Alnylam and Cubist Collaborates to Develop and Commercialize RNAi Therapeutics Targeting RSV Infection
News Jan 12, 2009
Cubist Pharmaceuticals, Inc. and Alnylam Pharmaceuticals, Inc. have announced that they have formed a strategic collaboration to develop and commercialize Alnylam's ALN-RSV program.
The RSV-specific RNAi therapeutic program includes ALN-RSV01, which is currently in Phase II clinical development for the treatment of respiratory syncytial virus (RSV) infection in adult lung transplant patients, as well as several other potent and specific second-generation RNAi-based RSV inhibitors in pre-clinical studies.
The collaboration is structured as a 50/50 co-development and profit share arrangement in North America, and a milestone- and royalty-bearing license arrangement in the rest of the world outside of Asia, where ALN-RSV is partnered with Kyowa Hakko Kirin Co., Ltd. Alnylam will receive an upfront payment of $20 million.
In addition, Alnylam is eligible to receive development and sales milestone payments from Cubist that could total $82.5 million, for a total in upfront and potential milestone payments of $102.5 million, as well as double digit royalties on net sales outside of North America and Asia.
After achieving certain development milestones, Alnylam could convert the North American co-development and profit share to a royalty-bearing license with development and sales milestones. Cubist will have sole rights for commercialization of the ALN-RSV program worldwide outside of Asia, subject to the cost and profit sharing in North America.
In 2008, Alnylam conducted the GEMINI study in which ALN-RSV01 was evaluated in a double-blind, randomized, placebo-controlled Phase II clinical trial. Data from this study showed that intranasally administered ALN-RSV01 demonstrated statistically significant anti-viral efficacy with an approximately 40% relative reduction in RSV infection rate and a 95% increase in the number of infection-free subjects, as compared with placebo.
The RNAi therapeutic is currently being studied in a double-blind, randomized, placebo-controlled Phase II clinical trial to assess the safety and tolerability of aerosolized ALN-RSV01 in adult lung transplant patients naturally infected with RSV.
As a secondary objective, this trial will evaluate the anti-viral activity of ALN-RSV01 in patients with a naturally acquired RSV lower respiratory tract infection. Based on these and other data, Cubist and Alnylam will aim to maximize the value of the entire RSV program for advancement in pediatric and adult RSV-infected patients.