While for months Alnylam Pharmaceuticals has said it was exploring the use of RNAi to treat pandemic influenza without formally adding the indication to its pipeline, the company this month said that it plans to file an investigational new drug application for a flu therapy in the second half of next year (see RNAi News, 12/16/2005).
The move, which puts pandemic flu second in line behind respiratory syncytial virus in the company's pipeline, did not come as much of a surprise given global concerns over influenza and Alnylam's apparent success with developing inhalable/intranasal delivery approaches (see RNAi News, 114/2005).
What was unexpected was the timeline Alnylam set forth for its flu program that, if met, would give the company a healthy lead over Cambridge neighbor Galenea, which has said it plans to file an IND on its own RNAi flu treatment in the second half of 2007.
According to former Galenea CEO John Oyler, who spoke with RNAi News this June, the companies had been in discussions about collaborating on an RNAi-based flu drug, and Alnylam's decision to investigate the indication on its own came as a shock (see RNAi News, 6/3/2005).
Galenea's siRNA "has been shown to work effectively against highly pathogenic strains [of the flu virus, and] Alnylam has seen all of our initial IP under non-disclosure," Oyler said at the time. Alnylam has "every disease known to mankind to potentially work on, and they chose the one our company has talked about working on.
Alnylam's interest in flu is a "validation of Galena's strategy" of targeting the virus with RNAi.
"It's surprising that they aren't choosing to address an unmet medical need for which there isn't already a solution," he added. "There's already a solution for pandemic flu Galenea has it."
But who could blame Alnylam with the market for effective flu treatments surging? Roche's Tamiflu, currently considered the top flu treatment available, pulled in roughly $440 million in sales in the first half of 2005 alone, and the company continues to face strong demand for the drug globally. Additionally, government concern over flu outbreaks has created a significant source of research and development funding.
With Alnylam on the scene, Galenea is not only faced with competition in the race to get to the market, but competition for resources useful in getting there a fact made clear when Alnylam reported last week that it had secured a $240,000 grant from the US Department of Defense's Defense Advanced Research Projects Agency for its flu program.
Pamela Esposito, head of business development and strategic planning at Galenea, told RNAi News this week that her company remains on track in its flu R&D efforts, and Alnylam's announcements have had no impact on Galenea's activities.
She said that Alnylam's interest in flu is a "validation of Galena's strategy" of targeting the virus with RNAi and that a solid financial opportunity exists. She added that her company continues to explore all avenues of financing, including ones with the government, and pointed out that the DoD is just one of many agencies interested in funding flu R&D.
Esposito declined to comment on whether Galenea was still in contact with Alnylam over a possible partnership.
In the meantime, however, it seems unlikely that Galenea will be struggling for cash. In February, 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.
Doug Macron ([email protected])