Pfizer retire le Torcetrapib
du marché
NOUVELOBS.COM | 03.12.06 | 08:07
Le premier groupe pharmaceutique mondial demande aux patients d'arrêter de prendre le médicament en raison d'un nombre élevé de décès et d'accidents cardio-vasculaires.
Pfizer, premier groupe pharmaceutique mondial, a annoncé samedi 2 décembre avoir mis fin à la mise au point et à tous les essais cliniques d'un nouveau médicament contre le cholestérol, en raison d'un nombre élevé de décès et d'accidents cardio-vasculaires parmi les patients qui l'utilisaient.
L'entreprise américaine a déclaré qu'un comité indépendant surveillant l'étude du médicament, appelé Torcetrapib, a recommandé la fin des travaux en raison d'un "déséquilibre dans la mortalité et les incidents cardio-vasculaires".
Pfizer a fait savoir qu'elle avait demandé à tous les responsables des essais cliniques du médicament, censé augmenter le niveau de bon cholestérol, d'ordonner aux patients d'arrêter leur traitement. (Avec AP)
Source
Cette molécule était censée remplacer le Lipitor dont le brevet expire en 2010. On ne m'ôtera pas l'idée qu'il s'agit là du domaine hors ophtalmologie prévu dans le contrat de partenariat (cf études en cours sur le NCX6560, no-atorvastatine molécule du Lipitor), pour rappel :
Dans l'éventualité où les deux sociétés identifieraient une indication potentielle en dehors du domaine de l'ophtalmologie pour un composé développé dans le cadre du programme de recherche conjoint, Pfizer disposerait d'un droit d'option pour son développement et sa commercialisation. Dans un tel cas, NicOx pourrait alors recevoir des paiements additionnels liés au franchissement d'étapes pouvant atteindre € 194,3 millions si Pfizer exerçait cette option. Des royalties d'un montant conforme à la pratique de l'industrie seraient payées par Pfizer pour tous les produits issus de cette collaboration qui seraient commercialisés.
Certes, le montant est faible, mais il est facile de faire un avenant à un contrat si la situation évolue...
Voici un article plus complet pour les anglophones, mentionnant que
Pfizer a 2 autres composés en cours d'étude pour remplacer le Lipitor, Nicox n'est donc pas seule en course (voir l'extrait mis en gras) :
Pfizer's Shares May Plunge After Cholesterol Trial Is Halted
By Shannon Pettypiece and Michelle Fay Cortez
Dec. 3 (Bloomberg) -- Pfizer Inc.'s shares will likely plunge after the world's biggest drugmaker unexpectedly ended development of its most important new drug, a cholesterol medicine expected to replace Lipitor when its patent expires.
Pfizer said it was ending all trials using torcetrapib after an independent board told the New York-based company that a higher number of patients died when torcetrapib was used with Lipitor than when Lipitor was taken alone. Chief Executive Officer Jeffrey Kindler said in a statement yesterday that Pfizer will ``accelerate'' plans to reduce costs and acquire products through acquisitions.
Pfizer invested $1 billion in developing torcetrapib and had planned to seek U.S. marketing approval in the second half of 2007. Analysts have said they expected the drug to eventually generate $20 billion a year. Lipitor produces about $13 billion annually, or about half of Pfizer's profit, and will lose patent protection in 2010, opening the way to generic competition.
``I'm terribly disappointed on behalf of our patients,'' said Steven Nissen, head of cardiology at the Cleveland Clinic, the top heart hospital in the U.S. News & World ranking, in a telephone interview late yesterday.
Drugs like Lipitor, which lower so-called bad cholesterol, or LDL, ``only reduce cardiovascular events by about one third,'' Nissen said. ``We were very hopeful'' use of drugs like torcetrapib, which raise HDL, the good cholesterol, ``would improve patient outcomes.''
``It didn't work out for Pfizer, but stopping the trial was obviously the right thing to do,'' Nissen said.
FDA Informed
Pfizer immediately informed the U.S. Food and Drug Administration about the decision and told research physicians to make certain all study participants stopped treatment, the company's statement said.
Eighty-two patients taking the combination of torcetrapib and Lipitor died compared with 51 deaths among patients who were only given Lipitor, Pfizer spokesman Andy McCormick said in an e-mailed response to questions.
Kindler said in the statement that Pfizer ended the trial, which involved about 15,000 people, in the ``interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible.''
The announcement came two days after Pfizer, for the first time, told analysts and investors in a meeting that
the company was in the early steps of studying two other drugs, in addition to torcetrapib, as potential candidates to replace Lipitor. Torcetrapib was in the third of three stages of trials needed for U.S. approval.
``With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it,'' Kindler said in the statement.
Blood Pressure
Pfizer said last month early results from its last-stage human testing showed the drug elevated patients' blood pressure an average of three to four millimeters in patients taking the drug, combined with Lipitor. Raising blood pressure that much could cause complications in patients already at risk of having a heart attack, analysts said.
All three candidates to replace Lipitor are designed to elevate levels of good, or HDL, cholesterol. Good cholesterol helps sweep LDL from arteries, doctors say.
Pfizer is in a race with other drugmakers to develop the new class of cholesterol drugs. Roche is studying a drug that works the same way as torcetrapib, and Merck may be developing a similar product, according to analysts and researchers. Abbott Laboratories is acquiring Kos Pharmaceuticals, the maker of Niaspan, the strongest HDL-raising drug on the market.
``We are first in class, best in class and I believe we wil own this class for as long as it exists,'' said John LaMattina, Pfizer's senior vice president for global research, in a Nov. 30 meeting with analysts.
