Paladin Labs to Commercialize Silenor in Canada, South America and Africa
Somaxon to Receive Up-front and Milestone Payments of Up to US$129 million
Paladin Labs to Purchase US$5 million of Somaxon Common Stock
SAN DIEGO & MONTREAL--(BUSINESS WIRE)-- Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX - News) and Paladin Labs Inc. (TSX:PLB.to - News) today announced that they have entered into an exclusive collaboration under which Paladin will commercialize Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. According to IMS Canada, the value of the Canadian insomnia market, mainly comprised of zopiclone, exceeded $79 million in 2010 alone and has been growing at a 5 year CAGR of 10%.
Under the terms of the agreements, Somaxon will receive an up-front payment of US$500,000, and Paladin will purchase 2,184,769 shares of Somaxon's common stock for a purchase price of US$5 million. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales in the licensed territories. Paladin will be responsible for regulatory submissions for Silenor in the licensed territories and will have the exclusive right to commercialize Silenor in the licensed territories. Governance of the collaboration will occur through a joint committee structure.
"Paladin is the ideal partner for the commercialization of Silenor in Canada and the emerging markets given its impressive track record of achieving regulatory approval and effectively commercializing branded pharmaceutical products," said Richard W. Pascoe, Somaxon's President and Chief Executive Officer. "This transaction helps us further our goal of maximizing the value of Silenor for our stockholders, as we estimate that the licensed territories present a very significant addition of people suffering from insomnia. We have also maintained rights to the product in the United States, Europe and Japan."
"We are pleased to partner with Somaxon to commercialize Silenor in Canada, South America and Africa. Silenor is an excellent fit with Paladin's commercial capabilities and portfolio, and we believe that there is a significant unmet need for Silenor. Importantly, this agreement also provides further momentum to our geographic footprint expansion across emerging markets," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "Based on our due diligence on Silenor's U.S. launch progress to date, its longer term commercial potential in that market, and of course its intellectual property protection and position, we are comfortable making a sizeable investment in Somaxon."
Silenor is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulties with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep. For more information, please visit www.silenor.com.
Important Safety Information
A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.
Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until patients know how they will react to Silenor, they should not drive or operate machinery at night after taking Silenor, and they should be careful in performing such activities during the day following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a history of depression, mental illness or suicidal thoughts. Patients should call their doctors right away if after taking Silenor they walk, drive, eat or engage in other activities while asleep. Drowsiness was the most common adverse event observed in clinical trials.
For more information, please see the complete Prescribing Information, including the Medication Guide, at www.silenor.com or www.somaxon.com.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon's product Silenor® (doxepin), now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.
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For more information, please visit the company's web site at www.somaxon.com.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the company's web site at www.paladinlabs.com.