Biogen Amevive Pre-Launch Work May Blunt Early Impact Of Formularies

The large pool of unsatisfied psoriasis patients means that the early uptake of Biogen's Amevive will not hinge on reimbursement issues, the company maintained during a July 18 conference call.

While Biogen expects payors to consider second-line limitations on Amevive, "there is already a huge population of patients for which if they started prescribing it now it would be their third, fourth, fifth different kind of a treatment," CEO James Mullen said.

Biogen has a database of more than 30,000 psoriasis patients who have identified themselves as "prescription-willing."

"There's a huge pool of patients right now that have been on virtually all of these other therapies," including anti-rheumatics, immune suppressants and photodynamic agents, Mullen said. "So...initially, I don't really expect [formulary restrictions] to be a huge issue to getting the product in the hands of a relatively large number of patients."

Mullen acknowledged that reimbursement will be important for Amevive's longer-term growth. "As we're into the marketplace in the first six and 12 months, we're going to have to really make progress on the reimbursement issue or it could be a real impediment to growing the market," he said. However, "I don't think it's an impediment to getting launched and getting started."

Amevive (alefacept) is under review at FDA and received a "complete response" letter June 6 (¹ 'The Pink Sheet' June 17, In Brief). Biogen is projecting a launch in late 2002 or the first quarter of 2003, depending on the clock for FDA's review of the company's follow-up submission.

Biogen said it expects to complete its submission in early August. "FDA will take a bit of time to review the responses and then they will indicate whether this is a Class I, which is a two month review, or a Class II, which is a six month review," Mullen said.

Mullen downplayed manufacturing issues raised in the "complete response" letter. Because the letter only takes into account materials received up until May 10, he explained, it includes questions and concerns that were resolved during FDA's mid-May inspection of the North Carolina facility.

"Many of the questions in the manufacturing section are procedure requests and they had already been answered prior to the June 6 complete response letter," Mullen said. "There's a few remaining items to tie up there, but nothing of great significance."

Biogen's facilities in Cambridge, Mass. and Research Triangle Park, N.C. and its contract facilities have all passed FDA and EU preapproval inspections, Mullen said. "The product is already manufactured. It is already in vials. None of the questions from the complete response letter impact the inventory of products that have already been made."

FDA's proposed label and postmarketing commitments for Amevive follow the recommendations of FDA's Dermatologic & Ophthalmic Drugs Advisory Committee, Mullen said. The committee reviewed Amevive May 23, voting 8-2 with one abstention in favor of approval (² , p. 28).

FDA's proposed indication for Amevive "is in line with the panel recommendations and we are generally pleased with the initial language," Mullen said. The indication is for "moderate to severe chronic plaque psoriasis in patients who are candidates for systemic or phototherapy."

The "complete response" letter asks that Biogen develop an Amevive patient registry, as discussed during the meeting, and also asks the company to submit "a number of other minor protocols."

When asked to comment on the current productivity level at FDA, Biogen noted that the experience has been different for each product. "We have different experiences with respect to each of our different products and different issues around each product. That therefore implies that there are probably not clear standards enforced throughout the agency that every reviewer absolutely understands how they're being judged and what their performance objectives are."

"With respect to the Amevive review: on the one hand, they certainly got to the advisory committee meeting and to sending us a complete response letter within the most aggressive timelines that they have laid out for themselves....Could everything have gone more smoothly? Could there have been sort of less of running between stoplights and rather more of a smoother process? Yeah, I would think so."