Tekmira Pharmaceuticals Corporation has entered into a product development agreement with global healthcare company Roche to advance Roche’s first two RNA interference (RNAi) product candidates into human clinical testing. Both of the product candidates will be based on Tekmira’s stable nucleic acid-lipid particle (SNALP) technology. Under the terms of the product development agreement, Roche will pay Tekmira up to US$18.4 million to support the advancement of the product candidates to the filing of Investigational New Drug (IND) applications. Tekmira is also eligible to receive up to US$32 million in milestones plus royalties on product sales as the first two products are advanced through development and commercialization based on Roche’s access to Tekmira’s intellectual property under previously announced agreements. Dr. Mark J. Murray, Tekmira’s President and CEO, said “We are extremely pleased to be working with Roche, a global pioneer in the development of important therapeutic products and a leader in the RNAi field. This agreement is consistent with our strategy of working with leading pharmaceutical companies to help them advance products based on our SNALP technology, and to leverage this work in order to advance our own products.” “At the same time, the funding from Roche will further strengthen our balance sheet and extend our cash resources as we execute on our business plan of advancing novel RNAi products,” said Dr. Murray. Dr. Louis Renzetti, Head of RNA Therapeutics at Roche, said “We are enthusiastic about the potential of RNAi therapeutics for patients with hard-to-treat diseases. We believe Tekmira’s SNALP is the leading lipid nanoparticle delivery technology and we are confident that Tekmira’s research and manufacturing capabilities will help us to meet our product development objectives.” Roche will use Tekmira’s SNALP technology for two RNAi product candidates. Each of the product candidates will be comprised of Roche proprietary small interfering RNAs (siRNAs) encapsulated in a Tekmira proprietary SNALP formulation. Roche and Tekmira expect an IND for the first product candidate to be filed before the end of 2010. Tekmira will develop and manufacture the drug product for use in all preclinical studies and both companies will collaborate on the preclinical testing. The agreement also provides that Tekmira will manufacture one batch of clinical product for a phase 1 clinical trial.
