Paladin now has rights to commercialize U.S.-approved Silenor in Canada, South America, and Africa.
Paladin Labs is paying Somaxon Pharmaceuticals $500,000 up front and will make a $5 million equity investment in the firm as part of a deal to commercialize Somaxon’s FDA-approved Silenor® (doxepin) insomnia drug in Canada, South America, and Africa. Somaxon could receive up to another $128.5 million in sales-based milestone payments as well as tiered double-digit royalties from sales in the licensed territories.
Paladin will shoulder regulatory submissions for Silenor in relevant countries and retains exclusive rights to commercialize the drug in its licensed regions. The firm says Silenor fits in with its commercial capabilities and existing portfolio, and it provides further momentum to expand it geographic footprint across emerging markets.
Silenor is a low-dose oral tablet formulation of doxepin, currently approved in the U.S. for the treatment of patients who have sleep maintenance insomnia. The drug was launched in September 2010 by Somaxon and co-promotion partner Procter & Gamble.
Somaxon recorded $2.2 million worth of Silenor shipments to its wholesale distributors in the first quarter of 2011, and recorded net product sales of $2.3 million. The firm says that in comparison with the fourth quarter of 2010, Silenor net sales were up 73% during Q1 2011, and the number of new Silenor patients increased by about 50%.