VANCOUVER, BRITISH COLUMBIA--(MARKET WIRE)--May 11, 2009 -- Tekmira Pharmaceuticals Corporation (Toronto:TKM.TO - News) announced today that it has entered into a product development agreement with global healthcare company Roche (Swiss:ROGVX.SW - News)(Swiss:ROS.SW - News)(OTCQX: RHHBY) 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.
About RNAi and SNALP
RNAi drugs have the potential to treat human diseases by “switching-off” disease causing genes. The technology, representing one of the most promising and rapidly advancing frontiers in biology and drug discovery, was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi drugs, such as siRNA, require delivery technology to be administered systemically. In preclinical studies, Tekmira’s SNALP (stable nucleic acid-lipid particles) technology has been shown to be a safe and effective way to deliver RNAi drugs to disease sites. Tekmira believes it has a leading intellectual property position in the field of siRNA delivery.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
There are forward-looking statements and information contained herein that are not based on historical fact, including, without limitation, statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions, and the negative of such expressions. These statements are only predictions.
Forward-looking statements and information should be considered carefully. Undue reliance should not be placed on forward-looking statements and information as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements and information involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, which contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements and information will not occur and may cause actual results or events to differ materially from those anticipated in such forward-looking statements and information.
With respect to the forward-looking statements and information in this news release regarding Tekmira’s product development agreement with Roche, there are circumstances or factors that may cause the benefits Tekmira expects to receive under the agreement that are expressed or implied by the statements in this news release to be different from the actual benefits received. In addition, circumstances or factors may arise that result in the agreement having an unanticipated or adverse effect on the business of Tekmira.
Such circumstances and factors include the following: if Roche fails to successfully develop products using Tekmira’s technology, Tekmira may not receive any milestone or royalty payments due or all the economic benefits expected under the agreement and Tekmira’s business could be otherwise adversely affected; if Roche fails to obtain the research results expected it may terminate or fail to renew its research and development relationship with Tekmira resulting in a loss of revenue for Tekmira; if in the future, competition develops between Tekmira and Roche, in particular in circumstances where Tekmira has disclosed proprietary information to Roche regardless of whether the information is protected by a confidentiality agreement, Tekmira’s business could be adversely affected.
There are also other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements and information. Such factors include, among others, the stage of development of Tekmira, lack of product revenues, additional capital requirements, the need to obtain regulatory approval to commence clinical trials, risks associated with the completion of clinical trials and obtaining regulatory approval to market Tekmira’s products, the safety and efficacy of Tekmira’s products, the ability to protect Tekmira’s intellectual property and dependence on collaborative partners.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s Annual Information Form dated March 31, 2009 available at www.sedar.com. Tekmira disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements or information contained herein to reflect future results, events or developments, except as required by law. Contact:
Contacts: The Equicom Group - Investors Adam Peeler 416-815-0700 x 225 apeeler@equicomgroup.com
Tekmira Pharmaceuticals Corporation - Investors Ian Mortimer Executive Vice President and Chief Financial Officer 604-419-3200 http://www.tekmirapharm.com
Longview Communications Inc. - Media David Ryan 604-694-6031 dryan@longviewcomms.ca
