Washington Editor

Eyetech Pharmaceuticals Inc. bought a manufacturing facility to aid in the production of its lead product, Macugen.

The New York company plans to use the oligonucleotide production site, which is located in Boulder, Colo., as a second source for commercial-scale production of the active pharmaceutical ingredient for Macugen (pegaptanib sodium injection). The ocular product remains under regulatory review for age-related macular degeneration, and if approved, would be sold by Eyetech and Pfizer Inc. under their collaboration. The partners filed a new drug application this summer. (See BioWorld Today, June 18, 2004.)

"It's always important to have backups, as one never wants to be completely dependent on one plant," Eyetech CEO David Guyer told BioWorld Today. "A natural disaster can happen anywhere, and it's just a smart thing to diversify risk."

Glenn Sblendorio, Eyetech's chief financial officer and senior vice president of finance, said the decision to find a secondary Macugen manufacturing site fits into the overall framework of Eyetech's relationship with New York-based Pfizer.

The facility purchase cost $3 million in cash, plus the assumption of certain equipment and facilities leases. Eyetech acquired the site from Transgenomic Inc., which used it for contract manufacturing services for preclinical and clinical products that support the development of nucleic acid-based therapeutic and diagnostic products.

Eyetech said it views the purchase as an investment that expands its capabilities in oligonucleotide synthesis, and plans to further invest in appropriate infrastructure at the facility to be able to use it for Macugen's production. In addition to its development for age-related macular degeneration, the product also is being developed for diabetic macular edema and retinal vein occlusion. Three months ago, Eyetech and Pfizer presented data on the product to the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, and its PDUFA date is scheduled for Dec. 17 based on its fast-track status. (See BioWorld Today, Aug. 27, 2004.)

"This site is currently structured to manufacture preclinical and clinical materials," Sblendorio told BioWorld Today. "There would have to be additional investments in the facility to get it up to commercial scale."

He said the company would model its plans on operations that belong to Degussa Chemicals, where Macugen's active pharmaceutical ingredient is manufactured on a contract basis. That site, in Canada, is the primary source of commercial-scale product.

Eyetech has created a 44-person sales force to take the drug to 1,500 retinal specialists in the U.S., should it receive approval, as part of the co-promotion side of its deal with Pfizer. For its part, Pfizer will promote the product in the U.S. through its 160-person glaucoma sales force. Overseas, Pfizer will commercialize the product on its own.

"This really continues our quest to be a fully integrated biopharmaceutical company," Guyer said. "We have preclinical expertise in our laboratory in Woburn, Mass., clinical and regulatory development, and we have commercialization expertise by having our own sub-specialty sales force. And now with manufacturing, it allows us to be the world's experts in aptamer manufacturing."

Although mainly a "second source" for Macugen production, the company plans to use the site's current assets to produce aptamers, and potentially other oligonucleotides, in support of internal development programs for its ophthalmic pipeline.

Guyer said, "We believe that aptamers are a very important new therapeutic."

Per terms of a deal with Archemix Corp., of Cambridge, Mass., Eyetech owns exclusive rights to the use of aptamers in all ophthalmic targets. The company's preclinical researchers have identified back-of-the-eye targets for which it is developing aptamer-based drugs. (See BioWorld Today, April 15, 2004.)

In other business news, Eyetech said it would be included in the Nasdaq Biotechnology Index effective Nov. 22. A number of companies were added, and others removed, as part of the index's semi-annual re-ranking.

On Monday, Eyetech's stock (NASDAQ:EYET) gained 13 cents to close at $42.84. Shares in Omaha, Neb.-based Transgenomic (NASDAQ:TBIO) fell 12 cents to close at $1.40.