Cubist Pharmaceuticals, Inc, a leading acute care biopharmaceutical company, and Alnylam Pharmaceuticals, Inc, a leading RNAi therapeutics company, have formed a strategic collaboration to develop and commercialize Alnylam's ALN-RSV programme. The RSV-specific RNAi therapeutic programme 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 programme worldwide outside of Asia, subject to the cost and profit sharing in North America.
"Cubist is pleased to be working with Alnylam and to be involved in the development and potential commercialization of a therapy for this significant infectious disease," said Michael W Bonney, president and chief executive officer of Cubist. "We expect that this collaboration will leverage the development expertise and commercial success we have achieved in the area of infectious disease. There is significant need for novel therapeutics to effectively treat patients with RSV infection, a leading cause of paediatric hospitalization and a prevalent infection in certain adult populations. We are convinced that developing a treatment for RSV infection is an important therapeutic and commercial opportunity, and, like Alnylam, are committed to addressing this need."
"We are excited to have formed this new alliance with Cubist – a like-minded organization that shares our commitment to bringing a novel RNAi therapeutic to patients infected with RSV. We have tremendous respect for the Cubist team, and have been impressed with the development and ongoing commercial success they have had with their lead anti-infective programme, Cubicin (daptomycin for injection)," said John Maraganore, chief executive officer of Alnylam. "Partnering this programme brings additional critical mass to the advancement of ALN-RSV01 and/or second-generation RSV-specific RNAi therapeutics in our broader programme which we aim to advance through ongoing pre-clinical studies toward potential clinical studies as early as 2010. The partnership also provides Alnylam with yet additional financial flexibility to invest beyond RSV in the multiple product opportunities represented by our growing pipeline of novel RNAi therapeutics."