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At BIO-CEO, Alnylam Highlights Flu Program, Says More Funding Is on the Way


Alnylam Pharmaceuticals President and CEO John Maraganore spoke to the biotechnology community this week at the Biotechnology Industry Organization's annual CEO and Investor conference in New York, providing a few new details about the company's pandemic influenza program.

At the meeting, Maraganore reaffirmed Alnylam's goal of filing an investigational new drug application for flu therapy in the second half of 2006, and noted that the company is poised to secure "significant additional" funding for the program in the first half of the year.

Alnylam had long been eyeing the flu space, but it wasn't until late last year that the company formally added the indication to its pipeline (see RNAi News, 12/23/2005). In doing so, it set itself up as a direct competitor of Cambridge, Mass., neighbor Galenea.

Galenea was co-founded by Massachusetts Institute of Technology researcher Jianzhu Chen, who has published data on the use of siRNAs to target conserved portions of the flu genome and became interested in RNAi after collaborating with MIT's Phillip Sharp — an Alnylam co-founder.

Although Galenea and Alnylam were set to be partners on the development of an RNAi-based flu therapy, Alnylam eventually opted to pursue the work on its own. Former Galenea CEO John Oyler told RNAi News last year that the companies had held discussions about a possible collaboration and that Alnylam's decision to go it alone came as a shock (see RNAi News, 6/3/2005).

"RNAi … has been identified as an important area for further investment [for flu preparedness and] we have significant discussions with the government as it relates to funding for this program."

Perhaps it shouldn't have. The flu market is a lucrative one: Roche, which makes the best-selling flu treatment Tamiflu, pulled in about $440 million in sales of the drug in the first half of 2005 alone. Meanwhile, with concerns about the possibility of avian flu spreading among humans, the government has become a key source of R&D dollars.

Already, Alnylam has secured $240,000 in flu funding from the US Department of Defense's Defense Advanced Research Projects Agency, and at the BIO-CEO meeting Maraganore noted that the company expects "to have significant additional funding for our pandemic flu program by the first half of this year."

"RNAi … has been identified as an important area for further investment [for flu preparedness and] we have significant discussions with the government as it relates to funding for this program."

According to Maraganore, driving the company's fund-raising is its "ability to use genomic sequences across over 900 flu genomes [which] will enable us to create a single siRNA that could be effective across all flu variants, and most importantly, at least in the near term, a potential pandemic flu variant that might emerge from the current avian H5N1 virus."

As evidenced by the DARPA award, Alnylam has been able to grab the attention of government agencies looking for ways to fight a severe flu outbreak. But where does this leave Galenea?

Pamela Esposito, head of business development and strategic planning at Galenea, did not respond to an e-mail inquiry from RNAi News about her company's fund-raising activities, but said late last year that Galenea was exploring all avenues of financing, including government ones.

Regardless, Galenea is not likely to face a cash shortage in the near term. About a year ago the company formed a collaboration covering its distinct RNAi and small molecule programs with Japanese drug firm Otsuka Pharmaceutical. The deal included an equity investment by Otsuka that remains undisclosed, although a source close to the transaction, speaking on the condition of anonymity, told RNAi News that it totaled about $50 million.

As for Galenea's flu program, the company is maintaining its previously disclosed timeline of filing an IND during the second half of 2007, meaning that it could be a full year behind Alnylam. Meanwhile, it continues to operate without a CEO after Oyler left last year to found a new company, a life science outsourcing services shop called BioDuro.

Esposito told RNAi News in an e-mail this week that the company continues to look for a new CEO.

— Doug Macron ([email protected])

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