UPDATED: Sanofi CEO touts partnership drugs as pipeline standouts

Posted under Blog, Chris Viehbacher, Companies, Diagnostics, Funding, Lemtrada, Medical Devices, Medical Supply, Partnering, partnerships, Pharmaceuticals, Pipeline, R&D, Sanofi, Startups, Universities, Videos by rmcbride

Chris Viehbacher (photo) named three of the programs in Sanofi's pipeline that excite him the most in a recent interview with the Boston Business Journal, and the trio of programs all stem from deals with external drug developers, underscoring the French drug giant's strategy to increase its bets on partnerships to fill its pipeline.

Asked to list the standouts in Sanofi's ($SNY) pipeline, Viehbacher mentioned the PCSK9 inhibitor his company is developing in partnership with Regeneron ($REGN), the MS drug Lemtrada acquired in his company's Genzyme buyout, and an experimental vaccine for dengue fever from another acquired biotech, Acambis. Given some of the success of these programs in clinical trials, it's no surprise to see Viehbacher double down on partnerships as a focus of his company's R&D strategy.

As he has in the past, Viehbacher told the BBJ that he'd like to see a 50-50 ratio of external and internal R&D programs at his company, and he explained his rationale for adding more collaborations and partnerships with external groups into the mix. Clearly, the pharma industry veteran and accountant by training likes his odds of success better with Sanofi sharing the high risk of drug development with other players.

"Well the reality is that if you fail more than you succeed, and you keep everything, you are keeping a lot of losses," the CEO told the business newspaper. "So I think there is an element of understanding that you are better off owning a piece of something that's going to succeed, rather than owning all of a lot of things that are probably going to fail. It's extremely important, that cultural shift, because unless you believe it in your heart, you'll never get a decent collaboration."

Still, Sanofi could use some decent new drugs to boost its sales after reporting lackluster revenue for 2011. Lemtrada, which had received mixed reviews from analysts, is epected to be submitted for FDA review for treating multiple sclerosis this year, and Sanofi could have a major blockbuster on its hands if REGN727, its PCSK9-targeting drug for lowering cholesterol, succeeds in planned Phase III trials and gains approval.

- read the interview

Special Report: Christopher Viehbacher - The 25 most influential people in biopharma today

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Correction: Lemtrada has not been submitted for FDA review, as was reported in this article initially. Lemtrada is due to be submitted for U.S. and European regulators for review in the second quarter of 2012, according to a representative for Sanofi. We regret the error.

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

Sanofi touts R&D hopefuls as tonic for plunging profits

Posted under Blog, Chris Viehbacher, Companies, Diagnostics, Elias Zerhouni, Funding, Genzyme, Medical Devices, Medical Supply, Pharmaceuticals, Sanofi, Startups, Universities, Videos by John Carroll

This is the year that the patent cliff arrives with a vengeance at Sanofi ($SNY). With copycat versions of Plavix and Avapro gobbling market share, the pharma giant predicted a 15% plunge in profits by the end of 2012. But CEO Chris Viehbacher (photo) and his executive team put on a full-court blitz this morning to convince analysts that big changes in its R&D operation are paving the way to major new product approvals.

In addition to five regulatory filings in the U.S. and Europe over the past 7 months, Viehbacher spotlighted the MS drug Lemtrada as its next big potential win. Recently Sanofi has been touting new data on its diabetes drug Lyxumia, or lixisenatide, and the MS drug Aubagio (teriflunomide, which troubled analysts when it failed to best Rebif), the start of a late-stage trial for its PCSK9 mAb, a new formulation of insulin glargine and the JAK-2 inhibitor SAR302503 for myelofibrosis, as well as plans for new mid-stage trials for five compounds in an R&D portfolio with 60 new molecular entities and vaccines.

There are 18 potential new drug launches to look forward to by the end of 2015, said R&D chief Elias Zerhouni, according to the company's live tweets of his remarks. And Zerhouni promised that the early-stage and pre-clinical pipeline is "quite promising."

While Sanofi has been working to ratchet down its legacy R&D costs as it shifts to a more open approach to development work with biotech companies and academic partners, adding Genzyme's substantial research operations helped jack up overall costs by 5.6% last year. Sanofi spent a little more than 4.8 billion euros on R&D last year, with a ratio of 14.4% of R&D expenses to net sales.

With profits sliding, Sanofi has reached the stage where it has to start delivering significant new blockbuster approvals if it expects to convince investors that it is out of the woods, or at least headed in the right direction.

- here's the press release on the results (.pdf)
- read the Bloomberg report

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Sanofi chief can’t spark much enthusiasm for new MS drugs

Posted under BG-12, Blog, Chris Viehbacher, Companies, Diagnostics, Funding, Genzyme, Lemtrada, Medical Devices, Medical Supply, multiple sclerosis, Pharmaceuticals, Sanofi, Startups, Universities, Videos by John Carroll

Back when Sanofi's Chris Viehbacher was in the hunt for Genzyme, one of the big sticking points was assessing the value of the experimental MS drug Lemtrada. Genzyme's forecasts were starry eyed. Sanofi ($SNY), which had its own late-stage MS drug in the pipeline, issued bleak forecasts. Which is why they ultimately established a CVR on the program to separate it in their $20 billion buyout deal.

Now, though, Viehbacher says he's seen the results of the late-stage trial, and he's a believer.

"Now that we have seen the clinical trial results--I have seen them but I cannot say more because we are going to publish them in April--we are very excited about this multiple sclerosis franchise," Viehbacher tells Reuters' Ben Hirschler.

But now he's finding it harder to get analysts enthusiastic as well. The problem: Novartis ($NVS) has beaten the competition to the marketplace with Gilenya and Biogen Idec has wowed the industry with impressive data on BG-12, its big new MS drug that appears to be on track to a blockbuster approval.

Reuters notes that peak sales forecasts for Lemtrada range from a billion euros a year at Morgan Stanley to a mere 360 million at Nomura. And the fact that Sanofi has a shot of debuting a second MS treatment, Aubagio, has done nothing to whet the enthusiasm of the analysts.

"Sanofi will remain a small player compared with Biogen or Novartis, but it will still remain on the radar screen," Natixis analyst Beatrice Muzard tells the wire service. Maybe Viehbacher did too good a job at downplaying Lemtrada.

- here's the article from Reuters

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