it allows us to commercially leverage the excellent relationships we have already established with leading acute cardiovascular centers in the U.S through our MC-1 clinical development."

Notification of Conference Call:

Medicure has scheduled a conference call and webcast to discuss the AGGRASTAT® acquisition:

Date: Wednesday, August 9, 2006
Time: 9:00AM Eastern Time
Telephone: 1-877-888-3490 or 1-416-695-5259
Webcast: Available at the Medicure website at http://www.medicure.com
Archive of Conference Call:

An archive of the AGGRASTAT® acquisition conference call will be available starting at 11:00AM Eastern August 9, 2006:

Telephone: 1-888-509-0081 or 1-416-695-5275
Passcode: 629105
Webcast: Available at the Medicure website at http://www.medicure.com
Expires: August 16, 2006
Important Information About AGGRASTAT®

AGGRASTAT® was approved by the Food and Drug Administration (FDA) on May 14, 1998.

AGGRASTAT®, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy.

AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm3 and in patients with hemorrhagic retinopathy. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

About GP IIb/IIIa Inhibitors

Platelets are blood cells that provide an early defense from the potential complications of vascular injury. When a blood vessel is damaged, platelets adhere to the site and promote blood clot formation. Clot formation prevents bleeding and recruits other cells to help heal the damage. While usually a beneficial process, this can be harmful when a clot forms on a ruptured lipid plaque within the coronary vasculature.

GP IIb/IIIa inhibitors block the ability of platelets to aggregate, inhibiting clot formation and reducing the potential for cardiac ischemia. Over the last 8-10 years, several large-scale, placebo-controlled clinical trials have established the efficacy of intravenous GP IIb/IIIa inhibitors for patients with acute coronary syndrome who are medically managed or those undergoing a percutaneous coronary intervention (PCI).

About Merrill Lynch Capital

Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., is a leading commercial finance business providing a broad range of structured financing solutions to middle market companies nationwide. Based in Chicago and with regional offices throughout the country, Merrill Lynch Capital is focused on four market segments-corporate finance, equipment finance, healthcare finance and real estate finance. The Healthcare Finance Group of Merrill Lynch Capital provides senior financing solutions for middle market healthcare companies, offering cash flow, asset, life sciences related and real estate based credit facilities and junior secured debt, and equity co-investments. The typical transaction size for senior debt is between $10 million and $250 million.

About Medicure Inc.

Medicure Inc. is a fully integrated, cardiovascular focused, biopharmaceutical company involved in the research, development and commercialization of novel compounds to treat unmet medical needs. The Company's solid position in this field is highlighted by the following:

- Sales and marketing rights to AGGRASTAT® Injection (tirofiban hydrochloride) in the United States

- Two drugs, MC-1 & MC-4232, in late stage clinical development

- Four positive Phase II trials completed

- FDA Fast Track designation for MC-1

- Robust clinical and preclinical cardiovascular pipeline

Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.



Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 23.390.674 von cristrader am 10.08.06 20:25:03

Hallo Cristrader
Volumen in USA ist ja endlich angezogen. Konnte mich aber immer noch nicht entscheiden hier auch noch einzusteigen.
Hoffe erst Mal das YMI wieder steigt.

Gruss Solarblase

[KnigRollo]

hi cristrader ?

stichwort partnerschaft.. kommt die jetzt mal bald oder wollen die alleine die phase III starten ? das kann doch nicht wahr sein..

rollo

[cristrader]

Hallo KnigRollo!

Medicure will im Herbst die MC-1 Phase III starten mit oder ohne Partner. Grundsätzliches Ziel ist allerdings eine Partnerschaft zu Beginn der Phase III ansonsten bis Ende des Jahres.

Lies dir mal den Jahresbericht durch da werden viele Fragen beantwortet:
http://www.medicure.com/pdfs/Medicure_AR_06.pdf

Fiscal 2006 and the months that followed were marked by significant growth for Medicure, highly positive
clinical results and a significant strategic acquisition. The most notable of these accomplishments was
the positive Phase II MEND-CABG study results with our lead clinical compound, MC-1. The medical and
market opportunity that MC-1 represents is enormous, and we are moving swiftly to initiate a pivotal
Phase III study and expedite its commercial development. With the announcement of the acquisition of
the rights to Agg rastat ® Injection (tirofiban hydrochloride) in the United States subsequent to the end
of the fiscal year, we can now proudly say that we are an integrated biopharmaceutical company, with
commercialization, development, and research capabilities. Looking towards fiscal 2007 we are in the
enviable position of having one product on the market, another entering a Phase III study, and a robust
pipeline of clinical and preclinical products. Our accomplishments during fiscal 2006 and the months
following have confirmed our commitment to being a world class cardiovascular focused biopharmaceutical
company. I look forward to sharing our progress with you throughout this fiscal year.

A Breakout Year For Medicure

Our focus over the past number of years
has been on the development of our
lead clinical candidates, most notably
MC-1 for ischemic reperfusion (IR) injury.
Our efforts were rewarded in December
2005 when we delivered positive
clinical results from the Phase II MEND CABG
study. This 901 patient study
was the largest clinical undertaking
in the Company’s history. The results
exceeded our expectations by
demonstrating that MC-1 had a
statistically significant reduction
in the composite of non-fatal heart
attacks (Peak CK-MB ≥ 100ng/ml),
non-fatal strokes and cardiovascular
death in patients 30 days post coronary
artery bypass graft (CABG) surgery
versus placebo. This reduction in the
composite was driven by a remarkable
47% decrease in heart attacks with
MC-1 versus placebo. The results from
MEN D-CABG clearly warrant advancing
MC-1 into a pivotal Phase III study,
and position Medicure as the leader
in cardioprotective drug development.
The market opportunity for MC-1 is
enormous as there are currently no
approved cardioprotective products
for the reduction of cardiovascular
events post CABG surgery. As the
leading drug in development for this
indication, we anticipate that MC-1
will achieve wide market acceptance
upon commercialization. In addition
we plan on developing MC-1 for the
broader indication of acute coronary
syndrome (ACS). The ACS market is
approximately three times that of CABG,
and similar to CABG there are currently
no approved cardioprotective products
for this indication. In September 2005
the U.S. Food and Drug Administration
(FDA) recognized the medical need for
treatments to reduce cardiovascular
events in CABG and ACS patients, by
granting MC-1 a Fast Track designation
for both indications.
In the coming months we will initiate
a pivotal Phase III study with MC-1 in
CABG patients. Based on the positive
Phase II MEN D-CABG study and an
End of Phase II meeting with the FDA
in April 2006, the Company plans to
proceed with a single confirmatory
Phase II study to gain approval for
MC-1 in the reduction of cardiovascular
events in patients undergoing CABG
surgery. This study, titled
MEN D-CABG II , will involve sites
throughout North America and Europe,
and enroll up to 3000 patients.
The anticipation around the outcome
of this study is immense, both from
the medical and financial community.
We look forward to keeping you
abreast of the progress of MEN DCABG
II throughout this fiscal year.
In September 2005, we announced
positive results with our other late
stage clinical compound, MC-4232
(MC-1 + lisinopril). The 120 patient
Phase II MATCHE D study assessed
the metabolic and antihypertensive
effects of MC-4232 in patients with
hypertension and type II diabetes.
The MATCHE D results were
very positive, demonstrating the
clinical benefits of MC-4232 in the
management of blood pressure,
blood sugars, and lipids. Based on
MATCHE D, we believe MC-4232
presents a unique development
opportunity; a novel product with
combined cardioprotective, blood
pressure and multiple metabolic benefits
for a high risk patient population.
Creating Shareholder Value
In fiscal 2006 we made significant
progress in attracting new institutional
investors to Medicure. This was
highlighted by a private placement
with U.S. and European institutional
investors that was completed in
May 2006, raising total gross proceeds
of approximately US$25.6 million.
We were extremely pleased with the
degree of U.S. institutional interest
exhibited in this placement, and are
delighted to welcome some of
the most knowledgeable biotech
investors as Medicure shareholders.
The proceeds of this financing provide
us with the flexibility to proceed
with the MEN D-CABG II study, while
continuing to negotiate with potential
partners on a licensing agreement
for MC-1.
As we transition into Phase II with MC-1,
we believe the interest in Medicure from
the investment community will continue
to increase and this should translate
into greater liquidity in Medicure stock
and increased institutional ownership.
We are committed to creating
shareholder value, and believe through
the execution of our strategy, that
Medicure’s valuation will better reflect
our late stage clinical development
and robust cardiovascular pipeline
Looking Ahead
Our highest priority for fiscal 2007
is the clinical development of MC-1.
The market opportunity and medical
need that MC-1 would meet is in our
opinion the most significant of any
cardiovascular product in late stage
clinical development today. The FDA
Fast Track designation and their
support of a single Phase II study
for registration are a reflection of the
need for cardioprotection in CABG
and ACS patients. With the imminent
initiation of the Phase II CABG study
we move one step closer to our goal
of the successful commercialization
of MC-1.
With the announcement of the
acquisition of the U.S. rights to
Aggra stat® subsequent to year
end, Medicure has transitioned to
a commercial player in the acute
cardiovascular market. Aggra stat®
provides us with an affordable, high
growth potential product to build our
cardiovascular business on. We believe
the past success of Aggra stat® in
the U.S., coupled with its current market
strength in Europe, are indicative of
the opportunity this product represents.
We are now in the process of building
the sales and marketing infrastructure
to support our Aggra stat® initiative.
Creating this infrastructure will
significantly increase awareness of
Medicure among target physicians and
surgeons in the acute cardiovascular
market. This awareness of Medicure,
generated by the marketing of
Aggra stat,® will be a significant
advantage for us once we begin
marketing MC-1 in the acute
cardiovascular market. As we near
the commercialization of MC-1 we
see Aggra stat® and MC-1 as being
highly complementary to one another,
both as monotherapies and also in a
potential combination. In recognition
of the complementary nature of MC-1
and Aggra stat,® Merck & Co., Inc.
has acquired the right of first refusal
on a potential combination of these
two products. Going forward we will
work towards securing a licensing
agreement for both monotherapy MC-1
and a potential future combination
with Aggra stat.®
On behalf of the Board of
Directors, I would like to thank all of
our committed investors for their
support throughout fiscal 2006.
I would also like to thank our staff
for their spirited energy over the
past year. I look forward to sharing
our success with you throughout this
fiscal year.
Albert D. Friesen, PhD
President & Chief Executive Officer


What is ischemic reperfusion injury
and what are its clinical implications?

Ischemic reperfusion (IR) injury occurs
when blood flow is restored to the
heart after a period of impaired or
blocked blood flow. In order to perform
a common coronary intervention,
such as coronary artery bypass graft
(CABG) surgery, blood flow must be
temporarily blocked to the heart
during surgery causing ischemia,
followed by the reinstitution of
blood flow after the surgery.
The reinstitution of blood flow
after CABG surgery is known to
cause a significant amount of IR injury.
All patients undergoing CABG surgery
experience some degree of IR injury;
however for some the injury can be
very severe leading to a heart attack,
and even death. Medicure is developing
MC-1 to reduce these serious events
following CABG surgery. The FDA
recently granted MC-1 a Fast Track
designation for the CABG surgery
indication, in recognition of the
significant medical need it would meet.


How does MC -1 work to prevent
ischemic reperfusion injury?

MC-1 is a naturally occurring small
molecule that protects heart muscle
cells during and following CABG surgery.
Other companies have focused on
treating the inflammatory component
of IR injury. Although MC-1 has
demonstrated protective antiinflammatory
properties, studies
suggest its cardioprotective effect
is derived mainly from its ability
to protect heart muscle cells.
Consequently MC-1 works early
in the IR injury cascade preventing
cellular death, whereas other
compounds in development have
focused further down the cascade
on the inflammatory component.
The benefits of treating IR injury at
the cellular level were demonstrated
in the Phase II MEND-CABG study where
MC-1 had a statistically significant 47%
reduction in non-fatal heart attacks
(Peak CK-MB ≥ 100ng/ml) following
CABG surgery. These results are
the most impressive seen of any
cardioprotective agent in this high
risk patient population, and support
Medicure’s rationale for treating
IR injury at the cellular level as opposed
to the anti-inflammatory approach.


What is the market opportunity
for MC -1 in CABG ?

There are currently no approved
cardioprotective products for the
reduction of events after CABG surgery.
Therefore MC-1 has the opportunity
to be the first approved product
for this indication. According to
the American Heart Association
there were approximately 467,000
CABG procedures performed in
the U.S. in 2002, and it is estimated
a similar number of surgeries are
performed annually throughout
the rest of the world.


What are the next steps in the
development of MC -1 for CABG ?

Medicure anticipates starting a pivotal
Phase II CABG study with MC-1 before
the end of calendar 2006. The study,
titled MEN D-CABG II , will be managed
by the Duke Clinical Research Institute
and Montreal Heart Institute. MEND-CABG
II will enroll up to 3000 patients
with sites throughout North America
and Europe.


What is ACS and what are its
clinical implications?

Acute Coronary Syndrome (ACS)
is a spectrum of cardiovascular
events that includes unstable angina
and non-Q-wave heart attacks.
The cause of ACS is insufficient
oxygen supply to the heart caused by
restricted blood flow to a single or
multiple coronary arteries that feed
blood to the heart. The mortality
incidence in the six months following
the diagnosis of ACS is approximately
20%, even higher than that observed
in CABG surgery. Medicure is developing
MC-1 to reduce mortality and morbidity
following the diagnosis of ACS. The FDA
recently granted MC-1 a Fast Track
designation for the ACS indication,
in recognition of the significant
medical need it would meet.

Why is Medicure pursuing ACS instead of PCI ?

The mortality rate is higher in the
ACS population versus the broader
percutaneous coronary intervention
(PCI) population, demonstrating
a greater medical need for
cardioprotection in ACS patients.
Many ACS patients receive
PCI treatment, therefore the ACS
indication will capture a significant
number of the higher risk PCI patients.
MC-1 has already demonstrated
positive results in high risk PCI
patients in the Phase II MEND-1 study,
giving us confidence in its success
in an ACS study that would enroll
a similar patient population.


How big is the ACS market?
Are there cardioprotective
products already approved
for this indication?

There are approximately 1.5 million
patients diagnosed with ACS in the
U.S. each year, with a similar number
diagnosed throughout the rest of
the world. Patients diagnosed with
ACS receive numerous therapeutics
(antithrombotics, etc.) in the hospital,
however there are currently no
cardioprotective products approved
to reduce events following the diagnosis
of ACS. Similar to the application of
MC-1 in CABG patients, ACS patients
would receive MC-1 on top of their
current standard of care treatment.


Does Medicure need to do
any Phase I or Phase II testing
for MC -1 for ACS ?

Medicure plans to proceed directly
into a pivotal Phase III study with
MC-1 for ACS. Based on ongoing
discussions with the FDA, Medicure
believes that both the Phase II MENDCABG
and the Phase III MEND-CABG II
studies will be considered supportive
for an ACS label for MC-1.

When does Medicure plan on
starting a Phase III study in ACS ?

Medicure plans to initiate a Phase III
study in ACS patients subsequent to
entering into a licensing arrangement
for MC-1. The Company is holding
discussions with several such
potential partners and will continue
to pursue a partner for the acute
application of MC-1 in ACS and
CABG surgery.


Why is Medicure combining MC -1
with other cardiovascular drugs.

Medicure has completed clinical studies
demonstrating MC-1’s efficacy in
controlling chronic conditions
such as hypertension, dyslipidemia,
and diabetes. There are a number
of high profile, proven cardiovascular
drugs that are currently or imminently
off patent, that Medicure is targeting
for MC-1 combinations. The first of
these products in development is
MC-4232, a combination of MC-1 and
the ACE inhibitor, lisinopril.

What are the target markets
for MC -4232?

MC-4232 is being developed for
patients with coexisting diabetes and
hypertension. There are approximately
15 million patients in the U.S. with these
coexisting conditions. MC-4232 is one
of the only drugs in development that
has demonstrated efficacy in controlling
blood pressure, blood sugars, and lipids.
Furthermore patients with diabetes
and hypertension are at high risk for
ischemic heart disease, so providing
MC-1 chronically in combination
with an ACE inhibitor could provide
cardioprotection in this high risk
patient population. In the past year
Medicure completed the 120 patient
Phase II MATCHE D study demonstrating
the positive clinical effects of MC-4232
on blood pressure, blood sugar,
and lipids.


Does Medicure plan to develop
other combination products?

Yes, Medicure has plans to develop
other MC-1 combination products
in addition to MC-4232. The strategy
is to develop novel combinations with
MC-1 which provide additional patent
protection and brand life to leading
cardiovascular products facing patent
expiration. The Company has already
announced the development of an
Angiotensin Receptor Blocker (ARB)
combination, known as MC-4262,
and has plans to explore and develop
additional combinations with a HMG
CoA Reductase Inhibitor (Statin) and
other leading cardiovascular products.

What are the next steps for
Medicure’s combination strategy?

There is a significant market opportunity
for Medicure’s combination products.
Nonetheless, in the next year Medicure
will allocate the majority of its current
capital and human resources towards
the Phase II CABG study with MC-1.
Medicure plans to accelerate the
development of MC-4232 and other
combination products upon the
consummation of a partnering
agreement for MC-1.




Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 23.600.540 von cristrader am 24.08.06 18:49:02

Moin zusammen,
habe mir auf Empfehlung den Wert auch angeschaut...die pipeline ist -vor allem wegen scheinbar geringer risiken- imponierend...dagegen ist das interesse wirklich gering. Kommt sicher noch..

Hinsichtlich der in Rede stehenden Partnerschaft:

Die Kosten für die Phase III (MC 1) belaufen sich nach Unternehmensangaben bei ca. 35 Mio $. Umsatzpotential: ca. 500 Mio $/Markteintritt ca. 2008/2009

Das zweite Leadmedikament MC-4232 (eigentlich der dickere Fisch)soll alleine durch die Phase III gebracht werden. Die Kosten sollen ca. 15 Mio $ betragen. Umsatzpotential: ca. 1,5 Mrd.$/Markteintritt 2009

also insgesamt sicher weit über 50 mio in der Phase III für beide kandidaten..die kosten der restlichen pipeline außen vor.Cash momentan unter 10 mio.... Das ist wohl kaum ohne partner zu wuppen...

grüße,
brom

[cristrader]

Antwort auf Beitrag Nr.: 23.625.141 von brombeeren am 26.08.06 20:41:18

Hallo brombeeren!

Freut mich von deinem Interesse an MCU zu hören.

Zu deinen Anmerkungen gibts noch einige Ergänzungen zu machen:

-durch die letzte Kapitalerhöhung beträgt der aktuelle Cash-Bestand etwas über 30 Mio $.

-die 500 Mio$ Umsatzpotential gelten nur für die Indikation MC-1 CABG

-die Indikation MC-1 für ACS (Acute Coronary Syndrome) hat ein Umsatzpotential von 1,5 Mrd. $

Der Phase III-Start von MC-1 für CABG wird als erstes stattfinden, während die Phase III-Starts von MC-1 für ACS sowie von MC4232 erst nach Bekanntgabe der Partnerschaft durchgeführt werden soll.

MC-4232 hat zwar mit möglichen 15 Mio Patienten/Jahr einen riesigen Markt vor sich. Die Konkurenzsituation ist allerdings auch etwas stärker. Für die Indikation MC-1 für CABG gibt es bisher keine Behandlungsmöglichkeit. Als erstes Medikament in dieser Indikation wird MC-1 den Kuchen erstmal nicht teilen müssen. Konkurrenz in dieser Indikation ist sehr wenig in der Entwicklung. Am nächsten kommt noch Neuren Pharma´s Glypromate das ebenfalls in Kürze in Phase III eintritt. Im Unterschied zu MC-1 welches vor Herzschäden nach der CABG-Prozedur schützt soll Glypromate vor neurologischen Schäden schützen.

Wenn alles normal läuft wird Medicure im Frühjahr´07 drei Phase III-Versuche am Laufen haben mit immensen Marktpotential. Wenn sich die überragenden Phase II-Ergebnisse in den Phase III-Tests bestätigen sind in den nächsten beiden Jahren gigantische Kurssteigerungen zu erwarten. Angesichts des riesigen Markt- und Umsatzpotential ´von Medicures Pipeline erwarte ich einen Deal der die Marktkapitalisierung um ein mehrfaches übersteigt.

Ich bin geradezu euphorisch was die Aussichten Medicures betrifft und sehe vielleicht alles alzu sehr mit rosaroter Brille! Das sich trotz der Aussichten so gut wie niemand für Medicure interessiert ist schon verblüffend gibt einem allerdings auch die Möglichkeit vor der breiten Masse günstig einzusteigen!

Grüße cristrader

[KnigRollo]

Antwort auf Beitrag Nr.: 19.470.878 von cristrader am 31.12.05 11:55:18

hi cristrader...

tut sich hier mal was.. ruhe vor dem sturm... ?

oder hast du dich schon aus dem stock verabschiedet...?

kursverlauf ist immer sehr mysteriös... wird hier professionell gedrückt ?

gruß rollo

[KnigRollo]

Antwort auf Beitrag Nr.: 21.468.038 von cristrader am 07.05.06 21:10:59

in deiner nachricht von mai hattest du wohl recht.. ???

Hallo!

Leider wenig erfreuliche News mit einer weiteren Kapitalerhöhung!
Man muss sich die Frage stellen wieso das Management ohne akuten Finanzbedarf zwei Kapitalerhöhungen durchführt kurz vor einer möglichen MC-1 Partnerschaft mit einem Big Pharma!

Das lässt natürlich viel Raum für Spekulationen.

-die mögliche Partnerschaft steht wohl frühestens Ende Sommer/Anfang Herbst bevor

-das Management scheint wohl den Mund etwas zu voll genommen zu haben mit dem angeblich so grossen Interesse von Big Pharma

-CEO und Präsident sieht kurz- bis mittelfristige Marktkapitalisierung bei 750 Mio bis 2 Millarden $ und verscherbelt ein Fünftel des Unternehmenswertes für 25 Mio? Wie passt das zusammen? weinen

-Sinn macht diese Kapitalerhöhung eigentlich nur wenn man beabsichtigt die Phase III-Studien der beiden Leadmedikamente alleine durchzuführen.

-teuer erkaufte Coverage in US und Europa auf Kosten der Shareholder

[cristrader]

Antwort auf Beitrag Nr.: 24.526.307 von KnigRollo am 09.10.06 21:47:12

Hallo KnigRollo!

Habe zurzeit relativ wenig Zeit zum Posten!

Habe die Rücksetzer der letzten Wochen genutzt um meinen MCU-Bestand nochmal deutlich aufzustocken (mittlerweile 90% Depotanteil)! Dafür musste YMI dran glauben Zudem bin ich in den letzten Wochen in Starpharma eingestiegen (absolute Hammeraktie unbedingt anschauen!!!)

Mittwoch findet die Jahreshauptversammlung von MCU statt dann werden wir sicherlich einige neue News erhalten.

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 24.527.634 von cristrader am 09.10.06 23:04:05

Hallo zusammen,

die Fragen von Knig Rollo sind berechtigt..sehe große Widersprüche in der strategischen Ausrichtung... Es fällt schwer daran zu glauben, dass die Phase III alleine geschultert werden soll...In diesem Fall ist die Kurs- und Risikoentwicklung -so finde ich- schwer abzuschätzen. Es wäre nicht die erste hervorragende Pipeline, die durch Managementfehler zerschrotet wird.

Hat jemand bereits die JahresHV analysiert ? Wo liegt der Hase im Pfeffer ? Habe ebenfalls MCU und starpharma gekauft, glaube aber im Gegensatz zu cristrader noch an das gute Ende bei YMI.

Gruß, Brombeeren

[cristrader]

Hallo brombeeren!

Grundsätzlich halte ich YMI immer noch für ein Biotech mit einem super Chance/Risiko-Profil. Medicure und Starpharma halte ich aktuell allerdings für noch wesentlich aussichtsreicher. Lt. Biotech Monthly gibt es einige Hedgefonds die geradezu auf ein Scheitern von Tesmilifene warten um dann zu Ausverkaufskursen vor allen Dingen wegen Nimotuzumab in YMI einzusteigen.


Wo der Hase bei Medicure im Pfeffer liegt?

Die Shareholder werden langsam ungeduldig! Dr. Friesen verspricht schon seit Jahren von einer baldigen Partnerschaft. Jetzt bei der AGM sagt er das er keine Partnerschaft macht nur um der Partnerschaft Willen sondern das der Partnerschaftsdeal den Unternehmenswert signifikant erhöhen müsse. Das bedeutet nichts anderes als das die bisherigen Offerten nicht Dr. Friesens Erwartungen entsprechen. Das lässt auch Zweifel bezüglich MC-1 aufkommen. Ist das Marktpotential doch nicht so enorm? Gibt es Zweifel an der Wirksamkeit? Ist das Interesse von Big Pharma so gering?



Der Phase-III Start von MC-1 ist bis Ende November angeküngigt und wird mit oder ohne Partner gestartet. Das Management hat sich jetzt meiner Meinung nach in eine heikle Lage gebracht. Entweder gibt es in Kürze eine Partnerschaft oder eine weitere (dritte) Kapitalerhöhung ist fällig. Zum einen verschlechtert das die Verhandlungsposition gegenüber Big Pharma zum anderen gibt es für Instis einen gewichtigen Grund den Kurs zu drücken um bei einer Kapitalerhöhung günstiger zum Zuge zu kommen.



Die Aussichten bleiben allerdings phänomenal. Die traditionell für Biotechs besten Börsenmonate stehen uns noch bevor und mit dem kommenden Newsflow (drei Phase III-Starts/Us Coverage/Partnerschaftdeal u.a.) ist doch einiges zu erwarten.


Grüße cristrader

[KnigRollo]

wir sind gespannt wie ein flitzebogen...
unverhofft kommt ofz..

aus so einer Aussage erwarte ich doch einen Deal vor dem phase III start..

inwieweit müsste so was nicht mit dem zukünftigen partner abgesprochen werden, oder reicht die auseinandersetzung mit der fda ??

[brombeeren]

Antwort auf Beitrag Nr.: 24.590.872 von cristrader am 12.10.06 23:18:32

hallo zusammen, hallo cristrader,

nicht nur hedge fonds werden bei ymi diese strategie fahren, fürchte ich... Die, die zu eher hohen Kursen gekauft haben und noch auf eine Zulassung von tesmi hoffen, müssen halt die zähne zusammenbeißen. Habe mich gegen einen Verkauf entschieden und gehe somit sehr laaang.

Medicures Hasen im Pfeffer konntest du scheinbar auch nur ungefähr verorten... Denn warum-wie du zu recht fragst- ist denn das Interesse von BigPharma scheinbar so gering...? Wenn das Interesse an medicure nur halb so groß wäre, wie die aussichten der pipeline momentan so erscheinen, dann müßte doch bei mehreren Interessenten der deal :confusednun endlich anstehen... Bei einer weiteren Kapitalerhöhung und alleinigem Marsch in Phase III läuft jedenfalls irgendetwas quer...

Hoffen wir das Rollo mit seiner Deutungsarbeit Recht behält

Übrigens ist dieser Thread schon lange nicht mehr über die Hauptseite Medicure bei wallstreet erreichbar, was die leserschaft offensichtlich klein macht....

Grüße Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 24.614.475 von brombeeren am 14.10.06 12:12:23

Hallo brombeeren!

Eine Kapitalerhöhung macht wirklich nur Sinn wenn die Phase III komplett in Eigenregie durchgeführt wird, alles andere wäre totaler Unsinn. Nur selbst bei einer Kapitalerhöhung wird es nicht möglich sein alle drei Phase-III-Starts selbst zu managen. Medicure hat bei der FDA für die Phase III ein SPA (Special Protocol Assessment) beantragt. Bin mal gespannt wie die genauen Details sein werden. Laut Dr. Friesen haben zwei US-Analysten ausführliche Recherche bezüglich MCU betrieben möglicherweise folgt bald die lang ersehnte US-Coverage.

Hier noch ein Bericht zur AGM:

Medicure mulling possible partnerships for its MC-1 lead drug
19:16:52 EDT Oct 11, 2006
Canadian Press: RITA TRICHUR
TORONTO (CP) - Heart drug developer Medicure Inc. (TSX:MPH) says it is considering possible partnerships to support the clinical development and commercialization of its lead drug MC-1.

President and CEO Albert Friesen made those remarks at the company's annual meeting late Wednesday, noting discussions with potential partners have already begun. "Medicure and I, personally, are committed to obtaining the greatest value for MC-1 and our drugs," Friesen told investors gathered at the TSX Broadcast Centre in Toronto.

"One of the ways of getting a good value for that is in partnership to drive not only the clinical development, but the commercialization and putting money on the table."

MC-1, Medicure's lead cardioprotective drug, is beginning a pivotal Phase 3 study this year as a treatment to reduce injury in patients undergoing coronary artery bypass graft surgery.

The U.S. Food and Drug Administration recently granted MC-1 "fast track designation," the company said.

"But we believe that a partnership deal must add significant value for the shareholders," Friesen added. "We are not going to stop the development to wait for a partner."

Earlier in the day, the company announced the launch of its U.S. sales organization to support sales and marketing for another heart drug called Aggrastat, which is used to treat acute coronary syndrome, including angina and myocardial infarction.

It also announced the opening of its wholly owned U.S. subsidiary, Medicure Pharma Inc., in Somerset, New Jersey.

Winnipeg-based Medicure acquired the U.S. rights to Aggrastat from MGI Pharma Inc. for US$19 million last month but continues to make royalty payments to Merck & Co. Inc., the drug's developer.

Aggrastat began selling in the United States in 1998 and is currently available in 82 countries. Merck continues to market it outside the United States, including in Europe where 2005 sales hit US$88 million.

Merck sold the U.S. rights to Aggrastat in 2003 to Guilford Pharmaceuticals Inc., which was later acquired by MGI Pharma.

Total U.S. sales for similar drugs in 2005 were more than $450 million US, including about $10.9 million US for Aggrastat.

Friesen, however, declined to provide specific guidance Wednesday on how the company plans to grow its U.S. sales.

Prior to the meeting, Medicure's shares gained a penny to close at $1.69 on the Toronto Stock Exchange.




Grüße cristrader

[KnigRollo]

hohes volumen und das teil schmiert ab..

das gefällt mir nicht !!

[brombeeren]

dafür sieht das schon besser aus http://www.canadianinsider.com/coReport/allTransactions.php?…

wird jetzt bald was passieren...

Gruß brombeeren

[KnigRollo]

das ist schon zu lange her.... die kriegen keinen partner....

das meint zumindest die börse..

[toothstone]

@ brombeeren

was sollen denn eingelöste options zu einem scheißkurs?

[cristrader]

Windhover Information's 2006 Therapeutic Alliance Series: Cardiovascular Conference


NORWALK, Conn.--(BUSINESS WIRE)--Oct 23, 2006 - Windhover Information's 2006 blockbuster partnering meeting, "Therapeutic Alliances: Cardiovascular Conference," a meeting point for business development and R&D that is focused strictly on cardiovascular technology, still has a few spaces available.

The conference, the most efficient partnering meeting this year for the cardiovascular industry, is slated for Nov. 15-16 in Chicago, immediately following the American Heart Association conference. Online registrations are still being accepted at www.cardioalliances.com.



Online partnering is now officially open. Registered attendees have access to Windhover's proprietary online, interactive partnering system, which enables participants to market their company and developments and engage in an ongoing dialogue with potential partners. Companies are therefore able to move quickly from identification of prospective partners to face-to-face meetings.

Companies from the US, Switzerland, South Korea, Finland, Denmark, Canada, the United Kingdom and Germany are among those on the attendee list. Among the major players planning to attend are Boehringer Ingelheim, Genzyme Corp., Merck, Novartis, Orion Corp., Pfizer, The University of Pittsburgh and Wyeth.

A complete list of attending companies to date is available at www.cardioalliances.com.

Windhover's most promising projects

The Top 10 Unpartnered Licensable Cardiovascular Projects list, developed by Windhover and Defined Health, is an eagerly-awaited feature of TA: Cardio.

Presentations from the companies will include the product's target and first indication(s); other compounds addressing the same target; the relative advantage of the compound; the clinical results to date and general clinical plan for the future; IP on the compound or target; any partnerships currently held on the compound; and competitive advantage in the marketplace.

The presenting companies to date are (listed in no specific order):

-- Proteo Biotech AG Compound: Elafin, a human protein that inhibits leukocyte elastase and proteinase 3. Elafin is produced in human skin, lungs and mammary gland naturally. Elafin seems to protect cells against destruction by the immune system. Inner organs, particularly muscles and vessels, do not contain Elafin, and therefore may be destroyed by the immune system, if affected by an inflammation.

-- ARYx Compound: ATI-2042, a proprietary compound in Phase 2 development for the treatment of atrial fibrillation (AFIB). ARYx has engineered ATI-2042 with the goal of developing a therapy equally effective but safer than the "gold standard" treatment, amiodarone.

-- Cytokinetics Compound: CK-1827452, a novel, small-molecule, direct activator of cardiac myosin.

-- Forbes Medi-Tech Inc. Compound: FM-VP4 (disodium ascorbyl phytosanyl phosphate), novel analogue of phytostanols which has demonstrated dramatic cholesterol-lowering and anti-atherosclerotic properties in pre-clinical trials. Study results showed that FM-VP4 was well tolerated and had significant LDL-lowering activity.

-- deCODE genetics Compound: DG 031, aimed at lowering risk of heart attack by inhibiting the activity of this pathway and reducing LTB4 production.

-- Isis Pharmaceutical Compound: ISIS 301012, a second-generation antisense inhibitor of apolipoprotein B-100 (ApoB), which has demonstrated potent, prolonged dose-dependant reduction of ApoB, cholesterol, low-density lipoprotein (LDL-C) and very low-density lipoprotein (VLDL) in Phase 1 trials. Triglyceride levels were also reduced.

-- Medicure Inc. Compound: MC 1, a potential treatment for blockages of blood to the heart (i.e. myocardial ischemia, associated with heart attacks, angina and arrhythmia) and the brain (i.e. ischemic stroke) and to prevent injury from ischemic reperfusion injury.

-- Surface Logix Compound: SLX 2101, an oral selective, fast-onset, long-acting (48 h) PDE-5 inhibitor designed specifically to expand the therapeutic potential of PDE-5 inhibition beyond erectile dysfunction into larger cardiovascular markets.

-- Viron Therapeutics Inc. Compound: VT 111, the first in a completely new class of therapeutic compounds for the treatment of inflammatory-based disorders. VT-111 will soon enter the clinic in its second indication, chronic organ rejection in transplant patients. In pre-clinical testing, VT-111 has shown a remarkable ability to reduce atherosclerosis and increase the stability of vulnerable plaques that can cause heart attacks; and the completed Phase I clinical study demonstrated a strong safety profile with no adverse events.

Top cardio experts to share insights

In addition to partnering and networking, attendees at TA: Cardio will be able to benefit from workshops and sessions led by industry leaders. The agenda includes:

-- Heart of the Matter: Key Issues and Opportunities in the Cardiovascular Drug Space with Michael Rice, Consultant, Defined Health

-- Translating Cardiovascular Advances into Prescribed Drugs moderated by Edward C. Saltzman, President, Defined Health, and with Dr. Richard Pasternak, Vice President of Clinical Research in Cardiovascular/Atherosclerosis, Merck and Co.; and Robert A. D. Scott, MD, Executive Vice President of Research & Development and Chief Medical Officer, AtheroGenics.

-- Trends, Valuations, and Success Rates in Cardiovascular Business Development: What Every Dealmaker Needs to Know with John Delyani, PhD, MBA, Director, Strategic Alliances Cardiovascular Diabetes & Metabolism, Novartis Institutes for Biomedical Research

-- Workshop: Modeling your Market and Commercial Value for your Cardiovascular Drug

-- Workshop: Best Practices in Cardiovascular Clinical Trials

The complete schedule to date is available at http://www.cardioalliances.com.

Sponsorship opportunities available

The Cardiovascular Alliances Conference is sponsored by DefinedHealth and Merck. Media sponsors are Business Wire, Cardiovascular Drug News and CanBiotech. Sponsorship opportunities can still be arranged by contacting Stefanie Greenberg at [phone] x109 or [e-mail].

To register, contact Alexandria Riley at [phone] ext. 113 or [e-mail]; or register on the TA Cardiovascular Alliances Conference 2006 website at www.cardioalliances.com.

About Windhover Information

[cristrader]

Am besten Link anklicken!

http://www.theheart.org/article/750615.do

MC-1 shows promise in reducing perioperative MI in high-risk patients undergoing CABG

October 27, 2006 Marlene Busko






Vancouver, BC - Findings from the MC-1 to Eliminate Necrosis and Damage in CABG (MEND-CABG-1) phase 2 trial suggest that among high-risk patients undergoing CABG, 30-day therapy with MC-1 (pyridoxal-5-phosphate) is safe and appears to reduce perioperative MI, defined as peak creatine kinase MB isoenzyme (CK-MB) >100 ng/mL. The results were presented in a late-breaking trial session at the Canadian Cardiovascular Congress 2006 [1].

Lead investigator Dr Jean-Claude Tardif (Montreal Heart Institute, QC) told the audience that despite the benefits, the risks that are associated with CABG—death, MI, heart failure, arrhythmias, renal insufficiency, and stroke—are not trivial, and are often due to ischemia and reperfusion. "The incident rates of major vascular events in high-risk patients following CABG can be up to 20%," he said.

The randomized, placebo-controlled MEND-CABG-1 trial was sponsored by Medicure Inc (Winnipeg, MB), the developer of MC-1. This drug is a purinergic P2-receptor antagonist that blocks intracellular calcium influx, potentially reducing cell damage and cell death. The primary objective of the study was to evaluate the potential cardioprotective and neuroprotective effects of MC-1 in patients considered to be at high risk for perioperative vascular events when undergoing CABG.

To qualify for the study, patients had to be scheduled for CABG surgery and have at least two specified high-risk characteristics (such as age >65 years, current smoker, diabetes). A total of 901 high-risk patients were randomized to one of three arms: placebo (n=299); MC-1 250 mg/day (n=301); or MC-1 750 mg/day (n=301). Patients received a dose of MC-1 or placebo three to 10 hours before surgery, and then every day for 30 days; they were then followed for an additional 60 days. The 250-mg dose emerged as the more effective dose of MC-1.

The primary efficacy end point was a composite of cardiovascular death, nonfatal MI (defined as peak CK-MB >50 ng/mL), and nonfatal cerebral infarction up to and including postoperative day 30. Secondary end points were the individual and composite end points up to postoperative day 90.

Most of the study patients were men. The most common risk factors were hypertension, age >65 years, previous MI, and diabetes.

The drug was well tolerated. In the MC-1 250 mg/day group, the 14% reduction in the composite primary end point with the prespecified peak CK-MB level of 50 ng/mL was not statistically significant.

However, when the team performed exploratory analyses using a higher peak CK-MB level (for example >100 ng/mL)—as was used in large studies such as GUARDIAN and PRIMO-CABG—treatment with MC-1 was associated with a significant reduction in perioperative MI and in the composite end point.

Outcome 30 days after CABG: MC-1 250 mg/day vs placebo


Peak CK-MB level used to define MI, ng/mL
Reduction in composite endpoint*, %
p

>50
14.0
0.3124

>70
32.3
0.0349

>100
37.2
0.0283




*Composite endpoint = cardiovascular death, nonfatal MI (defined by peak CK-MB), and nonfatal cerebral infarction

Outcome 30 days after CABG: MC-1 250 mg/day vs placebo


Peak CK-MB level used to define MI, ng/mL
Reduction in perioperative MI, %
p

>50
15.2
0.2988

>70
37.6
0.0192

>100
47.2
0.0083




To download tables as slides, click on slide logo below

Tardif concluded: "We think that a larger trial needs to be performed and we just launched the MEND-CABG-2, which will have 3000 patients. In couple of years we will be able to tell you if we can confirm these results."



Drug "could be very important"
Dr Stephen Edward Fremes (University of Toronto, ON), who was assigned to comment on this presentation, told the audience that there are few randomized controlled trials in cardiac surgery, and they are generally flawed. "MEND-CABG-1, on the other hand, was a moderate-sized, multicenter, blinded trial, and the primary end point was a relevant, robust clinical outcome," he said. One of his concerns was that the definition of MI as a peak CK-MB >50 ng/mL resulted in a high signal-to-noise ratio; a higher threshold would have resulted in a positive study.

Fremes concluded: "MC-1 appears safe, at least in a dose of 250 mg/day; it appears feasible; and it may reduce perioperative MI. I recommend a larger trial be done, such as the one that is being initiated. . . . Perioperative MI remains an important adverse outcome following cardiac surgery, and a simple, safe, preventive strategy such as MC-1 could be very important."

[cristrader]

Hallo Leute!

Lasst euch vom Kursverlauf nur nicht nervös machen!

Die Jahreshauptversammlung (AGM) hat deutlich den Hinweis gegeben das die Phase III erstmal alleine gestartet wird und keine Partnerschaft unmittelbar bevorsteht zudem wird eine weitere Kapitalerhöhung immer wahrscheinlicher. Das ändert alles nichts an der Story sondern nur am Zeitrahmen. Der momentane Kursrückgang hat wohl grösstenteils steuerliche Gründe. Für amerikanische Fonds endet Ende Oktober das Steuerjahr. Fonds die im Frühjahr zu höheren Kursen eingestiegen sind sichern sich ihre steuerwirksamen Verluste.

Jetzt gilt es erstmal den Phase III-Start abzuwarten. Es wird interessant sein wie das SPA (Special Protocol Assessment) mit der FDA gestaltet wird insbesondere ob es vielleicht vorzeitige Abbruchkriterien gibt.


Grüße cristrader

[cristrader]

Hallo!

Der Trend wendet sich zum Guten!

Heute fand die Präsentation auf der Rodman & Renshaw Konferenz statt.

Hier das wichtigste:

MC-1 Fahrplan lt. CEO/Präsident Friesen

-MC-1 Phase III Genehmigung und SPA(Special Assessment Protocol) in den nächsten Wochen

-Beginn der Patientenrekrutierung bis Ende 2006
-Abschluss der Rekruitierung nach 121 Monaten also Ende 2007
-Zulassungsantrag ca. 2.Quartal 2008
-mit Fast Track Status erfolgt Zulassung ca. Ende 2008


Besonders interessant:

"we are also in fairly advanced discussions with a couple, no three pharma companies to partner this in the next little while for world wide rights. One of the things we had looked to was to continue to perhaps retain co-marketing or co-promotion in the U.S. & North America, but we are in advanced discussions with a number of partners."

MCU ist in ziemlich fortgeschrittenen Partnerschaftsdiskussionen mit drei Pharmaunternehmen über weltweite Rechte. Ziel ist es auch Co-Marketing Rechte in den USA zu erhalten.

Vielleicht kommen wir ja doch um eine Kapitalerhöhung herum.


Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 25.226.487 von cristrader am 08.11.06 21:01:10

"Abschluß der Rekrutierung nach 12 Monaten"


Diese News kann sehr bedeutend werden!

Medicure Announces New Aggrastat'R' Data to be Presented at 2006 Scientific Sessions of the American Heart Association
Monday November 6, 6:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Nov 6, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that an abstract outlining a recently completed meta-analysis comparing Single High-Dose Bolus AGGRASTAT® (tirofiban) and ReoPro® (abciximab) in patients undergoing percutaneous coronary intervention (PCI) will be presented at the 2006 Scientific Sessions of the American Heart Association (AHA), which is being held November 12-15, 2006 in Chicago, Illinois. Medicure acquired the exclusive U.S. rights to AGGRASTAT®, a glycoprotein (GP) IIb/IIIa inhibitor, in August 2006.
ADVERTISEMENT


The abstract titled, "Meta-analysis of high-dose single-bolus tirofiban versus abciximab in patients undergoing PCI" will be presented by Dr. Bart Dawson, from the Cardiovascular Medicine Division, University of Kentucky College of Medicine, between 9:30 AM and 11:00 AM Central Time, Tuesday November 14th in a poster session in Hall A2 of the McCormick Place Convention Center.

"This meta-analysis is a compilation of 5 clinical trials evaluating the safety and efficacy of Single High-Dose Bolus tirofiban against abciximab in PCI patients," commented Dr. Moliterno, Chief of Cardiovascular Medicine at the University of Kentucky and the study's senior author. "Head-to-head data between GP IIb/IIIa inhibitors are very limited, therefore this meta-analysis provides a unique and direct comparison of two drugs within the class. We look forward to sharing these findings with the cardiovascular community at AHA."



Bisher wurde die Aquisition der Aggrastat US-Rechte als eher negativ gesehen obwohl der Preis sicherlich sehr niedrig war.

Kurze Info zu Aggrastat:

Es gibt drei Medikamente die bei Patienten mit instabiler Angina Pectoris oder bei NON-Q-Wave-Myokardinfarkten eingesetzt werden und zwar Aggrastat, ReoPro und Integrilin.

Aggrastat ist Marktführer in Europa, während Aggrastat in den USA nur ca. 10 Mio $ Umsatz macht, das heißt nur etwa 2% des 400 Mio $ US-Gesamtmarktes. Der Rest des Marktes teilen sich ReoPro und Integrilin. Aggrastat wurde nach mehreren Rechtewechseln und Übernahmen der Rechteinhaber in den letzten Jahren nicht mehr vermarktet was was diese Diskrepanz zu Europa erklärt. Mit dem Aufbau der Vertriebsmannschaft vor drei Wochen will man den Marktanteil erhöhen.

Es gab vor einigen Jahren (2001) eine Studie nach der ReoPro im Vergleich zu Aggrastat(Tirofiban) überlegen war.
http://www.expertopin.com/doi/abs/10.1517/14656566.2.9.1507
"ReoPro rules: results from the 'Do Tirofiban and ReoPro Give Similar Efficacy Trial' (TARGET)
Sheila A Doggrell‌
Department of Physiology and Pharmacology, The University of Queensland, Brisbane, 4072 Australia, E-mail: [e-mail]

In the treatment of atherosclerotic disease, stenting in the presence of a glycoprotein (GP) IIb/IIIa antagonist is becoming an increasingly common procedure. The 'Do Tirofiban and ReoPro Give Similar Efficacy Trial' (TARGET) was designed to determine whether the cheaper tirofiban was as effective and safe as abciximab in the prevention of ischaemic events with stenting. Unexpectedly, abciximab was shown to be superior to tirofiban. Tirofiban is a selective GP IIb/IIIa antagonist whereas abciximab has additional anti-inflammatory actions, which may contribute to its superiority.


Diese Überlegenheit von ReoPro(wesentlich teurer als Aggrastat!) wurde von Ärzten angezweifelt. Mit der richtigen Dosierung könnte Aggrastat die gleiche Wirkung bei weitaus geringeren Kosten haben.
http://eurheartj.oxfordjournals.org/cgi/reprint/23/11/835

Der gleiche Arzt hat folgende Studie durchgeführt:
http://clinicaltrials-nccs.nlm.nih.gov/ct/show/NCT00383136;j…

Diese Studie soll zeigen ob Aggrastat vergleichbar oder zumindest nicht unterlegen ist.


Diese Studie wurde vor kurzem fertiggestellt und die Ergebnisse werden am 14. November vorgestellt!

Nun man kann davon ausgehen das das MCU-Management die Ergebnisse bereits kennt. Würde MCU diese Pressemeldung veröffentlichen wenn die Ergebnisse nicht vorteilhaft sind!

Vorteilhafte Ergebnisse würden den Wert von Aggrastat erheblich erhöhen und die Vermarktung erheblich begünstigen!

Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 25.229.534 von cristrader am 08.11.06 22:15:14

Hallo!

Sehr gute News!

Medicure Announces New AGGRASTAT'R' Data at 2006 Scientific Sessions of the American Heart Association


WINNIPEG, MANITOBA, Nov 14, 2006 (MARKET WIRE via COMTEX) -- Medicure Inc.
(TSX: MPH)(AMEX: MCU), a cardiovascular focused biopharmaceutical company, today
announced that new data comparing Single High-Dose Bolus AGGRASTAT(R)
(tirofiban) versus ReoPro(R) (abciximab) in patients undergoing percutaneous
coronary intervention (PCI) were presented today at the 2006 Scientific Sessions
of the American Heart Association (AHA) in Chicago, Illinois. Medicure acquired
the exclusive U.S. rights to AGGRASTAT(R), a glycoprotein (GP) IIb/IIIa
inhibitor, in August 2006.Dr. Bart Dawson, from the Cardiovascular Medicine Division, University of
Kentucky College of Medicine, presented results from a meta-analysis of 5
prospective randomized studies comparing Single High-Dose Bolus (25 mg/kg)
tirofiban plus infusion with conventional abciximab regimen on the 30-day
composite of death, myocardial infarction (MI) and target vessel
revascularization (TVR), in 1392 patients undergoing PCI. The study results
demonstrated an event rate for the 30-day composite of 6.1% with tirofiban and
7.3% with abciximab (p=0.46). There were no significant differences in major and
minor bleeding and thrombocytopenia between the groups."This pooled analysis of existing data suggests that Single High-Dose Bolus
tirofiban may be as effective as abciximab in patients undergoing PCI with a
comparable safety profile," commented Dr. David Moliterno, Chief of
Cardiovascular Medicine at the University of Kentucky and the study's senior
author. "Given the substantial price difference between the two products, Single
High-Dose Bolus tirofiban would be a cost effective alternative to abciximab for
PCI patients."About Medicure Inc.Medicure is a biopharmaceutical company focused on the research, development and
commercialization of novel compounds to treat cardiovascular disorders. The
Company's solid position in this field is highlighted by the following:- Two drugs, MC-1 & MC-4232, in late stage clinical development- Four positive Phase II trials completed with MC-1- FDA Fast Track designation for MC-1- U.S. rights to AGGRASTAT(R) Injection (tirofiban hydrochloride)- Dual action antithrombotic, MC-45308, with positive preclinical resultsMedicure also has a medicinal chemistry based Drug Discovery program focused on
discovery and advancement of novel small molecule anti-ischemics and
antithrombotics towards human clinical studies.



Bei fünf Vergleichsstudien mit 1392 Patienten zwischen Aggrastat und ReoPro schnitt Aggrastat vergleichbar bzw. sogar leicht besser ab.

Wenn man bedenkt das Aggrastat ca. 10 Mio $ Umsatz jährlich hat und ReoPro ca. 100 Mio. $ (bei deutlich höheren Preis!!!) sollte die neue Vertriebsmannschaft von Medicure dieses Missverhältnis zumindest teilweise reduzieren können.


Diese sehr interessante deutsche Studie in der die drei Medikamente Aggrastat, ReoPro und Integrilin bezüglich Preise und Wirksamkeit analysiert wurden müsste wohl teilweise neu gestaltet werden!
http://gripsdb.dimdi.de/de/hta/hta_berichte/hta064_bericht_d…
"Die Kosten liegen bei A (ReoPro) pro Applikation bei € 1.050 gegenüber € 655 bei T (AGGRASTAT). Der höheren
Wirksamkeit von A (ReoPro) in der Behandlung von ACS stehen deshalb geringere Kosten pro
Applikation gegenüber. Das inkrementelle Kosten-Nutzen-Verhältnis (Kosten pro Applikation
mal NNT) variiert bei A (ReoPro) je nach Studie zwischen € 15.500 und € 30.300 und beträgt bei Trofiban (AGGRASTAT)
rund € 20.000."


Grüße cristrader

[cristrader]

Medicure Announces Initiation of Enrollment in Pivotal Phase III MEND-CABG II Study
WINNIPEG, MANITOBA -- (MARKET WIRE) -- November 17, 2006 -- Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular focused biopharmaceutical company, today announced it has commenced enrollment in the MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery.

"We are very pleased to have commenced the final stage of clinical development for MC-1 in CABG surgery. We look forward to the study outcome with confidence based on the positive results from the previous Phase II studies with MC-1," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We are appreciative of the support from the MEND-CABG II principal investigators and study chairs, who, along with the rest of the project team, were able to finalize the protocol and commence enrollment according to schedule."

"There are currently no approved cardioprotective products to reduce cardiovascular events after CABG surgery. MC-1 has the opportunity to be the first such product available to help the hundreds of thousands of patients undergoing CABG surgery every year" added Dr. Friesen.

About MEND-CABG II

MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. The study design was reviewed with the United States Food and Drug Administration (FDA). Study patients will be randomized to receive placebo or MC-1 250mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis.

Medicure is conducting the MEND-CABG II study in conjunction with the Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI). Principal investigators for the study are Dr. Robert Harrington, Director of DCRI, and Dr. Michel Carrier, Director of Cardiovascular Surgery Program at MHI. Dr. Jean-Claude Tardif, Director of the Research Centre, MHI, will serve as co-chair of the MEND-CABG II steering committee together with Dr. Robert W. Emery, Jr., Cardiac Surgical Associates.

The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase II MEND-CABG study, the results of which were announced in December 2005. MEND-CABG was a Phase II study involving 901 patients that evaluated two doses of MC-1, 250 mg and 750 mg, versus placebo in patients undergoing CABG surgery. While efficacy was seen with both dose groups, the 250 mg dose of MC-1 had the strongest effect with a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated at both dose levels. The incidence of adverse events in the study was comparable across both treatment and control groups.

About MC-1

MC-1 is a novel cardioprotective compound that prevents cardiac damage via inhibition of the purinergic receptors on cardiomyocytes (heart muscle cells). Medicure has completed two Phase II studies with MC-1 demonstrating its cardioprotective efficacy. In addition to the MEND-CABG study outlined above, the 60 patient MEND-1 study demonstrated that MC-1 had a statistically significant reduction in the cardiac enzyme CK-MB in patients undergoing percutaneous coronary intervention (PCI). MC-1 received a Fast Track Designation from the FDA in 2005.

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 25.483.628 von cristrader am 17.11.06 13:26:58

Hallo Cristrader
Ich beobachte immer noch. Nur gute News in letzter Zeit und der Kurs bewegt sich kaum. Ich rechne mit einer KE in nächster Zeit. Wenn vorher Partnerschaft habe ich den richtigen Zeitpunkt verpasst. Hatte aber schon 3 Mal das Glück kurz vor KE´s einzusteigen.

Gruss Solarblase

PS: Hoffe ja immer noch auf Tes

[cristrader]

Antwort auf Beitrag Nr.: 25.495.361 von solarblase am 17.11.06 20:23:32

Hallo Solarblase!

MCU hat zwar aktuell noch ca. 23-24 Mio $ Cash doch damit kommt man nur bis ins dritte Quartal 2007. Es ist also dringend eine Cash-Infusion nötig. Kommt die durch eine KE oder durch eine Partnerschaft? Die Unsicherheit einer drohenden KE ist ja auch das große Problem von Medicure. Bei aktuellen Kurs kann bei einer Kapitalerhöhung die benötigte Menge Cash nur durch eine kräftige Verwässerung erzielt werden. Ich könnte mich mit einer weiteren Kapitalerhöhung (ca. 30-40 Mio $) durchaus anfreunden wenn sich das Management fest entschließt die Phase III alleine durchzuführen. Beim vorgegebenen Zeitrahmen der MC-1 CABG-Phase III-Entwicklung - Zulassungsantrag 2 Q/08 und Zulassung mit Fast Track-Status Ende 2008 könnte sich das durchaus auszahlen.

Ich glaube aber nicht das es dazu kommen wird. Insbesondere die Äußerung von CEO Friesen auf der Rodman & Renshaw Konferenz
"wir sind in sehr fortgeschrittenen Verhandlungen mit drei Pharmaunternehmen für weltweite Vermarktungsrechte" macht mich da zuversichtlich.

Allgemein gesehen bin ich für die nächsten Monate megabullisch eingestellt insbesondere was die Biotechwerte betrifft. Das deutlich zunehmende Interesse von Pharmaunternehmen an Biotechübernahmen wird die ganze Sparte beflügeln. Ich denke mit Medicure bin ich da bestens positioniert!


Hier noch eine Slide-Show vom gestrigen Analysten und Investorentag:
http://library.corporate-ir.net/library/10/108/108925/items/…


Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 25.506.059 von cristrader am 18.11.06 14:56:06

Hallo zusammen,
die bemerkung von CEO Friesen scheint eindeutig für eine baldige Partnerschaft zu sprechen. Dennoch spricht Friesen schon weit über ein Jahr so daher... Der Markt reagiert darauf offensichtlich auch mit Vertrauensverlust. Der wird sich noch vergrößern, wenn dann entgegen diesen Äußerungen die KE kommt. Friesen ist dann (für mich) verbrannt.
Scheint also so, dass die Solarblase bisher ein besseres Timing bewiesen hätte als der Unterzeichner Trotzdem denke ich, dass die Partnerschaft bald kommt..und dann wird es nicht so billig wie jetzt.

Gruß Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 25.728.296 von brombeeren am 26.11.06 18:46:05

Hallo!


Ich habe schon mehrfach erwähnt das sich das Management in eine verzwickte Lage gebracht hat und der Markt reagiert entsprechend.

Friesen hat ja bei der letzten AGM deutlich gesagt das die Zahlen bisher nicht gestimmt haben, also das BigPharma bisher nicht bereit war die gewünschten Meilensteine und Revenues nach Friesens Vorstellungen hinzublättern. In einem Interview im März/April war Friesen überaus optimistisch das für MCU nach Phase III-Start eine Marktkap. zwischen 750 Mio und 2 Mrd. US $ gerechtfertigt sei. Um diese Vorstellungen zu erreichen ist natürlich ein entsprechend guter Deal vonnöten. Nur BigPharma ist natürlich auch nicht ganz blöd. Wieso sollte man mit MCU einen mehrere hundert Mio. $ umfassenden Deal eingehen, wenn man das komplette Unternehemen locker für schlappe 300 Mio. übernehmen könnte? Die Finanzsituation MCU´s spielt BigPharma natürlich voll in die Karten!

MCU hat dadurch nur zwei Optionen:

Entweder eine Kapitalerhöhung oder einen Deal mit geringeren Zahlen als angedacht. Beides nicht gerade optimal.

Es ist schon recht beachtlich was das Management nach dem Hype nach Bekanntgabe der super Phase II-Daten von MC-1 erreicht hat.

-zweimal wird positiver Kursverlauf jäh durch eine KE gestoppt.
-trotz der KE ist es nicht gelungen die involvierten Instis zu Coverage zu bewegen.
-kein Partnerschaftsdeal nach fast einem Jahr Verhandlungen mit div. Pharmas.


Trotz der glänzenden Perspektiven von MC-1 bestehen Zweifel ob dieses Management das Potential jemals (zugunsten der Shareholder) wird ausschöpfen können.

Hoffentlich gelingt es dem Management diese Zweifel bald zu beseitigen!

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 25.738.348 von cristrader am 26.11.06 23:58:58

Hallo cristrader,

deinem Beitrag ist wohl -wie des öfteren- nichts mehr hinzu zu fügen... vielleicht noch, lieber ein mittelmäßiger bis etwas schwächlicher Deal als eine KE...

Gruß brombeeren

[cristrader]

Hallo!

Charttechnisch wird es jetzt interessant. Fällt die 1,20 $-Marke wird wohl nochmal die 1,0 $-Marke getestet, ansonsten sehen wir wohl wieder einen Rebound in den Bereich von 1,65 $. Die MCU Präsentation am 28.11. auf der Lazard Capital Konferenz konnte den Kursverfall leider nicht stoppen. Trotz der deutlichen Hinweise das die Partnerschaft unmittelbar bevorsteht bleibt der Markt skeptisch. Das Management scheint jeglichen Kredit verspielt zu haben. Mit bloßen Ankündigungen und leeren Versprechungen geben sich die Investoren mittlerweile nicht mehr zufrieden. Es wird Zeit die Partnerschaft endlich einzutüten!



Grüße cristrader

[cristrader]

Auch diese Meldung hilft nicht weiter!

Medicure Announces Special Protocol Assessment With the FDA For Phase III MEND-CABG II Study
Tuesday December 12, 7:32 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Dec 12, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that it has completed a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the Phase III MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery. The SPA provides official confirmation from the FDA that the Phase III protocol is appropriately designed to form the basis of a New Drug Application (NDA) submission.

"We are pleased to have finalized the SPA agreement with the FDA on the design of the ongoing MEND-CABG II trial. This agreement provides Medicure with a well defined pathway towards regulatory approval for MC-1," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We believe MC-1 will be an important therapeutic addition to the standard of care for patients undergoing CABG surgery."

The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning the design of pivotal clinical trials, including; clinical endpoints, study conduct, data analysis, and other clinical trial issues. The final approval of a product by the FDA requires demonstration of statistically significant efficacy and acceptable safety.

About MEND-CABG II

MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. Study patients will be randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. Study enrollment was initiated in November 2006.

The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase II MEND-CABG study. MEND-CABG was a Phase II study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups.

About MC-1

MC-1 is a novel cardioprotective compound that prevents cardiac damage via inhibition of the purinergic receptors on cardiomyocytes (heart muscle cells). Medicure has completed two Phase II studies with MC-1 demonstrating its cardioprotective efficacy. In addition to the MEND-CABG study outlined above, the 60 patient MEND-1 study demonstrated that MC-1 had a statistically significant reduction in the cardiac enzyme CK-MB in patients undergoing percutaneous coronary intervention (PCI). MC-1 has received a Fast Track Designation from the FDA as a treatment to reduce cardiovascular and cerebrovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions, coronary artery bypass graft surgery and acute coronary syndrome (ACS). Medicure intends to develop MC-1 for the CABG surgery and ACS markets, which have a combined annual incidence of approximately two million in the United States.






Versant:
Medicure announced it has secured a special protocol assessment with the fda for mend-cabg III pivotal study for its lead product, mc-1. spa is a binding agreement with the fda that provides confirmation that the phase III clinical trial is appropriately designed to support a new drug application (nda).
bottom line
the spa is positive news that mitigates some regulatory risk for mend-cabg II. the trial is set to enroll 3000 patients and study enrollment was initiated in nov 2006. of note, mph will be able to file for registration based solely on this trial, setting the stage for a F2010 (2HJ/2009) launch. no change to our outlook.
focus points
the mend-cabg II phase III trial is similar in design to the phase II trial results reported earlier that indicated mc-I had a 37.2% reduction in a composite of cardiovascular death, non-fatal myocardial infarction and not-fatal stroke versus placebo (p=0.028).
the next key milestone is a partnership for mc-1, discussions for which may be accelerated by today's announcement.
in addition, we look forward to the launch of aggrastat, which is expected in H1/07. we forecast F07 sales of $8.7 million.


Grüße cristrader

[solarblase]

9:41AM Medicure raises $20.3 mln in private placement (MCU) 1.30 -0.06 : announces it has entered into Securities Purchase Agreements with U.S. institutional investors raising total gross proceeds of approx $20.3 mln. Under terms of the Agreements, the co intends to issue approx 15.6 mln common shares at a price of $1.30, together with warrants, to purchase approx 3.1 mln shares.

[cristrader]

Antwort auf Beitrag Nr.: 26.343.117 von solarblase am 20.12.06 17:03:59

Tolle Weihnachtsüberraschung!

[cristrader]

Hallo!

Hier einige Analysteneinschätzungen:

Medicure Tgt Lowered By Haywood; RBC Maintains Rtg, Tgt
12:09pm ET
TORONTO (DJ)--Haywood Securities has lowered its target on Medicure Inc. but maintained its rating while RBC Capital Markets reiterated both its rating and target, following the Winnipeg biotechnology company's announcement of a private placement to raise about US$20.3 million

In a research report Thursday, Haywood analyst David Denduk reiterated his Sector Outperform rating for Medicure and lowered his target to C$2.90 from C$3.75. RBC analyst Phillipa Flint confirmed her rating at Sector Perform and target at C$2.50...

Denduk said he believes the placement ensures that Medicure has sufficient cash to fund its operations until the end of 2007. Coupled with the start of enrolment in the MEND-CABG II, Phase III trial with MC-1, he sees little benefit for a potential partner to enter an agreement with the company at this time. The previous target assumed that Medicure would enter a partnership before the release of Phase III results, which would raise its share-price valuation.

Flint agreed that a partnership doesn't appear imminent, but noted that she believes a partnership deal is necessary "to solidify Medicure's position and add credibility to the MC-1 development program." She reiterated her sector perform rating until Medicure enters into a partnership.



Die Unsicherheit ob eine Kapitalerhöhung kommt lag in den letzten Monaten wie ein Damoklesschwert über dem Kurs. Vielleicht wird jetzt endlich mehr Aufmerksamkeit auf das Potential der Pipeline gelegt. Vielleicht wurde ja jetzt durch die dritte KE die benötigte US Coverage erkauft. AG Edwards wäre sicherlich ein idealer Kandidat!

Grüße cristrader

[cristrader]

Medicure Completes US$25.9 Million Private Placement
Thursday December 28, 10:29 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Dec 28, 2006 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced it has closed a private placement raising total gross proceeds of US$25.9 million. The amount raised represents an increase of US$5.6 million from the previously announced private placement of US$20.3 million. The additional US$5.6 million was raised with European investors. A total of 19.9 million common shares were issued in the private placement at a price of US$1.30, together with warrants, to purchase 3.98 million additional common shares. The warrants have a five year term and an exercise price of US$1.70.
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Proceeds of the private placement will be used to help fund the ongoing development of Medicure's lead clinical product, MC-1 as well as for general corporate purposes.

"We are pleased to have been able to up-size the private placement to raise an additional US$5.6 million. With the proceeds of this financing we are able to fund the Phase III MEND-CABG II study through to completion," commented Medicure's President and CEO, Albert D. Friesen, PhD. "We are very pleased to welcome several new institutional shareholders who share our commitment to the successful clinical and commercial development of MC-1 for coronary artery bypass graft (CABG) surgery patients."

Deutsche Bank Securities Inc. acted as the lead placement agent and A.G. Edwards & Sons, Inc. and Montgomery & Co., LLC served as co-placement agents for the transaction.

The securities offered were not registered under the Securities Act but were sold to institutional accredited investors on a private-placement basis pursuant to the exemption from registration contained in Regulation D under the Securities Act. Medicure Inc. has agreed to qualify the resale of the common shares issued under the private placement by filing a prospectus in certain provinces of Canada and to register such securities under the Securities Act of 1933, as amended (the "Securities Act").

This press release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offering, solicitation or sale would be unlawful.

Dr. Friesen added, "This financing closes out an exciting year for Medicure and puts us in a strong position for 2007."

Medicure's 2006 Accomplishments

- The Company initiated enrollment in the MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery.

- The Company completed a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the Phase III MEND-CABG II study. The SPA provides official confirmation from the FDA that the Phase III protocol is appropriately designed to form the basis of a New Drug Application (NDA) submission.

- The Company acquired the exclusive U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride) from MGI PHARMA, INC for US$19 million. AGGRASTAT®, a glycoprotein (GP) IIb/IIIa inhibitor, is used for the treatment of acute coronary syndrome (ACS) including unstable angina and non-Q-wave myocardial infarction.

- The Company announced the launch of its U.S. sales organization to support the sales and marketing efforts for AGGRASTAT®. The Company has assembled a sales organization, with extensive experience in acute cardiovascular medicine and hospital based sales.

- The Company announced scientific presentations of the Phase II MEND-CABG clinical results at both the American Heart Association (AHA) and the Canadian Cardiology Congress (CCC) meetings. These presentations to the cardiovascular medical community highlight the importance of the MEND-CABG results and the need for novel approaches to managing ischemic reperfusion injury.

- The Company announced that new data comparing Single High-Dose Bolus AGGRASTAT® (tirofiban) versus ReoPro® (abciximab) in patients undergoing percutaneous coronary intervention (PCI) was presented at the 2006 American Heart Association (AHA) meeting. The meta-analysis suggests that Single High-Dose Bolus tirofiban may be as effective as abciximab in patients undergoing PCI with a comparable safety profile.

- The Company strengthened its cash position with equity and debt financings, to support its clinical and commercial development. These financings included several private placements led by Deutsche Bank with U.S. and European institutional investors raising total gross proceeds of US$51.5 million.


Grüße cristrader

[cristrader]

Hallo!

Ein deprimierendes Börsenjahr für MCU-Aktionäre ist endlich zu Ende. Drei Kapitalerhöhungen, die Aquisition eines bisher gefloppten Medikamentes (Aggrastat) sowie das Ausbleiben der versprochenen Partnerschaft kennzeichnen das Jahr 2006.

Das Statement vom Märchenonkel Friesen das jetzt genügend Kapital bis zur Beendigung der MC-1 CABG Phase III vorhanden ist muss zumindest angezweifelt werden. MCU wird noch vor Bekanntgabe der Phase-III-Ergebnisse und Einreichen des Zulassungsantrages (2.Quartal 2008)von MC-1 eine weitere Kapitalerhöhung durchführen müssen, da sonst bei einem Scheitern von MC-1 das Fortbestehen des ganzen Unternehmens in Frage gestellt ist. Und was passiert mit der restlichen Pipeline? Es wird höchste Zeit das endlich mit den Phase III-Planungen für die Medikamente MC-1 in der Indikation ACS und MC-4232 begonnen wird! Dazu wird allerdings eine Partnerschaft benötigt!

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 26.587.061 von cristrader am 30.12.06 19:41:31

Hallo zusammen,
wahrscheinlich sind die Zwänge für das Management keinesfalls geringer geworden.Die Frage nach der Partnerschaft liegt weiter über dem Wert.Die restliche pipeline will bearbeitet werden.Vertrauensverlust des Marktes. Die Frage ist doch, was sollte sich zunächst für big pharmas-verhandlungsposition 2007 vor diesem Hintergrund ändern ? Ob gute news über MC-1CABG Phase III den Kurs und die Verhandlungen mittelfristig beleben können ?

Hat jemand Infos über ymbioscienes Phase III tes ? Man hört aber auch rein GARNICHTS.... Mein kleiner ausflug in den biotech-Bereich hätte mal ein paar positive news nötig !

Ein gutes Jahr !

brom

[cristrader]

Antwort auf Beitrag Nr.: 26.629.882 von brombeeren am 01.01.07 17:47:33

Hallo brombeeren!

Der dritte Interimspunkt für YMI´s Tesmilifene Phase III ist laut statistischer Analyse für den 10. Januar datiert, kann allerdings auch einige Wochen früher oder später kommen. Laut BiotechMonthly rechnen die meisten institutionellen Investoren mit einem positiven Abbruch, sollte dieser nicht eintreffen und die Studie wird fortgeführt bis zum 4.Interimspunkt im Mai, ist mit einem erheblichen Kurseinbruch zu rechnen. Das BiotechMonthly Model Portfolio hat sich kräftig mit Puts eingedeckt. Also Vorsicht!




Zu Medicure:

Ein Aussetzen der klinischen Weiterentwicklung bis Mitte 2008 von MC-1 in der Indikation ACS und von MC-4232 ist nicht akzeptabel. Soweit wird es das Management auch nicht kommen lassen! Vielleicht gibt es ja einen Strategiewechsel und es gibt nur eine Partnerschaft von MC-1 ACS und/oder MC-4232 mit dem Ziel MC-1 CABG alleine bis zur Zulassung zu führen. In etwa zwei Wochen gibt es die nächsten Quartalszahlen mal sehen welche Story wir dann aufgetischt bekommen.

Die Unzulänglichkeiten des Managements und der IR-Abteilung haben sicherlich bedeutenden Einfluß auf die weitere Unternehmensentwicklung. Nur entscheidend sind bei einem Biotech immer noch die klinischen Ergebnisse und die sind bisher ziemlich beeindruckend. Erreicht MC-1 die Zulassung Ende 2008 wird aus Medicure auch trotz dieses Managements ein Überflieger.

Warum ist es so schwer den Markt von Medicure´s Potential zu überzeugen?

MC-1 Cabg
--> weltweites Marktpotential von mehr als 1 Mrd. US $
--> es gibt bisher noch keine Behandlungsmöglichkeit, MCU wird den Kuchen nicht teilen müssen!
--> bei bisherigen Studien sind keinerlei Nebenwirkungen aufgetreten
--> zwei positive Phase II-Studien mit mehr als 900 Patienten
--> nur eine einzige Bestätigungsstudie mit 3000 Patienten nötig!!!
--> Fast Track-Status/SPA mit FDA
--> Zulassungsantrag 2Q/08
--> Zulassung Ende 2008

MC-1 in der Indikation ACS:
--> weltweites Marktpotential von mehr als 3 Mrd. US$
--> es gibt bisher kaum wirksame Behandlungsmöglichkeiten
--> Fast-Track-status


MC-4232 (MC-1 in Kombination mit ACE-Inhibitor (Lisinopril)
Behandlung von Diabetes in Verbindung mit Bluthochdruck
-->zwei erfolgreiche Phase II-Studien
-->mehr als 15 Mio. Patienten in den USA leiden an Diabetes und zugleich Bluthochdruck
--> Marktpotential gigantisch!!! (allerdings auch hart umkämpft!)


In der Präklinik mit MC-45308 noch ein Thrombosemedikament mit Gigapotential



Mit obigen Argumenten sollte es einer guten IR-Abteilung möglich sein Interesse zu wecken!

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 26.630.511 von cristrader am 01.01.07 21:36:54

Hallo zusammen !

ymi: Herzlichen Dank für deine Einschätzung hinsichtlich ymi. Auch noch kräftig mit puts eingedeckt ? Mmmmh, das klingt nach einer "Zitterpartie" . CEO hat hingegen 50.000 im public gekauft, insider haben (für kleines Geld) zahlreiche calls gesetzt und der Aktionär hat im Oktober noch mal nachgekauft (na, ja, der Sack Reis in China....). Na, schaun wer mal, biotech monthly wirds hoffentlich nicht wieder am besten wissen.. Außerdem war der Kurseinbruch schon erheblich..Schluss damit, is ja anderer thread. Selbst schuld, wieso macht man nicht im herdentrieb rohstoffe

MC: Bei teilweiser Verpartnerung der Pipeline hat medicure keine gute verhandlungsposition: Keine Partnerschaft, dann liegt die restliche pipeline brach. Ansonsten schlage ich vor, dass cristrader im Interesse aller Investierten die PR-Abteilung infiltriert.

brom

[cristrader]

Antwort auf Beitrag Nr.: 26.639.367 von brombeeren am 02.01.07 17:39:20

Hallo!

Ich verwende keine Puts (habe auch gar keine Möglichkeit dazu) .
Sehe durchaus eine hohe Wahrscheinlichkeit von positiven Tesmi Ergebnissen. Nur mein Depot verträgt momentan keine weiteren Nackenschläge!

MCU:
Hier noch ein interessanter Bericht zur MC-1-Entwicklung:

http://japan.medscape.com/viewarticle/538912

MC-1 shows promise in reducing MI post-CABG, lowering BP


Shelley Wood
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Important Considerations



December 8, 2005
Winnipeg, MA - MC-1, a metabolite of vitamin B6, may reduce the risk of MI following CABG surgery, early results from the MC-1 to Eliminate Necrosis and Damage in CABG (MEND-CABG) study suggest. The 30-day primary-end-point results were released this week during a conference call hosted by the drug developer, Medicure Inc (Winnipeg, MA).

Full results of the 90-day study, including safety information, will not be made public until early next year, although company representatives said yesterday that unblinded review of the results by the data safety and monitoring committee halfway through the trial showed "no signals of concern."

MC-1 is also being tested in combination with lisinopril (dubbed MC-4232) in the phase 2 MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics (MATCHED) study, the results of which were also recently released by the company. MC-1 plus lisinopril reduced systolic and diastolic blood pressure in these patients to a greater degree than lisinopril alone and positively affected glucose control.

To renalwire, MEND-CABG lead investigator Dr Jean Tardiff (Montreal Heart Institute, QC) explained that MC-1 is a naturally occurring small molecule believed to protect cardiomyocytes from ischemic reperfusion injury by inhibiting ATP-induced calcium influx. The agent has also been studied in the phase 2 MEND-1 study of patients undergoing PCI.



Mending the heart
MEND-CABG was a 901-patient study designed to demonstrate the clinical efficacy of MC-1 during and after CABG, as well as identify the appropriate dose. As such, patients at 42 centers were randomized to a 250-mg dose, a 750-mg dose, or placebo before undergoing CABG, then maintained on this dose or placebo for 30 days postsurgery. The primary end point of the study is a combination of death, MI, and stroke at 30 days, while the secondary end point?for which results have not yet been released?is reduction in death, MI, and stroke at day 90, difference in CK-MB area under the curve between 0 and 24 hours, and neurological protection.

As Medicure spokespeople revealed during a webcast presentation, the 250-mg dose emerged as the more effective dose of MC-1. This dosage reduced the composite primary end point of death, nonfatal MI (defined as peak CK-MB >50 ng/mL), and nonfatal stroke by 14%, compared with placebo, although this result was not statistically significant. When MI was redefined by a CK-MB >100 ng/mL, however?a definition in keeping with major recent trials, such as PRIMO-CABG?the reduction in death, MI, and stroke was a statistically significant 37.2%.

Medicure president and CEO Dr Albert D Friesen explained that the >50-ng/mL definition was chosen for the phase 2 study as the most conservative estimate of MI but ultimately yielded too much "noise" to distinguish a difference in true MI between the two groups.

Assessed in isolation, nonfatal MI as defined by peak CK-MB >100 ng/mL was reduced by 46.9% compared with placebo (p=0.008).

Tardiff, speaking during the webcast, acknowledged that the >100-ng/mL definition might be "a more reasonable cut-off value" than the >50-ng/mL definition. Elaborating in an interview with renalwire, Tardiff pointed out that in the recent GUARDIAN study, six-month mortality for patients following CABG was 8% for patients with a CK-MB between 50 and 100 ng/mL, whereas it was 20% for patients with a CK-MB greater than 100 ng/mL, suggesting that the >100-ng/mL definition might be more clinically meaningful.

"I would anticipate the company would pursue a phase 3 study using the >100-ng/mL definition of MI," Tardiff commented.

Moreover, as Tardiff highlighted in the press conference, the higher cut point also mirrored clinically reported MI: the 250-mg dose of MC-1 was associated with a 78.7% reduction in physician-diagnosed myocardial infarctions vs placebo (p=0.0065).




MC-1/ACE-inhibitor combo also promising
In the MATCHED study, 120 patients with coexisting type 2 diabetes and hypertension were randomized in a crossover, double-blind fashion to a 100-, 300-, or 1000-mg dose of MC-1 alone and in combination with 20 mg of lisinopril, or placebo, for eight weeks before being switched to a different treatment arm for an additional eight weeks. At follow-up, the 300-mg MC-1 dose combined with 20-mg lisinopril produced greater reductions in diastolic and systolic blood pressure than lisinopril alone. Patients taking the combination agent also experienced improvements in primary and secondary metabolic end points, including glycemic control, as measured by fasting serum glucose and glycated hemoglobin, as well as lipid control, after 16 weeks of treatment. Notably, the 300-mg MC-1/20-mg lisinopril and 1000-mg MC-1/20-mg lisinopril doses of MC-4232 demonstrated comparable clinical efficacy for both the hypertensive and metabolic end points, without raising any red flags for safety or drug intolerance. Principal investigator for the MATCHED trial was Dr Yves Lacourciere (Universit¿ Laval Saint-Foy, Quebec, QC).

The company is moving ahead with plans for a phase 3 study of this combination agent.

-SW

[solarblase]

Antwort auf Beitrag Nr.: 26.639.367 von brombeeren am 02.01.07 17:39:20

Hier wäre der Job für Cristrader

http://www.medicure.com/careers.html

Careers
Medicure is seeking a qualified and motivated individual to fill the following position(s):

Scientific Affairs Associate

Medical Science Liason

Manager, Investor & Public Relations 

Manufacturing Manager

Project Manager

Cardiovascular Pharmacologist

Clinical Safety Associate

Payroll Administrator / Intermediate Accountant

Quality Assurance Associate

Apply to Medicure Inc.,
4-1200 Waverley Street,
Winnipeg, MB R3T0P4,
fax [phone]

[cristrader]

Antwort auf Beitrag Nr.: 26.663.837 von solarblase am 03.01.07 21:03:52

Hallo Solarblase!

Die Jobinitiative bei Medicure kann man fast nur so deuten das Friesen überhaupt nicht daran denkt eine Partnerschaft einzugehen. Die Kurs reagiert mal wieder entsprechend!

Die wichtigste Jobofferte ist sicherlich die des Managers -Investor & Public Relations. Hoffentlich wird dieser schnell gefunden!
Ein Nachfolger für Friesen wäre auch mehr als wünschenswert!


Hier noch ein interessanter Artikel von gestern:

Analysis: Alexion's pexelizumab fails
By STEVE MITCHELL
UPI Senior Medical Correspondent
WASHINGTON, Jan. 2 (UPI) -- Alexion appears to have killed the development of pexelizumab due to disappointing phase 3 results indicating the heart-attack drug is no better than placebo.

The impact of the news, which appears in the Jan. 3 issue of the Journal of the American Medical Association, may be slight because the results have previously been released by Alexion, which had been developing pexelizumab in collaboration with Proctor & Gamble.

Experts say that although this is the end of pexelizumab, the concept of using an anti-inflammatory to treat a specific kind of heart attack known as acute ST-elevation myocardial infarction, or STEMI, is still very much alive.

"I think it does mean an end for this drug, but not an end for the concept," Paul Armstrong of the University of Alberta and lead investigator of the trial told United Press International.

"The flip side of these things is that it opens up new opportunities for contenders to the throne," Armstrong added. "And this area for inflammation as it relates to how big heart attacks are and what are the consequences is still an untapped frontier."

One possible contender, he said, is an agent called MC-1 that is being developed by Medicure. The drug is currently in a trial involving patients with coronary bypass, and Armstrong is serving as a scientific consultant to the company.

In the pexelizumab study, which was known as the APEX AMI trial and involved 5,745 STEMI patients, Armstrong and colleagues evaluated infusion of the drug in conjunction with reperfusion procedures, such as angioplasty or stent placement.

No difference was detected in the rate of death at 30 or 90 days between the pexelizumab group and the placebo group. Both groups had a low death rate (3.92 percent in the placebo arm at 30 days versus 4.06 percent in the pexelizumab group). Rates of cardiac shock and heart failure were also similar between the two groups.

Although the pexelizumab results were disappointing, "the good news is that the mortality was the lowest ever reported in a trial of this magnitude," Armstrong said. This means that if patients are rapidly treated with currently available therapies, they may fare better than previously thought.

However, there's still a substantial unmet need in this setting, so Armstrong's group is working on developing strategies for getting treatments to patients faster. This includes possibly teaching paramedics how to recognize this condition, using new technology to transmit electrocardiograms from the field so a physician at a remote site can help make the diagnosis.

This could allow clotbusters, such as fibrinolytics, tenectaplase and tPA, to be delivered earlier, which may avoid heart-muscle damage altogether, Armstrong said.

John Eikelboom of McMaster University in Hamilton, Ontario, Canada, who co-authored an editorial in JAMA, told UPI he agreed that the concept of using anti-inflammatories was still a potentially viable strategy.

"The trial results probably mean the end of pexelizumab," Eikelboom said. "It would be difficult for it to find a niche in practice," he said.

However, Eikelboom added, "I don't think the concept can now be dismissed." There are still questions that remain unanswered, such as whether pexelizumab acted on the right target and whether there might be more effective ways of developing a potential drug.

Other anti-inflammatories in development that may have potential include an inhibitor of C-reactive protein and drugs that target white blood cells, Eikelboom said.

Stephen Squinto, Alexion's executive vice president and head of research, told UPI pexelizumab was essentially a dead program.

"We don't think we intended to take this drug forward," Squinto said. He noted that the phase 3 results have been publicly disclosed two previous times, the most recent being at the American Heart Association meeting in November.

Alexion will now focus its attention on Soliris, a potential treatment for a rare, life-threatening blood disease called paroxysmal nocturnal hemoglobinuria. The company has filed for approval in both the United States and Europe and hopes to launch in 2007, Squinto said.


Grüße cristrader

[cristrader]

Hallo!

Es scheint als ob die charttechnisch kritische Situation bald überwunden sein wird. Ich denke das aktuelle 52. Wochentief bei 1,17 US$ wird auch in einem Jahr noch das 52.Wochentief sein. Hoffe das diese Woche die Halbjahreszahlen rauskommen mit einigen Neuigkeiten.




Grüße cristrader

[cristrader]

Hallo!
Freitag vor Börsenbeginn gibt es die Zahlen!

Medicure to Report Second Quarter Fiscal 2007 Financial Results
Tuesday January 9, 4:15 pm ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Jan 9, 2007 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that the Company will report second quarter fiscal 2007 financial results on Friday, January 12, 2007 at 8:00 AM Eastern Time. A conference call and audio webcast will be conducted on Friday, January 12, 2007 at 8:30 AM Eastern Time, during which management will discuss second quarter results.


Notification of Conference Call:
Date: Friday, January 12, 2007
Time: 8:30 AM Eastern Time
Telephone: [phone] or 1-416-695-5259
Webcast: Available at the Medicure website at http://www.medicure.com

Archive of Conference Call:
Telephone: [phone] or 1-416-695-5275
Passcode: 638087
Webcast: Available at the Medicure website at http://www.medicure.com
Expires: January 26, 2007


About Medicure Inc.

Medicure is a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders. The Company's solid position in this field is highlighted by the following:

- Two drugs, MC-1 & MC-4232, in late stage clinical development

- Four positive Phase II trials completed with MC-1

- FDA Fast Track designation for MC-1

- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)

- Dual action antithrombotic, MC-45308, with positive preclinical results

Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.



Grüße cristrader

[solarblase]

Bin jetzt auch mit dabei

Gruß Solarblase

[brombeeren]

Antwort auf Beitrag Nr.: 26.814.672 von solarblase am 10.01.07 17:27:19

Hallo solarblase,
willkommen im club,
Friesen ist allerdings nicht mehr Mitglied, da er seine frisch eingelöste option wieder zu 1,46 an die Wand drückt. Hoffen wir mal, es ist ein zeichen, dass er den Hut nimmt.

http://www.canadianinsider.com/coReport/allTransactions.php?…

Gruß

brom

[cristrader]

Antwort auf Beitrag Nr.: 26.836.295 von brombeeren am 11.01.07 17:14:19

Hallo brombeeren!

Soweit das Friesen zurücktritt wird es sicher nicht kommen.
Die 150.000 Aktien die er jetzt verschenkt (Disposition by gift)hat, schmälern seine Aktienanzahl natürlich beträchtlich. Friesen hält aktuell nur noch 7.662.099 Aktien!

Grüße cristrader

[brombeeren]

Moin cristrader,

danke fürs Nachzählen...(Quelle?) Ich fürchte jetzt auch, mein aus geläuterter Unwissenheit gestreutes Rücktrittsgerücht ist nicht so ganz stichhaltig: Heißt also er gibt die bereits eingelöste Option an medicure ohne Gegenleistung zurück ?

Grüße brom

PS: So groß ist sein Paket nun auch nicht, sofern ich kommata verschiebe, bin ich ähnlich investiert..

[cristrader]

Antwort auf Beitrag Nr.: 26.841.453 von brombeeren am 11.01.07 20:38:49

Hallo!

Unter sedar.com am 29.August 2006
http://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issu…

Nein er gibt die eingelöste Option nicht an Medicure zurück! Er hat hat die Aktien einem Bekannten (möglicherweise Kinder/Enkel/Geschwister/Freund u.ä.) geschenkt.


Friesen´s enormer Aktienanteil gibt zumindest die Gewißheit das er MCU nicht mit Absicht gegen die Wand fahren wird und durchaus ein Interesse an einem Ansteigen des Aktienkurses haben sollte.


Grüße cristrader

[cristrader]

Hallo!

Hier einige interessante Auszüge vom Stockhouse Message Board. Es zeigt wie das Medicure Management aus institutioneller Sicht gesehen wird und erklärt u.a. den Kursverfall der letzten Monate.

SUBJECT: Leadership Posted By: RedDawg
Post Time: 9/13/2006 14:38
« Previous Message Next Message »

Bert has been approached several times by several key individuals offering their time, talent and treasure as Director's for MPH. Bert has not been to interested in these approaches given his previous experiences in running a Public Company.
We continue to view him as running a Public Company in a Private Manner....until he brings in some Outside influences that are financially committed to MPH....we could be in for a long haul.

The individuals I am aware of continue to show amazing patience considering their share position with MPH.

The AGM could prove interesting.

Dawg


SUBJECT: Leadership Posted By: RedDawg
Post Time: 9/21/2006 21:54
« Previous Message Next Message »

I would like to reopen my previous post.....regarding Bert turning down some solid Board leadership that was proposed to him several times in the past two years. Does anyone want to discuss something that can effect our collective investment in MPH.???
We will be given a Board slate to vote on at the AGM....there is a possibility that two potential new candidates might come forward prior to the AGM....we are working on them.

Their collective experience in both the public and the Bio-tech markets could assist us in prompting Bert to revisit some of the opportunities that he has passed on.

We are concerned that Bert is Running a Public Company in a Private Manner and would like this changed. We see the Board as the First step in this.

DAWG


SUBJECT: Board Seat Posted By: RedDawg
Post Time: 9/22/2006 14:14
« Previous Message Next Message »

SS;
There are many ways to get on the Board. The individuals to which I refer, have met several times with Bert and have politely inquired about the potential. As you can imagine they are not interested in being nominated from the Floor at the AGM as a potential Board Member. (Somewhat Hostile) They would prefer to be invited by the Chairman and President.

The issue as I understand is....

Bert's previous Public company experience has tainted his view for outside guidance. He likes to bring in his own.

In the Past, Bert has shown a tendancy to want to manage the process of choosing a new director, rather than delegate it to a nominating committee of the Board. As you can appreciate this is not a "Best Practice".

I would like to see performance options for both Senior mgt and Board members used as a tool more effectively. ....its a great tax efficient way to align company's interests with their own. In addition not all Board members have some "skin" in the game. This would align them with "outside" shareholders.

DAWG


SUBJECT: Directors / Lack of Leadership Posted By: RedDawg
Post Time: 9/27/2006 14:53
« Previous Message Next Message »

We am still committed to our game plan for two outside directors for consideration of the shareholders at the AGM. The President and Chairman are currently reviewing their options at this time.
DAWG



SUBJECT: Board /Leadership Posted By: RedDawg
Post Time: 9/27/2006 20:31
« Previous Message Next Message »

Gentlemen;
No one challenged me on my last comment regarding the Chairman and the President.

Why we are currently concerned with the following (5 but not limited to) about MPH's Board of Directors.

The following is
Adapted from Excellence in the Boardroom by Bill Dimma..Published by john Wiley and Sons Canada Ltd.

1) Separate the Roles of Board Chariman and CEO. (Currently Bert is both) The most compelling argument for separation is that, ideally, a board and managment create a coherent system of checks and balances, which provides that well-known creative tension which can enhance corporate performance.
2) Delegate CEO succession issues to boards. With a controlling or substantial shareholder (Bert) and a public float, the argument for board involvement is much stronger. The views of the dominant shareholders matter (Bert), but so do the best interests of the minority shareholders and the enterprise itself.

3) Performance Options has already been addressed in one of my earlier e-mails

4) Delegation of directors to a board committee (previously addressed as well)

5) We do not see evidence of the current directors staying current through ongoing education and training

Something has too give on the above....

DAWG


SUBJECT: RE: Board /Leadership Posted By: RedDawg
Post Time: 9/27/2006 21:56
« Previous Message Next Message »

Let me suggest that you might be taking my comments a little too personally.
I would like to politely remind you how the Public marketplace has changed in the last while.

MPH's Board has yet to even consider those "Best Practices"...leading to a possible conclusion that Bert is running this Public entity like it is a Private Company.

It is in all the stakeholders best interests that they reconsider their decision to consolidate Chair / Pres / CEO when Dr. Bill Cochrane stepped down.

This could be a FIRST step towards a fundemental change in direction of this company.

Everying else I have mentioned could then follow.

Not to worry about your challenge of attending the AGM and inquiring about these....I have already made plans.

Thank you for the motivation...but it was already done.

DAWG



SUBJECT: RE: Board /Leadership Posted By: RedDawg
Post Time: 9/27/2006 22:09
« Previous Message Next Message »

Second Pt...very important.
Just because I am suggesting the Board start to wake up and follow a Public Best Practice approach to Governance...does not mean that I do not believe in the Company, its employees or its products in various phases of development.

I truly believe in MPH and the opportunity..why would I bother to fly to AGM?

DAWG



SUBJECT: Best Practices Posted By: RedDawg
Post Time: 10/26/2006 10:34
« Previous Message Next Message »

Gentlemen;
I can confirm that some of our suggestions have been taken as positive Board Governance suggestions by Bert and rest of the Board.

Stay tuned as Bert has finally recognized and is starting to respect that MPH is a publicly traded entity and not his private company.

Our group prefers to work with them behind the scene to assist in influencing positive changes as opposed to a direct public and nasty confrontation. This is a pragramatic and reasonable approach given Bert's Share ownership position with MPH.

DAWG


SUBJECT: Split of CEO and Chair responsibilities Posted By: RedDawg
Post Time: 10/26/2006 21:44
« Previous Message Next Message »

Gentlemen;
We are advocating the separations of Chair and CEO to align with most institutional Investors criteria.

The following is an excerpt from the Ontario Teachers' Pension Plan Board Proxy Voting Guidelines...

The Chief Executive Officer, or CEO, is responsible for the day to day operations and management of the company. The Chair of the Board is responsible for coordinating the activities of the Board, which, in turn, is responsible for evaluating the performance of the company and its CEO. We believe that these reponsibilities put a combined Chair / CEO in the very difficult position of evaluating his or her own performance. We are also concerned that in these situations too much power or control may reside in one individual.

For these reasons we believe that is it appropriate, in most instances, to separate the roles of CEO and Chair. We feel there is a great potential advantage for the corporation, the CEO, and the directors to have a separate Chair, who can deal with matters from the Board's point of view, and who can provide a greater measure of independence to the Board's oversight role.

DAWG



SUBJECT: Lefty - Response Posted By: RedDawg
Post Time: 10/27/2006 13:00
« Previous Message Next Message »

I am a long term investor with some size in MPH who is very concerned about the direction of the company.
I would suggest that the strategic direction of MPH and the financial implications (re share dilution ) were not probably understood by both Senior Management and the Board.

As a result we are pressing Bert to understand that perhaps optically an objective Board environment might assist MPH going forward.

DAWG



SUBJECT: MPH Power Posted By: RedDawg
Post Time: 11/9/2006 12:18
« Previous Message Next Message »

MPHPOWER;
You have assisted in validing the extremely busy and demanding schedule of our CEO/CHAIR..while also overseeing two other public companies...

This only helps to illuminate the need to separate the role of Chair and CEO for him asap. Not only can it be seen as in the best interests of MPH, shareholders but also for Bert. The challenge as you seem to know him personally is in him accepting this limitation and moving ahead.

DAWG



SUBJECT: RE: MPH Power Posted By: RedDawg
Post Time: 11/9/2006 13:16
« Previous Message Next Message »

MPHPOWER;
Thank you for the discussion...this is the kind of debate that I see as important to this BB

I would suggest that today is the time (ie prior to a partnership arrangement being considered)....a respected seasoned Chair with an astute business skill set..is what is desired..

You point our the relative old age of the Board...yes that is a concern from many perspectives. No need to go further on this one.

MPHPOWER, you attempt to justify that the timing is improper due to resources not available....I would suggest that many more qualified prospects would available and interested in a Chair position when their options are at the current market price due to the upside too them.

DAWG



SUBJECT: RE: MPHPowerShortage Posted By: RedDawg
Post Time: 11/27/2006 08:58
« Previous Message Next Message »

How can you unlock the potential when you are serving two roles Chair and CEO for MPH (not including his other public commitments)...I would submit that perhaps the good Dr. is stretched too thin and is in constant conflict due to his inability to strategically understand this.
DAWG


SUBJECT: RE: webcast 10:00.........................eom Posted By: RedDawg
Post Time: 11/28/2006 10:21
« Previous Message Next Message »

Perhaps he is introducing MPH's new Chair....we could only hope.
DAWG


SUBJECT: FRUSTATION UPDATE Posted By: RedDawg
Post Time: 1/11/2007 17:02
« Previous Message Next Message »

DEAR FELLOW SHAREHOLDERS;
I wish you all well with your support of MPH. Our efforts in regards to the separation of Chair and CEO have been unwelcome and somewhat futile.

It has been very difficult to decide to sell our large share position held with Blackmont, as we have believed for a long time in MPH's opportunity. We are very frustrated with the CEO.

To assist the market, several crosses within Blackmont have taken place once a buyer was flushed out.

Good Luck

DAWG



Das letzte Posting von RedDawg ist wohl das interessanteste. Es zeigt das alle Versuche die konzentrierte Machtfülle von Albert Friesen zu brechen und auf mehrere Schultern zu verteilen kläglich gescheitert sind und Blackmont Capital (bisher einer der grössten Shareholder) aus Verärgerung die Position in Medicure glattgestellt hat. Von dieser Seite ist wohl jetzt kein Verkaufsdruck mehr zu erwarten. Dieser ganze Vorgang macht auch Friesens EGO und Machtbesessenheit deutlich. Es ist daher auch nicht verwunderlich das BigPharma bisher noch keine Einigung über eine Partnerschaft erzielen konnte.


Grüße cristrader

[solarblase]

Hallo Cristrader
Vielen Dank für die Infos

Gruss Solarblase

[cristrader]

Hallo!

Medicure Announces Second Quarter Fiscal 2007 Financial Results
Friday January 12, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Jan 12, 2007 -- Medicure Inc. (TSX:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today reported the results of operations for the three and six month periods ended November 30, 2006. All amounts referenced herein are in Canadian dollars unless otherwise noted. At close of business on November 30, 2006 the exchange rate was CAD$1.00 equals US$0.8755.
ADVERTISEMENT





"Medicure's second quarter of fiscal 2007 was highlighted by the initiation of enrollment in the Phase III MEND-CABG II study. We are very pleased to have commenced this pivotal Phase III study for registration, as its result could have a significant benefit and lasting impact on the standard of care of CABG patients," commented Medicure's President and CEO, Albert D. Friesen, PhD.

"Our commercial business was highlighted by the launch of our specialized cardiovascular U.S. sales organization midway through the quarter. In November, the first full month with our sales organization in place, AGGRASTAT® product sales increased significantly over the previous month. This sales trend continued in December where AGGRASTAT® product sales were once again higher than the previous month. We are very encouraged by the momentum we are seeing in our AGGRASTAT® business," added Dr. Friesen.

Corporate Highlights for the Quarter

The following are significant events which occurred since the last quarterly report:

- The Company initiated enrollment in the MEND-CABG II study. This single confirmatory Phase III study for registration will evaluate the cardioprotective effects of the Company's FDA Fast Tracked product, MC-1, in approximately 3,000 patients undergoing coronary artery bypass graft (CABG) surgery.

- Subsequent to the end of the quarter the Company completed a Special Protocol Assessment (SPA) agreement with the FDA for the Phase III MEND-CABG II study. The SPA provides official confirmation from the FDA that the Phase III protocol is appropriately designed to form the basis of a New Drug Application (NDA) submission.

- The Company announced scientific presentations of the Phase II MEND-CABG clinical results at both the 2006 American Heart Association and the 2006 Canadian Cardiology Congress meetings. These presentations to the cardiovascular community highlight the importance of the MEND-CABG results and the interest in novel approaches to managing ischemic reperfusion injury.

- The Company launched its U.S. sales organization to support the sales and marketing efforts for AGGRASTAT® (tirofiban).

- The Company established its wholly owned U.S. subsidiary, Medicure Pharma Inc., with its head office located in Somerset, New Jersey.

- The Company announced that new data comparing Single High-Dose Bolus AGGRASTAT® (tirofiban) versus ReoPro® (abciximab) in patients undergoing percutaneous coronary intervention (PCI) were presented today at the 2006 American Heart Association meeting. The meta-analysis suggests that Single High-Dose Bolus tirofiban may be as effective as abciximab in patients undergoing PCI with a comparable safety profile

- Subsequent to the end of the quarter the Company strengthened its cash position by completing a private placement led by Deutsche Bank raising total gross proceeds of US$25.9 million.

Net product sales for the three month period ending November 30, 2006 totaled $1,419,000 compared to $nil for the same period in fiscal 2006. Net product sales for the six month period to date were $1,699,000 compared to $nil in the same period last year. The increase in net sales for fiscal 2007 as compared to the same period in fiscal 2006 was due to product sales from the Company's first commercial product AGGRASTAT®, which was acquired on August 8, 2006. The Company launched a U.S. sales organization on October 11, 2006. Subsequent to the launch of the sales organization, product sales increased significantly in November 2006 as compared to October 2006. The Company currently sells AGGRASTAT® to drug wholesalers. Inventory levels at the Company's wholesalers were higher than expected upon the Company's acquisition of AGGRASTAT®, with inventory levels exceeding 90 days at one of the Company's largest wholesalers. Consequently net product sales were impacted by the higher than anticipated wholesaler inventory levels during the first three months of product sales. As at November 30, 2006, it appears AGGRASTAT® wholesaler inventory levels have returned to traditional levels of approximately 30 days.

Research and development expenditures for the second quarter of fiscal 2007 were $3,816,000 as compared to $3,010,000 for the same quarter in fiscal 2006. As expected, research and development expenditures were higher for the second quarter of fiscal 2007 as compared to the same quarter in fiscal 2006, due primarily to increased clinical activities associated with the planning and initiation of enrollment for the Phase III MEND-CABG II study, which commenced in the current quarter. Research and development for the six month period to date were $6,602,000 compared to $6,307,000 for the same period last year.

Selling, general and administrative expenditures for the second quarter of fiscal 2007 totaled $2,658,000, compared to $636,000 for the same quarter in fiscal 2006. Selling, general and administrative expenditures increased during the second quarter of fiscal 2007 as compared to the same quarter in fiscal 2006 primarily due to the acquisition of AGGRASTAT® and the resulting start-up costs, field selling expenses and product promotion costs. Selling, general and administrative expenditures for the six month period to date totaled $3,818,000, compared to $1,173,000 for the same period in fiscal 2006.

As a result of the above noted items, the financial results for the three month period ended November 30, 2006 include a consolidated net loss from operations of $6,093,000 or $0.06 per share, compared to $3,538,000 or $0.05 per share for the three-month period ended November 30, 2006. The six month year-to-date loss for fiscal 2007 was $9,339,000 or $0.10 per share, compared to $7,410,000 or $0.11 per share for the six month period ended November 30, 2005.

At November 30, 2006, the Company had cash and cash equivalents totaling $21,806,000 as compared to $34,920,000 as of May 31, 2006. Subsequent to November 30, 2006, the Company strengthened its cash position by raising gross proceeds of US$25,900,000 (before share issuance costs of approximately US$2,150,000) in a private placement led by Deutsche Bank Securities Inc. A total of 19.9 million common shares were issued in the private placement at a price of US$1.30, together with warrants, to purchase 3.98 million additional common shares. The warrants have a five year term and an exercise price of US$1.70.

An expanded version of Management's Discussion and Analysis and the financial statements for the three and six month periods ended November 30, 2006 is accessible on Medicure's website at www.medicure.com.



Ausführlicher Quartalsbericht:
http://library.corporate-ir.net/library/10/108/108925/items/…


Besonders bemerkenswert die Entwicklung der Aggrastat-Vermarktung:
Verkaufszahlen Oktober: 418.000 $
Verkaufszahlen November: 706.000 $
Verkaufszahlen Dezember: 1,000.025 $

Diese Steigerungen nach gerade mal zweimonatigem Vermarktungsstart sind geradezu sensationell!!!

Grüße cristrader

[cristrader]

Medicure bullish on future prospects

Winnipeg Free Press (Manitoba, Canada) - Jan. 13, 2007

THE fall was a season of firsts for Medicure Inc., and not just because it posted its largest quarterly loss ever.

During the second quarter that ended Nov. 30, 2006, the city's premier biotech company started enrolment in what will be the largest clinical trial ever conducted by an independent Canadian drug company. It also opened a sales office in the United States for the angioplasty drug Aggrastat, which it acquired from Merck earlier in the year.

And near the end of the quarter, Medicure completed a private placement of $25.9 million in new equity, giving it $45 million in cash in the bank, enough to finance the massive, 3,000-patient phase-III clinical trial on its cardio-protective drug, MC-1.

"We're pretty pleased to be where we are," said founder and CEO Albert Friesen. "In 1998, we had two employees, now we're around 100."

The phase-III trial of MC-1, which will pave the way for the drug to be commercially registered if it produces adequate results, will be conducted on patients undergoing coronary bypass surgery at 100 sites in the U.S., 20 in Canada and 10 in Germany.

Enrolment is expected to be completed by November and Friesen hopes initial data should be ready to be released publicly by March or April 2008.

The company did post a net loss of $6.1 million for the quarter ending Nov. 30, 2006, but that was due to expenses in ramping up for the clinical trial and costs involved in setting up the U.S. sales office in New Jersey. Friesen said costs will likely peak in the next couple of months.

Medicure only opened its U.S. sales operations in October and November was the first full month of sales of Aggrastat. In total, sales for the quarter were $1.4 million but Friesen said December sales topped $1 million.

"The company is doing very well," said Claude Camiré, an analyst with Paradigm Capital in Toronto. "I would say Medicure stands out in the top tier of health-care, medical device and biotech companies in the country. It has a strong balance sheet, two drugs in late-stage development and another in commercial sales. It is not a flashy company but they are doing all the right things."

In addition to Aggrastat and MC-1, Medicure also has another drug to treat people with high blood pressure and diabetes that has completed a phase-II trial. It has a third drug in an earlier stage of development.

Medicure's shares closed down seven cents on Friday to $1.47. Camiré is forecasting the stock to hit $3 in the next 12 months.

Camiré said the fact that Medicure has not teamed up with a larger pharmaceutical company with the marketing might to put a drug like MC-1 into the market is not necessarily a bad thing.

Friesen said he has had opportunities to make deals with larger partners but chose not to because he believed the company could grow in value better on its own.

Camiré agreed, saying the timing might suit many potential partners better to wait until results of the phase-III trial of MC-1 is completed.

Not only that, after its latest private placement Medicure can easily fund the clinical trial on its own. Friesen said that the new money includes significant investment from mutual funds that are prepared to hold their investments for five to seven years.

As a sign of the company's maturity, Friesen said the shareholder base has transitioned from having 50 to 60 per cent institutional investors to 80 per cent today.

Grüße cristrader

[cristrader]

Medicure: MC-1 Phase III enrollment on track for Nov completion- Montgomery notes that MCU has indicated enrollment of its pivotal Phase III for MC-1 is ahead of estimates, which in their view, indicates physicians are excited about this drug. Firm believes that MCU is in a good position to partner MC-1 and such a partnership could come as early as mid-07. Given MCU's cash position, firm believes it should be able to negotiate from a position of strength and make the best deal for shareholders. They believe Medicure is attractive at very low enterprise value with one drug in Phase III trials and another ready to enter Phase III.

Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 26.882.606 von cristrader am 13.01.07 14:33:50

Hallo!

Gestern gab es einige sehr interessante Neuigkeiten.

Die monatlichen Umsätze von Aggrastat haben bereits im Dezember die 1 Mio $ Marke überschritten. Laut Statement auf der Pressekonferenz betragen die "product margins "zwischen 80 und 90 Prozent!!!

Selbst wenn die 1 Mio Marke nur konstant bleibt hat sich die Aggrastat Aquisition bereits nach zwei Jahren selbst finanziert bei weiteren Steigerungen entsprechend früher!

Die Aggrastat-Aquis. scheint sich als wahrer Glücksgriff zu erweisen.
Das Medicure Aggrastat so günstig erwerben konnte ist wohl nur damit zu erklären das Merck im Gegenzug die EX-USA Rechte (right of first refusal)für MC-1 in Kombination mit Aggrastat erhielt.

Gerade diese Kombinationsprodukte mit MC-1 sollen bei BigPharma jetzt ein erhebliches Interesse geweckt haben. In 2009/2010/20011 läuft der Patentschutz von vielen Angiotensin Receptor Blockern (ARB), Statinen und insbesondere von Plavix (eines der umsatzstärksten Medikamente mit 5-6 Mrd $) ab. Kombinationsprodukte mit MC-1 werden als Low-Risk-Möglichkeit gesehen den Patentschutz auszuweiten. In diesem Bereich ist am ehesten eine Partnerschaft zu erwarten. Medicure ist weiterhin in intensiven Partnerschaftverhandlungen.


Grüße cristrader

[cristrader]

Claude Camiré 1 January 15, 2007
Senior HealthCare Analyst [phone]
Medicure Inc
(MPH-T $1.62, MCU-A $1.40)
Q2 Financials On Target – Aggrastat Revenues Looks Promising

Financial Summary C$m
(end-May) Rev ($m) EPS ($) EV/Rev (x) P/E (x)
FY05 0.0 (0.22) NA NM
FY06 0.0 (0.17) NA NM
FY07e 21.2 (0.15) 4.5 NM
FY08e 33.7 (0.10) 2.8 NM

• Re-launch of Aggrastat in the US looks promising
• MC-1 pivotal clinical trial underway; expected to be
completed by December 2007
• Buy rating maintained, target price at $3.00

Q2 Financials Without Any Surprises
For the quarter ending November 2006, Medicure reported revenues of $1.4m
slightly below our forecast of $1.5m and a net loss of $0.06/share. This is the first
quarter of revenues for Aggrastat in the United States as the sales force reengaged
connections with physicians and distributors for the first time in years.

Clinical Data Supporting Increase Use of Aggrastat
Aggrastat just received very positive data showing better profile than the standard
drug of care, Reopro. Recent presentation of a meta-analysis of five prospective
randomized studies demonstrated Aggrastat had a better safety profile and similar
efficacy results to ReoPro, the current standard of care, for patients undergoing
percutaneous coronary intervention (PCI). We believe the combination of rapid
onset of action and lower therapy cost could become an attractive selling point for
hospital settings. We expect Aggrastat could reach $70m in revenues by FY10.
This remains less than a 15% market share of the US$450m (2005 data). This
product remains an attractive cash flow generator with above 90% gross margins.

MC-1 Final Journey
In the last quarter, Medicure announced the start of the final Phase III clinical trial
expected to enroll 3,000 patients and to be completed by the end of this calendar
year. This is the largest undertaking by any Canadian company in the last five
years. We see this trial as a low risk with a positive potential outcome given the
trial is “identical” in terms of protocol to the previously successful Phase II, 901
patients, completed in December 2005. Medicure also received an SPA (Special
Protocol Assessment) with the FDA which maps out the expectations in advance
and reduce surprises such as approvable letters.


Never Too late For Partnership
Medicure has a strong balance sheet with $45m in cash ($0.47/share) at the end of
December. Wit a strong balance sheet, Medicure can now be more confident to
complete the MC-1 clinical trial, expected to cost $30m. Partnerships remain on
the table but the strong balance sheet provides more flexibility for discussions. We
believe the recent failure of Alexion Pharmaceuticals (ALXN-Q) in Phase III for the
same indication as MC-1 could give an extra edge for Medicure. We also believe
that as part of the strategy to become a specialty pharmaceutical company,
Medicure could license another marketed drug to be promoted by the salesforce.
This acquisition could further open the possibility to co-market MC-1 in the United
States in 2008 and accelerate revenues earlier than we had anticipated. With an
enterprise value of $90m, we believe Medicure become vulnerable for acquisition.
We maintain our Buy rating and our target price to $3.00 based on discounted cash
flow.
Table 1: Medicure Inc - Income Statement – C$000’s – Fiscal Year ending May
Medicure Inc.
2004 2005 2006 Q-1a Q-2a Q-3e Q-4e 2007e 2008e
MC1 for CABG patients 10,368 12,101
MC-4232 for diabetes patients with Hypertension
Aggrastat 280 1,418 3,000 6,116 10,814 21,641
Revenues 280 1,418 3,000 6,116 21,182 33,742
Cost of Sales 10 54 450 1,108 1,622 3,246
Royalties 150 1,026 1,176 2,094
Cost of Sales 10 54 600 2,134 2,798 5,340
Operating Margin 270 1,364 2,400 3,982 18,384 28,402
General Admin 1,958 2,256 2,858 1,160 1,183 1,207 1,250 4,800 5,280
Marketing & Sales 1,475 1,623 2,403 5,500 7,500
Research & development 4,435 13,011 10,219 2,785 3,816 6,000 8,399 21,000 23,100
Depreciation & Amortization 41 58 107 137 582 600 681 2,000 2,200
Operating Expenses 6,434 15,325 13,184 4,082 7,056 9,429 12,732 33,300 38,080
EBITDA -6,393 -15,267 -13,077 -3,675 -5,110 -6,429 -8,070 -12,916 -7,478
EBIT -6,434 -15,325 -13,184 -3,812 -5,692 -7,029 -8,751 -14,916 -9,678
Other Revenue
Other Items 445 459 577 566 -400 166 300
EBT -5,989 -14,866 -12,607 -3,246 -6,092 -7,029 -8,751 -14,750 -9,378
Income Taxes
Net Earnings -5,989 -14,866 -12,607 -3,246 -6,092 -7,029 -8,751 -14,750 -9,378
EPS Fully Diluted ($0.11) ($0.22) ($0.17) ($0.03) ($0.06) ($0.07) ($0.09) ($0.15) ($0.10)
FD Avg Shares Out.(Mil) 55.7 66.7 75.1 96.0 96.2 96.2 96.2 96.2 96.2
Source: Company and Paradigm Capital Inc.
Claude Camiré 3 January 15, 2007
Senior HealthCare Analyst [phone]

Buy
12-month target $3.00
Potential ROR 104%
Sector Healthcare
Ticker MPH-T
MCU-A
Avg. FD Shares O/S (m) 96.1
Free Float (m) 85.5
Mkt cap (US$m) 141.3
Mkt float (US$m) 125.7
Free float (%) 89
Enterprise Value (US$m) 94.3
Key Metrics
Debt/EBITDA
Debt/Equity
Operating Cash Flow/ Share
Claude Camiré
[phone]
[e-mail]
Sales
Toronto [phone]
Calgary [phone]
Paradigm Capital research is available on First Call,
Reuters or at http://www.paradigmcap.com
Refer to last page for official disclaimer
Issued by Paradigm Capital Inc.

[cristrader]

Antwort auf Beitrag Nr.: 26.936.769 von cristrader am 15.01.07 16:17:41

Hallo!

"We expect Aggrastat could reach $70m in revenues by FY10.
This remains less than a 15% market share of the US$450m (2005 data). This
product remains an attractive cash flow generator with above 90% gross margins."


Wenn das eintrifft ist alleine Aggrastat mehr Wert als die aktuelle Marktcapitalisierung. Nach Abzug der Merck Royalties bleiben dann jährlich ca. 50 Mio US $ Cash übrig! Die Einschätzung ist meiner Ansicht nach auch nicht zu optimistisch. Ein Medikament mit nahezu gleicher Effektivität, mit schnellerem Wirkungseintritt, günstigeren Nebenwirkungsprofil und zudem weitaus günstigeren Preis sollte sich einen 15 % Marktanteil sichern können, auch wenn Rheopro mit Eli Lilly eine viel schlagkräftigere Vertriebsmannschaft zur Verfügung hat.

Der Markt hatte die Aggrastat Aquisition anfangs eher mit Unverständnis und Skepsis aufgenommen. Die jüngsten klinischen Daten und vor allen Dingen die Umsatzentwicklung in den nächsten Monaten wird das Bild umkehren.


Ich glaube aber nicht das wir das volle Potential von Medicure werden ausschöpfen können. Dadurch das Medicure bisher keinerlei Partnerschaften vorweisen kann und noch alle Rechte besitzt macht es sich zu einem idealen Übernahmeziel. Hoffentlich gelingt es Medicure sich zumindest noch bis Mitte 2008 vor einer Übernahme zu schützen.



Hier ist noch ein interessanter Artikel bezüglich Aquisitionen von BigPharma:

http://www.bloomberg.com/apps/news?pid=20601202&sid=aDsAVhSs…

Drugmakers' `Arms Race' May Spur Biotechnology Deals (Update2)

By Angela Zimm

Jan. 12 (Bloomberg) -- Vincent Aita of Kilkenny Capital Management says he picks biotechnology stocks on their potential as takeover targets. The strategy is paying off.

The number of biotech deals, including acquisitions and product alliances, rose 32 percent to 232 last year, according to data compiled by Bloomberg. At least four of Aita's holdings, including Serono SA and Kos Pharmaceuticals Inc., were bought by bigger drugmakers. Aita, who manages about $200 million in health stocks, is betting there will be even more transactions in 2007.

``There is an escalating arms race,'' Aita said in an interview at the JPMorgan Healthcare Conference this week in San Francisco. ``There are more deals to be had.''

Pfizer Inc., the world's largest pharmaceuticals maker, and Merck & Co. may buy biotech companies to make up for a scarcity of experimental medicines and expiring patents for best-selling products. On the shopping list are companies with experimental compounds as well as those with new drug-development science and technologies, investors at the conference said.

Last year the number of biotech deals in North America, including company acquisitions and joint ventures, increased from 175 in 2005, and the average premium rose to 33 percent from 23 percent, based on Bloomberg data.

Upward Trend

More transactions and higher premiums are likely this year, according to analysts, investors and company executives interviewed this week at the San Francisco conference, the annual meeting where buyers and sellers gather to make deals. About 7,000 people packed hallways and conference rooms at the Westin St. Francis Hotel to hear presentations from 310 companies.

``Premiums are going up,'' JPMorgan analyst Geoffrey Meacham said in an interview. ``You're seeing a lot of bidding wars.''

Driving the trend are big pharmaceutical companies with billions in cash that need new drugs to ensure growth. New York- based Pfizer may lose almost half of its $51 billion in 2005 sales as a result of competition from generic drugmakers to products with expiring patents. Pfizer, with $30 billion, has entered at least six research partnerships since November. Two transactions for which a value was disclosed totaled a combined $450 million.

Merck's Deals

Merck, the fourth-largest U.S. drugmaker, may lose $3 billion in sales this year from its top-selling Zocor cholesterol pill because of generic competition. It signed 35 transactions last year, including the $1.1 billion million purchase of San Francisco-based Sirna Therapeutics Inc., which is developing drugs based on blocking genes involved in disease.

Whitehouse Station, New Jersey-based Merck aims to become ``the best biotechnology company,'' Chief Executive Officer Richard Clark said in an interview at this week's meeting. Merck's biotech deals totaled $1.4 billion in 2006.

``It's science and technology and potential companies -- we're looking at all ends of the spectrum,'' Clark said. ``Obviously, it's competitive.''

Eli Lilly & Co., which is offering $2.28 billion to buy its biotech partner Icos Corp., is spending $1.5 billion this decade on building its own biotechnology operations.

``The price of poker has definitely gone up,'' said John Lechleiter, Indianapolis-based Lilly's president and chief operating officer, at the conference. ``There are too few good assets and too many bidders.''

Amgen Inc., the world's biggest biotechnology company, and Biogen Idec Inc. also are considering acquisitions and alliances.

Biogen

Biogen since May has bought three companies with a combined value exceeding $270 million to reduce reliance on its biggest product, the multiple sclerosis treatment Avonex. Last week, the Cambridge, Massachusetts-based company agreed to pay as much as $120 million for closely held Syntonix Pharmaceuticals, adding experimental treatments for hemophilia.

Merck's shares rose 53 cents, or 1.2 percent, to $44.79 at the close of New York Stock Exchange composite trading. Pfizer added 18 cents to $26.64, and Lilly increased 37 cents to $52.60. Amgen jumped $1.36, or 1.9 percent, to $73.27 in Nasdaq Stock Market composite trading, and Biogen rose 53 cents, or 1 percent, to $50.97.

`Most Active'

The pace of acquisitions ``is the most active in our history,'' Biogen CEO James Mullen told investors in a presentation at the conference. There were 10 announced company acquisitions last year, up from 8 in 2005, JPMorgan analyst Meacham said in a Jan. 5 investment report

Premiums over the market price of traded shares also are rising. They ranged from 21 percent for Swiss drugmaker Actelion Ltd.'s purchase of Cotherix Inc., a U.S. biotechnology company, to 170 percent for AnorMed Inc., which Genzyme Corp. took over in a bidding war with rival Millennium Pharmaceuticals Inc.

``Last year saw the first hostile bid by a biotechnology company,'' in the Genzyme takeover of AnorMed, said Steven Burrill, CEO of Burrill & Co., a life-sciences investment adviser in San Francisco.

``Premiums are running 50 percent to 100 percent, which means the market is undervaluing the stocks,'' Burrill said.

Biotechnology companies raised $20 billion in partnership deals last year, up from $17 billion in 2005, according to Burrill.

Companies already aligned with bigger drugmakers through partnerships are likely takeover targets, said Kilkenny's Aita.

Amgen

Last year Amgen, purchased its partner, Abgenix Inc., to gain control of the cancer drug Vectibix. Genentech Inc., the world's No. 2 biotechnology company, agreed to buy its partner Tanox Inc. in November, gaining the asthma medication Xolair. The $919 million transaction was the first acquisition in Genentech's history.

Biotech companies in partnerships that may be takeover targets include Onyx Pharmaceuticals Inc., which co-markets the Nexavar kidney cancer drug with Bayer AG, and New River Pharmaceuticals Inc., which sold rights to its hyperactivity treatment to London-based Shire Plc, Aita said. Onyx shares rose 24 cents, or 2 percent, to $12.22 at the close of Nasdaq Stock Market trading. New River fell 37 cents to $55.76.

Others include BioMarin Pharmaceutical Inc., which shares a rare-disease drug with Genzyme, and Millennium, which co-markets its Velcade cancer drug with Johnson & Johnson. BioMarin shares gained 33 cents, or 1.9 percent, to $17.67 today and Millennium rose 21 cents, or 1.9 percent, to $11.46.

``You don't often see biotechnology companies selling out of weakness,'' Aita said. ``Partnering and M&A have been the lifeblood of the industry. Consolidation isn't going away.''

To contact the reporter on this story: Angela Zimm in San Francisco [e-mail]



Grüße cristrader" target="_blank" rel="nofollow ugc noopener">[http://www.bloomberg.com/apps/news?pid=20601202&sid=aDsAVhSs…

Drugmakers' `Arms Race' May Spur Biotechnology Deals (Update2)

By Angela Zimm

Jan. 12 (Bloomberg) -- Vincent Aita of Kilkenny Capital Management says he picks biotechnology stocks on their potential as takeover targets. The strategy is paying off.

The number of biotech deals, including acquisitions and product alliances, rose 32 percent to 232 last year, according to data compiled by Bloomberg. At least four of Aita's holdings, including Serono SA and Kos Pharmaceuticals Inc., were bought by bigger drugmakers. Aita, who manages about $200 million in health stocks, is betting there will be even more transactions in 2007.

``There is an escalating arms race,'' Aita said in an interview at the JPMorgan Healthcare Conference this week in San Francisco. ``There are more deals to be had.''

Pfizer Inc., the world's largest pharmaceuticals maker, and Merck & Co. may buy biotech companies to make up for a scarcity of experimental medicines and expiring patents for best-selling products. On the shopping list are companies with experimental compounds as well as those with new drug-development science and technologies, investors at the conference said.

Last year the number of biotech deals in North America, including company acquisitions and joint ventures, increased from 175 in 2005, and the average premium rose to 33 percent from 23 percent, based on Bloomberg data.

Upward Trend

More transactions and higher premiums are likely this year, according to analysts, investors and company executives interviewed this week at the San Francisco conference, the annual meeting where buyers and sellers gather to make deals. About 7,000 people packed hallways and conference rooms at the Westin St. Francis Hotel to hear presentations from 310 companies.

``Premiums are going up,'' JPMorgan analyst Geoffrey Meacham said in an interview. ``You're seeing a lot of bidding wars.''

Driving the trend are big pharmaceutical companies with billions in cash that need new drugs to ensure growth. New York- based Pfizer may lose almost half of its $51 billion in 2005 sales as a result of competition from generic drugmakers to products with expiring patents. Pfizer, with $30 billion, has entered at least six research partnerships since November. Two transactions for which a value was disclosed totaled a combined $450 million.

Merck's Deals

Merck, the fourth-largest U.S. drugmaker, may lose $3 billion in sales this year from its top-selling Zocor cholesterol pill because of generic competition. It signed 35 transactions last year, including the $1.1 billion million purchase of San Francisco-based Sirna Therapeutics Inc., which is developing drugs based on blocking genes involved in disease.

Whitehouse Station, New Jersey-based Merck aims to become ``the best biotechnology company,'' Chief Executive Officer Richard Clark said in an interview at this week's meeting. Merck's biotech deals totaled $1.4 billion in 2006.

``It's science and technology and potential companies -- we're looking at all ends of the spectrum,'' Clark said. ``Obviously, it's competitive.''

Eli Lilly & Co., which is offering $2.28 billion to buy its biotech partner Icos Corp., is spending $1.5 billion this decade on building its own biotechnology operations.

``The price of poker has definitely gone up,'' said John Lechleiter, Indianapolis-based Lilly's president and chief operating officer, at the conference. ``There are too few good assets and too many bidders.''

Amgen Inc., the world's biggest biotechnology company, and Biogen Idec Inc. also are considering acquisitions and alliances.

Biogen

Biogen since May has bought three companies with a combined value exceeding $270 million to reduce reliance on its biggest product, the multiple sclerosis treatment Avonex. Last week, the Cambridge, Massachusetts-based company agreed to pay as much as $120 million for closely held Syntonix Pharmaceuticals, adding experimental treatments for hemophilia.

Merck's shares rose 53 cents, or 1.2 percent, to $44.79 at the close of New York Stock Exchange composite trading. Pfizer added 18 cents to $26.64, and Lilly increased 37 cents to $52.60. Amgen jumped $1.36, or 1.9 percent, to $73.27 in Nasdaq Stock Market composite trading, and Biogen rose 53 cents, or 1 percent, to $50.97.

`Most Active'

The pace of acquisitions ``is the most active in our history,'' Biogen CEO James Mullen told investors in a presentation at the conference. There were 10 announced company acquisitions last year, up from 8 in 2005, JPMorgan analyst Meacham said in a Jan. 5 investment report

Premiums over the market price of traded shares also are rising. They ranged from 21 percent for Swiss drugmaker Actelion Ltd.'s purchase of Cotherix Inc., a U.S. biotechnology company, to 170 percent for AnorMed Inc., which Genzyme Corp. took over in a bidding war with rival Millennium Pharmaceuticals Inc.

``Last year saw the first hostile bid by a biotechnology company,'' in the Genzyme takeover of AnorMed, said Steven Burrill, CEO of Burrill & Co., a life-sciences investment adviser in San Francisco.

``Premiums are running 50 percent to 100 percent, which means the market is undervaluing the stocks,'' Burrill said.

Biotechnology companies raised $20 billion in partnership deals last year, up from $17 billion in 2005, according to Burrill.

Companies already aligned with bigger drugmakers through partnerships are likely takeover targets, said Kilkenny's Aita.

Amgen

Last year Amgen, purchased its partner, Abgenix Inc., to gain control of the cancer drug Vectibix. Genentech Inc., the world's No. 2 biotechnology company, agreed to buy its partner Tanox Inc. in November, gaining the asthma medication Xolair. The $919 million transaction was the first acquisition in Genentech's history.

Biotech companies in partnerships that may be takeover targets include Onyx Pharmaceuticals Inc., which co-markets the Nexavar kidney cancer drug with Bayer AG, and New River Pharmaceuticals Inc., which sold rights to its hyperactivity treatment to London-based Shire Plc, Aita said. Onyx shares rose 24 cents, or 2 percent, to $12.22 at the close of Nasdaq Stock Market trading. New River fell 37 cents to $55.76.

Others include BioMarin Pharmaceutical Inc., which shares a rare-disease drug with Genzyme, and Millennium, which co-markets its Velcade cancer drug with Johnson & Johnson. BioMarin shares gained 33 cents, or 1.9 percent, to $17.67 today and Millennium rose 21 cents, or 1.9 percent, to $11.46.

``You don't often see biotechnology companies selling out of weakness,'' Aita said. ``Partnering and M&A have been the lifeblood of the industry. Consolidation isn't going away.''

To contact the reporter on this story: Angela Zimm in San Francisco [e-mail]



Grüße cristrader

[cristrader]

Hallo1

Hier mal einige Punkte zum Potential von Medicure!

Leadmedikament MC-1: Stoffwechselprodukt was im Körper bei Reaktion von Vitamin B6 mit Enzymen entsteht, im Prinzip die wirksame Form von Vitamin B6. MCU hält alle Patente an MC-1 in Verbindung mit Herz-Kreislaufkrankheiten (Patentschutz bis 2025) .

Am weitesten fortgeschritten ist MC-1 in der Indikation CABG (Bypass-Operationen). Bei diesen Eingriffe kommt es recht häufig zu Komplikationen die mit Schlaganfällen und Absterben von Herzgewebe enden. Bisher gibt es kein Medikament auf dem Markt das vor diesen Risiko schützt. MC-1 ist das mit Abstand am weitesten fortgeschrittene Medikament in diesem Bereich. Die Phase II mit mehr als 900 Patienten wurde mit überragenden Ergebnissen abgeschlossen. Die im November gestartete Phase III ist nur eine Bestätigungsstudie mit 3000 Patienten, wobei das Studiendesign dem der Phase II entspricht. Der Zeitplan sieht vor das die Rekrutierung bis November 2007 abgeschlossen sein wird, im April/Mai 2008 der NDA-Antrag gestellt und die Zulassung Ende 2008 erfolgt. Durch die Kapitalerhöhung hat Medicure genügend Cash um die Studie alleine durchzuführen. Das Marktpotential liegt in den USA bei ca. 500 Mio $ und weltweit bei ca. 1 Mrd $.


Aufgrund der bisher fehlenden Partnerschaft verzögern sich allerdings die Phase III-Starts von MC-1 in der Indikation ACS (Acute coronary syndrome) weltweites Marktpotential 3 Mrd. $ und von MC-4232 (Kombinationsproduktt MC-1 + ACE-Hemmer - Behandlung von Diabetikern mit Bluthochdruck --> mehr als 15 mio Patienten alleine in den USA !!!) . Laut Management gibt es ein riesiges Interesse von Pharmas an Kombiprodukten mit MC-1. In den nächsten Jahren laufen zahlreiche Patente von Angiotensin Receptor Blockern (ARB), Statinen und insbesondere von Plavix (Top Ten der Umsatzstärksten Medikamente). Kombiprodukte mit MC-1 werden als risikoarme Möglichkeit gesehen den Patentschutz zu verlängern bzw. den Umsatzrückgang abzumildern.

Das Umsatzpotential von MC-1 und all seinen möglichen Kombinationsprodukten beläuft sich im zweistelligen Mrd.-Bereich. Bei einem Unternehmen mit 150 Mio $ Marktkapitalisierung ist da noch recht viel Platz nach oben!

So richtig interessant wird es spätestens Ende 2007 wenn die Rekrutierung beendet ist bzw. Frühjahr 2008 mit den Phase III-Ergebnissen. Kommt es allerdings schon vorher zu einer Partnerschaft wird der grösste Teil des Kursanstieges schon vorweggenommen.

Das Problem bei Medicure liegt ausschließlich am Management und der IR-Abteilung. Der Präsident/CEO/Chair Albert Friesen hat eine extreme Machtbesessenheit und will sozusagen alle Fliegen mit einer Klappe schlagen. Sein Ziel ist es das Potential von MC-1 maximal auszureizen nur er vergißt dabei durch geschickte Partnerschaften auch das Risiko zu optimieren.
Das Management befindet sich in zahlreichen Verhandlungen und spricht von intensivsten Interesse von Pharmaseite insbesondere an den MC-1 Kombinationsprodukten. Ich bin zuversichtlich in den nächsten Monaten eine Partnerschaft zu erhalten!


Grüße cristrader

[KnigRollo]

was geht denn hier ab ??


cristrader.. dein flaggschiff schwächelt
worauf ist der große umsatz und der rückgang zurückzuführen ??

[brombeeren]

Antwort auf Beitrag Nr.: 27.475.154 von KnigRollo am 06.02.07 22:31:27

Guten Tag zusammen,
habe momentan auch keine Erklärung....übersehe ich news ?

Grüße
Brom

[cristrader]

Antwort auf Beitrag Nr.: 27.483.566 von brombeeren am 07.02.07 12:35:32

Hallo Leute!

News kann ich auch keine finden. Nach dem Bruch des Widerstandes bei 1,20 $ ist charttechnisch gesehen ein Antesten der 1 $ Marke fällig.

Die nicht vorhandene Kontrolle des Vorstandes und vor allen Dingen die uneingeschränkte Machtfülle von Präsident/CEO/Chair Albert Friesen scheint den Instis gar nicht zu gefallen. Möglicherweise hat das Management jetzt dadurch einen weiteren Großinvestor vergrätzt. Bezüglich der Pipeline stehen in naher Zukunft keine News an. Außer möglichen Partnerschaften ist bis zum Abschluss der Patientenrekruitierung im November auch wenig zu erwarten. Wenn kein Partnerschaftsdeal kommt mit den damit verbunfenen Phase III-Starts von MC-1 in der Indikation ACS und von MC-4232 wird die Kursentwicklung sicherlich auch von den Aggrastat-Verkaufszahlen abhängen.

Grüße cristrader

[solarblase]

Medicure to Present at BIO CEO & Investor Conference
Friday February 9, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Feb 9, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced its President and CEO, Albert D. Friesen, PhD, will deliver a corporate presentation at the 9th annual BIO CEO & Investor Conference at 12:45 PM Eastern on Tuesday, February 13, 2007 in the Louis XVI Center of The Waldorf Astoria Hotel in New York City. The presentation will be made available by webcast and can be accessed on the Investor Relations page of the Medicure website at www.medicure.com.

[brombeeren]

Hallo Leute,

"charttechnisch" scheint 1,0 eher nicht zu halten.... wo sich der Boden hier bilden wird, wird für ein (risikobehaftetes) Nachlegen interessant. Es steht letztendlich wohl tatsächlich eine recht lange nachrichtenarme zeit bei diesm Wert an...wenn man von den Verkaufszahlen oder Partnerschaft absieht. Der Markt sieht letzteres offensichtlich momentan als fast ausgeschlossen an..

Gruß

brom

[solarblase]

Immer noch kein Boden erreicht Hat sich doch fundamnental nichts geändert. Hat Friesen einen Hedge Fond geärgert

[solarblase]

THE NEW YORK TIMES ARTICLE: IN THE STENT ERA, HEART BYPASSES GET A NEW LOOK

http://www.nytimes.com/2007/02/25/health/25bypass.html?ex=11…

Oder geht auf die Medicure Homepage

[brombeeren]

Antwort auf Beitrag Nr.: 27.993.604 von solarblase am 27.02.07 07:34:53

Guten Tag zusammen,

Insidertrades: Reimer ist der Finanzvorstand.

http://www.canadianinsider.com/coReport/allTransactions.php?…

Vielleicht kommt ja doch schon jetzt Bewegung in den Wert...

Gruß Brom

[solarblase]

Heute großes Volumen in USA und Kanada. Finde aber keine News dazu.

[brombeeren]

Antwort auf Beitrag Nr.: 28.434.018 von solarblase am 22.03.07 15:58:15

Guten Tag zusammen,
guten Tag solarblase,

schönes volumen amex , selbst in Frankfurt für die Minimalumsätze der letzten zeit. Aber auch mir fehlen die news, die fast 10 % wert sind. Dachte, wir kämpfen noch eine ganze Zeit um 1 Dollar, ohne wesentliche Bewegungen. Sieht jemand eine Nachricht..oder geht es jetzt wider gegen 1 Dollar...

Gruß Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 28.439.664 von brombeeren am 22.03.07 19:50:21

Hallo!

Bin heute mal kurz aus meinem Winterschlaf erwacht

Heutiger Kursanstieg hängt vielleicht mit der Teilnahme Medicures an der ACC`07 vom 24-27.März zusammen.

http://www.expo.acc.org/ACC2007/public/ExhibitorList.aspx?In…

Ansonsten steht in ca. 2-3 Wochen der nächste Quartalsbericht an. Gute Aggrastat-Verkaufszahlen und Info´s zur Phase III können dem Kurs vielleicht etwas auf die Sprünge helfen.

Grüße cristrader

[solarblase]

Bin jetzt nicht der große Charttechniker. Aber sieht doch gar nicht schlecht aus

[cristrader]

Medicure Article in Cdn. Bus. Mag.
MCU - amex, MPH - tse

Winning over hearts
Erin Pooley
From the March 26, 2007 issue of Canadian Business magazine
In the global cardiovascular drug industry, Medicure Inc. is a David among the Goliaths. With just 90 employees and a market capitalization of less than $140 million, the Winnipeg-based drug-discovery company is a small player compared to the pharmaceutical giants that compete in the US$70-billion heart-disease space. But despite its size, Medicure is working on a drug with the capacity to reduce the risk of heart damage due to cardiovascular disease — the No. 1 killer in both Canada and the United States. Recent safety concerns regarding drug-coated stents — an alternative treatment to coronary artery bypass surgery — could also pump some new life into this biotech's sagging share price (TSX: MPH).

Currently in pivotal Phase 3 trials, Medicure's MC-1 drug is a cardio-protectant, designed to reduce the damage to the heart when arteries are blocked and when they are subsequently reopened after bypass surgery. In a previous trial involving 900 bypass patients, the drug reduced the heart attack rate by nearly 50% in the first 30 days. If Phase 3 trials are successful — results are expected in March 2008 — MC-1 could be on the market in the U.S. as early as the beginning of 2009, following shortly after in Canada. (Medicure has already received fast-track approval from the U.S. Food and Drug Administration for MC-1.)

"I call it the second Aspirin," says Claude Camiré, a biotechnology analyst at Toronto-based Paradigm Capital Inc. "A lot of people use Aspirin or blood thinners [after surgery], but those only help your blood flow — they don't really protect your heart like MC-1. I think Medicure has a good chance of succeeding." Camiré rates MPH a Buy, with a 12-month price target of $3.

Shares in Medicure reached as high as $2.24 a year ago but now trade at around $1.20, despite speculation late last year they might pop, pending the announcement of a marketing partnership with a U.S. firm. Although nothing materialized, that option is still on the table, says co-founder, president and chief executive Bert Friesen (left). "We have stated that we are certainly open and interested, but only if it maximizes the value to the shareholders," he says. "If a partnership deal of significant value is presented to us before the data, we could still entertain it, but we're keeping the options open."

Camiré says Medicure could also be considered a target for acquisition, with Connecticut-based biotech firm Alexion Pharmaceuticals Inc. a possible buyer. "The recent failure of Alexion's similar type of drug in Phase 3 for the same indication as MC-1 could give an extra edge for Medicure," he says. "It may be looking to buy."

In the meantime, Medicure will continue to capitalize on safety concerns regarding drug-eluting stents — tiny, drug-coated tubes made of metal mesh that are implanted in the coronary artery after angioplasty to keep arteries open longer. Considered less invasive than bypass surgery — which involves grafting part of a healthy blood vessel onto a blocked coronary artery — drug-coated stents soared in popularity when they were approved by Health Canada in late 2002 and by the U.S. FDA in 2003. Vancouver-based device maker Angiotech Pharmaceuticals Inc. (TSX: ANP; Nasdaq: ANPI) — which was in partnership with Massachusetts-based Boston Scientific Corp. — saw its shares climb as high as $38 three years ago with the introduction of its drug-coated Taxus stent to North America. Recent news of the increased risk of blood clots in stent patients, however, has put Angiotech's stock on life support — it now flutters around $7 on the Toronto market. "Angiotech has seen a dramatic reduction in royalty revenue, which has caused a significant ripple effect through the company's financial situation," writes UBS analyst Jeff Elliott in a recent research report.

While Friesen is careful to point out that drug-eluting stents are not going away — and that the risk of blood clots is still relatively low — he remains hopeful the news will mean an uptick in the number of bypass surgeries performed each year in North America and, consequently, the amount of MC-1 prescribed as a post-surgery treatment. His five-year vision for Medicure is to become an integrated Canadian pharmaceutical company with "up to three products on the market [and] other ones in the pipeline — all focused in the cardiovascular space."

Medicure currently has the exclusive U.S. licensing rights to Aggrastat — a blood thinner — and has concluded Phase 2 trials on MC-4232, a combination drug intended to reduce high blood pressure in diabetic patients. With $45 million of cash on hand and a reported $1.4 million in second-quarter sales for the period ending Nov. 30 — compared to no revenue a year earlier — the company's goal is to ramp up Aggrastat sales, which could reach as high as $70 million by 2010, according to Camiré. Like all biotechs, Medicure does not come without risks, although analysts say the company is in a good position to finance MC-1's third — and final — trial, and there appear to be no competing drug candidates.

In the meantime, the company will have to work hard to muscle its way into the highly competitive — and fast-growing — field of cardiovascular drug development, where billion-dollar pharmaceutical companies easily outnumber the Medicures of this world. A battle of biblical proportions, indeed.

[brombeeren]

Tag zusammen,
wäre anzumerken, dass nur Bären Winterschlaf halten...passt also bei diesem Wert zukünftig überhaupt nicht..Ein positiver Artikel:Ergebnisse Phase III MC1 CABG März 2008 (Rekrutierung bis November 2007 ?), Markteinführung USA möglich Anfang 2009, Kursziel 3 Dollar 12 Monate, weiterhin scheinbar kein wirkliches Konkurrenzprodukt in der Entwicklung, Aggra Zahlen 70 Mio bis 2010.Unterstützung bei 1 Dollar hat gehalten, vielleicht generieren gute Aggra-Zahlen und ein paar news ein schönes kaufsignal. Der bisherige Fahrplan wird immerhin im Artikel bestätigt, es war ohne verpartnerung eh von einer längeren Kapitalbindung auszugehen. Friesens Bemerkungen zur Partnerschaft -er handle nur im interesse der shareholder- klingen beim kursverlauf der letzten zeit verwegen.Worüber ich nicht orientiert bin, ist Phase III MC-4232 finanziert? Beginn ? MC4262 Phase II und MC 45308 Phase I ? es hieß mal Mitte 2006 "in the near future"? Nuvelo und Bayer sind in Phase III mit Alfimeprax (segment von MC-4232) in Phase III (-80 %) übel "Baden gegangen".

Gruß Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 28.600.145 von brombeeren am 31.03.07 14:10:56

Hallo brombeeren!

Finanzierung reicht nur für Phase III von MC-1 in CABG, alle anderen klinischen Programme sind bis auf weiteres auf Eis gelegt bzw. bis zu einer Verpartnerung. Das Ziel von Friesen nur eine Partnerschaft zu optimalen Konditionen einzugehen ist ja grundsätzlich zu begrüssen. Es stellt sich nur die Frage weshalb BigPharma für ein Medikament das scheinbar konkurrenzlos ist und einen Milliardenmarkt anvisiert kein vernünftiges Verpartnerungsangebot auf den Tisch legt. Das alles schürt natürlich Zweifel an der Wirksamkeit und dem Umsatzpotential on MC-1.

News zu MC-45308 wären sicherlich auch mal wieder angebracht1

In den letzten beiden Jahren wurden die Zahlen immer in der Woche vor Ostern bekannt gegeben vielleicht ja auch dieses Jahr.

Grüße cristrader

[cristrader]

Hallo!

Sieht doch schon alles wieder viel besser aus! Jetzt fehlt bei den Quartalszahlen nur eine positive Entwicklung der Aggrastat-Zahlen und ein positiver Zwischenbericht zur Phase III-Rekruitierung (von Ankündigung einer bevorstehenden Partnerschaft will ich gar nicht sprechen) und der Kurs wird sich zumindest im aktuellen Bereich stabilisieren. Positive Presse wie folgende tragen auch zu einem positiven Bild bei.

http://www.medadnews.com/News/Index.cfm?articleid=429867

New Cardioprotective Drug Could Provide Boost For Post-Bypass Surgery Heart Health



SOMERSET, N.J., April 5, 2007-- Stent thrombosis, restenosis and lifelong prescriptions. Millions of patients have discovered that the drug-coated stents used as part of their heart operations may be having more of a detrimental effect on their health than medical experts have ever publicly acknowledged. Recent articles in medical journals suggest that unless patients who receive drug-eluting stents continue to take blood thinners, they could more than double their risk of heart attack or death.



This emerging safety controversy around drug-coated stents has some experts predicting a resurgence in heart bypass operations. The bypass operations, although more invasive and dangerous, are believed to have longer lasting benefits compared to stents.

"Doctors have been less inclined to recommend bypass surgery for their patients because of the risk associated with the procedure, most notably post-operative heart attacks," stated Dr. Bob Harrington of Duke Clinical Research Institute. "Unfortunately there are currently no approved drugs to lessen that risk."

One company that could improve bypass outcomes for patients is Medicure, Inc. The company has developed a cardio-protective drug known as MC-1 that in recent clinical trails cut the threat of post-operative heart attacks in bypass patients nearly in half. Medicure's MC-1 is currently in a late-stage clinical trial and if successful could lead to its approval for sale in the U.S.

"MC-1 has the opportunity to be the first drug available to help the hundreds of thousands of patients undergoing bypass surgery every year," says Medicure CEO Dr. Albert D. Friesen.


Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 28.603.015 von cristrader am 31.03.07 18:48:23

Tag zusammen,
warum kein vernünftiges Partnerangebot durch BigPharma? Vielleicht will Friesen tatsächlich zum Schaden an der anderen Pipeline MC1-CABG tatsächlich grundsätzlich nicht mehr verpartnern.Alles andere ist nur PR ? Im März 2006 hat er zudem geäußert, MCU habe nach Phase III Start Mc1 CaBG einen Wert zwischen 750 Mio und 2 Mrd !! Das ist eine sehr stolze Vorstellung für ein Unternehmen mit 90 "Menneken" und einem Medikament am Anfang Phase III.Ganz zu schweigen, dass die Marktkap. wohl deutlich drunter liegt. Würde ich zu diesem Preis wahrscheinlich auch noch nicht kaufen, dann schon eher einkassieren.Ob natürlich die fehlende Verpartnerung an uns unbekannten Risiken der Phase III liegen könnte, ist immer etwas Dunkelargument, aber natürlich auch nicht zu entkräften. Hier sind für die Phase III aber schon die Stichworte "nur Bestätigungsstudie mit gleichem Studiendesign wie Phase II "gefallen.

Gruß Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 28.687.171 von brombeeren am 06.04.07 13:07:17

Hallo brombeeren!

Friesen´s Vorstellung von einem Unternehmenswert 750-2000 Mio$ bereits vor Zulassung von MC-1 Cabg ist angesichts der Marktkapitalisierung sicherlich ambitioniert wenn man sich allerdings das Marktpotential von MC-1 mit seinen ganzen Kombinationsmöglichkeiten ansieht jedoch gerechtfertigt. Eine Zulassung von MC-1 CABG wird die ganze MC-1 Technologie(Kombiprodukte, MC-1-Analoge) erst richtig in den Wert bringen. Friesen hat so seine Vorstellungen was MC-1 Wert ist. Das Problem bei den Verhandlungen mit BigPharma ist die geringe Marktkapitalisierung von MCU. Wieso soll ich das Mehrfache der Marktkapitalisierung in einem Partnerschaftsdeal investieren wenn ich die ganze Firma für den gleichen Preis bekomme. Ein Übernahmeangebot von 3-4 $ würde bei diesem Management kein institutioneller Anleger ausschlagen!

Grüße cristrader

[solarblase]

April 12, 2007
MEDICURE ANNOUNCES THIRD QUARTER FISCAL 2007 FINANCIAL RESULTS
WINNIPEG , Manitoba – (April 12, 2007) Medicure Inc. (TSX:MPH/Amex:MCU), a cardiovascular focused biopharmaceutical company, today reported the results of operations for the three and nine month periods ended February 28, 2007. All amounts referenced herein are in Canadian dollars unless otherwise noted. At the close of business on February 28, 2007, the exchange rate was CAD$1.00 = US$0.8548.

MEND-CABG II Update:

In its third quarter, Medicure continued to make significant progress with the MEND-CABG II study. This single confirmatory Phase 3 study for registration is evaluating the cardioprotective effects of the Company’s FDA-Fast Tracked product MC-1 in patients undergoing coronary artery bypass graft (CABG) surgery.

“Enrollment is on track to meet our guidance for a November 2007 completion,“ stated Medicure’s President and CEO, Albert D. Friesen, PhD. “Momentum is building at the trial sites throughout North America and Europe. We believe the current pace of enrollment is indicative of the investigators’ enthusiasm for a novel cardioprotective drug that reduces risk for their bypass patients.”

The double-blind, randomized, placebo-controlled clinical trial is enrolling up to 3,000 patients at approximately 120 cardiac surgical centers throughout North America and Europe.

During the quarter, Medicure completed a Special Protocol Assessment (SPA) with the FDA for the Phase 3 MEND-CABG II study. The SPA provides official support from the FDA that the Phase 3 protocol is appropriately designed to form the basis of a New Drug Application (NDA) submission. Furthermore, this agreement provides Medicure with a well defined pathway towards regulatory approval for MC-1.

Corporate Update:

Net sales for AGGRASTAT® for the third quarter were $2,522,000, representing a 78% increase over the previous quarter sales of $1,419,000.

“We are encouraged that our team was able to deliver quarter-over-quarter revenue growth,” stated Dr. Friesen. “We have invested in re-vitalizing relationships with key opinion leaders, individual hospital accounts, hospital group purchasing organizations and the wholesaler distribution network in order to solidify the product’s revenue base. Going forward, the Company’s growth strategy for AGGRASTAT® is to leverage clinical guidelines and key opinion leader relationships, and to create awareness of the clinical and cost benefits associated with the use of AGGRASTAT® to the medical community.”

AGGRASTAT® is a GP IIb/IIIa inhibitor indicated for the treatment of acute coronary syndrome. Medicure holds the U.S. rights to sell AGGRASTAT®. Merck & Co., Inc. own the license for the rest of the world.

The Company also closed a US$25.9 million private placement led by Deutsche Bank Securities Inc. and including A.G. Edwards & Sons, Inc. and Montgomery & Co., LLC. A total of 19.9 million common shares were issued in the private placement at a price of US$1.30, together with warrants, to purchase 3.98 million additional common shares.

Financial Results:

Net product sales for the three month period ending February 28, 2007 totaled $2,522,000 compared to $nil for the same period in fiscal 2006. Net product sales for the nine month period to date were $4,221,000 compared to $nil in the same period last year. The increase in net sales for fiscal 2007 as compared to the same period in fiscal 2006 was due to product sales from the Company’s first commercial product AGGRASTAT®, which was acquired on August 8, 2006. Net product sales for the quarter ended February 28, 2007 increased significantly over the prior fiscal quarter.

Cost of goods sold for the three month period ending February 28, 2007 totaled $177,000 compared to $nil for the same period in fiscal 2006. Cost of goods sold for the nine month period to date were $240,000 compared to $nil in the same period last year. Cost of goods sold represents product costs associated with AGGRASTAT® and royalties due to Merck & Co., Inc. based on net sales of AGGRASTAT®.

Research and development expenditures for the third quarter of fiscal 2007 were $6,518,000 as compared to $1,881,000 for the same quarter in fiscal 2006. Research and development expenditures were higher in the three and nine month periods ended February 28, 2007 as compared to the same period in fiscal 2006, due primarily to the Phase 3 MEND-CABG II study and the increasing enrollment rate and the resulting clinical activities. Research and development for the nine month period to date were $13,119,000 compared to $8,188,000 for the same period last year.

Selling, general and administrative expenditures for the third quarter of fiscal 2007 totaled $3,425,000, compared to $861,000 for the same quarter in fiscal 2006. Selling, general and administrative expenditures increased during the three month period ended February 28, 2007 as compared to the same period in fiscal 2006 primarily due to costs associated with AGGRASTAT®, which totaled $2,180,000 and included field selling expenses and product promotion costs, which were not incurred in the previous year. The other less significant factors were increased business development activities and stock-based compensation expense. Selling, general and administrative expenditures for the nine month period to date totaled $7,243,000, compared to $2,035,000 for the same period in fiscal 2006.

As a result of the above noted items, the financial results for the three month period ended February 28, 2007 include a consolidated net loss from operations of $8,365,000 or $0.08 per share, compared to $2,718,000 or $0.04 per share for the three-month period ended February 28, 2006. The nine month year-to-date loss for fiscal 2007 was $17,704,000 or $0.18 per share, compared to $10,128,000 or $0.14 per share for the nine month period ended February 28, 2006.

At February 28, 2007, the Company had cash and cash equivalents totaling $43,423,000 as compared to $34,920,000 as of May 31, 2006. During the quarter ended February 28, 2007, the Company strengthened its cash position when it closed a private placement raising total gross proceeds of US$25,900,000. A total of 19,923,044 common shares were issued in the private placement at a price of US$1.30, together with warrants, to purchase 3,984,608 additional common shares.

An expanded version of Management’s Discussion and Analysis and the financial statements for the three and nine month periods ended February 28, 2007 is accessible on Medicure's website at www.medicure.com.

Notification of Conference Call:

Date: Thursday, April 12, 2007

Time: 8:30 AM Eastern Time

[cristrader]

Antwort auf Beitrag Nr.: 28.777.733 von solarblase am 12.04.07 15:45:54

Hallo!

Habe mir gestern eigentlich irgendwelche positiven Infos erwünscht, habe leider kaum welche gefunden.

-Entwicklung der Aggrastat-Zahlen ist ziemlich enttäuschend. Nachdem die Dezember-Umsätze bereits bei 1 Mio $ lagen sind die Jan-Feb-Umsätze von zusammen nur 1,5 Mio $ ziemlich ernüchternd. Habe mir da doch etwas mehr erhofft. Wenn ich es auf der CC richtig verstanden habe liegt der Break-Even der Aggrastat-Aquisition bei Jahresumsätzen von 10 Mio $ welche sicherlich leicht zu übertreffen sind. Innerhalb der nächsten 12 Monate sind zudem mit Ergebnissen von mehreren großen Aggrastat Studien in Europa (Merck) zu rechnen. Die Zukunft liegt sowiso nicht bei Aggrastat sondern bei MC-1. Aggrastat finanziert sich selbst und wird die künftige Vermarktung von MC-1 erheblich beschleunigen von daher bleibt es eine gute Investition.

Die MC-1 CABG Phase III-Rekrutierung läuft völlig nach Plan. Bestätigung der Timelines November: Abschluss der Rekrutierung/ Ende März Bekanntgabe der Endergebnisse/ Zulassung Ende 2008/Anfang 2009

-sonst nicht viel Erwähnenswertes nur das übliche bla-bah.


Hier noch ein interessanter Artikel:
Medicure on last leg of 12-year heart drug project

Winnipeg Free Press (Manitoba, Canada) - Apr. 13, 2007

By Martin Cash

IF all goes according to plan, Winnipeg's Medicure Inc. could have its new heart medication on the market by 2009.

The Winnipeg drug discovery company is on the last leg of a 12-year development process of the drug designed to reduce heart tissue damage for patients who undergo coronary bypass surgery.

Final enrollment in a 3,000 patient international phase III trial will be complete in November, and Medicure CEO Albert Friesen said he hopes the company will be able to present final data from the study at the major American College of Cardiology in Chicago at the end of March 2008.

Medicure has received fast-track approval for the new drug (called MC-1) from the U.S. Food and Drug Administration as long as the current trial produces results that reach a certain level of reliability.

Friesen said the new drug application will then take another six months to complete after the final results are in.

When (and if) it receives approval to sell the drug to doctors and hospitals in the U.S. and Canada it will complete a 12-year process for the company that started with research undertaken by University of Manitoba heart specialist Dr. Naranjan S. Dhalla, who recently retired as head of the university's Institute of Cardiovascular Sciences.

Friesen said Medicure continues to negotiate potential partnership agreements with large pharmaceutical companies that might ultimately market MC-1. But in the meantime, it is also developing its own sales and marketing organization.

Last year, Medicure acquired the U.S. rights for another heart medication called Aggrastat and has developed a marketing and sales force to sell that product through the U.S. Sales of that drug are underwriting the costs of the sales and marketing network.

[e-mail]



Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 28.797.943 von cristrader am 13.04.07 17:22:14

Hier einige Bemerkungen von Analyst Montgomery
* Yesterday Medicure Inc. reported 3Q07 EPS of ($0.08) and
indicated
that its pivotal Phase III for MC-1 is on track to complete
enrollment in November. We expect Phase III results from MC-1 in
1Q08. Medicure reported 3Q07 Aggrastat revenues of $2.52M. We
find
it encouraging that Aggrastat sales are up nicely
quarter-over-quarter. Our long-term estimates, primarily driven
by
MC-1, remain unchanged. We have made minor changes to our
near-term estimates based on a better understanding of near-term
cost drivers.

* Approximately 90% of Medicure's R&D expenses are attributable to
MC1. There were significant up-front costs in starting the MC-1
trial, which resulted in higher than normal R&D in Q3. R&D is
likely to be high over the next few quarters as Medicure
continues
to enroll patients, after which we believe it is likely to
decline
from current levels.

* Due to its poor brand image in the US, we give very little credit
to Aggrastat. However, we believe its brand image could be
improved with additional data from head-to-head studies against
competitors such as ReoPro and Integrillin. We were pleasantly
surprised to hear on the conference call that Merck is running
several large trials to prove equivalence of Aggrastat. Positive
results from these trials could lower the risk for Medicure in
running similar trials in the US, which could eventually lead to
substantial sales growth for Aggrastat, in our view. We believe
that results from these trials could become available as soon as
at ACC next year. We are not altering our current Aggrastat
forecast of no change in sales from 2007 to 2012.

* Management clarified that the p-value needed for success in the
Phase III trial was close to 0.05 but lower than that, and at the
same time much higher than 0.01. We believe this is a good
revelation because there have been rumors that the statistical
barrier for the Phase III trial is very high owing to the
substantially low p-value that is required to be met.


Grüße cristrader

[solarblase]

Medicure "buy"

Saturday, April 14, 2007 2:20:23 AM ET
Montgomery & Co

NEW YORK, April 14 (newratings.com) - Analyst Shiv S Kapoor of Montgomery & Co reiterates his "buy" rating on Medicure Inc (ticker: MCU). The target price is set to C$3.

In a research note published yesterday, the analyst mentions that the company has reported its 3Q07 EPS at -C$0.08. Sales of Medicure’s Aggrastat drug grew at a healthy q/q pace, the analyst says. The company has indicated that it is on track to completing the pivotal Phase III enrollment for its cardioprotective drug MC-1 in November.

[solarblase]

17-Apr-07 Up/Down MCU: Merriman Curhan Ford starts at BUY

[cristrader]

Antwort auf Beitrag Nr.: 28.860.724 von solarblase am 17.04.07 16:42:58

Hallo!

MERRIMAN CURHAN FORD MCU
.
600 California Street
9th Floor
San Francisco, CA 94108
[phone] Main
[phone] Fax
[phone] Trading
www.mcfco.com
AMEX: MEM
Member NASD/SIPC
Please see important
disclosures at the end of
this report
April 17, 2007
Medicure, Inc. (MCU) Buy
An Undervalued Late-Stage Cardiovascular Biotechnology Company;
Initiating Coverage at Buy
• Unmet need for a cardioprotectant. Ischemic reperfusion injury
(IRI) is associated with a high risk of death, MI, heart failure, arrhythmia,
renal insufficiency, and stroke. All of these can add up to
a 20% incidence of major vascular events following CABG surgery.
• MC-1, Medicure’s lead product, is currently in the midst of a pivotal
Phase III trial for the treatment of IRI. This trial is being conducted
under the auspices of an SPA agreement with the FDA, which
reduces the regulatory risk of the product. We believe that this
product has a high probability of being partnered within the next
three years. Final Phase III data may be presented at next year’s
ACC in March 2008.
• AGGRASTAT is an undervalued asset, in our view. We believe
Medicure’s re-growth of this brand can generate solid revenues and
provide a commercial platform for the eventual launch of MC-1.
• Initiating coverage at Buy. We are valuing the company on a
modified sum-of-the-parts basis. We are projecting that the company
will re-grow the AGGRASTAT brand to C$23M in three years.
For MC-1, we are assuming a 2009 launch, under a co-promote
model in the United States. Based on these assumptions, we believe
the stock can trade towards the US$2.00-2.20 level in 12 months.
Jose J Haresco, Ph.D.
Senior Vice President
[phone]
[e-mail]
Medicure engages in the R&D and
commercialization of therapeutics
for cardiovascular needs. It develops
products for the treatment
of acute cardiovascular events,
such as acute coronary syndrome,
coronary artery bypass,
and graft surgery, as well as
heart attacks to chronic conditions,
including hypertension and
metabolic syndrome.
Market Cap (M): $139.4
Shares Out. (M): 111.0
Float (M): 106.2
10-Day Avg. Volume: 167,600
Institutional Ownership: 24.2%
Enterprise Value (M): $107.2
MCF Estimates
Market Data
Stock Performance
Company Description
Valuation (FY07E)
Key Metrics
Price: $1.20
Rating: Buy
52-Week Range: $0.91-1.91
Book Value/Share: 0.256
Debt/Capital: 21.7%
Debt (M): C$13.4
Cash (M): C$47
EV/Sales: NM
EV/EBITDA: NM
PEG Ratio: NM
Summary
Medicure is, in our view, an undervalued late-stage biotechnology
company in the cardiovascular sector. We believe that Medicure can
re-grow the AGGRASTAT brand to a conservative C$23M in three
years. The company’s lead product, MC-1, is currently in pivotal
Phase III for the treatment of ischemic reperfusion injury following
CABG surgery; the trial is being conducted under the auspices of the
SPA agreement with the FDA, which reduces regulatory risk, in our
view.
Investment Conclusion
FY06A FY07E* FY08E
REVS. (M)
1Q C$0.00 C$0.3
2Q 0.00 1.4
3Q 0.00 2.6A
4Q 0.00 3.5
FY (May) C$0.00 C$7.8 C$13.0
P/S NM NM NM
EPS
1Q (C$0.05) (C$0.04)
2Q (0.05) (0.06)
3Q (0.03) (0.08)A
4Q (0.03) (0.07)
FY (Dec) (C$1.16) (C$0.24 (C$0.24)
P/E NM NM NM
Source: BigCharts.com
* EPS reflects share count adjustment
MERRIMAN
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April 17, 2007 2
Cardiology
Medicure, Inc. Buy
Company Description
Medicure is, in our view, an undervalued biotechnology company in the cardiovascular sector. The company
recently acquired AGGRASTAT, an injectible anti-platelet therapy for the treatment of acute coronary syndrome
(ACS). AGGRASTAT offers superior efficacy in diabetics at a much lower cost relative to its competitors,
ReoPro and Integrilin, but has for several years not been aggressively marketed. We believe that Medicure
can re-grow the product to a conservative C$23 million in three years. The AGGRASTAT franchise also
provides a platform upon which to launch future cardiovascular products. The company’s lead development
candidate, MC-1, is currently in pivotal Phase III for the treatment of ischemic reperfusion injury following
CABG surgery; the trial is being conducted under the auspices of SPA agreement with the FDA, which reduces
the regulatory risk, in our view. The company is headquartered in Manitoba, Canada. As of the publication
of this report, the company had approximately C$47 million in cash and equivalents.
Investment Highlights
Unmet need for a cardioprotectant. Ischemic reperfusion injury (IRI) is thought to be responsible for the
myocardial damage that can occur following a coronary artery bypass graft (CABG). IRI is associated with a
high risk of death, MI, heart failure, arrhythmia, renal insufficiency, and stroke after CABG surgery. All of
these can add up to a 20% incidence of major vascular events following CABG surgery.
Unique technology. We believe MC-1 blocks the signaling cascade that ultimately causes ischemic reperfusion
injury. It is has shown very promising results in multiple Phase II trials, and is currently in the midst of
a pivotal Phase III trial. This trial is being conducted under the auspices of an SPA agreement with the FDA,
which reduces the regulatory risk of the product, in our view. The upside to this product may be its eventual
use in percutaneous coronary intervention (PCI). We believe that this product has a high probability of being
partnered within the next three years.
AGGRASTAT is an undervalued asset, in our view. Medicure acquired AGGRASTAT in late 2006 from MGI
Pharma. Despite offering better efficacy in diabetics at a lower cost, AGGRASTAT sales have floundered due
to lack of a coherent commercialization effort. We believe Medicure’s re-growth of this brand can generate
solid revenues and provide a commercial platform for the eventual launch of MC-1.
Significant potential market opportunities. AGGRASTAT operates in the US$500 million U.S. platelet
inhibitor market. We believe that the market for MC-1 in the CABG setting is worth US$185 million in the
United States alone. The use of MC-1 in coronary artery stenting procedures provides another US$750 million
in market opportunities.
Initiating coverage at Buy. We are valuing the company on a modified sum-of-the-parts basis. We are
projecting that the company will re-grow the AGGRASTAT brand to C$23 million in three years. For MC-1, we
are using a risk-adjusted probability model of success. We are conservatively assuming a CY2009 launch using
a co-promotion model in which Medicure earns 40% of the revenue generated by the partnership/joint
venture in the United States. We are assuming 30% penetration of the market in the first year, which we
believe is reasonable given that there is no product in the market for use as a cardioprotectant. We are also
only assuming a probability of 60% success to the trial, despite the fact that it is a pivotal study being conducted
under an SPA. We believe the stock can trade toward US$2.00-2.20 in 12 months, and we are therefore
initiating coverage with a Buy rating.
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April 17, 2007 3
Cardiology
Medicure, Inc. Buy
Pipeline Summary
Source: Medicure
Twelve-Month Milestones
Source: Medicure
Pipeline Detail: AGGRASTAT
Medicure acquired AGGRASTAT (tirofiban hydrochloride) from MGI Pharma in August 2006. AGGRASTAT is a
glycoprotein (GP) IIb/IIIa inhibitor. AGGRASTAT inhibits platelet aggregation in a dose- and concentrationdependent
manner by preventing the binding of fibrinogen to the GP IIb/IIIa receptor, reducing the risk of
clot formation.
AGGRASTAT approved by the FDA for the treatment of acute coronary syndrome (ACS) including unstable
angina and non-Q-wave myocardial infarction. Acute coronary syndrome (ACS) is a broad set of symptoms
attributed to acute myocardial ischemia — chest pain due to a lack of blood flow to the heart resulting from
coronary artery disease (CAD). ACS covers a range of clinical conditions ranging from unstable angina to
non-Q-wave myocardial infarction and Q-wave myocardial infarction.
Originally developed by Merck, AGGRASTAT was launched in the United States in 1998, and is currently
available in 82 countries worldwide. Merck continues to market AGGRASTAT outside the United States, including
Europe where 2006 sales for AGGRASTAT were approximately US$95 million. Merck sold the U.S.
rights to AGGRASTAT to Guilford Pharmaceuticals Inc. in 2003, which was subsequently acquired by MGI in
2005. Total U.S. sales for the GP IIb/IIIa inhibitor class in 2006 were in excess of US$500 million, which included
US$8 million in AGGRASTAT sales.
Superior efficacy in diabetics. There are currently three GPIIb/IIIa compounds on the market. These include
Millennium Pharmaceuticals/Schering’s Integrilin (US$363 million in sales in 2006), Eli Lilly’s ReoPro
Product Clinical Indication Preclinical Phase I Phase II Phase III NDA Market
Aggrastat Acute Coronary Syndrome
MC-1 CABG Surgery
Acute Coronary Syndrome
Stroke
MC-4232 Diabetic Hypertension
MC-4262 Hypertension Complicated
w/ Metabolic Syndrome
MC-45308 Thrombosis
MC-5422 Ischemia Discovery
1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
SPA Granted for MC-1
MC-1 Phase III Enrollment Completed
MC-1 Phase III Completed
MC-1 NDA Submitted
MC-1 Approval and Launch
2006 2007 2008 2009
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Cardiology
Medicure, Inc. Buy
(US$156.5 million in sales in 2006), and AGGRASTAT. Of these, Integrilin has the broadest indication; it is
approved for use both during and before PCI procedures, which largely accounts for its dominant market
share. All three drugs are intravenously delivered and have therefore been overshadowed by orally available
compounds like Bristol Myers Squibb’s Plavix (US$3.4 billion in sales in 2006).
AGGRASTAT is the most cost-effective of the three. It has superior efficacy in diabetic patients, is convenient
to use (Integrilin requires refrigeration), and part of the recommended treatment regime for Non ST-Elvated
ACS in the 2005 American Heart Association guidelines.
AGGRASTAT is More Effective in Diabetic Patients (Composite Endpoint)
Impact of AGGRASTAT on Mortality in Diabetic Patients
As effective and safe as ReoPro in PCI. The 2004 study by Danzi compared a high-dose bolus of AGGRASTAT
to Reopro in patients undergoing coronary stenting. The study compared two cohorts of patients
who underwent coronary stent placement between January 2000 and December 2002. In the first cohort,
ReoPro which was given to 280/802 (34.9%) of 802 stented patients; in the second cohort, AGGRASTAT was
administered to 274/716 (38.3%) stented patients.
The primary endpoints were the proportion of patients with major bleeding and the rate of site access complications.
The study also evaluated the 30-day incidence of major adverse cardiac events (MACE). After the
procedure, the patients were given Plavix for four weeks and aspirin on an ongoing basis. Major bleeding episodes
were observed in four patients receiving ReoPro and in none receiving AGGRASTAT (1.4% vs. 0%; P =
0.12); the rates of site access complications were similar (3.6% vs. 3.3%; P = 0.96). The 30-day incidence
of MACE was 7.1% in the ReoPro group and 5.8% in the AGGRASTAT group (P = 0.65). Thus, in patients
30-Day Death or MI in Diabetic Patients
TRIAL Compound IIb/IIIa Inhibitor Placebo p value
PRISM AGGRASTAT 8.1% 4.3% 0.04
PRISM-PLUS AGGRASTAT 15.5% 4.7% 0.00
PURSUIT Integrilin 18.8% 18.1% 0.70
GUSTO IV ReoPro 11.4% 10.3% 0.50
PARAGON A Lamafiban 16.2% 11.7% 0.21
PARAGON B Lamafiban 13.7% 13.0% 0.74
Source: Circulation 2001; 104; 2767-2771
30-Day Death in Diabetic Patients
TRIAL Compound IIb/IIIa Inhibitor Placebo p value
PRISM AGGRASTAT 4.2% 1.8% 0.07
PRISM-PLUS AGGRASTAT 6.7% 3.6% 0.17
PURSUIT Integrilin 6.1% 5.1% 0.33
GUSTO IV ReoPro 7.8% 5.0% 0.51
PARAGON A Lamafiban 6.2% 4.6% 0.93
PARAGON B Lamafiban 4.8% 4.9% 0.01
Source: Circulation 2001; 104; 2767-2771
MERRIMAN
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Cardiology
Medicure, Inc. Buy
undergoing coronary stenting, the high bolus dose of AGGRASTAT is as safe as ReoPro. Nevertheless, AGGRASTAT
is only approved for the treatment of ACS, and is not approved for use in PCI.
Market opportunity. The market for GP IIa/IIIb inhibitors should remain stable at the US$500 million level
until the end of the decade given its use in the PCI market, in our view. AGGRASTAT has previously suffered
from Merck and MGI’s lack of interest in driving AGGRASTAT product sales. Sales of AGGRASTAT under
Merck and then MGI fell from US$33.6 million in 2003 to US$12.3 million in 2005. By the time Medicure acquired
the product, virtually no sales and marketing dollars were being spent on the product. We believe that
Medicure’s investment of a proprietary 24 person sales force and marketing dollars can reinvigorate the
product. The product offers superior efficacy in diabetics at a 72% discount to ReoPro and a 43% discount to
Integrilin. The company is largely banking on off-label use to grow its franchise; for this reason we have kept
our estimates fairly conservative going forward. We believe that Medicure can re-grow the product to the
CAN$23 million level over the next 24 months.
MC-1
Background: vascular disease. Vascular disease (atherosclerosis) is a progressive and chronic condition
caused by the buildup of fatty cells in the inner lining of the vascular arteries, which turns into a localized,
patched, thickening, called a plaque or lesion. Expansion of the plaque into the interior of the artery (the lumen)
results in a narrowing of the artery (known as stenosis). The narrowing reduces blood flow to tissues
(such as the heart), which leads to tissue death (necrosis). Vascular disease can occur in arteries of any organ
of the body, and often leads to impaired organ function or death. Heart attacks, congestive heart failure,
kidney failure, or diabetes-related vascular diseases can all be caused by vascular disease.
Atherosclerosis in the coronary arteries is referred to as Coronary Artery Disease (CAD) or Coronary Heart
Disease (CHD). Coronary artery bypass graft surgery, or CABG, was the first treatment for CAD and involves
circumventing a blocked artery using a healthy vein or artery. Coronary artery bypass graft surgery is a surgery
in which one or more blocked coronary arteries are bypassed by a blood vessel graft to restore normal
blood flow to the heart. These grafts usually come from the patient's own arteries and veins located in the
chest, leg, or arm. The graft goes around the clogged artery to create new pathways for oxygen-rich blood to
flow to the heart. The goals of the bypass surgery are: 1) to relieve symptoms of coronary artery disease
(including angina), 2) Enable the patient to resume a normal lifestyle, and 3) lower the risk of a heart attack
or other heart problems.
This highly-invasive procedure is considered the standard care for CAD, but is associated with long hospital
stays and recovery times. In particular, it is associated with a high risk of death, MI, heart failure, arrhythmia,
renal insufficiency, and stroke. All these can add up to a 20% incidence of major vascular events following
CABG surgery.
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Cardiology
Medicure, Inc. Buy
Coronary Artery Bypass Graft Surgery
In coronary artery bypass graft surgery, a surgeon makes a vertical incision in the skin
and muscle in the middle of the chest and then cuts through the breastbone (sternum).
The surgeon spreads the rib cage to expose the heart and then cuts through the lining
that protects the heart (pericardium). To reroute blood flow around the diseased blood vessel,
surgeons typically use a portion of the saphenous vein in the leg or an internal mammary artery.
Source: health.yahoo.com
MC-1 Mechanism of Action
In order to perform CABG surgery, blood flow to the descending arteries is cut off for a short period of time.
A major source of vascular damage following CABG surgery is caused by the act of unblocking the blood flow
(reperfusion). During the earliest phases of reperfusion, cardiomyocytes (cells responsible for the heart’s
muscular contractions) undergo extreme contraction — sustained shortening and stiffening of the myocardium.
If this lasts for an extended period of time, cell death through apoptosis or necrosis can ensue. This
eventually aggravates the vascular problem and leads to immune-mediated vascular damage. This is known
as ischemic reperfusion injury, or IRI.
The core cause of ischemic reperfusion injury is thought to be the rapid release of extracellular ATP. At the
ischemic phase, ATP within the cell is depleted and cardiomyocytes accumulate Na+ via various pathways in
the membrane including the Na+ channel, the Na+/H+ exchanger, and the Na+/HCO3 symporter. Na+ cannot
exit the cell since the Na+/K-ATPase is rendered non-functional due to the lack of ATP. Na+ influx leads to
Ca2+ buildup since the Na+/Ca2+ exchanger (NCE) operates in reverse mode in a depolarized, Na+-overloaded
cell. Extracellular ATP from platelets and nerve endings further exacerbate the problem by binding to the P2
purnergic receptors, which also cause an influx of Ca2+ . Consequently, ischemic cells develop cytosolic Ca 2+
overload.
During reperfusion, the cell is re-supplied with ATP and it starts hoarding excess intracellular Ca2+. The overload
of intracellular Ca2+ has been implicated in several mechanisms that lead to irreversible cellular injury:
initiation of signaling cascades that lead to the activation of phospholipase A2 (PLA2), PLAC, endonucleases,
proteases, and several genes that control the cellular life cycle. These processes eventually lead to cell
death, which in turn causes further injury through activation of local, cytokine-mediated, immune responses.
MERRIMAN
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Cardiology
Medicure, Inc. Buy
Elevated Calcium Levels Contribute to Ischemic Reperfusion Injury
High intracellular concentrations of [Ca2+], have been implicated in several mechanisms
that lead to irreversible cell death, which in turn leads to local immune responses that aggravate vascular damage.
MC-1 can prevent this cascade by blocking Ca+ influx into the cell.
Source: FASEB Journal (1995) 9, 219-228; Cardiovascular Research (2004) 61, 365-371
MC-1 is a cardioprotectant. It prevents the cascade ischemic reperfusion cascade by stopping at one of its
core sources: it prevents extracellular ATP from binding to the P2 purinergic receptors and further increasing
the cytosolic [Ca2+ ] level. Blocking this cascade can prevent cell death, which in turn prevents further downstream
immune responses from aggravating the damage.
Multiple clinical studies demonstrate MC-1’s potential. MC-1 has been evaluated in several clinical
studies. Most recently, the MEND-CABG (Phase II/III) trial showed that MC-1 may mitigate adverse events
after CABG surgery.
MC-1 Trials
MEND-I. MEND-I was a double-blind, placebo-controlled study to evaluate MC-1’s ability to reduce cardiomyocyte
death as measured by changes in the MB fraction of the enzyme creatine kinase (CK-MB), which is
secreted from damaged cardiac muscles. CK-MB levels have been previously correlated with the risk of myocardial
infarctions.
Sixty patients were randomized in a 2:1 manner, receiving either MC-1 (10 mg/kg) or placebo prior to Percutaneous
Coronary Intervention (PCI) The primary endpoint was infarct size based on CK-MB measurements
24 hours after PCI. Secondary endpoints were the occurrence of major cardiac events (MACE) within 30 days
and occurrence of MI within 24 hours of PCI.
MC-1 showed a 43.5% reduction in infarct size (32.9 ng / ml, p=0.038). However, there no deaths in either
the placebo or experimental groups, so the occurrence of non-fatal MI was the same.
MEND-CABG I. MEND-CABG enrolled 901 patients in a placebo-controlled Phase II/III trial. Patients were
enrolled into three treatment arms: 250 mg MC-1, 750 mg MC-1, or placebo in a 1:1:1 manner. Patients received
treatment once a day for 30 days. The study enrolled high-risk patients that two of the following criteMERRIMAN
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Medicure, Inc. Buy
ria: ACS within 28 hours, MI within seven days, TIMI 0-2 flow, angiographic evidence of thrombus, LVEF
<=30%, or saphenous vein graft lesion.
The primary composite endpoint included cardiovascular death, non-fatal MI defined by CK-MB levels >= 50
ng/ml and non-fatal cerebral infarction at post-operative day (POD) 30. The study was not powered to detect
significance, but merely show a trend towards significance. It was powered at 78% to detect a 37% reduction
in the primary endpoint. The trial failed to meet its primary endpoint under the definition of non-fatal MI
having CK-MB levels > 50 ng/ml, showing only a 14% reduction in MI under this definition. However, at a
definition of MI having CK-MB levels > 100 ng/ml, an alternative definition of MI, MC-1 showed remarkably
good results. MC-1 was well tolerated.
Exploratory Analysis of 100 ng/ml Definition of MI
Source: Medicure
MEND-CABG II (Pivotal Phase III). The company is in the midst of a pivotal Phase III trial that will enroll
3,000 high-risk CABG patients. In December 2006, Medicure announced that it had completed an SPA agreement
with the FDA. The study will be conducted in 120 sites across the United States and Europe, and uses a
composite endpoint and a definition of CK-MG >= 100 ng /ml as the definition of MI. The FDA had previously
allowed Alexion to use this definition in its ischemic reperfusion injury trials. Patients will be treated for 30
days and followed for an additional 90 days. Enrollment began in early 2007. As of April 12, 2007, over 90%
of sites were active; enrollment is on track to be completed in late 2007. Final Phase III data should be available
at next year’s Late Breaking ACC at the end of March 2008. We estimate that the company will file a
rolling NDA in 2007/2008 and launch the product in late 2008 or early 2009 at the latest.
Regulatory Pathway
We are optimistic about the outcome of this trial, particularly given that the SPA agreement lowers regulatory
risk, the trial’s similarity to MEND CABG-1, and the FDA’s agreement that an additional Phase III trial
will not be required. Furthermore, this product has been granted priority six-month review. The FDA has said
will allow MEND-CABG-1 data to be included in the submission.
The company has been in continuous contact with the EMEA regarding a European submission, and expects
to file for European approval shortly after an approval in the United States. What remains to be seen, however,
is whether the EMEA will require the company to perform an additional Phase III trial.
Timepoint Placebo
POD30 49 31 (37.2% difference, p=0.028) 34 (31.1% difference, p=0.071)
POD90 50 32 (36.5% difference, p=0.030) 35 (30.5% difference, p=0.071)
Incidence of MI Only
Timepoint Placebo
POD30 43 23 (47.2% difference, p=0.008) 23 (47.2% difference, p=0.008)
POD90 44 23 (48.3% difference, p=0.006) 23 (48.3% difference, p=0.006)
250 mg / day 750 mg / day
Composite Endpoint of Cardiovascular Death, MI, Stroke
250 mg / day 750 mg / day
MERRIMAN
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April 17, 2007 9
Cardiology
Medicure, Inc. Buy
U.S. MC-1 Regulatory Timeline
Source: Medicure
Market Opportunity
There are approximately 370,000 CABG procedures performed in the United States every year, and there is
currently no product approved for use as a cardioprotectant during cardiovascular surgeries. The number of
CABG procedures, according to our channel checks with cardiovascular surgeons, has been increasing in recent
months given the controversies regarding drug eluting stents. We believe that the use of MC-1 in the
U.S. CABG setting, at a conservative price of US$750 per treatment, is worth US$185 million in the United
States alone.
An upside to this is MC-1’s potential use in Percutaneous Coronary Intervention (PCI). MC-1’s ability to prevent
local cellular damage during balloon catherization or stent deployment could be of significant clinical
value in the face of the recent debates surrounding long-term complications associated with drug eluting
stents. There were approximately 1 million PCI procedures performed in 2006 in the United States alone — a
potential additional market value of US$750 million for MC-1. It is unlikely that Medicure can pursue this indication
on its own. Rather, we believe that this indication is something a larger partner would have to fund.
We believe that solid results in Phase III for the PCI indication can lead to a strong commercialization partnership.
Procter & Gamble had previously signed a co-development partnership with Alexion Pharmaceuticals
prior to the initiation of Alexion’s Phase IIb trial for pexelizumab. The partnership was valued at US$95 million,
which included a US$10 million upfront payment, royalties, and milestones.
Competitive Landscape
There are two primary competitors in the injectible anti-platelet market: Millenium/Schering’s Integrilin and
Eli Lilly’s ReoPro. Integrilin was originally developed by Millenium Pharmaceuticals, but is co-marketed with
Schering Plough in the United States and licensed to GlaxoSmithKline overseas. Integrilin is approved for use
in both ACS and PCI — hence its dominant share; patients can be treated with Integrilin once they are admitted
to a hospital and can be kept on it until the PCI procedure. ReoPro is approved for use as an adjunct
therapy in addition to heparin and aspirin in percutaneous coronary intervention for the prevention of cardiac
ischemic complications, or in patients with unstable angina who are non-responsive to conventional medical
therapy if a PCI is planned within 24 hours. Integrillin is approved for the treatment of patients with acute
coronary syndrome (unstable angina/non-ST-segment elevation myocardial infarction), including patients
who are to be managed medically and those undergoing percutaneous coronary intervention (PCI), and for
the treatment of patients undergoing PCI, including those undergoing intracoronary stenting. In contrast,
Aggrastat is approved for use on in ACS and not PCI. We believe this narrow label, as well as the lack of
marketing effort, has contributed to the product’s lackluster performance prior to its acquisition by Medicure.
Despite the need for a cardioprotectant, there is little competition for MC-1. The two most notable products,
Aventis’ caroporide and Alexion’s pexelizumab, both failed in recent years to show any efficacy as a cardio-
1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
SPA Granted for MC-1
MC-1 Phase III Enrollment Completed
MC-1 Phase III Completed
MC-1 Approval and Launch
2006 2007 2008 2009
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Cardiology
Medicure, Inc. Buy
protectant. Frankly, we believe this is the primary reason for Medicure’s stock being undervalued relative to
its late-stage peers. We are not discouraged by these companies’ failures to develop a drug for use in preventing
ischemic reperfusion injury. We believe that both compounds failed because the mechanisms of action
were too specific to engender a broad reduction in the immunomodulatory response to ischemic reperfusion
injury. MC- 1 attempts to prevent injury at the beginning of the signaling cascade which leads to the
immune response, rather than trying to modulate the immune response itself.
There are a number of compounds in development, but most are being pursued by academic research institutions.
We highlight the competitive products being pursued by private and public companies in the table
below.
Competitive Landscape for Cardioprotectants
Source: MCF & Co.
MC-4232
MC-4232 combines MC-1 with lisonopril, an ACE inhibitor, and is targeted at the extremely competitive high
blood pressure market. Phase II (MATCHED) clinical trials demonstrated blood pressure and metabolic control.
The MATCHED trial enrolled 120 patients in a randomized, placebo-controlled, double-blind, crossover study.
100, 300, and 1000 mg of MC-4232 were combined with 20 mg of lisonopril (normal dosing range is 20-40
mg). The primary endpoint was mean daytime ambulatory systolic flow (MDASBP); the study was not powered
to detect significance. The 300 mg/20 mg combination of MC-1/lisonopril reduced MDASBP by 12 mmHg
compared to baseline (p=0.0001) and to 7.5 mmHg for lisonopril alone (p=0.13). The results were encouraging
enough for the company to decide to push the product into later stages of development.
We expect this therapeutic category to grow to US$32 billion by 2010, driven largely by demographic shifts
which highlight the increasing prevalence of metabolic diseases. Treatment options in this market include
angiotensin receptor blockers, diuretics and beta blockers. This is a highly competitive market with a multitude
of generic options; a product will have to show a significant benefit in terms of efficacy, safety, or convenience
to be successful. Hence, we remain cautiously optimistic about the prospect of this product. The
company will, in our view, have to push the product into later stages of clinical development before it can be
effectively partnered.
Compound Company Description Development Phase
Avandia(rosiglitazone) GSK Assessment of IRI following 8 weeks of rosiglitazone
treatment in patients with metabolic disease; Expected
completion in 2007
Phase II
Lipotor (atorvastatin) Merck Assessment of IRI following 3 day treatment with
atorvastating 80 mg daily; Expected completion in 2007
Phase IV
Angiomax (bivalirudin) Medicines Company Evaluate use of Angiomax in patients with ACS prior to PCI Phase III
Reprieve Radiant Medical Endovascular therapeutic cooling technology; 225 patient
trial in patients with PCI
Phase II/III
TP-10 Avant Immunotherapeutics Complement inhibitor Phase II completed
FX06 Fibrex Medical Fibrin derived peptide; 220 patient trial in PCI patients
KAI9803 Kai Pharma Delta-PKC inhibitor; Phase I
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Medicure, Inc. Buy
Discovery-Stage Compounds
MC5422 anti-ischemia program. This program revolves around modifying MC-1 and creating mimetics to
further address ischemic and reperfusion injury.
MC-45308 antithrombotics program. Preliminary results have shown significant potential for the lead
drug candidate in this program, MC-45308, in preventing blood clots. The compound has demonstrated both
anti-platelet and anti-coagulant effects, which could make MC-45308 a major player in the management
strategy of cardiovascular diseases such as Myocardial Infarction (MI), stroke, Pulmonary Emboli (PE) and
Peripheral Arterial Disease (PAD). A drug of this type currently is non-existent within the antithrombotic marketplace.
Management
According to the company:
Albert D. Friesen, Ph.D., president and CEO, holds a Ph.D. in Protein Chemistry from the University of
Manitoba. As the first full-time employee and president of the Winnipeg Rh Institute, he oversaw the development
and initial pharmaceutical approval of WinRho. Dr. Friesen has also been instrumental in founding
several health industry companies including Novopharm Biotech Inc. (now Viventia Biotech Inc.), Genesys
Pharma Inc., and KAM Scientific Inc.
Jan-Ake Westin, M.Sc., VP, clinical development, has worked as a managing director at two of Canada’s
leading CROs — i3 Research and Innovus. In this capacity he has overseen the management of numerous
large cardiovascular clinical trials. Mr. Westin spent more than 20 years with Astra Pharma Inc., holding such
positions as international clinical research manager and senior clinical research scientist. Following this, Mr.
Westin proceeded to senior leadership positions with Pharmacia & Upjohn Inc. and Pfizer/Pharmacia Corp.,
where he served as director of clinical operations and director of clinical outsourcing, respectively. Mr. Westin
received his M.Sc. (Social Pharmacy) from the University of Uppsala in Sweden.
Derek G. Reimer, CA, CFO, came to Medicure from Deloitte & Touche LLP where he served as a senior
manager in the Assurance and Advisory Services group. In this role, Mr. Reimer dealt mainly with major corporate
clients, including several TSX 100 companies, providing advice regarding complex accounting, regulatory,
and compliance issues. His previous experience includes several years providing international accounting
services to clients exclusively in the financial services industry. Mr. Reimer is a chartered accountant who
also holds a Bachelor of Commerce (Hons.) degree in accounting from the University of Manitoba. Mr. Reimer
is responsible for managing financial systems, programs, and processes to ensure the successful accomplishment
of Medicure's business objectives.
Valuation and Rating
We are valuing the company on a modified sum-of-the parts basis.
We are projecting that the company can re-grow the AGGRASTAT brand to C23 million in three years. We are
opting to stay on the conservative side of the estimates because the company is inherently relying on offlabel
use to drive AGGRASTAT’s growth. We value this franchise at a multiple of 3x sales. We assume a gross
margin of 90% for this product.
For MC-1, we are using a risk-adjusted probability model of success. We are conservatively assuming a
CY2009 launch using a co-promotion model in which Medicure earns 40% of the revenue generated by the
partnership/joint venture in the United States. We are assuming 30% market penetration in the first year,
which we believe is reasonable given that there is no product in the market for use as a cardioprotectant. We
are pricing MC-1 at US$750 per treatment, which seems comparable to other therapeutics used in a cardioMERRIMAN
CURHAN
FORD
GROW WITH US SM
April 17, 2007 12
Cardiology
Medicure, Inc. Buy
vascular surgery setting. We are also assuming a probability of 60% success to the trial, despite the fact that
it is a pivotal study being conducted under an SPA.
We believe that good Phase III results for MC-1 in IRI should lead to a partnership that targets the use of
MC-1 in PCI. Hence, we include in our valuation model the impact of milestone payments (US$15 million upfront,
US$35 million in development milestones, another US$40 million for commercialization milestones) as
well as a royalty-based revenue stream. In order to remain conservative, we model a 20% probability of success
since we view this aspect of the model rather dependent on MC-1’s performance in the IRI indication.
At the time of this report’s publication, the company had cash and equivalents of approximately C$47 million.
We believe this is enough to fund the company’s activities until the end of the pivotal U.S. Phase III trial. The
company may have to access the capital markets at least one time prior to commercializing the product.
Based on these assumptions, we believe the stock can trade toward the US$2.00-2.20 level in 12 months.
We are therefore we are initiating coverage with a Buy rating.
Medicure Valuation Model (in US$)
Source: MCF & Co.
Key Risks
Medicure may be unsuccessful in marketing AGGRASTAT. The company acquired AGGRASTAT on the
assumption that a lack of sales and marketing efforts are the primary reason that product sales faltered
since 2003. The lack of an effective and continuous marketing campaign for the product in the last few years
prior to the acquisition may have made the brand “stale” in the minds of interventional cardiologists. Despite
the product’s superior performance in diabetics, it may be difficult to overcome the product’s recent track
record.
MC-1 may fail its pivotal phase III trial. At least half of the company’s valuation rests on MC-1. While
the data from MEND-CABG 1 are encouraging, it was only through a retrospective analysis of the data that
led to the decision to redefine MI as CK-MB >=100. We are comforted that the company has reached an
agreement with the FDA regarding this issue, and that the agency had previously allowed Alexion to use the
same definition of MI in the company’s clinical trials for pexeluzimab.
Sales Roy. MCU Launch Year PV Sales Prob. Weighted Per Sh.
Product Indication Partner Ph. ($M) % Rev. ($M) Year Used Pds Rate ($M) Mult. (%) Value ($) Value ($)
AGGRASTAT ACS None Marketed 13 100% 13 2006 2008 0 10% 13 2 100% 26 0.23
MC-1 Cardioprotection None Phase III 185 40% 74 2009 2012 4 10% 51 4 60% 121 1.08
PCI-Upfront None 15 100% 15 2009 2009 1 10% 14 1 20% 3 0.02
PCI-Development None 35 100% 35 2010 2010 2 10% 29 1 20% 6 0.05
PC-Commcerial None 40 100% 40 2012 2012 4 10% 27 1 20% 5 0.05
PCI-Sales None 750 18% 135 2011 2016 8 10% 63 5 20% 63 0.56
MC-4232 Hypertension None Phase II
@ Yearend
Cash 22.3 19 0.17
112.0 $243 $2.17
Discount
Current 12-Mnt Burn
Not considered in valuation
40.8
Current shares outstanding (M) 12-18 Month Valuation
MERRIMAN
CURHAN
FORD
GROW WITH US SM
April 17, 2007 13
Cardiology
Medicure, Inc. Buy
Other Public Companies Mentioned in This Report
Avant Immunotherapeutics (AVNC, $2.33, Not Rated)
Alexion Pharmaceuticals Inc. (ALXN $44.46, Not Rated)
Bristol-Myers Squibb (BMY $27.99, Not Rated)
Eli Lilly & Co. (LLY $56.76, Not Rated)
GlaxoSmithKline plc (GSK $57.97, Not Rated)
Merck & Co., Inc. (MRK $49.86, Not Rated)
MGI Pharma Inc. (MOGN $23.69, Not Rated)
Millenium Pharmaceuticals Inc. (MLNM $11.44, Not Rated)
The Medicines Company (MDCO, $26.11, Not Rated)
Sanofi Aventis SA (SNY $45.56, Not Rated)
MERRIMAN
CURHAN
FORD
GROW WITH US SM
April 17, 2007 14
Cardiology
Medicure, Inc. Buy
Jose J Haresco, Ph.D.
Senior Vice President
[phone]
[e-mail]
Source: MCF & Co.; company filings
Medicure, Inc.
Quarterly Income Statement
(In CAN$)
2008 2009 2010
8/31/2005 11/30/2005 2/28/2006 5/31/2006 FY 8/31/2006 11/30/2006 2/28/2007 5/31/2007 FY 5/31/2008 5/31/2009 5/31/2010
Revenue
AGGRASTAT $ - $ - $ - $ - $ - $ 2 80 $ 1 ,419.0 $ 2 ,552 $ 3 ,500 $ 7 ,751 $ 1 3,000 $ 1 8,000 $ 2 3,000
MC-1 $ 1 7,000 $ 4 0,000
MC-1 Milestones
Cost of Goods - - - - - 2 8 5 4.3 1 77 3 50 6 09 1 ,300 1 ,800 2 ,300
Gross Profit - - - - - 2 52 1 ,364.7 2 ,375 3 ,150 7 ,142 1 1,700 3 3,200 6 0,700
Operating Expenses
R&D 3 ,297 3 ,010 1 ,881 2 ,031 1 0,219 2 ,783 3 ,816.0 6 ,518 7 ,000 2 0,117 2 5,000 1 2,500 1 3,000
Amortization 5 82.9 7 74 7 80 2 ,909 1 ,800 1 ,800 1 ,800
Investments Tax
SG&A 5 37 6 36 8 61 8 24 2 ,858 1 ,160 2 ,658.0 3 ,425 3 ,700 1 0,943 1 5,000 2 5,000 2 7,000
Total Operating Expenses 3 ,834 3 ,646 2 ,742 2 ,855 1 3,077 3 ,943 7 ,056.9 1 0,717 1 1,480 3 3,196 4 1,800 3 9,300 4 1,800
Operating Income (3,834) (3,646) (2,742) (2,855) (13,077) (3,691) (5,692.2) (8,342) (8,330) (26,055) (30,100) (6,100) 1 8,900
EBITDA (3,834) (3,646) (2,742) (2,855) (13,077) (3,691) (5,692.2) (8,342) (8,330) (26,055) (30,100) (6,100) 1 8,900
Interest & Other Expense (790.0) (462) (600) (1,852) 1 ,600 1 ,400
Interest Income 2 5 3 5 6 1 1 79 3 00 2 90 3 90.0 4 67 4 40 1 ,587 1 ,400 2 ,000 2 ,100
Pretax Income (3,809) (3,611) (2,681) (2,676) (12,777) (3,401) (6,092.2) (8,365) (8,490) (26,349) (27,100) (2,700) 2 1,000
Taxes - - - - - - - - - - - -
Net Income $ (3,809) $ (3,611) $ (2,681) $ (2,676) $ (12,777) $ (3,401) $ (6,092) $ (8,365) $ (8,490) $ (26,349) $ (27,100) $ (2,700) $ 21,000
EPS $ (0.05) $ (0.05) $ (0.03) $ (0.03) $ (0.16) $ (0.04) $ (0.06) $ (0.08) $ (0.08) $ (0.24) $ (0.24) $ (0.02) 0.17
Weighted Average 8 0,000 8 0,000 8 0,000 8 0,000 8 0,000 9 2,200 9 6,200 1 11,000 1 12,000 1 12,000 1 13,000 1 25,000 1 26,000
Margins
Cost of Goods Sold NA NA NA NA NA NA NA NA NA NA 10.0% 10.0% 10.0%
Gross Margin NA NA NA NA NA NA NA NA NA NA 90.0% 184.4% 263.9%
SG&A NA NA NA NA NA NA NA NA NA NA 192.3% 69.4% 56.5%
Research & Development NA NA NA NA NA NA NA NA NA NA 115.4% 138.9% 37.1%
Operating Expenses NA NA NA NA NA NA NA NA NA NA 321.5% 218.3% 181.7%
Operating Income NA NA NA NA NA NA NA NA NA NA -231.5% -33.9% 82.2%
Net Income, net of taxes NA NA NA NA NA NA NA NA NA NA -208.5% -15.0% 91.3%
2006 FY2007
MERRIMAN
CURHAN
FORD
GROW WITH US SM
April 17, 2007 15
Cardiology
Medicure, Inc. Buy
Jose J Haresco, Ph.D.
Senior Vice President
[phone]
[e-mail]
Medicure, Inc.
Balance Sheet
(In CAN$)
Source: MCF & Co.; company filings
2/28/2007 5/31/2006
Assets
Current assets
Cash and cash equivalents C$ 43,423 C$ 3 4,920
Accounts recievable 3,287 4 58
Inventories 706
Research advance 200 2 00
Prepaid expense 1,282 2 63
48,898 3 5,842
Property and equipment 133 5 1
Intangible assets 23,922 2 ,922
Defered debt issue expenses
72,953 3 8,814
Liabilities and Shareholders Equity
Current liabilities
Accounts payable and accrued liabilities C$ 6,882 C$ 1 ,644
Current portion of long-term debt 5,054
11,936 1 ,644
Long-term debt 13,476
Shareholder's equity
Capital stock 109,035 8 1,227
Contributed surplus 2,754 2 ,071
Deficit (63,831) (46,128)
47,957 3 7,170
C$ 73,368 C$ 3 8,814
MERRIMAN
CURHAN
FORD
GROW WITH US SM
April 17, 2007 16
Cardiology
Medicure, Inc. Buy
This research has been prepared by Merriman Curhan Ford & Co, a wholly owned subsidiary of MCF Corp. Some companies
Merriman Curhan Ford & Co. follows are emerging growth companies whose securities typically involve a higher degree of risk and
more volatility than the securities of more established companies.
The securities discussed in Merriman Curhan Ford & Co. research reports may be unsuitable for some investors depending on their
specific investment objectives, financial status, risk profile, or particular needs. Investors should consider this report as only a single
factor in making their investment decisions and should not rely solely on this report in evaluating whether or not to buy or sell the securities
of the subject company.
Regulation Analyst Certification (“Reg. AC”)
All of the views expressed in this research report accurately reflect the research analyst’s personal views about any and all of the
subject securities or issuers. No part of the research analyst’s compensation was, is, or will be, directly or indirectly, related to the
specific recommendations or views expressed by the research analyst in the subject company of this research report. Research analysts
are not compensated for revenue generated by the firm’s investment banking activities.
Specific Disclosures
- MCF & Co. has not received compensation for investment banking services within the last 12 months, and does not expect to receive or
intend to seek compensation for investment banking services in the next three months, from Millennium Pharmaceuticals Inc. or Medicure
Inc.
- Within the last 12 months MCF & Co. has not managed or co-managed a public offering for Millennium Pharmaceuticals Inc., or Medicure
Inc.
- MCF & Co. makes a market in MLNM and as such buys and sells from customers on a principal basis. MCF & Co. does not make a market
in MCU.
- Neither Jose Haresco nor a member of his household owns shares of MCU.
- Neither MCF & Co. nor its officers, principals, employees, or owners own options, rights, or warrants to purchase MLNM or MCU.
- No MCF & Co. employee serves on the board of directors of Millennium Pharmaceuticals Inc. or Medicure Inc.
- Neither Jose Haresco nor a member of his household serves on the board of directors of Medicure Inc.
- Neither MCF & Co. nor its affiliates beneficially owns 1% or more of an equity security of Millennium Pharmaceuticals Inc. or Medicure Inc.
Key to Investment Rankings (expected total share price return inclusive of dividend reinvestment, if applicable)
MCF & Co. archives and reviews outgoing and incoming email. Such may be produced at the request of regulators. Sender accepts
no liability for any errors or omissions arising as a result of transmission. Use by other than intended recipients is prohibited.
The information contained herein is based on information obtained from sources believed to be reliable but is neither all-inclusive nor
guaranteed by Merriman Curhan Ford & Co. No independent verification has been made as to the accuracy or completeness of the
information. Opinions, if any, reflect our judgment at the time the report is first published and are subject to change without notice.
Merriman Curhan Ford & Co. does not undertake to advise you of changes in its opinion or information.
Member NASD / SIPC. Copyright © 2007. All rights reserved. Additional information supporting the statements in this report is available
upon request.
Rating Percent of
Universe
No. of
Stocks Description
Percent of companies under research
coverage from which MCF & Co. received
compensation for investment banking
services provided in the previous 12 months
or expects to receive or intends to seek in
the next three months
Buy 73% 131 MCF & Co. expects the stock price to appreciate 10% or
more over the next 12 months. Initiate or increase position. 15%
Neutral 25% 46 MCF & Co believes the stock price is fairly valued at current
levels. Maintain position or take no action. 2%
Sell 2% 4 MCF & Co. expects the stock price to depreciate over the
next 12 months. Sell or decrease position. 0%


Grüße cristrader

[solarblase]

Press Release Source: Medicure Inc.


Medicure's AGGRASTAT(R) Highlighted in Expert Opinion Journal
Friday April 20, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Apr 20, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced that AGGRASTAT® (tirofiban), indicated for the treatment of acute coronary syndrome, is the focus of an article titled, "Current strategies with high-dose tirofiban", in the April edition of the peer reviewed journal Expert Opinion on Drug Metabolism & Toxicology. The article's lead authors are Dr. Debabrata Mukherjee, from the Gill Heart Institute at the University of Kentucky and Dr. Marco Roffi, from the Division of Cardiology, University Hospital, Zurich, Switzerland. Medicure acquired the exclusive U.S. rights to AGGRASTAT®, in August 2006.
"This paper highlights the emerging strategies for high-dose bolus tirofiban utilization in percutaneous coronary intervention (PCI)," commented Dr. Marco Roffi. "The available data suggests that high-dose bolus tirofiban may be as effective and safe as abciximab in patients undergoing PCI. These findings, combined with tirofiban's price advantage may explain the emerging utilization of high-dose bolus tirofiban as an alternative treatment to abciximab for PCI patients."

Important Information About AGGRASTAT®

AGGRASTAT® was approved by the Food and Drug Administration on May 14, 1998.

AGGRASTAT®, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy.

ADVERTISEMENT


AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm3 and in patients with hemorrhagic retinopathy. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

The recommended dosage of AGGRASTAT® in most patients is administered intravenously, at a rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. The AGGRASTAT® high-dose bolus referenced in the Expert Opinion article represents an investigational dosage regime. Please see full prescribing information.

[cristrader]

Hallo!

Neue US-Coverage von Noble Financial!

Hier der sehr gute Researchreport!

MMBUY MCU: Aggrastat’s rebirth + MC-1’s potential = likely upside before Mar-08 data
Analyst: Laurence S. Bleicher
303-257-3263
[e-mail]
US$1.87
US$0.91
US$144.2M
US$122.0M
116.3M
105.4M
24.2%
294K
126K
MC-1 PHASE 2 DATA SUGGEST A RELATIVELY LOW-RISK PHASE 3 TRIAL
We believe the current Phase 3 CABG surgery trial of MC-1 will
succeed, as it is much better statistically powered than a Phase 2b trial
that yielded statistically and clinically significant results
MC-1 HAS SIGNIFICANT POTENTIAL BEYOND CABG ALONE & IN COMBINATION
Phase 2 trials have shown positive MC-1 data in PCI, positive ace-inhibitor/
MC-1 combination data in diabetic hypertension
AGGRASTAT A NEAR-TERM SLEEPER FOR MCU
Early efforts to recapture market share are meeting with success; if
nothing else Aggrastat keeps a future MC-1 salesforce productive
2007 US$3 PRICE TARGET ATTAINABLE BEFORE MARCH-08 BINARY EVENT
MCU is significantly undervalued despite MC-1’s stage of
development given its potential; applying a 30x multiple to our Nov-2012
estimate or a 25x multiple to our Nov-2013 estimate and
discounting by 40% for four or five
years, respectively, yields a 2007
price target of US$3, attainable
before pivotal MC-1 data in
March-08
Revenue (US$millions)
F2007E F2008E F2009E
Aug US$0.2 US$3.0 US$4.3
Nov US$1.3 US$3.4 US$4.6
Feb US$2.2 US$3.7 US$4.9
May US$2.7 US$4.0 US$5.1
FY US$6.4 US$14.1 US$18.9
Earnings (per share, US$)
(future q’s omit amortization, forex gains)
F2007E F2008E F2009E
Aug US$(0.03) US$(0.11) US$(0.06)
Nov US$(0.06) US$(0.11) US$(0.06)
Feb US$(0.07) US$(0.12) US$(0.07)
May US$(0.11) US$(0.06) US$(0.07)
FY US$(0.27) US$(0.40) US$(0.26)
P/E n/a n/a n/a
Five-Year EPS Growth n/a
EV/EBITDA (ttm) n/a
ROE (ttm) n/a
Debt/Cap (mrq) n/a
Div./Div. Yield n/a
Fiscal Year May-31
Refer to pages #16-17 for Disclosures
Throughout 2007 add’l MC-1 &
Aggrastat data publications
November-07 finish enrolling
pivotal MC-1 CABG trial
Interim DSMB look at pivotal
MC-1 CABG trial
March-08 pivotal MC-1 CABG
trial data
US$3
04/24/07
Biotechnology & Specialty Pharmaceuticals
M
2
Medicure, Inc. (MCU - US$1.24) 04/24/07
Medicure, Inc. (MCU) is a commercial-stage and research
and development-stage pharmaceuticals company. At
this time, MCU’s commercial portfolio consists of
Aggrastat, a GP IIb/IIIa inhibitor for use in Acute
Coronary Syndrome. MCU’s most advanced pipeline
product is MC-1, an unpartnered, highly novel agent, in
Phase 3 for use in Coronary Artery Bypass Graft surgery.
MCU’s pipeline includes several other unpartnered
cardiovascular compounds, both chronic and acute, from
pre-clinical to pre-Phase 3.
We believe that the current Phase 3 CABG surgery trial
of MC-1 will be successful, as that study is much better
statistically powered than a Phase 2b trial that yielded
statistically and clinically significant results. MCU has a
Special Protocol Assessment from the FDA for the
current Phase 3 CABG surgery trial of MC-1. Pivotal
data are expected in March of 2008; an interim Data
Safety Monitoring Board look will occur before that.
Also, we believe that MCU’s early success in its initial
efforts to increase the market share of its recently
acquired product, Aggrastat, will continue. Finally, we
are optimistic about the rest of MCU’s pipeline, to which
we assign no value at this time to be conservative.
Price Target
Our US$3 2007 price target is an average of two 2007
price targets. We apply a 30x multiple to our Nov-2012
estimate and discount by 40% for four years to attain a
2007 price target of US$3.20; we apply a 25x multiple to
our Nov-2013 estimate and discount by 40% for five
years to attain a 2007 price target of US$2.90. (If we
were to model flat Aggrastat market share going forward,
our new 2007 price target would still imply
approximately 100% upside. If the Phase 3 CABG
surgery trial of MC-1 were to be successful, we would
lower our discount rate to the low-20s, which would raise
the 2007 present value of what would then be our 2008
price target to between US$5 and US$6, not including
whatever value might have emerged in the meantime
from the pipeline.).
A survey of seven US and Canadian analysts reveals an
average rating closer to Buy than Hold. Over the last
month, this average rating has not changed. The mean
price target among these analysts is US$2.69, with a price
target range from US$2 to US$3.34.
2
Medicure, Inc. (MCU) is a commercial and R&D-stage pharmaceuticals company. At this time, MCU s commercial portfolio consists of Aggrastat, a GP IIb/IIIa
inhibitor for use in Acute Coronary Syndrome. MCU s most advanced pipeline product is MC-1, an unpartnered, highly novel agent, in Phase 3 for use in
Coronary Artery Bypass Graft surgery, and in pre-Phase 3 and earlier stages of clinical development for other acute cardiovascular indications. MCU s pipeline
includes several other unpartnered cardiovascular compounds, both chronic and acute, at various stages of development, from pre-clinical to pre-Phase 3.

3
Medicure, Inc. (MCU - US$1.24) 04/24/07
Overview
Medicure, Inc. (MCU) is a commercial-stage and research
and development-stage pharmaceuticals company. At
this time, MCU’s commercial portfolio consists of
Aggrastat, a GP IIb/IIIa inhibitor for use in Acute
Coronary Syndrome (ACS), for which MCU obtained US
rights from MGI Pharmaceuticals (MOGN, Not Rated) in
August of 2006. MCU’s most advanced pipeline product
is MC-1, an unpartnered, highly novel agent, in Phase 3
for use in Coronary Artery Bypass Graft (CABG)
surgery, and in pre-Phase 3 and earlier stages of clinical
development for other acute cardiovascular indications.
MCU’s pipeline includes several other unpartnered
cardiovascular compounds, both chronic and acute, at
various stages of development, from pre-clinical to pre-Phase
3, of which some are combinations of MC-1 with
other agents while others are not based on MC-1.
Aggrastat for ACS
MCU currently commercializes Aggrastat in the US.
Aggrastat is the only small-molecule therapy among the
GP IIb/IIIa inhibitors, a class of antiplatelet agents for use
in ACS that also includes Integrilin from Schering-Plough
(SGP, Not Rated) and ReoPro from Eli Lilly
(LLY, not rated). Aggrastat enjoys a pricing advantage
vs. these harder-to-manufacture large molecule agents.
While the GP IIb/IIIa class saw its penetration of the ACS
market decline for several years, that penetration appears
to have stabilized in the low-20s over the last few
quarters; MCU’s acquisition of US Aggrastat rights
appears therefore to have been very well-timed.
Similarly, while Aggrastat’s share of the GP IIb/IIIa class
fell for several years, that share has increased markedly
over the last few quarters—MCU’s initial efforts to
promote the agent appear to have met with success thus
far, having likely been bolstered by the presentation of
data suggesting Aggrastat’s non-inferiority vs. ReoPro at
the 2006 American Heart Association meeting shortly
after MCU acquired US Aggrastat rights. MCU owes
Merck (MRK, Not Rated) at least a 5% royalty on US
Aggrastat sales.
MCU is initially developing its lead drug candidate, an
orally available, small-molecule, P2 purinergic (P2x)
receptor antagonist called MC-1, in three different acute
cardiovascular indications. MCU was founded to in-license
the worldwide rights to MC-1, which had been
discovered at the University of Manitoba. MC-1 is
unpartnered at this time, although MRK has acquired the
ex-North America right of first refusal for any
combination of Aggrastat and MC-1. MRK negotiated
this option in the course of MRK’s approval of MOGN’s
sale to MCU of US rights for Aggrastat; MRK had
retained the right to review and ultimately authorize any
Aggrastat transaction made by MOGN.
We believe that our sales assumptions for Aggrastat in
ACS and MC-1 in CABG surgery, to be detailed below,
are conservative. For Aggrastat, we assume that the GP
IIb/IIIa class will maintain its current, stable penetration
of the ACS market. We assume that Aggrastat will very
gradually increase its share of the GP IIb/IIIa class,
reaching only 17% volume-share in mid-2013, its seventh
full year of active detail by the MCU salesforce. We feel
this is conservative, as Aggrastat is the class leader in
Europe, and held 17% volume-share in the US as recently
as 2003. Additionally, our due diligence suggests that
Aggrastat arguably has not in several years, if ever, been
as high a priority for any US salesforce as it is now for
MCU’s; and, that Aggrastat appears to offer at least
equivalent efficacy to its competitors at a lower price.
MC-1 CABG surgery indication
MC-1’s most advanced indication is CABG surgery, for
which the agent is currently in a Phase 3 trial under a
Special Protocol Assessment (SPA): a non-binding
agreement with the FDA that the trial, if successfully
completed, will, in combination with other, previously
attained data, form an adequate basis for a New Drug
Application (NDA). MCU began enrolling this 3,000-
patient Phase 3 trial of MC-1 in November of 2006, and
targets enrollment completion in November of 2007, data
release in March of 2008 (an earlier, interim Data Safety
Monitoring Board (DSMB) examination of the data is
scheduled), and MC-1 NDA submission for CABG
surgery in June of 2008. The trial generally replicates the
protocol of a successfully completed, randomized,
placebo-controlled, double-blind, dose-ranging 900-patient
Phase 2b trial in CABG surgery. In that trial, the
regimen of MC-1 currently being pursued in Phase 3
(250mg pre/post-op, then once daily for 30 days)
demonstrated a statistically significant 37% reduction in a
composite of cardiovascular-related death, non-fatal
myocardial infarction (MI), and non-fatal stroke at post-operative
day 30 vs. placebo (p-value less than 0.03);
maintained a statistically significant reduction of similar
size in that composite vs. placebo throughout a follow-up
period out to post-op day 90; and displayed an equivalent
adverse event profile vs. placebo.

4
Medicure, Inc. (MCU - US$1.24) 04/24/07
Our due diligence has determined that the results attained
in the Phase 2b CABG surgery trial of MC-1 suggest that
MCU had probably substantially underestimated the
actual effect size of the agent in planning that trial, thus
overpowering it. The Phase 3 CABG trial nonetheless
assumes the same MC-1 effect size, and is probably
therefore better powered than its ostensible 85% power to
detect a 20% reduction in the composite endpoint.
Regardless, the Phase 3 trial is much better powered than
the successful Phase 2b trial, due to its size among other
reasons; as such, we believe that the current Phase 3
CABG surgery trial of MC-1 will be successful.
We believe that after completing this trial, MCU will
attain a commercial partner for MC-1 outside the US, but
will retain US rights to the drug and market it through its
existing US Aggrastat salesforce. With US$22M of net
cash, MCU has sufficient resources to conclude this trial.
Based upon MCU’s aforementioned target of a June of
2008 NDA filing of MC-1 for CABG surgery, we expect
MCU will launch MC-1 in the US in mid-2009, and
MCU’s partner will launch MC-1 ex-US one year later.
As MCU has received fast-track designation for MC-1 in
CABG surgery (as well as in other indications), the NDA
might receive expedited review; accordingly, we feel our
expectation of a mid-09 US launch of MC-1 is
conservative.
For MC-1, we assume that the agent will garner slightly
less than a one-half penetration/share of the US CABG
surgery market in mid-2014, after five full years on the
market; we model half that trajectory for the EU market,
beginning one year later as previously discussed. We
believe this assumption would be highly conservative if
MC-1 were to succeed in its current Phase 3 trial, as it
would then offer a unique mechanism by which to reduce
death and/or MI in CABG surgery patients. We further
assume that the price of a course of MC-1 therapy will be
set initially at only US$600 per course of therapy, about
25% above the price of a course of Aggrastat therapy
(despite the latter being 60-75% cheaper than the other
GP IIb/IIIa inhibitors), and will undergo minimal price
increases. We feel that this assumption too would be
highly conservative if MC-1 were to succeed in its current
Phase 3 trial.
MCU’s other unpartnered pipeline products
Besides MC-1 for CABG surgery, MCU also possesses
an unpartnered pipeline of other MC-1 indications and of
other agents, from pre-clinical to pre-Phase 3, addressing
both acute and chronic markets. MC-1 has received fast-track
designation for not only CABG surgery, but also for
ACS and for angioplasty, also known as Percutaneous
Coronary Intervention (PCI). MCU has successfully
completed a Phase 2a trial of MC-1 in PCI; however, as
this was only a biomarker-endpoint trial, and MCU
intends to pursue MC-1 in Phase 3 next in ACS
(admittedly a closely related indication to PCI), we assign
no value to MC-1 in ACS or PCI at this time for the sake
of conservatism. This is probably excessively
conservative, as the biomarker measured in this trial is
known to be correlated strongly with meaningful clinical
events. MCU is also investigating MC-1 in a Phase 1
trial in stroke, which at this time is omitted from
valuation due to the lack of Phase 2 data thus far.
Two combination products of MC-1 with other agents are
currently in clinical-stage testing. MC-4232 is a
combination of MC-1 and the ACE-inhibitor, lisinopril,
for which MCU is finalizing a Phase 3 program design in
diabetic hypertension. MC-4232 has successfully
completed a randomized, placebo and active-controlled,
double-blind, 120-patient, 16-week, dose-ranging Phase 2
trial in diabetic hypertension. Although the trial was only
designed to suggest an optimal dose of MC-4232 rather
than to evaluate its efficacy, the best-performing dose
demonstrated statistically significant improvements vs.
baseline in four of the numerous pre-specified endpoints,
as well as trends towards improvements vs. baseline and
vs. active control in several endpoints. For the sake of
conservatism, we assign no value to MC-4232 at this
time, despite its early signs of efficacy, as it has not yet
unambiguously demonstrated efficacy vs. active
control—although admittedly this is more likely due to
the dose-ranging design of the trials conducted thus far
than it is due to any shortcomings of the agent.
MC-4262 is a combination of MC-1 and an unidentified
angiotensin receptor blocker (ARB) currently in Phase 1
trials for metabolic-syndrome hypertension. MC-45308
is a molecule unrelated to MC-1 undergoing preclinical
evaluation for thrombosis. MC-5422 is the first of
several MC-1 variations MCU is studying and has not yet
entered preclinical testing. No value is assigned to any of
these compounds at this time due to the lack of Phase 2
data thus far.
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Price target rationale
In addition to our sales assumptions, we believe, as will
be detailed below, we have been reasonably conservative
throughout our model. For example, we assume greater
share count dilution than has occurred historically, and a
greater tax rate in profitable years than MCU suggests.
We conservatively model fully-taxed diluted EPS of
US$0.41 and US$0.62 in the twelve-month periods
ending in November of 2012 and November of 2013,
respectively.
Our US$3 2007 price target is an average of two 2007
price targets. We apply a 30x multiple to our Nov-2012
estimate and discount by 40% for four years to attain a
2007 price target of US$3.20; we apply a 25x multiple to
our Nov-2013 estimate and discount by 40% for five
years to attain a 2007 price target of US$2.90. We
believe that each of the aforementioned multiples is
conservative, as they imply PEG ratios of less than 0.5 for
the 2013-based target and less than 0.2 for the 2012-based
target. We believe the 40% discount rate we have
selected is conservative given the strength of the data thus
far for MC-1 in CABG surgery, and the early signs of
success with Aggrastat re-launch efforts. The average of
these two 2007 price targets is slightly greater than our
official 2007 price target of US$3. (If we were to model
flat Aggrastat market share going forward, our new 2007
price target would still imply approximately 100%
upside. If the Phase 3 CABG surgery trial of MC-1 were
to be successful, we would lower our discount rate to the
low-20s, which would raise the 2007 present value of
what would then be our 2008 price target to between
US$5 and US$6, not including whatever value might
have emerged in the meantime from the pipeline.)
Company Background
Medicure, Inc. (MCU) is a commercial-stage and research
and development-stage pharmaceuticals company.
Medicure was founded on September 15, 1997, to acquire
the discoveries of Dr. Naranjan Dhalla of the University
of Manitoba, which would eventually form the basis for
the development of MC-1, currently MCU’s most
advanced pipeline candidate. Dr. Dhalla and Dr. Albert
Friesen, the current CEO of MCU, were among the
principal owners of Medicure at the time of its founding.
The MC-1 technology had originally been licensed by the
University of Manitoba to Genesys Pharma, Inc., a
consulting firm owned entirely at the time by Dr. Friesen,
on August 18, 1997. Genesys transferred the technology
at minimal cost to Medicure on September 26, 1997. On
August 30, 1999, Medicure completed a new license
agreement with the University of Manitoba in order to
modify slightly the terms of the original agreement
transferred from Genesys.
On November 22, 1999, Medicure was acquired by Lariat
Capital, led at the time by Dr. Friesen, in an arm’s length
transaction through a reverse takeover. As a result of the
merger, control of Lariat passed to the former
shareholders of Medicure. Lariat had been incorporated
on June 3, 1997, for the purpose of acquiring a project or
company through a reverse takeover. Lariat went public
on the Alberta Stock Exchange in March of 1999. On
December 22, 1999, Medicure and Lariat were
amalgamated as Medicure, Inc., resulting in Medicure,
Inc.’s assumption of Lariat’s listing on the Alberta Stock
Exchange. In December of 2002, Medicure, Inc. listed on
the Toronto Stock Exchange under the ticker, MPH.
Medicure, Inc. listed on the American Stock Exchange in
February of 2004 under the ticker, MCU.
At this time, MCU’s commercial portfolio consists of
Aggrastat, a GP IIb/IIIa inhibitor for use in ACS, for
which MCU obtained US rights from MOGN in August
of 2006. MCU’s most advanced pipeline product is MC-1,
an unpartnered, highly novel agent, in Phase 3 for use
in CABG surgery, and in pre-Phase 3 and earlier stages of
clinical development for other acute cardiovascular
indications. MCU’s pipeline includes several other
unpartnered cardiovascular compounds, both chronic and
acute, at various stages of development, from pre-clinical
to pre-Phase 3, of which some are combinations of MC-1
with other agents while others are not based on MC-1.
MCU enjoys a highly experienced executive team, led by
CEO Dr. Albert Friesen. Dr. Friesen earned a Ph.D. in
protein chemistry at the University of Manitoba. Dr.
Friesen was a founding executive of Rh Pharmaceuticals,
where he oversaw the development and approval of
WinRho, one of his two successful NDAs; Rh
Pharmaceuticals was eventually acquired by Cangene
(CNJ.to, Not Rated). Among other firms, Dr. Friesen has
also played a founding executive role at ABI
Biotechnology, eventually acquired by Apotex (private),
and Novopharm Biotech, now Viventia (private). MCU’s
Scientific Advisory Board includes Dr. A. Michael
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Medicure, Inc. (MCU - US$1.24) 04/24/07
Lincoff of the Cleveland Clinic, as well as several other
acknowledged thought leaders in cardiology.
Aggrastat
At this time, MCU’s commercial portfolio consists of
Aggrastat, generically known as tirofiban hydrochloride.
Aggrastat is an antagonist of the platelet glycoprotein
IIb/IIIa receptor, also known as a GP IIb/IIIa inhibitor.
MCU obtained US rights to Aggrastat from MOGN in
August of 2006 for a purchase price of US$19M plus the
value of assumed inventory, as well as the assumption of
the royalty owed the inventor of the molecule, MRK.
MCU owes MRK a moderate royalty on US sales of
Aggrastat: 5% on sales of up to US$25M annually, 10%
on sales from US$25-50M, 12% from US$50-75M, 14%
from US$75-100M, and 20% on sales greater than
US$100M annually. MCU currently commercializes
Aggrastat in the US, and has actively promoted the agent
with its own internal salesforce since November of 2006;
MCU did not immediately actively promote Aggrastat
after acquiring it in order to allow wholesaler inventory
levels of the agent to return to historical, approximately
one-month levels.
Like another of the GP IIb/IIIa inhibitors, Integrilin from
SGP, Aggrastat is indicated for use in ACS or PCI in
combination with the anticoagulant, heparin; the third GP
IIb/IIIa inhibitor, ReoPro from LLY, is indicated for use
in ACS in combination with heparin only when PCI is
planned within 24 hours. The antagonism of the platelet
glycoprotein IIb/IIIa receptor impedes clotting, making
these agents useful additions to heparin in these
indications. The GP IIb/IIIa class saw its penetration of
the ACS market decline for several years, up until
recently. This decline was primarily due to the
emergence during that period of additional anticoagulant
options for ACS besides heparin; as GP IIb/IIIa inhibitors
had not been studied in combination with these newer
anticoagulants, their use fell while the use of these
alternative anticoagulants rose.
GP IIb/IIIa penetration of the ACS market has stabilized
in the low-20s recently as the agents’ core use in PCI has
proven resilient despite the emergence of alternative
anticoagulants in ACS. MCU’s acquisition of US
Aggrastat rights appears therefore to have been very well-timed.
Our due diligence suggests that the current
penetration will remain stable in the future. The recent
hue and cry over the long-term equivalence of outcomes
data for bare-metal stents and for drug therapy as an
alternative to PCI is unlikely to spell the end of the
procedure anytime soon; physicians will probably cling to
the hope that drug-coated stents, commonly used in PCI
today, would have fared better than their bare-metal
predecessors vs. drugs alone. Relatedly, as yet further
new anticoagulants are approved for ACS, they are
unlikely to stem the tide of PCI.
Although Aggrastat’s share of the GP IIb/IIIa class fell
while the penetration by the class of the ACS market was
declining, Aggrastat’s share has increased markedly over
the last few quarters—MCU’s initial efforts to promote
the agent appear to have met with success thus far. Our
due diligence suggests that the main culprit behind
Aggrastat’s share decline was its lack of promotional
emphasis. Aggrastat was never the primary focus of
whichever salesforce was promoting it any given moment
in the US until MCU acquired the agent. Both MOGN
and its predecessor, Guilford Pharmaceuticals, promoted
Aggrastat within a broad portfolio of other, non-cardiovascular
hospital products; obviously MRK also
enjoyed other demands on its attention besides Aggrastat.
MCU’s initial Aggrastat promotional efforts have likely
been bolstered by the presentation at the 2006 American
Heart Association meeting of a large, retrospective
dataset that suggests single high-dose bolus Aggrastat’s
non-inferiority vs. ReoPro across a number of important
clinical endpoints. Trends observed in this dataset
suggest if anything the superiority of Aggrastat vs.
ReoPro in the endpoints of death (0.7% vs. 1.7%,
respectively, p-value of about 0.40) and
thrombocytopenia (1.3% vs. 2.8%, respectively, p-value
of about 0.26). This presentation occurred shortly after
MCU acquired US Aggrastat rights. Additionally,
Aggrastat is known to be the fastest-reversing of the GP
IIb/IIIa inhibitors, which means that any if its recipients
who later have to undergo CABG surgery will need their
surgery delayed the least to allow time for their platelet
functions to return to normal.
The growing awareness of Aggrastat’s clinical
equivalence at least vs. its competitors meshes well with
the agent’s cost advantage. While all three GP IIb/IIIa
inhibitors are injectible agents, Aggrastat is the only
small-molecule therapy among the GP IIb/IIIa inhibitors;
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Medicure, Inc. (MCU - US$1.24) 04/24/07
Integrilin is a large-molecule peptide chain and ReoPro is
an antibody. Accordingly, Aggrastat enjoys a pricing
advantage vs. these harder-to-manufacture large molecule
agents: MCU sells Aggrastat for US$400-500 per course
of therapy, whereas Integrilin and ReoPro retail between
US$1,200-2,000 per course of therapy.
We believe that our sales assumptions for Aggrastat are
conservative. We assume that the GP IIb/IIIa class will
maintain its current, stable penetration of the ACS
market. We assume that Aggrastat will very gradually
increase its share of the GP IIb/IIIa class, reaching only
17% volume-share in mid-2013, its seventh full year of
active detail by the MCU salesforce. We feel this is
conservative, as Aggrastat is the class leader in Europe,
and held 17% volume-share in the US as recently as 2003
(the year in which MRK divested the product to
Guilford). Additionally, as discussed above, our due
diligence suggests that Aggrastat arguably has not in
several years, if ever, been as high a priority for any US
salesforce as it is now for MCU’s; and, that Aggrastat
appears to offer at least equivalent efficacy to its
competitors at a lower price.
Aggrastat enjoys composition of matter patent protection
into 2013. Additional Orange Book-listed patents extend
into 2019, and a final patent on the use of a single high-dose
bolus of the drug reaches out to 2023. MCU is in
the process of negotiating with the FDA about adding
single high-dose bolus Aggrastat to the product’s label,
and hopes eventually to do a prospective trial of this
version of the agent.
MC-1
Background
MCU’s lead drug candidate, MC-1, is an orally available,
small-molecule, P2 purinergic (P2x) receptor antagonist.
MC-1 is a metabolite of Vitamin B6. To attain the
biolevels of MC-1 through Vitamin B6 administration
and subsequent metabolism that direct administration of
MC-1 attains, Vitamin B6 would have to be dosed at
levels orders of magnitude higher than those at which it is
known to cause dose-limiting neurotoxicity. MC-1 has
been given at doses three to four times higher than the
levels currently being explored in Phase 3 trials for up to
16 weeks in humans and up to nine months in dogs, with
none of the side effects of Vitamin B6 observed (nor with
any side effects observed different from and/or greater
than those seen in placebo controls). In fact, MC-1
appears to produce neuroprotective effects opposite to
those of Vitamin B6, suggesting another metabolite of the
latter besides MC-1 is responsible for its neurotoxicity.
P2x receptors are found on the surfaces of
cardiomyocytes in the heart, glial cells in the brain, and
endothelial cells and macrophages throughout the body.
In endothelial cells and macrophages, P2x receptors
appear to play a role in modulating inflammatory activity.
In cardiomyocytes and glial cells, P2x receptors appear to
be agonized endogenously by adenosine 5’-triphosphate
(ATP), one of the primary carrier molecules for
intracellular energy transfer in the body. When agonized
by ATP, P2x receptors open calcium channels (not all
calcium channels are P2x-mediated, but all P2x receptors,
at least in cardiomyocytes and glial cells, mediate calcium
channels).
Our due diligence suggests that in a healthy person, this
ATP-activated P2x-mediation of calcium channels helps
to induce the contraction of tissues composed of
cardiomyocytes, i.e., to pump blood. In an individual
suffering an ischemic event, however, cellular stress
triggers an overabundance of ATP, which in turn causes
excessive P2x-mediated calcium-channel opening. This
leads to a surplus of calcium-ion transport into
cardiomyocytes, which might exacerbate their damage
and therefore the ischemic event itself. MC-1
antagonizes the P2x receptor, preventing the excessive
binding of ATP to it when administered to individuals
suffering an ischemic event, and therefore preventing the
surplus of ischemia-reinforcing calcium-ion transport into
already-damaged cardiomyocytes. While theoretically
this could result in an over-prevention of P2x-mediated
calcium-channel opening, thereby starving
cardiomyocytes of calcium ions minimally needed for
tissue contraction, this dose-limiting toxicity appears to
occur only at doses of MC-1 about 100 times greater than
those at which therapeutic activity is observed in patients
undergoing cardiac stress.
As discussed above, MCU was founded to in-license the
worldwide rights to MC-1, which had been discovered at
the University of Manitoba. Under the terms of its
license, MCU owes the University up to a 3.9% royalty
on sales of MC-1, but faces no other requirements (no
milestones, etc.). MC-1 is unpartnered at this time,
although MRK has acquired the ex-North America right
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Medicure, Inc. (MCU - US$1.24) 04/24/07
of first refusal for any combination of Aggrastat and MC-1.
MRK negotiated this option in the course of MRK’s
approval of MOGN’s sale to MCU of US rights for
Aggrastat; MRK had retained the right to review and
ultimately authorize any Aggrastat transaction made by
MOGN. MC-1 enjoys several issued method patents
regarding the targeting of the P2x receptor to treat
ischemia that extend into 2015/2016, as well as several
issued drug-specific use patents that last until 2017.
Several formulation patents, some of which pertain to
specific dose levels, are pending for MC-1; if issued on
schedule in 2008 they will protect the compound until
2025.
MC-1 CABG surgery indication
MC-1’s most advanced indication is CABG surgery, for
which the agent is currently in a Phase 3 trial under a
SPA with the FDA. The proposed cardioprotective
method of action of MC-1 relevant in CABG surgery is
the prevention, via P2x-receptor antagonism, of ischemia
reinforcement by calcium-ion transport, as described
previously. MCU began enrolling this 3,000-patient
Phase 3 trial of MC-1 in November of 2006, and targets
enrollment completion in November of 2007, data release
in March of 2008 (an earlier, interim DSMB examination
of the data is scheduled), and MC-1 NDA submission for
CABG surgery in June of 2008.
Data from a randomized, placebo-controlled, double-blind,
dose-ranging, 900-patient Phase 2b trial of MC-1 in
CABG surgery were reported in December of 2005. In
that trial, the regimen of MC-1 currently being pursued in
Phase 3 (250mg pre/post-op, then once daily for 30 days)
demonstrated a statistically significant 37% reduction in a
composite of cardiovascular-related death, non-fatal MI,
and non-fatal stroke at post-operative day 30 vs. placebo
(p-value less than 0.03); maintained a statistically
significant reduction of similar size in that composite vs.
placebo throughout a follow-up period out to post-op day
90; and displayed an equivalent adverse event profile vs.
placebo. These data were attained using a definition of
MI of peak CK-MB as determined by blood test of at
least 100ng/mL (CK-MB is an enzyme released by
cardiomyocytes that have burst in the course of dying; it
is considered an effective, proportionate marker of the
extent of cardiomyocyte death). MI itself was reduced
47% by 250mg daily of MC-1 with a p-value less than
0.01 with this definition.
MI is somewhat subjectively defined; different peak CK-MB
levels can be used to determine the MI threshold.
The 100ng/mL level, however, has been accepted by the
FDA as an appropriate MI threshold in the SPA for the
MC-1 Phase 3 CABG surgery trial. Furthermore, this
level had previously been condoned by the FDA in other
clinical programs examining cardioprotective agents,
such as the cariporide trials conducted by Aventis (now
Sanofi-Aventis, SNY, Not Rated) and the pexelizumab
studies conducted by Alexion (ALXN, Not Rated) and its
partner, Procter & Gamble (PG, Not Rated).
Nonetheless, the MC-1 Phase 2b CABG surgery trial’s
protocols initially defined MI as peak CK-MB of at least
50ng/mL. MCU chose this definition so that a higher
event rate would occur than with a more stringent, more
typical MI threshold, thereby allowing the capital-constrained
firm to avoid having to recruit thousands of
patients for a proof of concept trial. This strategy worked
too well, however; with such a loose definition of MI, so
many events occurred in every trial arm that MC-1 did
not separate sufficiently from placebo. Under the
50ng/mL definition, 250mg of MC-1 attained only mid-teens
reductions in composite events and in MIs
specifically vs. placebo, with p-values of about 0.3.
Physicians advising MCU on the Phase 2b MC-1 trial in
CABG surgery, who hailed from such respected
institutions as Duke University and Montreal Heart
Institute, recommended that the firm reanalyze the data
with a more stringent, more typical MI threshold. They
did not make this recommendation out of any desire to
game the results in MCU’s favor; rather, they observed
that the 26% placebo event rate seen in the study under
the 50ng/mL definition of MI greatly exceeded the
historical placebo event rates from other trials, which
were typically in the teens.
Furthermore, they noted that individuals suffering MIs
under the 50ng/mL definition in other studies had been
observed to experience cardiovascular mortality in only
the low-single digits within 90 days post-CABG surgery,
i.e., at a similar or lower rate than that of the real-world
post-CABG surgery population, which endures a mid-single
digit rate of one-year post-CABG surgery
cardiovascular mortalities, of which the vast majority
occur in the first 90 days post-op. Intuitively, patients
suffering MIs ought to experience greater death rates than
the overall population, which includes patients who do
not suffer MIs; when this does not occur, the MI
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threshold has likely been set incorrectly low. Data from
these other studies suggest a more appropriate threshold
for MI might be as low as 60-100ng/mL, as at that level, a
90 days post-CABG surgery cardiovascular mortality in
the mid-single digits has been observed. At 100ng/mL or
greater, 90 days post-CABG surgery cardiovascular
mortality in the low-double digits has been observed.
Following their recommendation, MCU reanalyzed the
very blood samples that had been used to attain the initial
results, again in a double-blind fashion, but now under
two alternate definitions of MI: peak CK-MB levels of at
least 70ng/mL and of at least 100ng/mL. Under the
70ng/mL definition, the 250mg dose of MC-1 reduced
composite events by 32% vs. placebo, with a p-value less
than 0.035; MIs specifically were reduced 38% vs.
placebo, with a p-value less than 0.02. As previously
discussed, under the 100ng/mL definition, the 250mg
dose of MC-1 reduced composite events by 37% vs.
placebo, with a p-value less than 0.03; MIs specifically
were reduced 47% vs. placebo, with a p-value less than
0.01.
We take great comfort in the FDA’s granting of a SPA for
the ongoing Phase 3 trial of MC-1 in CABG surgery in
light of the aforementioned MI threshold issues. The
Phase 3 trial very closely follows the protocol of the
Phase 2b trial, with a few key differences. Only the
250mg dose of MC-1 is being studied; an additional dose
was explored in the Phase 2b trial. Up to 3,000 patients
are being enrolled in the Phase 3 trial, rather than the 900
recruited into the Phase 2b study; this, combined with the
pursuit of only a single MC-1 dose, greatly increases the
Phase 3 trial’s power over that of the Phase 2 trial. MI is
prospectively defined as peak CK-MB of at least
100ng/mL in the Phase 3 trial, the definition at which the
greatest MC-1 effect was observed in Phase 2b study.
Finally, stroke has been eliminated as a component of the
composite endpoint in the Phase 3 trial; were stroke to
have been omitted from the Phase 2b study, the 250mg
dose of MC-1 would have reduced composite events vs.
placebo by 42%, with a p-value of about 0.01.
Our due diligence has determined that the results attained
in the Phase 2b CABG surgery trial of MC-1 suggest that
MCU had probably substantially underestimated the
actual effect size of the agent in planning that trial, thus
overpowering it. That MCU defined MI initially as
50ng/mL for fear of not having enough patients in the
trial to attain significant results with a more stringent MI
threshold, but subsequently achieved the aforementioned
results for MI definitions of 70ng/mL and 100ng/mL,
further suggests that MCU had underestimated MC-1’s
effect size. The Phase 3 CABG trial nonetheless assumes
the same MC-1 effect size as was input into the Phase 2b
trial design, and is probably therefore better powered than
its ostensible 85% power to detect a 20% reduction in the
composite endpoint. Regardless, the Phase 3 trial is
much better powered than the successful Phase 2b trial,
due to its size, its exploration of only a single dose of
MC-1, and its elimination of stroke from the composite
endpoint. Accordingly, we believe that the current Phase
3 CABG surgery trial of MC-1 will be successful.
Nonetheless, in light of the aforementioned MI threshold
issues in the Phase 2b trial, we are discounting our MCU
estimates by a healthy 40% annually to attain a price
target we feel is conservative.
We believe that after completing this trial, MCU will
attain a commercial partner for MC-1 outside the US, but
will retain US rights to the drug and market it through its
existing US Aggrastat salesforce. With US$22M of net
cash, MCU has sufficient resources to conclude this trial.
Based upon MCU’s aforementioned target of a June of
2008 NDA filing of MC-1 for CABG surgery, we expect
MCU will launch MC-1 in the US in mid-2009, and
MCU’s partner will launch MC-1 ex-US one year later.
As MCU has received fast-track designation for MC-1 in
CABG surgery (as well as in other indications), the NDA
might receive expedited review; accordingly, we feel our
expectation of a mid-09 US launch of MC-1 is
conservative.
We believe that our sales assumptions for MC-1 in
CABG surgery are also conservative. We assume that the
agent will garner slightly less than a one-half
penetration/share of the US CABG surgery market in
mid-2014, after five full years on the market; we model
half that trajectory for the EU market, beginning one year
later as previously discussed. We believe this assumption
would be highly conservative if MC-1 were to succeed in
its current Phase 3 trial, as it would then offer a unique
mechanism by which to reduce death and/or MI in CABG
surgery patients. We further assume that the price of a
course of MC-1 therapy will be set initially at only
US$600 per course of therapy, about 25% above the price
of a course of Aggrastat therapy (despite the latter being
60-75% cheaper than the other GP IIb/IIIa inhibitors), and
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will undergo minimal price increases. We feel that this
assumption too would be highly conservative if MC-1
were to succeed in its current Phase 3 trial.
Additional MC-1 indications
MC-1 has received fast-track designation for not only
CABG surgery, but also for ACS and for PCI. MCU has
successfully completed a Phase 2a trial of MC-1 in PCI,
in which periprocedural CK-MB levels were reduced by
MC-1 administration vs. placebo by about 30%, with a p-value
of about 0.035. However, as this was only a
biomarker-endpoint trial, and MCU intends to pursue
MC-1 in Phase 3 next in ACS (admittedly a closely
related indication to PCI), we assign no value to MC-1 in
ACS or PCI at this time for the sake of conservatism.
This is likely excessively conservative, as the biomarker
CK-MB is known to be closely correlated with
meaningful clinical endpoints, as discussed previously.
MCU intends to begin enrolling a Phase 3 trial of MC-1
in ACS within three to six months of successfully
completing the Phase 3 trial of MC-1 in CABG surgery,
and anticipates concluding the ACS trial within 12-18
months, i.e. between June of 2009 and March of 2010.
MCU is also investigating MC-1 in a Phase 1 trial in
stroke, which at this time is omitted from valuation due to
the lack of Phase 2 data thus far.
Pipeline
Besides the aforementioned MC-1 indications, MCU also
possesses an unpartnered pipeline of other agents, from
pre-clinical to pre-Phase 3, addressing both acute and
chronic markets. Some of these agents are combinations
of combinations of MC-1 with other agents while others
are not based on MC-1.
Two combination products of MC-1 with other agents are
currently in clinical-stage testing. MC-4232 is a
combination of MC-1 and the ACE-inhibitor, lisinopril,
for which MCU is finalizing a Phase 3 program design in
diabetic hypertension. MC-4232 has successfully
completed a randomized, placebo and active-controlled,
double-blind, 120-patient, 16-week, dose-ranging Phase 2
trial in diabetic hypertension. Although the trial was only
designed to suggest an optimal dose of MC-4232 rather
than to evaluate its efficacy, the best-performing dose
demonstrated statistically significant improvements vs.
baseline in four of the numerous pre-specified endpoints,
as well as trends towards improvements vs. baseline and
vs. active control in several endpoints. The best-performing
dose of MC-4232 reduced systolic blood
pressure vs. baseline (147.0mmHg) by 12mmHg (p-value
less than 0.0001) and vs. lisinopril alone by 4.5mmHg (p-value
of 0.13); reduced diastolic blood pressure vs.
baseline (82.6mmHg) by 7.5mmHg (p-value less than
0.0001) and vs. lisinopril alone by 3.4mmHg (p-value of
0.06); reduced fasting serum glucose from baseline
regardless of lisinopril use by 1.5mmol/L for patients
with baseline of 7.8mmol/L (p-value of 0.03) and by
3.4mmol/L for patients with baseline greater than
10mmol/L (p-value unspecified); reduced triglycerides in
patients with at least 1.7mmol/L baseline values by 27%
(p-value of 0.04); reduced LDL-cholesterol vs. placebo
by 10.6mg/dL (p-value of 0.095); and reduced HbA1c in
patients with at least 8.0% baseline values regardless of
lisinopril use by over 0.6%-points (p-value of about
0.27). For the sake of conservatism, we assign no value
to MC-4232 at this time, despite its early signs of
efficacy, as it has not yet unambiguously demonstrated
efficacy vs. active control—although admittedly this is
more likely due to the dose-ranging design of the trials
conducted thus far than it is due to any shortcomings of
the agent.
MC-4262 is a combination of MC-1 and an unidentified
angiotensin receptor blocker (ARB) currently in Phase 1
trials for metabolic-syndrome hypertension. MC-45308
is a molecule unrelated to MC-1 undergoing preclinical
evaluation for thrombosis. MC-5422 is the first of
several MC-1 variations MCU is studying and has not yet
entered preclinical testing. No value is assigned to any of
these compounds at this time due to the lack of Phase 2
data thus far.
Model
In addition to our sales assumptions, we believe we have
been reasonably conservative throughout our model. We
assume that MCU will enjoy no pipeline advances. This
is conservative with regard to MCU’s revenues, as well as
its multiple. Admittedly, this assumption reduces R&D
expenses, which some might suggest is not conservative;
however, we feel we have kept R&D expenses adequately
high. Furthermore, despite MCU possessing substantial
net operating loss carry-forwards at this time, which will
only increase between now and profitability, we assume
that MCU will begin paying taxes in full in its first
quarter of profitability, at a greater tax rate than MCU
11
Medicure, Inc. (MCU - US$1.24) 04/24/07
suggests it will ever have to endure. Finally, with regard
to share count, we assume that MCU’s historical rate of
share dilution will increase. We conservatively model
fully-taxed diluted EPS of US$0.41 and US$0.62 in the
twelve-month periods ending in November of 2012 and
November of 2013, respectively.
Risks
Risks to the attainment of our estimates and price targets
include, but are not limited to, the following: the failure
of MC-1 to succeed in its Phase 3 CABG surgery trial;
the failure of MC-1 to receive FDA approval in a timely
fashion; the failure of Aggrastat to penetrate the ACS
market; the failure of MC-1 to penetrate the CABG
surgery market; the potential for inaccuracy in our
estimates of expenses; the potential for fluctuation in the
exchange rate of the US dollar vs. the Canadian dollar,
etc. 11
Medicure, Inc. (MCU - US$1.24) 04/24/07
suggests it will ever have to endure. Finally, with regard
to share count, we assume that MCU’s historical rate of
share dilution will increase. We conservatively model
fully-taxed diluted EPS of US$0.41 and US$0.62 in the
twelve-month periods ending in November of 2012 and
November of 2013, respectively.
Risks
Risks to the attainment of our estimates and price targets
include, but are not limited to, the following: the failure
of MC-1 to succeed in its Phase 3 CABG surgery trial;
the failure of MC-1 to receive FDA approval in a timely
fashion; the failure of Aggrastat to penetrate the ACS
market; the failure of MC-1 to penetrate the CABG
surgery market; the potential for inaccuracy in our
estimates of expenses; the potential for fluctuation in the
exchange rate of the US dollar vs. the Canadian dollar,
etc.edicure, Inc. (MCU - US



Grüße cristrader

[cristrader]

Medicure Announces Appointment of Senior Advisor to Commercial Operations
Monday April 30, 8:30 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Apr 30, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that Bonnie Zell has been appointed as the Company's Senior Advisor to Commercial Operations.

Ms. Zell brings to Medicure 30 years of experience in the pharmaceutical and biotech industry where she recently held the position as Vice President of Sales for Millennium Pharmaceuticals, Inc. Prior to Millennium, Ms. Zell was Vice President of Sales for COR Therapeutics, Inc., which was acquired by Millennium. Ms. Zell was instrumental in the launch of INTEGRILIN®, a GP IIb/IIIa inhibitor. In 2006, INTEGRILIN® sales exceeded US$300 million in the United States.

"I am very pleased to be joining the Medicure team at this exciting point in their history. In Medicure, I see a similar commercial opportunity that existed at COR and Millennium," stated Ms. Zell. "Having competed in the GP IIb/IIIa market, I am very familiar with AGGRASTAT®, and believe it is well positioned for a resurgence in the U.S. given its impressive clinical data and cost advantages versus competing products. I look forward to working with Medicure on its commercial expansion of AGGRASTAT® in the U.S., and its preparations for the launch of MC-1."

Medicure's President & CEO, Albert D. Friesen PhD added that bringing Ms. Zell to the Medicure team will help build the foundation to drive AGGRASTAT® sales higher.

"We are excited to have someone with Ms. Zell's acute cardiovascular sales experience join the Medicure team," stated Dr. Friesen. "Through Ms. Zell's extensive network, we have been able to successfully attract a number of sales leaders within the GP IIb/IIIa and acute cardiovascular market and been able to strengthen relationships with our key customers."

About AGGRASTAT®

Developed by Merck & Co., Inc., AGGRASTAT® was launched in the U.S. in 1998, and is currently available in 82 countries worldwide. Merck continues to market AGGRASTAT® outside the U.S. Merck sold the U.S. rights to AGGRASTAT® to Guilford Pharmaceuticals Inc. in 2003, which was subsequently acquired by MGI PHARMA, INC. in 2005. Medicure purchased the U.S. rights to AGGRASTAT® in August, 2006.


Grüße cristrader

[solarblase]

Press Release Source: Medicure Inc.


Medicure to Present at Deutsche Bank's Annual Health Care Conference
Tuesday May 1, 9:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 1, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced its President and CEO, Albert D. Friesen, PhD, will deliver a corporate presentation at Deutsche Bank's 32nd Annual Health Care Conference at 4 p.m. Eastern on Wednesday May 2, 2007 in the Chinese Room of The Mayflower Hotel in Washington, D.C. The presentation will be made available by webcast and can be accessed on the Investor Relations page of the Medicure website at www.medicure.com.

[brombeeren]

Antwort auf Beitrag Nr.: 29.080.245 von cristrader am 01.05.07 11:18:08

Tag zusammen,
die neue coverage gefällt, ebenso, dass auf die mäßigen Aggra-Zahlen schnell durch Verpflichtung Von Ms. Cell reagiert wurde.Merck hat die europäischn Rechte und wird auch etwas tun, so dass ein europäischer Erfolg sicher auch in Amerika positive Folgen zeitigen wird. Mit dieser Strategie sollte bei guten research-updates MC-1 bis November ein solider chart generiert werden, der eher nordwärts geht. Die vielfach beschworenen 3 Dollar sehe ich allerdings bis November auch noch nicht, es sei denn erste MC1-Zulassungshysterien machen den Wert etwas bekannter.

Sollte nicht einmal ein neuer thread bei Wallstreet gegründet wäre, der auch auf der Kurs und Chartseite sichtbar ist? Sozusagen, neue deutsche coverage...

Gruß, Brombeeren

[cristrader]

Medicure Announces MC-1 Symposium at American Association for Thoracic Surgery Meeting
Thursday May 3, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 3, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced it is providing an educational grant to support an accredited satellite symposium during The American Association for Thoracic Surgery's 87th Annual Meeting in Washington, D.C. The symposium will highlight Medicure's lead clinical product MC-1's potential role in the treatment of coronary artery bypass graft (CABG) surgery patients.
ADVERTISEMENT


The symposium, titled "Novel Cardioprotective Treatment for Coronary Artery Bypass Graft", is scheduled for Monday, May 7, 2007, at 6 p.m. Eastern at the Renaissance Washington Hotel in the Renaissance Ballroom West. The symposium has been assessed by the Accreditation Council for Continuing Medical Education and awarded accreditation as a provider of continuing medical education for physicians.

Symposium panel members will include Dr. Michel Carrier, Director of Cardiovascular Surgery Program at the Montreal Heart Institute and a Principal Investigator for the MEND-CABG II trial. Also on the panel are MEND-CABG II steering committee members Dr. John H. Alexander, Associate Professor of Medicine in the Division of Cardiovascular Medicine at Duke Clinical Research Institute, and Dr. Robert W. Emery, Jr., Chief of Cardiac Surgery at St. Joseph's Hospital, in St. Paul, Minnesota.

"This symposium is the ideal setting to update the thoracic surgery community on the clinical development of MC-1," stated Dr. Alexander. "If the ongoing Phase 3 MEND-CABG II study delivers similar data to the previous Phase 2 study, MC-1 could represent a major and easy-to-implement advance in the treatment of patients undergoing CABG and perhaps other major cardiac surgery. I look forward to sharing my enthusiasm for the MC-1 clinical development program with the thoracic surgery community."

The American Association for Thoracic Surgery (AATS) was founded in 1917. Its annual meeting brings together almost 3,000 of the most prominent specialists from around the world to address cutting-edge modalities of therapy for cardiothoracic diseases.

About MC-1

MC-1 is a novel cardioprotective compound that is being evaluated in the prevention of cardiac damage. Medicure has completed two Phase 2 studies with MC-1 demonstrating its cardioprotective effects. MC-1 has received a Fast Track Designation from the FDA as a treatment to reduce cardiovascular events associated with ischemic and/or ischemic reperfusion injury in patients experiencing percutaneous coronary interventions, coronary artery bypass graft surgery and acute coronary syndrome (ACS). Medicure intends to develop MC-1 for the CABG surgery and ACS markets, which have a combined annual incidence of approximately two million in the United States.

About MEND-CABG II

The Phase 3 MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that will enroll up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. Study patients will be randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. Study enrollment was initiated in November 2006.

The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase 2 MEND-CABG study. MEND-CABG was a Phase 2 study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB equals 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups.

In addition to the MEND-CABG study, the 60 patient MEND-1 study demonstrated that MC-1 had a statistically significant reduction in the cardiac enzyme CK-MB in patients undergoing percutaneous coronary intervention (PCI).


Grüße cristrader

[solarblase]

Medicure Announces Successful DSMB Review for the Phase 3 MEND-CABG II Trial
Monday May 7, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--May 7, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, announced today that following a meeting of the independent Data Safety Monitoring Board (DSMB), the Company has received a recommendation to continue its Phase 3 MEND-CABG II trial.
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The DSMB is primarily responsible for monitoring the safety of patients participating in the study and for reviewing the safety data throughout its duration. The MEND-CABG II study is evaluating the safety and efficacy of the Company's novel cardioprotective drug MC-1 in patients undergoing coronary artery bypass graft (CABG) surgery.

"The positive recommendation by the DSMB to continue the study provides further confirmation of the safety profile of MC-1 and affirms the progress being made in this Phase 3 registration study," stated Medicure's President and CEO, Albert D. Friesen, PhD.

The DSMB is comprised of independent medical experts and was established by Medicure, in coordination with Duke Clinical Research Institute and Montreal Heart Institute, as part of the Company's compliance with good clinical practices guidelines. Based on its analysis, the DSMB recommended that Medicure continue the MEND-CABG II trial as planned.

Medicure anticipates completing enrollment in the study by November 2007.

[solarblase]

May 11, 2007

MEDICURE TO PRESENT AT RODMAN & RENSHAW'S ANNUAL HEALTH CARE CONFERENCE
WINNIPEG , Manitoba – (May 11, 2007) Medicure Inc. (TSX:MPH/Amex:MCU), a cardiovascular focused biopharmaceutical company, today announced its President and CEO Albert D. Friesen, PhD, will deliver a corporate presentation at the Acumen BioFin Rodman & Renshaw 4th Annual Global Healthcare Conference at 3:35 p.m. local time (9:35 a.m. Eastern) on Monday May 14, 2007 at the Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco. The presentation will be made available by webcast and can be accessed on the Investor Relations page of the Medicure website at www.medicure.com.

[KnigRollo]

spricht doch für unseren laden:



Studien warnen Herzpatienten vor Risiken neuer Stents
Gefahr von Blutgerinnseln.
Medizinische Drahtgeflechte, sogenannte Stents, wurden bislang als entscheidende Neuerung für die Kardiologie gefeiert: Die mit Medikamenten überzogenen Drähte verhindern erneute Verschlüsse. Doch in der ersten Euphorie wurden offenbar gravierende Nebenwirkungen übersehen.
Herzuntersuchung: Medikamentenbeschichtete Stents werden in neuen Studien kritisch hinterfragt, Symbolbild: dpa
Artikelbild vergrößern
Herzuntersuchung: Medikamentenbeschichtete Stents werden in neuen Studien kritisch hinterfragt, Symbolbild: dpa
Medikamentenbeschichtete Stents galten vor wenigen Jahren als die Innovation in der Kardiologie. Hauchdünne Drahtgeflechte, die nach einer Aufweitung von Herzgefäßen in die Arterien eingesetzt werden, wurden mit einem Überzug versehen, aus dem Arzneimittel in den Körper freigesetzt werden, um ein erneutes Zusetzen der Adern zu verhindern. Studien zeigten, dass dadurch die Zahl der Wiederverschlüsse – so genannten Restenosen – deutlich verringert werden konnte.

Inzwischen ist die Euphorie verflogen. Berichte, wonach medikamentenbeschichtete Stents Blutgerinnsel auslösen können, haben Kardiologen wie Patienten verunsichert. Ärzte aus Basel hatten im Herbst vergangenen Jahres auf einem Kardiologenkongress in Barcelona von gehäuften Komplikationen berichtet. Die Schweizer Forscher hatten Studien zu arzneibeschichteten Stents ausgewertet und berichtet, dass sie eine leicht erhöhte Sterblichkeit bei Patienten beobachten konnten, denen eine solche Gefäßstütze implantiert wurde.

Die Mediziner führen dies auf Thrombosen in den Kranzgefäßen zurück – eine Gefäßerkrankung, bei der sich Blutgerinnsel bilden. Die Gerinnsel entstehen, weil beschichtete Stents langsamer als unbeschichtete in die Gefäßwand einheilen. Jeder Fremdkörper fördert die Bildung von Blutgerinnseln, wodurch die Arterie wieder verstopfen kann. Noch ist vieles unklar. So weiß man nicht, warum auch noch ein Jahr später Stent-Thrombosen auftreten.

Große Enttäuschung bei Medizinern

Vor allem unter den Medizinern ist die Enttäuschung groß, dass die ehemals gefeierten beschichteten Stents jetzt in die Kritik geraten. Ihr vermeintlicher Vorteil überzeugte einst viele Kardiologen: Während sich bei der Verwendung von reinen Metallstents das Gefäß in 25 bis 35 Prozent der Fälle innerhalb weniger Wochen wieder zusetzte und erneut geweitet werden musste, blieben die Kranzarterien mit den beschichteten Stents in mehr als 90 Prozent frei.

Nun müssen die Ergebnisse unter einem neuen Licht betrachtet werden. „Die neuen Erkenntnisse zeigen, dass die Vorteile der neuartigen Stents deutlich überbewertet wurden“, sagt der Vorstandsvorsitzende der Deutschen Herzstiftung Hans-Jürgen Becker. Es gebe nur noch wenige Indikationen, die den Einsatz der medikamentenbeschichteten Stents rechtfertigten.

Die Deutsche Gesellschaft für Kardiologie (DGK) geht nicht ganz so weit. „Die erhöhte Sterblichkeit beim Einsatz beschichteter Stents ist statistisch nicht gesichert“, beschreibt Sigmund Silber, Kardiologe und Vorstandsmitglied der DGK, die Datenlage. Der Mediziner geht davon aus, dass sich Vorteile und Nachteile im Hinblick auf die Sterblichkeit die Waage halten. „Stent-Thrombosen bergen zwar ein höheres Todesrisiko, sind dafür aber wesentlich seltener als Restenosen“, sagt Silber.

Dennoch empfiehlt der Kardiologenverband, die neuen Stents künftig „bevorzugt bei erhöhtem Risiko einer Restenose“ einzusetzen und bei Patienten mit erhöhtem Risiko für eine Stent-Thrombose zurückhaltender zu sein. „Die neuen Stents wurden zu schnell bei Patienten mit komplexen Krankheitsbildern eingesetzt“, sagt Silber. Bis zu drei Viertel der beschichteten Stents fanden außerhalb der relativ eng gefassten Zulassungsgrenzen Anwendung.

[brombeeren]

Antwort auf Beitrag Nr.: 29.324.382 von KnigRollo am 15.05.07 13:54:32

Tag zusammen,
recht viele Patienten mit medikamentenbeschichteten Stents fühlen sich recht unwohl-die Diskussion kocht hoch -damals für den "Mercedes unter den angebotenen Lösungen" entschieden, nun zeigen sich noch schwer einschätzbare Gefährdungspotentiale.

Gruß

Medicure's MEND-CABG Trial Results Published in Peer Reviewed Journal
WINNIPEG, MANITOBA, May 31, 2007 (MARKET WIRE via COMTEX News Network) -- Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular focused biopharmaceutical company, today announced that the results from its Phase 2 MEND-CABG trial are featured in a peer reviewed article in the June edition of The Journal of Thoracic and Cardiovascular Surgery, published by the American Association of Thoracic Surgery.
The article, titled, "Effects of pyridoxal-5-phosphate (MC-1) in patients undergoing high-risk coronary artery bypass surgery: Results of the MEND-CABG randomized study", outlines evidence of MC-1's potential efficacy in reducing ischemic reperfusion injury. Additionally, the article presents further detail, background information and analysis of Medicure's positive MEND-CABG study.

"We are pleased that our novel cardioprotective product MC-1 is being recognized by one of the leading cardiovascular surgery journals," stated Medicure's President and CEO, Albert D. Friesen, PhD. "The results from MEND-CABG clearly show that patients treated with MC-1 experienced clinically meaningful reductions in the composite endpoint, driven by a pronounced reduction in large non-fatal myocardial infarctions, which comprise the majority of events after CABG surgery. We eagerly anticipate the results of the ongoing pivotal Phase 3 MEND-CABG II registration trial."

Additional Clinical Data

The article also includes new data from a post-hoc analysis demonstrating a statistically significant lower incidence of atrial fibrillation in the MC-1 groups (250 mg equals 5.7% and 750 mg equals 6.0%) compared to the placebo group (11.9%) between post operative day (POD) four and the end of the trial.

"Atrial fibrillation is one of the most common complications after CABG surgery, and is associated with a significant increase in morbidity and mortality, as well as prolonged hospital stay and increased hospital costs," commented Dr. Friesen. "Prevention of atrial fibrilllation therefore would have a significant positive impact on patients undergoing CABG surgery. Given the limited success of prophylactic drug therapy for atrial fibrillation, the beneficial effects of MC-1 are promising and warrant further evaluation in future studies."

[cristrader]

Hallo!

Die Kursentwicklung von MCU ist mehr als enttäuschend. Der Businessplan des Managements die MC-1 Cabg Phase III alleine durchzuführen, auf eine Partnerschaft vorerst zu verzichten und die Entwicklung der restlichen Pipeline bis zu den Phase III-Ergebnissen zu stoppen wird vom Markt nicht gerade positiv aufgenommen. Man muss zudem stark mit einer weiteren Kapitalerhöhung noch vor den Ergebnissen im Frühjahr 2008 rechnen.
Mit richtigen News abgesehen von der Umsatzentwicklung von Aggrastat ist bis November auch nicht zu rechnen. In den kommenden nachrichtenarmen, ruhigen Sommermonaten ist daher ein erneutes Antesten der 1 $ -Marke zu befürchten.

Abgesehen vom Kursdilemma erscheint die Unternehmenssituation jedoch weitaus rosiger, denn im Endeffekt wird es fast nur auf die klinischen Phase III Ergebnisse ankommen. In ca. 6 Monaten ist die Phase III-Rekrutierung beendet und Ende März `08 ist mit den Endergebnissen zu rechnen. Die letzten News mit der positiven Empfehlung des DSMB die Phase III wie bisher weiterzuführen und die jetzt veröffentlichten zusätzlichen Phase II-Daten erhöhen die Zuversicht eines positiven Ergebnisses der Phase III-Studie enorm.

Ich bin sicher spätestens Ende des Jahres wird der Zulassungshype beginnen bis dahin gilt es Gedult zu bewahren!

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 29.620.232 von cristrader am 03.06.07 22:35:48

Hallo Cristrader
Muß Dir leider rechtgeben. Mit einer Partnerschaft ist wohl erst mal nicht zu rechnen. Hoffen wir mal kurfristig auf Aggrastat.

Gruss Solarblase

[solarblase]

New Potential Treatment in Development for Patients Facing Heart Health Challenges
Medicure's MC-1 Receives Fast Track Designation from FDA

Winnipeg, Manitoba, CANADA, June 20, 2007-A new drug being developed to help provide a health boost for post heart bypass surgery patients has received a Fast Track Designation from the FDA. Medicure, a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders, has developed MC-1 for the treatment of acute ischemia and ischemic reperfusion injury.

MC-1 has currently completed two positive Phase 2 studies, one in angioplasty patients and most recently a 901 patient coronary artery bypass graft (CABG) study, called MEND-CABG. In the MEND-CABG study, patients undergoing coronary artery bypass graft surgery who received biopharmaceutical company Medicure's lead drug MC-1 in Phase II clinical trails showed a 47% decrease in post-operative hearts attacks. MC-1 is currently being evaluated in a Phase 3 trial (MEND-CABG II) that is enrolling up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. Medicure is conducting the Phase 3 study in conjunction with the Duke Clinical Institute (DCRI) and Montreal Heart Institute (MHI).

Millions of patients have discovered that the drug-coated stents used as part of their heart operations may be having more of a detrimental effect on their health than medical experts have ever publicly acknowledged. Recent medical journal articles suggest that unless patients who receive drug-eluting stents continue to take blood thinners, they could more than double their risk of heart attack or death. This emerging safety controversy around drug-coated stents has some experts predicting a resurgence in heart bypass operations. The bypass operations, although more invasive and dangerous, are believed to have longer lasting benefits compared to stents.

"Some doctors have been less inclined to recommend bypass surgery for their patients because of the risk associated with the procedure, including post-operative heart attacks," stated Dr. Robert Harrington of Duke Clinical Research Institute. "Unfortunately there are currently no approved drugs to specifically lessen that risk."

One company that could improve bypass outcomes for patients is Medicure Inc. The company has developed a cardioprotective drug known as MC-1 that in recent clinical trails cut the threat of post-operative heart attacks in bypass patients nearly in half. Medicure's MC-1 is currently in a late-stage clinical trial and if successful could lead to its approval for sale in the U.S.

"MC-1 has the opportunity to be the first drug available to help the hundreds of thousands of patients undergoing bypass surgery every year" stated Medicure's CEO Dr. Albert D. Friesen.

About MEND-CABG II The Phase 3 MEND-CABG II is a double-blind, randomized, placebo-controlled clinical trial that is enrolling up to 3,000 patients undergoing CABG surgery at approximately 120 cardiac surgical centers throughout North America and Europe. Study patients will be randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the reduction in the composite of cardiovascular death and non-fatal myocardial infarction up to POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. Study enrollment was initiated in November 2006.

The study protocol and entry criteria for MEND-CABG II closely follow that of the Phase 2 MEND-CABG study. MEND-CABG was a Phase 2 study involving 901 patients that evaluated MC-1 versus placebo in patients undergoing CABG surgery. The 250 mg dose of MC-1 had a 37.2% reduction in the composite of cardiovascular death, non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml), and non-fatal stroke versus placebo (p equals 0.028). The reduction in the composite endpoint was driven by a significant 46.9% decrease in the incidence of non-fatal myocardial infarction (peak CK-MB greater than or equal to 100ng/ml) with the 250 mg dose of MC-1 versus placebo (p equals 0.008). The clinical results reported at POD 30 were maintained throughout the 90 day follow up period (POD 90). Safety analysis included in the MEND-CABG study demonstrated MC-1 was safe and well tolerated. The incidence of adverse events in the study was comparable across both treatment and control groups. About Medicure Inc.

The Company's solid position in this field is highlighted by the following:

Lead compound MC-1 in pivotal Phase 3 study for FDA approval - Four positive Phase 2 trials completed with MC-1 - FDA Fast Track designation for MC-1 - U.S. rights to AGGRASTAT(R) Injection (tirofiban hydrochloride) - Combination of MC-1 and lisinopril (MC-4232) completed Phase 2 - Dual action antithrombotic, MC-45308, with positive preclinical results

http://www.drugs.com/news/new-potential-development-patients…

[brombeeren]

Antwort auf Beitrag Nr.: 30.101.659 von solarblase am 21.06.07 21:19:34

Tag zusammen,
beim verschärften Nachdenken über ein Nachlegen, war ich davon ausgegangen, dass es Nachrichtenarmut und keine wesentlichen Überraschungen bei den Aggra-Zahlen geben würde. So dass ein Abwarten auf das Antesten der 1 Dollar Grenze bis zum Einpreisen der ersten Zulassungsphantasien Oktober/November angezeigt schien. Stabilisieren wir uns auf einem höherem Niveau oder sollte man zumindestens auf Einstiegskurse von 1,0 bis 1,08 innerhalb der nächsten Monate spekulieren ? Was meint ihr ?

Gruß von Brombeeren

[cristrader]

Antwort auf Beitrag Nr.: 30.199.200 von brombeeren am 23.06.07 12:44:40

Hallo brombeeren!

Habe in den letzten Wochen mit einem erneuten Antesten der 1 $-Marke gerechnet. Im Bereich 1,08-1,10 $ hat MCU jedoch überraschend Stärke gezeigt. Ich denke die Marken 1,20 $ und 1,33 $ sind zu beachten. Wird die 1,20 $ nach unten durchbrochen sehen wir ein erneutes Antesten des 1-1,10 $-Bereiches, wird die 1,33 $ mit höherem Volumen nach oben durchbrochen erwarte ich ein Antesten des Bereiches 1,60-1,65 $. Wie der Kurs in den nächsten Wochen und Monaten reagieren wird ist natürlich schwer vorherzusagen für die Instis wird es bei den niedrigen Handelsumsätzen in der Tradingrange 1,08-1,33 $ jedoch schwierig eine größere Position aufzubauen.

Die nächsten Zahlen kommen am 13. August
Q4 2007 Medicure Inc. Earnings Release
Monday, August 13, 2007


Die Zulassungsspekulationen werden spätestens Ende´07/Anfang ´08 kommen mit bei weit höherem Volumen und höherer Volarität was sich in höheren Kursen wiederspiegeln wird. Wer MCU nur als kurzfristige Spekulation ansieht dem werden Ende des Jahres einige Chancen geboten. Wer allerdings an die MCU-Story glaubt und auf eine MC-1-Zulassung baut muss sich des Risikos bewußt sein. Bei einem Scheitern von MC-1 wird sich Medicure bei einer Marktkapitalisierung von ca. 40-50 Mio $ wiederfinden bzw. ca. 0,34-0,42 $. Bei Zulassung von MC-1 haben wir es hier auf Sicht von 12-24 Monaten mit einem 10/20-Bagger (Marktkap. 1,5-3 Mrd.) zu tun, das ist schon ein gewisses Risiko wert!

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 30.270.027 von cristrader am 24.06.07 11:15:50

Hallo cristrader,
herzlichen Dank für deine immer wieder interessanten und kompetenten Analysen auf dem board. Richtig ist natürlich, dass alle Investierten im Jan./Feb.08 Farbe bekennen müssen. Dennoch ist MCU nach meinem gegenwärtigen Kenntnisstand für mich eine wirkliche Zulassungsspekulation: Trotz des drohenden Risikos eines Kapitalverlustes von bis zu 80 %.Nach MCU werde ich allerdings mal wohl wieder etwas ruhigere Pferde satteln...

Grüße Brom

[solarblase]

http://www.bnn.ca/servlet/HTMLTemplate/!robVideo/robtv0726.2…

[solarblase]

Medicure Inc.: Positive AGGRASTAT(R) Results Featured in the Journal of the American College of Cardiology
Wednesday July 11, 8:52 am ET


PROTOCOL FOR NEW AGGRASTAT(R) STUDY IN AMERICAN HEART JOURNAL


WINNIPEG, MANITOBA--(MARKET WIRE)--Jul 11, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused, biopharmaceutical company, today announced that the two-year, follow-up results from the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare Metal Stent In Acute Myocardial Infarction) study were published in the July edition of the Journal of the American College of Cardiology (JACC).
ADVERTISEMENT


The article, titled, "Two-Year Clinical Follow-Up After Sirolimus-Eluting Versus Bare-Metal Stent Implantation Assisted by Systematic Glycoprotein IIb/IIIa Inhibitor Infusion in Patients With Myocardial Infarction", outlines the potential benefit of AGGRASTAT® (tirofiban hydrochloride) plus sirolimus-eluting stent (SES) versus Reopro® (abciximab) plus bare-metal stent (BMS) in the prevention of the cumulative incidence of death, myocardial infarction (MI), or target vessel revascularization (TVR) in acute myocardial infarction patients after two years.

At two years, the cumulative incidence of death, MI, or TVR was lower in the AGGRASTAT®-SES group compared with the Reopro®-BMS group (24.2% vs. 38.6%, p equals 0.038). This statistically significant outcome at two years is similar to the previously reported eight month results that were published in The Journal of the American Medical Association (May 2005).

The positive results from STRATEGY were the impetus for an ongoing larger factorial design study titled MULTI-STRATEGY (Multicentre Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab and Sirolimus-Eluting Stent Versus Base Metal Stent in Acute Myocardial Infarction). The MULTI-STRATEGY protocol was published in the July edition of the American Heart Journal.

This 600-patient study will further assess AGGRASTAT®-SES versus Reopro®-BMS in the prevention of the cumulative incidence of death, MI, and TVR in acute myocardial infarction patients. The results from MULTI-STRATEGY are anticipated to be presented at a prominent scientific symposium in early 2008.

"These papers highlight the ongoing interest in evaluating new investigational uses of AGGRASTAT® in the treatment of high risk cardiovascular disease patients," stated Medicure's President and CEO, Albert D. Friesen, PhD. "We believe AGGRASTAT® has significant untapped potential, and look forward to the presentation of new data from studies such as MULTI-STRATEGY in the coming year."

Medicure acquired the exclusive U.S. rights to AGGRASTAT®, in August 2006.

Important Information About AGGRASTAT®

AGGRASTAT® was approved by the Food and Drug Administration on May 14, 1998.

AGGRASTAT®, in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting AGGRASTAT® has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT® has been studied in a setting that included aspirin and heparin.

AGGRASTAT® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT®; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT®. Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy and in patients in chronic hemodialysis. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT®, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued.

[cristrader]

A N A L I T I K A
Focus on Healthcare
Medicure Inc. (MCU)

Biotechnology

Quote: $1.35 // Price Target: $6.00 (+344%)
Research Alert

Erik Danielsen

July 10th, 2007

[e-mail]

w w w . a n a l i t i k a . c o m

MARKET DATA

Mkt. Cap.: $157.0MM
Enterprise Value: $134.M
52Wk Hi-Low: $1.70 -$0.91
Outst. Shares: 116.26M
Fully Dil. Shares: 131.0M
Float: 105.3M
Daily Volume: 109,000
Short Position: n/a
VARIOUS METRICS
Cash : $43.4M
Cash Burn ‘07: $27.0M
LTD (MM): $11.5M
Short Position: 107,000
Insider buying: None
Insider Ownership: ~10%
Institutional
holdings: 24%
EARNINGS DATA
FY – 05/31 2006 2007E 2008E
Q1 (0.06) (0.03) (0.06)
Q2 (0.05) (0.06) (0.04)
Q3 (0.04) (0.08) (0.04)
Q4 (0.03) (0.08)E (0.04)
FY EPS (0.17) (0.17)E (0.09)
Revenue 0.3M 9.5M 20.0
VALUATION METRICS
FY – 12/31 2006 2007E 2008E
P/E NM NM NM
PEG NM NM NM
Sales Mult. NM NM NM

Medicure’s shares have continued to trend downwards since the shares set a high in February 2006, which, in our view, is in sharp contrast to the underlying fundamentals at the company. The company has implemented its business plan, reported highly positive
clinical data for both of its lead compounds and thereby built significant tangible share-holder value. Consequently, we strongly encourage investors to take advantage of the current price weakness and either build or add to their positions.

Key Investment Considerations:

•Strong Management: Medicure has a strong, proven management team that consis-tently delivers on all major corporate milestones.

•Late-Stage Product Candidates: Medicure clearly has one of the clinically most ad-vanced cardiovascular product pipelines of any biotech companies in our 900+ companies database. The company’s lead product, MC-1, is being developed as a cardioprotective agent and entered a 3000 patient Phase III registration study in December 2006. Top-line results are expected by the end of Q1-2008 and the product could be on the market by H1-2009. Medicure’s second product candidate, MC-4232 for diabetics with concomitant hypertension, has successfully concluded Phase IIb clinical testing and is now ready to enter pivotal Phase III clinical testing. These two products alone have by our estimate a combined market potential in excess of $1.5BN in the U.S. alone. Currently, Medicure own 100% worldwide rights to its product candidates.

•Near-Term Growth Opportunity: The August 2006 acquisition of Aggrastat, an FDA approved platelet aggregation inhibitor used to treat acute coronary syndromes, has catapulted the company into an exclusive, small group of biotech companies with significant near-term, sales-growth potential. Aggrastat was re-launched in the United States in late October 2006 with a 15 person dedicated sales-force. At the time of launch, Aggrastat generated ~$8M in annualized revenues equivalent to less than a 2% market share of a an estimated $450M annual market in the U.S. Aggrastat had not been actively marketed in the U.S. for some 3-4 years. By contrast, in Europe, where the product has been marketed actively in recent years, Aggrastat is the market leader of the three competing products in the therapeutic class with an estimated 35% market share. Aggrastat is not only a near-term, sales-growth opportunity, but importantly, it also allows the company to build and train a sales-force in anticipation of the approval of MC-1.

•Additional Licensing Opportunities Could Provide Near-Term Upside: We believe there is an excellent probability that the company will be announcing additional commercial initiatives over the next year that would be immediately incremental to
its revenue base. We look for either additional co-promotion and/or out-right product licensing agreements.

•Significantly Undervalued: At current valuation levels, we believe Medicure’s common stock is significantly undervalued. We expect the stock to appreciate sharply in value, as the company continues to execute its business plan that we expect will result
in a strong news-flow over the next 9 months. We believe Medicure’s stock should be valued at $600-$900M today, implying a 12-18 months price target of $6-9.

Medicure Is Grossly Undervalued Relative To Other Small Cap Biotech Companies

We strongly believe that Medicure, at current valuation levels of ~US$157M (and enterprise value of less than $134M), continues to represent an extraordinary investment opportunity. The company is significantly undervalued by any valuation parameter that we use. In particular, Medicure is trading at an unjustified discount to a group of cardiovascular biotech companies, as highlighted by the table:

Company Ticker Quote Mkt Cap
Alexion Pharma ALXN $47.95 $1.774,0M
Cardiome CRME $9.20 $581.0M
CV Therapeutics CVTX $12.57 $746.2M
Average: $1.033,8
Median: $746.0
Medicure MCU $1.35 $157,0
Discount to median: 79%

We actually believe that Medicure’s commercial potential is much larger than any of the companies indicated in the table above. Furthermore, we have reviewed, not only the companies highlighted in the table, but also a number of other biotech companies in our database, in particular
with regard to:

• Management’s track record of delivering on corporate milestones in a timely fashion.

• Near-term sales-growth potential.
• Breadth, depth and clinically advanced stage of product pipeline.

• Long-term market potential of late-stage product pipeline.

• Anticipated news flow over the next 12 months.

* Current market cap in relation to the above parameters.

Based on our review, we feel very comfortable stating that Medicure ranks among the most attractively valued companies for all of the parameters reviewed. As the table above indicates, the company trades at a 79% discount to companies we feel are comparable, but at the same time have weaker fundamentals. One of the companies highlighted above is Alexion. Alexion once enjoyed a market cap of approximately $1Bn prior to reporting disappointing Phase III results for its heart-protective agent, Pexelizumab. Pexelizumab was being developed basically for the same indications Medicure is pursuing with MC-1. We mention this because we believe Alexion’s valuation at the time based entirely on the prospects of Pexelizumab.

However, in the meantime, Alexion gained FDA approval for another of its product candidates, Soliris, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), which one leading Wall Street analyst recently estimated has a peak sales potential of approximately $400M annually. This is virtually the same as Medicure’s Aggrastat’s market opportunity in the U.S. Alexion’s market cap has despite the disappointment with Pexelizumab soared from $1Bn to $1.77Bn based on the prospects of Soliris. Considering that Medicure in addition to Aggrastat has two products with blockbuster sales potential in late-stage clinical development, and that MC-1 could reach the market within the next 18 months, we conclude that Medicure must be grossly undervalued.

Medicure is currently enjoying a market cap equivalent to about 8.8% (!) of Alexion’s current market cap.

Medicure Consistently Delivers Tangible Value To Shareholders

Medicure has had an impressive news flow over the past twenty four months; including the publication of two highly successful phase IIb clinical trials for MC-1 and MC-4232 and, most recently, the acquisition of Aggrastat, which we estimate has the potential to grow at least 5 times over the next 2-3 years. Aggrastat was purchased at a very reasonable price of roughly 2x its trailing twelve
months revenues.

Since Alexion’s Pexulizumab failed to show efficacy in Phase III as a cardio-protective agent, Medicure has now emerged as the leader in the field. This statement is shared by leading clinical investigators we have spoken to at the most prestigious hospitals in the U.S.

We Expect A Strong News Flow Through 2008

The next 12 months will be extremely exiting to Medicure’s shareholders as we expect the company to report top-line date from its confirmatory Phase III trial for MC-1 in CABG in early 2008. This will clearly be a crucial time in the company’s history. We believe the probability of success in the MC-1 Phase III trial is high and thus a significant revaluation of the stock is likely to occur at the latest by the end of Q1-2008.

The following table summarizes some of the value-driving events we expect to occur over the next 18 months.

Milestone Event Timing

~ Completion of patient enrollment in confirmatory Phase III trial for MC-1 in CABG Oct-2007
~ In-licensing of new commercial products H1-2008
~ Report accelerating sales growth of Aggrastat Dec-2007
~ Report Top-Line Results from MC-1 Phase III Trial Q1-2008
~ File NDA for MC-1 H1-2008
~ FDA Clearance and launch of MC-1 End-2008
~ Announce corporate partner for MC-1 H1-2008

Conclusion

We believe Medicure is significantly undervalued at current valuation levels. We believe Medicure is a “quality small-cap biotech stock” that has a broad product portfolio and a proven management team, lead by Dr. Albert Friesen. Consequently, we strongly recommend growth-oriented investors, familiar with inherent risks of investing in biotech companies, to either add to or take
new positions in Medicure at current price levels.

For more information: www.analitika.com

The author is compensated by Medicure through a consulting agreement for his business develpment services.

ANALITI KA Identifying Investment Opportunities In Healthcare



Grüße cristrader

[solarblase]

Was treibt der dennn für spielchen

Medicure Inc. (MPH) As of July 15th, 2007
Filing Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Jul 13/07 Jul 12/07 Dhalla, Naranjan S. Direct Ownership Common Shares 10 - Acquisition in the public market 5,000 $1.550
Jul 11/07 Jul 11/07 Dhalla, Naranjan S. Direct Ownership Common Shares 10 - Disposition in the public market -5,000 $1.500

[brombeeren]

Antwort auf Beitrag Nr.: 30.714.545 von solarblase am 16.07.07 18:06:04

Tag zusammen, man muss wirklich nicht alle insidertrades verstehen. Trotz mittlerweile größeren medialen Interesses finde ich die Kursentwicklung und das Volumen schon überraschend. Wenn es so weitergeht und bei positiven Überraschungen am 13.August nehmen wir noch nachhaltig die 1,65 ? Wer hätte das gedacht ?

Gruß brom

[solarblase]

Antwort auf Beitrag Nr.: 30.758.528 von brombeeren am 19.07.07 12:55:05

Die Entwicklung habe ich auch nicht erwartet. Hatte auf positive Aggrastat-Zahlen gehofft und dann höhere Kurse erwartet. Aber wollen wir uns mal nicht beschweren
Was meint Ihr. Droht uns noch eine KE ?

Gruß Solarblase

[cristrader]

Antwort auf Beitrag Nr.: 30.765.238 von solarblase am 19.07.07 19:42:22

Hallo!

Meine Kursprognose vom 24.06.07 scheint sich ja tatsächlich zu erfüllen. Es würde mich allerdings sehr überraschen wenn wir ohne News die 1,65$-Marke überwinden. Aber das Zeitfenster um noch günstig vor den richtigen News einzusteigen wird immer kürzer, vielleicht startet der Hype ja bereits jetzt. Eine KE steht sicherlich noch bevor den finalen Ergebnissen im März bevor, aber hoffentlich zu weit höheren Kursen! Ich kann mich allerdings auch irren, denn MCU ging vor den beiden eigentlich viel viel kritischeren Phase II-Ergebnissen keine KE ein. Hoffentlich besitzt das Management in diesem Fall die gleiche Zuversicht!

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 30.765.740 von cristrader am 19.07.07 20:23:29

July 27, 2007

POSITIVE AGGRASTAT® RESULTS VERSUS INTEGRILIN® FEATURED IN AMERICAN HEART JOURNAL

WINNIPEG , Manitoba – (July 27, 2007) Medicure Inc. (TSX:MPH/Amex:MCU), a cardiovascular focused biopharmaceutical company, today announced that data from MR PCI (Multicenter Registry of High-Risk Percutaneous Coronary Intervention and Adequate Platelet Inhibition), a head-to-head study comparing the platelet inhibition effects of AGGRASTAT® (tirofiban hydrochloride) and INTEGRILIN® (eptifibatide), will be published in the August edition of the American Heart Journal.

The article, titled, “Optimal platelet inhibition in patients undergoing PCI: Data from the Multicenter Registry of High-Risk Percutaneous Coronary Intervention and Adequate Platelet Inhibition (MR PCI) study”, outlines a higher degree of platelet inhibition with high-dose AGGRASTAT® versus double-bolus INTEGRILIN® at 10 minutes (p=0.003) and at 6 to 8 hours (p<0.001) in patients undergoing elective high-risk PCI. In addition the study demonstrated that significantly more patients achieved >95% inhibition of platelet aggregation (IPA) with the high-dose AGGRASTAT® regimen.

“The MR PCI trial results indicate that high-dose AGGRASTAT® effectively inhibits platelet aggregation at 10 minutes and 6 to 8 hours and compares favorably with double-dose INTEGRILIN®,” commented Dr. David Moliterno, Chief of Cardiovascular Medicine at the University of Kentucky and the study’s senior author. “These findings add to the existing data favoring the potential use of high-dose AGGRASTAT® during elective high-risk PCI in acute coronary syndrome patients.”

“Positive data now exists comparing AGGRASTAT® with both INTEGRILIN® and REOPRO® in new investigational uses, such as high-risk PCI,” commented Medicure’s President and CEO, Albert D. Friesen, PhD. “We look forward to further data presentations and publications on AGGRASTAT® later this year.”

Medicure acquired the exclusive U.S. rights to AGGRASTAT® , in August 2006.

Important Information About AGGRASTAT®

AGGRASTAT® was approved by the Food and Drug Administration on May 14, 1998.

AGGRASTAT ® , in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be medically managed and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. In this setting AGGRASTAT® has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT® has been studied in a setting that included aspirin and heparin.

AGGRASTAT ® is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT® include: a history of thrombocytopenia following prior exposure to AGGRASTAT® ; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT® is also contraindicated in patients with: severe hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis.

Bleeding is the most common complication encountered during therapy with AGGRASTAT ® . Administration of AGGRASTAT® is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT® occurs at the arterial access site for cardiac catherterization. Fatal bleedings have been reported. AGGRASTAT® should be used with caution in patients with platelet count less than 150,000/mm 3, in patients with hemorrhagic retinopathy and in patients in chronic hemodialysis. Because AGGRASTAT® inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT® when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT® , patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT® and heparin should be discontinued

[cristrader]

Antwort auf Beitrag Nr.: 30.877.351 von solarblase am 27.07.07 15:16:19

Hallo!

Die Aggrastat-Aquisition entwickelt sich immer mehr zu einem genialen Coup! Die beiden Konkurrenten Integrilin und Rheopro müssen sich warm anziehen. Bessere Verkaufsargumente kann man einem Vertriebsteam kaum auf den Weg mitgeben.

1. Aggrastat kann im Gegensatz zu Integrilin und Rheopro bei Raumtemperatur gelagert werden.

2. Aggrastat ist wesentlich günstiger als die beiden anderen.

3. Aggrastat ist effektiver in direkten Vergleichsstudien!

In Europa werden zurzeit mehrere große Vergleichsstudien durchgeführt . Werden die jüngsten Ergebnisse bestätigt dann gute Nacht den Mitbewerbern. Der momentan 2%ige Marktanteil sollte leicht zu steigern sein.

Die positive Entwicklung von Aggrastat nimmt bei momentaner Bewertung ein grosses Stück Risiko aus der Aktie.



Die wirkliche Story bei Medicure ist allerdings MC-1!

Hier ein neues Präsentationsvideo über MC-1: Are you ready?

http://www.medicure.com/mc_1video.html

Yes, I am!


Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 30.943.638 von cristrader am 30.07.07 22:21:21

Hier nochmal der Link zum MC-1 Video!

http://www.medicure.com/mc_1video.html" target="_blank" rel="nofollow ugc noopener">http://www.medicure.com/mc_1video.html

[cristrader]

Antwort auf Beitrag Nr.: 30.943.862 von cristrader am 30.07.07 22:38:58

Verflixt, hoffentlich funktioniert dieser Link ansonsten auf die Startseite von Medicure gehen.

http://www.medicure.com/video/MC_1_July27_sml.wmv

[solarblase]

Nettes Video. Die IR-Abteilung macht jetzt einen ordentlichen Job. Hoffen wir das die Zahlen für Agg jetzt schon gut ausfallen. Dann haben wir vielleicht mal etwas höhere Handelsumsätze.

Gruß Solarblase

[brombeeren]

Antwort auf Beitrag Nr.: 30.953.773 von solarblase am 31.07.07 17:14:56

http://www.canadianinsider.com/coReport/allTransactions.php?…

Gruß Brom

[cristrader]

Antwort auf Beitrag Nr.: 31.022.384 von brombeeren am 04.08.07 21:17:08

Hallo!

Management hält ca. 8 Mio Aktien zzgl. Optionen da fällt der Verkauf von 25000 Stück nicht ins Gewicht. Erst wenn Friesen anfängt zu verkaufen ist Vorsicht geboten.


Neue Coverage:

Thomas Weisel Partners and its affiliates do and seek to do business with companies covered in its research reports. As a result, investors
should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Customers of Thomas Weisel
Partners in the United States can receive independent, third-party research on the company or companies covered in this report, at no cost
to them, where such research is available. Customers can access this independent research at www.tweisel.com or can call [phone] to
request a copy of this research. Investors should consider this report as only a single factor in making their investment decision.
Please see analyst
certification and other
important disclosures
starting on page 9 and
continuing through
page 10.
MEDICURE INC. —MCU
CLOSE TO THE HEART
Overweight AMEX: $1.42 as of 7/31/07
Initiation Report
Key Data FY 2006 2007 2008
52-Week Range: $1 - 2 EPS
Market Cap. (mn): $165.1 1Q $(0.05)A $(0.03)A $(0.06)E
Shares Outstanding (mn): 116.3 2Q $(0.04)A $(0.06)A $(0.03)E
Average Daily Volume: 95,410 3Q $(0.03)A $(0.06)A $(0.02)E
Free Float (mn) 105.4 4Q $(0.03)A $(0.08)E $(0.02)E
Short Int. (% Free Float) 0.0 Year $(0.15)A $(0.23)E $(0.13)E
Fiscal Year End: 5/31 P/E NM NM NM
Revenue (mn)
Total Debt/Equity 34% 1Q $0.03A $0.25A $4.04E
TEV/TTM Sales: 41.0x 2Q $0.03A $1.26A $4.93E
Net Cash/Share: $0.13 3Q $0.05A $2.16A $5.72E
Book Value/Share: $0.27 4Q $0.15A $3.12E $6.29E
Price/Book Value: 5.4x Year $0.26A $6.79E $20.98E
Price Target $3.00 TEV/Sales NM 23.1x 7.5x
Source: Company reports, Thomson Financial and Thomas Weisel International estimates
Note: Medicure Inc. reports in CN$ we have used convenience translation into US$ equivalents. Price is as of the close on the date
indicated. Any price target displayed in the data box above represents either a specific price target or the midpoint of a range. EPS are pro
forma for stock-based compensation expense and one-time items.
• We are initiating research coverage of Medicure Inc. (MCU) with an Overweight rating and
a 12-month price target of $3.
• Growing Aggrastat sales; near-term phase III data on MC-1: Medicure is a cardiovascular drug
company. It has acquired and started marketing Aggrastat, a GPIIb/IIIa inhibitor. Lead pipeline
drug MC-1 is currently in a pivotal phase III study in coronary artery bypass graft (CABG) patients.
• Aggrastat set to recover; peak sales to cross $100mn: We believe that Aggrastat will recapture
significant market share in light of focused marketing efforts and an active salesforce. We estimate
peak sales to cross $100mn by 2015.
• MC-1 phase II data indicative of efficacy; likely to meet phase III endpoints: MEND-1 and
MEND-CABG phase II study results were clearly indicative of the cardio-protective properties of
MC-1. Based on that, we believe that the endpoints in the MEND-CABG II phase III studies are
likely to be met. We expect a mid-2009 launch of the drug and estimate that peak sales will reach
$700mn if additional indications of angioplasty and acute coronary syndrome are approved.
• Valuation: We obtained our 12-month price target of $3 by applying a 30x P/E multiple to our
2012 pro forma EPS estimate of $0.20 and discounting it back at 20%. There are always risks that
the price target for any security will not be realized. In addition to general market and
macroeconomic risks, for Medicure, Inc., these risks include, among other things, clinical trial
failure of its ongoing MC-1 development programs and competition from bigger pharmaceutical
companies.
August 1, 2007
HEALTHCARE
Biopharmaceuticals
Bino Pathiparampil
415.262.6365
[e-mail]

August 1, 2007 Thomas Weisel International
2 Bino Pathiparampil 415.262.6365
CARDIOVASCULAR DRUG DEVELOPER WITH IMPRESSIVE PORTFOLIO
One product in market; high potential product in phase III; rich pipeline:
Medicure, Inc, located in Winnipeg, Manitoba, focuses on developing therapeutics for
the treatment of cardiovascular diseases. Aggrastat, Medicure’s sole product on the
market, was acquired from MGI Pharma in August 2006 and is used in patients
undergoing invasive cardiac procedures such as angioplasty. The company has one drug
currently in phase III studies to prevent ischemic injury in coronary artery bypass graft
(CABG) patients and two other clinical stage drugs—one in phase II for treatment of
hypertension in diabetics and another in phase I to treat hypertension in patients with
metabolic syndrome.
Aggrastat set to recover; peak sales could cross $100mn: Aggrastat (tirofiban
hydrochloride), a GPIIb/IIIa inhibitor, is used for the treatment of acute coronary
syndrome (ACS) and as an adjuvant to percutaneous transluminal coronary angioplasty
(PTCA) or atherectomy. After several years of languishing sales as a result of inadequate
marketing efforts, Aggrastat was acquired in the United States by Medicure. Its newly
formed, 25-person-strong salesforce is working actively and turning around the product.
We believe that Aggrastat can improve its market share significantly and we estimate that
peak annual sales will cross $100mn by 2015. Total U.S. sales for GPIIb/IIIa inhibitors,
including Reopro (abciximab) marketed by J&J and Integrilin (eptifibatide) marketed by
Schering Plough, totaled $430mn in 2006 (a 0.1% increase y/y), with Aggrastat
accounting for only $8.6mn. In the EU, however, where Merck actively markets the
product, Aggrastat has a significant market share and commands sales comparable to
those of Integrilin. Available data comparing the three GPIIb/IIIa inhibitors suggest that
Aggrastat is as efficacious as Reopro and Integrilin, with some added advantages.
Aggrastat is currently being evaluated in several clinical studies by Merck. Data from an
Italian study comparing Aggrastat with Reopro is expected in the spring of 2008. We
estimate Aggrastat FY07 U.S. sales of $6.79mn.
MC-1—fast-track status and SPA agreement with the FDA: MC-1, a vitamin B6
metabolite, has significant cardio-protective effects that can mitigate the effects of
reperfusion injury. Reperfusion injury occurs when blood flow to the heart muscle cells is
restored after a period of ischemia, leading to a flurry of cell-damaging immune
mediators. This typically happens in the setting of a coronary artery bypass graft
(CABG), PCTA and thrombolysis in ACS. MC-1 was granted fast-track status with the
FDA as a treatment to reduce cardiovascular and cerebrovascular events associated with
ischemic and/or ischemic reperfusion injury in patients undergoing angioplasty, CABG
surgery and in ACS.
$1bn potential opportunity; serving an unmet medical need: According to the
American Heart Association (AHA), approximately 400,000 CABG and 1.4mn
angioplasty procedures were conducted in the United States in 2006. There is currently
no cardio-protective drug available against reperfusion injury resulting from these
procedures. Assuming a per-patient cost of $600 for MC-1, this could represent a $1bn
opportunity, should the drug receive FDA approval.

August 1, 2007 Thomas Weisel International
3 Bino Pathiparampil 415.262.6365
MC-1 Phase II data suggestive of efficacy: In the 60-patient, MEND-1 phase II
study, MC-1 reduced the median area under the periprocedural CK-MB curve (AUK)
from 32.9ng/ml to 18.6ng/ml (a 43.5% reduction; p=0.038) on post-operative day 30
(POD30). It also showed a good safety profile. In the 900-patient, placebo controlled,
multi-dose MEND-CABG study, MC-1 achieved a 37.2% reduction in the composite
endpoint, with myocardial infarction (MI) defined as peak CK-MB ≥100ng/ml, in the
250mg arm versus placebo (p=0.028). The composite endpoint consisted of death, non-fatal
MI and non-fatal stroke. In addition, there was also a 46.9% reduction in the
incidence of non-fatal MI (peak CK-MB band ≥100ng/ml) in the 250mg MC-1 group.
MC-1 also achieved a 31.7% reduction in the composite end, with MI defined as peak
CK-MB ≥70ng/ml, in the 250mg arm versus placebo (p=0.035). The POD30 findings
of significant reduction in the composite endpoint continued to POD90; however, MC-1
could not establish significant improvement in the composite endpoint versus placebo
when MI was defined as peak CK-MB ≥50ng/ml. Also, the 750mg arm performed
worse than the 250mg arm; the company explains this as a result of the peaking of
plasma levels of MC-1 followed by accelerated excretion from the body. The compound
exhibited a good safety profile in the study.
MEND-CABGII phase III study ongoing; expect results in 1H08: MC-1 is
currently being studied in a 3,000-patient, double-blind, randomized, placebo-controlled
phase III trial, the MEND-CABG II study. This trial is being conducted in 120 centers
across the United States, Canada and Germany, and results are expected in 1H08. The
primary endpoint is a reduction in a composite of death and nonfatal MI (peak CK-MB
band ≥100ng/ml) up to POD30 compared to placebo. We believe that the trial has a
good chance of meeting its endpoint and expect a mid-2009 launch. We estimate that
peak annual sales could exceed $700mn if the other indications (PTCA and ACS) are also
approved. The company intends to conduct future label expansion studies in ACS and
stroke patients
RICH PIPELINE ADDS TO THE PROMISE
Satisfactory MC-4232 phase II data: phase III study pending: According to the
Centers for Disease Control and Prevention (CDC), more than 14mn Americans are
currently living with diabetes with another 6.2mn undiagnosed with the disease. Of those
diagnosed with diabetes, around 73% suffer from hypertension. MC-4232 is a
combination of MC-1 and lisinopril, an ACE inhibitor, and was recently evaluated in a
phase II trial, the MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics
(MATCHED) study. Results from this study showed that MC-4232 reduced mean
daytime ambulatory systolic blood pressure (MDASBP) by 4.5mm Hg more when
compared with the use of lisinopril alone and reduced fasting serum glucose by
1.45mmol/L. No statistically significant decrease in HbA1c levels was seen, however.
The company intends to conduct a 1,500-patient phase III study, but further
development is currently on hold until results are available from the MEND-CABG II
study.
Good early stage drugs in MC-4262 and MC-4538: Other drugs in the pipeline
include MC-4262 (a combination of MC-1 and an angiotensin II receptor blocker (ARB))
currently in phase I for treatment of hypertension in individuals with metabolic

August 1, 2007 Thomas Weisel International
4 Bino Pathiparampil 415.262.6365
syndrome. Medicure is also developing a novel compound, MC-4538 which is currently
in preclinical evaluation for use as an anti-thrombotic agent.
MCU Pipeline
Products
Aggrastat ®
Acute Coronary Syndrome (ACS)
MC-1
Coronary Artery Bypass Graft (CABG)
Acute Coronary Syndrome
Stroke
MC-4232
Diabetic Hypertension
MC-4262
Hypertension Complicated
with Metabolic Syndrome
MC-45308
Thrombosis
MC-5422
Ischemia DISCOVERY
Source: Company reports
Approval Market Preclinical Phase I Phase II Phase III
COMPANY INSIGHTS
Experienced management: Dr. Albert Friesen, Medicure’s founder and CEO, has
been with the company since its inception in 1997. Prior to that, he held senior
management positions in several companies such as Viventia Biotech and Genesys
Pharma. He also played a significant role in the founding and successful sale of
companies including Rh Pharmaceuticals (acquired by Cangene) and ABI Biotechnology
(acquired by Apotex). Other senior management includes personnel with several years of
significant industry experience.
Good cash position: Medicure ended 3Q07 with more than $37mn in cash. Based on
our estimates, the company will be able to make it through late 2008 with the current
drug development plans. Medicure raised approximately $25mn in December 2006 via a
private placement of common stock at a price of $1.30 per share, in addition to the
issuance of approximately 4mn warrants.
Key shareholders: Major shareholders of Medicure include Columbia Wanger Asset
Management, L.P. (7.94%) and Dr. Albert Friesen (6.59%).
ESTIMATES
Our 4Q07 and FY07 revenue and pro forma estimates are $3.12mn and $(0.08) and
$6.79mn and $(0.23), respectively. Our FY08 revenue and pro forma estimates are
$20.98mn and $(0.13), respectively.

August 1, 2007 Thomas Weisel International
5 Bino Pathiparampil 415.262.6365
POTENTIAL UPSIDES TO OUR ESTIMATES
MC-1 label expansion; off-label use: Our current estimates for MC-1 only include
revenue from its use in CABG procedures. There could be significant upside potential to
our estimates should the drug be used for patients undergoing angioplasty procedures
and in ACS patients.
FDA approval of MC-4232: Our current revenue estimates do not include sales of MC-4232,
since further development of the drug is currently on hold. If results from the
planned 1,500-patient trial turn out positive and the drug receives FDA approval, there
would be significant upside to our revenue estimates.
POTENTIAL DOWNSIDES TO OUR ESTIMATES
Failure of MC-1 phase III trial: All of Medicure’s resources are currently directed
toward the MC-1 MEND-CABGII trial. Failure of MC-1 to demonstrate significant
benefit in the phase III trial would result in significant downside to our estimates.
Inability of the sales force to deliver: Medicure competes in the cardiovascular space
currently dominated by large pharmaceutical companies. Should the salesforce be unable
to gain a foothold in the market, this could result in lower revenue and downside to our
estimates.
Medicure, Inc - Near-Term Milestones
Drug Indication Milestone Timing
Aggrastat ACS Data from four ongoing clinical studies 2Q08
MC-1 CABG Phase III data 2Q08
MC-4232 Hypertension in Diabetics Initiation of phase III study 2H08
Source: Company reports and Thomas Weisel International estimates
RISKS
Drug development risks: All drug development programs carry an inherent risk of
failure by virtue of the unpredictable nature of clinical trial results and could result in
significant financial loss in terms of resources spent on the program.
Market risk: Medicure’s drug serves an unmet medical but will cater to the
cardiovascular market, which is highly dominated by large pharmaceutical companies.
Medicure could face intense competition from these firms with bigger salesforces,
especially in relation to Aggrastat.
VALUATION
We obtained our 12-month price target of $3 by applying a 30x P/E multiple to our 2012
pro forma EPS estimate of $0.20 and discounting it back at 20%. There are always risks
that the price target for any security will not be realized. In addition to general market
and macroeconomic risks, for Medicure, Inc., these risks include, among other things,
clinical trial failure of its ongoing MC-1 development programs and competition from
bigger pharmaceutical companies.





Nächsten Montag 13.08.07 gibt es die nächsten Zahlen, deshalb ist diese Woche wieder mit ansteigendem Volumen zu rechnen. Erwarte ein erneutes Antesten der 1.60-1,65 $ Marke!


Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 31.040.828 von cristrader am 05.08.07 20:20:38

Hallo!

Quartalszahlen um eine Woche auf den 20.08.07 verschoben!

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 31.070.830 von cristrader am 07.08.07 21:27:31

Kam nicht gut an

[brombeeren]

Guten Tag zusammen,

übersehe ich news? Amex gegenwärtig -12 %... Was ist da los ?


Gruß

Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.188.013 von brombeeren am 16.08.07 17:05:47

Bei den Handelsumsätzen von MCU kann der Kurs leicht in eine Richtung gelenkt werden. Bei dem Umsatz jetzt habe ich noch keine Panik. Kann leicht wieder drehen.
Hoffen wir es mal

Gruß Solarblase

[solarblase]

Schaut mal an der TSX
Wieder mit Minumsätzen.

[solarblase]

August 21 , 2007

MEDICURE ENTERS INTO AGREEMENTS TO RAISE US$40 MILLION

WINNIPEG , Manitoba – (August 21, 2007) Medicure Inc. (TSX:MPH/Amex:MCU), a cardiovascular focused biopharmaceutical company, today announced it has entered into two separate agreements to raise gross proceeds of US$40 million.

Medicure has signed a term sheet to monetize a percentage of the Company’s current and potential future commercial revenues with Manchester Securities Corp., an affiliate of Elliott Associates, L.P. (“Elliott”) for a US$25 million upfront cash payment. Under the proposed terms, Elliott will receive an escalating minimum annual return starting at US$2.5 million based on AGGRASTAT® revenue for a period of approximately 12 years. Elliott will also receive the option to convert its rights based on AGGRASTAT® to MC-1 within six months after MC-1’s commercialization, if achieved. The exact percentage of AGGRASTAT® or MC-1 revenue that Elliott will receive is tiered and declines as certain revenue levels are achieved. Upon conversion to MC-1, Elliott is entitled to a blended return of approximately 7% on the first US$75 Million in MC-1 revenues and 3% thereafter.

The Elliott agreement is subject to a number of typical closing conditions and the execution of a definitive agreement. The transaction is expected to be completed by September 7, 2007. Leerink Swann & Company served as Lead Advisor on the transaction.

In a separate transaction Medicure has entered into Securities Purchase Agreement, with investors to raise total gross proceeds of US$15 million. Under terms of the Agreement, Medicure intends to issue approximately 13.04 million common shares at a price of US$1.15, together with warrants , to purchase approximately 3.9 million additional common shares. The warrants have a five year term and an exercise price of US$1.50. The Agreement is subject to standard closing conditions including regulatory approval and is expected to close in September. In addition to Leerink Swann & Company, A.G. Edwards & Sons, Inc., Merriman Curhan Ford & Co. and RBC Capital Markets Inc, served as financial advisors.

[solarblase]

Press Release Source: Medicure Inc.


Medicure Announces Second Successful DSMB Review for the Phase 3 Mend-CABG II Trial
Wednesday August 22, 8:30 am ET


MEND-CABG II ENROLLMENT AHEAD OF SCHEDULE


WINNIPEG, MANITOBA--(MARKET WIRE)--Aug 22, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced that following the second and final planned meeting of the independent Data Safety Monitoring Board (DSMB), the Company has received another recommendation to continue its Phase 3 MEND-CABG II trial as planned. Medicure is also pleased to announce that it anticipates completion of study enrollment around late September 2007, approximately two months ahead of schedule.
ADVERTISEMENT


"This second positive recommendation by the DSMB further substantiates the safety profile of MC-1, and confirms the rapid progress being made in this 3,000 patient Phase 3 registration study", commented Medicure's President and CEO, Albert D. Friesen, PhD.

"We are also pleased to report that enrollment has exceeded our expectations, and we are now anticipating completion around late September 2007, rather than our previously forecasted completion of November 2007," added Dr. Friesen. "We feel the rapid pace of enrollment reflects positively on the medical need for MC-1 and its acceptance by the thoracic surgery and interventional cardiology communities."

[solarblase]

Biotech firm looks to drug trial completion to stem losses


Fri Aug 24 2007

By Martin Cash



AS Medicure Inc. closes in on completion of its clinical trials and prepares for the commercial launch of a new drug the wheels are churning on several different fronts.
One of those developments could even include a new pharmaceutical production plant in Manitoba, although that wouldn't be likely for at least five years.

On Thursday, the company reported a loss of $31.7 million for the fiscal year ending May 31, 2007 -- more than twice the burn rate of the previous year. It's mostly because of the increased costs associated with the final 3,000-patient trial that's now nearing completion.

The Winnipeg bio-tech company lost $14 million for the quarter ending May 31 and company officials said they anticipate there will be similar losses in the next two quarters until the results of the trial are released, but that losses would subside after that.

If so, Medicure will have gone through more than $100 million of investors funds since 2000 to get to the point where it has a drug ready to apply for regulatory approval perhaps as early as mid-2008.

But investors may be rewarded yet their patience. Analysts forecast that if the new drug, called MC-1, is approved as expected sales could be in the range of several hundred million dollars per year in a few years.
MC-1 is designed as a cardio-protective therapy to treat patients who undergo coronary artery bypass surgery. There is currently no similar drug on the market.

Earlier this week, the company secured US$40 million in new financing, enough cash to get the company through another 12 to 18 months which is about the time MC-1 is launched.

Meanwhile, Medicure is fine tuning a U.S. sales force to boost sales of another heart drug called AGGRASTAT that it acquired the U.S. marketing rights for last summer.

Although those sales were disappointing in the last quarter of the fiscal year -- $1.7 million compared to $2.5 million the previous quarter -- Medicure has recently hired 30-year industry veteran Bonnie Zell to lead the sales efforts. Zell helped launch AGGRASTAT's main competitor in the late '90s.

Zell said the AGGRASTAT sales force is important for Medicure because it will help the Winnipeg company get some profile with U.S. hospitals and cardio surgeons prior to the launch of MC-1, which is expected to have significantly more sales than AGGRASTAT.

Medicure CEO Albert Friesen said if sales of MC-1 do get up to the levels that are anticipated the company will consider setting up its own production facilities.

[e-mail]

http://www.winnipegfreepress.com/subscriber/business/story/4…

[solarblase]

Sehr enttäuschender Kursverlauf. Meint Ihr wir sehen die 1 $ wieder ?

[brombeeren]

Antwort auf Beitrag Nr.: 31.446.307 von solarblase am 07.09.07 18:36:37

Guten Tag zusammen,
der Kursverlauf ist in der Tat bescheiden. Die Bewertung der jüngsten Transaktionen ist negativ. Kostenverdopplung, 13 Millionen shares zu 1.15 und das Beleihen der zukünftigen Produktverkäufe, bescheidene Aggra Zahlen. Wir werden jetzt wohl noch länger bei 1,15 rumgondeln. 1 Dollar sehen wir nicht mehr. Wollen hoffen das die Zulassungsphantasien sich in den nächsten Monaten gut entwickeln, denn die Phase III scheint doch ordnungsgemäß zu laufen. Eine Prognose, wo wir märz 2008 vor den ergebnissen stehen, vermag ich nicht abzugeben. Das wäre interessant !

Gruß

Brom

[solarblase]

Die Konferenzen diese Woche sind bisher nicht sehr erfolgreich. Hoffe der Verkäufer ist bald fertig.

[solarblase]

Press Release Source: Medicure Inc.


Medicure Announces Completion of Enrollment in Pivotal Phase 3 MEND-CABG II Trial
Thursday September 20, 8:00 am ET


Top-Line Results Expected in First Quarter 2008


WINNIPEG, MANITOBA--(MARKET WIRE)--Sep 20, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced the completion of enrollment of 3,000 patients in its MEND-CABG II trial. This pivotal Phase 3 trial for registration is evaluating the Company's FDA Fast Tracked product MC-1's safety and cardioprotective efficacy in patients undergoing coronary artery bypass graft (CABG) surgery.
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"The completion of patient enrollment in MEND-CABG II, which is two months ahead of schedule, is a testament to the support and confidence of the clinical investigators and patients participating in the trial," stated Medicure's President and CEO, Albert D. Friesen, PhD. "We believe MC-1 represents an important advancement in the care of CABG surgery patients, and could become the first cardioprotective therapy approved to reduce mortality and morbidity in this patient population. We therefore look forward to reporting top-line results from MEND-CABG II early next year."

About MEND-CABG II

The Phase 3 MEND-CABG II trial is a double-blind, randomized, placebo-controlled clinical trial that enrolled 3,000 patients undergoing CABG surgery at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients were randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.

About Medicure Inc.

Medicure is a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders. The Company's solid position in this field is highlighted by the following:



- Lead compound MC-1 in pivotal Phase 3 study for FDA approval
- Four positive Phase 2 trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT® Injection (tirofiban hydrochloride)
- Combination of MC-1 and lisinopril (MC-4232) completed Phase 2
- Dual action antithrombotic, MC-45308, with positive preclinical
results
Medicure also has a medicinal chemistry based Drug Discovery program focused on discovery and advancement of novel small molecule anti-ischemics and antithrombotics towards human clinical studies.

This press release contains forward-looking statements, as defined under applicable securities legislation, that involve risks, which may cause actual results to differ materially from the statements made, and accordingly may be deemed to be forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise except as required by law. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the Company's stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence on collaborative partners and the ability to meet its debt obligations. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of its Form 20F for the year ended May 31, 2007.

[solarblase]

Medicure mulling early data release for heart drug
Thu Sep 20, 2007 11:52am EDT

Market News
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More Business & Investing News... Featured Broker sponsored linkTORONTO, Sept 20 (Reuters) - Medicure Inc (MPH.TO: Quote, Profile, Research) said on Thursday it completed enrollment of patients for the Phase 3 trial of its heart treatment ahead of schedule, which could pave the way for early dissemination of the data.

The small biotech company said it enrolled more than 3,000 patients in the study for its MEND-CABG II trial, a treatment for reducing post-operative heart attacks in patients undergoing coronary artery bypass.

Medicure had targeted completion by November. The company is still sticking to its original schedule to release the data in early 2008, but a company spokesman said it could be sooner.

"This is probably one of, if not the biggest independent Phase 3 trials in Canadian biotech history. Three thousand patients is a big number to manage by one company and we've pulled it off so far," said Medicure spokesman Adam Peeler.

"This brings things into focus in terms of how close we actually are to data from the trial."

Peeler said the company is eyeing the summer of 2008 to submit a new drug application to the U.S. Food and Drug Administration.

"This is huge, positive news for the sector. The fact that it's the largest clinical trial for a biotech company in Canada, this is a major milestone that they have achieved here," said Paradigm Capital analyst Claude Camire.

"This really speaks to the true value of management that was able to complete this ahead of time."

Medicure shares were unchanged by late morning at C$1.10 after climbing as high as C$1.15 earlier in the day.

($1=$1 Canadian)

[brombeeren]

Antwort auf Beitrag Nr.: 31.679.725 von solarblase am 20.09.07 20:04:55

Tag zusammen,

so der Deal ist eingetütet. Wo ist denn cristrader abgeblieben...?

Medicure Completes US$25 Million Financing
WINNIPEG, MANITOBA, Sep 24, 2007 (CCNMatthews via COMTEX News Network) -- Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular drug discovery and development company, today announced that it closed its previously announced financing agreement with Elliott Associates, L.P. ("Elliott"), raising total gross proceeds of US$25 million.
Under the terms of the final agreement, Birmingham Associates Ltd., an affiliate of Elliott Associates, will provide Medicure with an upfront cash payment of US$25 million. Elliott will receive an escalating minimum annual return starting at US$2.5 million based on AGGRASTAT(R) revenue or MC-1, if approved until May 31, 2020. Elliott will also receive the option to convert its return based on AGGRASTAT(R) to a return based on MC-1 sales within six months after MC-1's commercialization, if achieved.

"We are pleased to have worked with Medicure to construct a financing structure that provides the necessary capital to complete the Phase 3 MEND-CABG II study of MC-1," stated Elliott's Senior Technology Analyst, Jesse A. Cohn. "Medicure has developed an impressive cardiovascular pipeline, and this transaction allows Elliott to participate in the growth opportunity of AGGRASTAT(R) and MC-1, if approved."

The exact percentage of AGGRASTAT(R) or MC-1 revenue that Elliott will receive is tiered and declines as certain revenue levels are achieved. Upon conversion to MC-1, Elliott is entitled to a blended return of approximately 7% on the first US$75 Million in MC-1 annual revenues and 3% thereafter.

The proceeds of this transaction will be used to fund the ongoing research and development of MC-1 and the sales and marketing efforts for AGGRASTAT(R). As part of this transaction, Medicure has also amended the terms of its existing US$13.9 million term loan facility, which includes the immediate payment of US$1.9 million in principal, with the balance cash collateralized. In addition, Medicure has deferred further monthly principal payments on the facility for a minimum period of one year from the date of the final agreement.

Leerink Swann served as Lead Advisor on the transaction.

Medicure anticipates that the previously announced private placement component of the agreement will close later this month.

Gruß

Brombeeren

[solarblase]

Antwort auf Beitrag Nr.: 31.721.984 von brombeeren am 24.09.07 14:39:26

Cristrader war lange nicht mehr online Vielleicht im Urlaub

[solarblase]

Press Release Source: Medicure Inc.


Medicure to Present at UBS Global Life Sciences Conference
Tuesday September 25, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Sep 25, 2007 -- Medicure Inc. (Toronto:MPH.TO - News) (AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced its President and CEO, Albert D. Friesen, PhD, will deliver a corporate presentation at the 2007 UBS Global Life Sciences Conference at 2 p.m. Eastern on Thursday, September 27th at the Grand Hyatt Hotel in New York. The presentation will be made available by webcast and can be accessed on the Investor Relations page of the Medicure website at www.medicure.com.

[cristrader]

Antwort auf Beitrag Nr.: 31.728.580 von solarblase am 24.09.07 20:12:45

Hallo solarblase und brombeeren!

Habe momentan nur ganz wenig Zeit. Bin immer noch voll investiert und warte auf bessere Zeiten

Nur ganz kurz:

Die Entwicklung von Medicure gefällt mir zurzeit überhaupt nicht. Die Kapitalerhöhung zu solch ungünstigen Bedingungen und insbesondere der Deal mit Elliott Associates machen mich fast sprachlos. Das Management agiert als ob es kurz vor der Pleite steht, als ob die MC-1 Cabg Phase III zum Scheitern verurteilt ist und als ob diese Finanzierung der letzte Strohhalm ist um das Unternehmen zu retten. Der Kurs hat natürlich entsprechend reagiert. Kann natürlich auch sein das dieses Kursdisaster vom Management gewünscht wird um sich nochmal richtig günstig mit Optionen zuzuschütten (Optionsprogram steht bei der AGM im Oktober zur Abstimmung).

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 31.740.646 von cristrader am 25.09.07 19:02:51

Hallo Cristrader
Schön mal wieder von Dir zu hören. Kann Dir nur voll und danz zustimmen.

Gruß Solarblase

[brombeeren]

Antwort auf Beitrag Nr.: 31.740.646 von cristrader am 25.09.07 19:02:51

Hallo zusammen,
na, wenn wenig Zeit da ist, kann man die allerdings auch tatsächlich besser verbringen als sich die gegenwärtige Kursentwicklung hier anzuschauen. Zeitpunkt und Bedingungen der KE usw. sind wirklich nicht nachvollziehbar. Ich glaube aber auch nicht das der Grund im Optionsprogramm liegt. Die Grenze zum seriösen Management wäre damit weit unterschritten.

Zumindestens scheinen die Personalentscheidungen positiv.
Medicure Announces Appointment of Vice President of Marketing
WINNIPEG, MANITOBA, Sep 27, 2007 (MARKET WIRE via COMTEX News Network) -- Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular focused biopharmaceutical company, today announced that Brian Best has been named the Company's Vice President, Marketing. Mr. Best has 16 years of pharmaceutical industry experience including six years with Millennium Pharmaceuticals Inc. and Cor Therapeutics Inc. where he held senior positions including Director of Medical Affairs and Director of Marketing, Cardiovascular.
Most recently, Mr. Best held a senior business development position with PDL BioPharma Inc., and led the development of its Ularitide Program.

"Mr. Best's cardiovascular marketing experience will be invaluable to Medicure as we focus on stabilizing and increasing AGGRASTAT(R)'s market share, and building awareness for our lead cardioprotective product MC-1," stated Medicure's President and CEO, Albert D. Friesen, PhD.

Mr. Best's distinguished pharmaceutical career also includes several years of experience as a Consultant for the American College of Cardiology, where he facilitated strategic research planning for national registry programs including the multi-sponsored CRUSADE registry. Additionally, Mr. Best has served as Senior Director, Clinical Affairs for Arginox Pharmaceuticals Inc.

As Millennium's Director of Marketing, Cardiovascular, Mr. Best was responsible for the management of the INTEGRILIN(R) brand. INTEGRILIN(R) is a GP IIb/IIIa inhibitor that competes against AGGRASTAT(R).

Mr. Best will be replacing Moray Merchant who has resigned as the Company's Vice President, Market and Business Development to pursue other interests. "We thank Moray for his dedicated service, and wish him well in his future endeavors," stated Dr. Friesen

Gruß

Brom

[solarblase]

Na hoffen wir mal auf das nächste Quartal. Hoffe doch das dann Instis einsteigen.
Sind eben Forscher unsere Doc´s und keine Finanzmarktprofis. Sollten wir wirklich erst bis zur möglichen Zulassung warten müssen das der Kurs steigt. Hatte mir das Szenario etwas anders vorgestellt

Gruß Solarblase

[solarblase]

Just what the doctor ordered?
Medicure could benefit from smaller Winnipeg biotech firm

Wed Oct 3 2007

By Martin Cash



MARC GALLANT / Winnipeg free press
Medicure CEO Bert Friesen says Canadian biotech sector ‘is hurting’.


WINNIPEG biotechnology company Medicure Inc. might get some help from an unlikely source -- positive clinical trial results from a much smaller Winnipeg firm -- to boost its disappointing stock price.
Medicure, whose annual general meeting was held Tuesday in Winnipeg, expects positive results this spring from a massive, 3,000 patient Phase 3 clinical trial of its lead compound, MC-1. But the company's shares still languish around the $1 mark.

The MC-1 trial is to gauge its ability to prevent heart damage to patients undergoing coronary artery by-pass surgery.

However, strong results from a much smaller clinical trial by another Winnipeg company, DiaMedica Inc., on a potential novel treatment of diabetes and more good news from Montreal biotech company Theratechnologies on an HIV-related treatment boosted the stock price of both those companies this week.

According to Claude Camire, a biotech analyst with Paradigm Capital in Toronto, it might be just what Medicure needs.

"It is not Medicure, per se," Camire said, referring to Medicure's lagging stock price. "It is the sector in general in Canada. We need to get to see more positive news."
He said the Canadian biotech industry has been beset by bad news this year with Biovail Corp., Labopharm Inc., and Cipher Pharmaceuticals Inc. experiencing delays in new drug approvals. Failures of drugs in late stage trials by Conjuchem Biotechnologies Inc. and Neurochem Inc. have also hurt the industry.

One other analyst, who asked that his name not be used, said investors may still be cautious of Medicure because there have been failures of other drugs that have addressed the same indication that MC-1 targets.

Bert Friesen, CEO and co-founder of the 10-year-old company, agreed the company's poor stock price is unrelated to good performance of clinical trials or the drug's potential.

"The Canadian biotech sector is hurting," Friesen said Tuesday. "There has also been a number of Phase 3 clinical failures in cardiovascular over the past two or three years. Although our results are very positive and doing a 3,000-patient study is very positive and the potential is very large, there is a little bit of hesitation because of past failures."

However, with results of the Phase 3 trial expected by the end of the first quarter of 2008, many believe the market response should start corresponding with the potential.

Camire said that since the current trial is similar to a 900-patient, Phase 2 trial that yielded strong results, those familiar with the trial expect good results.

"The likelihood of positive results is extremely high," he said.

Camire and another analyst have 12-month target prices of $3, and both suggest they are being conservative. If the trial results meet expectations, application for approval with the U.S. Food and Drug Administration will probably be filed about two months later and the FDA could render its decision by the end of 2008.

One analyst said MC-1 could generate up to $750 million in annual sales after about eight years.

On Tuesday Medicure's shares closed unchanged at $1.10.

[e-mail]

[solarblase]

Da wartet man mal auf einen positiven Analystenkommentar und nun das:

RBC CAPITAL MARKETS EQUITY RESEARCH
Price Target Revision | COMMENT
October 3, 2007
Medicure Inc.
TSX:MPH; AMEX: MCU
Sector Perform
Speculative Risk

Lowering target to $1.25; high risk ahead.

Priced as of prior trading day's market close, EST (unless otherwise stated).
For required disclosures, please see Required Disclosures section at the end
of this comment.

[brombeeren]

Antwort auf Beitrag Nr.: 31.846.624 von solarblase am 04.10.07 19:38:41

Guten Tag,
das ist gegenwärtig für mich nicht zu erklären und schaut auch alles andere als gut aus. Die Risikoeinschätzung der Phase III scheint sich bei RBC geändert zu haben ? Sollte also die Art und Bedingungen der Finanzierung doch bereits etwas vorweggenommen haben ?

Gruß Brom

[solarblase]

Auf jeden Fall ist das Kursziel ein Witz. Wenn MC-1 zugelassen wird vervielfacht sich der Kurs. Wenn nicht sind wir beim Cash.

[brombeeren]

Antwort auf Beitrag Nr.: 31.858.440 von solarblase am 05.10.07 17:09:34

Tag zusammen,
WE, so dass ich die Zeit gefunden habe, die Analyse von Frau Phillipa Flint, RBS, in Ruhe zu lesen. Ob am Montag die 1 $- dollar Marke hält, ist danach fraglich. Noch im Januar 07 hatte sie als Kursziel 2,35 $ angegeben

Zusammengefaßt:
- MC1 Mend Cab Zulassungswahrscheinlichkeit von unter 50 % wegen nicht sinnvoller Phase II Daten (!!)
- Unfähigkeit zur Partnerschaft
- Finanzierung mit Elliot stark nachteilhaft für MCU
- Zweifel ob MCU die vereinbarten Mindestumsätze Aggra schafft
- schlechte Aggra-Zahlen
- die vergangenheit habe gezeigt, dass ein kleines Unternehmen mit einzelprodukt fast immer an der Zulassung scheitere (aha)

Mag teilweise richtig sein, was mich aber wirklich erbost, ist die Stellungnahme zu den Phase 2 Daten. Die lagen nun lange auf dem Tisch und jetzt kommt die Dame mit dieser Einschätzung zu diesem Zeitpunkt. Die Zulassungsrallye ist erstmal gelaufen. Was für ein taktisches Kalkül dahinter steckt, ist mir nicht klar. Im stockhouse board wird der übliche verschwörungssch.. vermutet, also die kleinen rausschütteln, feindliche Übernahme, da will jemand billig rein usw. Ich persönlich glaube, die Analysten haben einfach alle die Nase voll von der Unternehmenspolitik des Herrn Friesen.

Die entscheidene Frage ist jedoch: Was ist dran an der Kritik der Phase 2 Daten, wobei die Analystin nur mit "nicht sinnvollen Phase 2 Daten" orakelt. Folgende Kritik an den Phase 2 Daten ist an verschiedenen Stellen zu lesen:

-es gäbe grundsätzliche schwierigkeiten eine leichte myokardiale Infarktbildung (event) korrekt festzustellen (vor allem bei CK-MB 50ng/m test)dies könne die ergebnisse erheblich verfälschen.
-bei ck-MB 50 sei in Phase II der primäre Endpunkt bereits verfehlt worden (richtig?)
- es sei teilweise widersprüchlich gewesen, dass höhere Dosierungen statistisch schlechtere Ergebnisse zeitigten
-hochgerechnet auf 3000 Patienten bestehe eine große Möglichkeit, dass der 90 Patienten Unterschied beim CK-MB 50 Test verfehlt werde und Phase III bereits damit scheitere (RICHTIG?)
Übertragen aus aus Phase 2 wären die ergebnisse:

16 % Fallrate in Placebo-Arm bei 1500 Patieten macht 245 events
10,6 % Fallrate in MC1-Arm bei 1500 Patienten macht 155 events

So dass mindestens 90 events weniger bestätigt werden müssen ?! (Richtig?)

Jetzt hoffen wir, dass sich keine weiteren Analysten anschließen und die 1 Dollar Unterstützungslinie hält.

Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.884.284 von brombeeren am 07.10.07 13:48:53

Auf jeden Fall sind Sie viel unterwegs:

Press Release Source: Medicure Inc.


Medicure to Present at BIO Investor Forum
Monday October 8, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Oct 8, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today announced its President and CEO, Albert D. Friesen, PhD, will deliver a corporate presentation at the 4th Annual BIO Investor Forum at 4:15 p.m. Pacific on Wednesday, October 10th at the Palace Hotel in San Francisco. The presentation will be made available by webcast and can be accessed on the Investor Relations page of the Medicure website at www.medicure.com.
ADVERTISEMENT


About Medicure Inc.

[brombeeren]

Antwort auf Beitrag Nr.: 31.900.353 von solarblase am 08.10.07 16:39:49

Tag,
nun ja, viel mehr als trockener Humor bleibt einem auch gegenwärtig nicht. Zumindestens haben sich die amis bisher nicht dauerhaft unter 1 Dollar getraut. Jemand noch Einschätzungen zu der Kritik an den Phase II Daten parat ? Friesen hat verkündet, die Phase III Auswertung sei mit sicherheit nicht vor Febr. 2008 da.

Gruß Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.910.640 von brombeeren am 09.10.07 14:42:20

Einie Kritiken unterschreibe ich: Aggra, Partnerschaft, Finanzierungen.
Aber die Kritik zu den MC 1 Daten verstehe ich nicht. Warum sollen jetzt plötzlich die Daten der Phase 2 nicht sinnvoll sein. Schaut sich das die FDA nicht an. Hmmm

[solarblase]

Immer noch kein Boden erreicht

[brombeeren]

Antwort auf Beitrag Nr.: 31.943.410 von solarblase am 11.10.07 18:18:06

Mmmh..gegenwärtig haben die amis und kanadier zwischen 7 und 10 % des Wertes runter gehandelt. Muss eine news sein, die in die RBC Kerbe haut??? Habe noch nichts.Sieht jemand was ? RBC Analyse hat ja bereits fast 15 % gekostet... Wir werden verprügelt zu einem Zeitpunkt, wo es langsam bullish werden sollte.

Genervte GRüße

Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.944.635 von brombeeren am 11.10.07 19:22:04

Finde auch nichts. Einzig positive ist noch das die Handelsumsätze nicht sehr hoch sind. MK von Medicure jetzt 110 mio $. Wenn man sich da andere Firmen mit fortgeschrittener Phase 3 anschaut.

[brombeeren]

Antwort auf Beitrag Nr.: 31.944.994 von solarblase am 11.10.07 19:38:47

Moin,
auch keine neuen Nachrichten im stockhouse board (nur eine, nicht verifizierte Meinung, ein insti verkaufe, was aber an den Umsätzen nicht unbedingt nachvollziebar ist) Vor allem hat keiner der anderen Analysten mit kritischen Äußerungen nachgezogen. Immerhin sind neun weitere unter coverage auf der mcusite zu finden. Der erneute Rutsch scheint also "nur" auf der Flint/RBS Nachricht zu beruhen. Die stockhousler meinen aus interviews heraus zu lesen, dass das management nicht mehr inhaltlich auf die RBS Kritik reagieren wird. 90 canadische Cent wird jetzt aber halten
Mein Güte, wir haben jetzt Kurse wie Mitte 2005 mit Phase III Ergebnissen in vier Monaten!! Wenn es zur Zulassung von MC1 kommt (was ich bedeutend krtischer sehe!) ist das ein Superschnapp hier.

Grüße Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.952.671 von brombeeren am 12.10.07 11:49:00

Na kommt Heute mal die Wende. Schaut euch mal die TSX-Umsätze an.

[solarblase]

Jetzt auch US

[brombeeren]

Antwort auf Beitrag Nr.: 31.960.417 von solarblase am 12.10.07 18:18:22

Na, hier macht man was mit. in Canada jetzt 967500 shares gehandelt, gegenwärtig 11 % im Plus: 1 Dollar.

Im Vergleich Handel seit Ende August:
Price History for Symbol: MPH-T
Last: 1.000 Last Trade: Oct 12, 2007 13:05 EST
Date Close High Low Volume
Oct 11 0.900 0.960 0.880 153,380
Oct 10 0.960 1.000 0.950 206,201
Oct 09 0.980 1.000 0.960 132,975
Oct 08 1.000 1.000 1.000 0
Oct 05 1.000 1.040 1.000 280,569
Oct 04 1.050 1.100 1.040 181,430
Oct 03 1.100 1.150 1.100 103,100
Oct 02 1.100 1.160 1.090 116,050
Oct 01 1.100 1.140 1.100 141,351
Sep 28 1.120 1.140 1.100 151,200
Sep 27 1.130 1.170 1.120 91,907
Sep 26 1.150 1.160 1.130 41,750
Sep 25 1.140 1.150 1.120 80,350
Sep 24 1.130 1.210 1.130 147,850
Sep 21 1.110 1.150 1.090 371,163
Sep 20 1.100 1.150 1.070 299,518
Sep 19 1.100 1.140 1.060 118,622
Sep 18 1.090 1.160 1.070 227,676
Sep 17 1.160 1.180 1.100 211,160
Sep 14 1.160 1.200 1.160 108,330
Sep 13 1.160 1.220 1.150 116,450
Sep 12 1.180 1.210 1.160 76,300
Sep 11 1.160 1.190 1.150 43,616
Sep 10 1.180 1.210 1.160 74,700
Sep 07 1.210 1.230 1.150 160,060
Sep 06 1.230 1.260 1.200 117,890
Sep 05 1.240 1.260 1.220 66,310
Sep 04 1.220 1.320 1.220 75,300
Sep 03 1.270 1.270 1.270 0
Aug 31 1.270 1.270 1.250 12,780

News ?

Gruss Brom

[solarblase]

Antwort auf Beitrag Nr.: 31.961.427 von brombeeren am 12.10.07 19:27:54

Eigentlich brauchen wir keine news für einen solchen Anstieg auf dem aktuellen Niveau. Ist durch die RBC ganz schön runtergeprügelt worden.

[solarblase]

Medicure to Report First Quarter Fiscal 2008 Financial Results
WINNIPEG,
MANITOBA, Oct 12, 2007 (MARKET WIRE via COMTEX News Network) --
Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular focused
biopharmaceutical company, today announced that the Company will
report first quarter fiscal 2008 financial results on Monday, October
15, 2007 after market close. A conference call and audio webcast will
be conducted Tuesday, October 16, 2007 at 8:30 AM Eastern Time,
during which management will discuss first quarter results.

[brombeeren]

Antwort auf Beitrag Nr.: 31.965.535 von solarblase am 13.10.07 08:45:58

Hallo solar,
wir scheinen die letzten Mohikaner zu sein. Du wirst mir sicher zustimmen, dass cristraders stets fundierte Meinung fehlt, gerade wo es jetzt sehr spannend und interessant wird:

Oct 12/07 Oct 11/07 Hoie, Lars Henrik Direct Ownership Warrants 16 - Acquisition under a prospectus exemption 3,913,043
Oct 12/07 Oct 11/07 Hoie, Lars Henrik Direct Ownership Common Shares 16 - Acquisition under a prospectus exemption 13,043,478 $1.150 USD
Oct 12/07 Oct 11/07 Hoie, Lars Henrik Direct Ownership Warrants 00 - Opening Balance-Initial SEDI Report
Oct 12/07 Oct 11/07 Hoie, Lars Henrik Direct Ownership Common Shares 00 - Opening Balance-Initial SEDI Report

Dr. Lars Hendrik Hoie
...
Dr. Høie has more than 15 years experience in research and clinical practice of medicine. Dr. Høie is published internationally and has submitted a Ph.D. thesis on the treatment of obesity with low calorie diets. He entered formal commercial agreements with Nycomed Pharma AS in 1989. In 1993 Dr. Høie founded Nutri Pharma, where he is Senior Advisor Medical and Scientific Affairs. Dr. Høie is the inventor of the various products and composition patents owned by Nutri Pharma and is a major shareholder of the company.

Da haben wir wohl den Grund.Sieht doch ganz gut aus.
Ich vermute allerdings, die Zahlen Montag werden wieder nicht zu überzeugen wissen. Trotz der neuen Vertriebsleute ist die Zeit einfach zu kurz. Sollten wir jedoch wider Erwarten sehr gute Aggra Zahlen erleben, wird es nochmal tiefgrün.

Gruß brom

[solarblase]

Antwort auf Beitrag Nr.: 31.967.665 von brombeeren am 13.10.07 14:14:10

Hallo Brom
Hoffe auch das Cristrader bald mal wieder Zeit hat hier zu posten.
Sieht heute ja auch sehr gut aus. Wollen mal auf heute Abend hoffen. Nicht das Morgen alles wieder vorbei ist. Denke auch das es für Aggrastat noch etwas Zeit braucht.

Gruß Solar

[brombeeren]

Antwort auf Beitrag Nr.: 32.002.089 von solarblase am 15.10.07 16:43:27

Tag zusammen,
morgen vielleicht einige Prozent Rücksetzer. Wenn gleich hier deutlich wird, dass die Einschätzungen zur Phase III hier offensichtlich verschieden sind:

Dr.Hoie hat zu 1.15 ja fast die gesamte KE "gekauft". Damit dürfte er ja an die 10 Prozent Aktienkapital herankommen. Das ist eine Überzeugungstat oder ein großer Zock !

Anderseits hat RBC am Tag mit Handelsvolumen von über 1.000,000 alleine 500.000 ! (eigene?) shares zu Tiefstkursen abgegeben. Auch dort scheint eine Überzeugung vom Scheitern der Phase III vorhanden zu sein. Also nichts mit Rausschütteln, Einstiegskurse produzieren ect...

Auf jeden Fall nimmt das Hoie-Investment für mich die RBC -Unsicherheit raus... .

Oder sieht das jemand anders ?

Gruss

Brom

[solarblase]

Antwort auf Beitrag Nr.: 32.003.280 von brombeeren am 15.10.07 17:28:39

Das die RBC eigene Aktien abgegeben hat kann ich mir so kurz nach dem Rating nicht vorstellen. Dann hätten Sie vorher verkauft. Sieht natürlich auch etwas unschön aus wenn man verkauft und danach die Firma runterstuft. Weiß jetzt nicht welche Wartezeiten es gibt wegen Insiderhandel.

[brombeeren]

Antwort auf Beitrag Nr.: 32.007.512 von solarblase am 15.10.07 19:59:43

Mmmmh, jetzt haben wir über 1.000.000 shares auf dem US markt, während die Kanadier hingegen wieder normalen Umsatz haben. Wenn das nicht auch überwiegend RBC mit eigenen Aktien ist, wer verkauft dann solche Mengen ? Solar, ich hoffe nicht du !

[solarblase]

Antwort auf Beitrag Nr.: 32.009.311 von brombeeren am 15.10.07 21:04:06

Hab letzte Woche erst ne mio verkauft. Halte mich diese Woche etwas zurück

[cristrader]

Hallo!

Leider haben wir in den letzten Wochen wieder erleiden müssen das Friesen und seine Führungscrew mit der Leitung einer AG völlig überfordert ist. Den Institutionellen ist dies natürlich nicht verborgen geblieben und nutzen dies natürlich gnadenlos aus. Wie alleine Elliott Associates das Management um MCU über den Tisch gezogen hat habe ich bisher nur bei akuten Pleitekandidaten annähernd gesehen. Friesen ist es bisher auf jeden Fall bestens gelugen jeden aufkommenden Zulassungshype frühzeitig im Keim zu ersticken. Ich bin echt tierisch angefressen was in letzter Zeit gelaufen ist.

Es wird jetzt Zeit das im Vorfeld der Phase III-Ergebnisse eine positive, zuversichtliche Stimmung verbreitet wird. Vielleicht geling das ja bei den Quartalszahlen.

Der RBC Downgrade insbesondere der Zeitpunkt und die zu Teilen die Begründung sind natürlich mehr als fragwürdig. Hat Friesen mal wieder einen Insti vergrault?

Das momentan hohe Volumen sehe ich auf jeden Fall positiv. Bin mal gespannt auf die Entwicklung der Short-Positionen vermute mal das die sprunghaft angestiegen sind.


Grüße cristrader

[cristrader]

Aggrastat Zahlen ein Desaster!

http://media.corporate-ir.net/media_files/irol/10/108925/Med…

[brombeeren]

Antwort auf Beitrag Nr.: 32.012.792 von cristrader am 15.10.07 23:22:56

Hallo cristrader,
schön mal wieder von dir zu hören. Ich meine, die schlechten Aggra-Zahlen sind zum großen Teil bereits eingepreist, so dass wir heute nicht allzu viel verlieren. Bitter sind die entwicklungen allemal.

Nachtrag zum Hoie investment:

Lars Hoie - Announcement - Acquisition of Shares of Medicure Inc.
TORONTO, Oct. 15 /CNW/ - Dr. Lars Hoie ("Dr. Hoie") announces he has
recently acquired beneficial ownership of 13,043,478 units ("Units") issued by
Medicure Inc. ("Medicure"). The Units were issued at a purchase price of
US$1.15 per Unit. Each Unit consists of a common share of Medicure (a "Common
Share") and 0.30 of a common share purchase warrant (each whole warrant, a
"Warrant"). Each Warrant entitles the holder thereof to acquire one Common
Share at a price of US$1.50 for a period of 5 years from the date of issuance.
The Common Share were acquired pursuant to a private placement completed by
Medicure.
Immediately after the transaction, Dr. Hoie owned directly or indirectly
17,994,030 Common Shares, representing 13.8% of the issued and outstanding
Common Shares. In addition, Dr. Hoie owned 4,674,573 Warrants. If all of these
Warrants were exercised, Dr. Hoie would own an aggregate of 22,668,603 Common
Shares, representing approximately 16.8% of the then issued and outstanding
Common Shares (assuming no other Warrants were exercised). Subsequently, Dr.
Hoie purchased 2,024,200 common shares of Medicure on the TSX.
Dr. Hoie purchased the securities for investment purposes. Dr. Hoie
reserves the right to acquire further securities of Medicure depending on
market conditions and other relevant factors.

Gruß Brom

[solarblase]

Hab ja keine besonders guten Agg-Zahlen erwartet. Aber so etwas
Dafür hält sich der Kurs jetzt aber gut. Dachte wir finden uns heute bei 0,90 $ wieder.

[solarblase]

Kurs bewegt sich nicht mehr. Umsatz ist auch wieder gering. Denke das wir jetzt bis Jahresende eine Handelsspanne von 1 bis 1,20 $ haben werden. Außer ein Analyst meldet sich. Höhere Kurse dann erst im neuen Jahr. Was meint Ihr?

Gruß Solar

[solarblase]

Antwort auf Beitrag Nr.: 32.031.434 von solarblase am 16.10.07 20:01:12

Nun doch noch Verkaufsdruck in der letzten Stunde. Hatte das eigentlich von Handelsbeginn an erwartet. So schnell ändert sich das Blatt.

[solarblase]

Medicure Inc. (MPH) As of October 17th, 2007
Filing Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Oct 16/07 Oct 15/07 Hoie, Lars Henrik Direct Ownership Common Shares 10 - Acquisition in the public market 1,200,000 $1.050 USD
Oct 16/07 Oct 12/07 Hoie, Lars Henrik Direct Ownership Common Shares 10 - Acquisition in the public market 614,200 $0.950 USD
Oct 16/07 Oct 12/07 Hoie, Lars Henrik Direct Ownership Common Shares 10 - Acquisition in the public market 210,000 $0.940 USD

[solarblase]

Oct 22/07 Oct 19/07 Friesen, Albert David Direct Ownership Common Shares 10 - Acquisition in the public market 17,000 $0.940
Oct 22/07 Oct 22/07 Gluchowski, Charles Direct Ownership Common Shares 10 - Acquisition in the public market 4,000 $0.950 USD
Oct 22/07 Jul 12/06 Gluchowski, Charles Direct Ownership Common Shares 00 - Opening Balance-Initial SEDI Report
Oct 22/07 Oct 22/07 Best, Brian Richard Direct Ownership Common Shares 10 - Acquisition in the public market 1,000 $0.950 USD
Oct 22/07 Sep 27/07 Best, Brian Richard Direct Ownership Common Shares 00 - Opening Balance-Initial SEDI Report

Wahnsinnssumme Aber besser als verkäufe

[brombeeren]

Antwort auf Beitrag Nr.: 32.121.856 von solarblase am 23.10.07 16:19:10

Moin solar,
immerhin...aber wirklich vertrauensbildende Insiderkäufe sehen anders aus
Aber vielleicht auch der Beginn von umfangreicheren Käufen....warten wir es ab...


Grüße

Brom

[brombeeren]

Antwort auf Beitrag Nr.: 32.124.852 von brombeeren am 23.10.07 19:35:28

Oct 23/07 Oct 18/07 Best, Brian Richard Direct Ownership Options 50 - Grant of options 225,000
Oct 23/07 Sep 27/07 Best, Brian Richard Direct Ownership Options 00 - Opening Balance-Initial SEDI Report
Oct 23/07 Oct 19/07 Reimer, Derek George Indirect Ownership Common Shares 10 - Acquisition in the public market 5,000 $0.930

Gruß,

Brom

[solarblase]

Hoher Umsatz an der AMEX. Mal sehen ob weitere Insiderkäufe gemeldet werden.

[solarblase]

Medicure Inc. (MPH) As of October 24th, 2007
Filing Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Oct 24/07 Oct 18/07 Kapoor, Kishore Direct Ownership Options 50 - Grant of options 50,000
Oct 24/07 Oct 19/07 Reimer, Derek George Control or Direction Common Shares 10 - Acquisition in the public market 5,000 $0.930

[solarblase]

Medicure Inc. (MPH) As of November 1st, 2007
Filing Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Nov 01/07 Oct 19/07 Friesen, Albert David Direct Ownership Common Shares 10 - Acquisition in the public market 5,500 $0.920
Nov 01/07 Oct 19/07 Friesen, Albert David Direct Ownership Common Shares 10 - Acquisition in the public market 10,000 $0.940

[brombeeren]

Antwort auf Beitrag Nr.: 32.257.724 von solarblase am 02.11.07 16:17:54

Tag zusammen,

kurzzeitig 0,88 canadische Dollar...so richtig glauben kann ich das alles nicht.. Kurse von 2005...

Gruß Brom

[solarblase]

Antwort auf Beitrag Nr.: 32.431.368 von brombeeren am 14.11.07 22:52:10

Mir fällt dazu auch nichts mehr ein.

Gruß Solar

[cristrader]

Antwort auf Beitrag Nr.: 32.439.965 von solarblase am 15.11.07 16:28:52

Hallo!

Es scheint so als ob die im Vorfeld der Phase-III zu erwartende Rally ausfällt! Die letzten Maßnahmen des (Mis-)Managements haben einfach zuviel Misstrauen gestreut.

Grüße cristrader

[solarblase]

Lasst uns mal wetten wie groß die nächste Order in Kanada ist. 500 Stück vielleicht So etwas habe ich selten gesehen. Hoffe Genuity ist mit dem verkauf bald fertig.

Gruß Solar

[brombeeren]

Antwort auf Beitrag Nr.: 32.458.481 von solarblase am 16.11.07 20:42:38

Hallo, natürlich drückt das den Kurs, wobei genuity die Wochen und Tage vorher noch eingesammelt hatten. Im stockhouse wird über diese Aktion auch nur gerätselt... nun ja, mittlerweile kann einen ja nicht mehr viel schocken

Gruß

Brom

[solarblase]

http://www.clinicaltrials.gov/ct/show/NCT00402506?order=1

This study has been completed.

ClinicalTrials.gov processed this record on November 16, 2007

[brombeeren]

Antwort auf Beitrag Nr.: 32.465.073 von solarblase am 17.11.07 20:58:13

Tag zusammen,
gut im Zeitplan, d.h. ja wohl im Ergebnis, dass die relevanten Daten vorliegen bzw. die Behandlung der Probanden abgeschlossen ist. Ab jetzt wird das Management in der Auswertung wohl klüger werden, wohin die Reise geht. Hinsichtlich roher, alters- und fallspezifischer Mortalitätsrate in den vergleichsarmen wird wahrscheinlich bald ein erster Schluss gezogen werden können. Hätte eigentlich mal ne Nachricht auf der Homepage wert sein können. Ansonsten muss cristrader energisch widersprochen werdenie Rallye fällt nicht aus, sie fährt nur in die falsche Richtung.

Gruß
Brom

[solarblase]

0,78 $ Tagestief in USA Aber trifft zur Zeit den ganzen Sektor. Wir brauchen so langsam mal eine positive Nachricht. Chart Juli bis jetzt ist wirklich bitter.

Gruß
Ein frustrierter

[cristrader]

Antwort auf Beitrag Nr.: 32.514.742 von solarblase am 21.11.07 18:39:03

Hallo!

Ja, so langsam wird es ziemlich bitter

Hoffentlich kommt es endlich mal zu einer Trendwende. Wirkliche News bis zu den Phase III-Ergebnissen bzw. zu den nächsten Quartalszahlen sehe ich leider keine.

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 32.515.287 von cristrader am 21.11.07 19:08:51

Hallo zusammen,

ein bitterer Kursverlauf ist schwer vorstellbar. Neben dem vertrauensvernichtenden Management -deals als ob MC1 bereits gescheitert wäre- hat sich der Kursverlauf vom dubiosen RBC downgrade nicht erholt. Eine paradoxe Situation ein paar Monate vor den entscheidenden Ergebnissen: Vertrauen ist völlig raus aus dem Wert und Mitteilungen die Kaufsignale aussenden, sind in den verbleibenden Monaten auch nicht ersichtlich.Was für läppische insiderkäufe! Es wird sich zudem hier wohl kaum einer was von den Qartalszahlen erhoffen. Dabei hat sich an den Zulassungschancen von MC1 substantiell für mich wesentlich doch nichts geändert.
Zu diesen Kursen steht MCU bestimmt auf so mancher watchlist, so dass kräftige Kurskorrekturen bei Kaufsignalen/Nachrichten nach oben durchaus drin sind. Leider wird ein Zug wohl abgefahren sein: Die Möglichkeit zur Risikominimierung durch Teilverkäufe zu wirklich ansprechenden Kursen kurz vor den Ergebnissen.

nicht minder frustriert,
Brom

[cristrader]

Antwort auf Beitrag Nr.: 32.540.961 von brombeeren am 23.11.07 16:46:56

Hallo Brom!

Treffender kann man die Situation kaum beschreiben! Insbesondere der Punkt der Risikominimierung liegt mir schwer im Magen! Aber bis zu den Ergebnissen sind noch etwa 2 Monate Zeit, vielleicht gibt es ja mal einen Trendwechsel. Ehrlich gesagt hoffe ich aber momentan nur noch einigermaßen Heil aus diesem Wert rauszukommen.

Grüße cristrader

[KnigRollo]

Antwort auf Beitrag Nr.: 32.544.223 von cristrader am 23.11.07 20:32:23

mensch cristrader... hoffnung aufgegeben ?? das klang ja mal ganz anders...

[solarblase]

Antwort auf Beitrag Nr.: 32.544.223 von cristrader am 23.11.07 20:32:23

Hallo Cristrader
Ist ja kein gutes Zeichen wenn auch Du jetzt so pessimistisch bist. Habe aber noch Hoffnung das bsich bis Jahresnede der Kurs noch erholt. Wir haben bei den Verlusten keine besonders hohen Umsätze. Vielleicht stützt einer der großen Anteilseigner jetzt mal den Kurs.

Gruß Solarblase

[brombeeren]

Antwort auf Beitrag Nr.: 32.547.319 von solarblase am 24.11.07 10:44:06

Hallo,
na ja, selbst wenn wir bestenfalls Zulassungsphantasien noch mit 30-40 Prozent einpreisen, so wird das bei dem jetzigen Ausgangskurs für mich ein blaues auge bedeuten. Nur 30 %, wo sollen die herkommen? Vertrauensverlust gibt sich nicht von alleine.Für mich das Schlimmste: das Management wirkt, als habe es selbst kein Vertrauen in die Zulassung.Es bleibt zu hoffen, dass es bessere pharmakologen sind, als manager. Der ganze Wert ist so unberechenbar gelaufen, dass eine Zulassung von MC1 nur folgerichtig wäre. Ich rechne noch nicht in zwei Monaten mit den Ergebnissen, sondern Anfang März. Ihr nicht ?

Gruß
brom

[brombeeren]

Antwort auf Beitrag Nr.: 32.549.246 von brombeeren am 24.11.07 17:06:01

Mittlerweile bin ich völlig sprachlos. Das Ding gibt wieder 9 % ab. So schnell könnte ich das Geld nicht ausgeben. Quartalszahlen am 30 nov...? Ist das der Vorgeschmack?

[solarblase]

Antwort auf Beitrag Nr.: 32.586.615 von brombeeren am 27.11.07 19:44:25

Ich kann es auch nicht mehr glauben. Zu keinem Kurs setzen käufe ein. Auf Agg brauchen wir wohl nicht hoffen. Welche Nachricht soll den Kurs stützen. Das Vertrauen ist völlig weg. Vielleicht ein Prtner bei den anderen Projekten. Glaube ich aber auch nicht wirklich dran. Vielleicht mal eine positive Analystenmeinung.

[solarblase]

0,64 $
Zieht mal cash von der MK ab. Die Pipeline ist bald nichts mehr Wert.

[brombeeren]

Antwort auf Beitrag Nr.: 32.663.555 von solarblase am 04.12.07 19:34:03

Hallo solar,
im stockhouse halten Sie einen Fall auf 0,50 $ Dollar für möglich. Und das vor Bekanntgabe der Ergebnisse ! Dann wären wir ca. beim Cash.

Gruß Brom

[solarblase]

Press Release Source: Medicure Inc.


Medicure Announces Appointment to Board of Directors
Wednesday December 5, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Dec 5, 2007 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular drug discovery and development company, today announced that David Banks has joined its Board of Directors. Mr. Banks brings to the Board more than 35 years of international investment banking and private equity investing experience.
ADVERTISEMENT


"Mr. Banks possesses extensive investment banking knowledge that will be invaluable as we build greater shareholder value," stated Medicure's President and CEO, Albert D. Friesen, PhD. "Mr. Banks has forged an outstanding reputation as a business leader and advisor, and Medicure will benefit greatly from his strategic insight and capital market experience."

"I am pleased to be working with the Company at such an exciting time in its history," stated David Banks. "Medicure has an innovative cardiovascular product portfolio, with significant market opportunities. I look forward to utilizing my experiences and knowledge to further the Company's success."

About David Banks

Mr. Banks is presently a Principal of Carlyle Banks & Company Inc., a Toronto-based investment banking firm. Mr. Banks also brings to the Board nearly 20 years of experience at The Chase Manhattan Bank where he held various roles including Senior Vice President. The Chase Manhattan Bank, now known as JPMorgan Chase, is a leading global financial services firm with assets of $1.5 trillion.

Additionally, Mr. Banks has served as AT&T Capital Corporation's Chief Executive Officer. AT&T Capital was the fifth largest leasing company in the world, operating in 26 countries.

Prior to his current role at Carlyle Banks & Company, Mr. Banks held the position of Vice Chairman of Lawrence & Company Inc., a Toronto-based global asset management firm with interests and investments in various sectors in Canada and throughout the world.

Mr. Banks' appointment to Medicure's Board of Directors is subject to regulatory approval.

Medicure's Board now consists of:

- Albert D. Friesen, PhD (Chairman), President & CEO, Medicure Inc.

- David Banks, JD, Independent Corporate Director, Principal of Carlyle Banks & Company Inc.

- Kishore Kapoor, CA, (Chair, Audit and Finance Committee), Independent Corporate Director, President, Wellington West Holdings Inc., Co-Founder of Assante Corporation

- Gerald McDole, MBA, Independent Corporate Director, Past President AstraZeneca Canada Inc.

- Arnold Naimark, MD, F.R.C.P. ©, F.R.S.C, (Chair, Executive Compensation, Nominating and Corporate Governance Committee), Independent Corporate Director, Director of the University of Manitoba Centre for the Advancement of Medicine, and Past President of the University of Manitoba

- Peter Quick, BE, Independent Corporate Director, Past President and CEO of Quick & Reilly, Inc. and former President of the American Stock Exchange

[solarblase]

Antwort auf Beitrag Nr.: 32.668.413 von brombeeren am 05.12.07 09:19:35

Hallo Brom
Eigentlich wollte ich getröstet werden und nichts über
Kursziele von 0,50 $ hören. Diese Kurszieldiskussionen sind ja alle ganz nett. Aber 1. kommt es anders und 2. als man ....
Man hat ja auch schon Kursziele von 15 $ gesehen und zur Zeit wäre man froh ohne Verluste rauszukommen. Mit Biotech habe ich bisher noch kein Glück gehabt.

Gruß Solar

P.S.
Wir sind aktuell im Plus. Kommt ja auch nicht oft vor

[cristrader]

Antwort auf Beitrag Nr.: 32.673.700 von solarblase am 05.12.07 16:32:21

Hallo!

Ich glaube wir haben endlich den Boden mit 0,61 US$ erreicht und werden in den nächsten Wochen wieder steigende Kurse erleben. Die Zittrigen sind sicher längst aus dem Wert ausgestiegen. Was mich zuversichtlich macht ist das alle Institutionellen ihre Positionen aufgestockt haben! http://www.thomsoninvestortools.com/component/firm/aol/view.…

Im Prinzip hat sich an der Story in den letzten Wochen auch nichts geändert. Entscheidend sind die Phase III-Ergebnisse sonst nichts. Bei Scheitern der Phase III ist MCU mausetot, da wird man froh sein mit 0,20 US$ aus dem Wert rauszukommen, bei Erfolg haben wir hier sicherlich einen Tenbagger, aber das ist seit langem bekannt.


Hier eine Analyse von gestern:
Dec 04, 2007 (Datamonitor via COMTEX) -- ALXN | charts | news | PowerRating -- Medicure\'s MC-1 is in Phase III development for prevention of reperfusion injury after coronary artery bypass graft surgery. Positive results in this trial are important not only to convince regulators of its value and to secure a partner with sales experience in cardiology, but also to facilitate a partnering agreement for an acute coronary syndrome trial, a much larger market opportunity.
The failure of Alexion Pharmaceuticals\' pexelizumab (a monoclonal antibody), which was designed to inhibit inflammation due to reperfusion injury, has cast doubt on MC-1. However, Medicure\'s MC-1 works earlier in the process, attempting to prevent reperfusion from occurring. Interviewed physicians are comfortable with MC-1\'s mechanism of action and Datamonitor believes that the Phase III MEND-CABG II trial is designed for success. If approved, the drug could potentially launch in Q3 2009.

However, Datamonitor expects MC-1 sales in coronary artery bypass graft (CABG) surgery to increase from $21 million in 2009 to $89 million in 2012 - below Wall Street estimates. This is because interviewed physicians had difficulty assessing where MC-1 would fit in their treatment paradigm. Based on physician feedback, Datamonitor believes that cardiothoracic surgeons will not change their standard practice easily. While positive results from a single Phase III trial are unlikely to increase physician interest in MC-1, an effective sales team (possibly via a co-promotion partner) could provide additional upside to these estimates.

Positive MEND-CABG II data should ease the concern surrounding MC-1 and open up potential partnering agreements for the MC-1 platform. Medicure will likely need help from a sophisticated sales team to increase MC-1 utilization upon launch. A partner with sales experience in cardiology would greatly help MC-1 utilization upon launch. In addition, a partnering agreement would likely expedite movement into a Phase III acute coronary syndrome (ACS) trial for MC-1, a much larger market opportunity than CABG surgery. Datamonitor believes that positive MEND-CABG II data will expedite the partnering process.

Medicure hopes to initiate a Phase III ACS trial soon after the MEND-CABG II data are released, in order to study the effects of MC-1 on reducing infarct size in patients diagnosed with ACS. In 2004, the American Heart Association estimates approximately 249,000 patients underwent coronary artery bypass graft (CABG) surgery, while there were approximately 1.6 million patients diagnosed with ACS.


http://www.datamonitor.com



Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 32.676.336 von cristrader am 05.12.07 19:46:12

Hallo cristrader,
dass die Institutionellen aufgestockt haben, ist erstmals seit dem hoie investment wieder eine gute Nachricht, die soetwas wie zuversicht produziert.Ohne Ausnahme, gutes Zeichen! Hoffen wir, das unser Mut zum Risiko belohnt wird.Mal ein Tenbagger dürfte auch genügend Tröstung für solar bedeuten

Gruß Brom

[solarblase]

Antwort auf Beitrag Nr.: 32.677.093 von brombeeren am 05.12.07 20:46:32

However, Datamonitor expects MC-1 sales in coronary artery bypass graft (CABG) surgery to increase from $21 million in 2009 to $89 million in 2012

Diese Umsatzentwicklung wäre aber etwas entäuschend.



Tenbagger wäre schon schön. Erwarte das, gehen wir mal von positiven Ergebnissen für MC1 aus, aber erst wenn weitere positive news aus der Pipeline kommen. Biotech ist zur Zeit nicht so gefragt. Kann sich natürlich schnell ändern.

[solarblase]

Es ist schon unglaublich mit welch geringem Umsatz dieses Kursplus möglich ist. Aber wollen erst mal zufrieden sein das der Kurs überhaubt wieder steigt.

[solarblase]

Genuity treibt wieder spielchen. Aber mal in die richige Richtung

[brombeeren]

Antwort auf Beitrag Nr.: 32.718.661 von solarblase am 10.12.07 19:48:42

Tag zusammen,
im stockhouse wird verbreitet, die kurz bevorstehenden Quartalszahlen beinhalten eine positive Überraschung zu den Aggra-Zahlen. Angeblich sei ein bedeutener Klinikverband in Kalifornien auf Aggra umgestiegen, was sich bereits in einem deutlichen Umsatzplus niedergeschlagen habe ?! Na, mal sehen, die Jungs dort bekommen langsam gute Laune....

Noch ein paar Fragen:

Angeblich seinen 13 Mio laut Optionsprogrammm verteilt worden, die nicht bei canadianinsider gelistet sind ? Richtig ?

Wann sind die Ergebnisse denn nun offiziell zu erwarten: Anfang März ? Richtig ?

Witzigerweise steht nach dem RBC Downgrade folgendes an:Medicure to Present at RBC Healthcare Conference
WINNIPEG, MANITOBA, Dec 10, 2007 (MARKET WIRE via COMTEX News Network) -- Medicure Inc. (TSX: MPH)(AMEX: MCU), a cardiovascular focused biopharmaceutical company, today announced its President and CEO, Albert D. Friesen, PhD, will participate on the "Replacing The Mainstay With Newer And Better Agents" panel at the 2007 RBC Capital Markets Healthcare Conference in New York. The panel discussion is scheduled for Wednesday, December 12th at 4:30 p.m. Eastern.
A live audio webcast of the presentation will be accessible through Medicure's Investor Relations website at www.medicure.com. An archived edition of the presentation will be available later that day.


Gruß,

Brom

[solarblase]

Zu dem Aktienoptionsplan schau Dir mal die SEC fillings vom 09.10.07 an

Aggrastat glaube ich persönlich nicht mehr dran. Währe ja schön wenn die Recht hätten.

Ich persönlich rechne ab Februar mit Ergebnissen. Aber kann überhaubt nicht einschätzen wie lange die Auswertung der Daten dauert.

[solarblase]

Medicure Inc. (MPH) As of December 21st, 2007
Filing Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Dec 21/07 Dec 11/07 McDole, Gerald P. Direct Ownership Options 50 - Grant of options 10,000
Dec 21/07 Dec 15/07 Naimark, Arnold Direct Ownership Options 52 - Expiration of options -100,000
Dec 21/07 Dec 11/07 Naimark, Arnold Direct Ownership Options 50 - Grant of options 110,000
Dec 21/07 Dec 11/07 Quick, Peter Direct Ownership Options 50 - Grant of options 10,000
Dec 21/07 Dec 12/07 Banks, David F. Direct Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.980
Dec 21/07 Dec 11/07 Banks, David F. Direct Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.990
Dec 21/07 Dec 03/07 Banks, David F. Direct Ownership Common Shares 00 - Opening Balance-Initial SEDI Report
Dec 21/07 Dec 03/07 Banks, David F. Direct Ownership Warrants 00 - Opening Balance-Initial SEDI Report
Dec 21/07 Dec 11/07 Banks, David F. Direct Ownership Options 50 - Grant of options 100,000
Dec 21/07 Dec 03/07 Banks, David F. Direct Ownership Options 00 - Opening Balance-Initial SEDI Report

[solarblase]

Hallo Cristrader und Brombeeren
Ich wünsche Euch und euren Familien ein schönes Weihnachtsfest.

Gruß Solar

[brombeeren]

Antwort auf Beitrag Nr.: 32.856.732 von solarblase am 23.12.07 20:02:11

Hallo Solar, auch von mir die besten Wünsche inklusive streessfreier Zeit für Euch beide und Eure Familien.

Gruß Brom

[cristrader]

Antwort auf Beitrag Nr.: 32.856.732 von solarblase am 23.12.07 20:02:11

Hallo!

Wünsche euch auch frohe Weihnachten!

Albert Friesen hat uns auch wieder ein Weihnachtsgeschenk gemacht.http://www.canadianinsider.com/coReport/allTransactions.php?…

Verkauf von 326.000 Aktien zu 0,89 $ am 19.12.07 !!!


Grüße cristrader

[cristrader]

Antwort auf Beitrag Nr.: 32.863.904 von cristrader am 25.12.07 19:07:53

Kleine Korrektur!

Albert Friesen

326.000 Aktien --> Disposition by gift (Kein Verkauf sondern nur verschenkt - vielleicht ein Weihnachtsgeschenk innerhalb der Familie o.ä.)

Grüße cristrader

[solarblase]

Antwort auf Beitrag Nr.: 32.864.572 von cristrader am 25.12.07 19:46:54

Nettes Weihnachtsgeschenk
Die Meldung "Disposition by gift" habe ich noch nie gesehen. Hoffe nicht das jetzt so getrickst wir um Insiderverkäufe zu tarnen.

[solarblase]

reger Handel an der TSX. Nur mal wieder 1 Händler. So ein Umsatz müsste mal breiter angelegt sein.

[brombeeren]

Antwort auf Beitrag Nr.: 32.890.617 von solarblase am 28.12.07 19:52:05

Tag zusammen,
disposition by gift sollte keine sorgen machen... Friesen hat dieses mit geringeren Mengen schon mehrfach gemacht. Immerhin hat Banks trotz seiner optionen nochmals 100000 gekauft.

Guten Rutsch ....

[brombeeren]

Antwort auf Beitrag Nr.: 32.904.073 von brombeeren am 31.12.07 12:13:28

Tag zusammen,
still ruht der see.Alle sitzen auf ihren Positionen.Wirkliches Vertrauen hat sich nicht gebildet, so dass die meisten ihr Risikokapital nicht nachlegen. Wir gehen wohl ungefähr mit diesen Kursen in die Phase III Nachrichten. Sofern wir tatsächlich Anfang Februar die Ergebnisse erhalten, ist es mir persönlich zu ruhig. Hat jemand noch Erhellendes zu vermelden?

Grüße, Brom

[solarblase]

Antwort auf Beitrag Nr.: 33.011.378 von brombeeren am 10.01.08 19:35:01

Hoffte ja wirklich das ab Januar noch einige einsteigen. Aber wieder nichts. Jetzt müssen wir wohl auf das Ergebnis warten. Auf Aggra ist wohl nicht zu hoffen.
Tja Gesamtmarkt nicht gut. An Biotech zur Zeit kein großes Interesse. Und bei dem Kursverlauf von Medicure braucht man zur Zeit wirklich nicht einzusteigen. Man kann auf das Ergebnis warten und wenn positiv reicht der Einstieg immer noch. Wie hoch kann Sie wohl am Ersten Tag steigen wenn positive Ergebnisse gemeldet werden.

[brombeeren]

Antwort auf Beitrag Nr.: 33.012.667 von solarblase am 10.01.08 21:08:07

Hallo solar,
am 14 Januar sollen wohl die Quartalsergebnisse kommen ! Spannend !Vielleicht ein wenig Rückenwind ! Wie bei positiven Ergebnissen zu handeln/ zu verkaufen ist, ist unabhängig von steuerlichen Besonderheiten schwierig zu beantworten! Positive Ergebnisse sind auch relativ, da die Einzeltatsachen den Kurs bestimmen werden ! Einen Teil liegen lassen, einen anderen Teil zu 3-5 Dollar verkaufen :-). An einen tenbagger glaube ich nicht! Aber eigentlich werden wir wohl andere Probleme haben...

Gruß Brom

[cristrader]

Hallo!

Ziemlich enttäuschende Zahlen!

ausführlicher Quartalsbericht:
http://library.corporate-ir.net/library/10/108/108925/items/…


Medicure Announces Second Quarter Fiscal 2008 Financial Results
Monday January 14, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Jan 14, 2008 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular focused biopharmaceutical company, today reported the results of operations for the three and six month periods ended November 30, 2007. All amounts referenced herein are in Canadian dollars unless otherwise noted. At the close of business on November 30, 2007, the exchange rate was CAD$1.00 = US$1.00.

"The second quarter of fiscal 2008 brought us closer to the results from our Phase 3 MEND-CABG II trial," stated Medicure's President and CEO, Albert D. Friesen, PhD. "The results of more than a decade of hard work are on the horizon and the anticipation at Medicure and within the cardiology community is increasing."

Clinical Update

In September, Medicure announced it completed enrollment for its MEND-CABG II trial two months earlier than it had forecast. The Company believes MC-1 represents a significant improvement in the care of CABG surgery patients, and could become the first cardioprotective therapy approved to reduce mortality and morbidity in this patient population. This pivotal registration study is evaluating the Company's FDA Fast Tracked product MC-1's safety and cardioprotective efficacy in patients undergoing coronary artery bypass graft (CABG) surgery, with top-line results expected in the third quarter of fiscal 2008.

Corporate Update

During its second quarter of fiscal 2008, Medicure strengthened its cash position through the completion of two financings totaling US$41 million.

Under the terms of the first agreement, Birmingham Associates Ltd., an affiliate of Elliott Associates, L.P., provided Medicure with an upfront cash payment of US$25 million. Birmingham will receive an escalating minimum annual return starting at US$2.5 million based on AGGRASTAT® revenue or MC-1 until May 31, 2020. Birmingham will also receive the option to convert its rights based on AGGRASTAT® to MC-1 within six months after MC-1's commercialization, if achieved.

In a separate transaction, Medicure raised total gross proceeds of US$16 million. Under terms of the private placement, Medicure issued approximately 13.9 million common shares at a price of US$1.15, together with warrants, to purchase approximately 4.37 million additional common shares. The warrants have a five-year term and an exercise price of US$1.50.

Subsequent to quarter end, Medicure announced that David Banks joined its Board of Directors. Mr. Banks brings to the Board more than 35 years of international investment banking and private equity investing experience, and possesses extensive investment banking knowledge that will be important as Medicure looks to build greater shareholder value.

AGGRASTAT® Update

During the first half of fiscal 2008, sales of AGGRASTAT® continued to decline as compared to the same period in fiscal 2007. The Company recognized that the initial commercial structure, which consisted of a contract sales organization (CSO) was not optimal as the Company was not able to maintain sufficient control and direction of the sales organization. The Company believes it has taken the corrective steps to address this issue with the recent hiring of Mr. Brian Best as Vice President, Marketing and the transition to an internally managed and more cost effective operation under Brian's leadership. Brian has 16 years of pharmaceutical industry experience including six years with Millennium Pharmaceuticals Inc. and Cor Therapeutics Inc. where he held senior positions including Director of Medical Affairs and Director of Marketing, Cardiovascular. Brian will play a critical role in the stabilization and long-term expansion of the Company's commercial operations in the United States.

"While revenues slightly declined from the previous quarter, we believe the change in strategic direction is beginning to show progress," stated Dr. Friesen. "We are building a dynamic and entrepreneurial team with extensive acute cardiovascular experience and are optimistic that it will translate into revenue growth for AGGRASTAT® in the coming year."

Financial Results:

Total product revenue for the three-month period ending November 30, 2007 was $324,000 compared to $1,419,000 for the same period in fiscal 2007. Revenues for the six month period to date were $803,000 compared to $1,699,000 in the same period last year.

AGGRASTAT® revenues were lower for the three and six month periods ended November 30, 2007 as compared to the same periods in fiscal 2007 for several reasons including the reconfiguring of the Company's commercial operations during the first quarter of fiscal 2008. While the Company's focus has been on stabilizing revenues, it was recognized that the initial commercial structure, which consisted of a contract sales organization (CSO) was not optimal as the Company was not able to maintain sufficient control and direction of the sales organization and has since transitioned to an internally managed and more cost effective operation.

This transition will require additional time to fully implement and establish customer relationships in order to stabilize and eventually increase product revenues. The Company also reduced the wholesaler inventory levels during the first half of fiscal 2008, and will continue to make adjustments as required. Finally, the Company's estimate for customer chargebacks increased during the quarter which resulted in an additional decrease in net product sales.

Research and development expenditures were $11,231,000 in the second quarter of fiscal 2008 as compared to $3,816,000 in the same period of fiscal 2007. As expected, research and development expenditures were significantly higher as compared to the same period in fiscal 2007 due to the ongoing Phase 3 MEND-CABG II clinical trial that commenced in the second quarter of fiscal 2007. Research and development for the six month period to date were $22,468,000 compared to $6,602,000 for the same period last year.

Selling, general and administrative expenditures increased by $1,214,000 to $3,872,000 during the three-month period ended November 30, 2007 as compared $2,658,000 in the same period in fiscal 2007 primarily due to costs associated with the Company's AGGRASTAT® operations. The Company acquired the US rights to AGGRASTAT® near the end of the first quarter of fiscal 2007 and did not have a sales force in place until partially through the second quarter of fiscal 2007. In addition, other selling, general and administrative expenses were higher during the quarter due to higher salaries and professional fees. Selling, general and administrative expenditures for the six month period to date totaled $7,096,000 compared to $3,818,000 for the same period in fiscal 2007.

Interest and other income for the second quarter of fiscal 2008 was $297,000 compared to $287,000 for the same quarter in fiscal 2007. Interest and other income for the six month period to date totaled $603,000 compared to $676,000 for the same period in fiscal 2007.

As a result of the above noted items, the financial results for the three-month period ended November 30, 2007 include a consolidated net loss from operations of $16,940,000 or $0.14 per share, compared to $6,093,000 or $0.06 per share for the three-month period ended November 30, 2006. The six month year-to-date loss for fiscal 2008 was $32,023,000 or $0.27 per share, compared to $9,339,000 or $0.10 per share for the six month period ended November 30, 2006.

At November 30, 2007, the Company had cash and cash equivalents totaling $38,751,000 as compared to $31,770,000 as of May 31, 2007.

An expanded version of Management's Discussion and Analysis and the financial statements for the three-month period ended November 30, 2007 is accessible on Medicure's website at www.medicure.com.



Phase III-Ergebnisse kommen Ende Februar lt. Konferenz, sonst wenig Interessantes auch kaum Medieninteresse.

Medicure steht und fällt mit den Phase III-Ergebnissen hoffentlich sind wenigstens diese mal positiv!

Grüße cristrader

[solarblase]

Insgeheim hofft man ja immer wieder auf überraschungen. Tja jetzt können wir nur noch auf die Zulassung hoffen. Der Kurs wird wohl vorher nicht mehr hoch gehen. Hatte mir das doch etwas anders vorgestellt. Für Januar schwebten mit Kurse um die 2 $ vor.

Gruß Solar

[brombeeren]

Antwort auf Beitrag Nr.: 33.044.373 von solarblase am 14.01.08 18:35:23

Moin zusammen,
plötzlich verlieren wir in Canada über 10 %...?? Was ist da schon wieder los ?

[solarblase]

Schau Dir die Umsätze an. Vielleicht enden wir auch wieder ausgeglichen.
Was für ein Massaker Heute. Da möchte man doch eigentlich keine Aktien besitzen. Mal sehen was Morgen noch kommt wenn die US-Börsen dabei sind.

[cristrader]

Antwort auf Beitrag Nr.: 33.122.199 von solarblase am 21.01.08 20:58:06

Hallo Solar und Brombeeren!

Es hat sich heute nichts verändert was zählt sind die Phase III-Ergebnisse! Falls es noch eine positive Kursrally im Vorfeld der Ergebnisse geben wird dann wohl erst frühestens ab Mitte Februar.

Die Panik am Gesamtmarkt wird sicherlich einige Übertreibungen zur Folge haben und somit auch einige Chancen bringen.

Grüße cristrader

[cristrader]

Hallo!

Columbia Wanger als grösster Insti. scheint seine Position auf unter 5% reduziert zu haben!

http://www.sec.gov/Archives/edgar/data/908733/00009087330800…

If this statement is being filed to report the fact that as
of the date hereof the reporting person has ceased to be
the beneficial owner of more than five percent of the class
of securities, check the following [ X ].


Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 33.145.706 von cristrader am 23.01.08 17:33:31

Hallo cristrader,

wird im stockhouse uneinheitlich bewertet. Sie müssten bestimmt 2 mio shares abgegeben haben, was aber verschiedene Gründe haben könnte. Ob man da eine Zulassungs- oder ergebnisprognose reinlesen kann....?

Brom

[cristrader]

Hallo Brom!

Ich denke eine Prognose bezüglich Ergebnissen lässt das nicht zu. Columbia Wanger hat sich das Investment vieleicht auch etwas anders vorgestellt. Insbesondere die letzte KE und das Aggrastat-Desaster sind ihnen sicherlich ebenso bitter aufgestossen!

Columbia Wanger hatte im August (Posting 169) eine 7,94 % Position von damals 116 mio Aktien also ca. 9,2 mio Aktien. Denke es wurden eher ca. 3 Mio Aktien verkauft!

Sieht heute ja schon wieder etwas besser aus!

Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 33.162.705 von cristrader am 24.01.08 22:24:23

Tag zusammen,

wahrscheinlich alle schon gelesen, ich stell die etwas kryptischen Äußerungen meines Lieblings-CEO noch mal rein. Hoffen wir auf eine kleine Miniralleye ab Anfang/Mitte Febr.:

Investors shun Medicure despite advancements
Tue Jan 15 2008
By Martin Cash

MEDICURE Inc. is only weeks away from the seminal event in the Winnipeg company's 10-year history, with mounting quarterly losses and its share price languishing.

Early results from its 3,000 patient phase-III clinical study on MC-1 -- Medicure's primary drug to prevent heart damage for patients undergoing coronary bypass surgery and angioplasty -- are expected by the end of February.

While company officials and Bay Street analysts say they are optimistic the study will prove the efficacy of the drug, the company's share price continues to languish below the $1 mark.

Albert Friesen, co-founder and CEO, put on a brave face regarding the disappointing level of interest in the company's shares, saying his company is not alone when it comes to the Canadian biotech sector's performance.

"There are plenty of Canadian companies out there with a good amount of positive results that (the capital markets) have not responded to," he said. "Still, we are very encouraged where we are at right now."

By the time the final data are released, the company will have burned through about $100 million to get the drug ready for approval. Some biotech analysts are projecting that if the trial results are successful and MC-1 is certified, it could rack up as much as $750 million in sales in its first seven or eight years.

In addition to the results of the MC-1 trials, the company is just about finished restructuring its U.S. sales force that is attempting to relaunch a U.S. heart drug called Aggrastat.

Sales of Aggrastat were down this quarter ($324,000 compared with $1.4 million last year), but company officials said more positive sales results for that drug are expected over the next two quarters.

Medicure released results for the second quarter of the year on Monday showing research and development expenses of $11.2 million for the period ending Nov. 30, 2007 (compared with $3.8 million for the same period last year). Selling and general administrative expenses also increased by close to 50 per cent to $3.8 million and the total net loss for the quarter was $19.9 million compared with a loss of $6 million for the same quarter last year.

But Friesen remains optimistic that with positive data from the Phase 3 clinical trial, it will be able to file for regulatory approval of the new drug by the fall with possible approval for commercial sales by as early as the first quarter of 2009.

On Monday, Medicure shares closed down two cent to 91 cents. In July, they were trading at $1.60.

Industry officials say the Medicure scenario is not uncommon in Canada.

Richard Wong, manager of the $50-million Investors Global Healthcare Fund and the $80-million Investors U.S. Small Cap Fund, said "life sciences make up about one per cent of the TSX composite index, so investors have other choices."

With the surging oil and resource sector in Canada, investors are finding better and faster returns in other places than life sciences.

Wong said that since the company only has a modest revenue stream from an existing product and lacks significant activity in its pipeline development, investors are likely waiting for the data from the MC-1 clinical trial.

Cate McCready, an official with the Ottawa-based Biotecanada, a national biotech industry association, said there is a challenge for biotech at large to compete for investment dollars in Canada.

"Somehow investors' expectation are not being met by the dynamics of the biotech life cycle," she said. "Everyone needs a return on investment but we need to create a better value equation for the sector. We are in danger of leaving a lot on the table."

[e-mail]

[solarblase]

Was für Handelsumsätze

[brombeeren]

Antwort auf Beitrag Nr.: 33.220.015 von solarblase am 30.01.08 21:53:18

Hallo zusammen,

wer verfolgt die Diskussion auf dem stockhouse board mit dem (angeblichen) Ergebnis, das MC1 (molekular identisch) ein nicht patentgeschützter Stoff sei, der als Lebensmittelzusatz (P-5-P) bereits länger auf dem Markt sei?
(P-5-P or call it MC-1...is an active ingredient of many cardio-vascular food supplemments readily available at relative low cost on the market).

Das fällt schwer zu glauben ?!!

Brom

[solarblase]

Antwort auf Beitrag Nr.: 33.247.214 von brombeeren am 02.02.08 12:09:24

Denke nicht das diese identisch sind. Da wird Medicure schon etwas verändert haben. Verfolge die Diskussion aber auch.

[solarblase]

Press Release Source: Medicure Inc.


Medicure's Pivotal Phase 3 MEND-CABG II Results to be Presented at Late-Breaking Session at the American College of Cardiology Conference
Tuesday February 5, 8:00 am ET


WINNIPEG, MANITOBA--(MARKET WIRE)--Feb 5, 2008 -- Medicure, Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular-focused biopharmaceutical company, today announced that the results of the Company's pivotal Phase 3 MEND-CABG II trial have been accepted for presentation as a Late-Breaking Clinical Trial at the American College of Cardiology 57th Annual Scientific Session. The Annual Scientific Session is being held March 29 to April 1, 2008 in Chicago.
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Medicure's MEND-CABG II data will be presented on April 1 at McCormick Place in Chicago. The Company will issue a press release providing details on the trial results at the time of the presentation.

[brombeeren]

Antwort auf Beitrag Nr.: 33.273.883 von solarblase am 05.02.08 16:43:59

Hallo zusammen,
da wären wir wohl auf der Zielgeraden...! Es mag naiv sein, zu schlussfolgern, dass wenn gerade die Präsentation auf dem ACC gewählt wird, die primären endpunkte der studie wohl nicht verfehlt worden sind.... Ich mach es trotzdem, denn an Friesens Stelle wäre das bei dem Verfehlen aller Endpunkte nicht sinnig.

Hier noch ein Artikel aus dem Dezember der über stockhouse/yahoo kommt:
http://www.pharmaceutical-business-review.com/article_featur…

Wie die (steuerfreien) shares zu handeln wären, bei sehr guten Ergebnissen, ist sehr fraglich !

Grüße Brom

[cristrader]

Antwort auf Beitrag Nr.: 33.318.713 von brombeeren am 09.02.08 13:50:21

Hallo!

Die ACC-Konferenz mit mehr als 30000 teilnehmenden Kardiologen ist sicher das ideale Forum um die Phase III-Ergebnisse zu präsentieren. Die Teilnahme lässt jedoch nicht zwingend folgern das die Ergebnisse auch positiv sind. Der Antrag zur Präsentation der Phase III-Ergebnisse musste bis zum 07. Januar `08 gestellt werden, wo sicherlich noch keine Ergebnisse vorlagen. Es zeigt aber zumindest die Zuversicht des Managements. Bis zum Ende des Monats werden wir Wissen wohin der Weg führt. Wir werden zwar keine genauen Details vor dem 1.April(ACC) erfahren aber zumindest eine News ala "Phase III meets primary endpoint" und Angabe des P-Values.

Mit positiven Ergebnissen beginnt der Zug erst zu Laufen. Die gesamte MC-1 Pipeline wird extrem aufgewertet!

-Partnerschaft mc-1 cabg
-Partnerschaft mc-1 ACS und Partnerschaft
-zahllose MC-1 Kombi Partnerschaften möglich


Wie die steuerfreien Shares zu händeln sind hängt wohl vor allem vom Kursverlauf ab, denke aber das Kurse oberhalb von 5 $ nach entgültiger Zulassung und verschiedenen Partnerschaftsdeals möglich sind!


Grüße cristrader

[brombeeren]

Antwort auf Beitrag Nr.: 33.318.921 von cristrader am 09.02.08 14:53:20

Hallo cristrader und solar,

dass mit der Anmeldefrist zum 7. Januar ist ein Argument.Selbst das eine oder andere angemeldet ?
Die kanadischen Jungs und Mädels auf stockhouse und yahoo gehen in ihrer gerüchteküche davon aus, dass die Ergebnisse (nur top line data ja oder nein) am 25 Febr. veröffentlicht werden. Angeblich ein Telefonat mit der IR Abteilung von medicure... Lets see.. Sofern jemand sein Risikopotential noch nicht ausgeschöpft hat...

Gruß

brom

[cristrader]

Antwort auf Beitrag Nr.: 33.394.210 von brombeeren am 17.02.08 10:35:20

Hallo brom!

Lt. Bio CEO Konferenz werden die Top Line Ergebnisse (positiv oder negativ) bis Ende Februar bekannt gegeben. Grundsätzlich kann ab Dienstag (Montag Börsenfeiertag in Can und USA) jeden Tag die News kommen! Bei Bekanntgabe von Ergebnissen gilt häufig Anfang der Woche gleich positive Ergebnisse und Bekanntgabe am Ende der Woche gleich negative Ergebnisse, daher der 25.02.08 als Termin. Müsste eigentlich meinen Einsatz noch deutlich reduzieren kann mich bei solchen Kursen aber nur schwer von meinen Aktien trennen. Bei der Bio CEO hörte sich Friesen eigentlich sehr optimistisch an, denke nicht das ihm schon negative Ergebnisse bekannt waren. Auf jeden Fall ist die nervtötende Warterei bald zu Ende!

Grüße cristrader

[Neoe]

Nur im Zusammenhang mit der Spekulation um dia ACC Konferenz:

Das hat gar nichts, und wirklich rein gar nichts, mit der Qualität der Ergebnisse zu tun. Die können Grottenschlecht sein und trotzdem werden sie präsentiert. Die Froschung legt keinerlei Wert darauf nur positive Ergebnisse zu diskutieren. Auch nicht erfolgreiche Ergebnisse lassen wichtige Rückschlüsse zu, nur dann eben nicht mehr uín Zusammenhang mit MC1. Diese Komponente ist nur ein klienes Zähnchen im Rad. Wär dennoch schön, wenn die Ergebnisse positiv sind, was ja auch seine Berechtigung hat, das zu erwarten.

[solarblase]

Wollen mal hoffen das Heute keine news mehr kommen.

[cristrader]

Antwort auf Beitrag Nr.: 33.451.022 von solarblase am 22.02.08 18:47:43

Bad News!

MC-1 did not meet primary endpoint!

Medicure Announces Top-Line Results From Pivotal Phase 3 MEND-CABG II Clinical Trial
Friday February 22, 4:32 pm ET


MEND-CABG II Study Does Not Meet Primary Efficacy Endpoint


WINNIPEG, MANITOBA--(MARKET WIRE)--Feb 22, 2008 -- Medicure Inc. (Toronto:MPH.TO - News)(AMEX:MCU - News), a cardiovascular-focused biopharmaceutical company, today announced that an analysis of the data from its pivotal phase 3 MEND-CABG II clinical trial showed that it did not meet the primary endpoint. The trial was designed to evaluate the effect of Medicure's lead product MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal myocardial infarction up to and including 30 days following coronary artery bypass graft (CABG) surgery.
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Based on the results, the Company does not plan on submitting an application for MC-1 marketing approval to the U.S. Food and Drug Administration for the CABG indication at this time.

The study results will be presented at the Late-Breaking Clinical Trial session on April 1, 2008 at 1 p.m. Central Time during the American College of Cardiology (ACC) 57th Annual Scientific Session in Chicago.

Trial Design

The pivotal Phase 3 MEND-CABG II trial was a double-blind, randomized, placebo-controlled clinical trial that enrolled over 3,000 patients undergoing CABG surgery at more than 130 cardiac surgical centers throughout North America and Europe.

Study patients were randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II was the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients were followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.

Medicure conducted the MEND-CABG II study in conjunction with Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI). Principal investigators for the study are Dr. Robert Harrington, Director of the DCRI, and Dr. Michel Carrier, Director of Cardiovascular Surgery Program at MHI.

Dr. Jean-Claude Tardif, Director of the Research Centre, MHI, and Dr. Robert W. Emery, Jr., Medical Director of Cardiovascular Services, St Joseph's Hospital, served as co-chairs of the MEND-CABG II steering committee.

About CABG

CABG is performed to improve blood flow to the heart by re-routing blood around blocked arteries. CABG surgery is one of the 10 most frequently performed procedures in North America. More than 400,000 CABG procedures are performed each year in the U.S. alone. Coronary artery disease incidence is increasing dramatically worldwide, creating a major demand for products that make CABG surgery safer for patients.

Notification of Conference Call

Medicure has scheduled a conference call and webcast to reiterate Medicure's Phase 3 MEND-CABG II top-line results.



cristrader

[solarblase]

Da ist der Traum vorbei

[solarblase]

In USA und Kanada wird gehandelt und hier noch ausgesetzt