Sanofi colorectal cancer contender Zaltrap suffers a PhIII trial setback

Posted under Aflibercept, Blog, Chris Viehbacher, colorectal cancer, Companies, Diagnostics, FDA approval, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Prostate Cancer, Regeneron, Regulatory, Sanofi, Startups, Universities, Videos, Zaltrap by john

Sanofi and Regeneron opened their update on the cancer drug Zaltrap (aflibercept) on a sweet note: The FDA has granted a priority review of their new drug application for colorectal cancer. But the news wrapped a bitter pill, as they quickly went on to acknowledge that their cancer contender had failed a late-stage study for prostate cancer.

The Phase III Venice study involving patients with metastatic, androgen dependent prostate cancer "did not meet the pre-specified criterion of improvement in overall survival," the companies reported. No data was put out in the release and investigators noted that they would review the results at a later scientific meeting.

Last fall, as analysts were growing increasingly skeptical about Sanofi ($SNY) CEO Chris Viehbacher's (photo) promise for better results from the pharma giant's restructured R&D operation, the company listed Zaltrap as one of its top late-stage prospects in the pipeline. Today's mixed news may not help much in making its case for a turnaround, but the primary focus in R&D has long been on the positive colorectal cancer results seen in Phase III. And that's the note Sanofi was trying to stay focused on today.  

"Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant priority review to Zaltrap in metastatic colorectal cancer," said Debasish Roychowdhury, who heads up Sanofi's cancer drug work. "We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease."

The target date for their application on colon cancer is August 4. 

- get the press release
- here's the Reuters story

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Sanofi, Regeneron buoyed by PhIII colon cancer success for aflibercept

Regeneron finally captures an FDA OK with new eye drug

Posted under Aflibercept, Avastin, Blog, Companies, Diagnostics, Eylea, Funding, Genentech, Lucentis, macular degeneration, Medical Devices, Medical Supply, Pharmaceuticals, Regeneron Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

Late on Friday Regeneron Pharmaceuticals ($REGN) scored a big win as it announced that the FDA has approved Eylea (aflibercept) for wet, age-related macular degeneration. But after pricing an injection at a slight discount to Roche's Lucentis--$1,850 to $1,950--most of the market buzz centered on the $50 competitor available from an off-label dose of Genentech's Avastin.

As The New York Times' scribe Andrew Pollack noted, Regeneron has racked up $1.2 billion in losses as it spent its way through 24 years of R&D, often plagued by setbacks in the clinic. But the approval marks a solid achievement for CEO Leonard Schleifer, who holds the title for longest-running chief in the biotech industry.

"We thought that good science would win out a little earlier, but we are patient," he told Pollack.

He'll need all the patience he can muster on this next step. Eylea has an edge on Lucentis, with an injection needed every eight weeks--significantly less frequent than Lucentis. And almost every practitioner will tell you that patients are highly motivated to reduce the number of injections they need in their eyes. But the much cheaper off-label Avastin has a solid hold on 60% of the market, according to Bloomberg.

"Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements," said Jeffrey Heier, M.D., a clinical ophthalmologist, in a release from Regeneron. 

- read the press release
- get the story from The New York Times
- here's the Bloomberg report

Special Report: Regeneron Pharmaceuticals - Biotech's Biggest Spenders 2011

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