Sanofi-Aventis had high hopes for iniparib, which was intended for treatment of metastatic triple-negative breast cancer. It had even been accepted for the U.S. Food and Drug Administration's fast-track regulatory-submission procedure. But late Thursday, Sanofi said iniparib hadn't met the 519-person study goal of showing significant difference in survival and progression-free survival when compared to a treatment regimen involving only chemotherapy.
A String of Setbacks
Other pharmaceutical companies have also experienced recent setbacks as they scramble to bolster their pipelines ahead of the impending "patent cliff," when they will be forced to compete with cheaper generics.
In June, Eli Lilly (LLY) and Bristol-Myers Squibb's (BMS) Erbitux, which is already approved for advanced colon cancer, failed to slow tumor growth in patients with an earlier stage of the disease. In March, Antisoma's lung cancer drug, developed with Novartis, also failed to demonstrate survival benefit in patients with previously untreated non-small-cell lung cancer in a late-stage trial. And there were several other announcements in March of late-stage cancer drug failures, including from Roche and Pfizer (PFE).
Cancer drugs are increasingly becoming more targeted and, therefore, more difficult to develop. But they also come with considerable rewards because many can command high prices even for minor benefits. Some companies decide to concentrate on cancer treatments because of the promises they hold.
There are inherent risks in any drug development program, even in late stage, but iniparib's failure also highlights the challenges drugmakers face to replace lost revenue due to patent expirations over the next couple of years.
Sanofi, which obtained the experimental drug through a $500 million purchase of BiPar in 2009, is currently in a takeover battle with rare-disease drugmaker Genzyme (GENZ). Like other pharmas, Sanofi needs to bolster its pipeline of drugs because it stands to lose patent protection on many of its bestsellers. This major setback, however, might make it reconsider its original offer of $69 per share, or $18.5 billion, for the Cambridge, Mass.-based biotech.