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Alnylam Updates R&D, Partnering Activities

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During Alnylam Pharmaceuticals’ conference call discussing the company’s fourth-quarter and full-year financial results, President and CEO John Maraganore said that an update of the company’s in vivo data on siRNAs targeting VEGF in its age-related macular degeneration program will be provided at upcoming scientific meetings, including the Macula Society meeting being held on Feb. 23-26 at the Ritz Carlton Key Biscayne in Florida.

He also noted that Alnylam presented data at the Keystone Symposium in Breckenridge, Colo., in January that demonstrated “intranasal administration of short-interfering RNAs specifically inhibited RSV infection in mice.” In addition, he said, “the inhibition of RSV infection in mice by RSV-specific siRNA was more potent than that observed with comparable dosages of a monoclonal antibody targeting RSV.”

Barry Greene, COO of Alnylam, said that an update on RSV in vivo data will be presented at the American Academy of Allergy, Asthma, and Immunology meeting next month in San Antonio.

Maraganore reiterated the company’s expectation that it will have a drug for age-related macular degeneration in phase I testing in the second half of 2005, and that an RSV treatment would enter the clinic in the first half of 2006.

Greene added during the conference call that by the end of 2005, Alnylam expects to announce a third development program that the company plans to advance into clinical trials in the near term.

Although no timeline was provided for Alnylam’s Parkinson’s disease program, Maraganore did note that the company’s recently announced partnership with Medtronic “is expected to accelerate our abilities to delivery RNAi therapeutics for CNS, including Parkinson’s” disease.

Alnylam announced last week that it will collaborate with Medtronic to co-develop therapies for neurodegenerative disorders. Under the arrangement, Alnylam would contribute RNAi-based drugs for various diseases, while Medtronic would develop devices to deliver the drugs to specific locations in the body (see RNAi News, 2/11/2005).

Maraganore noted during the conference call that initially the company is “working with Medtronic to explore the compatibility of short-interfering RNAs with their drug-infusion pumps for delivery into the [central nervous system]. Those data will provide us … guidance [about] which specific neurodegenerative disease to approach” using RNAi agents.

In a US Securities and Exchange Commission filing released after the announcement of the Medtronic deal, Alnylam stated that the companies had agreed to “engage in an initial joint technology development program for a term of two years.” The term may be extended if both companies agree, and either company may terminate the partnership at any time.

Should Alnylam terminate the arrangement before the end of its term, or if Medtronic ends the deal at any time, any licenses granted to Medtronic under the collaboration will “generally terminate,” according to the SEC filing. “In the event that Alnylam terminates the collaboration agreement after the completion of the term of [the arrangement], Medtronic generally may retain any licenses granted to it … and continue product development unilaterally, subject to modified financial terms.”

The companies said last week that after they complete their initial joint technology development work and both agree to pursue product development, Medtronic would make an undisclosed equity investment in Alnylam. According to the SEC filing, “the aggregate amount of Alnylam common stock that Medtronic would purchase would be $21 million.”

Maraganore noted during the conference call that, “at Alnylam’s discretion, the initial investment would be between $1 million and $8 million, and priced at the then fair-market value of Alnylam stock. Additional equity investments would be made upon the achievement of specific milestones at a 20 percent premium to our stock price at the time of that investment.”

Greene noted during the call that, “in addition to … [the] Medtronic collaboration, we expect to announce at least one more strategic alliance” in 2005.

— DM

 

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