By Brady Huggett
Biogen Inc. said Monday it completed a simultaneous registration filing in the U.S. and Europe seeking approval to market Amevive for treating moderate to severe chronic plaque psoriasis.
¿The story is this extraordinary timeline that we met in doing [the filing] in less than 100 days,¿ said Kathryn Bloom, senior director, public affairs at Biogen, referring to the less than three months Biogen took to file after gathering up final data from its Phase III trial.
The Cambridge, Mass., company said in June the filings were coming when it released statistically significant results from Phase III intramuscular and intravenous trials showing the immunomodulatory agent met the primary efficacy endpoint, a 75 percent or greater improvement in the Psoriasis Area and Severity Index score two weeks after completion of a 12-week course of treatment. (See BioWorld Today, June 13, 2001.)
Biogen filed a common technical document (CTD) on the two continents under new guidelines implemented last month by the International Conference on Harmonization.
¿[The CTD] was put into place last month, so we are one of the first to have used it,¿ Bloom said. Using the new method, the application was filed electronically in the United States.
Amevive (alefacept) is designed to selectively target the CD45RO+ subset of T cells (memory effector T cells). Biogen said psoriasis affects about 2 percent of the population in Europe and North America.
With the CTD filed for two large markets, Biogen can now turn its attention to attacking psoriasis in the rest of the world.
¿We will be doing other filings,¿ Bloom said. ¿That will be the next step ¿ to file in other markets, including Australia and Canada.¿
The filing represents Biogen¿s second for a product that it owns exclusively. Its first product, Avonex, for treating multiple sclerosis, brought Biogen $243 million in the second quarter, a 28 percent increase over the same quarter in 2000.
Taking Amevive from discovery through development and now to a filing is something the company can boast about, Bloom said.
¿We are very proud of this achievement and it was a very strong effort put out by several hundred people throughout the corporation,¿ she said. ¿It is another example of Biogen¿s focus and our ability to move products through our pipeline.¿
Biogen¿s stock (NASDAQ:BGEN) moved, too, jumping $1.11 Monday to close at $58.60. The news was released shortly before the market closed.