Tekmira Pharmaceuticals Receives Approval from FDA to Initiate TKM-Ebola Phase 1 Clinical Trial

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, announced today that its Investigational New Drug (IND) application for TKM-Ebola has been approved by the United States Food and Drug Administration (FDA) allowing Tekmira to initiate a Phase 1 clinical trial.Tekmira is developing TKM-Ebola, a systemically delivered RNAi therapeutic that utilizes Tekmira's lipid nanoparticle (LNP) delivery technology, for the treatment of Ebola virus infection. There are no approved treatments for Ebola or other hemorrhagic fever viruses. Preclinical studies published in the medical journal The Lancet demonstrated that when small interfering RNA (siRNA) targeting the Ebola virus and delivered by Tekmira's LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010)."We are pleased to have received the FDA's approval of our TKM-Ebola IND. With this approval, we remain on track to achieve another significant milestone for the company by initiating the Phase 1 clinical trial of this product in early 2012," said Dr. Mark J. Murray, Tekmira's President and CEO."TKM-Ebola is being developed under a $140 million contract awarded to us by the U.S. Government's Transformational Medical Technologies (TMT) Program. We look forward to continuing this successful collaboration to drive the TKM-Ebola program forward in clinical development," added Dr. Murray.In addition to the TKM-Ebola product development work sponsored by TMT, this program has supported further development of Tekmira's LNP technology, resulting in a successful 100-fold scale up of the LNP manufacturing process as well as the development of lyophilization (freeze drying) processes while maintaining key LNP product characteristics. These advances will support the late stage clinical development and commercialization of TKM-Ebola and Tekmira's other LNP products.Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners

Tekmira files suit against Alnylam for misuse of trade secrets & confidential information

Tekmira Pharmaceuticals Corporation a leading developer of RNA interference (RNAi) therapeutics, has filed a complaint against Alnylam Pharmaceuticals, Inc. for misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising.

The suit, filed in the Business Litigation Session (BLS) of the Massachusetts Superior Court, alleges Alnylam exploited its confidential relationship as a collaborator with Tekmira to engage in inappropriate and harmful conduct concerning Tekmira's proprietary Lipid Nano-Particle (LNP) siRNA delivery technology, resulting in damage to Tekmira's intellectual property and business interests.

In summary, the complaint states that Alnylam has harmed Tekmira and its shareholders by: misappropriating confidential information, including trade secrets and other commercially valuable information from Tekmira; disclosing Tekmira's step-by-step LNP formulation manufacturing instructions to at least one third-party collaborator; incorporating Tekmira's confidential information into Alnylam's patent filings and claiming ownership in direct violation of a licensing agreement between the two companies; willfully and knowingly misusing Tekmira's confidential information for Alnylam's own enrichment; and engaging in other unfairly competitive, deceptive and misleading actions in their public disclosures such as claiming Tekmira's technology as their own.

The damages that Tekmira will be seeking are substantial. Among these damages, Tekmira believes it has rights to Alnylam's pipeline products. These damages, including future milestones and royalties associated with these products alone could exceed one billion dollars. In addition, Tekmira will also seek the profits that Alnylam has unjustly received from collaborations based on the wrongful use of Tekmira's technology. All of this will be subject to what Tekmira learns in discovery in prosecuting this case, but even at this early stage, Tekmira believes that it is entitled to very significant damages by reason of Alnylam's illegal conduct as alleged in the complaint.

“Tekmira's goal for this litigation is to regain — as soon as possible — control over our proprietary LNP technology and preserve its full value. We believe this is the right and only course of action to achieve our goal, and we are fully committed and prepared to pursue this lawsuit until we have a fair and satisfactory resolution,” said Dr Mark J Murray, Tekmira's president and CEO.

“Tekmira is the industry-leading innovator in RNAi delivery technology, and our continued leadership depends on preserving, protecting, and growing our IP estate in order to support our internal product development and enable our pharmaceutical partners,” Dr Murray added.

Tekmira has taken appropriate steps to ensure that the company can pursue this lawsuit without interruption to its core business activities. Tekmira's financial guidance and expected cash runway remain the same, with the current cash on hand enabling execution of its business strategy into 2012. Tekmira plans to report its year-end 2010 audited financial results on March 30, 2011.

RNAi therapeutics has the potential to treat a broad number of human diseases by ‘silencing’ disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as ‘siRNAs,’ require delivery technology to be effective systemically.

Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading Lipid Nano-Particle delivery (LNP) technology to pharmaceutical partners.

Tekmira Pharmaceuticals Comments on Roche Restructuring

Tekmira Pharmaceuticals Corporation a leader in RNA interference (RNAi) therapeutics, announced that Roche disclosed earlier today that it plans to undertake a corporate restructuring. As part of this restructuring, Roche stated it intends to discontinue activities in certain areas of research and early development including its research in RNAi.

Dr. Mark J. Murray, Tekmira's President and CEO, said, "We have enjoyed a productive relationship with Roche for the past several years and respect their strategic decision to focus resources in other areas. At Tekmira, we believe strongly in the future of RNAi drug development and we are committed to advancing our development pipeline and supporting our partners using our leading LNP delivery technology. This confidence is supported not only by the progress we making with our own RNAi-based programs but also by the continued advancement we are seeing across the industry."

"We do not expect Roche's decision to have a substantive impact on our business going forward. The majority of our revenue now comes from our exclusive manufacturing relationship with Alnylam Pharmaceuticals and our growing relationship with the United States Government's Transformational Medical Technologies program. We expect these will be the principal drivers of revenue through 2011, along with the ongoing research relationships we have with Pfizer, Takeda and Bristol-Myers Squibb as well as the opportunity for new business relationships."

In May 2009, Tekmira and Roche entered into a product development agreement to advance Roche's RNAi product candidates into human clinical testing.

Tekmira Stk Jumps On Licensing Pact With Roche >TKM.T

TORONTO (DOW JONES)--Shares of Canadian biotech Tekmira Pharmaceuticals Corp. (TKM.T) got a boost Monday from a drug-development agreement with pharma giant Roche Holding AG (RHHBY).

As reported, Tekmira is licensing its drug-delivery technology, called SNALP, to Roche for its first two products in the field of RNA interference, or RNAi, a promising new class of drugs that's believed to apply to many types of diseases.

If both products make it to Phase I testing, Tekmira would collect $18.4 million, with potential product-development payments of up to $32 million, plus sales royalties after approval.

In an interview, Tekmira's chief financial officer, Ian Mortimer, said the deal demonstrates that the company has leading technology in an important new field. He noted that Roche, which owns a 4% stake in Tekmira, had been studying the company's technology for about a year before committing to the agreement.

While Tekmira has its own RNAi drug candidates in development, with one expected to begin Phase I in the next couple of months, it's signed licensing deals with pharma companies to help finance development of its own pipeline. "We think there's lots of freedom to operate and lots of room for companies to advance products in the RNAi field," he said, adding that Roche isn't the only company that's taken an interest in Tekmira's drug-delivery technology.

Other companies that have licensed Tekmira's intellectual property include Alnylam Pharmaceuticals Inc. (ALNY), Takeda Pharmaceutical Co. (4502.TO), and Merck & Co. (MRK). Bristol Myers Squibb Co. (BMY) and Johnson & Johnson (JNJ) are evaluating the technology.

Mortimer said the company was in good shape financially before the deal, with enough cash to last through the second half of 2010. The Roche deal will "further strengthen" its balance sheet, and the company plans to give more detailed guidance when it reports quarterly results Wednesday.

In Toronto Monday, Tekmira is up 26 Canadian cents, or 27%, to C$1.23 on 231,000 shares. It traded as high as C$1.30 earlier in the session.