关键词: Sanofi 新药研发
2013年1月9日讯 /生物谷BIOON/ --Sanofi公司主管研发的Elias Zerhouni在参加J.P. Morgan conference会议上,介绍公司目前进行的17种新药研发情况。以向公众展示公司研发新药的成就。同时Elias Zerhouni也借此机会宣布公司将会放弃一些不尽如人意的新药研发项目。例如与Exelixis公司合作研发了四年的治疗子宫内膜癌的新药。
与之类似命运的还有用于治疗肿瘤的新药ombrabulin,这种药物曾经被寄予厚望,但是由于该项目三期研究宣告失败,使得Sanofi公司与其伙伴Ajinomoto公司被迫放弃该药物的研发。公司正在进行的另一种药物SAR245408(前身为XL147)也由于在二期实验中没能表现出显着的临床优势而被终止。Sanofi公司同时也宣布一项治疗代谢综合征的新药Aubagio失败。
在接下来的六个月中,Sanofi公司将深入分析所有的实验数据,并继续研究治疗高雪氏病的eliglustat、第一种Xa抑制因子药物otamixaban和治疗骨髓纤维化的SAR302503等。
目前,Sanofi公司正进行的最重要的研发项目之一是对于SAR236553的研究。这种药物被认为能够降低人体内LDL胆固醇水平。两个月前,公司共招募了18000患有急性冠心病的患者参加药物试验。
同时Zerhouni还介绍了Sanofi公司进行的研究项目:如Clostridium difficile 毒性疫苗的三期试验,治疗哮喘病的新药SAR231893等。
Zerhouni称,在过去的几年中,Sanofi公司在药物研发过程中取得了极大地成功。今后将继续致力于新药物的研发以促使公司的发展。(生物谷Bioon.com)
详细英文报道:
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: