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With Roche Deal Signed, Tekmira Says It Has Funds to Last Until Mid-2011

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This story has been updated to include comments from Tekmira's management.

Tekmira Pharmaceuticals said this week that its recently announced RNAi product-development deal with Roche will give it enough resources to fund its drug-development operations into the middle of 2011, about one year longer than it had projected in March.

Tekmira made the disclosure as part of its first-quarter earnings release, which included a more than 400 percent jump in revenues and a roughly 425 percent rise in net loss as its operations expanded following its merger with Protiva Biotherapeutics last year.

Earlier this week Tekmira announced that it had signed an agreement to help Roche develop two undisclosed siRNA-based therapeutics in exchange for up to $50.4 million in research funding and milestones, plus royalties (see RNAi News, 5/11/2009). Under the deal, the two drugs will incorporate Tekmira's proprietary stable nucleic acid-lipid particle, or SNALP, technology.

As a result of that deal, Tekmira "now believes that current funds on hand, plus expected interest income and contractually payable further funds from collaborators will be sufficient to continue product development until mid-2011," the company said in a statement.

During a conference call held this week to discuss the first-quarter results, Tekmira CFO Ian Mortimer noted that "if we are able to generate partner revenue greater than what is contractually committed, then we may be able to extend our cash even further."

And according to Tekmira President and CEO, an ongoing SNALP technology-evaluation arrangement with Takeda Pharmaceutical is a likely source of that greater revenue.

"We're optimistic that this relationship will evolve, as have our relationships with other companies that have evaluated our technology," he said during the call.

Q1

For the three months ended March 31, Tekmira's net loss jumped to C$2.1 million ($1.8 million), or C$0.04 per share, from C$400,000, or C$0.02 per share, in the year-ago period.

Contributing to the higher losses was a rise in research, development, and collaboration costs to C$3.6 million from C$2 million in the first quarter of 2008. Driving these higher expenses was Tekmira's merger with Protiva (see RNAi News, 6/5/2008), which resulted in an increase in R&D staff to 60 from 39, as well as the initiation of two in-house drug-development programs.

The company's lead drug candidate, the hypercholesterolemia drug ApoB SNALP, was just cleared to enter phase I testing (see RNAi News, 5/7/2009). Its second product, the cancer treatment PLK1 SNALP, is expected to enter the clinic in 2010 (see RNAi News, 3/26/2009).

Tekmira's general and administrative spending in the first quarter edged up to C$1 million from C$700,000 a year earlier, in part due to higher salary and facility costs.

Revenues in the quarter climbed almost 400 percent, to C$2.9 million from C$600,000, largely as a result of an expansion of the company's manufacturing arrangement with Alnylam (see RNAi News, 1/9/2009).

At the end of the first quarter, Tekmira had cash and cash equivalents totaling roughly C$30 million.

Dealmaker

Tekmira has long been one of the RNAi field's biggest partnership magnets, largely on the strength of its SNALP technology and siRNA-delivery expertise.

The company's list of disclosed partners include Johnson & Johnson Pharmaceutical Research & Development, which has been using SNALPs to deliver siRNAs against targets in the liver; Bristol-Myers Squibb, which earlier this year extended the companies' ongoing alliance; and Alnylam Pharmaceuticals, which recently confirmed that it would use SNALPs in its liver cancer program (see RNAi News, 11/13/2008).

As reported by RNAi News, about two months ago Alnylam CEO John Maraganore characterized SNALPs as two to three years ahead of another lipid-based delivery technology his company had previously expected to use in both its liver cancer and hypercholesterolemia programs (see RNAi News, 3/12/2009).

The arrangement with Roche was further validation of the promise of Tekmira's delivery technology; less than a year ago, Roche paid $125 million to acquire Mirus Bio, primarily for its polymer-based dynamic polyconjugate delivery technology (see RNAi News, 7/24/2008).

During today's conference call, Tekmira's Murray expressed similar sentiments, referring to lipidoids as "potentially something in the future that could contribute to the SNALP platform." Meanwhile, Mirus' technology is "much earlier in development [and] maybe something that will come along and contribute in the future, but not now," he said.

"From my perspective, [the] SNALP technology remains the technology that is ready for primetime," Murray noted.

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