Somaxon and CJ CheilJedang : Silenor® Collaboration in South Korea

April 27, 2012 - Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) and CJ CheilJedang Corporation announced that they have entered into an exclusive collaboration under which CJ CheilJedang will commercialize Silenor® (doxepin) for the treatment of insomnia in South Korea.

Under the terms of the agreements, Somaxon will receive an up-front payment of US$600,000. CJ CheilJedang will be responsible for regulatory submissions for Silenor and will have the exclusive right to commercialize Silenor in South Korea. Once Silenor is approved in South Korea, Somaxon will also be eligible to receive sales-based milestone payments as well as a royalty based on net sales of Silenor in South Korea. Somaxon will also supply CJ CheilJedang's requirements for commercial quantities of Silenor in South Korea at a separate transfer price... Somaxon Pharmaceuticals' Press Release -

Somaxon and Paladin : Silenor® EX-US Collaboration

June 8, 2011 - Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) and Paladin Labs Inc. (TSX:PLB) 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... Somaxon's Press Release - Paladin Labs' Press Release -

SOMAXON PHARMACEUTICALS : SILENOR® CO-PROMOTION AGREEMENT WITH PROCTER & GAMBLE

August 25, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that Somaxon and Procter & Gamble (NYSE: PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.
Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the U.S. market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians.

Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor. Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the U.S... [PDF] Somaxon Pharmaceuticals' Press Release -

SOMAXON : FDA APPROVAL OF SILENOR® (DOXEPIN) FOR THE TREATMENT OF INSOMNIA

March 18, 2010 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance.
Sleep maintenance difficulty, defined as waking frequently during the night and/or waking too early and being unable to return to sleep, is the most commonly reported nighttime symptom of insomnia. Silenor is approved for the treatment of both transient (short term) and chronic (long term) insomnia characterized by difficulty with sleep maintenance in both adults and elderly patients. In clinical trials, Silenor demonstrated maintenance of sleep into the 7th and 8th hours of the night, with no meaningful evidence of next day residual effects... [PDF] Somaxon Pharmaceuticals' Press Release -

Somaxon : Pharmacological Data on Doxepin at the 21st European College of Neuropsychopharmacology Congress

September 02, 2008 - Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, announced that data from a pharmacological profiling study relating to doxepin, the active ingredient in the company’s product candidate Silenor for the treatment of insomnia, were presented yesterday at the 21st European College of Neuropsychopharmacology (ECNP) Congress.

The data presented at the ECNP Congress are from a study that examined the in vitro pharmacological profile of doxepin. The study evaluated the relative affinity and functional activity of doxepin at various central nervous system (CNS) targets known to play a role in its overall pharmacological profile.

The results demonstrate that doxepin has high affinity for and potent antagonistic activity at the human H₁ histamine receptor, which is thought to be a primary mediator of the sleep-wake cycle. In addition, doxepin was shown to have lower or little affinity for a number of other CNS binding sites.

It is hypothesized that at the point in the circadian cycle during which the release of histamine and wakefulness are both naturally reduced, blocking the H₁ receptor can further reduce wakefulness and promote the initiation and maintenance of sleep. The high potency of doxepin as an H₁ antagonist represents the likely mechanism for its sleep-promoting effects and provides a potential explanation for its efficacy in humans at oral doses of 1 mg, 3 mg and 6 mg, the doses evaluated in the company’s clinical trials of Silenor for the treatment of insomnia. In addition, the relative selectivity of doxepin for H₁ as compared to a number of other neuropharmacological sites may account for the low incidence in such clinical trials of adverse events that have been associated with higher doses (25 mg to 50 mg) of doxepin... [PDF] Somaxon's Press Release -

SOMAXON PHARMACEUTICALS : CLINICAL DATA ON PRODUCT CANDIDATE FOR THE TREATMENT OF INSOMNIA PRESENTED

May 7, 2008 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that data from three Phase 3 clinical trials of the company’s product candidate SILENOR™ (doxepin HCl) for the treatment of insomnia were presented at the American Psychiatric Association (APA) 161st annual meeting in Washington, D.C..
The data presented at the APA meeting are a subset of the data from Somaxon’s completed Phase 3 development program, which comprised four Phase 3 clinical trials evaluating SILENOR™, a low-dose (1-6 mg) formulation of doxepin for the treatment of insomnia. As the company has previously reported, all of these clinical trials demonstrated statistically significant differences relative to placebo for their primary endpoints and multiple secondary endpoints. The clinical trials demonstrated significant and clinically meaningful improvements in sleep onset, sleep maintenance and the prevention of early morning awakenings... [PDF] Somaxon's Press Release -

SOMAXON PHARMACEUTICALS : NEW DRUG APPLICATION FOR SILENOR FOR THE TREATMENT OF INSOMNIA

January 31, 2008 - – Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR™ (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR™ for the treatment of insomnia... [PDF] Somaxon's Press release -