From Friends To Foes: Tekmira Slaps Partner Alnylam With Lawsuit

Suit alleges Alnylam stole Tekmira's RNAi delivery technology, but Alnylam dismisses the claims and says its delivery technology falls within its licensing agreement or other partnerships.

In the effort to develop RNA interference-based therapeutics, Alnylam Pharmaceuticals Inc. and Tekmira Pharmaceuticals Corp. have been both competitors and allies.

But the biotechs' partnership took a turn March 16 when Tekmira filed a lawsuit against Alnylam in the Business Litigation Session of the Massachusetts Superior Court. The suit alleges that Cambridge, Mass.-based Alnylam stole trade secrets and other confidential information about Tekmira's lipid nanoparticle technology, used that information in its own patent filings and shared it with third parties.

Both companies are developing proprietary products and striking partnerships with pharmaceutical companies, but the two also have been partners since 2006. Alnylam, a pioneer and early IP consolidator in the field, and Tekmira, a nanoparticle technology specialist, are joined via a series of research collaborations, IP licensing pacts and equity investments. Each company stands to receive milestone and royalty payments from the other as a result of those deals.

As recently as November 2010, when Tekmira licensed Alnylam's fundamental RNAi therapeutics IP to go create an LNP-enabled siRNA against Ebola virus, the companies were publicly complimentary about their relationship. Tekmira has since changed its tune.

"Alnylam abused its collaborator status and access to our confidential information by improperly using this information for its own internal purposes and to replicate a competing technology in ways that were unauthorized and without our consent," Tekmira CEO Mark Murray said in a same-day conference call.

But Alnylam abruptly dismissed the allegations. In an interview March 17, CEO John Maraganore said he was shocked when Murray e-mailed him yesterday to notify him of the lawsuit, the first he claims to have heard of any dispute. "There's no merit to any of the claims they're making," he said. "It's a partner biting the hand that feeds them."

Alnylam has paid Tekmira $45 million since 2007, including equity funding. That includes $6 million in manufacturing-related payments in 2010, with similar levels expected in 2011. Under a 2009 alliance, Tekmira is manufacturing several of Alnylam's clinical candidates, ALN-VSP for liver cancer, ALN-TTR for transthyretin amyloidosis and ALN-PCS for high cholesterol. Tekmira said it will continue to provide those products.

A Case Of He Said, She Said?

In exchange for its investment, Alnylam said it gained rights to Tekmira's intellectual property, including exclusive rights, with the sole right to sublicense, many patents and patent applications, including the so-called "Semple" and "Wheeler" patent families. Those patents cover lipid encapsulated polyanionic nucleic acid composition and novel lipid nucleic acid particulate complexes for gene transfer, respectively. In addition, Alnylam said it has rights to other novel lipid nanoparticle formulations through agreements with AlCana Technologies Inc., the University of British Columbia and the Massachusetts Institute of Technology.

But in the lawsuit, Tekmira counters that it provided Alnylam with secret information about its proprietary delivery technology only under the protection of written agreements that restricted the company's rights to use it and that Alnylam was "strictly prohibited" from disclosing the information to third parties without Tekmira's written consent.

"Tekmira did not grant Alnylam ownership of its delivery technology; the delivery technology remained Tekmira's property before, during and after Tekmira's collaboration with Alnylam," according to the suit.

Additionally, the suit says that Alnylam is telling current and potential business partners, including Novartis AG and Sanofi-Aventis SA, that it is developing novel siRNA delivery formulations and lipids that can be obtained from Alnylam instead of Tekmira.

Tekmira is seeking rights to Alnylam's pipeline products, and said damages, including future milestones and royalties associated with those products, could exceed $1 billion.

The dispute comes at a challenging time for Alnylam and amid increasing uncertainty in the RNAi space, as the industry has yet to generate proof-of-concept data in the field. Though Alnylam now has its own pipeline drug candidates in development, the company made its money by signing rich non-exclusive licensing deals with big pharma partners.

But last year, the partnering winds began shifting away from Alnylam. In November, Roche announced its intention to walk away from RNAi research and to focus instead on next-generation antibodies and peptides. And just weeks earlier, Novartis passed over an option to expand its licensing deal with the biotech, claiming that its Alnylam-enabled RNAi pipeline was full. That led Alnylam to trim its workforce (Also see "With Novartis Ending RNAi Research Partnership, Alnylam Trims Workforce" - Pink Sheet, 26 Sep, 2010.).

Despite the hits to its platform strategy, Alnylam's Maraganore has remained upbeat about the prospects for RNAi therapeutics. The company unveiled a product-focused strategy, tagged 5X15, with a goal to deliver proof-of-concept data for five RNAi programs by 2015 in January .

-Jessica Merrill ([email protected])