Staff Writer

A day after an FDA advisory panel narrowly backed the approval of Dyax Corp.'s Kalbitor (ecallantide, DX-88) for acute attacks of hereditary angioedema, the company expanded its phage display drug discovery deal with Biogen Idec Inc.

Under the expanded deal, Dyax will receive $5 million up front as well as annual research funding to mine its antibody libraries on behalf of Biogen Idec. Dyax will deliver a minimum of 10 product licenses to Biogen Idec during the course of the three-year deal, and each product could generate up to $85 million in milestone payments as well as eventual royalties for Dyax.

The two Cambridge, Mass.-based companies originally teamed up in 2004. Dyax's discovery work led to the generation of Biogen Idec's Phase I anticancer antibody BIIB-022 as well as an antibody targeting LINGO-1, which is moving into clinical trials for multiple sclerosis. (See BioWorld Today, Nov. 11, 2004.)

"I think we have become an important part of their pipeline generation," Dyax President and CEO Gustav Christensen told BioWorld Today.

Biogen Idec isn't the only one to rely on Dyax for discovery work. The company's phage display platform - which can be used to screen antibodies, peptides or small proteins - has formed the basis for more than 70 licenses and collaborations.

Christensen said Dyax's work for its partners has generated seven products in Phase I trials, five products in Phase II trials and one product in Phase III trials. Revenues totaled about $15 million last year, he said.

For the next eight years, some of those revenues will be used to pay off a $50 million revenue-backed loan from Cowen Healthcare Royalty Partners that Dyax took last August. The company used $35 million of the cash from the loan to pay off a pre-existing royalty-backed loan from Paul Royalty Fund that had less attractive terms, Christensen said. The remaining $15 million went into Dyax's coffers.

Those coffers totaled $74.5 million as of Sept. 30, 2008. At the time, Dyax predicted its net cash burn for the year would be less than $20 million. The company also secured a $50 million committed equity financing facility after the close of the quarter. (See BioWorld Today, Oct. 31, 2008.)

Shares of Dyax (NASDAQ:DYAX) fell 32 cents, to close at $2.66 on Thursday - a fact that probably had nothing to do with the Biogen Idec deal and everything to do with the FDA advisory committee's late Wednesday decision on Kalbitor.

Kalbitor, which was developed using phage display technology, is a recombinant small protein that inhibits plasma kallikrein, a component in the regulation of inflammatory and blood-clotting processes. Dyax is seeking approval of the drug for the treatment of acute attacks of hereditary angioedema.

The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 6 to 5, with two abstentions, that Dyax's studies provided substantial and convincing evidence to support the drug's approval. The committee also voted 8 to 4 that there was strong evidence of a clinically meaningful benefit in adults but 11 to 2 that Dyax had failed to provide the same level of evidence in children and adolescents, also noting that safety had not been adequately assessed in younger patients. (See BioWorld Today, Feb. 5, 2009.)

The FDA is expected to make a decision regarding Kalbitor's approval next month. If approved, Dyax plans to market the drug in the U.S. and seek a partner abroad.

Also seeking approval for the treatment of HAE is ViroPharma Inc.'s Cinryze (C1-esterase inhibitor). The product gained approval in the prevention of the condition last year, and ViroPharma submitted a supplemental biologics license application in December 2008 for acute HAE treatment. (See BioWorld Today, Oct. 14, 2008.)

Behind Kalbitor, Dyax has the matrix metalloproteinase-14 inhibitor DX-2400 in preclinical studies for cancer. The company's other preclinical cancer candidate, DX-2240, was licensed last year by Sanofi-Aventis in a potential $500 million deal that also included a phage display license. (See BioWorld Today, Feb. 13, 2008.)

Christensen said Dyax has "about a dozen antibodies and proteins" derived from phage display in earlier preclinical development. He also noted that clinical trials evaluating Kalbitor in other types of angioedema are in the works.