Merck KGaA shores up Rebif defenses to fend off new MS rivals

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Merck KGaA's multiple sclerosis treatment Rebif is holding its own. Considering that the German drugmaker's flagship product faces some formidable new competitors--including Biogen Idec's ($BIIB) brand-new powerhouse, Tecfidera--that's not too shabby.

The drug brought in €1.86 billion last year, or about $2.56 billion, a decline of 1.5%, despite what Merck calls "severe competitive pressure" in the U.S. Tecfidera launched last spring, and joining Novartis' ($NVS) Gilenya and Sanofi's ($SNY) Aubagio in the oral MS market. Rebif is an injected treatment, and like other MS injectables, faces bleed-off from patients defecting to the easier-to-take pills.

Merck expects the scuffle for sales to intensify this year, and it's building up its battlements, particularly in the EU. "Several new competitors to our product Rebif are expected to enter the market (in Europe)," the company says in its annual report. "Strategies for defending market share have been launched."

Among those new products are Biogen's Tecfidera, approved in Europe last month, and Sanofi's Lemtrada, which got the nod last fall. Sanofi has some head-to-head data it can tout in its cause. In a head-to-head study between the two drugs, funded by the French company, Lemtrada bested Rebif at reducing relapse rates and slowing disability.

The European onslaught won't be instantaneous, because the tedious process of reimbursement negotiations will make both launches a country-by-country affair. Meanwhile, delays in new product launches could help Rebif's cause, the company notes. And the drug could well benefit from Sanofi's setback on Lemtrada in the U.S. The FDA asked for more safety data, and if new clinical trials are required, that could delay its entry by three years, analysts said at the time.

Merck is plowing forward with a cost-cutting program that has so far paid off big-time for the company, allowing it to hit its financial goals in spite of currency losses and other woes. But cost cuts don't build sales, and so the company will fight for every Rebif script it can get. And Merck can take heart in one analyst prediction: EvaluatePharma predicts that the drug will still amount to $1.76 billion in sales in 2018.

- see the Merck annual report (PDF)

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