December 1, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Recent analysis of October sales records by IMS Health and RBC Capital Markets suggest that Paris-based Sanofi is quietly gaining market share in multiple sclerosis (MS) against Biogen, Inc. .
According to reports, Biogen had U.S. sales of its MS drug Tecfidera in October of $284 million. RBC Capital analyst Michael Yee indicates that this is an increase of 3 percent from September’s sales. In a Nov. 30 research report, Yee wrote, “We’d like to see scripts start to grow consistently and this could really improve sentiment on the stock, given investors have been bearish on Tecfidera recently. Consensus sales are around +5 to 7 percent next year, which is mostly all price-increase assumptions, in our view, and investors don’t like to rely on price increases to hit consensus.”
Biogen has been under the gun recently as stock prices drop and investors abandon the company. The company’s MS drug, Tecfidera, had $883 million in this year’s second quarter compared to $700 million in the same quarter in 2014. The breakdown was $721 million in the U.S. and $163 million outside the U.S. In the U.S., Tecfidera revenues increased 11 percent in the U.S., but were offset by an 8 percent decrease outside the U.S., primarily due to lower pricing in Germany.
This has made investors nervous, despite the overall sales volume increases. There have been two deaths reported related to the common ingredient in Tecfidera, although the side effect, treatment-related progressive multifocal leukoencephalopathy (PML), is extremely rare and not directly correlated to Biogen’s drug.
Meanwhile, Sanofi’s MS drug, Aubagio, appears to be making some headway against Biogen, even though Aubagio has been labeled with the U.S. Food and Drug Administration (FDA)‘s strong black box warning over safety concerns. According to Yee, Sanofi currently has a 24 percent share of the oral MS market, up from 20 percent six months ago.
In September, Sanofi’s Genzyme Corporation announced positive interim results from the second year of an extension of study for its MS drug Lemtrada (alemtuzumab). Lemtrada is sold in Europe, but is not yet approved in the U.S.
Genzyme (GENZ)’s Bill Sibold, head of its MS unit, had said that the company is “very active” in hunting for companies to acquire that could strengthen its MS franchise. He turned down the opportunity to cite potential targets, however.
Genzyme and Sanofi are battling a class action lawsuit regarding MS drug Lemtrada. As part of its 2011 acquisition of Genzyme Corp. for more than $20 billion, Sanofi promised to make “diligent efforts” to get Lemtrada approved by the FDA by March 31, 2014. The lawsuit alleges that Sanofi intentionally ignored the FDA’s concerns about its clinical trial design, which led to the FDA turning down Sanofi’s first drug application for the drug.
The suit accuses Sanofi of deliberately undermarketing the drug after its approval in November 2014, instead heavily promoting Aubagio. This led to Lemtrada failing to hit any of its sales benchmarks, according to the suit, deliberately stalling development and slowing sales in order to avoid paying at least $708 million to the rights holders.
Lemtrada hit the market in late 2014 with a price tag of $158,000 per two-treatment regimen. Biogen’s Tecfidera launched around the same time, as did Novartis ‘s Gilenya. Lemtrada was approved as a third-line therapy, a drug to be used after patients didn’t have good results with two other medications. Merck KgaA also has a long-acting infusion treatment for MS, Rebif, which costs about $135,000 per treatment.
Tecfidera runs wholesale about $55,000 per year. Gilenya runs about $60,000 and Aubagio about $45,000.
