Drugs To Watch: Late Stage - 500 Beiträge pro Seite

[Neoe]

Grüße an alle Biotech-Interessierten:

Ich denke ein grundsätzliches Problem im Biotech-Sektor ist es, die entscheidenden Quellen für gute Infos zu finden, um in entscheidenden Momenten dabei sein zu können.
Da man nicht immer alles mitbekommen kann, verpasst man natürlich vieles und ärgert sich dann, wenn man das Press Release zum neuesten Wundermedikament liest, der Kurs dann aber natürlich schon über alle Berge ist.

Deswegen schlage ich vor, dass hier jeder seine vielversprechendsten Late-Stage-Kandidaten (ab Phase III oder vor Zulassung), die vielleicht gerade nicht die nötige Aufmerksamkeit genießen, hier vorstellt und am besten noch das Unternehmen dazu.

Ich würde mich wirklich freuen, wenn dieser Thread auf Gegenliebe stoßen würde, da wir glaube ich alle davon profitieren würden.

[torcidaa]

da fällt mir gerade mal unigene auf (ugne.ob). ist in der 3. phase und ich persönlich erwarte das approval noch vor ende jahr, spätestens frühling. sobald das approval da ist, könnte die aktie abgehen wie eine rakete. sie haben bereits 30 jahre erfahrung mit calcitonin und deswegen ist auch nicht anzunehmen, dass die bude verkauft wird. der ceo hat zu viel arbeit in das projekt gesteckt als das er sein lebenswerk verkaufen würde.

nächsten donnerstag wird gemunkelt sollte ein bericht in www.aktienbrief.de rauskommen, der recht positiv sein sollte.

lassen wir uns überraschen und sehen was in ein paar monaten passiert.



Unigene Laboratories, Inc. is a biopharmaceutical company engaged in the research, production and delivery of small proteins, referred to as peptides that have demonstrated or may have potential medical use. It has a patented manufacturing technology for producing many peptides and patented oral and nasal delivery technologies that have been shown to deliver medically useful amounts of various peptides into the bloodstream. The Company`s primary focus is the development of calcitonin and other peptide products for the treatment of osteoporosis and other indications. The Company has licensed worldwide rights to manufacturing and delivery technologies for oral parathyroid hormone, which it refers to as PTH, to GlaxoSmithKline. It has also licensed in the United States its nasal calcitonin product, which it has trademarked as Fortical, to Upsher-Smith Laboratories, Inc.

[therman]

Hi,

Avanir AVN 886393

Siehe:Thread: AVANIR : Deutliches Potential .

therman

[Neoe]

torcidaa:

Unigene interessiert mich persönlich auch sehr. Die Fortical-Zulassung kämpft zur Zeit mit den Problemen, die durch eine sogenannnte "Citizen`s Petition" entstanden sind. Diese verlangt Fortical nicht zuzulassen. Über die Richtigkeit der Argumentation dieser Petition muß die FDA noch entscheiden. Eigentlich sollte die Entscheidung schon im Juli fallen. Sollten hier positive Nachrichten kommen ist Unigene wirklich ein Geheimtip.

[torcidaa]

ich kenne leute, die persönlichen kontakt zu levi haben und der meint, die "citizen`s petition" bereite ihm keine schlaflosen nächte, im gegenteil, dies sei gang und gebe und habe in der regel keine chance, da das stadium schon zu fortgeschritten sei. normalerweise hat die fda 180 tage zeit um das abzuklären, weiss auch nicht wieso dort noch keine antwort vorhanden ist.

wie siehst du sonst die situation. wir haben mal kalkulationen betrieben, spielereien halt und angenommen das wir in china pro patient 1 dollar bekommen, würde dann auf einen kurz von 20 dollar kommen. natürlich haben wir nicht alle osteporose-kranken berücksichtigt, da sich nicht alle chinesen so eine therapie werden leisten können, wir gingen von 10% aus. (wie gesagt, träumereien)

was hast du denn sonst noch ins auge gefasst, ähnliche eventuell-kracher?

[Neoe]

Kandidat Nummer 1:

GTC Biotherapeutics: ATRYN

ATryn®
GTC recently received the Consolidated List of Questions from the European Medicines Agency (EMEA) on the information submitted in a Marketing Authorization Application (MAA) for the use of ATryn® in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations such as surgery and childbirth. GTC is in the process of preparing responses to the Consolidated List of Questions. Subject to satisfactory approval of the MAA, GTC is planning for a European market launch of ATryn® in mid-2005.

GTC is continuing discussions with the Food and Drug Administration (FDA) regarding a clinical protocol for ATryn® in the United States in the HD indication. Following these discussions, GTC plans to submit an amended Investigational New Drug (IND) application during the next three months. An IND had been previously filed to include US patients in the clinical trials that were submitted to the EMEA.

In addition, GTC is continuing potential partnering discussions to support the anticipated market launch of ATryn® in mid-2005.

Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties. GTC expresses this protein in the milk of goats that have the human antithrombin gene linked to a milk-protein promoter. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in conventional production methods.


ABOUT GTC BIOTHERAPEUTICS

GTC Biotherapeutics (GTC) is a leader in the development of therapeutic proteins in the milk of transgenic animals. Transgenic animals carry specific genetic material that allows them to express human proteins in their milk. Unique molecular biology expertise has enabled GTC to express more than 60 therapeutic proteins, including monoclonal antibodies, plasma proteins and certain hard-to-express proteins in the milk of mice, rabbits, goats and cows.

GTC`s efforts are focused on the development of proteins for commercial use. Particularly, the company has developed substantial expertise and increasing focus on monoclonal antibodies for therapeutic use in chronic diseases such as rheumatoid arthritis, other autoimmune conditions and cancer. To this end, the Company actively seeks partnerships with pharmaceutical and other biotechnology companies to develop drug candidate proteins transgenically in exchange for revenues and royalties. GTC may also use transgenic technology to develop novel proteins and seek to commercialize these proteins through collaborative agreements with corporate partners.

Tickersymbol:GTCB
Marketcap:65 Millionen Dollar



Allerdings gibt es bei GTCB noch einiges mehr zu entdecken. Meiner Meinung nach ist das Potential hammermäßig. Für weitere Infos:
http://www.gtc-bio.com

[derschweizer]

@all

Ich glaube hier lohnt es sich, mal einen längeren Blick drauf zu werfen.

909400 Maxim Pharmaceuticals (MAXM)

http://www.cytovia.com

http://www.maxim.com/pdfs/corpfactsheet.pdf

Die Aktie wird im Moment extrem geshortet, was aber nichts am Potenzial des Unternehmens ändert.

grüße derschweizer

[BrauchGeld]

Hi Leute

Bin da vor einigen tagen auf diese Aktie gestossen scheint wirklich interesant zu sein.
Schaut euch mal die fortgeschrittene Pipeline an.

Barrier Therapeutics (Nas:BTRX)
Kurs: 13$ Mk:ca.284 mio$

Our Product Development Pipeline

Our product pipeline includes eight product candidates in various stages of clinical development for the treatment of a range of dermatological conditions. We also have a number of products in preclinical development, one of which we expect will enter clinical development in 2005. In addition, we have rights to two other products that are marketed by third parties in some countries outside the United States and Europe, which we plan to reformulate prior to initiating clinical trials.

Advanced Stage Products in Clinical Development

Our four most advanced product candidates are Sebazole™, Zimycan™, Hyphanox™ and Liarozole.

Zimycan™. Zimycan™ is a topical ointment of 0.25% miconazole, an antifungal agent, in a zinc oxide and petrolatum base. We are developing Zimycan™ for the treatment of infants with Candida-associated diaper dermatitis, which is an inflammatory disease in which an infant`s diaper rash is complicated with an infection by a fungus called Candida. Diaper dermatitis is one of the most common skin conditions in infants and is observed in approximately one million pediatric outpatient visits each year. Based on multiple published reports, we believe that more than 40% of all diaper dermatitis, seen by phyhsicians, involves Candida. In the United States, there currently is no prescription drug specifically approved to treat Candida-associated diaper dermatitis. If approved, we believe that Zimycan™ would have favorable attributes, including a formulation without a steroid that is specifically designed for Candida-associated diaper dermatitis. In August, 2004 we announced positive results from our Phase III study with Zimycan™ in Candida-associated diaper dermatitis and plan to file an amendment to our NDA with the FDA by the end of the year. In May, 2004 we received marketing authorization from the Belgian Health Authority, and are now commencing Mutual Recognition Procedure in the EU with Belgium as our Reference Member State.

Sebazole™. Sebazole™ is a topical formulation of 2.0% ketoconazole, an antifungal agent, in a waterless gel that we are developing as a short (2 weeks) once daily treatment for seborrheic dermatitis. Seborrheic dermatitis is an inflammation of the skin that is characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, behind the ears and in the middle of the chest, which affects approximately 8.5 to 14.3 million people in the United States. The most commonly used prescription drugs for the treatment of seborrheic dermatitis typically must be used at least twice daily for four to six weeks to be effective in treating this condition. If approved, we believe that Sebazole™ would have favorable attributes, including a dosing regimen of once daily treatment for two weeks, a fast onset of action and a lower likelihood of recurrence of symptoms in comparison with steroid treatment. In November 2003, we completed two Phase III clinical trials for the treatment of seborrheic dermatitis in which Sebazole™ achieved the primary efficacy endpoint with statistical significance. We commenced a confirmatory Phase III trial with Sebazole™ in the second quarter of 2004 which we expect to complete by the end of the year.

Hyphanox™. Hyphanox™ is a unique 200 mg tablet formulation of itraconazole, an antifungal agent, that is used for the treatment of various fungal infections, including vaginal candidiasis, commonly known as vaginal yeast infection, onychomycosis, commonly known as nail fungus, and tinea pedis, commonly known as athlete`s foot. Our unique formulation provides the benefits of once-a-day dosing, lower inter-subject variability and higher bioavailability than generic itraconazole capsules. Itraconazole is effective in treating these fungal infections. In January, 2004, we commenced a Phase III pivotal clinical trial for the use of a single day, single dose treatment of two 200 mg tablets of Hyphanox™ in the treatment of vaginal candidiasis. This trial compares Hyphanox™ to fluconazole, the most widely prescribed oral treatment for this disease. We are currently in discussions with the FDA concerning clinical programs leading to approval for an onychomycosis indication. Janssen Pharmaceutica Products, L.P. and a number of other Johnson & Johnson companies currently market different formulations of itraconazole, under Sporanox® and other brand names, in various countries.

Liarozole. Liarozole is our first product candidate based on a class of molecules known as retinoic acid metabolism blocking agents, or RAMBAs. We are developing Liarozole as an oral treatment for congenital ichthyosis. Congenital ichthyosis is a rare genetic disease, affecting one in 6,000 people in the United States, characterized by severe dryness and scaling of the skin with the scaling often occurring over large areas of the body. There is no oral prescription drug currently approved in the United States that is indicated for the treatment of congenital ichthyosis. Liarozole has been granted orphan drug status in the United States and in Europe for the treatment of congenital ichthyosis. We are currently in discussions with regulatory authorities concerning final requirements for filing.

Earlier Stage Products in Clinical Development

Our four product candidates in earlier stages of clinical development are Rambazole™, Azoline, Hivenyl™ and Atopik. Our product candidate in preclinical development which we expect will enter clinical development in 2005 is Ecalcidene.

Rambazole™. Rambazole™ is our second product candidate based on the RAMBA class of molecules. We are developing an oral formulation of Rambazole™ for the treatment of psoriasis and severe acne. Preclinical studies suggest that Rambazole™ is more selective and more active than first generation RAMBA-based product candidates, such as Liarozole. We have initiated two pilot clinical studies in Europe using oral Rambazole™ to determine safety and preliminary indications of effectiveness in the treatment of both psoriasis and severe acne.

Azoline. Azoline is an antifungal agent that we are developing as a short course oral treatment for skin and mucosal fungal infections. We have completed a Phase I clinical trial for Azoline, which indicated that at the doses tested, Azoline has a half-life in the body, which is nearly three times longer than that of itraconazole. During 2004, we are pursuing additional Phase IIa clinical studies in Europe for the use of Azoline in treating various types of dermatological fungal infections.

Hivenyl™. Hivenyl™ is an antihistamine that we are developing as an oral treatment for allergic reactions of the skin, such as hives, which will not cause sedation typically associated with antihistamines. The results of two Phase I clinical trials suggest that Hivenyl™ inhibits allergic reactions, has a fast onset of action and does not cause sedation, even at doses much higher than the anti-allergic dose.

Atopik. Atopik is a PDE4 inhibitor that we are developing as a topical treatment for eczema, which is an inflammatory skin condition. We are currently developing a new topical formulation of Atopik to be used in future pilot clinical studies.

Products in Preclinical Development

Ecalcidene. Ecalcidene is an orally available vitamin D(3) derivative that we are developing for the treatment of psoriasis. Based on preclinical studies, we believe that Ecalcidene may offer benefits over natural vitamin D(3) in the treatment of psoriasis. It has demonstrated the potential to become the first vitamin D(3) derivative that can be taken orally on a routine basis.

Other Product Candidates

We have rights to two other products that are marketed by third parties in some countries outside the United States and Europe which we plan to reformulate prior to initiating clinical trials.

Ketanserin. Ketanserin is a topical serotonin 2 antagonist that an affiliate of Johnson & Johnson developed and markets in some countries outside the United States and Europe as a wound healing agent for the treatment of chronic skin ulcers. We plan to reformulate ketanserin prior to pursuing further clinical development for the treatment of diabetic and arterial ulcers and serious cracking of the skin.

Oxatomide. Oxatomide is a topical histamine, serotonin and leukotriene antagonist that an affiliate of Johnson & Johnson developed and markets in some countries outside of the United States and Europe for the prevention and treatment of allergies. In preclinical studies, a topical formulation of oxatomide demonstrated early indications of effectiveness in the treatment of pain and itch. We plan to reformulate oxatomide as a topical ointment prior to pursuing further clinical development for the treatment of itch associated with various skin conditions.

Gruss
B.M.

[Neoe]

@derschweizer:

Habe mir auf deinen Hinweis hin Maxim nochmals genauer angeschaut.
Die Glaubwürdigkeit des Managements ,und noch wichtiger, die Studiendaten zu Ceplene werden zu unrecht in Zweifel gezogen.
Einziger schwarzer Fleck in der Historie war die verzögerte Prozedur bei der Ceplene-Zulassung. Diesen Fall habe ich genauer betrachtet (ich beschreibe es jetzt mal für die Allgemeinheit, du wirst es denke ich sowieso wissen):
Die NDA wurde mit den 12-Monatsdaten für die Behandlung mit Ceplene eingereicht, die statistische Relevanz war damals für die Behandlung von Hautkrebs generell noch nicht gegeben (p=0.125) für eine spezielle Subpopulation lag aber bereits damals eine hervorragende, nachgewiesene Wirksamkeit vor.
Mit den 24-Monatsdaten wurde bereits eine statistische Relevanz erreicht (p<0.05) und durch noch bessere 36-Monatsdaten bestätigt.

Im Oktober kommen die endgültigen Daten, dann wird Maxim meiner Meinung nach abheben.Das Potential ist atemberaubend, besonders unter dem Aspekt, dass das Material für eine sNDA (Leukemie) schon vorliegt...Danke dir, Schweizer.

[therman]

Hi,

Zu MAXM: Sieht jetzt auch Charttechnisch interessant aus.
Bullishe Divergenz im RSI und Williams%R weisen meist auf
einen bevorstehenden Kursanstieg hin.

INTROGEN
Introgen scheint mir interessant zu sein:
Das Medikament Advexin ist in Phase III, der Zulassungs
antrag wird noch dieses Jahr gestellt.

Ausfühliche Infos: http://www.introgen.com/main.html

Kurzinfo:
About ADVEXIN

Introgen has received FDA Fast Track designation for ADVEXIN therapy and ADVEXIN has been designated as an Orphan Drug for the treatment of head and neck cancer under the Orphan Drug Act. There are two Phase 3 trials of ADVEXIN therapy currently underway in cancer of the head and neck and phase 2 trials have been completed in lung and breast cancer.

ADVEXIN supplies the tumor suppressor p53 protein in very high concentrations in cancer tissue to selectively kill cancer cells. p53 is a normal constituent of cells and is known as a tumor suppressor because it inhibits the growth of tumor cells. One of the major roles of this protein is to eliminate cancerous cells by recognizing when the cell has been damaged by mutations and stopping cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.

therman

[puhvogel]

AGEN mit Oncophage in Phase 3, Melanom + Nierenkrebs
Patientenrekrutierung der Studie bei Hautkrebs ist bereits abgeschlossen

Der Chart ist allerdings nicht ermutigend

[asics01]

hallo puhvogel
der kurslauf von agen ist wirklich katastrophal,aber der kurs wird gedrückt.ich halte agen schon lange habe jetzt auch noch mal nachgekauft,aber was auffällig ist die letzten paar wochen wurden viele 10000,5000, 3000 blöcke gehandelt.so wars bei supergen auch und dann stieg mig pharma ein.agen ist noch ohne partner da könnte was kommen,ich denke eine ganz heiße sache.und deren pipline ist auch vom feinsten.

asics

[derschweizer]

@Neoe

Habe da noch etwas zu Maxim gefunden.
Ich werde die nächsten Tage mit einer Position einsteigen.
Maxim könnte der Mega-Rebound im Herbst gelingen.

http://www.thestreet.com/_tsdsii/comment/adamfeuerstein/1017…

grüße derschweizer

[Neoe]

@derschweizer:

Der Feuerstein-Artikel besitzt gerade soviel Wahrheit uns mitzuteilen, dass der Tag der Abrechnung bevorsteht. Konferenzen gibt es in den nächsten vier Wochen mehr als genug, um Daten rauszulassen.

Ansonsten war das eine Short-Covering-Aktion hoch zehn. Die Großen haben vermutlich ihre Positionen gedeckt und die restlichen Shorties werden wohl bald ihre Häuser verpfänden.
Shortquote liegt bei rekordverdächtigen 25 Prozent, dass wird ein wahres Fest.
Feuerstein hat ja noch nicht mal erwähnt, dass die Studie lediglich eine erneute Überprüfung der Wirksamkeit von Ceplene bei der Untergruppe von Patienten mit Lebermetastasen vornimmt. In der ersten Studie erreichte man fantastische Zahlen (p=0.00?), nach 36 Monaten war p=0.006. Obwohl zu diesem Ergebnis auch einige Zweifel geäußert wurden, wird p auch dieses Mal auf jeden Fall bei <0.05 liegen. Durch das Spezialprotkoll mit der FDA reicht das auf jeden Fall zur Zulassung.

[derschweizer]

@Neoe

Alles klar auf was Warten wir noch?

Die Story passt, werde Maxim nächste Woche sehr genau beobachten und bei einer eventuellen neuerlichen Kursschwäche zuschlagen.
Börse Online hatte Maxim bis vor 2-3 Wochen im Musterdepot. Der Kurs viel dann unter ihren Stopp. Fundamental schwärmten Sie in den höchsten Tönen von Maxim. Ich glaube die empfanden fast Schmerzen beim Verkauf.

grüße derschweizer

[asics01]

heute besteht die möglichkeit billig einzusteigen aktuell
-51%.

[BrauchGeld]

Hi

Und hier auch der Grund für den absturz.

Maxim Pharmaceutical Phase 3 Trial for Advanced Malignant Melanoma Fails to Meet Primary Endpoint
Sunday September 19, 11:18 pm ET
Conference Call Scheduled for September 20, 2004, 7:30 AM Pacific Time


SAN DIEGO--(BUSINESS WIRE)--Sept. 20, 2004--Maxim Pharmaceuticals (Nasdaq:MAXM - News; SSE:MAXM) today announced that its confirmatory Phase 3 trial (M104) of the investigational drug Ceplene(TM) (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) for the treatment of advanced malignant melanoma patients with liver metastases failed to demonstrate an improvement in overall patient survival, the primary endpoint. The combination therapy was generally well tolerated, and safety was consistent with previous clinical experience. Maxim will continue evaluating the M104 clinical data, its malignant melanoma program, and the related regulatory submissions seeking approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).
ADVERTISEMENT


"We would like to thank the patients and their families, and the dedicated clinicians and nurses, who participated in this study. While this study did not meet its primary endpoint, we remain committed to further studying Ceplene`s potential. It is our belief, as supported by the Phase 3 Acute Myeloid Leukemia data released this past May, and other clinical and preclinical evidence, that Ceplene still holds promise for the treatment of certain cancers," commented Larry G. Stambaugh, Maxim`s Chief Executive Officer.

"Moving forward, our dedication to meeting the challenge of improving survival and quality of life for seriously ill cancer patients will remain unchanged. Maxim plans to pursue regulatory submissions to the FDA and EMEA seeking approval of Ceplene to treat AML patients in complete remission, and to continue evaluating the M104 study data. We will also conduct a review of our pipeline, our operations and resources, so that we can focus on efficiently advancing Ceplene and other product candidates towards the market. Additional information will be provided after we further evaluate the melanoma study data and our other programs, and we have met with regulators," added Mr. Stambaugh.

Gruss
B.M.

[Neoe]

Bitter böse, ich häng bereits bis zum Hacken in der Maxim-Scheise

[puhvogel]

@asics:
Die Verfahren von AGEN gefällt mir außerordentlich, so stelle ich mir zukünftige Tumorbehandlung in Kombi mit anderen Verfahren vor. Das Verfahren gefällt mir mehr noch als damals mit AVXT, nur wären letztere eher am Markt gewesen.

Nur haben Biotechs so an sich, dass Insider ganz gerne vorher mal einsteigen, weil sie zB große Unterschiede in dem Fortkommen der Patientenpopulation sehen oder auch eben nicht.
Es gibt durchaus Fälle, in denen von solchen Insidern im Vorfeld der Ergebnisse nix zu sehen ist, aber eben auch viele, wo das deutlich erkennbar ist zB damals mit Neotherapeutics. Wenn ich solche Kursbewegungen im Vorfeld zu 80 % richtig deuten könnte, dann wäre ich ein reicher Mann, aber retrospektiv erschliesst sich so manches.

Das Maxim keine Zahlen veröffentlicht scheint auf eine Totalpleite hinzudeuten, Schade, da in den ersten Studien Ceplene gerade bei Punkt Schmerzempfinden gepunktet hatte!

[Neoe]

Das ist echt schmerzhaft mit Maxim, jetzt muss ich halt volles Risiko gehen. Entweder ich lande jetzt Ende September mit einem ähnlichen Kandidaten einen Volltreffer oder ich muss mich langsam aus dem Biotech-Geschäft zurückziehen: Die Nerven.
(Unternehmen bleibt aber bis zu den (erfolgreichen)Daten geheim, ich will mich ja bei Nicht-Erfolg nicht zur totalen Lachnummer machen).

[Neoe]

Nebenbei zu Maxim:
Die heutigen Daten machen Maxim zu einer unhaltbaren Aktie, da leider nicht nur das worst-case-scenario in dem Sinne eingetroffen ist, das der primäre Endpunkt der Studie nicht errecht wurde. Die Daten von heute belegen, dass die M01-Studie mit der Auwertung einer Untergruppe (p=0.006) ein Fake war. Das erreichen der statistischen Relevanz nach 24 und 36 Monaten für alle Patienten wird damit auch erheblich in Frage gestellt.
Das rückt Maxim in ein sehr düsteres Licht.

[asics01]

hey neoe
so ist das nun mal wenn man sein geld in bios investiert,aber das geht uns allen so.also zur lachnummer machst du dich deswegen nicht,denn bios sind halt für solche meldungen sehr anfällig.ich hoffe du hängst nicht zu fett drin. überlege mal wieviel geld in den biotechschmieden verbrannt wird .hoffe dein 2ter kandidat macht es besser.

asics

[fettinsky]

für entschlossene Anleger :
Der Antikörper gegen Anthrax von VaxGen wird vermutlich Ende September von der US-Regierung angefordert. Ein binäres Ereignis. Allerdings sehe ich die Chancen detlich höher als das Risiko.

[Neoe]

Also ich werde jetzt meinen neuesten Tip doch mal vorstellen, schließlich wurde der Thread ja eröffnet, um Chancen aufzuzeigen, bevor die Dinger gelaufen sind.
Ich bin seit Montag dabei und hoffe hier auf einen kurzfristigen Sprung. Allerdings Risiokoklasse 10 (auf der Skala von 1-10).


Nasdaq:AGIX
Atherogenics: AGI-1067

AGI-1067 for Atherosclerosis
Our lead v-protectantTM product candidate, AGI-1067, is a novel small molecule that was designed to treat atherosclerosis of the blood vessels of the heart, or coronary artery disease. We believe that AGI-1067 may treat all areas of the coronary artery susceptible to atherosclerosis in a way that cannot be achieved with any existing therapy.

AGI-1067 was studied pre-clinically in multiple species to establish its therapeutic properties. Dosed orally, AGI-1067 blocked VCAM-1 expression, prevented atherosclerosis and showed potent anti-oxidant activity. Based upon the successful completion of pre-clinical testing, AGI-1067 was studied in seven Phase I clinical trials in more than 150 men and women, including healthy volunteers and patients up to the age of 85, to assess tolerability and potential for interaction with other drugs. In addition, we have given AGI-1067 in combination with other drugs commonly used in patients with atherosclerosis. In these clinical trials the subjects tolerated AGI-1067 well, with no dose or use-limiting side effects. These positive results supported our progress to Phase II clinical trials.

In November 2001, data presented at the American Heart Association 2001 Scientific Sessions suggested that AGI-1067 had a direct anti-atherosclerotic effect on coronary blood vessels, consistent with reversing the progression of coronary artery disease.

CART-1 was a 305-patient clinical trial that compared three oral doses of AGI-1067 (70 mg, 140 mg and 280 mg), given for six weeks, to placebo and probucol, a drug that has been shown to prevent restenosis. The primary endpoint of the trial was the size of the lumenal area (coronary artery opening), as measured by intravascular ultrasound (IVUS), six months after angioplasty. CART-1 results showed that the study met its primary endpoint, with mean minimal luminal areas of: 2.66 mm2 (placebo); 3.69 mm2 (probucol); 2.75 mm2 (70 mg), 3.17 mm2 (140 mg) and 3.36 mm2 (280 mg) (p<0.05 for both the AGI-1067 dose response and for 280 mg AGI-1067 vs. placebo). Angiographic restenosis was also assessed using a standard definition of restenosis as measured by quantitative coronary angiography (QCA). Rates of angiographic restenosis in stented arteries were 37.5 percent for placebo, 25.5 percent for probucol, and 26.0 percent in the combined AGI-1067 arms. This yielded a restenosis rate reduction of 32 percent and 31 percent by probucol and AGI-1067, respectively.

In addition, an early direct benefit on coronary artery disease was evident at two weeks as shown by a dose response improvement (p<0.05) of the luminal area at the site of angioplasty for patients who received AGI-1067. This direct benefit was maintained at the angioplasty site at the six-month follow-up, as measured by repeat angiography.

Data from a post-study IVUS analysis of reference vessels (blood vessels of coronary arteries that were not targets of angioplasty procedures) indicated lumen volumes actually increased for patients who received either of the top two doses of AGI-1067. In contrast, patients on placebo had decreased lumen volumes, consistent with the expected progression of atherosclerosis. These lumen volume changes were measured as: -5.3 mm3 for placebo, -0.2 mm3 for probucol, -2.4 mm3 for AGI-1067 70 mg, +3.5 mm3 for AGI-1067 140 mg, and +1.8 mm3 for AGI-1067 280 mg.

Based on the results of an End of Phase II meeting with the U.S. Food and Drug Administration in 2002 and a subsequent FDA Special Protocol Assessment in early 2003, AtheroGenics has initiated a pivotal Phase III clinical trial to evaluate AGI-1067 for the treatment of atherosclerosis.

The Phase III trial, referred to as ARISE (Aggressive Reduction of Inflammation Stops Events), is being conducted in approximately 180 cardiac centers throughout the United States, United Kingdom, Canada and South Africa. ARISE will evaluate the impact of AGI-1067 on important outcome measures such as death due to coronary disease, myocardial infarction, stroke, coronary re-vascularization and unstable angina in patients who have coronary heart disease. The study will also assess the incremental benefits of AGI-1067 versus the current standard of care in this patient population. As such, all patients in the trial, including those on placebo, will be receiving other appropriate heart disease medications, including statins and other cholesterol-lowering therapies, high blood pressure medications and anti-clotting agents. ARISE will enroll 4,000 patients who will be followed for an average of 18 months or until a minimum of 1,160 primary events, or outcome measures, have occurred.



Was in dem Text oben mitgeteilt wird, heißt nichts weniger als das AGI-1067 das Potential zum größten Blockbuster aller Zeiten hat und diese Analyse kommt nicht von mir. Um dieses Potential aber tatsächlich heben zu können, muss nachgewiesen werden, dass AGI-1067 tatsächlich die Fähigkeit hat verkalkte Arterien wieder freizulegen. Wäre das wirklich so, könnte die Komponente unter der Voraussetzung der richtigen Vermarktung sogar Lipitor von Pfizer in den Schatten stellen. Lipitorumsatz 2003: 9 Milliarden Dollar.
Ende September sollten Daten einer Phase II-Studie veröffentlicht werden, die zeigen werden, ob AGI-1067 diese Fähigkeit besitzt. Sollte diese Studie erfolgreich sein, erhöht sich die Wahrscheinlichkeit auf Erfolg einer bereits laufenden Phase III zudem auf 90 %.
Als kleiner Zusatz gibt es noch Phase II Ergebnisse einer Studie zur Wirksamkeit bei Patienten mit rheumatoider Arthritis.


Potential: bei Erfolg + 50-100%
bei Mißerfolg - 50%

[derschweizer]

@Neon

Was für üble Nachrichten, dass gibts doch nicht
War 3 Tage geschäftlich in Berlin und dann diese Bombe.
Hatte noch nicht in Maxim investiert, reines Glück für mich.
Ich hoffe, dass Du nicht volle Kalotte eingestiegen bist.
Mann oh Mann, werde keine Tips mehr anbieten, sorry.

grüße derschweizer

[Neoe]

@derschweizer:

"Volle Kalotte" trifft es ganz gut. Allerdings war ich mir des Risikos schon bewusst. Allerdings wollte ich nicht dran glauben, dass die Maxim-Leute in der M01-Studie tatsächlich die Ergebnisse zu ihren Gunsten manipuliert haben. Die haben wirklich den relativ gesunden
Personen Ceplene+Il-2 verabreicht und den sehr kranken Il-2, wäre das nicht so gewesen wären die Studienergebnisse äußerst positiv gewesen. Der Verdacht ist also leider zur Gewissheit geworden.
Deswegen habe ich auch meine Verluste realisiert, ich denke dass die restlichen Studien unter Umständen genauso gefaked sind.

Und übrigens:
Ich erwarte natürlich weitere Empfehlungen von dir, MAXM war ja vom Potential her auch ein absoluter Knaller...wie es eben so läuft: diesmal schlecht, vielleicht bald wieder besser.

Hab mit Atherogenics immerhin schon wieder 20 Prozent seit Montag rausgeholt. 70 Prozent brauch ich noch um auf Null rauszukommen.

[derschweizer]

@Neoe

Ich habe gelesen, dass sich eine Sammelklage gegen Maxim in Vorbereitung befindet.
Das ganze Theater bietet schon den klassischen betrügerischen Ansatz.
Als Investment ist Maxim definitiv seit einigen Tagen gestorben.

Hoffe auf ein besseres Händchen bei der weiteren Auswahl.

viele grüße derschweizer

[BrauchGeld]

Hi Schweizer und Neoe

Glücklicherweise kamen die Ergebnisse schon Montag vorbörslich sonst wäre ich auch eingestiegen.

Schweizer guck Dir bitte mal diese Aktien an und sag uns welche zu empfehlen sind:

Samaritan Pharma (LIV)
Neurobiological (NTII)
Bioenvision (BIVN)
Tercica (TRCA)
Immtech (IMM)

Danke im vorraus

Gruss
B.M.

[Neoe]

@Brauchgeld:

Anscheinend stoßen die Biotech-Fans früher oder später immer auf die selben Werte. Ich möchte Schweizers Kommentar nicht vorwegnehmen, aber zumindest mit Bioenvision habe ich mich bereits intensiv beschäftigt.
Sicher auch einer meiner tragischen Momente, damals standen sie unter 1 Dollar und ich bin nicht eingestiegen.

Sowohl Modrenal als auch Clofarabine sind hochinteressant. Modrenal ist im Tierbereich auch schon zugelassen.
Um etwas abzukürzen: Einziges Manko für Bioenvision ist die Tatsache, dass sie nicht die kompletten Rechte an der Vermarktung haben. ILEX greift Nordamerika ab, wenn ich mich richtig erinnern kann.
George Soros ist übrigens an dem Unternehmen beteiligt.

[derschweizer]

@BrauchGeld

Ich habe mir die Bios eher oberflächlich angeschaut (leider Zeitmangel).
Herausragend finde ich wie Neoe, Bioenvision. Super Pipeline und enormes Potenzial.
Neoe hast du noch mehr detaillierte Infos zu dem Unternehmen?
Immtech ist auch nicht uninteressant, muss ich mit mehr Zeit noch mal richtig anschauen.

Ich habe noch was für Euch

Inhibitex (INHX)

grüße derschweizer

[Neoe]

@derschweizer:
Inhibitex ist auch sehr interessant. Fast Track für ein Phase II Produkt und ein weiteres in Phase III ist nicht schlecht.
Allerdings läuft anscheinend aber gerade eine Lock-Up-Periode für Altaktionäre aus, könnte also nochmal tiefer gehen.

[Neoe]

@schweizer:

Ich werd wahnsinnig :

Atherogenics: Nachbörslich 38 Dollar (=65%)

Seit Einstieg letzten Montag bei 18.2 Dollar also satte 110% Gewinn. Damit ist die Maxim-Angelegenheit ad acta gelegt.



AtheroGenics Announces Positive Interim Results From CART-2 Study
Monday September 27, 4:30 pm ET
Data Show Highly Statistically Significant Plaque Regression with AGI-1067 in One-Year Study
Conference Call and Webcast at 5:30 p.m. EDT on September 27, 2004


ATLANTA, Sept. 27 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - News), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced positive interim data from the CART-2 Phase IIb clinical trial with AGI-1067, its novel anti-inflammatory agent that targets atherosclerosis, as compared to current Standard of Care therapy. Data from the trial were independently analyzed by two of the world`s leading cardiac intravascular ultrasound (IVUS) labs; the Montreal Heart Institute (MHI) under the direction of Jean-Claude Tardif, M.D., and the Cleveland Clinic Foundation (CCF) under the direction of Steven Nissen, M.D.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040730/ATATHEROGENICSL… )
The primary endpoint of the trial was a change in coronary atherosclerosis, measured as total plaque volume after a 12-month treatment period compared to baseline values. Results of the interim analysis from the two labs indicate that AGI-1067 reduced plaque volume by an average of 6.4 cubic millimeters (3.8%), which was statistically significant (p<0.0003). An important secondary endpoint from the trial, change in plaque volume in the most severely diseased subsegment, also showed statistically significant (p<0.0001) regression from baseline by an average of 2.7 cubic millimeters (7.1%). Overall adverse event rates were similar in the AGI-1067 and Standard of Care groups, and AGI-1067 was generally well-tolerated.

"The interim analysis is providing a clear picture of AGI-1067`s ability to regress plaque in coronary arteries when dosed over a 12-month period," said Rob Scott, M.D., Senior Vice President of Clinical Development and Regulatory Affairs and Chief Medical Officer at AtheroGenics. "The data we have reviewed to date suggest that there is a measurable and rapid beneficial effect that is consistent with reversing coronary heart disease. If confirmed in the final study results, we believe this regression of plaque volume may provide clinical benefit to patients with coronary artery disease."

The data presented in the CART-2 interim analysis resulted from the following process: CART-2 was originally designed as a restenosis trial with change in atherosclerosis plaque volume as a secondary endpoint. As such, all of the randomized patient IVUS scans evaluated by MHI would not ordinarily have been included in an atherosclerosis trial. AtheroGenics and MHI subsequently commissioned CCF to independently read the entire set of IVUS scans in a blinded manner to identify the patients who were most suitable for quantitative analysis in an atherosclerosis study. The 133 patients included in this interim analysis were identified as a result of the CCF review of the IVUS scans, and both MHI and CCF have concurred that these patients are the appropriate subjects for the analysis.

The data analysis by both labs demonstrated that the reduction in plaque volume in the combined AGI-1067 treatment groups was greater than the Standard of Care group, although given the small number of patients in the interim analysis, the difference between groups was not statistically significant. The following is a table of the plaque changes for the AGI-1067 and Standard of Care groups, as reported by the two IVUS labs:

Change in Plaque Volume
Montreal Heart Institute Cleveland Clinic
Primary Endpoint cubic millimeters % cubic millimeters %

Total AGI-1067
groups (n=93) -5.4 (p<0.003) -3.3% -7.4 (p<0.0006) -4.2%

Standard of Care
group (n=40) -2.6 (p= NS*) -1.6% -4.4 (p= NS*) -2.4%

Most Severely Diseased Subsegment

Total AGI-1067
groups (n=93) -2.4 (p<0.0001) -6.3% -3.0 (p<0.0001) -8.0%

Standard of Care
group (n=40) -1.4 (p= NS*) -3.6% -1.3 (p= NS*) -3.5%

*NS = Not Statistically Significant


"As the lead investigator in CART-2, I consider these interim results promising since they show significant plaque regression in patients treated with AGI-1067," said Dr. Tardif. "These data also support the similar results from the CART-1 study. I look forward to the final analysis of CART-2 to confirm these results."

"The interim results of the CART-2 study are very promising," said Dr. Nissen. "I view this trial as a `proof-of-concept` study, in which AGI-1067 appears capable of inducing clinically meaningful reduction in atherosclerosis burden. It must be recognized that these are interim results of a subset of patients and will need to be confirmed when the study is completed. If confirmed by the final analysis, the prospect for successful development of AGI-1067 and a reduction in clinical events in the ARISE study is improved by these results."

About the CART-2 Study

Patients in the CART-2 study were randomized to placebo plus Standard of Care or to one of three treatment groups. Starting 14 days prior to a scheduled angioplasty procedure, the first treatment group received AGI-1067 for the full 14 days, the second group received placebo for the first 11 days and AGI-1067 for the last three days, and the third group received placebo for the full 14 days. Following the angioplasty, all three treatment groups continued receiving AGI-1067 for 12 consecutive months. The dose of AGI-1067 used for all patients in the treatment groups was 280 mg, dosed orally once per day, plus Standard of Care. Plaque volume was measured at the time of angioplasty and again at the end of one year using intravascular ultrasound (IVUS). With IVUS, a catheter containing a tiny ultrasound probe is inserted into a non-instrumented coronary artery to directly image and measure the size of the atherosclerotic plaques.

"We continue to be encouraged by the striking interim data from our studies with our anti-inflammatory compound, AGI-1067," said Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer at AtheroGenics. "This interim analysis further supports the new paradigm in cardiology, that inflammation is a driving factor in atherosclerosis. We expect to report final top-line data from the CART-2 study later this year."

About AGI-1067

AGI-1067 is a novel oral compound that was designed to selectively block the inflammatory process in atherosclerosis. AGI-1067 blocks signaling pathways within the endothelial cells that make up the inner lining of blood vessels, which in turn inhibits the production of VCAM-1 and other molecules involved in the inflammatory process. VCAM-1 recruits inflammatory cells to the surface of the endothelial cell, initiating the chronic inflammatory reaction that ultimately results in atherosclerosis.

Conference Call and Webcast Information

AtheroGenics will be hosting a conference call and webcast today at 5:30 p.m. EDT to discuss the interim results of the CART-2 clinical study of AGI- 1067. To participate in the audio portion and have the opportunity to pose questions, dial [phone] for domestic callers, and [phone] for international callers, and provide the Passcode 879664. A link to the webcast of the audio portion of the call and the accompanying slide presentation will be available on the Investor Relations section of the Company`s website, under the "Investor Calendar" tab, http://www.atherogenics.com .


@all:

P.S.:
Hat den Tip einer für sich genutzt ? Nur so aus Interesse.

[BrauchGeld]

Hi Neoe

Ich freue mich mit Dir und hoffe natürlich das die noch weiter steigt.
Ich selber bin nicht drin weil für mich atherogenics einfach zu riskant war.

Aber ein paar € hab ich jetzt auch schon mit Access Pharma verdient .Die steigt wirklich schön nur halt volumen fehlt noch.

Grüsse
B.M.

[fettinsky]

Vaxgen. Letzte Chance.
Morgen entscheidet das Verteiigungsministerium USA über den Großeinsatz von Anthrax-Impfstoffen von V.
Obohl ich vor solchen 50:50 Ereignissen normalerwesie sehr vorsichtig bin, glaube ich z.B. nicht, daß vor der Wahl eine negative Entscheidung fallen kann.

Gruß

[BrauchGeld]

Hi Leute !

Normalerweise meide ich zur Zeit Kanadische Biowerte ,aber bei Dimethaid Research (Kürzl: DMX.TO) musste ich einfach zugreifen.

Hier ein kleiner grund für mein Einstieg:

Topical anti-arthritic safer than pills
Thursday September 30, 2:55 pm ET


Rheumatology Journal Publishes Pennsaid(R) Oral Equivalence Trial
TORONTO, Sept. 30 /CNW/ - The Journal of Rheumatology has published a clinical study sponsored by Dimethaid Research Inc. (TSX: DMX - News), demonstrating that Pennsaid(R), the company`s anti-arthritic lotion, has an overall better safety profile than pills containing the same active ingredient. The 12-week trial also shows that Pennsaid works as well as the maximum daily dose of comparable oral medication at relieving knee osteoarthritis symptoms.

In an accompanying editorial, J. Rheum. editor Dr. R. Andrew Moore describes the pyramid of evidence supporting topical NSAID efficacy and his view that "the pinnacle is this new trial, demonstrating equivalence of topical and oral diclofenac in a large, valid, high quality trial."

"Without doubt, Pennsaid is as effective as the oral anti-arthritics," said Patrick Gushue, Dimethaid`s director, marketing and sales. "Couple that with the recent, worldwide withdrawal of Vioxx and we`re obviously sitting on a winner. Over the next two weeks, patients will be walking into doctors` offices asking what they should do. As Dr. Tugwell`s study shows, Pennsaid offers a realistic, and safer, alternative."

The study, which included 622 patients at 41 Canadian sites, found that oral diclofenac and Dimethaid`s topical formulation of the same active drug were equally effective at relieving pain and improving physical function when evaluated by the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The two treatments also produced a statistically equivalent increase in patient global assessment (PGA), a standard measure of all-round well- being.

"These results strongly support our strategy of creating commercial success based on a topical drug application," said Dimethaid`s president and chief executive officer, Dr. Henrich Guntermann. "They send a clear signal to doctors, especially given the severe side effects other NSAIDs can cause."

Pennsaid, which is spread on the skin, uses a chemical carrier to deliver drugs directly to the disease site. Unlike pills, the topical treatment exposes the bloodstream to negligible amounts of active drug. Dimethaid credits its patented technology for the low incidence of side effects reported in this latest peer-reviewed publication.

The article points out that patients treated with Pennsaid experienced noticeably fewer gastrointestinal adverse events - dyspepsia, diarrhea, nausea, flatulence and abdominal pain - and in particular, a lower incidence of GI events classified as severe. These patients also had a much smaller change in liver enzyme, hemoglobin, creatinine, and creatinine clearance levels.

Pennsaid-treated patients did have more skin-related adverse events, mostly mild cases of dry skin, although some experienced rash, itching or minor blisters at the application site. During followup, these reactions disappeared quickly when patients stopped treatment. To make sure all skin reactions were detected, the study protocol prohibited using emollients.

The Journal of Rheumatology paper was authored by lead investigator Dr. Peter S. Tugwell, director, Centre for Global Health, University of Ottawa, along with Dr. George A. Wells, chair and professor, Department of Epidemiology and Community Medicine, University of Ottawa, and Dr. J. Zev Shainhouse, Dimethaid`s medical director. Initial results were presented at the 4th European Congress of Rheumatology in Lisbon, Portugal and published as an abstract in the June 2003 edition of Annals of the Rheumatic Diseases. The full paper will be available online at www.jrheum.com.

Results from an earlier placebo-controlled Pennsaid study, recently published in the Canadian Medical Association Journal by rheumatologist Dr. Arthur Bookman, chair of The Arthritis Society`s medical advisory committee, can be found at http://www.cmaj.ca/cgi/content/full/171/4/333.

About Dimethaid

Dimethaid Research Inc. is a publicly traded, Canadian, pharmaceutical company headquartered in Markham, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany. The company develops and commercializes targeted therapeutic drugs designed to produce minimal side effects. Dimethaid`s two technology platforms focus on transcellular drug delivery and immune system regulation. Products are aimed at expanding treatment options in rheumatology, dermatology, oncology, immunology, and the therapeutic management of chronic viral infections. For more information, please visit www.dimethaid.com.

This release may contain forward-looking statements, subject to risks and uncertainties beyond management`s control. Actual results could differ materially from those expressed here. Risk factors are discussed in the Company`s annual information form filed with the securities commissions in each of the provinces of Canada. The Company undertakes no obligation to revise forward-looking statements in light of future events.

Was denkt ihr Freunde über diese Firma ?

Grüsse
B.M.

[BrauchGeld]

Hab wirklich Glück gehabt mit der Aktie.
Aktie knapp 60% im plus

Merck`s arthritis pain is Dimethaid`s gain: lotion maker`s stock rises
9/30/04

TORONTO, Sep 30, 2004 (The Canadian Press via COMTEX) --
Shares in Canadian drugmaker Dimethaid Research rose in value by by more than one-quarter Thursday amid expectations that its arthritis lotion will benefit from the troubles of Merck & Co.`s Vioxx.

Merck withdrew its blockbuster arthritis drug f
rom the market after a study found it doubled the risk of heart attack and stroke. The American pharmaceutical giant said about two million people worldwide were currently taking Vioxx.

Dimethaid quickly issued a news release noting that a recent 12-week medical trial on 622 Canadian patients found its Pennsaid ointment - applied to the site of the pain, instead of swallowed - "has an overall better safety profile than pills containing the same active ingredient" and "works as well as the maximum daily dose of comparable oral medication at relieving knee osteoarthritis symptoms."

The Toronto-headquartered company`s stock (TSXMX) jumped as much as 35 per cent after the news from Merck, hitting 46 cents on the Toronto stock market before receding to 42.5 cents late in the afternoon, still up by 8.5 cents or 25 per cent. The stock has a 52-week range between $1.88 and 25 cents.

"Without doubt, Pennsaid is as effective as the oral anti-arthritics," stated Patrick Gushue, Dimethaid`s director of marketing and sales.

"Couple that with the recent worldwide withdrawal of Vioxx and we`re obviously sitting on a winner."

Pennsaid uses a patented chemical carrier to deliver drugs through the skin directly to the disease site.

The Dimethaid-sponsored study reported in the Journal of Rheumatology found that the lotion produced fewer gastrointestinal side-effects but more skin-related adverse events, mostly mildly dry skin but also some rashes or itching where the lotion was applied.

The online source for news sports entertainment finance and business news in Canada

Grüsse
B.M.

[Mr.Arrogance]

na dann herzlichen glückwunsch...
wann und wo hast du denn gekauft?

[Neoe]

Wer meine Threads beobachtet, wird es natürlich schon kennen:

Ampligen für Chronic Fatigue Syndrome.

Hemispherx (NASD:HEB)

Phase III erfolgreich abgeschlossen. NDA in Q4. Orphan Drug Status und Treatment IND (Zulassungschance dadurch >90%).

Umsatz dürfte bei 150.000.000 (nur USA) bis 300.000.000 (nach Zulassung in USA und Europa) liegen.

Kein Konkurrenzprodukt am Horizont (Reminyl von Shire hat vor ein paar Tagen kläglich versagt).




Ampligen®
Nucleic acid compounds represent a potential new class of pharmaceutical products that are designed to act at the molecular level for treatment of human diseases. The Hemispherx Biopharma drug technology utilizes specifically-configured RNA. The Hemispherx double-stranded RNA drug product, trademarked Ampligen®, an experimental, unapproved drug, which is administered intravenously, is in human clinical development for various therapeutically oriented studies, including treatment for CFS/ME, HIV, renal cell carcinoma and malignant melanoma.

Based on the results of pre-clinical studies and clinical trials, Hemispherx believes that Ampligen®, an experimental agent, may have broad-spectrum anti-viral and anti-cancer properties. Approximately 500 patients have received Ampligen® in clinical trials authorized by the Food and Drug Administration (“FDA”) at over twenty clinical trial sites across the U.S., representing the administration of more than 40,000 doses of this drug, and Ampligen® is available only through clinical trials for limited indications.

Clinical trials already conducted by Hemispherx U.S. include treatments of CFS/ME, other infectious diseases such as Hepatitis B, HIV, and clinical trials for cancer including patients with renal cell carcinoma and malignant melanoma. Certain of these studies to date have not been well-controlled and accordingly additional tests will be necessary for support of regulatory approvals.

Hemispherx U.S. has been issued certain patents on the use of Ampligen® alone and Ampligen® in combination with certain other drugs including AZT, ddI, ddC, interferon and/or IL-2, for the treatment of HIV.

[derschweizer]

@Neoe

Freut mich für Dich, dass du die Scharte mit Maxim mehr als ausgleichen konntest.
Hemispherx steht bei mir nach wie vor unter strengster Beobachtung.

@all

Schaut mal nach dem Mauerblümchen Oscient Pharmaceuticals
Der Kurs ist in letzter Zeit stark zurückgekommen.
Gute Pipeline, starke Partnerschaften und ausreichend Cash.

Eure Meinungen würden mich interessieren.

grüße derschweizer

[BrauchGeld]

Hi Leute

derschweizer ich glaube bei Hemispherx ist jetzt eigentlich die beste Gelegenheit zu kaufen,ich denke mal das bei Positiver nachricht die Aktie explodiert oder natürlich auch abstürzt was ich nicht hoffe.

So und hier noch ein schöner Wert :

We are a biopharmaceutical company developing our proprietary humanized lung surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs` ability to absorb oxygen and to maintain proper airflow through the respiratory system. The absence or depletion of surfactants is involved in a number of respiratory diseases.

Our humanized surfactant technology is an engineered version of natural human lung surfactant containing a peptide, sinapultide, that is designed to precisely mimic the essential human lung surfactant protein B (SP-B). We believe that our proprietary surfactant technology is the only surfactant technology presently available to potentially treat a broad range of respiratory diseases including Respiratory Distress Syndrome (often referred to as RDS) in adults and infants, asthma, Chronic Obstructive Pulmonary Disease (often referred to as COPD, which is a chronic condition of the lung that prevents enough oxygen from reaching the blood), Acute Lung Injury (often referred to as ALI), and upper airway disorders such as sinusitis (infection of the sinuses) and sleep apnea.

Surfaxin®, our lead product, is being developed initially for critical care patients with life-threatening respiratory disorders where there are few, if any, approved therapies. We completed two Phase 3 trials for Surfaxin for the prevention of Respiratory Distress Syndrome in premature infants. In April 2004, we filed a New Drug Application (NDA) for this indication. The FDA has accepted the NDA filing. We are currently in Phase 3 and Phase 2 clinical trials for Meconium Aspiration Syndrome in full-term infants, and a Phase 2 clinical trial for Acute Respiratory Distress Syndrome in adults. We completed a successful Phase 1b clinical trial intended to evaluate the safety, tolerability and lung deposition of our humanized lung surfactant, delivered as an inhaled aerosol (development name DSC-104), to treat patients with asthma. We intend to initiate a Phase 2 clinical trial late in 2004 for patients with moderate to severe asthma.

We are preparing to initiate a Phase 2 clinical trial in late 2004, using aerosolized formulations of our humanized surfactant in combination with nasal continuous positive airway pressure (nCPAP) as a non-invasive means to potentially treat premature infants in Neonatal Intensive Care Units in hospitals that are suffering from pulmonary disorders. We are evaluating aerosolized formulations of our humanized surfactant to potentially treat Acute Lung Injury, chronic obstructive pulmonary disease (often referred to as COPD, which is a chronic condition of the lung that prevents enough oxygen from reaching the blood), rhinitis, sinusitis (infection of the sinuses), sleep apnea and otitis media (inner ear infection).

Presently, we are developing a dedicated sales and marketing capability through a collaboration with Quintiles Transnational Corp. to commercialize Surfaxin in neonatal indications in the United States. We also have entered into a strategic alliance with Laboratorios del Dr. Esteve to commercialize Surfaxin in Europe and Latin America. We intend to establish additional strategic alliances, where appropriate, for the development and commercialization of our products in other indications and markets.

Irgendwelche Meinungen dazu ?

Grüsse
B.M.

[derschweizer]

@BrauchGeld

Ich sage nur erste Sahne!
Discovery Labs (DSCO)

Werde Morgen meine Oma anpumpen

grüßle derschweizer

[derschweizer]

@all

und noch ein Mauerblümchen

Corixa Corp. (CRXA)

http://www.corixa.com

http://www.corixa.com/default.asp?pid=product_pipeline

lohnt sich wirklich etwas länger dran zu bleiben!

derschweizer

[BrauchGeld]

Hallo

Corixa hatte ich auch mal ,aber wenn einer sich den Chart anschaut wird man verstehen warum ich verkauft habe.

Ich verfolge schon seit längerem Medicure,aber irgendwie schreckt mich auch da die performance ab.
Ich werde aber dennoch die woche einsteigen ist einfach zu reizvoll.

Medicure (MPH.TO) (MCU)

MC-1 in angioplasty - strong Phase 2 results in MEND-1 trial.
MC-1 in coronary artery bypass surgery - currently in Phase 2/3 trial
MC-1 further development plans - Phase 3 trials for acute coronary syndrome, heart attack and angioplasty. Investigating usefulness of MC-1 in brain-related ishemia caused by stroke.

MC-4232 combination product using MC-1 plus an ACE inhibitor to not only reduce ishemic damage and control blood pressure, but also help control blood glucose levels (in initial Phase 2 study with MC-1 only, the blood glucose control aspect of MC-1 was shown). Currently the combination product is in an expanded Phase 2 trial in diabetic hypertensive patients.

MC-45228 Anti-thrombitic (for blood clots) not yet in clinical trials.

MC-4522 Second anti-ishemic to be produced, not yet in clinical trials.

Other combination drugs using MC-1 are being investigated.

Quite an interesting pipeline for a market cap of only about $65-$70 million.


Grüsse
B.M.

[Neoe]

@brauchgeld:

Medicure steht bei ebenfalls auf der Watchlist. Mit dem Symposium nächste Woche könnte der Wendepunkt kommen. Hier haben die selben Leute die Hände im Spiel, die auch bei Atherogenics zugange sind (Tardif).

Anfang nächster Woche könnte ein guter Zeitpunkt zum Einstieg sein, mal sehen. Wenn sie sich jetzt stabilisiert, sieht es sogar charttechnisch gut aus (66iger Retracement von 52 Wochen hoch). Obwohl mir Charts in der Regel schnuppe sind.

[BrauchGeld]

Hi Leute

Gude Schweizer falls Du im lande bist ,dann schau Dir mal bitte Enhance Biotech (EBOI.Pk) an und sag mir was Du davon hälst.

Danke

Grüsse
B.M.

[derschweizer]

@BrauchGeld

Nochmal kurz zu Corixa
Das Unternehmen ist gerade noch mit 260 Mio. US $ bewertet und verfügt über 168 Mio. US $ Cash (ca.3,00 US $ / Aktie)
Bei dem augenblicklichen Kurs von 4,65 US $ schon sehr verlockend.
Bei der Pipeline und der daraus resultierenden Chancen kann man nicht mehr viel falsch machen.
Normale Risiken und Nebenwirkungen inbegriffen.

Werde mir Deinen Vorschlag anschauen!

derschweizer

[Neoe]

@derschweizer:

Hab mir Oscient mal angesehen, Irgendwie scheint FACTIVE zumindest bei den Analysten nicht so gut anzukommen. Ich habe mich nicht sonderlich in die Materie vertieft. Weisst du was zum Umsatzpotential ?

[derschweizer]

@Neoe

Der Artikel beschäftigt sich ausschliesslich mit Factive.

http://www.pslgroup.com/dg/22fc46.htm

Das Umsatzpotenzial ist vorhanden, muss aber im Markt von Oscient erkämpft werden.

[derschweizer]

@BrauchGeld

Habe mir die Präsentation angeschaut
Mehr als vielversprechend, könnte wirklich eine Bereicherung für`s Depot werden.
Wenn Enhance den Zeitplan einhalten kann, ein echter Kracher.
Was mir nicht so recht gefällt, Listing an der OTC und ich habe keine News und Finanznachrichten auf der Homepage gefunden.
Kannst du mir da auf die Sprünge helfen?

derschweizer

[BrauchGeld]

Hi Leute

Schaut euch dieses Unternehmen an ich glaube das wird n Highflyer.

Es geht um Bioaccelerate (BACL.OB) das unternehmen investiert in aussichtsreiche Biotech Firmen also eine art BB Biotech .

Die Marktcap beträgt ca.18 mio$

Hier das Portfolio :

COMPANY NAME TICKER PIPELINE
Pre Clin/ Phase I /Phase II /Phase III /At Mkt
Evolve OncologyEVON 2 /2/ 2/ 0 /0
Enhance BiotechEBOI 1/ 3/ 2 /1 /0
BioenvisionBIV 1/ 3/ 2 /2 /3
CNS TheraN/A 1/ 1 /3 /0 /0
Innova LifestyleN/A 1/ 1/ 3 /0 /0
InncardioN/A 2/ 0/ 0/ 3/ 0
AnviraN/A 0/ 0/ 0/ 3/ 0
Neuro BioScienceNUBI 1 /2 /1/ 4 /0
BiocardioN/A 3/ 0/ 0/ 2 /0
OncbioONCB 3 2 0 2 0
Innovative OncologyN/A 3/ 1/ 0 /0 /0
Genar OncologyN/A 3/ 2 /1/ 1/ 0

Also insgesamt:
18 Produkte in Phase 3
14 " " " 2
17 " " " 1
21 " " " Pre -Clinical

Für mehr Informationen geht auf die Seite:
WWW.BIOACCELERATE.COM

Leute sagt mir was Ihr davon haltet

Schönes Wochenende

Grüsse
B.M.

[Neoe]

@brauchgeld:

Das meinst du jetzt aber nicht ernst mit Bioaccelerate.
Überhaupt ist mir die ganze Angelegenheit um Enhance und so weiter sehr suspekt. Enhance hat gerade mal 300,000 Cash und 2 Millionen Schulden und will damit eine Phase III einleiten. Eigentlich lächerlich, außer ich habe da was übersehen. Die restlichen Unternehmen sind auch samt und sonders an der OTC gelistet (oder gar nicht), sofern die Anteile von Bedeutung sind (Bioenvision und Australian Cancer sind die Ausnahme, die Beteiligungen sind aber sehr gering).
Diese ganze Struktur macht alles sehr unübersichtlich. Zudem werden die Aktien der Unternehmen die an der OTC gelistet sind kaum gehandelt, haben aber aufgrund des künstlich hoch gehaltenen Kurses "theoretisch" einen hohen Wert, worauf Bioaccelerate im Quartalsbericht (aber abseits der Bilanz) gerne mal hinweist.


Um mal bezüglich der Marktkapitalisierung etwas Klarheit zu schaffen:

Bioaccelerate Inc. Announces Closing of Acquisition
Thursday September 23, 2:29 pm ET
NEW YORK--(BUSINESS WIRE)--Sept. 23, 2004--Bioaccelerate Holdings Inc. (formerly Mobile Design Concepts Inc.), a Nevada corporation approved for trading on the OTC BB (trading symbol "BACL"), announced that it has completed the acquisition of Bioaccelerate Inc., a Delaware corporation. As part of the acquisition of Bioaccelerate, the company changed its name from Mobile Design Concepts to Bioaccelerate Holdings Inc., appointed a new board of directors and changed its offices to New York.
A 3.5-to-1 reverse stock split is effective with the opening of trading on Sept. 24, 2004, which reduces the previously outstanding common shares from 4,812,800 to 1,375,085. The company issued 32,325,000 shares in the transaction to the Bioaccelerate shareholders and now has 33,700,085 shares of common stock outstanding.

Der Kurs steht bei 13.75 Dollar (OTCBB:BACL.OB)


Also sollte ich hier nicht irgendetwas gravierendes übersehen haben, komme ich auf eine absolut rekordverdächtige bzw. sagenumwobene Marketcap von 463,375,000 Millionen Dollar


Damit bewegt sich das Papier in recht illustren Kreisen...

[BrauchGeld]

Gude Neoe

War wohl nix mit Highflyer was ,hab die Daten von
TheStreet.com
Hätte wohl selber forschen sollen.Sorry das nächste mal gucke ich mir die Sache genauer an .

Bioaccelerate Hldgs Inc (OTC BB: BACL)
13.00 -0.57 -4.20%
Data as of 12:00 AM ET 10/8/04
Chart: 1dy 5dy 1mo 6mo 1yr 5yr

Open High Low
n/a n/a n/a

Previous Close Bid / Size Ask / Size Dividend
13.57 13.00 14.00 n/a

Market Cap Shares Outstanding Price/Earnings Ratio
17.9 Million* 1,375,000* n/a

52-Week High 52-Week Low Today`s Volume
14.00 9.10 n/a
*Numbers include tradable shares only

Grüsse
B.M.

[BrauchGeld]

Hi Leute

Ym Biosciences Tsx:YM.TO Amex:YMI

YM BioSciences Inc., the cancer drug development company, was established in Canada in 1994. Its drug development portfolio, which includes three products in clinical development, is based on technologies licensed principally from academic centres of excellence internationally. Drugs in development include tesmilifene, a small molecule chemopotentiator (for taxanes and anthracyclines) that has been cleared by the FDA for a pivotal Phase III in metastatic breast cancer, which was initiated in Q1 2004, and for which it had completed a Phase III trial with positive results. In addition to tesmilifene, the company is developing an EGFr humanized monoclonal antibody that has completed Phase II trials; and a GnRH cancer vaccine also in clinical trials. In addition, the company had supported the preclinical development of two additional cancer products, a HER-1 and TGFa vaccine, which were licensed to CancerVax Corporation in July 2004. YM`s therapeutic candidates are in development programs in the United States, Canada, the UK, and Eastern and Western Europe.

ProduktPipeline:
http://www.ymbiosciences.com/main.cfm?docID=16

Marktdaten:
28.167.652mio shares Kurs: 2,75 c$ Marktcap:77.461.043mio c$

Grüsse
B.M.

[derschweizer]

@all

Hallo Leute,

schaut mal dieses Unternehmen an

http://www.axonyx.com

Axonyx entwickelt und forscht im Bereich "Alzheimer Erkrankung".

Marketcap. 240 Mio. US$
Cash 94 Mio.US$
Aktien 45,2 Mio.

derschweizer

[Neoe]

@schweizer:

Axonyx ist grundsätzlich interessant und zudem hochspannend, da es demnächst losgeht (Phase-III-Ergebnisse in Q1 2005.
Allerdings bin ich als Anhänger der Prana-Theorie äußerst skeptisch gegenüber jeder anderen Substanz, die sich in der Testphase befindet.
Auch Axonyx wird es schwer haben, relevante Daten vorzulegen. Immerhin ist ihr Produkt ähnlich den bisher zur Behandlung angewendeten ACeH-Inhibitors, also da muss wirklich schon ein Unterschied bestehen, dass das Medikament zugelassen wird. Das wird meiner MEinung nach eine Erbsenzählerei (die aber sicherlich auch zum Erfolg führen kann).


Was ich auf jeden Fall ins Feld führen möchte ist ein Ergebnis der Phase-II:

...an improvement in memory and cognition as a result of Phenserine treatment (ADAS-cog: 2.556-point improvement from baseline with Phenserine, 0.722-point improvement for placebo).

Sollte sich dies bestätigen, hätten wir es mit dem ersten Medikament zu tun, dass Alzheimer nicht nur verlangsamt, sondern aufhält oder sogar zurückdrängt.
Allerdings lief die Studie über lediglich 12-Wochen und sogar die Placebo-Empfänger wiesen eine Verbesserung auf.

Daran sieht man, dass diese Daten noch gar nichts aussagen. Ein Alzheimer-Patient verliert pro Jahr 6-12 Punkte auf der ADAS-cog-score-Liste. Das heisst die Placebo-Gruppe wird bei längerer Betrachtung radikal abstürzen, die Frage bei Phenserine ist nun, wie wird es da aussehen und das vorauszusagen, kommt der Vorhersage der Lottozahlen gleich:

Also: ein absoluter Zockkandidat, wenn es soweit ist....

[derschweizer]

@Neoe

Du hast vollkommen Recht, mittleres bis großes Risiko!
Wenn aber die Phase 3 Ergebnisse zufriedenstellend ausfallen sollten, geht Axonix durch die Decke.
Über das Marktpotenzial von Phenserine nach einer eventuellen Zulassung müssen wir wohl nicht lange diskutieren

Hast du dir Oscient (OSCI) nochmal genauer angeschaut?
Der Kurs kommt stark zurück, die Marketcap. beträgt noch 220 Mio.US$. Nach der Kapitalerhöhung verfügt das Unternehmen über 225 Mio.US$ Cash.
Die kompletten Vermarktungsrechte der Pipeline liegen in Händen von Oscient.

grüße derschweizer

[BrauchGeld]

Hallo !

Pain Therapeutics (PTIE)

OXYTREX™

• For the treatment of chronic pain, such as severe osteoarthritic pain, cancer pain or low-back pain
• Phase III trials initiated June 2003 and March 2004
• $1.9 billion market opportunity

Our lead candidate is a novel oral opioid called Oxytrex. Oxytrex is a small molecule drug that is currently in a Phase III clinical program. We are developing Oxytrex to treat severe chronic pain, such as low back, osteoarthritic pain or cancer pain.

Previous clinical results have shown that Oxytrex provides enhanced pain relief and prolonged pain relief. In a previously announced Phase II study with 350 patients suffering from severe osteoarthritic pain, Oxytrex reduced patients` pain scores by over 40% (p<0.001 vs. placebo and p=0.006 vs. oxycodone) over a 21-day treatment period. By comparison, oxycodone reduced patients` pain scores by 24%. Published pre-clinical results also demonstrate that the technology used in Oxytrex results in a lack of opioid addiction, tolerance, physical dependence or withdrawal symptoms in animals.

What is the status of PTI’s clinical programs?

We have two drug candidates in Phase III clinical trials: Oxytrex for chronic pain and PTI-901for patients with Irritable Bowel Syndrome. Our third drug candidate, Remoxy is an abuse resistant, long-acting oxycodone. We initiated a Phase I study in January 2004. Assuming positive Phase I results, we believe we remain on-track to initiate a Phase III efficacy program with Remoxy by the end of 2004.

How much cash does PTI have and what is the Company`s estimated cash requirement for 2004?

Cash, cash equivalents and marketable securities were $61.0 million at June 30, 2004. We continue to expect our cash requirements for 2004 to be approximately $37 million, plus or minus 10 percent. We continue to expect our net loss for 2004 to be approximately $39 million, plus or minus 10 percent. The net loss is expected to be higher than the cash requirements primarily due to non-cash expenses included in the net loss.


In June 2003, we announced the initiation of our first Phase III efficacy study. This randomized, double-blinded study compares the analgesic efficacy of Oxytrex against placebo and oxycodone over a three-month treatment period in up to 700 patients with severe chronic low-back pain. In March of 2004, we initiated a second Phase III clinical study of Oxytrex. This randomized, double-blinded study will compare the analgesic efficacy of Oxytrex against placebo and oxycodone over a three-month treatment period in up to 700 patients with severe chronic osteoarthritic pain.

PTI-901

• For the treatment of Irritable Bowel Syndrome (IBS)
• Phase III program initiated November 2003

Our third drug candidate is called PTI-901 and treats chronic Irritable Bowel Syndrome (IBS). PTI-901 is a proprietary drug candidate that consists of an oral low-dose opioid antagonist. If approved by the FDA to treat men and women with IBS, we believe PTI-901 will target a market in excess of $1 billion per year. We own all commercial rights to PTI-901.

We believe PTI-901 represents a novel approach to treat patients with IBS. We believe an appropriate dose of PTI-901 modulates aberrant neuronal communication within the gut, thus restoring proper bowel function and relieving pain in IBS patients.

Results from a 50-patient pilot study with PTI-901 in men and women were announced in May 2003 and presented at the American College of Gastroenterology meeting in October 2003. In this open-label study, patients with IBS reported a 76% response rate to PTI-901. This response rate was observed in both men and women and occurred without drug-related safety issues.

In November 2003, we announced the initiation of a Phase III program with PTI-901. The Phase III program consists of two clinical studies that are identical in all respects, except for gender. One study will enroll 600 women and the other will enroll 600 men, all of whom have been diagnosed with chronic IBS by a gastroenterologist according to clinically accepted criteria. Each Phase III study is randomized, double-blinded and will assess the clinical effect of PTI-901 against placebo during a three-month treatment period.

REMOXY™

Please note: Clicking on any of the following links will take you out of PTI`s web site. These links do not constitute an endorsement by PTI.

• Long-acting oxycodone with abuse-deterrent properties
• $1.9 billion market opportunity

In November 2003, we announced our second novel drug candidate, which we named Remoxy.

Remoxy is a proprietary abuse-resistant version of time-release oxycodone, a powerful narcotic painkiller. Oxycodone is also the active ingredient in Oxycontin®, a brand name drug with sales of nearly $1.9 billion.

In June 2004 we announced new study results in humans that demonstrate Remoxy is significantly less abusable than Oxycontin. The data demonstrate that Remoxy maintains its time-release mechanism under attempts to chew or to extract the drug in high-proof alcohol.

We conducted clinical studies in human volunteers to confirm Remoxy’s anti-abuse properties and to assess the drug’s pharmacokinetics. When used as directed, Remoxy provides twice daily dosing similar to Oxycontin. However, tests indicate that physically crushing Remoxy does not trigger a significant release of its oxycodone content compared to Oxycontin. Likewise, stirring Remoxy in high-proof alcohol releases just a fraction of its oxycodone content compared to Oxycontin. In addition, Remoxy’s sticky, high-viscosity capsule formulation makes it nearly impossible for drug abusers to snort or to inject the drug. These properties make Remoxy an unattractive choice for drug abusers who are looking to achieve a quick or powerful euphoric high. Remoxy’s unique formulation also prevents patients from accidentally overdosing on time-release oxycodone.

In recent years, the U.S. Drug Enforcement Administration and the national media have linked Oxycontin with widespread patterns of drug abuse, addiction, diversion and overdose. Abusers can easily extract the full dose of oxycodone from currently marketed time-release preparations, resulting in an immediate and large spike in oxycodone blood levels. This provides abusers with a fast and powerful morphine-like high. Recreational use of oxycodone can also lead to respiratory depression, death or opiate addiction. In 2002, oxycodone abuse resulted in over 20,000 visits to Emergency Rooms and of deaths in the U.S.

Please visit the U.S. Drug Enforcement Administration’s website for more information: http://www.usdoj.gov/dea/pubs/intel/02017/02017.html.

Remoxy is formulated with Durect Corporation’s SABER™ technology under a joint development and license agreement. SABER is a patented technology based on sucrose acetate isobutyrate, a high-viscosity, biodegradable liquid matrix that forms the basis for a number of different injectible depot and oral gel-cap drug candidates, including Remoxy. Under the terms of the license agreement between Pain Therapeutics and Durect, Pain Therapeutics has exclusive worldwide rights to develop and to commercialize Remoxy and certain other opioid drugs formulated with Durect’s SABER technology. Pain Therapeutics controls all of Remoxy’s preclinical, clinical, commercial manufacturing and sales/marketing activities. Durect is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, and will receive milestone payments based on the achievement of certain technical, clinical or regulatory milestones, in addition to receiving royalties on product sales.

What is the status of PTI’s clinical programs?

We have two drug candidates in Phase III clinical trials: Oxytrex for chronic pain and PTI-901for patients with Irritable Bowel Syndrome. Our third drug candidate, Remoxy is an abuse resistant, long-acting oxycodone. We initiated a Phase I study in January 2004. Assuming positive Phase I results, we believe we remain on-track to initiate a Phase III efficacy program with Remoxy by the end of 2004.

How much cash does PTI have and what is the Company`s estimated cash requirement for 2004?

Cash, cash equivalents and marketable securities were $61.0 million at June 30, 2004. We continue to expect our cash requirements for 2004 to be approximately $37 million, plus or minus 10 percent. We continue to expect our net loss for 2004 to be approximately $39 million, plus or minus 10 percent. The net loss is expected to be higher than the cash requirements primarily due to non-cash expenses included in the net loss.



Grüsse
B.M.

[BrauchGeld]

Hi Leute

Bin heute bei Insmed eingestiegen ,die haben ein interessantes Diabetes produkt in der Pipeline.

Lest mal diesen Artikel (habs aber nicht deswegen gekauft)

Insmed Incorporated (INSM) is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders. The company`s approach is to correct metabolic defects in the human body by replacing key regulatory molecules in a physiologically relevant fashion. Insmed has two lead drug candidates, recombinant human (rh) IGF-I/rhIGFBP-3 (also known as SomatoKine), and rhIGFBP-3. Insmed is actively developing these drugs to treat indications in the metabolic and oncology fields.
Insmed`s SomatoKine drug received orphan drug designation as a treatment for extreme insulin resistance. This is the first step to the FDA approval for ALL diabetes drugs -- that`s the promised land.

Every biotech firm with a new single molecule drug facing a multibillion-dollar market in phase III trial is valued at over $1 billion - EXCEPT Insmed. With approval of their diabetes drug, we expect 8X - 10X valuation improvement.

We are tracking a variety of companies in the diabetes space, and Insmed is one of the most promising speculative names. The idea behind this pick is simple -- they own the intellectual property via patents for a type of hormone replacement therapy that has shown significant impact in controlling diabetes.

The market for hormone replacement therapies is huge, with growth hormones representing a billion-dollar market and insulin being a $2 billion-plus sector.

Insmed owns the "key" (via dominant patent position) to safely deliver an insulin-like growth factor-binding proteins. Management believes their compound called SomatoKine has a $1 billion annual market potential and could help diabetics reduce their use of insulin -- an exciting prospect for treatment of the disease. It has already been proven effective for diabetes, severe burns and osteoporosis. Those indications are just the tip of the iceberg.

This is a great legacy play -- buy under $3 on their third-stage diabetes molecule.

Remember our five-year horizon here--we have a $25-$30 stock if our intelligence is right on their diabetes and cancer drugs. This is the way you get rich on stocks like this, using the bottom of the trading range to nibble and then forget about the short term.

Grüsse
B.M.

[Kelbi]

Schon vergessen?

Discovery Labs.- ein vielversprechendes Small Cap-Biotechnologieunternehmen?

Durch den Wirkstoff Surfaxin versucht das Unternehmen verschiedene Medikamente gegen Atemwegserkrankungen zu entwickeln.
Der größte Vorteil des Unternehmens ist es, dass die Konkurrenten Surfaxin nur aus tierischen Quellen gewinnen können, was sich sehr schwierig und teuer gestaltet.(Probleme bsp. durch BSE der Rinder)

Das kurzfristige Ziel ist es,die Testreihen in der Phase 3 mit Surfaxin gegen IRDS und MAS erfolgreich abzuschließen.
(Das Marktpotenzial von IRDS liegt jährlich bei 250MILL$)

Um große Rückschläge im Zulassungsverfahren zu vermeiden will das Unternehmen in Zukunft eine agressive Akquisitionsstrategie fahren, also im großen und ganzen Kann das ´Teil ein ganz großer werden und wird auf Grund des Wirkstoffes Surfaxin, dessen Gewinnungsverfahren patentiert ist, eher aufgekauft, als das es einfach pleite geht!

IRDS= idiopathische Atemwegserkrankung bei Frühgeborenen
MAS= Kindspeech Atemwegsinfektion

Inzwischen kurz vor Abschluss Phase III....gibt auch nen aufschlußreichen Thread hier

[Kelbi]

PS:

Wie konnte ich nur ...sorry an der Schweizer und Brauch geld....

[Kelbi]

PS:PS: aber was haltet Iht von Miravant(.ob) und ISTA

[kalabrienfan]

Danke für Euren echt guten Thread.
Habe mir diverse Werte angeschaut und mich für Discovery Labs entschieden. Habe gestern meine Nastech gut verkaufen
können, steuerfrei. Hoffe, das klappt diesmal auch. Gestern
war der Druck nach oben in USA bei DSC0 ganz schön.
Schaun wir mal.

[derschweizer]

@all

Jetzt kommt "Leben" in die Bude!
Ich finde den Thread auch Klasse, Danke an Neoe!

Oscient lässt mir momentan keine Ruhe, ich suche noch den Haken an der Story.
Der Kurs schmiert ab ohne Ende, obwohl die fundamentalen Daten stimmen (aus meiner Sicht).
Factive in unterschiedlichen Indikationen ziehlt auf einen 3 Milliarden US$ Markt ab.
Die Chance auf tolle Umsätze und Gewinne sind also gegeben.
Was könnten die wirklichen Gründe sein?
Vielleicht, dass Oscient eine eigene Sales Force (100 MA) aufbaut.
Natürlich belastet das im erste Schritt das Ergebniss.
Wer hat eine Meinung?
Wie denkt ihr darüber?

grüße derschweizer

[BrauchGeld]

Hi Biotech Freaks

Zur Abwechslung mal ein Wert aus UK

Alizyme (AZM.L) Kurs: ca. 1,81€ MK:262 mio €

Alizyme is a drug development company. It develops new products to treat diseases with high unmet medical need and substantial market opportunity. To date it has focused on obesity and related diseases, such as diabetes, and on gastrointestinal disorders including irritable bowel syndrome, inflammatory bowel disease and mucositis, a serious side effect of cancer therapy.

Alizyme takes drug product candidates from an early stage into clinical development with the objective of demonstrating their efficacy in patients and providing a comprehensive data package to support the further development and commercialisation of the drug. Alizyme owns the intellectual property rights to all four drug products currently in clinical trials and has an exclusive worldwide licence to the COLAL™ drug delivery system.

At a suitable stage Alizyme aims to license its products to pharmaceutical companies that have the ability to complete the clinical development of the product, to gain approval from the regulatory authorities and to successfully market the product.

Alizyme has developed its business with a high emphasis on outsourcing, controlled by its core management team and specialist advisors. Rather than establish its own laboratories and development facilities, it has worked with collaborators and service providers such as contract research organisations. This has the benefit of allowing Alizyme to focus its investment onto its development programmes in a cost effective way.



Hier die fortgeschrittene ProduktPipeline:
http://www.alizyme.co.uk/default.htm

Grüsse
B.M.

[Neoe]

@derschweizer:

Bei Oscient sehe ich drei Gründe (allerdings nur oberflächlich bewertet, da ich mich immer noch nicht intensiv damit beschäftigt habe):

1. Markt ist sehr groß, es bedarf eines hohen Marketingaufwandes, um sich durchzusetzten (unabhängig von der Qualität des Medikaments). Wie du schon sagtest, Oscient versucht diesen langen Weg alleine zu gehen.
Deswegen: hohe Kosten + ungewisser Erfolg
(ich habe dasselbe bei Novavax erlebt: bestes Produkt am Markt, vermarkten es auch selbst; Kurs liegt am Boden).

2. Tax-Loss-Selling: Wenn man sich den Kursverlauf im Jahre 2004 anschaut eine plausible Erklärung. Egal zu welchem Zeitpunkt 2004 gekauft wurde, momentan hat jeder Verluste in den Büchern. Die werden wohl derzeit realisiert. Frage: Ist Oscient jetzt schon am Boden oder kommt der richtige Sell-off noch ?

[Neoe]

Ich weiß nicht, ob wir es schon mal hatten:

Auf jeden Fall zu beobachten ist auch PHARMOS (NASD:PARS):

DEXANABINOL in Phase III. Ergebnisse Ende 2004/Anfang 2005


Update :.

Pharmos` pivotal, Phase lll clinical trial of dexanabinol for TBI is in its final stage. In mid-March 2004, the Company completed enrollment of 861 U.S. and international TBI patients and results of the trial are expected around yearend 2004. In September 2003, the FDA granted dexanabinol designation as a fast track drug, a program codified under the FDA Modernization Act of 1997 to streamline development and expedite review of new drugs for serious life-threatening conditions such as TBI.

:: The Opportunity ::

TBI is a leading cause of death and disability in industrialized societies. Annually within the U.S., there are about two million emergency room visits for head injury, roughly 300,000 admissions for head trauma, nearly 52,000 deaths and approximately 80,000-90,000 cases of severe long-term disability. The annual cost of acute care and rehabilitation in the U.S. for new cases is estimated to be as high as $10 billion. Additionally, survivors of severe head injury often face five to ten years of intensive rehabilitative treatment and lifelong disability. Lifetime treatment costs can reach $4 million. A study by the National Foundation for the Brain estimates the annual societal cost in the U.S. for TBI is $48.3 billion.


The annual market potential for a drug treating new TBI victims in the U.S. is over $500 million. The worldwide market potential exceeds $1 billion. Currently there is no FDA approved product for the treatment of severe head injury.

For more information on traumatic brain injury, please visit:

Centers for Disease Control and Prevention National Center for Injury Prevention and Control Traumatic Brain Injury in the United States - A Report to Congress, December 1999
Brain Injury Association, Inc.

top

:: The Indication ::

Injury to the brain, by physical trauma, stroke, or other insult, triggers a complex network of cascades that magnify neuronal damage and death far beyond that caused by the initial insult. The physical insult causes rapid release of excitatory amino acid neurotransmitters from damaged brain cells. The sharp increase in extracellular neurotransmitters overwhelm ion channel receptors on nearby brain cells that have not been damaged by the physical injury, leading to a massive influx of calcium ions into the cells. The excessive intracellular calcium levels trigger a host of biochemical events that generate large amounts of toxic and pro-inflammatory molecules such as free radicals, nitric oxide, prostaglandins, tumor necrosis factor-alpha (TNF-a) and other inflammatory cytokines. The resulting inflammatory cascades lead to breakdown of the vasculature at the blood-brain barrier and to neuronal brain cell death via necrosis and apoptosis. Within hours of the initial insult, these cascades cause intracranial pressure (ICP) to rise, leading to expansion of ischemia and development of secondary brain damage. The secondary neurological damage increases the probability of a bad clinical outcome for the patient.

[derschweizer]

@Neoe

Danke für Deine Einschätzung.
Einen Sell-Off auf dem jetzigen Kursniveau kann ich mir nicht vorstellen (muss nichts bedeuten).
Der Kurs bewegt sich auf Cash-Basis (3,00US$/Aktie), dass müsste normal eine gewisse Absicherung gewährleisten.
Das Investment ist für mich eine Wette in die Zukunft.
Sämtliche Vermarktungsrechte, hohe Margen, satte Gewinne.
Das Risiko hast du ja bereits geschildert.

derschweizer

[therman]

Hi Neoe,

die von Dir erwähnten Novavax, NVAX, #65,sind zur Zeit auf
einem sehr interessanten Niveau und einen Kauf wert.
Zumal sich in den Indikatoren bullishe Divergenzen zeigen.
So wie es aussieht könnte der Kurs nach oben ausbrechen.
Bin heute zu 3,34 eingestiegen.

Die Technologien und Produkte von Novavax haben wehr viel Potential denke ich.


@ brauchgeld #58
Ich bin ebenfalls in INSM investiert und traue diesem
Wert ein ganz aussergwöhnliches Potential zu.


therman

[Mr.Arrogance]

bin etwas besorgt wegen der positiven resonanz hier bzgl. DSCO... bin auch seit ende letzter woche investiert.
allerdings sehr riskant... sehe surfaxin in ards sehr skeptisch. auch die kingsbridge-finanzierung kann man kontrovers diskutieren, sehe ich aber eher positiv.
aber das gehört auch eher in einen DSCO-thread.

hier könnte man noch hinweisen auf CGTK... hop oder top hängt ab vom wert der TF decoy-technologie...

mr.A

[BrauchGeld]

Hallo

Cellegy Pharma

Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY)

Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs targeting primarily gastroenterology conditions and sexual dysfunction using proprietary topical formulations and nitric oxide (NO) donor technologies. Cellegy filed a New Drug Application (NDA) in June 2004 for CellegesicTM (nitroglycerin ointment) to treat chronic anal fissure pain, after reporting earlier this year positive results of its Phase 3 study. In August, Cellegy received approval for CellegesicTM (branded Rectogesic overseas) in the United Kingdom. TostrexTM (testosterone gel) for treatment of male hypogonadism is currently pending approval in Sweden. In July 2004, Cellegy entered into an exclusive license agreement with Strakan Pharmaceuticals to commercialize TostrexTM in Europe. TostrelleTM gel is nearing completion of a Phase 2 trial to improve libido in testosterone deficient women. Cellegy`s pipeline reflects its expertise using nitroglycerin ointment and NO donors to address a number of serious medical conditions including: Female Sexual Dysfunction (FSD), Raynaud`s Disease, prostate cancer and Restless Leg Syndrome.

INVESTMENT HIGHLIGHTS
High-Value Product Pipeline: Cellegesic, which produced positive results in a Phase 3 trial for chronic anal fissure pain reduction and is in a Phase 2 trial for hemorrhoids, addresses a potential domestic market exceeding $1 billion with no other approved prescription drug available for these indications. Additionally, Cellegy is in advanced clinical studies using Tostrelle for treatment of female hormone deficiency (reduced libido).

Lower-Risk Business Model: Cellegy is applying its proprietary technologies to develop new uses and/or formulations of well characterized FDA-approved compounds. Cellegy believes this affords a time-sensitive, cost-effective and lower risk development strategy.

Strong Global Patent Portfolio: Cellegy`s IP includes 22 domestic and 60+ foreign issued patents covering its products and technologies, and Cellegy enjoys a strong patent position in NO donors and phosphodiesterase (PDE) inhibitors for the treatment of FSD. The Company has 80+ patent applications.

Solid Ownership Mix: Cellegy`s shares outstanding are about two-thirds held by important institutional investors, including 33% by SJ Strategic Investments and Kingsway, which are funds controlled by John and Joseph Gregory, respectively. The Gregory brothers were instrumental in building King Pharmaceuticals, a premier specialty pharmaceutical company. An additional 20% is held by the Tisch Family Funds. About 4% of shares are held by directors and officers, representing a significant holding for an established public company.

Recently Bolstered Cash Position, Tightly Controlled Spending: Cellegy has approximately $14.0 million of cash and equivalents, which includes $10.3 million raised in a July 2004 private placement. This represents 12 months of cash based on the current, well-controlled burn rate. Cellegy also has access to a $15 million equity facility with Kingsbridge Capital Ltd.

Seasoned Executive Team: President and CEO, K. Michael Forrest, has extensive executive experience in the healthcare industry, ranging from privately-held to publicly-traded biotechnology companies and divisions of two major pharmaceutical companies. Richard Juelis, Chief Financial Officer and John Chandler, Vice President, Corporate Development, and David Karlin, M.D., Vice President, Clinical Research, all are experienced pharmaceutical professionals.

Premier Board of Directors: Within the last year, Cellegy appointed new Board Chairman, Richard C. Williams, and three new directors: John Q. Adams and Thomas M. Steinberg and Robert B. Rothermel, adding a wealth of experience and specific expertise to the Board, including extensive financial, corporate development, merger & acquisition and regulatory affairs capabilities.

PRODUCT DETAILS
Cellegesic™ (nitroglycerin ointment) is Cellegy`s lead product candidate, and is intended for the treatment of pain associated with chronic anal fissures and hemorrhoids. The Company has gained extensive clinical experience with NO donors in several clinical trials using Cellegesic. Analysis of the Phase 3 clinical trial completed in January 2004 shows that Cellegesic produced a statiscally significant (p<0.05) recuction in anal fissure pain in comparison to a placebo control during the first three weeks of the trial, the primary efficacy endpoint of the study. Cellegy filed an NDA in June 2004 and expects to have input from the FDA on approvability early next year. Cellegy also has a Phase 2 trial underway with Cellegesic for the treatment of various complications of hemorrhoids.

Rectogesic® (nitroglycerin ointment) is a proprietary formulation, similar to Cellegesic, currently marketed in Australia, New Zealand and in South Korea for the treatment of anal fissures. Rectogesic sales have more than doubled in Australia over the last two years achieving the No. 3 position in its category. The Company estimates the European market for Rectogesic, which recently received approval notification in the U.K. to be approximately $750 million. Cellegy is in the process of selecting a marketing partner to launch Rectogesic in Europe.

Tostrelle™ (testosterone gel) 0.5% is designed to restore deficient testosterone levels in postmenopausal women. Tostrelle uses a proprietary pump for metered dosing to deliver a specific amount of drug. It is a transparent, non-staining and convenient once-a-day gel that is applied to a small area of the skin. Cellegy has successfully completed two Phase 2 trials, and is currently conducting an amended Phase 2 trial in the U.S. Interim results of the ongoing Phase 2 trial showed that 71% of women receiving Tostrelle experienced improvement in sexual satisfaction. Cellegy is planning to initiate a Phase 3 trial in the first half of 2005.

Fortigel™ (testosterone gel) 2% (Tostrex™ overseas) treats male hypogonadism, a condition caused by a testosterone deficiency frequently resulting in lethargy, lack of concentration and a significant decline in libido. More than 5 million men in the U.S., primarily age 40+, have clinically deficient levels of testosterone. Based on market research, Cellegy believes Fortigel has the potential to capture a significant share of this large and growing market. In 2002, Cellegy filed an NDA and licensed North American marketing rights to PDI, Inc. In July 2003, Cellegy received a Not Approvable letter from the FDA. The Company is currently working with the FDA to determine next steps toward gaining marketing approval of Fortigel, including a Phase 3 clinical trial protocol under review by the FDA.

While not core to its pharmaceutical product strategy, Cellegy sells its C79 Intensive Moisturizer to a major specialty retailer that incorporates C79 into a line of skin care products. C79 has generated revenue in excess of $5 million since market launch.


CONDENSED FINANCIAL STATEMENTS
(In thousands, except per share data)
Six Months Ended
6/30/04 6/30/03
Total revenues $430 $ 263
Costs and Expenses $ 3,318 $4,428
Net income (loss) $ (2,708) $ (4,165)
Net income (loss) per share $ (0.13) $ (0.21)



RECENT ACCOMPLISHMENTS AND
NEAR-TERM MILESTONES
Announced positive interim results of Tostrelle trial - Phase 3 trial planned.
Rectogesic approved in the UK - Partnership pending.
License agreement with Strakan Pharmaceuticals for European commercialization of Tostrex.
Cellegesic NDA filed with and accepted by the FDA.
Raised $10.3 Million in Private Placement.
Announced positive results of Cellegesic Phase 3 clinical trial.
Secured $15 million equity financing facility with Kingsbridge Capital.
Appointed new Board Chairman and Directors.
FORWARD-LOOKING STATEMENTS
This web site contains forward-looking statements, including numerous risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors, the timing and outcome of the NDA review by the FDA of Cellegesic and the completion of trials for hemorrhoids and dyspareunia. There can be no assurance that the FDA will find the Cellegesic trial data, the statistical analysis methodology used by the Company, or other sections of the NDA acceptable. The FDA may not agree that the trial data satisfy the standards specified in the Special Protocol Assessment and may not ultimately grant marketing approval for Cellegesic. In addition, there is no certainty as to the outcome and timing of discussions with the FDA, particularly with regard to requirements, including the size and scope of an additional Phase 3 trial, for marketing approval of Fortigel.

In October 2003, Cellegy announced that it had received a communication from PDI, Inc. invoking mediation procedures under the exclusive license agreement between PDI and Cellegy relating to Fortigel. After mediation was completed in December 2003, both PDI and Cellegy initiated litigation proceedings against each other. The Company believes PDI`s claims are without merit. The Federal Court in New York recently decided that the cases would be consolidated in the Northern District of California and that future proceedings will be held in that jurisdiction. However, there can be no assurances regarding the outcome of litigation proceedings by Cellegy and PDI. The Company could be required to devote significant time and resources to the proceedings and an adverse outcome could have a material adverse financial impact on Cellegy.

Readers of this web site are cautioned not to place undue reliance on forward-looking statements, and we undertake no obligation to update or revise statements made herein. For more information regarding risk factors, refer to the Company`s Annual Report on Form 10-K for the year ending 2003, the 2004 First Quarter Form 10-Q and other documents the Company has filed with the Securities and Exchange Commission.

Pipeline:
http://www.cellegy.com/investors/press/table.html

Gruss
B.M.

[Neoe]

@fettinsky:

Heute wird sich also erweisen, was dein Tip wert war. Bin pünktlich zum Showdown drin.

[Neoe]

Verzögerter Showdown bei Vaxgen, aber trotzdem keine schlechten News. Der 5. Novemebr ist ins Auge zu fassen.
Besonders pikant, da jetzt über den Zeitpunkt der Wahl hinweg spekuliert werden muß.

[Neoe]

Nächster Kandidat:

LABOPHARM mit TRAMADOL.

Labopharm ist böse unter die Räder gekommen, da sie für ihren potentiellen Blockbuster TRAMADOL eine weitere Phase III in Amerika durchziehen, um sicher zu gehen, dass es zugelassen wird, nachdem eine von drei (Europa und Amerika zusammengenommen) Phase III Studien statisitsch unzulänglich war, aufgrund ausergewöhnlicher Daten im Placebo-Bereich.

TRAMADOL steht aber in Europa (Mutual Recognition Process) unmittelbar vor der Zulassung (Oktober wurde genannt) und wurde bereits von einer Arbeitsgruppe zur Zulassung empfohlen, hier werden auch erhebliche Meilensteinzahlungen erfolgen (circa. 15 Millionen Euro für die erste Zulassung in Frankreich).


http://www.labopharm.com

Marketcap: 70 Millionen Euro

[fettinsky]

#73
Bei Labopharm bin ich sehr skeptisch. Tramadolol ist mittlerweile ein preiswertes Generikum, das von vielen Firmen vertrieben wird, aber als 12 Stunden Retard Präparat, nicht als "once daily". Bei den vorherrschenden Sparzwängen im Gesundheitswesen weltweit wird nur ein sehr geringer Unterschied zu den konventionellen "twice daily" Pillen von Ärzten und Kassen toleriert werden. Ob damit ein großes Geschäft zu machen ist, möchte ich bezweifeln. Zudem kommt die Konkurrenz der Schmerzpflaster , eins alle 3 Tage.

Gruß

[Neoe]

@fettinsky:

Hier zählt vorerst nur eins: die positive Nachricht, für mich wird Labopharm sicher keine längere Geschichte.

Nebenbei bin ich mir sicher, dass du dir auch im Klaren bist, dass nicht zählt, ob ich das allerbeste Produkt habe (obwohl das der Fall ist: versus Placebo (standard-of-care) überlegen), sondern wer das Ding in solch einem weitläufigen Markt vertreibt und hier liegt der klare Vorteil für Labopharm; mit Aventis, Hexal und Esteve hat man die richtigen Partner an der Angel.
Zudem hat sich durch den Vioxx-Skandal (und die daraus resultierende kritische Betrachtung aller COX-2-Hemmer) für TRAMADOL ein größeres Anwendungsgebiet eröffnet.

Von welchem Pflaster sprichst du im Übrigen, würde mich interessieren (wo ist das zugehörige Unternehmen gelistet und in welcher klinischen Phase ist das Pflaster ?)

[Neoe]

@fettinsky:

Hier nochmal was zur Klärung des von dir benannten Generika-Problems. Ich denke mit höherer Wirksamkeit und nur einmaliger Anwendung, ist TRAMADOL gegenüber der sechsfach-täglich Generika-Produkte doch eindeutig überlegen:


Labopharm Europe eröffnet neue Hauptstelle in Dublin

Die Labopharm Europe Ltd., eine vollständige Tochter des kanadischen Spezialpharma-Unternehmen Labopharm Inc., gab heute die offizielleEröffnung ihrer neuen Hauptstelle im irischen Dublin bekannt......
....Das Unternehmen steht vor der kommerziellen Verwertung seines ersten Produkts, einer ein Mal täglich zu verabreichenden Formel des AnalgetikumsTramadol. Das Präparat dient zur Linderung mäßiger bis mittelschwerer Schmerzen. In Europa ist Tramadol derzeit als generische Formel mit sofortiger Wirkung verfügbar, die bis zu sechs Mal täglich verabreicht werden muss, und als Markenformel mit nachhaltiger Wirkung für zwei Mal tägliche Dosierung.

[BrauchGeld]

Hi Leute

Ich hab im moment ein auge auf Nutra Pharma(NPHC.OB)geworfen.Ist eine Biotech Holding mit zwei Produkten
(Multiple Sclerosis und HIV) beide in Phase 2 .

Vor ein paar Tagen gabs Positive Daten :
Nutra Pharma Reports Positive Results for ReceptoPharm`s RPI-78M in Multiple Sclerosis Animal Model
Thursday October 14, 9:44 am ET


BOYNTON BEACH, Fla.--(BUSINESS WIRE)--Oct. 14, 2004--Nutra Pharma Corp. (OTCBB:NPHC - News), a biotechnology holding company that owns rights to intellectual property related to the development of drugs for HIV and Multiple Sclerosis, has announced that its minority holding, ReceptoPharm, Inc. has reported the successful completion of studies in an animal model of Multiple Sclerosis (MS).
ADVERTISEMENT


EAE (experimental allergic encephalomyelitis) is the standard benchmark animal methodology for the study of MS. ReceptoPharm`s drug, RPI-78M, proved to be very effective in preventing the onset of disability in acute and chronic models of the disease. The drug was also very effective in preventing the infiltration of immune cells into the central nervous system. This research was conducted to confirm the reported benefits of similar products in immune mediated diseases such as Multiple Sclerosis and Rheumatoid Arthritis.

"The EAE study yielded the results we expected though we were pleasantly surprised at the reduced CNS infiltration by lymphocytes," commented Paul Reid, PhD, CEO of ReceptoPharm. "The results of this study complete the rationale for entering into clinical trials for the MS indication. We are actively working on one IND for the Phase II/III AMN (Adrenomyeloneuropathy) indication and when that is completed we will be in a good position to enter into MS trials," he added.

"These remarkable results provide supporting rationale for our microarray work with RPI-78M," commented James Flowers, President and Chief Scientific Officer of Eno Research and Development, Inc. (ERDI). "After reviewing this study, we expanded our efforts to include analysis of the interactions between the different cell types of the MS lesion," he continued. "Understanding how this compound affects the MS lesion and which genes it modulates, may help us understand the mechanism of action for RPI-78M." Nutra Pharma has engaged ERDI to study RPI-78M and its effects on gene expression using cDNA microarray technology. Their research aims to identify any potentially unique changes in gene expression that may be caused by the therapy.

"RPI-78M reduced the clinical symptoms by more than 80 percent," remarked neurologist Mitchell S. Felder, M.D. "There was also more than an 87 percent reduction in the number of EAE histopathologic lesions. If these results are duplicated in the human trials it could possibly revolutionize the treatment of MS. The results from an EAE model indicate that this drug may also have therapeutic potential for a great number of other neurologic conditions such as Acute Disseminated Encephalomyelitis, Transverse Myelitis, Krabbe`s Leukodystrophy, Alexander`s Disease, Canavan`s Disease and Adrenoleukodystrophy," he concluded.

"These results are very encouraging," commented Rik Deitsch, CEO of Nutra Pharma. "The positive results of the animal model support our move into Phase II human clinical trials," he added.

About Nutra Pharma Corp.

The Company`s minority-owned subsidiary, ReceptoPharm, Inc, is developing technologies for the development of drugs for HIV and Multiple Sclerosis ("MS"). The Company`s other holding, Infectech, Inc., is engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious diseases such as Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma continues to identify and acquire intellectual property and companies in the biotechnology arena. http://www.nutrapharma.com

Kurs:0,31$ Marktcap:15,7mio$ Shares Out:ca.50.700.000

Servus Schweizer und Neoe vielleicht könnt Ihr mir ja etwas helfen beim Recherchieren.
Lohnt es sich hier einzusteigen ?

Vielen Dank im vorraus

Gruss
B.M.

[BrauchGeld]

Hi


Alfacell (ACEL) MK:ca.110 mio$

PP:
http://www.alfacell.com/pipeline/pipeline.shtml

Alfacell is recognized as the global industry leader and pioneer in the development of novel ribonucleases (RNases), a family of proteins isolated from the leopard frog (Rana pipiens). Alfacell is developing new classes of RNase-derived therapeutics from this novel technology platform for cancer and other life-threatening diseases.

ONCONASE® (ranpirnase), the lead candidate in the robust Alfacell pipeline, is the first RNase protein fully chemically characterized by the Alfacell research and development team, and is the first RNase to reach late-stage clinical development. ONCONASE® is currently being evaluated in a confirmatory, international Phase III trial for the treatment of malignant mesothelioma, a form of cancer which usually affects the pleura (membrane that lines the chest cavity and the lungs). Nearly 75 percent of all malignant mesothelioma cases can be attributed to asbestos exposure.

Alfacell`s proprietary drug discovery program is also the basis for the development of recombinant designed RNases for chemical conjugation and fusion (gene and protein) products with various targeting moieties, such as monoclonal antibodies, growth factors, and cytokines. This program also provides for joint design and development of new products with outside partners seeking line-extensions and/or improvements of the therapeutic effectiveness of their existing products. The reproducibility of our conjugation and fusion methodologies and the stability of these products has been demonstrated, and thus can be produced in a cost-effective and controlled manufacturing environment.

Gruss
B.M.

[kalabrienfan]

Good News bei DSCO, Discovery Labs, heute.
Könnte aber auch mal wieder einen kleinen Hype vertragen.
Noch jemand dabei, außer mir??

[fettinsky]

Vaxgen kommt wie erwartet.

[Mr.Arrogance]

glückwunsch fettinsky und danke... denn ich habe zugegebenermaßen in relativ kleinem rahmen von deinem tip profitiert...
wo liegen deine kurserwartungen nach der $877 mio entscheidung?

[Neoe]

fettinsky:

Vaxgen bringts in der Tat. Mitte November kehrt Vaxgen an die NASDAQ zurueck. Bis dahin sollte Vaxgen nochmal zulegen. Also danke dir.

alle:
Halten mir die Threads am Laufen. Bin fuer einige Zeit im Ausland und kann mich nicht staendig melden.Haltet die Ohren steif und nutzt die Tips.

[derschweizer]

@Neoe

Hi Neoe,
mach`s gut und halte die Ohren steif.
Wir halten die Stellung, bis bald, viele Grüße.

derschweizer

[fettinsky]

Sehr interessant imho Genaera.
Das führende Produkt ist ein Hemmer der Gefäßneubildung und wird nicht wie viele andere Angiogenesehemmer in der Krebstherapie eingesetzt, sondern zur Verhinderung von Gefäßneubildung an der Netzhaut des Auges. Die sog. „feuchte Makuladegeneration“, die häufigste Ursache der Erblindung im späten Erwachsenenalter in der westlichen Welt, kann damit nach Phase II Daten zum Teil rückgängig gemacht, z.T. aufgehalten werden. Die Daten werden auf der Homepage von Genaera präsentiert.
Auf diesem Feld sind auch Genentech mit Novartis und Pfizer aktiv, beide sogar schon mit Phase III Ergebnissen und kurz vor der Zulasung oder schon frisch zugelassen. Doch deren Produkte müssen in den Glaskörper des Auges injiziert werden, was niemand gerne hat und was auch Komplikationen verursachen kann, während das Produkt von Genaera in die Vene als Infusion gegeben werden kann.
Anfang 2005 werden erste Ergebnisse der Phase III Studie erwartet. Die Nebenwirkungen scheinen tolerable zu sein.

Gruß

[Neoe]

Eine Empfehlung aus fernen Landen:

Wer noch dieses Jahr zu den Gewinnern gehoeren moechte sollte ein paar Euros auf Insmed setzen.

INSM wurde hier bereits empfohlen, ist nach einer Finazierungsrunde aber nochmal ordentlich eingebrochen.

Was bisher nicht beachtet wird, die Phase III fuer Somatokine (lead drug) verlaeuft bestens. Die NDA wird in den naechsten vier Wochen auf Basis der 6 Monatsdaten eingereicht (in Uebereinstimmung mit der FDA).
Die Studie dauert 12 Monate, die Sechsmonatsdaten waren aber bereits statistisch aussagekraeftig oder besser gesagt sagenhaft (p<0.0001). Besser geht nicht.

http://www.insmed.com

[therman]

Hi Neoe,

Bin ebenfalls überzeugt von Insmed INSM, und habe den
Kurseinbruch bei 1,30$ genutzt um meinen Bestand zu
verdoppeln.

Ich traue INSM langfristig eine Kurssteigerung von
mehreren 100% zu.

siehe auch der Thread: Thread: INSMED: MILLIARDENMARKT DIABETES, u.a....

therman

[derschweizer]

@all

Hallo Leute,

ich möchte euch Heute auf (WKN 883107) Protherics aufmerksam machen. Das Unternehmen hat sich auf Nischenprodukte spezialisiert und ist bereits profitabel. Der entgültige Durchbruch ist für 2005 geplant und dürfte den Kurs zusätzlich beflügeln. Für interessierte, hier der Link.

http://www.protherics.com

grüße derschweizer

[BrauchGeld]

Hi Leute

Hier ist ein wert mit einer geringen MK von knapp 23 Mio$ und einem Produkt gegen Hiv in Ph3 .
Was denkt Ihr kann man hier was verdienen ?

Polydex Pharma (Polxf)

Phase III Ushercell (Cellulose Sulfate) Trial for HIV Prevention Under Way
Tuesday October 19, 8:00 am ET


TORONTO--(MARKET WIRE)--Oct 19, 2004 -- Polydex Pharmaceuticals Limited (NasdaqSC:POLXF - News) (Boston:PXL - News) announced the commencement of a Phase III clinical trial of Ushercell (Cellulose Sulfate) a microbicidal gel which is being tested for its effectiveness in the prevention of HIV and other sexually transmitted infections. In ongoing contraceptive studies, Cellulose Sulfate, a high molecular weight polymer, may also prove to be a major advance in fertility regulation. Preclinical and clinical studies have already demonstrated its high level of safety. Laboratory tests revealed the potential of Cellulose Sulfate to act as an effective guard against both unwanted pregnancies and against sexually transmitted infections, including HIV/AIDS, gonorrhea, chlamydia and herpes 1 and 2.
ADVERTISEMENT


"The initiation of this Phase III trial is an important milestone in celebrating our successful partnership with CONRAD, as Ushercell becomes the first of our products to reach this critical stage in product development," said George Usher, President and CEO of Polydex.

CONRAD, located in Arlington, VA, has played an instrumental role in developing Cellulose Sulfate with the support of USAID and private foundations, and in clinical collaboration with Family Health International, WHO and NIH. CONRAD, which was established and funded by USAID at the Eastern Virginia Medical School, has focused on developing safe, effective, acceptable and affordable methods of contraception and microbicides for the prevention HIV/AIDS and other sexually transmitted infections.

Jeff Spieler, Chief of USAID`s Research Technology and Utilization Division of the Bureau for Global Health said: "USAID`s highest priority in microbicide research and development is to undertake the trials to demonstrate that a safe product can reduce the risk of acquiring HIV. Microbicides represent the best chance we have over the next several years to provide a life-saving HIV prevention technology for women who cannot negotiate condom use, including women whose only risk factor is their husband`s or partner`s lack of faithfulness."

In the summer of 2004, the FDA gave permission for the first Phase III HIV prevention study of Cellulose Sulphate to be carried out by FHI in two sites in Nigeria. A second study`s protocol has just been approved by the FDA and will be conducted by CONRAD in several countries with a high incidence of HIV infection.

The randomized placebo-controlled studies will assess the effect of 6% CS gel on HIV transmission among HIV negative women, who are at high risk of contracting HIV through intercourse. The primary objective of the trials is to determine the effectiveness of 6% CS gel (3.5mL) compared to a placebo, in preventing male-to-female vaginal transmission of HIV; the secondary objective is to determine the effectiveness of CS gel, compared to a placebo gel, in preventing male-to-female transmission of Neisseria gonorrhoeae and Chlamydia trachomatis.

Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry.

Note: This press release may contain forward-looking statements, within the meaning of the United States Securities Act of 1933, as amended, and the United States Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited. Actual events or results may differ materially from the Company`s expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to changing market conditions, future actions by the U.S. Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors discussed in the Company`s filings with the United States Securities and Exchange Commission may also affect the actual results achieved by the Company.

www.polydex.com

Gruss
B.M.

[Neoe]

Heisser Tip fuer die naechsten Tage und Wochen:

Aphton (APHT); irgendwann zwischen morgen und Weihnachten sind Ergebnisse zur Phase III von Insegnia (+Gemzitabine) zur Behandlung von Pancreatic Cancer (genaue Uebersetzung =???) zu erwarten. Als Monotherapie wurde Insegnia bereits in der Schweiz, Australien und Kanada zur Zulassung eingereicht.

Positive Ergebnisse sind also auch in diesem Fall zu erwarten, der entscheidende Punkt ist aber das Terceva (von Onyx) ebenfalls eine erfolgreiche Studie vorgewiesen hat und diese Ergebnisse muessen geschlagen werden, was meiner Meinung nach sehr, sehr gut moeglich ist, wenn man die bisherigen Insegnia-Ergebnisse und die Terceva-Ergebnisse vergleicht.

Potential kurzfristig bis zu plus 100% (bzw. minus 35-45%).

[Mr.Arrogance]

pancreas = bauchspeicheldrüse

was die ergebnisse von insegia betrifft, bin ich skeptisch... wie auch der markt, wenn man sich den kurverlauf der letzten wochen anschaut. die anträge in aus, can, sui scheinen unter dem motto "wir üben mal zulassungsanträge" gestanden zu haben.

positiv allerdings, daß der markt apht nix zutraut... bei einer positiven überraschung explodiert der kurs!

du meinst wahrscheinlich tarceva?! ist aber nicht von onxx... (dna, osip)

[Neoe]

mr.arrogance:

Alles richtig, danke fuer die Korrekturen.

Ich erwarte jedoch positive Ergebnisse, zumindest in der Gruppe von Personen die Antikoerper bildet, wird sich die Lebenserwartung von jetzt ca. 6 Monaten (Tarceva 6.4) auf 8 bis 12 Monate erhoehen, diese Behauptung kann man unter Beachtung der bisherigen Ergebnisse beruhigt aufstellen.

[fettinsky]

Supergen SUPG
in den nächsten Tagen erwarte ich eine interessante Bewegung bei SUPG. Es ist recht wahrscheinlich, daß in Kürze - heute?- Rubitecan, ein Topoisomerasehemmer, der bei Pankreaskarzinomen getestet wurde - NICHT zugelassen wird von der FDA.
Andererseits beginnt am 4.12. der ASH -Amerikanischer Hämatologenkongress- in San Diego, auf dem mit hoher Wahrscheinlichkeit gute Daten für Decitabine präsentiert werden.
Wenn diese Erwartungen nicht bereits von den Beobachtern der Szene und Investoren eingepreist sind, wäre vielleicht ab einem Abtauchen des Kurses unter 4 US $ eine gute Chance. Ein schmales Fenster.

[asics01]

hallo fettinsky
wie kommst du denn darauf das orathecin nicht zugelassen werden soll.??bist du hellseher ??

[derschweizer]

@asics

sind wir nicht alle ein bisschen Hellseher?
Mr.Arrogance ist auch Hellseher, "wir üben mal zulassungsanträge", so ein schmarrn.

Wir werden erleben was passiert.
Immer locker und geschmeidig bleiben.

derschweizer

[Mr.Arrogance]

schweizer, es ist zu merken, daß du apht erst seit diesem jahr beobachtest... dies erklärt deine euphorie und dein etwas oberflächliches wissen...

[derschweizer]

@Mr.Arroganz

schön für Dich, dass du über den totalen Überblick verfügst und im Zentrum des Wissens lebst und handelst.
Meine Bemerkung richtete sich etwas ironisch und mit einem zwinkernden Auge gegen deine Aussage "Zulassungen üben", nicht gegen deine Person. Du bist Profi genug um zu Wissen das die Aussage ein schmarrn war. Mit Euphorie hat das meiner Meinung nach nichts zu tun. Ich beschäftige mich sehr wohl kritisch mit Aphton und sehe logisch auch das enorme Risiko der Aktie.
Rauchen wir eine Friedenspfeife?

derschweizer

[fettinsky]

hallo asics01,

wäre ich Hellseher, würde ich Dir die Lottozahlen von heute mailen.
Rubitecan bringt nach der beim ASCO 2004 veröffentlichten Studie beim Pankreaskarzinom gegenüber "best choice therapy" keinen Überlebensvorteil und nur einen marginalen Vorteil von 10 (!) Tagen längere progressionsfreie Zeit. Man kann Studienergebnisse auch schönreden auf Kongressen.
Ich persönlich würde mir Rubitecan nicht antun.
Gruß

[BrauchGeld]

Hi Leute

Novadel Pharma (NVD) Kurs:1,58$ Mk:52 mio$

Hier ist ein wert das noch nicht so bekannt ist aber dennoch aussichtsreich ist.
Novadel Pharma hat sein erstes Produkt bei der FDA eingereicht und soll im juni 2005 zugelassen werden.
Also bei Zulassung (wovon ich überzeugt bin) könnte die Aktie in die Höhe schnellen.


Inyx Selected by NovaDel Pharma to Produce Nitroglycerin Lingual Spray
Tuesday November 23, 10:32 am ET


NEW YORK, Nov. 23 /PRNewswire-FirstCall/ -- Inyx, Inc. (OTC Bulletin Board: IYXI - News), a specialty pharmaceutical company with a focus on niche drug delivery technologies and products, announced today that it has been selected by NovaDel Pharma Inc. (AMEX: NVD - News) to produce NovaDel`s nitroglycerin lingual spray for the treatment of acute angina, under an exclusive five-year contract.
ADVERTISEMENT


In June, NovaDel filed a New Drug Application (NDA) with the U.S. Food and Drug Administration seeking marketing approval for its aerosol lingual spray version of nitroglycerin under Section 505(b) (2) application that relies on data developed by NovaDel and historical data published in the literature. On September 29, 2004, NovaDel reported that the NDA has been accepted for review by the FDA. The Prescription Drug User Act (PDUFA) goal date is June 4, 2005.

As a result, the targeted date for Inyx to commence production of the NovaDel product is mid-2005. Under the contract, Inyx will produce the nitroglycerin spray for the United States and most international markets for the first five years on an exclusive manufacturing basis, and then on a non- exclusive basis for the following five years. Inyx intends to produce the NovaDel nitroglycerin spray out of Manati, Puerto Rico. On October 7, 2004, Inyx announced it had agreed to acquire from Sanofi-Aventis Group (NYSE: SNY - News) the Aventis Pharmaceuticals Puerto Rico site in Manati, with the acquisition anticipated to close by March 31, 2005.

Jack Kachkar, M.D., Chairman and CEO of Inyx, said, "We are very gratified to have been selected by NovaDel to produce this very important product for the company. We are looking forward to a long-term relationship with NovaDel." Discussions are already underway regarding agreements for additional products currently in NovaDel`s pipeline.

Gary A. Shangold, M.D., NovaDel`s President and CEO, said, "This is the first of NovaDel`s six Tier One priority products to reach the stage of NDA submission. Inyx was selected because of its manufacturing expertise for metered dose sprays in particular and inhalation-therapy products in general."

If the NDA is approved as submitted, NovaDel`s nitroglycerin lingual spray will be intended for acute relief of an attack or acute prophylaxis of angina pectoris, which is chest pain or discomfort due to coronary artery disease. The nitroglycerin treatment is delivered via a metered dose dispenser designed to ensure accurate dose delivery. This will enable patients to self- administer the product just as they would a breath freshener.

In the United States alone, nearly seven million people suffer from acute angina pectoris, according to the American Heart Association, and U.S. retail sales of nitroglycerin (both capsules and sprays) are in excess of $100 million annually. Approximately the same number of patients in the five largest markets of Europe (Germany, United Kingdom, France, Italy and Spain) have acute angina, according to the British Heart Foundation. It is prescribed that anyone with chronic stable angina keep nitroglycerin tablets or spray with them at all times.

On September 8, 2004, NovaDel announced that it entered into a licensing agreement with Par Pharmaceutical Companies, Inc. (NYSE: PRX - News) to market its nitroglycerin lingual spray in the U.S. and Canada. In July, NovaDel was awarded European Union patent No. 0927032 covering the product.
http://www.novadel.com/

Gruss
B.M.

[asics01]

hallo fettinsky
gibt es nicht auch noch andere zulassungskriterien wie
verträglichkeit nebenwirkungen ....??

[fettinsky]

in erster Linie muß ein Medikament was bringen.
Ich kann mich allerdings sehr irren. Meine Stellungnahmen sind immer sehr subjektiv eingefärbt. Da ich nicht in SUPG investiert bin, ist es mir egal. Wenn Rubitecan allerdings nicht zugelassen wird und die Akte schmiert ab, werde ich wahrscheinlich zugreifen.

Gruß

[asics01]

also das supergen nochmal kräftig abschmiert kann ich mir nicht vorstellen.sicher gibts was auf die mütze wenn die zulassung nicht klappt,aber das wird sich in grenzen halten denn bei supergen gings ja in letzter zeit nur nach unten trotz kooperationen und zulassungsanträgen usw.schau mer mal.

[Mr.Arrogance]

schweizer, mir liegt nichts an einer persönlichen auseinandersetzung.
dennoch, meine bemerkung zu den zulassungsanträgen ist nicht ohne hintergrund.
vielleicht erinnerst du dich an das chaos bei apht im sommer 2003, als der strategiewechsel verkündet wurde, g17dt-zulassung doch zuerst in usa zu beantragen und deshal später als geplant. zur gleichen zeit wurde übrigens ohne begründung eine phase 3 studie in europa gecancelt, auch nicht gerade eine vertrauensfördernde maßnahme. ich schrieb damals, es sei sehr unwahrscheinlich, daß g17dt aufgrund des placebo-trials zugelassen wird... dies bestätigte sich, der plan wurde wieder aufgegeben und man versuchte es doch zunächst einmal in australien... meine bemerkung "zulassungsanträge üben" basiert auf einer damaligen äußerung eines apht-offiziellen auf einer pressekonferenz, die in diese richtung ging... sinngemäß sagte er, wenn der versuch in australien scheitern würde, so hätte man doch zumindest schon einmal erfahrung gesammelt...

gruß mr.A

[Mr.Arrogance]

fettinsky, sehr interessante idee, supg zu traden... deutet einiges darauf hin, das rubitecan(orathecin) scheitert, und das ist keine hellseherei, sondern risikoabwägung. keine signifikanz beim primären ziel der kommunizierten phase 3 studie, kein odac-meeting, abbott ist abgesprungen... schätze zulassungswahrscheinlichkeit auf keinen fall größer als 20%.
stellen sich nur die fragen, wie weit sinkt der kurs, denn die meisten dürften bereits aufgrund des vielversprechenderen dacogen investiert sein, und kommt die ablehnung noch rechtzeitig vor den dacogen-news...

[BrauchGeld]

Hallo

Inex Pharm Mk:130 Mio €

Leute aufgepasst bei Inex pharma wird es am Mittwoch interessant.
An diesem Tag wird darüber beraten ob das Produkt(Marqibo)für die Zulassung am 15.1.2005 empfohlen wird.
Hier lohnt es sich meiner meinung nach ein auge drauf zu werfen.

Hier ein paar informationen :


Marqibo™

Product Strategy
INEX’s lead product is Marqibo™, a proprietary drug comprised of the widely used, off-patent, anticancer drug vincristine and the Company`s liposomal drug delivery technology.

INEX’s commercial strategy for Marqibo™ is to capture a portion of the market in which free-form vincristine is now used and where there is a need for more effective, less toxic therapies. These individual markets are relatively small, but since vincristine is used to treat approximately 200,000 individuals on an annual basis in North America, Western Europe and Japan, the combined markets would be sizeable.

On January 20, 2004, INEX announced that it had entered into a strategic partnership with Enzon Pharmaceuticals Inc. to develop and commercialize Marqibo™ in North America. INEX retains commercialization rights for Marqibo™ outside North America.

In 1998, INEX determined that the fastest route to market for Marqibo™ would be as a treatment for relapsed aggressive non-Hodgkin’s lymphoma (NHL). INEX chose this lead indication because no standard treatment was available for relapsed aggressive NHL and, therefore, Marqibo™ would be a candidate for accelerated development status and Fast Track designation from the U.S. Food and Drug Administration. Furthermore, management believes that this lead indication had a high potential for success because approximately 50% of worldwide vincristine usage is for lymphoma indications.

Once the lead indication was in advanced development, INEX’s strategy was to initiate clinical trials for other indications to broaden the potential market for the product. The largest of these follow-on indications is first-line NHL.


Executing the Strategy
In 1999, final results from a phase II clinical trial of Marqibo™, carried out at the University of Texas M. D. Anderson Cancer Center in 1998 and 1999, demonstrated the drug may be effective for reducing the size of tumors in patients with relapsed aggressive and transformed non-Hodgkin`s lymphoma (NHL).

In 1999, the FDA granted Accelerated Development status to Marqibo™. This allows a company to seek expedited marketing approval using a single clinical trial in which the drug demonstrates therapeutic benefit based on a surrogate endpoint. Normally, a drug can`t be submitted for approval until it has undergone a more extensive phase III program involving two adequate and well-controlled studies. Accelerated Development status is expected to reduce the clinical development program for Marqibo™ as a treatment for relapsed aggressive NHL by at least a year.

In late 1999, the FDA approved INEX’s protocol design for a pivotal phase II/III clinical trial protocol and the company began recruiting trial sites.

In 2000, INEX began enrolling patients for the pivotal phase II/III clinical trial and the FDA granted Marqibo™ Fast Track designation. Fast Track designation allows a company to submit data that supports a New Drug Application (NDA) as they become available. The FDA can begin its review when the first parts of the NDA are submitted, as opposed to the normal process in which the review begins only when all parts have been submitted.

In March 2004, INEX completed an NDA seeking marketing approval for Marqibo™ as a single-agent treatment for patients with relapsed aggressive NHL previously treated with at least two combination chemotherapy regimens.

On May 21, 2004, the NDA was accepted by the FDA and was granted Standard Review designation. Based on this designation, the FDA has established a target date of January 15, 2005 for completion of the review.

The FDA will review Marqibo™ at its December 1, 2004 ODAC meeting

Marqibo™ is also currently being evaluated in a number of phase II clinical trials as a treatment for first-line non-Hodgkin`s lymphoma, relapsed Hodgkin`s disease, relapsed acute lymphoblastic leukemia and relapsed pediatric malignancies.

Specific information on the clinical trials for Marqibo™ can be found in the clinical section.

Inex Pharmaceuticals Corporation was founded in 1992 based on the drug delivery technologies developed by Dr. Pieter Cullis, INEX`s Chief Scientific Officer, and his scientific team at the University of British Columbia.

This work put INEX on a course to its first scientific platform, called Targeted Chemotherapy, which encapsulates and delivers therapeutic compounds through the bloodstream to tumor sites.

INEX’s lead product candidate, Marqibo™ (vincristine sulfate liposomes injection), formerly referred to as Onco TCS, is based on this platform.

On May 21, 2004 the US Food and Drug Administration (FDA) accepted INEX`s New Drug Application (NDA) seeking marketing approval for Marqibo™ as a single-agent treatment for patients with relapsed aggressive non-Hodgkin`s lymphoma (NHL) previously treated with at least two combination chemotherapy regimens. The FDA provided INEX with a target date of response on the NDA of January 15, 2005.

On September 27, 2004 INEX announced that the FDA will review Marqibo™ at its December 1, 2004 Oncologic Drugs Advisory Committee(ODAC) meeting.

On January 20, 2004 INEX announced that it had entered into a strategic partnership with Enzon Pharmaceuticals Inc. to develop and commercialize Marqibo™ in North America.

In December 2002 and June 2003, INEX released positive results of a completed pivotal phase II/III clinical trial for Marqibo™ in the treatment of relapsed non-Hodgkin`s lymphoma. This data supported the submission of the NDA to the FDA. Marqibo™ is currently being evaluated in several additional phase II clinical trials to treat a variety of cancers.

In April 2003, INEX announced INX-0125 (liposomal vinorelbine) as the third product based on the Targeted Chemotherapy platform. INX-0125 is a combination of the anticancer drug vinorelbine with INEX`s drug delivery technology. Vinorelbine is used primarily to treat breast and lung cancers.

In 1998, INEX acquired a portfolio of novel compounds called oligonucleotides (oligos), which are short sequences of DNA. These compounds form the basis of INEX`s second scientific platform - Targeted Immunotherapy. This platform, which is in the early stages of research, is based on lipid-encapsulated oligonucleotides that activate the immune system to treat cancer and infectious diseases.

In 1996, the company went public on the Toronto Stock Exchange (TSX) under the symbol IEX.

http://www.inexpharm.com/
Gruss
B.M.

[Mr.Arrogance]

supg
review für orathecin verlängert bis zum 26.02.05

[asics01]

hallo mr.arrogance
was nun tun ??habe gerade einen teil meiner supg verkauft,ich denke mit dem rest bleibe ich dabei.

gruß asics

[BrauchGeld]

Hi

Hier was aktuelles von heute zu Inex Pharma:


http://www.yorkton.com/webapp/v3w3/getdoc.jsp?i=-1803684

Gruss
B.M.

[Mr.Arrogance]

asics01, bin nicht investiert, daher nicht ganz der richtige ansprechpartner.
wie fettinsky hätte ich gekauft bei einem kurseinbruch aufgrund einer ablehnung, daraus ist zunächst nichts geworden.
viele haben damit gerechnet, deshalb ist ein delay der entscheidung, normalerweise negativ für den kurs, heute mit kursanstieg belohnt worden. möglicherweise hat orathecin noch eine chance...
die entscheidung pro oder contra supg bei mehr als $350 mio mc hängt nun zunächst davon ab, wie positiv man die chancen von dacogen beurteilt. dies interessiert mich auch als celg/pharmion-investor. ich sehe die chancen von dacogen nicht so gut, als daß ich beim jetzigen kurs investieren würde. kann sich ändern, warten wir mal die ash ab...

gruß mr.A

[BrauchGeld]

Schnief ich hasse Biotechs scheiss Inex

[derschweizer]

@BrauchGeld

Ich hoffe du warst nicht übermässig in Inex investiert.
Mit Sicherheit ein harter Schlag, ich hatte mit einer Empfehlung zur Zulassung gerechnet.
Schade, wünsche dir Glück.

grüße derschweizer

[fettinsky]

Anormed.
Die Fa. produziert eine Substanz, die bei Stammzelltransplantationen die Ausbeute der Stammzellen aus dem Spenderblut erhöht. Das hat bedeutung bei einer Reihe Erkrankungen des blutbildenden Systemes. Kein blockbuster, sondern ein Nischenprodukt.
Heute Beginnt der Amerikanische Hämatologenkongreß (ASH) in San Diego. Ich erwarte positive Daten, die den Kurs kurzfristig treiben. Nicht als Langzeit-Investition geeignet.

Gruß

[BrauchGeld]

Hi Fettinsky

Kannst Du mal bitte erklären,warum Anormed sich nicht als Langzeit Investment eignet ?
Bin nämlich schon 2 jahre dabei.

Gruss
B.M.

[fettinsky]

sorry,
für MICH kein Langfristinvestment, da alles andere außer dem Stammzellmobilisierer meines Wissens in sehr frühen Stadien ist. Vielleicht ist der Chemokinantagonist XR.sowienoch von der Idee ganz interessant, aber noch in präklinischer Phase.
Die stammzellgestützte Hochdosischemotherapie wird nahezu nur noch bei bösartigen Blut- und Lympherkrankungen eingesetzt. Mit zunehmenden präziseren Medikamenten wie z.B. Antikörpern bei Lymphomen (Rituximab, Alemtuzumab) und Leukämien sowie neuen Zytostatika wie Velcade bem Multiplen Myelom wird sich der Einsatz der stammzellgestützten Hochdosischemotherapie verringern. Seit der Einführung von Glivec wird z.b. die autologe Hochdosistherapie bei der chronisch myeloischen Leukämie nicht mehr weiterverferfolgt.
Gruß

[fettinsky]

zu AMD 31000 sind beim ASH 17 Beiträge angemeldet einschl. Poster. Die Haupt-Session mit den klinischen Ergebnissen ist am Montag nachmittag.
Bin mal gespannt, ob das kursrelevant ist.

[fettinsky]

Anormed war kein Trade zum ASH.
Ligand.
Phase II Daten zu Targretin beim nichtkleinzelligen Bronchialkarzinom wurden zum ASCO 2004 in New Orleans präsentiert. Die Ergebnisse waren sehr ermutigend. Mittlerweile ist eine Phase III Studie kurz vor der Publikation, die Daten werden noch im ersten Quartal diesen Jahres erwartet. Targretin ist bislang lediglich als Nischenprodukt zugelassen, auch in D, nämlich zur Behandlung "kutaner T-Zell-Lymphome second-line", eine relativ seltene Indikation. D.h. aber, das Präparat ist in der Praxis verfügbar und es kann von jedem Onkologen auch lange vor der offiziellen Zulassing in der EU aufs Rezept aufgeschrieben werden.
Insbesonders nach dem Versagen von Iressa, das in den USA nahezu vom Markt genommen wird, hat sich die Bedeutung für eine wirksame Substanz in Verbindung mit Chemotherapie deutlich gesteigert. Tarceva, das dem Iressa sehr ähnlich ist, wird jedoch noch mit Power weiterentwickelt. WEr weiß, wann da negative Daten kommen.
Es ist ein binäres Ereignis mit Targretin. Im positiven Falle rechne ich mit einer Kursverdopplung, im negativen Falle mit einem Abschlag von 30 %.
Immerhin hat Ligand ein weiteres Produktportfolio, das den totalen Absturz abbremst.

[Neoe]

Naechste Baustelle nach DSCO ist ganz klar CORGENTECH (CGTK):

Nach schlechten Phase-III-Daten fuer E2F Decoy im Dezember in Grund und Boden gestampft, allerdings kommen im Maerz andere Phase-III-Daten (PREVENT IV:Indikation CABG). Die Phase II fuer CABG zeigte statistisch signifikante Daten (p=0.03). Nach dem Beispiel dieser Phase-II wurde die Phase-III fuer CABG vorbereitet, entsprechend hoeher sind die Chancen auf positive Ergebnisse.

Sollte was positives Kommen sehe ich die Aktie bei plus 100%, sollte sich herausstellen das die Daten fuer die FDA ausreichend sind, um die NDA einzureichen: plus 250 bis 300%.


Das Marktpotential liegt bei 1-1,5 Milliarden fuer CABG allein. Zudem hat Corgentech eine sehr vorteilhafte PArtnerschaft mit Bristol-Myer Squibb:

Bristol-Myers Squibb and Corgentech Enter Global Agreement to Develop and Commercialize Novel Cardiovascular Therapy
(SOUTH SAN FRANCISCO, Calif. and NEW YORK, NY, October 13, 2003) -- Bristol-Myers Squibb Company (NYSE: BMY) and Corgentech Inc., a privately held biotechnology company, today announced they have entered into an agreement to jointly develop and commercialize Corgentech`s E2F Decoy (edifoligide sodium), a first-of-its-kind E2F Decoy treatment currently in Phase III development for the prevention of vein graft failure following coronary artery bypass graft (CABG) and peripheral artery (i.e. leg) bypass graft surgery.

"Corgentech has chosen Bristol-Myers Squibb as our partner in developing E2F Decoy based on the company`s broad expertise in the cardiovascular field," said John P. McLaughlin, president and chief executive officer, Corgentech. "We look forward to working with Bristol-Myers Squibb to develop and commercialize this product in order to potentially improve the lives of more than one million patients worldwide who undergo vascular bypass surgery each year."

Under terms of the deal, Bristol-Myers Squibb will make an initial payment to Corgentech of $45 million comprising cash and an equity investment in Corgentech, with the potential for an additional $205 million in clinical and regulatory milestone payments. Bristol-Myers Squibb and Corgentech will share development costs in the U.S. and Europe going forward based on a pre-agreed percentage allocation. In the United States, the parties will co-promote E2F Decoy and share profits. Bristol-Myers Squibb has exclusive rights in all other countries and will pay Corgentech a royalty on its sales. Bristol-Myers Squibb may make additional milestone payments based on the achievement of certain sales levels.

"Bristol-Myers Squibb has a broad portfolio of marketed products and pipeline compounds that, together, provide significant advances to health care providers who concentrate on treatments for patients with cardiovascular risk," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "In addition to advancing our current portfolio of cardiovascular compounds, we look forward to partnering with Corgentech to develop E2F Decoy. It is our hope that this compound may provide a new treatment option to reduce the risk of experiencing vein graft failure following artery bypass surgery."

E2F Decoy is an oligonucleotide that works by helping the walls of a grafted vein to strengthen over time, which helps the vein to maintain healthy blood flow. During surgery, E2F Decoy is applied to vein grafts ex vivo (outside the body).

E2F Decoy is currently being evaluated in two Phase III clinical trials. The peripheral artery bypass study, known as PREVENT 3, is testing E2F Decoy in 1,400 patients who have undergone peripheral artery bypass surgery at approximately 80 medical centers throughout the U.S. A second study, PREVENT 4, is evaluating the therapy in 2,400 patients who have undergone CABG surgery at more than 100 U.S. medical centers. Enrollment for both studies has been completed. The FDA has granted E2F Decoy Fast Track status for both coronary and peripheral indications due to the important unmet medical needs the product may address.

[BrauchGeld]

Hi

Damit der Thread nicht ganz verschwindet schreibe ich mal was rein.

Gute Aktie mit superchancen .
Produkte:

Oxytrex (Phase3)--- 1,9 Mrd$ Markt
Remoxy (Phase3) ---1,9 Mrd$ Markt
Pti-901 (Phase3)---1 Mrd$ Markt

Pain Therapeutics (Ptie)

Mk:240 mio$
Cash:91 mio$
Kurs:5,40$


Pipeline:
http://www.paintrials.com/pipeline_status.html

Oxytrex: New Drug To Treat Severe Pain---1,9mrd$ Markt

Oxytrex is a new opioid painkiller in Phase III testing. In March 2005, we announced positive clinical results from the first of two Phase III studies. In this variable-dose study of 719 patients with severe low-back pain, Oxytrex showed minimal physical dependence, better overall safety, less drug use and similar pain relief to oxycodone. Specifically, Oxytrex patients reported 50% less symptoms of physical dependence and withdrawal (p<0.01) after cessation of prolonged, high-dose opioid therapy and about 20% less overall opioid-related side-effects during treatment, including less somnolence (p<0.05), less uncontrollable itching (p<0.05) and less moderate-to-severe constipation (p<0.05). A second Phase III study is in progress. We plan to enroll over 700 patients with advanced osteoarthritic pain in this fixed-dose Phase III study.

Remoxy: Deters Oxycodone Abuse---1,9mrd$ Markt

Remoxy is a novel, abuse-resistant form of long-acting oxycodone in Phase III testing. Oxycodone is also the active ingredient in Oxycontin®, a controlled-release formulation with sales of nearly $2 billion. The U.S. Drug Enforcement Administration and the national media have linked oxycodone to widespread patterns of abuse, addiction, diversion and overdose. Remoxy`s unique formulation incorporates several abuse-deterrent properties. These properties make it exceedingly difficult and frustrating for drug abusers to extract the oxycodone in Remoxy for purposes of getting high. In December 2004, we announced data that highlight Remoxy`s abuse-resistance compared to Oxycontin. These clinical data were statistically significant (p<0.05) in the time points when abusers expect to get high.

PTI-901: New Drug for Irritable Bowel Syndrome (IBS)--1mrd$ Markt

PTI-901 is a novel IBS treatment in Phase III testing. It is intended to treat men or women with chronic IBS. The Phase III program for PTI-901 consists of two studies that are identical in all respects, except for gender. One study is enrolling 600 women while the other is enrolling 600 men, all of whom have been diagnosed with chronic IBS by a gastroenterologist according to clinically accepted criteria. Each study is randomized, double-blinded and will assess the clinical effect of PTI-901 against placebo during a three-month treatment period. As previously disclosed, the female study is enrolling patients faster than the male study. We believe this difference in patient enrollment rates occurs because IBS affects more women than men.

No Changes to Clinical Outlook

In the second half of 2005, we continue to expect to make the following clinical announcements:


Drug
Candidate Patient Population Expected Announcement

Oxytrex Osteoarthritic Pain - Phase III Report top-line results
PTI-901 Irritable Bowel Syndrome - P.III Complete enrollment in women
PTI-901 Irritable Bowel Syndrome - P.III Report top-line results in
women
Remoxy Severe Chronic Pain - P.III Complete patient enrollment
Remoxy Severe Chronic Pain - P.III Report top-line results
Remoxy Severe Chronic Pain - P.III Initiate second Phase III


About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. Our drug candidates target severe chronic pain, such as pain associated with low-back pain, osteoarthritis or irritable bowel syndrome. We have three unique drug candidates in clinical development: Oxytrex, Remoxy and PTI-901, all of which are in Phase III clinical trials. We believe the target market for our three drug candidates exceeds $3 billion per year. We own commercial rights to our drug candidates.

[blb]

up

[blb]

@BrauchGeld: Ist wirklich eine super Pipeline, die PTIE da hat. Drei!!! Medikamente in Phase III!

[BrauchGeld]

Hallo

Labopharm eine aktie mit Potential!

Labopharm kam unter druck nachdem konkurrent Biovail die Zulassung(Tramadol) für die USA erhalten hat.
Wie ich finde war es eine übertriebene kursreaktion,andererseits konnte ich diese gelegenheit für den einstieg nutzen.
Biovail hat zwar ein paar monate vorsprung das produkt in USA zuverkaufen,aber dafür hat Labopharm in allen anderen Ländern die nase vorn.
Labopharm hat vor 4 wochen die zulassung für 22 Europäische Länder erhalten weitere folgen in den nächsten wochen.
Es stehen einige kurstreibende news an ,also ich denke auf aktuellen kursniveau kann man nicht viel falsch machen.

MK:116mio€
Kurs:2,65€


Labopharm set to launch Tramadol pain drug in EU
Tue Sep 6, 2005 03:43 PM ET
(Adds interview with CEO, share price, background)
TORONTO, Sept 6 (Reuters) - Labopharm Inc. (DDS.TO: Quote, Profile, Research) said on Tuesday it has received regulatory approval for its once-daily pain killer, Tramadol, in 22 European countries and will launch the product by the end of the year.

The tiny Canadian company won approval from French regulators in January, which meant it could start gaining approval through the "mutual recognition procedure" in other European Union countries.

Shares of Labopharm rose 31 Canadian cents, or 6.68 percent, to C$4.95 on the Toronto Stock Exchange.

Labopharm now only needs marketing authorization from the individual countries, which include Germany, Italy, Spain and Portugal. It expects to start gaining that in the next month and into the first half of 2006.

Tramadol has been approved in a daily dose range from 100 mg to 400 mg.

"Our strategy is to launch our product as quickly as possible following our receipt of national marketing authorizations, giving priority to those countries where there is no pricing policy and where our product will command the highest price," Labopharm`s chief executive, James Howard-Tripp, said in a statement.

The company, based in Laval, Quebec, said it has secured marketing partnerships for the drug in 20 European countries, including four of the five largest European markets for Tramadol.

It is working on additional marketing partners for key markets such as Britain.

"We would expect direct product sales to have marginal impact this year (2005) but obviously pretty significant impact next year," Howard-Tripp said later in an interview.

"We think there`s good likelihood that we could see our first profitable quarter, Q4 of 2006, off of Europe alone, so that does not include the U.S. -- and obviously if we get to launch in the U.S. that will have a major upside."

The company expects to submit its new drug application for once daily Tramadol to the U.S. Food and Drug Administration before the end of the year. If all goes as planned, it expects the painkiller to be approved in the third quarter of 2006.

The United States is touted as the largest market for the painkiller, but for Europe, Labopharm has said its potential is seen between $800 million and $900 million a year.

Howard-Tripp said it was too early to detail what kind of share of the market the company expects to nab, but he did note that there were "two other so-called versions" of once daily Tramadol in Europe.

"But they both have issues as in if they are really once a day," he said.
---------

Labopharm hat für USA schon einen Partner ,die Zulassung wird hier in 10-12 monate erwartet.

15.08.2005 18:20
Labopharm und Purdue Pharma schliessen Lizenz- und Vertriebsabkommen für die USA über das einmal täglich zu verabreichende Tramadol ab

Laval, Kanada und Stamford, Connecticut (ots/PRNewswire) -

- Das Abkommen sieht Zahlungen in Höhe von bis zu 170 Mio. USD und
Lizenzgebühren von 20 % bis 25 % vor

Labopharm Inc (Nachrichten) (TSX: DDS) und Purdue Pharma L.P. gaben heute die
Unterzeichnung eines endgültigen Lizenz- und Vertriebsabkommens
bekannt, demzufolge Labopharm über seine Tochtergesellschaft
Labopharm Europe Limited Purdue Pharma Products L.P. das exklusive
Recht zur Vermarktung, zum Verkauf und zum Vertrieb von Labopharms
einmal täglich zu verabreichender Form des Schmerzmittels Tramadol in
den Vereinigten Staaten und seine Gebieten und Besitzungen erteilt.
Labopharm behält das Recht, parallel bestimmte medizinische
Sonderprodukte zu vermarkten.

"In Anbetracht der voraussichtlich im Laufe des Jahres
stattfindenden NDA-Einreichung war unsere oberste Priorität, mit
einem Partner zu zeichnen, der es uns ermöglicht, unser
Tramadol-Mittel auf dem weltweit grössten Pharmamarkt zu vertreiben",
sagte James R. Howard-Tripp, Präsident und CEO von Labopharm Inc.
"Wir sind nicht nur über die Konditionen, die u.a. Lizenzgebühren
nach unseren Erwartungen vorsehen, sondern auch über den kooperativen
Charakter unserer Vertriebspartnerschaft sehr erfreut. So werden
unsere Unternehmen zum Beispiel ein gemeinsames Marketingteam bilden,
um die Markteinführung des Medikamentes vorzubereiten. Nach dem
Start, wird Purdue uns dabei unterstützen, eines unserer strategisch
wichtigsten Ziele zu erreichen, nämlich den Aufbau und die Schulung
einer eigenen Vertriebsmannschaft, damit Labopharm bestimmte
Spezialmärkte in den USA verfolgen kann".

Der Vertrag sieht vor, dass Labopharm Zahlungen in Höhe von bis zu
170 Mio. USD erhält, u.a. eine Lizenzvorauszahlung von 20 Mio. USD,
eine Zahlung von bis zu 40 Mio. USD bei Zulassung von Labopharms
Produkt durch die US-amerikanische Food and Drug Administration (FDA)
sowie Zahlungen, die fällig werden, falls das Produkt festgelegte
Verkaufsvorgaben erreicht. Labopharm wird Lizenzgebühren in Höhe von
20 % bis 25 % des Produktumsatzes erhalten. Darüber hinaus werden die
Kosten für die Einstellung, Schulung und Vergütung der
Vertriebsmannschaft von Labopharm durch Purdue getragen.

"Es gibt einen grossen, bisher nicht befriedigten Bedarf an
zusätzlichen Medikamenten zur Schmerzbehandlung und die nur einmal
täglich zu verabreichende Form von Tramadol bietet Ärzten und
Patienten bei mässigen bis mittelschweren Schmerzen möglicherweise
eine wertvolle therapeutische Alternative", sagte Michael Friedman,
Präsident und Chief Executive Officer von Purdue. "Mit diesem
Abkommens baut Purdue seine führende Position und sein Engagement bei
der Schmerzbehandlung weiter aus. Wir sind davon überzeugt, dass wir,
nach der bevorstehenden FDA-Zulassung dieser nur einmal täglich zu
verabreichenden Form von Tramadol, in einer hervorragenden
Ausgangsposition sind, um einen bedeutenden Anteil des
Tramadol-Marktes zu erobern".

"Als Nummer Eins auf dem US-Markt für langwirkende Schmerzmittel,
wie z.B. OxyContin(R) (Oxycodon HCl gesteuerte Abgabe) Tabletten und
MS Contin(R) (Morphin Sulfat gesteuerte Abgabe) Tabletten, und mit
einem umfassenden Patent-Portfolio zu Tramadol mit Retardwirkung, ist
Purdue in den USA der ideale Partner für unser Produkt", sagte Dr.
Allan Mandelzys, Vizepräsident Business Development von Labopharm
Inc. "Purdue hat auf dem Markt der langwirkenden Schmerzmittel
bereits zahlreiche Erfolge aufzuweisen. Vor der Markteinführung von
Generika im Jahre 2004, erreichte der Jahresumsatz von OxyContin ca.
2 Mrd. USD".

Das Abkommen unterliegt in den USA noch der
Hart-Scott-Rodino-Freigabe.

Informationen zu Labopharms Vermarktungsprogramm für das täglich
einmal zu verabreichende Tramadol

Labopharm verfolgt ein globales Programm zur kommerziellen
Verwertung des einmal täglich zu verabreichenden Tramadols. In den
USA hat das Unternehmen zwei klinische Phase III Studien
abgeschlossen und unternimmt z.Z. gerade eine dritte. Labopharm
erarbeitet zur Zeit den New-Drug-Application-Antrag, den das
Unternehmen voraussichtlich vor Jahresende bei der US-amerikanischen
Arzneimittelzulassungsbehörde Food and Drug Administration einreichen
wird. In Europa ist Labopharms einmal täglich zu verabreichendes
Tramadol in Frankreich zugelassen und das Unternehmen schliesst
gerade das MRP-Verfahren zur gegenseitigen Anerkennung (Mutual
Recognition Procedure) ab, das die Zulassung in der gesamten
europäischen Union ermöglicht. Das Unternehmen geht davon aus, dass
die Markteinführung seines Produktes in Europa vor Jahresende
stattfinden wird. Zur Zeit verfügt Labopharm über gesicherte
Vertriebspartnerschaften für 20 europäische Länder, darunter vier der
fünf grössten Tramadol-Märkte und mit einer Deckung des gesamten
europäischen Tramadol-Martes von über 80 %.

Informationen zu Tramadol

Tramadol ist ein zentralnervös wirkendes Analgetikum, das bei
Erwachsenen mit mässigen bis mittelschweren Schmerzen indiziert ist.
Der weltweite Tramadol-Markt wird auf über 1,3 Mrd. USD geschätzt und
IMS Health schätzt, dass das weltweite Verkaufsvolumen von Tramadol
über die letzten fünf Jahre zusammengenommen um über 14 % pro Jahr
zugenommen hat. In den USA, wo Tramadol z.Z. nur in der
sofortwirkenden Form erhältlich ist, die typischerweise vier bis
sechs Einnahmen pro Tag erforderlich macht, schätzt Verispan, dass im
Jahre 2004 Tramadol-Mittel über 17 Millionen mal
verschrieben wurden
und dass der US-Markt für Tramadol-Mittel über die letzten fünf Jahre
insgesamt jährlich um 11 % wuchs.
--------

Auch für Lateinamerika wurde ein Partner(GlaxoSmithKline)gefunden .

Labopharm signs distribution deal with Glaxo
Mon Oct 3, 2005 03:50 PM ET
(Adds stock price, details, analyst, company comment. In U.S. dollars unless noted)
TORONTO, Oct 3 (Reuters) - Small Canadian drug maker Labopharm Inc. (DDS.TO: Quote, Profile, Research) said on Monday it has signed British pharmaceutical major GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) to distribute its once-daily painkiller, Tramadol, in 20 Latin American and Caribbean countries.

The news helped the Laval, Quebec-based company`s stock rise as high as C$3.85 before retreating a bit to C$3.79 on the Toronto Stock Exchange, for a gain of 24 Canadian cents, or 7 percent.

Labopharm has now secured marketing partners in Latin America, the Caribbean, the United States and 23 countries in Europe for the once-daily painkiller.

However Labopharm`s drug is approved only in Europe and its stock has fallen percent since its rival, Biovail Corp. (BVF.TO: Quote, Profile, Research) , won approval to market its version of Tramadol in the lucrative U.S. market.

Labopharm said it is on track to file a new drug application for its once-daily painkiller with the U.S. Food and Drug Administration before the end of the year. Approval is expected in the third quarter of 2006.

In terms of Latin America and the Caribbean, Labopharm expects the drug to be approved over the next year.

"We expect to see some of the approvals starting toward the end of this year and early next," said Jason Hogan, Labopharm`s spokesman.

"We will be fully launched across that jurisdiction by the middle part of next year, as to specifically when those approvals will come we don`t know at that time."

Under the deal, Labopharm will supply Glaxo with bulk tablets of once-daily Tramadol for distribution in the licensed areas.

Current sales of Tramadol in Latin America exceed $50 million a year, and have grown at a compounded annual rate of 18 percent over the last five years, Labopharm said.

"We view this agreement as an incremental positive. The company currently has Purdue as its distribution partner in the United States, and has also signed partners for four of the five largest European markets," said Dundee Securities analyst David Martin, in a note.

[Neoe]

Labopharm ist auf jeden Fall eine sehr schöne Gelegenheit.
Ich bin bereits einige Zeit vor dem Purdue-Deal eingestiegen und muss sagen, dass sich durch die Biovail-Angelegenheit nochmal eine unerwartete Einstiegschance geboten hat.
So wie ich die Situation hat Labopharm den Abschluss der Patientenaufnahme nicht bekannt gemacht. Ich vermute deswegen, dass es sogar möglich ist, dass sie auch den Studienabschluss nicht bekanntgeben und gleich mit den Ergebnissen aufwarten. Das kann ab Ende Oktober jeden Tag passieren. Positive Ergebnisse sind aufgrund des Aufbaus der Studie zu erwarten (Chance von mehr als 75 Prozent).
Aber ein Restrisiko, da es sich um ein Schmerzmedikament handelt, bleibt natürlich.


Weitere Interessante Titel neben Labopharm:

Epix Pharma
Halozyme
Insmed

[BrauchGeld]

Hallo

Grüss dich Neoe hoffe dir gehts gut.

Phytopharm die chance oder Flop des Jahres!

Wenn in Dezember die Phase2 daten zu Cogane gegen Alzheimer positiv ausfallen dann rechne ich mit einer kursexplosion .
Phytopharm hat aber noch mehr zu bieten ,die aktuelle bewertung ist einfach nur lächerlich.

MK:36mio€

Cogane™ (PYM50028) - has been shown to be neuroprotective against beta-amyloid and glutamate damage, to reverse the decrease of neuronal growth factors and to reverse neuronal degeneration observed in the ageing brain. Importantly, this product restores levels of proteins that are altered in the ageing brain, returning them to levels observed in the young and causing beneficial neurite outgrowth and branching. In addition, PYM50028 restores the learning and memory ability in Alzheimer`s disease models and thereby offers the potential to reverse the symptoms of Alzheimer`s disease,

Myogane™ (PYM50018) - has been shown to be neuroprotective against glutamate damage, to reverse the decrease of neuronal growth factors and to reverse neuronal degeneration observed in motor neurones. Comparative pre-clinical testing of Myogane™ with the only pharmaceutical agent licensed for the treatment of ALS, in recognised neurodegeneration models indicates that Myogane™ provides greater protection against neuronal damage in cell based systems. In addition, Myogane™ delays the loss of muscle strength and extends survival time to a greater extent in the SOD1 and PMN models of ALS.

PYM50028 - reverses free radical neurotoxicity produced by 1-methyl-4-phenylpyridium (MPP+) in dopaminergic neurones and reverses the decrease of neuronal growth factors and dopamine receptors in the brain.

[BrauchGeld]

Eine schöne zusammenfassung über Phytopharm (Motley Fool Board):

Phytopharm is a botanical drug development company. I think it`s arguably very cheap. So here`s an introduction.

I own shares.

Phytopharm is developing three lead products: an appetite suppressant licensed to Unilever, a potential treatment for Alzheimer`s, and a potential treatment for Motor Neurone disease.

All three products are “first in class.” That means they all work in a completely different way from current treatments. Phytopharm thinks all three have the potential to be much more effective than current treatments. The appetite suppressant could reach the market as soon as 2007.

I`m very excited by the company`s potential, but it`s a high-risk bet. Definitely not for widows and orphans.

Basic numbers

Shares in issue: 51.18m

Enterprise Value: £35.4m

The products

P57 (obesity)

P57 is an appetite suppressant. It`s derived from a South African plant called hoodia gordonoii. The cactus-like plant has traditionally been used by hunters in the San tribe. The tribe`s hunting trips can last for two or three days; so hunters eat some hoodia to ward off hunger during the hunt.

Phytopharm and its partners have patented the use of hoodia as a weight loss aid. They have also developed an extract from the plant called P57.

The original plan was that P57 would be marketed as a pharmaceutical drug. The drug was licensed to drugs giant Pfizer, and reached Phase II (mid-stage) clinical trials.
The results of the first Phase II trial for P57 were pretty impressive.

http://www.companyannouncements.net/cgi-bin/articles/2001120…

The Investor`s Chronicle said at the time: “Tests on its [Phytopharm`s] ground-breaking appetite suppressant P57 showed that it was safe and extremely effective. A group of 18 overweight men volunteered to spend a fortnight locked up in a lab with little to do but eat as much food as they wanted. Half of the volunteers were given P57 while the rest received a placebo. At the end of the trial, scientists measured each man`s weight and calorific intake.

Men on the placebo consumed an average of 3,300 calories a day and gained 0.91k over the course of the trial. But those taking P57 chose to eat only 2,200 calories and their weight dipped an average 0.98k. Phytopharm`s chief executive, Dr Richard Dixey, admitted the drug had been too potent and that future doses would have to be smaller.”(December 7th 2001)

Despite the good results Pfizer pulled out of its licensing deal with Phytopharm in 2003. Phytopharm said this was due to management changes after Pfizer`s merger with Pharmacia. Apparently new management was no longer interested in botanical products. Cynics didn`t believe this explanation and there have been reports that Pfizer pulled out due to problems with formulating P57 as a medicine.

However, all was not lost, and Unilever licensed the product in December 2004.
http://www.companyannouncements.net/cgi-bin/articles/2004121…

P57 is no longer being developed as a medicine. It`s now a nutraceutical product, and the plan is that Unilever will add the extract to some of its meal replacement products. The Slimfast range looks an obvious starting point. The core Slimfast product is a milkshake. Slimfast dieters are supposed to eat a light breakfast, have a Slimfast milkshake for lunch, and then a nutritious meal in the evening. If dieters follow that regime they should lose weight. The problem is that dieters often feel hungry at tea time and eat a couple of Mars bars as well.

Hoodia should be able to help here. If you add some P57 to the milkshake, dieters shouldn`t feel hungry in the afternoon and could then lose weight.

Unilever said in December 04 that it hoped to launch hoodia-based products in 2007 or 2008 although that`s far from certain. P57 is now starting the regulatory process with the FDA in the US. Given that P57 is no longer a pharmaceutical product, the regulatory hurdles may be lower. However, Unilever/Phytopharm still have to convince the FDA that P57 is safe. They will also need to convince the FDA that the product has some efficacy if they wish to put a statement like “clinically proven to help weight loss” on the packaging.

It`s hard to know how large sales will be. We do know that Slimfast generated sales of $1bn in 2002 – that`s before the Atkins craze took off and inflicted serious damage on the Slimfast business. Sales have fallen since then, but I`ve not been able to find a figure.

Unilever is contracted to pay milestones of up to £20m to Phytopharm plus undisclosed royalties. One analyst has suggested 5% may be the royalty figure.

It`s also hard to know what P57`s chance of success is. It completed a Phase II trial as a pharmaceutical drug. A typical drug at that stage has a 20 to 25% chance of success. As a nutraceutical, its COS should be higher. Evolution has suggested 50%.

Cogane

Cogane is potentially more exciting than P57. It is a treatment for Alzheimer`s that is derived from an unnamed Asian tonic.

What makes Cogane so exciting is that Phytopharm believes it`s disease-modifying drug. Current Alzheimer`s treatments alleviate the symptoms for a maximum of 18 months. Phytopharm believes that Cogane should be much more effective.

Cogane has been tested in animals and has demonstrated both efficacy and safety in those trials. Safety trials have been successfully conducted in humans.
http://www.companyannouncements.net/cgi-bin/articles/2005012…

Efficacy is being tested in the current Phase II trial. The results should be published towards the end of this year. I can`t predict what the results will be, but I take some comfort from the following statement from Phytopharm`s website:

“The neurodegeneration programmes are based around a single Asian plant extract used as a traditional tonic for the elderly. Initial interest arose from a small but successful double-blind placebo-controlled study in patients with mild to moderate senile dementia treated with a single chemical purified from the plant extracts which demonstrated a significant and highly relevant improvement in cognitive function.” (www.phytopharm.com)

In other words, a compound was developed from the Asian tonic before Phytopharm got involved. This compound was tested in humans and showed efficacy. The compound used in the earlier trial was not Cogane. The earlier trial was not conducted in line with all the rules and regulations demanded by the regulators. So the earlier trial is really just an anecdote. But it`s a very interesting anecdote and I think it increases the COS for Cogane a little.

Cogane is in Phase II. A typical drug at that stage has a 20% chance of gaining regulatory approval. Its chances of getting through the current trial are higher.. Cogane will almost certainly have to go through at least two more clinical trials before it wins final approval.

Future sales? It`s even harder to guess for Cogane than for P57. Nomura suggested in an April 03 analyst note that peak sales could be £2.78bn. (I love the precision of that forecast. Not £2.83bn, not £2.77bn, no it`s £2.78bn exactly.)

Anyway, let`s assume the analyst was too optimistic – I`ll slash the sales forecast down to £700m. I don`t think that`s an unreasonable forecast if Cogane really does prove to be disease modifying. Royalties for a pharmaceutical drug should be much higher than for a nutraceutical product. 15% is conservative. Cogane could be launched in 2011.

Myogane

Myogane is derived from the same Asian tonic as Cogane. It`s a potential treatment for Motor Neurone disease. It`s completed a Phase I clinical trial that primarily looked at safety. A typical drug at this stage has a 10% chance of success.

I wouldn`t be surprised if Phytopharm did a licensing deal for Myogane at some point in the next 18 months.

Finance

H1 04 Turnover(£): 1.05m PBT: -2.06m

FY 04 Turnover : 1.07m PBT: -6.75m

H1 05 Turnover : 6.8m PBT: 0.81m


You`ll see that the company went into profit for first half of this year (6 months to Feb 28th.) It will probably slip back into the red in 2006. That`s because the H1 05 figures were boosted by milestone payments from Unilever. All being well Unilever will make further payments in the next couple of years, but these payments will be lumpy.

Two animal drugs also made a tiny contribution to first half figures (sales: £74,000). Sales may rise as the products were only launched in the reported period.

The most important financial issue for Phytopharm is its balance sheet. Can it continue to develop its products without another fund raising?

The company had 3.7m cash on February 28th. Since then it raised £9m after expenses from a share issue in April. Phytopharm said after the fund raising that it now had sufficient resources to keep the company ticking over well into 2006. This included the whole cost of a further clinical trial for Cogane which may begin in 2006.

That said, Phytopharm would prefer not to pay the costs of the next Cogane trial. Richard Dixey, Phytopharm`s CEO, hopes that positive results from the current trial will be followed by a licensing deal for the drug. The licensee would then pay for some or all of the costs of future trials.

Even if a licensing deal is struck, I suspect that Phytopharm will raise some more cash from a further fund raising. That would make the company financially secure and it could crack on with other projects in its portfolio.

Of course, if the Cogane trial results are poor, Phytopharm will probably give up on Cogane. My guess is that Richard Dixey (RD) would then focus on P57 for a while. If that product made progress, the share price might rise and some more cash could be raised on the back of a higher share price. If the share price stayed low, RD could just wait and hope for P57`s launch. A successful launch would then generate plenty of cash for the company.

Phytopharm would be finished if both the current Cogane trial failed and P57 failed to get to market this decade. That`s my view anyway.

Share price falls

The share price has fallen for several reasons over the last year.

The most recent blow was Cannacord`s resignation as Phytopharm`s broker. Cannacord resigned because animal rights extremists blew up the car of one of the broker`s directors. The extremists object to Phytopharm because it used to have a licensing relationship with a Japanese company called Yamamouchi – the latter company worked with Huntingdon Life Sciences.

The actions of animal rights extremists are worrying. Phytopharm has taken out all the injunctions it possibly can against violent protestors. So far the operations of the company have not been affected. But Phytopharm will need an advisor should it want to raise cash.

The share price was also hit by the withdrawal of Yamamouchi from a Far Eastern licensing deal for Cogane.

Another problem was that some investors wrongly (IMO) interpreted the following statement as suggesting that Cogane would fail to show efficacy when the full trial results are released.
http://www.companyannouncements.net/cgi-bin/articles/2005012…

Valuation
This is the tricky bit. It`s very hard to value a company like Phytopharm.

Here`s one way of looking at it. Imagine that Slimfast Hoodia generates revenue of £450m in 2010. ((Remember that Slimfast generated revenue of $1bn in 2002. So I don`t think it`s unreasonable to expect that Slimfast Hoodia could do £450m in 2010.)

On a 5% royalty, Phytopharm would receive £22.5m from the product. Lop £3m off for company running costs, and tax at 30% leaves you with 13.65m. Stick that on a p/e of 15 and you have a market cap of £204m.

Yes, that valuation is not discounted, it`s for 2010, not for now. And there`s a 50% chance that the product won`t get to market. But it does show the kind of potential that Phytopharm has.

And I`ve included nothing for Cogane, Myogane or the animal drugs.
Then there`s milestone payments. If all goes well Unilever will make payments of £20m to Phytopharm. That`s before the royalties start. And the company`s market cap is just £40.4m. Looks cheap to me.

DCF

I know DCF (discounted cash flow) valuations have become very unfashionable because the results can vary hugely depending on discount rates, predictions of future revenues and other factors.
But I couldn`t resist having a bash anyway. Let`s start with P57.

I`ve made the following assumptions:

Launch: 2008
Royalty rate: 5%
Gross revenue for product: £100m in 08, rising to £300m in 09, and £450m in 10, then rising by 3% a year.

I`ve not ascribed a terminal value to P57. Instead I`ve estimated revenue for 7 years, and then pretended that revenue will fall to nothing – like a mine. Yes, I know P57 is not a mine, but the patent will expire at some point (drug patents often last for around 7 years after market launch), and revenue should fall after the patent expiry.

I`ve lopped £3m from the P57 annual cash flow for company running costs, and I`ve assumed that Phytopharm is paying 30% tax from 2010 onwards. Before then I`m assuming that it`s using up tax losses.

Chance of Success: 45%.

So I`ve multiplied my DCF total by 0.45 to produce the following totals for P57:

£43.9m (10% discount rate)
or
£35.6m (13% discount rate)

Cogane

Launch: 2011
Royalty rate: 15%
Gross revenue: £200m in 2011, rising to £350m in 12, £700m in 13, and then by 3% a year. Once again, I`m assuming that revenue falls to nothing after 7 years. Tax is 30%.

COS: 20%

So I`ve multiplied my DCF total by 0.2 to produce the following totals:

Total: £33m (10% discount rate)
£24m (13% discount rate)

So, using a 13% discount rate, £35.6m (P57) + £24m(Cogane) = £59.6m, which is well in excess of the current Enterprise Value (£35.4m)

And I`ve included nothing in the DCF valuation for Myogane nor the animal drugs where revenue should be starting to rise. There`s also nothing for future milestone payments from licensees.

I think all my assumptions in the DCF were conservative.

Conclusion

I expect this post will put some people off Phytopharm. In fact, writing this post has forced me to focus on the potential downside. I think I had underplayed the risk in my own mind until today.
The risks are significant. The animal rights extremists probably won`t go away. Who knows what they might do?

There`s also a decent chance that Cogane will fail its current trial. Unilever could lose interest and pull out. I read one press article which suggested that Unilever might give up on Slimfast and sell the business. (Sorry I`ve forgotten where I read that.)

Equally the potential upside is massive. So many drug companies are developing “me too” drugs which work in similar ways to current drugs and often offer similar efficacy and safety to current drugs. Phytopharm`s products are much more innovative which is one is one of the reasons their potential are so great.

[BrauchGeld]

Hallo

Schöner Kurssprung bei Phytopharm knapp 30% plus,hat sich gelohnt etwas geld rein zustecken.
Das ist aber erst der Anfang ,wenn die Daten zu Cogane positiv ausfallen rechne ich mit einer verdoppelung vom aktuellen kurs aus.

http://finance.yahoo.com/q?s=pym.l

Vom Motley Board aufgeschnappt:

There is a new research note out by Edison.
It takes 2 minutes to register.

www.edisoninvestmentresearch.co.uk

Some highlights.

-Pym expect Unilever to take action against the myriad hoodia merchants, possibly in conjunction with regulators, nearer to launch date (2008)

-a valuation on Cogane and the royalties from hoodia puts a value on Pym of £2.60 per share.

-Pym`s R&D portfolio is valuable and at a stage where it could be comparatively easily licensed to a pharma on attractive terms.

-the market interpretation of the Cogane trial is important as it may show efficacy, without reaching the p<0.05 level of statistical significance.

-there are relatively few compounds in clinical development for Alzheimers disease. Few appear to offer the disease modifying potential of Cogane.

-The hoodia plantations in S Africa are now managed by Unilever.

-Pym will pay a royalty to CSIR. This is important as it is often accused, unfairly, of exploiting the San people.

[BrauchGeld]

Wow inzwischen schon über 40% kursplus.geillll

[BrauchGeld]

Und die Rally geht weiter ......... Geilll


http://www.businessweekly.co.uk/news/view_article.asp?articl…

[BrauchGeld]

Chart 6M:

http://finance.yahoo.com/q/bc?s=PYM.L&t=6m

[BrauchGeld]

Supperrrrrr und die Party geht weiter......

http://finance.yahoo.com/q?s=pym.l&d=v1

[cyberhai]

Hallo,

wie verhalten sich denn die Insider bei Phytopharm, hat jemand einen Link, wo man das nachschauen kann?

Gruß Cyberhai

[BrauchGeld]

bestimmt wisst Ihr was jetzt kommt ,natürlich die Aktie steigt weiter hurraa und alle widerstände sind durchbrochen.
Phytopharm ist innerhalb der letzten tage um mehr als 100% gestiegen.
Analysten sehen den Fair Value bei 2,6pfund pro aktie aktuell notiert Phytopharm bei 1,03pfund.
Ich glaube für mich wird es langsam zeit um auszusteigen.

[BrauchGeld]

Auf Auf und Davon

http://finance.yahoo.com/q?s=pym.l

[Neoe]

Hallo BrauchGeld,

hier war ja einiges los, ist leider komplett an mir vorbeigezogen, aber Glückwunsch.

Habe mich in letzter Zeit etwas mit Pain Therapeutics beschäftigt, dass hat sich mittlerweile schon gelohnt, ohne dass die für mich entscheidenden News überhaupt rauskamen.
Für einen heißen Monat Dezember habe ich folgende Tips:

Nach wie vor Pain Therapeutics PTIE:
Im Dezember kommen zweimal Phase III Daten.
1.Oxytrex (Opiat+Antagonist, dass keine Erzugserscheinungen hervorruft)
2.PTI-901 (niedrig dosiertes Naltrexone) gegen IBS. Wenn die bisherigen Daten bestätigt werden, wird das ein schönes Weihnachten


Außerdem Pharmacyclics PCYC:
Mitte Dezember bis Anfang Januar sind Daten für Xcytrin gegen Gehirntumoren im Zusammenhang mit Lungenkrebs fällig. Risikoreiche Sache, aber immerhin wurde die Wirksamkeit schon einaml in einer Phase III unter Beweis gestellt, allerdings nur in einer Untergruppenanalyse.
Wenn es funktioniert, sind hier kaum abschätzbare Kurssteigerungen drin.


Und zuletzt meine Lieblingsaktie des Jahres Labopharm LP5:
Obwohl die Aktie schon sehr gut gelaufen ist, immer noch unterbewertet. Zudem warten neben Phase III Daten für den potentiellen Blockbuster Once-Daily-Tramadol noch weitere Marketingpartnerschaften, Zulassungsanträge und ein äußert wichtiges Pipeline-Update auf Interessierte.

[BrauchGeld]

Hallo

Die Schweizer Biotechfirma Speedel Holding ist seit kurzem an der Heimatbörse und hier in Deutschland handelbar.
Wie üblich sind die Schweizer Biotechs nicht gerade günstig aber dafür hochwertig so auch Speedel Holding mit einer erstklassigen pipeline und spitzen partner(Novartis,Roche,Abbott).
Auch wenn die Marktkap. über 620mio€ beträgt halte ich diese Firma für aussichtsreich.
Ende 2006 anfang 2007 soll das erste produkt(SPP100) auf den Markt kommen.


Homepage:
http://www.speedel.com/index_flash.php?form_skip=

Pipeline:
http://www.speedel.com/section/4


http://www.speedel.com/section/7/subsections/4?form_link=112…

[Neoe]

Hallo

Zu Speedel nur soviel:
Bis Jahresmitte 2006 sollte nochmal eine Kapitalerhöhung kommen, vorher sollten keine enscheidenden News mehr kommen (soweit ich weiß, aber Speedel hat natürlcih einiges am Laufen).

Auch für mich innerhalb des nächsten Jahres ein absoluter Top-Kauf

[BrauchGeld]

Gude Neoe schön dich wieder zulesen hoffe Dir gehts gut.

Übertriebene Kursreaktion bei Taro Pharmaceutical,leider kann ich nicht sofort zuschlagen muss erst bis morgen warten.

http://finance.yahoo.com/q?d=v1&s=taro

[BrauchGeld]

Manipulation pur während die aktie abgestuft wird decken sich die grossen mit billigen taro aktien ein.
Taro gehört zu den besten generic Unternehmen der Welt,würde mich nicht wundern wenn Taro bis zum Jahresende wieder über 20$ notiert oder gar übernommen wird.
Taro ist nach dem Kurssturz die Topempfehlung des Monats.

http://finance.yahoo.com/q/ks?s=TARO

[BrauchGeld]

FDA Filings

Currently, Taro has 25 ANDA filings at the FDA, including four tentative approvals. These filings address U.S. markets with annual sales of more than $1 billion. In addition, Taro and its affiliates have regulatory filings in Canada, Israel and other countries.

Taro Reports Third Quarter and Nine Month 2005 Results
Thursday November 17, 7:00 am ET


HAWTHORNE, N.Y.--(BUSINESS WIRE)--Nov. 17, 2005--Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Nasdaq: TARO) today reported results for the Company`s third quarter and the nine-month period ended September 30, 2005.

Third Quarter 2005 Results

Taro`s third quarter sales were $72.5 million, compared with $73.3 million in the third quarter of 2004. Sales in the third quarter of 2004 included the contribution from proprietary over-the-counter ("OTC") product lines, which were divested earlier this year. Gross profit for the quarter was $37.7 million, compared with $42.5 million in the third quarter of 2004.

Selling, general and administrative expenses ("SG&A") were $22.3 million, compared with $29.6 million in the year-ago quarter. The decrease in SG&A reflects a reduction of marketing expenses following the above mentioned divestiture of the Company`s proprietary OTC product lines and the Company`s continuing focus on expense control. R&D expenses were $11.7 million, compared with $10.5 million for the third quarter of 2004.

Operating income was $3.7 million, compared with $2.4 million for the year-ago quarter. Net income for the quarter was $2.1 million, or $0.07 per diluted share, compared with net income of $4.0 million, or $0.14 per diluted share, for the third quarter of 2004.

Accounting Treatment Revised for ElixSure® and Kerasal® Divestiture

In March 2005, the Company reported that it had entered into multi-year agreements to divest its over-the-counter ElixSure® and Kerasal® products in North America. Pursuant to the terms of the agreements, including the sale of inventories, the Company received $10 million in cash in the first quarter. Among other matters, the agreements provide for additional payments to be made to Taro in each of the next three years.

The Company accounted for the initial $10 million payment by recording the sale of inventories of approximately $4.9 million in the first quarter, and deferring the remaining $5.1 million, as well as all other revenues to be recognized over the ensuing three-year contract period. The Company has reconsidered the timing of revenue recognition for a portion of the $4.9 million in sales in the first quarter and accordingly revised the accounting treatment to allocate that portion over the three-year contract period. This change did not have any effect on the Company`s cash position. The change will reduce revenue and net income in the first quarter of 2005 by $4.8 million and $1.2 million respectively, and allocate the amount of the reduction in revenue and net income over the three-year contract period. In the second quarter, revenue was increased by $0.4 million and net income by $0.1 million. The results of the third quarter and the nine months reflect these changes.

Nine Month Results

Sales were $225.3 million for the nine-month period ended September 30, 2005, compared with $206.5 million for the same period in 2004. The Company`s gross profit in the nine-month period was $123.0 million, compared with $122.4 million for the same period in 2004.

SG&A expenses for the nine-month period were $72.1 million, compared with $94.4 million for the year-ago period. R&D expenses were $33.3 million for the first nine months of this year, compared with $32.7 million in the year-ago period.

Operating income for the nine-month period was $17.7 million, compared with an operating loss of $4.7 million for the year-ago period. Net income for the nine-month period was $12.6 million, or $0.42 per diluted share, compared with net income of $6.3 million, or $0.21 per diluted share, for the first nine months of 2004.

Discussion of Third Quarter Results

The results for the third quarter of 2005 were affected by various factors, including price erosion, an increase in production costs resulting from the strengthening of the Canadian dollar against the U.S. dollar, and the mix of products sold.

In the third quarter of 2005, according to industry sources, total prescriptions for Taro products increased approximately 8% compared with the third quarter of 2004 and approximately 3% from the second quarter of 2005.

Sales were reduced from $79.0 million in the second quarter of 2005 to $72.5 million in the third quarter, while prescriptions for the Company`s products increased. "The increase in prescriptions and the decrease in sales suggest a reduction in customer inventories," said Bill Seiden, Senior Vice-President of Sales and Marketing.

Financial Position

At September 30, 2005, Taro`s total assets were $710.2 million, an increase of $13.4 million compared with $696.8 million at December 31, 2004.

Total liabilities were $325.4 million at September 30, 2005, a decrease of $2.6 million compared with $328.0 million at the end of 2004.

Shareholders` equity at September 30, 2005 was $384.1 million, an increase of $16.0 million compared with $368.1 million at the end of 2004.

"Our results reflect the competitive nature of the generic drug industry and our continuing investment in the development of proprietary and generic drugs," said Barrie Levitt, M.D., Chairman of the Board. "We believe that Taro has a robust pipeline which includes the critical products necessary to sustain the long-term growth of our generic business. In addition, two of our major proprietary research initiatives are approaching definitive clinical studies."

Proprietary Research Update

Novel Formulation of Ovide®

On October 26, 2005, the Company announced that it will initiate a multi-center Phase III study in the United States to evaluate a novel formulation of Ovide®, a prescription product for control of head lice (Pediculus humanus capitis) in pediatric and adult subjects.

Taro Pharmaceuticals U.S.A., Inc. currently markets Ovide® (malathion) Lotion, 0.5%. The Company expects that the new formulation of Ovide® will maintain the efficacy of Ovide® Lotion with shorter application time and greater ease of use, thus improving patient compliance. Approximately six to twelve million cases of head lice are reported annually in the United States, according to the American Academy of Pediatrics. Taro has filed a patent application in the U.S. Patent and Trademark Office with claims that cover this new, proprietary formulation.

There can be no assurance as to the successful outcome of any studies of the novel formulation of Ovide®, or of its eventual approval by any regulatory authorities or successful commercialization if approved.

T2000 Studies

T2000 is the first compound in a group of long-acting, non-sedating barbiturates under development at Taro. As reported earlier, the Canadian Health Products and Food Branch Inspectorate has approved a multi-center, randomized, double-blind, placebo-controlled Phase III study of T2000 in patients with essential tremor. Essential tremor is a common form of involuntary shaking not related to Parkinson`s disease. It is estimated that essential tremor affects more than five million people in the U.S. To date, T2000 has been administered to 165 people in Phase I and II studies to evaluate the compound`s safety and efficacy.

There can be no assurance of the ultimate demonstration of safety and efficacy, or successful completion of Phase III testing, or of the approval by any regulatory authority of T2000 for any indication, or of its commercial success if and when approved.

FDA Approvals

During the third quarter, the Company reported that five final approvals were received from the U.S. Food and Drug Administration ("FDA") for Abbreviated New Drug Applications ("ANDAs") for topical generic pharmaceutical products. Three are prescription corticosteroids used in treating inflammatory skin conditions: Hydrocortisone Butyrate Cream USP, 0.1%, bioequivalent to Ferndale Laboratories` Locoid® cream; Halobetasol Propionate Cream, 0.05%, bioequivalent to Bristol-Myers Squibbs` Ultravate® cream; and Alclometasone Dipropionate Cream USP, 0.05%, bioequivalent to GlaxoSmithKline`s Aclovate® cream. Two are prescription products used in treating infections of the skin: Ciclopirox Topical Suspension USP, 0.77%, an antifungal product, which is bioequivalent to Medicis Pharmaceutical Corp.`s Loprox® Topical Suspension; and, Mupirocin Ointment USP, 2%, an antibiotic used to treat impetigo. This product is bioequivalent to GlaxoSmithKline`s Bactroban® Ointment.

In addition, during the quarter, Taro received tentative approval from the FDA of its ANDA for Gabapentin Capsules 100 mg, 300 mg, and 400 mg. Tentative approvals do not grant marketing rights. On October 4, 2005, Taro received FDA approval of its New Drug Application for Loratadine Oral Suspension, 5mg / 5mL. This spill-resistant OTC product, used for the temporary relief of symptoms due to upper respiratory allergies, utilizes the proprietary NonSpil® liquid drug delivery system developed by Taro

[BrauchGeld]

Es geht langsam aber sicher wieder aufwärts mit Taro Pharma ,der Institutionellen Anteil ist direkt von 67% auf 81% gestiegen.
Mit Taro kann man leicht geld verdienen und das bei sehr sehr geringem risiko.

Buy Low Sell High

[BrauchGeld]

Hallo

Taro Pharma ist für mich die nächste Teva deshalb wird position weiter erhöht ,die Aktie notiert gerade mal 1$ über buchwert.Taro ist keine pommesbude sondern schreibt schwarze zahlen was nicht üblich in der Branche ist.
Langfristig mit sicherheit eine Goldgrube.
-------------
-------------

Phytopharm kommt in die heisse Phase in den nächsten tagen sollen die ergebnisse kommen ,also eine spannende woche steht bevor.



Small-Cap Investor

By : Andrew Hore November 27, 2005



Pharmaceuticals developer Phytopharm is due to report trial results for its Alzheimer’s treatment in the next month. They will show whether it is safe and indicate whether it works. If the news is positive, it will help Phytopharm licence it to a larger pharmaceuticals company.

Phytopharm specialises in developing pharmaceuticals and functional food products using medicinal plant extracts. The Alzheimer’s treatment is called Cogane and it makes the interconnections between neurones in the brain regrow, slowing the degeneration related to age.

The phase IIa trials only need to show a trend towards improvement after three months to be a success. There are indications that the treatment continues to work over a longer period. If the news is good there will be a phase IIb study followed by a one-year phase III study. There is interest from big pharmaceutical companies and Phytopharm is likely to licence Cogane to one before the other trials are undertaken.

There is also a possibility that Cogane will work on Parkinson’s disease and a related treatment called Myogane could be used for motor-neurone disease.

Phytopharm’s other main potential product is an appetite suppressant based on a Southern African plant in the Hoodia family. Phytopharm originally worked with Pfizer on Hoodia, but as it is a functional food rather than a drug, Pfizer lost interest. Two months after Pfizer returned the rights, Unilever showed interest and it signed a global licence at the end of 2004. A product based on Hoodia could be ready for sale by 2008.

Annual overheads are just over £8m and the majority of these costs will be covered by contributions from Unilever.

Two drugs for skin and joint disorders in dogs also produce revenues. This means the cash outflows should reduce over the coming years. Phytopharm has net cash of £11.6m and it should have more than half of that left in two years’ time. All this ignores a licensing deal for Cogane.

Phytopharm has had a troubled year because of the termination of a licensing agreement with Japanese drug firm Yamanouchi and the resignation of its broker following actions by animal rights extremists. The shares started to recover at the beginning of November following the company’s full year results and the release of research by Edison Investment Research. Phytopharm is likely to appoint a new broker following release of the Cogane results and this should help the shares.

Edison estimates that a risk-adjusted net present value of the shares is 260p a share. If either of the two main products proves a success they will each be worth more than the market value of Phytopharm.

[BrauchGeld]

Hallo

Die Woche fängt gut an für Phytopharm,hoffentlich ist es kein fehler die Aktie länger zuhalten.


http://finance.yahoo.com/q?s=pym.l

[cyberhai]

Hallo BrauchGeld,

war hältst Du davon, mal einen Thread für PHYTOPHARM aufzumachen

Heute sind die ja zwischen +20 bis -20 % geschwankt.

Mit welcher Währung notiert die denn bei 93, wenn die Aktie in Euro mit 1,2 geführt wird

Gruß Cyberhai

[BrauchGeld]

@cyberhai

Ich hatte heute wirklich riesenglück das ich noch rechtzeitig verkauft habe.
Hab Phytopharm zu 48p gekauft und bei 113p verkauft wirklich mehr glück als verstand.
Die Geschichte mit Phytopharm ist fürs erste gelaufen die ergebnisse sind raus deshalb der absturz.

Meine nächsten Favoriten für Dezember sind Protherics,Alizyme und Halozyme.

Protherics gibt Partner bekannt .
Halozyme erhält hoffentlich die Zulassung
Alizyme veröffentlich Phase 2b daten.

Auf steigende Kurse!

[cyberhai]

[posting]19.055.937 von BrauchGeld am 28.11.05 21:30:09[/posting]Kannst Du kurz mitteilen, wie die Ergebnisse bei Phytopharm waren, habe da nichts gefunden...

Danke, Gruß Cyberhai

[BrauchGeld]

Hier mein lieber

Phytopharm PLC
28 November 2005


Company Contact: U.K. Investor Relations Contact:
Phytopharm, plc Financial Dynamics
Dr Richard Dixey David Yates / Ben Atwell
[phone] [phone]

www.phytopharm.com






Preliminary results of Phase II proof of principle study in Alzheimer`s disease



GODMANCHESTER, Cambridgeshire, U.K. (28 November 2005) - Phytopharm plc (LSE:
PYM; NASDAQBB: PHYOF; PHYOY) (`Phytopharm`) announces today the preliminary
results obtained from the Phase II proof of principle clinical study of PYM50028
(CoganeTM). The compound is novel, orally active and has neuroprotective and
neurotrophic properties. It is under development for Alzheimer`s disease as a
potential disease modifying agent. The Oxford Project to Investigate Memory and
Ageing (OPTIMA) was the lead clinical centre and 15 other sites in the UK
participated in the study.



Two hundred and fifty six subjects with mild to moderate Alzheimer`s disease
were randomly allocated to receive either CoganeTM (n = 127) or a placebo (n =
129) orally once daily for 12 weeks. The patients were monitored for a further 6
weeks following the completion of dosing, with measurements taken during the
study to determine the safety, efficacy and pharmacokinetic profile of CoganeTM
compared to placebo. The baseline demography data confirmed that the treatment
groups were well balanced for factors such as age, gender and severity of
disease.



The overall safety data confirm that CoganeTM administered orally once daily for
up to 12 weeks is well tolerated and has a good clinical safety profile. There
were no substantial differences in the adverse event and laboratory safety data
for each group. Treatment emergent adverse events considered to be possibly
attributable to the study medication were reported by 17 (13%) of the subjects
in the CoganeTM group and 21 (16%) of the subjects in the placebo group. Only
four subjects in the CoganeTM group prematurely discontinued the study due to an
adverse event compared with six in the placebo group.



One hundred and two subjects in the CoganeTM group and 106 subjects in the
placebo group completed the treatment period in accordance with the protocol and
were therefore included in the primary (`per- protocol`) analysis. The
prospectively defined primary efficacy measure was the change in word recall
score, assessed using the Hopkins verbal learning test. The average baseline
and end of treatment scores (maximum = 36) were 12.1 (33.7%) and 12.6 (35.1%)
for the CoganeTM group, compared with 10.9 (30.2%) and 11.6 (32.2%) for the
placebo group. The baseline scores and changes over time were not significantly
different between the groups. A variety of other secondary measures of
cognitive function (including a computerised neuropsychological test battery,
the clinical dementia rating and the mini mental state examination) did not
detect significant changes over the treatment period or a difference between
CoganeTM and the placebo treatment groups in the per protocol analysis.



Commenting on these results, Professor David Smith (OPTIMA Project Leader and
Emeritus Professor of Pharmacology, Oxford University) said: `This study
confirms that CoganeTM has a good clinical safety profile. Since the placebo
group did not show any evidence of deterioration during the 12 week treatment
period, a short term clinical study such as this is unlikely to detect a
significant treatment effect when attempting to evaluate a disease modifying
agent. However these results, together with the striking pre-clinical data,
suggest that this novel neurotrophic agent should now be taken forward into a
longer term clinical study to determine its efficacy as a treatment for
Alzheimer`s disease.`



Dr Richard Dixey, Chief Executive of Phytopharm, said: `Whilst we were surprised
by the lack of deterioration in the placebo group, the CoganeTM data show the
product has a good safety profile and was well tolerated. Taken together with
the encouraging and extensive pre-clinical and early clinical data pack we have
compiled on CoganeTM, we will immediately discuss these data with potential
licensing partners and look forward to the future development of this product.`

[BrauchGeld]

Nach Absturz eine Riesenchance ?

1.Unternehmslenker haben zu wesentlich höheren kursen gekauft
2.SFBC wächst von Quartal zu Quartal
3.Schreibt schwarze zahlen




Kurs:18,40$
Marktkap:339mio$
Buchwert:16,60$
Umsatz:362mio$

http://finance.yahoo.com/q?s=sfcc

23-Nov-05 GOLIEB, ARNOLD
Director 1,000 Direct Purchase at $22.43 per share. $22,430
21-Nov-05 GOLIEB, ARNOLD
Director 800 Indirect Purchase at $22.27 per share. $17,816
17-Nov-05 GOLIEB, ARNOLD
Director 2,000 Direct Purchase at $26.47 per share. $52,940
16-Nov-05 HANTMAN, ARNOLD
Chief Executive Officer 1,000 Indirect Purchase at $27.69 per share. $27,690
14-Nov-05 ELIAS, LEWIS R.
Director 1,000 Direct Purchase at $32.32 per share. $32,320
9-Nov-05 KRINSKY, LISA ANN MD
President 2,000 Indirect Purchase at $31.29 per share. $62,580
8-Nov-05 NATAN, DAVID
Officer 1,000 Direct Purchase at $30.88 per share. $30,880
8-Nov-05 LEVINE, JACK
Director 1,000 Indirect Purchase at $30.10 per share. $30,100
8-Nov-05 KRINSKY, LISA ANN MD
President 3,000 Indirect Purchase at $30.22 per share. $90,660
7-Nov-05 GOLIEB, ARNOLD
Director 2,000 Direct Purchase at $28.85 per share. $57,700


Sieht alles sehr interessant aus.

[BrauchGeld]

Bei Taro Pharma scheint der verkaufdruck endlich vorbei zu sein, jetzt heisst es 20$ wir kommen.

[BrauchGeld]

Hallo

Hab etwas Depomed aktien reduziert und bin zu 9,98$ in Bradley eingestiegen.
In kürze stehen hier News an und dann sind die Shorties fällig.
Ich sehe ein kurzziel von 20-25$ für dieses Jahr.

Bradley Pharma (NYSE:BDY)
Kurs:10,08$
Marktkap:159mio$
Cash:70,2mio$---4,4$ pro aktie
Buchwert:10,70$
Umsatz:~100mio$
KGV:8,4
Shares out:15,8mio
Short:4,25mio<<<<< 30%

Homepage:
http://www.bradpharm.com/

[Neoe]

CV Therapeutics
CVTX

27. Januar Zulassungsentscheidung der FDA zum Lead-Product RANEXA.

Die Zulassung scheint sicher, da bereits ein Approvable Letter vorliegt. Die letzte Phase III (Bestätigungsstudie) war ebenfalls erfolgreich und erfolgte unter einem SPA (Special Protocol Assessment), es gilt also die Vereinbarung, dass diese Studie bei Erfolg zulassungsausreichend ist.

RANEXA hat ein geschätztes Potential von 350 bis 500 MIO. USD pro Jahr und behandelt die chronische Angina.
Es läuft eine weitere Studie, die bei Erfolg einen Blockbuster aus dem Produkt macht.

Ich denke das Risiko ist in diesem Fall nicht sehr hoch, das wird allerdings auch schon durch die hohe Marketcap von 1.1 Milliarden reflektiert (davon aber 500 Mio. Cash und zwei weitere Produkte in Phase III)

[nort.]

Lesezeichen

[nort.]

Lesezeichen

[nort.]

Hallo,

möchte hier mal auf NABI aufmerksam machen.



Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for NicVAX®

ROCKVILLE, Md., March 9 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI) today announced that NicVAX® (Nicotine Conjugate Vaccine), the company's novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast Track regulations are also designed to expedite the review process for designated products, including the potential for companies to ask for priority review.

"We believe this is the first Fast Track Designation for a smoking cessation product candidate, which is unprecedented, and provides further validation for our unique approach to addressing nicotine addiction," stated Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. "Smoking is the number one preventable cause of death in the western world, yet current smoking cessation therapies do not effectively treat the root cause of the addiction. We believe the vaccine approach inherent to NicVAX will provide clear patient advantages and a strong differentiation from currently marketed and development-stage products."

How NicVAX is Designed to Work

NicVAX is designed to cause the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. It is believed that these nicotine antibodies will act like a "sponge" soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain. The positive stimulus in the brain that is normally caused by nicotine is no longer present, thereby eliminating the addictive properties of smoking and, consequently, helping people to quit. Unlike current therapies, such as nicotine patches and gums, smokers will not be able to eliminate the effects of NicVAX by stopping their treatment. In addition, because these antibodies are expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse, a significant challenge with existing smoking cessation therapies.

Progress to Date and Next Steps

Nabi Biopharmaceuticals has completed four Phase I/II studies, totaling close to 200 patients, for NicVAX. These studies demonstrated that NicVAX is well tolerated, highly immunogenic, produced dose-dependent increases in antibody titers, and showed a good indication of efficacy at the 200 ug dose with a 33 to 40 percent quit rate versus nine percent for smokers dosed with a placebo.

In September 2005, Nabi Biopharmaceuticals announced that it had received a $4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, for partial funding of the development program for NicVAX. Partnering remains Nabi Biopharmaceuticals' strategic goal for NicVAX.

Nabi Biopharmaceuticals will next conduct a Phase II "proof-of-concept" study for NicVAX, which is expected to commence during the second quarter of 2006. The study will be comprised of approximately 300 patients, a large enough sample size to establish both proof-of-concept and optimal dose identification for the company's Phase III program. The study results are anticipated in the second half of 2007.

Importantly, the vaccine manufactured for this Phase II study has been manufactured at commercial scale in an optimized formulation at the company's vaccine manufacturing facility in Boca Raton, Florida. This further demonstrates the significant advancements that have already been achieved in the development of Nabi Biopharmaceuticals' nicotine addiction program. The study design will incorporate recommendations from a newly formed scientific advisory panel. The panel is comprised of scientific and clinical experts in smoking cessation. The panel will also provide input to the company on other aspects of the NicVAX development program.

Nabi Biopharmaceuticals has also met with the FDA, as well as the European Medicines Agency (EMEA), to ensure all key regulatory requirements are built into the NicVAX Phase II trial design and overall development program.

Cigarette Smoking: A Growing Global Health Challenge

Smoking is a global healthcare problem, and The World Health Organization estimates that there are 1.3 billion smokers worldwide and nearly five million tobacco-related deaths each year. According to the U.S. Centers for Disease Control and Prevention (CDC), tobacco use is the single leading preventable cause of death in the United States and is responsible for more than 440,000 deaths each year. They estimate that approximately 70 - 80 percent of smokers in the U.S. want to quit, but less than five percent of those who try to quit remain smoke-free at 12 months. In addition, they estimate that tobacco use causes $75.5 billion in excess medical costs and $81.9 billion in illness- related productivity losses each year in the U.S. To learn more about NicVAX and how it works, please visit our website at: http://www.nabi.com/pipeline/pipeline.php?id=3 .

http://phx.corporate-ir.net/phoenix.zhtml?c=100445&p=irol-ne…

[Das_Modul]

...

[Fruehrentner]

@alle

dieser thread war inzwischen historisch und habe ihn nun wiederbeleben lassen - aus gutem Grund!

Bei GPC Biotech haben wir kürzlich gesehen, welche Kursgewinne bei positiven news möglich sind.

Wir sollten also hier weiterhin diejenigen Firmen nennen und im Auge behalten, bei denn in Kürze, sprich wenigen Wochen bzw. Tagen, entscheidende News anstehen, wie z.B. aktuell Medigene.

Wäre schön, wenn ihr weitere Kandidaten hier nennen würdet.

Bitte KEINE OTC-Werte/Pink Sheets etc.


Zu guter letzt nochmal das Eröffnungsstatement von Neoe:

Ich denke ein grundsätzliches Problem im Biotech-Sektor ist es, die entscheidenden Quellen für gute Infos zu finden, um in entscheidenden Momenten dabei sein zu können.
Da man nicht immer alles mitbekommen kann, verpasst man natürlich vieles und ärgert sich dann, wenn man das Press Release zum neuesten Wundermedikament liest, der Kurs dann aber natürlich schon über alle Berge ist.

Deswegen schlage ich vor, dass hier jeder seine vielversprechendsten Late-Stage-Kandidaten (ab Phase III oder vor Zulassung), die vielleicht gerade nicht die nötige Aufmerksamkeit genießen, hier vorstellt und am besten noch das Unternehmen dazu.

[BrauchGeld]

Antwort auf Beitrag Nr.: 24.763.999 von Fruehrentner am 21.10.06 19:52:24

Hallo

Somaxon präsentiert positive phase 3 daten .
Silenor ist ein medikament gegen schlaflosigkeit das so gut wie keine nebenwirkungen hat und somit wesentlich besser ist als Indiplon von Neurocrine.

Somaxon Pharmaceutical
Kurs:13,91 $
Marketkap: 251 mio$
Cash:79 mio$

Pipeline:
http://www.somaxon.com/pages/product.htm

Somaxon Pharmaceuticals' SILENOR(TM) Demonstrates Positive Results in a Phase 3 Transient Insomnia Clinical Trial
Monday October 23, 7:00 am ET
* SILENOR(TM) Demonstrates Statistically Significant Improvement vs. Placebo in Transient Insomnia
* Primary Endpoint of Latency to Persistent Sleep (LPS) Demonstrates Sleep Onset Action of SILENOR(TM)
* Represents Second Phase 3 Clinical Trial of SILENOR(TM) to Demonstrate Positive Results in the Treatment of Insomnia. Two Remaining Phase 3 Trials Will be Reported by End of 2006


SAN DIEGO, Oct. 23 /PRNewswire-FirstCall/ -- Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX - News) today announced positive results from the company's Phase 3 clinical trial evaluating SILENOR(TM) (doxepin HCl) in adults with transient insomnia. SILENOR(TM) demonstrated statistically significant improvements compared to placebo (p<0.0001) in the primary endpoint of this trial, Latency to Persistent Sleep (LPS), a measure of sleep onset. SILENOR(TM) also produced statistically significant improvements relative to placebo in multiple secondary endpoints, including measures of both sleep onset and sleep maintenance.
This Phase 3 trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group study that enrolled 565 adults in a sleep laboratory setting using a phase-advance, first night assessment model of induced transient insomnia. Efficacy assessments evaluated both objective PSG (polysomnography) and subjective measures of sleep. Results demonstrated that 6mg of SILENOR(TM) was effective at inducing sleep and maintaining sleep throughout the night.

SILENOR(TM) achieved statistically significant results in multiple endpoints including:


* Latency to Persistent Sleep (LPS): Improvement compared with placebo
of 13 minutes (p<0.0001)
* Latency to Sleep Onset (LSO), a subjective measure: Improvement
compared with placebo of 16 minutes (p<0.0001)
* Wake After Sleep Onset (WASO): Improvement compared with placebo of
40 minutes (p<0.0001)
* Total Sleep Time (TST): Improvement compared with placebo of
51 minutes (p<0.0001)

Additionally, SILENOR(TM) achieved statistically significant results compared to placebo in Sleep Efficiency (SE) for the entire night and in each third of the night, as well as in subjective measures of sleep maintenance (sWASO, sTST) and Sleep Quality (SQ).

The study also demonstrated that SILENOR(TM) was well tolerated. The incidence of adverse events was low and comparable to placebo. There were no reports of amnesia, memory impairment, or anticholinergic effects, and there were no clinically meaningful effects on measures of next day impairment.

Phil Jochelson, M.D., Somaxon's Chief Medical Officer, said: "We are extremely pleased with the results of this important Phase 3 clinical trial. This is the first clinical trial for SILENOR(TM) that we specifically designed to evaluate sleep onset as the primary endpoint. The results from this study demonstrate significant effects on both objective and subjective measures of sleep onset. We have now reported results from four randomized, controlled clinical trials of SILENOR(TM), with consistent and reproducible effects shown in both the chronic and transient insomnia populations."

Ken Cohen, Somaxon's President and CEO, added, "With clear positive SILENOR(TM) data on both sleep onset and sleep maintenance, along with a favorable safety and tolerability profile, we believe this product candidate, if approved by the FDA, has the potential to become a significant participant in a large and rapidly expanding insomnia market. We are hopeful that SILENOR(TM) can become the first non-scheduled insomnia treatment to help patients fall asleep and maintain sleep throughout the night. This transient insomnia result is also important because our patent covering the use of SILENOR(TM) in patients with transient insomnia extends until 2020."

The company expects results from its remaining two Phase 3 clinical trials for SILENOR(TM) by the end of this year. These include a three month PSG trial and a four week outpatient trial, both in elderly patients. Assuming that the company's ongoing Phase 3 clinical trials and planned preclinical studies for SILENOR(TM) are successful and proceed as currently scheduled, Somaxon expects to file a New Drug Application (NDA) with the FDA for SILENOR(TM) in the third quarter of 2007. This timing assumes that the initial NDA submission will include all of the data from the company's completed genotoxicity and ongoing reproductive toxicology studies requested by the FDA, but that the FDA will allow the company to submit the data from the requested carcinogenicity studies at a later date. The FDA has previously indicated to Somaxon that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment. The company has submitted the results of the genotoxicity studies to the FDA and is awaiting a response; as the company previously reported, no signal indicative of genotoxicity was observed in any of those studies.