Washington Editor

The FDA's positive feedback on Biogen Inc.'s Amevive application likely will be the first in a series of key events expected to drive the biotechnology industry this year, an analyst said.

Biogen, of Cambridge, Mass., Thursday released a statement saying the FDA had issued a complete response letter on Amevive (alefacept), a drug being developed for moderate to severe chronic plaque psoriasis.

Even though the agency is requesting "clarification and information related to data Biogen previously submitted," additional clinical trials will not be required.

Amy McKnight, a spokeswoman for Biogen, characterized the letter as "another step in the approval process." She said Amevive is on track for approval toward the end of 2002 or in the early part of 2003.

"It's not an approval letter; it says they want more information. But this is not going to push them back," Matt Geller, an analyst with CIBC World Markets in New York, told BioWorld Today. "I think the market is interpreting it positively - that they didn't ask for additional clinical trials. We interpret it as neutral to positive."

But in an industry that's faced a series of late-stage setbacks this year, the letter means more. Geller called it the first of three important approvals this year. The others are "a timely approval of MedImmune's FluMist, and a timely approval, strong launch and good label for Amgen's Aranesp. I think investors are focused on those things."

And for Biogen, the imminent launch of Amevive is tremendously important. "I think Amevive is critical to Biogen because they now have to share the Avonex market with Serono's Rebif," he said.

Avonex, a billion-dollar multiple sclerosis treatment, is Biogen's only marketed product. Geller's office forecasts 2002 worldwide sales of Avonex to reach $1.72 billion ($791 million in the U.S.). The number would be higher, but Rebif, an interferon beta 1-a made by Serono SA, won FDA clearance this year and is expected to sell $550.3 million worldwide in 2002, including $45.3 million in the U.S. (See BioWorld Today, March 11, 2002.)

But if Biogen launches Amevive early next year, Geller's office says the drug should reach $55 million in U.S. sales in 2003. Peak worldwide sales have been estimated between $350 million and $500 million.

While there are other products available to treat psoriasis, Geller said Amevive may have a leg up because it would be the first biologic for psoriasis.

Because of that, Eric Schmidt, an analyst with SG Cowen Securities Corp. in New York, said Amevive "has all the signs of a blockbuster."

Schmidt's research notes said the psoriasis market in the U.S. is worth $5 billion a year. He estimates sales of Amevive will reach $500 million by 2006.

"Amevive's first-to-market status should allow it to capture most of the low-hanging fruit," Schmidt said. "Needy patients are likely to try Amevive first, and stay with the drug through repeat administrations should they respond positively."

Geller said other serious competitors are Enbrel, a Phase II/III product being studied by Seattle-based Immunex Corp.; and Xanelim, a product of South San Francisco-based Genentech Inc. and Berkeley, Calif.-based XOMA Ltd. that has been delayed due to results of a pharmacokinetic study. (See BioWorld Today, Oct. 8, 2001, and April 8, 2002.)

"Although there haven't been head-to-head comparisons, neither of those drugs has the T-cell depletion issues associated with Amevive," Geller said.

Members of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee raised concerns about Amevive's role in reducing the T-cell count, but Biogen maintained the product affects only a subset of T cells that cause disease.

In its May meeting, the committee voted 8-to-2 in favor of Amevive approval. (See BioWorld Today, May 24, 2002.)

Burt Adelman, Biogen's executive vice president-research and development, released a prepared statement last week saying, "The FDA advisory committee vote last month was a clear indication of the importance the physician and patient communities place on Amevive as a potential new therapy for psoriasis. The FDA letter brings Biogen another step closer to meeting those unmet needs."

Biogen's stock (NASDAQ:BGEN) closed Friday at $42.42, up $2.98.