A vision for the future

Deal with Fovea helps Dyax expand reach of lead therapeutic protein candidate DX-88 into ophthalmology

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CAMBRIDGE, Mass.—Early February saw Dyax Corp. strike up an exclusive license agreement with French company Fovea Pharmaceuticals for the development and commercialization of an ocular formulation of DX-88 for the treatment of retinal diseases—a deal that Dyax President and CEO Gustav A. Christensen says is an important part of his company's overall strategy to not only advance DX-88, but also to strengthen and diversify the company overall.

The license with Paris-based Fovea grants exclusive marketing rights for DX-88 in ophthalmic indications in the European Union (EU), while Dyax retains marketing rights for these indications for all territories outside the EU. Under the terms of the agreement, Fovea will fund development of DX-88 for the treatment of retinal vein occlusion-induced macular edema for approval in worldwide markets.

For all other ophthalmic uses of DX-88, Fovea will be responsible for developing DX-88 to meet EU regulatory requirements and Dyax will be responsible for any additional requirements needed to obtain approval in territories outside the EU. Financial provisions of the agreement call for each company to pay the other a tiered royalty on net sales of DX-88 in their respective territories.

DX-88 (ecallantide) is a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications: a subcutaneous therapy for hereditary angioedema (HAE) and the prevention of blood loss during on-pump cardiothoracic surgery—the latter application being through a partnership with Cubist Pharmaceuticals, to whom Dyax licensed the intravenous formulation of DX-88 for surgical indications in North America and Europe.

Fovea had preclinical data suggesting that DX-88 might be useful in ophthalmic indications, and this attracted the attention of Dyax, which was interested in expanding the therapeutic and marketing opportunities for the protein.

"As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing macular edema, a leading cause of visual loss in multiple ophthalmic diseases," notes Bernard Gilly, president and CEO of Fovea. "Fovea's interest in DX-88 stems from an understanding of the central role played by plasma kallikrein in the onset of macular edema and from the clinical evidence of DX-88's ability to inhibit edema." Dyax's interest, on the other hand, was driven in larger part by a low-risk deal that could potentially pay off big.

"Here we had the chance for a company with specialized experience to develop DX-88 for an application we wouldn't have pursued ourselves," Christensen notes. "We retain rights outside of Europe, and if DX-88 works for this application, we get a free product handed to us that we can develop and market outside Europe, or bring in a partner to help us, since it would be a very attractive late-stage drug at that point. Unlike our recent deals with Cubist for DX-88 and Biogen Idec for antibody discovery, it doesn't bring in cash up front for us, but it could generate a lot of cash for us down the road, and it won't cost us anything to find out. Fovea has good financial backing, including support through the Wellcome Trust and they have the expertise as well to drive this forward."

News of the Fovea deal followed just six days after Dyax announced that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Advisory Committee voted in favor of approval of DX-88 for the treatment of acute attacks of HAE. The committee's findings will be weighed by the FDA in determining whether DX-88 is to be approved for marketing. If approved, DX-88 will be the first drug available in the U.S. for treating acute attacks of HAE and the first subcutaneously administered HAE therapy.

In addition, just five days before to the Fovea announcement, Dyax revealed that it had expanded its antibody-funded research and library license agreement with Biogen Idec to include the discovery of additional antibody products identified using Dyax's proprietary drug discovery technology, phage display. That deal meant a $5 million upfront fee and guaranteed research funding for Dyax, plus up to $85 million in development and sales milestones and royalties for each antibody product commercialized by Biogen Idec using Dyax's technology.

Christensen notes that Dyax is essentially supported by three legs. The first is its phage display technology, which not only supports its own internal discovery efforts, but also is licensed to some 70 companies. The second is an in-house pipeline of oncology-oriented antibodies. And the third is the development and commercialization of DX-88.

"The deal with Fovea, as with our other deals, ultimately serves to bolster one or more of our three legs," Christensen says, "so that we can maximize the value of our existing products and fund us toward having out first marketed protein: DX-88 for angioedema."

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