Biogen Idec Inc. (BIIB), the world’s biggest maker of multiple sclerosis drugs, said a European regulatory decision on its new pill will be delayed until the second half of the year after a patent on the medicine was extended.
Biogen said it’s seeking to clarify Tecfidera’s regulatory exclusivity status in Europe. A European patent on the pill was extended yesterday until 2028 and covers the expected 480-milligram dose planned for sale, the Weston, Massachusetts-based company said today in a regulatory filing.
Tecfidera cleared U.S. regulators on March 27, propelling Biogen shares to a 31 percent gain since the approval. The drug followed Novartis AG (NOVN)’s Gilenya and Sanofi (SAN)’s Aubagio to the market as oral options for MS, a central nervous system disease otherwise treated by injection or infusion. The illness affects 2.1 million worldwide, according to the National Multiple Sclerosis Society.
“Delay is prudent to preserve value over the long term,” Biogen said today in a presentation to investors at a conference organized by Deutsche Bank AG.
Biogen is working to make Tecfidera’s regulatory data protection clearer to all parties, Kate Niazi-Sai, a Biogen spokeswoman, said in an e-mail. “We originally anticipated that the dialogue would be completed by now, but it is not,” she said.
Biogen fell less than 1 percent to $238.89 at the close in New York.
The regulatory delay shouldn’t have a “significant negative impact” on near-term revenues, Brian Abrahams, an analyst with Wells Fargo & Co. in New York, said today in a note to clients.
“Though we believe Tecfidera will likely be safe from generics due through at least the late-2020s through its IP exclusivity, the delay in confirming EU regulatory exclusivity does highlight an incremental risk that may not have been appreciated,” Abrahams wrote.
Initial U.S. sales of Biogen’s pill, formerly known as BG-12, were greater than those of Gilenya and Aubagio, suggesting revenue may be more than analysts’ initial estimates of $240 million to $300 million this year, according to a Wells Fargo report on April 29. The medicine may have sales of $3.4 billion by 2017, according to the average of eight analysts’ estimates compiled by Bloomberg.
“We have been encouraged by early signs of physician and patient interest in this product,” Tony Kingsley, Biogen’s head of commercial operations, said April 25 on a conference call after the company released its first-quarter earnings. “U.S. physician awareness of Tecfidera is high and perceptions are strong.”
Biogen also sells Avonex, an injection, and Tysabri, an infusion.
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