Sanofi’s Lemtrada beats Rebif in head-to-head MS showdown

Posted under Blog, Companies, Diagnostics, Funding, Lemtrada, Medical Devices, Medical Supply, multiple sclerosis, Pharmaceuticals, Rebif, Sanofi, Startups, Universities, Videos by john

Sanofi has rolled out a fresh set of late-stage Lemtrada (alemtuzumab) data demonstrating its superiority to Rebif in a head-to-head matchup for multiple sclerosis. One of the key programs acquired in Sanofi's ($SNY) $20 billion Genzyme buyout, Lemtrada is increasingly looking like an odds-on winner at the FDA. And the pharma giant's success with the drug--alongside its other Phase III MS program--has inspired the pharma giant to spread its global BD net in search of other treatments.

Patients taking Lemtrada in the study scored better at slowing disease progression, with a sizable minority doing better as a larger proportion of Rebif patients faltered. Altogether 29% of the Lemtrada patients scored better on disability, compared to 13% for the Rebif group. Close to two thirds of the patients were relapse-free at 2 years, compared to 47% in the Rebif arm.

"To date, a key goal for MS treatment has been to delay the worsening of disability," said Jeffrey Cohen, M.D., an MS investigator. "Patients in the study whose prior MS treatment was inadequate at preventing relapses and received alemtuzumab in the CARE-MS ll trial experienced a slowing or reversal of their disability."

For Genzyme MS chief Michael Panzara, the bottom line is simple: "Alemtuzumab versus Rebif improves function; that's unique," he told Bloomberg.

Not everyone is happy about the drug's tox profile, though. Investigators have already noted that 16% of the patients taking the drug developed an autoimmune related adverse event, compared to 5% for Rebif patients.

But that AE profile hasn't reduced Sanofi's public confidence. Panzara went on to tell Bloomberg that Sanofi is always looking for more MS drugs to add to the pipeline, which includes Aubagio. "You can't have a world-class MS organization if you don't fill up the pipeline at all stages of development."  

- here's the press release
- get the Bloomberg report on the data
- read the Bloomberg report on the deal side

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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.

Biogen Idec races to FDA and EMA with a blockbuster app for BG-12

Posted under BG-12, Biogen Idec, Blog, Companies, Diagnostics, Funding, George Scangos, Gilenya, Lemtrada, Medical Devices, Medical Supply, multiple sclerosis, Novartis, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Biogen Idec has filed an NDA on BG-12, taking another step forward in its blockbuster quest to gain an approval on its best near-term hope for a game-changing new treatment. Biogen ($BIIB) racked up promising late-stage data on the program, giving the company good odds for achieving an ultimate OK from the FDA. And the Cambridge, MA-based biotech is putting the final touches on an EMA submission aimed at redefining the market for MS drugs in Europe.

BG-12 is a "real potential blockbuster in the space," Biogen R&D chief Doug Williams tells FierceBiotech. "The safety profile is really quite good, and the benefit/risk profile is really positive."

Biogen is hoping to land a priority review for the treatment, says Williams, which would shave four months off the standard 10-month regulatory cycle. But even if it doesn't, the developer can be upbeat about its prospects for an approval in late 2012 or early 2013. For Biogen Idec, which plans to spend about a quarter of its revenue on R&D this year, the ability to look forward to major league approvals gives the big biotech company some critical leeway with analysts.

"We think BG-12 is going to be a very successful drug in the marketplace," says Williams. "In this business, you have to make consistent investments in R&D over a period of time. That has paid off."

Speed is of the utmost importance right now. Novartis ($NVS) made it to the MS market first with Gilenya. Now the analysts expect that BG-12 will move in to snag significant market share. And if Biogen does nail down key approvals early, they'll continue to cast a shadow over Sanofi's ($SNY) big plans for Lemtrada, the experimental MS drug obtained in the Genzyme buyout.

Williams notes that while there's no head-to-head data with Gilenya, BG-12 can compete on data demonstrating "extremely strong disease control activity across a broad range of parameters."

- here's the press release

Special Report: BG-12 - 15 top blockbuster contenders

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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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Sanofi boasts superior relapse-free rate for Lemtrada in MS study
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