Washington Editor

At its annual shareholder meeting Wednesday, Nastech Pharmaceutical Co. Inc. promoted news of its latest in-licensing deal, which gives the company exclusive access to RNAi technology from Alnylam Pharmaceuticals Inc.

"We were pleased to be able to announce this arrangement," Nastech Chairman, President and CEO Steven Quay said of the agreement to pay for an exclusive license to discover, develop and commercialize RNAi therapeutics directed against the protein TNF-alpha. "Our assessment of the field, looking at the patent landscape in this area, is that Alnylam has control or license to some critical applications that I think have significant commercial value."

The companies declined to disclose financial terms of the license, but it entails up-front, annual and milestone payments, as well as royalties.

"We did it very early to make sure that it would not impact the economic viability of our program," Quay said. The in-licensing opportunity represented a chance for the Bothell, Wash.-based company to supplement its existing RNAi research efforts.

Nastech already has demonstrated the in vivo use of RNAi to suppress rheumatoid arthritis in mice. In that study, which compared the company's RNAi delivery formulation with Remicade (infliximab, from Centocor Inc.), Quay said "our delivery proteins are superior to the Remicade treatment."

TNF-alpha, the target of interest in the licensing deal, is associated with rheumatoid arthritis and other inflammatory diseases such as diabetes. Quay told BioWorld Today that since Remicade and other molecules designed to bind it actually increase its half-life and could cause the up-regulation of its synthesis, "we're very excited about having a new mechanism of treatment of TNF-alpha-related diseases."

Moving ahead, Nastech is looking to advance that program into early clinical trials next year after meeting goals related to manufacturing and preclinical toxicity studies. The company owns full rights to the program.

For Alnylam, which has worked to consolidate intellectual property related to siRNA therapeutics, the arrangement sends some of its RNAi technology to another partner. To do that, the Cambridge, Mass.-based company created what it terms its InterfeRx program as a licensing vehicle to grant access to its intellectual property for RNAi therapeutics outside its core interests.

"There really are a huge number of opportunities that we can't necessarily pursue on our own," said Nagesh Mahanthappa, senior director of business development and strategy. "So it makes sense to monetize those aspects of value."

Nastech's license represents the third such partnership with Alnylam's InterfeRx program. The two previous deals along those lines are with GeneCare Research Institute Co. Ltd. in Kamakura, Japan, and Benitec Ltd., of Sydney, Australia. Mahanthappa praised Nastech's TNF-alpha program and its related delivery technology, adding that Alnylam is "interested in Nastech's delivery technology, among others."

Going forward, he said Alnylam remains primarily focused on developing a pipeline of RNAi products using Direct RNAi - siRNAs delivered directly to cells of interest. To that end, the company has partnered an age-related macular degeneration program with Merck & Co. Inc., of Whitehouse Station, N.J., and is internally advancing a respiratory syncytial virus program and other pulmonary diseases. Those research areas remain in preclinical stages. Mahanthappa added that the company expects to enter another major partnership later this year.

Nastech's pipeline includes a Phase I obesity program centered on the PYY hormone that is partnered with Merck, a synthetic calcitonin hormone for postmenopausal osteoporosis that remains under FDA review (and licensed by Par Pharma Inc., of Woodcliff Lake, N.J.), and preclinical research into nasal parathyroid hormone for osteoporosis.

On Wednesday, Alnylam's stock (NASDAQ:ALNY) gained $1.10, or 13.3 percent, to close at $9.40. Shares in Nastech (NASDAQ:NSTK) gained 39 cents to close at $14.72.

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