EMD Serono chief steps down after MS drug disappointment

EMD Serono, an affiliate of Merck KGaA in Germany, finally got around to announcing today that its CEO Fereydoun Firouz resigned May 3. Firouz had a nice 22-year run with the company, yet it's hard to ignore that he stepped down after his group's oral multiple sclerosis drug cladribine failed to gain FDA approval in March.

For now, James Hoyes, EMD Serono's chief commercial officer, has taken over leadership of the group on an interim basis. Firouz took over U.S. operations of the company in 2003, and his group tripled its revenues during his tenure, according to EMD Serono. He also led the group, which is based in Rockland, MA, during a major expansion to its Massachusetts operations over the past several years, including the opening of a $65 million research center in Billerica, MA in February. That effort reflected the group's plans to add R&D jobs to help develop new treatments for cancer, neurodegenerative diseases and infertility.

Still, the group fell short on delivering its German bosses an FDA approval of cladribine, an oral drug for relapsing-remitting cases of MS. The agency handed EMD Serono a complete response on its application for approval of the drug, saying that it wanted more data on the safety of the pill. The company has been developing the drug in hopes of adding to its MS business, which already includes the injected therapy Rebif. Back in June 2009, Firouz told Xconomy about his oral MS hopeful and sounded optimistic that the drug would be an important new treatment for U.S. patients with MS. He had to have been disappointed that it failed to garner FDA approval.

Since that interview took place, Novartis won the prize of gaining the first U.S. approval of an oral MS drug, Gilenya. And Biogen Idec ($BIIB) remains in the running after delivering positive data from a late-stage study of its oral contender earlier this year.

- here's the release
- read the Boston Business Jounal's report

Special Report: FDA's Top Q4 Blockbuster Drug Decisions