LifeCycle Pharma -- First Class Investment - 500 Beiträge pro Seite

[BrauchGeld]

Hab mir erlaubt einen neuen Thread zu eröffnen der alte von Cyberhexe befindet sich nämlich im Nanotech forum und findet kaum Beachtung .

Die Produkte von LifeCycle haben riesiges Potential und besitzen teilweise \"Best in Class\" status .

Bin gestern in LifeCycle eingestiegen mit 1000st für 3,27€ (Frankfurt).

Ausblick 2008:

LCP-AtorFen (dyslipidemia) start Phase III ( 2H 2008 )
LCP-Tacro (kidney transplant) start Phase III ( 2H 2008 )
LCP-Tacro (liver transplant) Phase II Daten ( 2Q 2008 )
Vermarktungspartner für LCP-AtorFen ( 2H 2008 )

LifeCycle Pharma (LCP.CO)

Marktkap : 179,5 million €
Cash : 85,7 million €
Kurs : 25 Dkk ( 3,35 € )



LifeCycle Pharma ein aus einem spin-off der \\\"H. Lundbeck A/S\\\" im Juni 2002 entstandenes dänisches Unternehmen verfügt über eine Technologie --> \\\"MeltDose® technology\\\", mit deren Hilfe wasserunlösliche Aktivsubstanzen über nanoformulierte Partikelgrössen eine grössere Bioverfügbarkeit erhalten. Daraus ergeben sich möglich Vorteile bei der Dosierung sowie daraus abgeleitet beim Nebenwirkungsprofil. Ausserden sind geringere Schwankungen bei den Wirkstoffkonzentrationen im Blut/PLasma durch eine von der Nahrungsaufnahme geringer beeinflusste Resorptionsrate möglich.

Das Geschäftsmodell von LifeCycle Pharma beruht auf der Umformulierung von Aktivsubstanzen, welche bereits eine Marktzulassung erhalten haben. Nach Ablauf des Patentschutzes werden diese mit verbesserten Produkteigenschaften am Markt platziert und durch Vertriebspartner verkauft.

Mit LCP-FenChol, einer Fenofibrat-Formulierung zur Senkung des Blutfettwerte, wurde gestern eine erste Zulassung durch die FDA bekannt gegeben. Mit Sciele wurde ein Kooperationspartner gefunden, der bereits für diese Indikation eine Vertriebsmannschaft aufgestellt hat. Für die Vermarktungsrechte in Nordamerika erhält LifeCycle Pharma neben einer bereits getätigten Zahlung von 5 Mio$ nun bedingt durch die FDA-Zulassung weitere 4 Mio$ sowie abgestufte Lizenzzahlungen zwischen 15-19% vom Umsatz.
In der Pipeline befindet sich unter anderem auch eine Atorvastatin-Formulierung, und zwar unter dem Namen LCP-AtorFen, mit welchem vor kurzem eine Phase-2-Studie begonnen wurde.
Atorvastatin ist der generic name der Aktivsubstanz des derzeit umsatzstärksten Medikamentes in der Pharmabranche überhaupt --> mit dem Cholesterinsenker Lipitor generiert Pfizer derzeit über 10 Milliarden $/a.
Lipitors Patentschutz läuft 2011 ab.
Falls LifeCycles Formulierung LCP-AtorFen in den weiteren Phasen der Klinik die Phase 1-Ergebnisse bestätigt, dann könnte das gleichzeitige Angehen der drei wichtigsten kardiovaskulären Risikofaktoren, nämlich Chlolesterin mit niedriger Dichte (LDL), Cholesterin mit hoher Dichte (HDL) und Triglyzeride (TG) eine ausserordentlich interessante Variante darstellen.

LCP-AtorFen kombiniert Atorvastatin und die niedrigste Dosierung von Fenofibrat, die keine Auswirkung auf die Verdauung hat.


LifeCycle Pharma announces positive data from LCP‐AtorFen
Phase II clinical program (7 Mai 2008)
http://media.corporate-ir.net/media_files/irol/21/215658/new…


LifeCycle Pharma Announces Positive Top-line Results of Phase II Clinical Trial of LCP-Tacro for the Prevention of Organ Rejection after Kidney Transplantation ( 3 März 2008 )
http://www.finansnyheder.dk/news/ShowNewsStory.aspx?StoryId=…


LifeCycle Pharma launches its first product in the U.S.
It will be marketed under the brand name Fenoglide™ by Sciele Pharma, Inc. (21 Februar 2008 )
http://media.corporate-ir.net/media_files/irol/21/215658/Fen…

[BrauchGeld]

Ist gerade reingekommen.....

Tricor patent läuft in 2009 ab ,LifeCycle und Novartis-Tochter Sandoz könnten hier die ersten sein .

28.05.2008 17:57
LifeCycle Pharma A/S Announces Successful Completion of Pilot Studies on LCP-Feno and is Currently Preparing for Pivotal Studies

LifeCycle Pharma (News) A/S (OMX:LCP) today announced the successful completion of pilot studies for LCP-Feno, a product for the treatment of dyslipidemia which is being developed in collaboration with Sandoz Inc. LCP-Feno is designed to be an AB-rated, substitutable version of Tricor® 145 mg, currently marketed in the US by Abbott under the name Tricor® and in Europe by Solvay S.A. under the name Lipanthyl ®. In collaboration with Sandoz, LifeCycle Pharma is currently preparing for the initiation of pivotal studies to complete all the necessary requirements for a US ANDA filing.

“We are extremely pleased to have shown bioequivalence of LCP-Feno and Tricor® in this pilot study,“ said Dr. Michael Beckert, LifeCycle Pharma's Chief Medical Officer and Executive Vice President. “This is another important milestone for the company, and a clear validation of the breadth of application as well as versatility of the MeltDose® technology. The next step will be to prepare for pivotal pharmacokinetic studies to confirm these results.“

About the collaboration with Sandoz

Sandoz and LifeCycle Pharma entered into an exclusive development and commercialization agreement for LCP-Feno for the US market in September 2006. The parties are jointly responsible for the future development, and Sandoz will be solely responsible for later commercialization of LCP-Feno in the US. LifeCycle Pharma will receive milestone payments as well as a significant double-digit royalty rate on future sales. In 2006, the worldwide sales of all fenofibrate products were approximately USD 1.7 billion (IMS Health; All rights reserved).

Pipeline prioritization and discontinuation of two smaller service agreements

LifeCycle Pharma has a broad pipeline, primarily focused on select transplantation and cardiovascular products, two of which, LCP-Tacro and LCP-Atorfen, are expected soon to enter into Phase III. LifeCycle Pharma has also historically had a number of service (re-)formulation agreements with other companies. In order to optimize the use of scarce resources and focus the clinical development organization, a first step in prioritizing the pipeline has been to terminate a few service agreements outside the core therapeutic areas of interest for LifeCycle Pharma.

Therefore, LifeCycle Pharma today announced the discontinuation of both the LCP-Lerc service agreement with Recordati and the feasibility study agreement with Sciele Pharma. In agreement with LifeCycle Pharma, Recordati has decided to discontinue the LCP-Lerc service agreement which encompasses the development of a novel version of Recordati's lercanidipine (Zanidip®) for the treatment of hypertension. In addition, LifeCycle Pharma and Sciele Pharma mutually agreed to discontinue the feasibility study agreement pertaining to a product in preclinical development.

“We can now focus resources on our most promising pipeline projects. I am pleased to announce that we today have taken a first important step in this direction,“ says Hans Christian Teisen, LifeCycle Pharma's CFO and Executive Vice President. “We are also in the process of determining the organizational best route forward to optimize the MeltDose® technology in terms of service arrangements without distracting from our core focus which is transplantation and the immunosuppression market,“ he explained.

[HuskyEnergy]

Antwort auf Beitrag Nr.: 34.189.908 von BrauchGeld am 28.05.08 19:02:00

Hmmm...kenne die Firma nicht, kann aber nur allgemein sagen, dass der Biotechsektor zZ alles andere als rund läuft.

Zum Chart: Abwärtstrend mit eventueller Bodenbildung um die 3€, darunter sollte der Kurs nicht mehr fallen.

Lg

[BrauchGeld]

LCP-Tacro Präsentation 3.3.2008
http://library.corporate-ir.net/library/21/215/215658/items/…

insiderhandel

Datum Insider
2007-12-27 DYRBERG, THOMAS
2007-12-21: köp, 5 000 st LCP

2007-09-10 JENSEN, MICHAEL WOLFF
2007-09-10: köp, 100 000 st LCP <<<<<<<<<<<<<< hat dafür rund 650.000€ (6,50 € pro stück)

2007-09-06 DYRBERG, THOMAS
2007-09-06: köp, 3 800 st LCP

[medimmune]

Antwort auf Beitrag Nr.: 34.190.802 von BrauchGeld am 28.05.08 20:55:59

Köp steht wahrscheinlich für Kauf?

[BrauchGeld]

Antwort auf Beitrag Nr.: 34.193.074 von medimmune am 29.05.08 09:19:09

Er hat 650.000€ bezahlt so ist es richtig . Sorry

@Medimmune
Ja köp steht für kauf .

Orderbuch
http://bors.www.dn.se/dn/site/stock/stockdetail.page?magic=(…

[BrauchGeld]

LifeCycle Pharma to Present Data at American Transplant Congress (ATC) in Toronto
Thursday May 29, 2:55 pm ET


H0RSHOLM, Denmark--(BUSINESS WIRE)--LifeCycle Pharma A/S today announced that it will present clinical trial data on LCP-Tacro tablets at the 2008 American Transplant Congress to be held in Toronto, Canada, on May 31 through June 4. LifeCycle Pharma will present its data on Monday, June 2.

“The results of these two trials met all of our expectations, and we look forward to sharing the data with the medical community at the prestigious 2008 American Transplant Congress in Toronto,” said Dr. Michael Beckert, LifeCycle Pharma’s Chief Medical Officer and Executive Vice President.

Forty-seven kidney transplant patients contributed to a three-sequence, open-label, multi-center, prospective, conversion study to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets once-a-day versus Prograf® (tacrolimus, Astellas Pharma) capsules twice-a-day. LCP-Tacro given once-a-day increased the bioavailability of tacrolimus by about 40% allowing reduced total daily doses by about 30% compared to Prograf twice-a-day. Trough blood levels at 24 hours post-dose were well-correlated with total exposure to tacrolimus (AUC). Results will be presented by Rita R. Alloway, PharmD, Research Professor and Director of Transplant Clinical Research at the University of Cincinnati.

In a Phase I study, the bioavailability of LCP-Tacro tablets was compared to Advagraf® (MR4, Astellas Pharma) capsules in a two-sequence crossover study in 20 normal volunteers. Subjects received LCP-Tacro (one 2 mg tablet) or Advagraf (two 1 mg capsules) once daily for 10 days. After a two-week washout period, subjects then received the alternative treatment for 10 days. The overall systemic exposure of tacrolimus from the LCP-Tacro 2 mg tablets was significantly higher compared to Advagraf 1 mg capsules. At steady state, the bioavailability (AUCτ and Cmin) of tacrolimus from one LCP-Tacro 2 mg tablet was 49% and 66% higher than that of two Advagraf 1 mg capsules. LCP-Tacro tablets were well-tolerated without serious adverse events. Results will be given in an oral presentation by Robert D. Gordon, MD, Sr. Director of Medical and Clinical Research, LifeCycle Pharma, Inc.

[BrauchGeld]

In den nächsten Tagen (2Q) sind die Phase II Daten für LCP-Tacro(liver) zu erwarten .
Vorläufige Ergebnisse sind sehr vielversprechend .

New positive Interim phase II Data Underscores Potential of LCP‐Tacro; Kidney Transplantation Product
Candidate to Report Phase II Data in March 2008
http://media.corporate-ir.net/media_files/irol/21/215658/new…

[BrauchGeld]

800 million US$ Umsatzpotential für LCP-Tacro das hört sich gut an und bereits 2010 rechnet man mit der Markteinführung .

LifeCycle Pharma eyes several acquisition candidates
(2008.04.03)

LifeCycle Pharma aims to take a significant slice of the market for transplantation drugs and is looking at potential acquisitions
Danish speciality pharmaceutical company LifeCycle Pharma is looking at acquisitions that can help the company to gain a significant slice of the market for transplantation drugs, writes financial daily newspaper Børsen. Managing director of LifeCycle Pharma Flemming Ørnskov says he has several potential candidates in mind:

"In times of crisis, it is a good idea to go on the offensive and look at acquisition opportunities. I think we will land a product this year or next year, and we have a major focus on this."

LifeCycle Pharma recently achieved promising test results with a drug candidate that prevents rejection of organs in kidney and liver transplant recipients. Ørnskov anticipates that the drug could be launched on the market in 2010 and could generate sales of up to USD 800m.

"In addition to this product, I would like our sales staff to have another product so that we can gain a larger slice of the transplantation market," says Ørnskov.

The global transplantation market is estimated to be worth USD 5-10bn, a figure which is growing due to better drugs and better technology making it possible to transplant organs at an earlier stage and in older patients.

LifeCycle Pharma is headquartered in Hørsholm north of Copenhagen and has a fully owned subsidiary in New York, USA. The company was founded in 2002 as a spin-off from Danish pharmaceutical company Lundbeck, and is listed on the OMX Nordic Exchange. LifeCycle Pharma utilizes its proprietary Meltdose technology to improve the bioavailability of known and established compounds so that patients can absorb them more effectively.

[BrauchGeld]

Ich bin gespannt wen sich Lifecycle als Partner für AtorFen angelt .

Schon etwas älter diese Nachricht aber schön zu sehen das AtorFen hier mit auf der Liste ist .....

http://scientific.thomson.com/thomsonpharma/media/pdfs/tpqr/…

The five most promising drugs entering
Phase II trials

Drug
CPP-109
intranasal insulin formulation
LCP-AtorFen
EC-145
TG-100801

The world’s best-selling drug is Pfizer’s cholesterol-lowering treatment Lipitor, which
achieved sales of $12.9 billion in 2006 (and which is, incidentally, due to come offpatent
in 2011). Its active ingredient atorvastatin is also one of the components of
LCP-AtorFen, developed by LifeCycle for the treatment of a number of disorders
requiring lipid management, including atherosclerosis, coronary heart disease,
diabetes, obesity and metabolic syndrome.
LifeCycle believes that the once-daily oral formulation, combining atorvastatin with
the PPAR alpha agonist fenofibrate, will provide the lowest effective dose on the
market. It uses the company’s MeltDose technology to enhance the bioavailability
of compounds, eliminating the problems of absorption of oral drugs with low
water solubility.
With cholesterol imbalance arguably the disease of our age, as the success of
Lipitor shows — more than 36 million American adults have high cholesterol levels,
according to the American Heart Association — LifeCycle clearly hopes to maintain
the momentum after Lipitor’s loss of patent protection. Phase II trials studying 200
mixed dyslipidemia patients began in July 2007.

[Sinne]

08.07.08
lifecycle pharma announces positive topline results from phase II clinical study of LCP-tacro once daily in stable liver transplant patients. Quelle: Business wire (über Finanznachrichten.de)

[BrauchGeld]

Ach herje da geht man mal kurz in Urlaub und der ganze Markt bricht ein
-----------------------

Die Phase II Daten sind super aber bei diesem Marktumfeld wartet man vergeblich auf Kursgewinne .
Die Aktie ist unterbewertet und die 2 Jahre bis zur Markteinführung wenn alles gut geht ist auch keine lange zeit .


http://phx.corporate-ir.net/phoenix.zhtml?c=215658&p=irol-ne…

LifeCycle Pharma Announces Positive Topline Results from Phase II Clinical Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients

New data confirm potential best-in-class profile of LCP's once

daily tablet formulation with higher bioavailability when compared to

twice daily Prograf(R) which is currently marketed worldwide by

Astellas Pharma.

HORSHOLM, Denmark--(BUSINESS WIRE)--July 8, 2008--LifeCycle Pharma A/S (OMX:LCP) today announced positive top-line results from a completed Phase II clinical study of LCP-Tacro tablets in stable liver transplant patients which are in line with earlier data announced for stable kidney transplant patients. These new data for LCP-Tacro, a once daily immunosuppression drug to prevent rejection after organ transplantation, demonstrated that LCP-Tacro tablets also for stable liver patients have a potential best-in-class profile when compared to the currently marketed twice daily tacrolimus capsule, Prograf(R), by indicating:

-- Once daily administration

-- Improved bioavailability by approximately 30%, leading to a
70% dosing compared to Prograf(R)

-- Reduced variability (peak-to-trough ratio) with a 30% reduced
peak

On Wednesday July 9, 2008, the results will be presented at the 2008 Joint International Congress of ILTS, ELITA & LICAGE in Paris.

According to LCP, the positive Phase II clinical data in stable kidney and liver transplant patients provide a very robust, statistical confirmation of the proposed dosing regimen. With the results from the clinical phase ll program, LCP expects to initiate the Phase III clinical trial program in stable transplant patients by late 2008. In addition, these data are a solid basis to conduct Phase IIb pharmacokinetic studies in de-novo kidney and liver transplant patients, subsequently leading to Phase III de-novo studies in the first half of 2009.

"We are very excited about these data", said Dr. Michael Beckert, Executive Vice President and Chief Medical Officer of LCP. "The consistency of the results across different patient populations in Phase II, both in kidney and liver transplant patients, as well as compared to our Phase I data in more than 180 healthy volunteers, is very impressive and confirms LCP-Tacro's best-in-class profile", Dr. Michael Beckert added. "This is one more milestone, we have achieved on our way towards a fully integrated speciality pharmaceutical company in the area of transplantation care and immunology".

LCP-Tacro (Liver) Phase II Clinical Study Design

The Phase II clinical study, which commenced enrollment in December 2007, was a three sequence, open-label, multi-center, prospective, conversion study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets Once-A-Day versus Prograf(R) (tacrolimus) capsules Twice-A-Day. Stable liver transplant patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and kept on Prograf(R) for 7 days, followed by a 14-day treatment period with LCP-Tacro tablets. Pharmacokinetic assessment was performed on Day 7 (Prograf(R)) and Day 14 & 21 (LCP-Tacro). On Day 22, patients were offered to enroll in the 52-week open-label extension study. The phase II clinical study enrolled 57 evaluable patients in 15 sites in the U.S.

About LCP-Tacro & Tacrolimus

Tacrolimus is a leading immunosuppressive medication to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability in absorption when compared to Astellas' twice daily version of tacrolimus (Prograf(R) worldwide) and its prolonged-release version of tacrolimus (Advagraf in Europe). Clinical trials have demonstrated that LCP-Tacro has a superior bioavailability and PK profile and is expected to provide significant improvements for patients currently on Prograf(R). Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but too high levels increase the risk of serious side effects such as kidney damage or hypertension. Therefore, tacrolimus levels need to be managed carefully and transplant patients typically are obliged to make frequent visits to the hospital for monitoring and dose adjustments for months after receiving a new organ. Management of tacrolimus levels is complicated by the low bioavailability of Prograf(R), its variable absorption and interaction with food and other drugs. The current market size for immunosuppressants used in transplantation in the seven major markets (US, Japan, France, Germany, Italy, Spain and UK) is approximately $3.3B and growing by approximately 5-10% per year. In 2007, worldwide sales of tacrolimus were approximately $1.64 billion, with some 50% of such sales generated in the United States, and 30% in Europe.

[Sinne]

Hi BrauchGeld! Werden lifecycle pharma in Deutschland nicht gehandelt? sehe immer nur Eröffnungskurs G (ohne Umsatz)??