Ushering in what Biogen Inc. CEO and chairman James Mullen called "an exciting time for us and hopefully an exciting time for our investors," the FDA approved Biogen's Amevive for psoriasis, giving Biogen the first biologic treatment for that indication.

Throw in a deal announced Thursday with IDEC Pharmaceuticals Corp., of San Diego, in which IDEC will co-develop three oncology therapeutics, and the Cambridge, Mass.-based company closed the week on a high note.

The approval clears Amevive (alefacept) for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for the systemic therapy or phototherapy. It also stands as a beacon of hope for psoriasis patients, even as the line of competitors grows behind it.

"This is the necessary next step for Biogen," said Jason Kantor, analyst with WR Hambrecht & Co. "[Biogen's multiple sclerosis drug] Avonex has been under pressure and Biogen needed another product. This is a really good next product for them. It has blockbuster potential."

Mullen said the commercial organization and field force to sell the product are in place. Product will be available to ship to physicians today, he said.

The biologics license application for Amevive, a product designed to selectively target the CD45RO+ subset of T cells, was filed with the FDA in August 2001. In May, the Dermatologic and Ophthalmic Drugs Advisory Committee voted to recommend approval. In June, the FDA asked Biogen for clarifying information on the drug, and in September the agency said it planned to complete its review in a six-month time frame. (See BioWorld Today, June 17, 2002, and Sept. 15, 2002.)

If psoriasis sufferers in the past have silently dealt with the painful scaly plaques and social stigmata that can be associated with the disease, there now appears to be a wave of treatments on the horizon. Behind Amevive, potential products are Amgen Inc.'s Enbrel, Centocor Inc.'s Remicade, Genentech Inc. and XOMA Ltd.'s Raptiva and Abbott Laboratories' Humira. A once-empty market could be filling quickly.

But it's a big field, Kantor pointed out, and there could be room for everyone. However, Amevive is available today, which might be a significant advantage in the long run, he said.

"The arthritis market has generated multiple blockbusters," he said, suggesting the psoriasis field could play out much the same. But he acknowledged that "being first helps [Amevive]. Once [Biogen] makes some inroads, it will be hard to displace them."

Since a physician is required to administer Amevive, doctors might prefer to prescribe it because they can charge patients for administration, Kantor said. Also, Medicare reimburses in-office treatments, while it does not reimburse at-home self-injections.

Kantor estimates Amevive will generate $115 million for Biogen in 2003, and sees that figure climbing to $230 million in 2004. In 2005, he anticipates it will bring Biogen $410 million.

Considering the competition, Kantor said "the hurdle for Enbrel to get approved is pretty low," since it is already approved for other indications and doesn't need to show safety. Same goes for Remicade, he said, but Raptiva has "to go through the whole process, just like Amevive."

In a research note, however, William Tanner, analyst with Leerink Swann & Co., wrote: "We have frequently polled physician consultants for their insight into how the psoriasis biologics market is apt to unfold. In general, physician opinion appears to side with the anti-TNFs (e.g., Enbrel, Remicade, Humira) with regard to safety and efficacy."

Biogen said the price for the product ranges from $7,000 to $10,000 per course, depending on dosing. The product is given as a 12-week course and is available in intramuscular and intravenous formulations.

Biogen said in its conference call that it has agreed, as part of the approval, to "carry out a number of post-marketing clinical studies," including a long-term safety study that will evaluate at least 5,000 patients over five years.

How the psoriasis market will eventually be carved up is anyone's guess, but the approval of Amevive prompted the National Psoriasis Foundation to say Amevive marks "the emergence of a new class of treatment that represents the most significant advance in psoriasis care in 20 years."

IDEC Deal Frees Biogen Resources For Other Uses

The licensing deal with IDEC involves an anti-lymphotoxin beta receptor monoclonal antibody that is preclinical, an early development anti-CRIPTO monoclonal antibody and an interferon beta gene delivery product for glioma that is in Phase I.

IDEC, known for its oncology drugs Rituxan and Zevalin, has the cancer knowledge to develop the Biogen products. Tanner wrote that although "minimal details were disclosed," IDEC will fund development for four years and Biogen has an opportunity to get back in at future points and would then "bear their half of development and marketing costs." Tanner also said IDEC management disclosed a licensing payment in the deal of $1.5 million.

So while there aren't bags of money being exchanged, the deal allows Biogen funds to be used in other areas, perhaps areas in which it better excels, Kantor said.

"Biogen has never been considered a cancer company, and I don't think The Street has given it credit for any of its cancer programs," he told BioWorld Today. "This allows them to reallocate [funds] to what they have more core competency and focus in. IDEC is a company that can better extract value from those programs."

IDEC now will guide the three compounds, leaving Biogen to concentrate on other things, such as launching Amevive.

"They have a world-class oncology group pushing those products at no cost to them," Kantor said.

Biogen's stock (NASDAQ:BGEN) rose 26 cents Friday to close at $38.25.