Biogen Inc., which already has Amevive approved for psoriasis, licensed in a late-stage psoriasis product from Swiss company Fumapharm AG.
The drug, the second-generation version of Fumaderm, which already is marketed for psoriasis in Germany, is set to enter Phase III trials in Europe. With the exception of Germany, Biogen has licensed worldwide rights. Financial terms were not disclosed.
Looking at Amevive (alefacept) - a growing product that brought Biogen $7 million in the second quarter, up from about $4 million in the first - the acquisition of another psoriasis product might seem unsound, or at least cannibalistic. That's not the case, said Amy Ryan, associate director, public affairs at Cambridge, Mass.-based Biogen.
"We've been talking about expanding our dermatology franchise for some time," she told BioWorld Today, noting that Biogen had been pursuing a leukocyte function-associated antigen-1 (LFA-1) antagonist in psoriasis with ICOS Corp. "We are not cannibalizing Amevive at all."
Biogen in June returned rights to the LFA-1 product to ICOS, following disappointing Phase IIa results. Bothell, Wash.-based ICOS said at the time that the molecule - called IC747 - would not be developed any longer, although ICOS would continue to pursue its LFA-1 program. (See BioWorld Today, June 9, 2003.)
Fumapharm, of Lucerne, Switzerland, and Biogen are planning to collaborate on Phase III development and commercialization worldwide on the psoriasis product, called BG12 for now. Phase II results are scheduled to be presented at an upcoming scientific meeting.
While Fumaderm is approved in Germany, Amevive has had difficulty in Europe. In February, Biogen reported that the application for Amevive, which was filed in the U.S. and Europe at the same time through a common technical document, was denied in Europe. The move caught the company, and the investment community, by surprise, as the applications were the same on both continents and the product had already received approval in the U.S. (See BioWorld Today, Feb. 3, 2003.)
Regulatory authorities in Europe requested more information, causing Biogen to withdraw the application and work on accruing more data, effectively moving European approval "years away," it said at the time. (See BioWorld Today, Feb. 21, 2003.)
Regarding BG12, Biogen is "looking at setting up a Phase III trial" in the U.S. in 2004, Ryan said, although discussions with regulatory authorities will clarify that timeline. However, for Amevive, Europe is still a task at hand.
"We are getting back to the regulatory authorities over there, trying to set up the clinical trial," she said.
Biogen's stock (NASDAQ:BGEN) rose 31 cents Wednesday to close at $38.43.