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。
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:
Its Clostridium difficile toxoid vaccine, which is headed into Phase III in Q3 under a fast-track designation from the FDA.
SAR231893, also partnered with Regeneron, which will start a Phase IIb study in the middle of this year in asthma and atopic dermatitis.
And SAR302503, its JAK2 inhibitor in myelofibrosis, for which Phase III recruitment has been completed.
Sanofi has made significant progress in the transformation of its R&D over the last couple of years," said Zerhouni in a statement, "including advances in late stage projects and early stage pipeline as well as talent recruitment. We feel we have the ingredients to ensure R&D contributes to Sanofi's goal of sustainable growth in the coming years while rigorously managing R&D costs."
