關(guān)鍵詞: Sanofi 新藥研發(fā)
2013年1月9日訊 /生物谷BIOON/ --Sanofi公司主管研發(fā)的Elias Zerhouni在參加J.P. Morgan conference會(huì)議上,,介紹公司目前進(jìn)行的17種新藥研發(fā)情況,。以向公眾展示公司研發(fā)新藥的成就。同時(shí)Elias Zerhouni也借此機(jī)會(huì)宣布公司將會(huì)放棄一些不盡如人意的新藥研發(fā)項(xiàng)目,。例如與Exelixis公司合作研發(fā)了四年的治療子宮內(nèi)膜癌的新藥,。
與之類似命運(yùn)的還有用于治療腫瘤的新藥ombrabulin,這種藥物曾經(jīng)被寄予厚望,,但是由于該項(xiàng)目三期研究宣告失敗,,使得Sanofi公司與其伙伴Ajinomoto公司被迫放棄該藥物的研發(fā)。公司正在進(jìn)行的另一種藥物SAR245408(前身為XL147)也由于在二期實(shí)驗(yàn)中沒(méi)能表現(xiàn)出顯著的臨床優(yōu)勢(shì)而被終止,。Sanofi公司同時(shí)也宣布一項(xiàng)治療代謝綜合征的新藥Aubagio失敗,。
在接下來(lái)的六個(gè)月中,Sanofi公司將深入分析所有的實(shí)驗(yàn)數(shù)據(jù),,并繼續(xù)研究治療高雪氏病的eliglustat,、第一種Xa抑制因子藥物otamixaban和治療骨髓纖維化的SAR302503等。
目前,Sanofi公司正進(jìn)行的最重要的研發(fā)項(xiàng)目之一是對(duì)于SAR236553的研究,。這種藥物被認(rèn)為能夠降低人體內(nèi)LDL膽固醇水平,。兩個(gè)月前,公司共招募了18000患有急性冠心病的患者參加藥物試驗(yàn),。
同時(shí)Zerhouni還介紹了Sanofi公司進(jìn)行的研究項(xiàng)目:如Clostridium difficile 毒性疫苗的三期試驗(yàn),,治療哮喘病的新藥SAR231893等。
Zerhouni稱,,在過(guò)去的幾年中,,Sanofi公司在藥物研發(fā)過(guò)程中取得了極大地成功。今后將繼續(xù)致力于新藥物的研發(fā)以促使公司的發(fā)展,。(生物谷Bioon.com)
詳細(xì)英文報(bào)道:
Sanofi R&D chief Elias Zerhouni will take to the center stage at the J.P. Morgan conference in San Francisco today to spotlight a group of 17 late-stage drug programs that will ultimately make or break the pharma giant's case that it has reenergized its multibillion-dollar R&D effort. And it's using the occasion to provide last rites for some of its work that didn't measure up to expectations, burying a Phase III sarcoma drug along with a midstage program for endometrial cancer for a drug in-licensed four years ago in a billion-dollar deal with Exelixis ($EXEL).
Sanofi ($SNY) announced this morning that work on ombrabulin, once considered a hot prospect, was being halted after it flopped in a Phase III sarcoma study and investigators had to halt a midstage trial for ovarian cancer following a disappointing interim analysis. The drug, partnered with Ajinomoto, hit its primary endpoint on progression-free survival, but Sanofi concluded that the drug wouldn't pass regulatory muster. The Phase II trial of SAR245408--formerly XL147--was discontinued after investigators determined that the study had failed to demonstrate sufficient clinical benefit. A Phase II breast cancer trial in combination with letrozole continues alongside an early-stage combo study with SAR256212.
Sanofi also noted that it decided to slam the brakes on a Phase III study of Aubagio, an MS drug its subsidiary Genzyme wrested an approval for late last year. The study had combined the oral drug--which has modest market expectations--with interferon, which Sanofi concluded isn't a promising approach to MS these days.
In the next 6 months Sanofi says it will post late-stage results for a head-to-head study of eliglustat with Cerezyme for Gaucher disease; otamixaban, the first intravenous direct and selective factor Xa inhibitor; SAR302503 for myelofibrosis; a new glargine formulation for diabetes; and iniparib, its high-profile non-small cell lung cancer treatment.
One of the lead roles in Sanofi's Phase III revival effort now goes to SAR236553, its high-profile PCSK9 drug partnered with Regeneron ($REGN) and engaged in a slate of studies for dangerously high levels of LDL cholesterol. Two months ago Sanofi launched a monster Phase III trial for this drug that will recruit 18,000 patients suffering from acute coronary syndrome. Zerhouni's pipeline update also focused on: