Synta estimates that results of the current Phase III trial will be available by the end of 2008, with a potential FDA delivery
date of 2009. The drug is on path to hit the market by 2010.
Phase II trial results were positive. One trial compared patients who received the drug with a control group, and the patients
that received the drug lived twice as long as the control group, without the disease getting worse.
GSK is currently hedging its bets on cancer drugs, entering a licensing frenzy over cancer drugs.
"One of the things you want as a small company is a sense that the larger company is going to be very committed to advancing
the program," Bahcall said. "This is one of the largest deals for a single product in the industry, and if you look at where
GSK is as a pipeline, it is clear that this drug will be a priority to them." –GK
French pharma giant Sanofi-Aventis and Tarrytown, New York–based Regeneron have been cozy for some time now, and they took
their relationship a step further last November with an announcement that generated some excited chatter in the industry and
in the press.
The deal was actually an expansion of an existing partnership rather than the establishment of a brand-new coalition.
Regeneron is a biotech with a specialty in human monoclonal antibodies. It currently has therapeutic candidates in clinical
trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other
diseases and disorders. Regeneron and Sanofi already had various protein-based product candidates in development, including
the experimental cancer drug aflibercept. (Aflibercept, a VEGF trap, is an antiangiogenic agent, like the Genentech/Roche
publicity magnet Avastin.) The first product to enter clinical trials under the collaboration was an antibody to the Interleukin-6
receptor (IL-6R), which Sanofi and Regeneron hope will show promise in the treatment of rheumatoid arthritis. At press time,
Sanofi and Regeneron had slated a second therapeutic product, an antibody to Delta-likes ligand-4 (Dll4), to begin clinical
development this year.
The new deal gives Sanofi-Aventis access to Regeneron's VelociSuite—a group of technologies that includes the company's VelocImmune
technology for discovering, producing, and validating human monoclonal antibodies. VelocImmune is the centerpiece of Regeneron's
business. In 2007, the company struck additional nonexclusive deals for the use of VelocImmune with Astellas and Bayer.
Like so many other Big Pharma companies, Sanofi moved to strengthen its relationship with a relatively small biotech firm
as a way to counteract profit erosion in the current tight market. Consultant Daniel Teper, managing director of North America
business at BioNest Partners in Manhattan, sees both a step forward and a need for greater strides: "Finally Sanofi-Aventis
is stepping up investment in biotech. Under the previous management, they were much more conservative. But they should probably
consider synergies between their very strong vaccine division and biologics, including antibodies."
Teper adds, "A number of companies are looking at synergies. I don't think it's a secret that AstraZeneca is looking at that.
How you organize that is a bigger question. But for Sanofi-Aventis to be a player in biologics, they probably need to invest
Whether the expanded partnership will yield gold is anyone's guess, but one thing is sure: Prospects for small firms like
Regeneron gleam brighter than ever in the new age of pharma. –SARA DONNELLY