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Debiopharm Drops Out of Bladder Cancer Deal with Cash-Strapped Marina

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This article has been updated to include comment from Marina's management.

Beleaguered RNAi drug developer Marina Biotech, already facing the prospect of bankruptcy, received more bad news earlier this month when partner Debiopharm said that it will terminate its license to Marina's preclinical bladder cancer drug at the beginning of December.

In a filing with the US Securities and Exchange Commission last week, Marina said that Debiopharm provided notice that it would pull out of the arrangement on Dec. 5 due to its own “operational reasons.” At that point, the program will be returned to Marina without any additional obligations beyond “minor activities associated with the termination period,” it added in the filing.

Marina President and CEO Michael French said in an email this week that Debiopharm had developed the program to the point where it is ready for investigational new drug application-enabling studies.

Marina said that it intends to further develop the bladder cancer drug once it has obtained the appropriate funding or found another partner. However, whether it will be able to do so remains a question given that Marina has just about run out of money. As reported by Gene Silencing News, the firm previously disclosed that its resources would only last until around the end of October.

French declined to provide an update on the company's current financial status.

Officials from Debiopharm were not available for comment.

Marina's bladder cancer program had once been the company's lead research and development effort, with in vivo data showing that the company's proprietary siRNA molecules, targeting the cancer-associated protein survivin and delivered intravesically using its liposomal delivery technology, could reduce tumor growth in an orthotopic bladder cancer models (GSN 10/15/2009).

Buoyed by such data, Marina moved bladder cancer to the front of its pipeline, and by 2010 company officials were predicting a candidate could be ready for clinical testing as early as the next year (GSN 3/25/2011).

Around the beginning of 2011, however, Marina found a licensee for the program in Debiopharm, which picked up the worldwide rights to develop and commercialize a bladder cancer candidate in exchange for up to $25 million in research and development milestones, plus undisclosed royalties on product sales (GSN 2/3/2011).

Filling in the gap at the front of Marina's R&D queue was CEQ508, a phase I treatment for familial adenomatous polyposis that was acquired through the firm's buyout of Cequent Pharmaceuticals in late 2010.

But work on CEQ508 was halted this summer as part of a cost-cutting effort that saw Marina shut down virtually all of its operations after it was unable to raise necessary financing (GSN 6/7/2012). But it wasn't until last month, when Marina filed its long-delayed 2011 financial results with the SEC, that the extent of its fiscal problems became clear.

In that disclosure, Marina revealed that at the end of last year, it had just $2 million in cash, half of which was restricted (GSN 10/18/2011). More importantly, Marina revealed that it had only enough funds to last until the end of October.

“As a result, there is a significant possibility that we will file for bankruptcy,” Marina cautioned in the SEC filing. “If we restructure our debt or file for bankruptcy protection, it is very likely that our common stock will be severely diluted, if not eliminated entirely.”

At the time, French told Gene Silencing News that the end of October wasn't necessarily the “drop-dead date” for the company, and that “there's nothing to say that we can't squeak beyond” that date, providing a little more time to figure out some sort of money-making transaction.

Given that Marina has not yet filed for bankruptcy, it appears that the firm remains afloat. But how long it can keep going is uncertain, and losing Debiopharm as a partner, along with its potential milestone payments, represents yet another setback for the struggling Marina.

Still, there is the possibility that one of its other partners might come through with some desperately needed cash. Marina has inked deals for access to its technologies with a number of companies including Novartis, which holds a non-exclusive license to its conformationally restricted nucleotide oligo-modification technology for drug development; Girindus, which has the rights to use the CRN technology to make and sell certain oligo constructs; and Monsanto, which exclusively licensed a range of Marina's technologies for ag-bio applications.

But perhaps the most near-term opportunity lies with Mirna Therapeutics, which licensed Marina's Smarticle liposomal delivery technology for use with its microRNA drugs, including its lead liver cancer candidate MRX34 (GSN 1/5/2012).

The most advanced candidate in Mirna's pipeline, MRX34 is expected to reach the investigational new drug application-filing stage early next year, with a phase I trial beginning shortly thereafter (GSN 10/25/2010).

While the specific terms of Mirna's deal with Marina have not been made public, Marina's French previously indicated that the start of human testing with MRX34 would trigger some sort of payment from Mirna.

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