Officials from Tekmira Pharmaceuticals last week said that several undisclosed biopharmaceutical firms are currently evaluating its core siRNA delivery technology, and at least a few are expected to sign licensing deals.
A technology-evaluation arrangement with Swiss biopharmaceutical giant Roche has recently ended, however, and the future of the partnership remains up in the air.
Tekmira’s current list of disclosed partners for its stable nucleic acid-lipid particles includes Bristol-Myers Squibb, which signed a deal this summer to use the technology to deliver siRNAs to tissues outside of the liver (see RNAi News, 8/14/2008); Johnson & Johnson Pharmaceutical Research & Development, which has been using SNALPs to deliver siRNAs against targets in the liver; and Alnylam Pharmaceuticals, which recently confirmed that it would use SNALPs in its liver cancer program (see RNAi News, 11/13/2008).
And Roche, through its broad partnership with Alnylam (see RNAi News, 7/12/2007), has the option to use the SNALP technology in certain of its RNAi drug programs (see RNAi News, 4/3/2008). However, the future of this relationship is unclear, according to Tekmira President and CEO Mark Murray.
After paying $5 million for access to SNALPs and a roughly 4 percent stake in Tekmira this year, Roche began a six-month evaluation of the technology, Murray said during a third-quarter financials conference call held last week. He added that the companies are “nearing the completion of this evaluation, and [we] expect to determine our future work with Roche over the coming months.”
Given the success Tekmira has had with its collaborators, notably RNAi kingpins Alnylam and Merck’s Sirna Therapeutics (see RNAi News, 10/18/2007), and the company’s status as a key player in the field of siRNA delivery, it would come as no surprise if Roche extended the arrangement.
Roche and Tekmira are “nearing the completion of this evaluation, and [we] expect to determine our future work with Roche over the coming months.”
Yet keeping its research in-house has increasingly become Roche’s hallmark, at least in the RNAi space. For instance, when it forged its alliance with Alnylam, Roche paid $15 million to acquire the RNAi shop’s German subsidiary, Alnylam Europe, in a move designed to give the company its own core of expertise with the gene-silencing technology, according to Lee Babiss, Roche’s head of global pharma research (see RNAi News, 2/14/2008).
The following summer, Roche spent $125 million to buy Mirus Bio in a deal that was largely driven by Mirus’ polymer-based dynamic polyconjugate delivery technology (see RNAi News, 7/24/2008). While Roche had been considering collaborating with Mirus, it again saw more value in bringing the company into the Roche fold, Lou Renzetti, vice president and global head of Roche’s RNA therapeutics unit told RNAi News a few months later (see RNAi News, 9/25/2008).
Even if Roche decides against pursuing the SNALP technology further, Tekmira does not expect there to be a shortage of other interested parties.
Although Tekmira did not provide guidance regarding upcoming partnerships, “companies are continuing to want access to the SNALP technology,” Tekmira CFO Ian Mortimer said during the conference call. “We’ve shown that with Johnson & Johnson and [Bristol-Myers Squibb], and we’re comfortable … that the number and scope of those relationships will continue to increase.”
In August, during Tekmira’s second-quarter conference call, Murray said that the company was anticipating that Japanese drugmaker Takeda Pharmaceutical would likely be interested in licensing the SNALP technology, also because it is an Alnylam partner (see RNAi News, 8/21/2008).
Murray was not available for comment on the status of any possible talks with Takeda or to elaborate on the deal with Roche.
On Track for 2009
As it eyes partnerships, Tekmira is also continuing its own internal drug programs, and Murray said last week that the company remains on track to meet its goal of moving its first two product candidates into human studies in 2009.
The company’s lead drug, ApoB SNALP, is an siRNA targeting apolipoprotein B, a protein involved in cholesterol metabolism. Tekmira said last week it expects to begin a phase I study of the molecule in the first half of 2009 as a treatment for hypercholesterolemia.
The second drug, PLK1 SNALP, is an siRNA that inhibits polo-like kinase 1, a gene linked to the growth of certain solid tumors. The company said it plans to test this drug in a phase I study in the second half of 2009 as a treatment for cancer.
At the same time, Murray said that Tekmira has generated efficacy data in both liver cancer models and distal-tumor models using different SNALP formulations in line with its continued focus on “broaden[ing] the applications of our SNALP technology … for use outside the liver.”
He added that the company also expects to select a third siRNA drug for development next year, but did not elaborate. Under its arrangement with Alnylam, Tekmira has the right to use the RNAi shop’s intellectual property to develop seven siRNA drugs, including ApoB SNALP and PLK1 SNALP.
Cash to Last Into 2010
For the third quarter, Tekmira, based in Vancouver, BC, reported a net loss of CDN$6 million ($4.9 million), or CDN$0.12 per share, versus net earnings of CDN$1.5 million, or CDN$0.06 per share, a year ago.
According to the company, the reversal was due in part to the inclusion of operating results from Protiva Biotherapeutics, which merged with Tekmira earlier this summer (see RNAi News, 4/3/2008).
Tekmira’s revenues in the quarter slipped to CDN$4.2 million from CDN$5.7 million in the same period last year, while research and development spending climbed to CDN$5.4 million from CDN$3.2 million.
General and administrative costs in the third quarter edged up to CDN$1.1 million from CDN$800,000 the year before.
As of Sept. 30, Tekmira had cash resources totaling CDN$34.2 million, which Mortimer said would be sufficient to fund the company into the second half of 2010.
When the company reported its second-quarter results, “we had estimated that our funds on hand, plus expected interest and revenue, would be sufficient to continue our product development until the first half of 2010,” he said. “Given our estimated revenue for 2009 and 2010, and salary savings resulting from our recent reorganization, we now expect to extend our cash runway to the second half of 2010.”
Tekmira did not offer specific revenue guidance for 2009 or 2010.