Somaxon signs agreement to have Patheon Pharma make Somaxon's Silenor tablets

By Ted A. Knutson

Washington, Feb. 7 - Somaxon Pharmaceuticals, Inc. said Tuesday it has entered into non-exclusive agreement with Patheon Pharmaceuticals Inc. to have Patheon make commercial quantities of Somaxon's Silenor 1 mg, 3 mg and 6 mg tablets product candidate, which is an oral formulation of doxepin currently under development.

Somaxon has completed two placebo-controlled phase 2 clinical trials and is enrolling patients in phase 3 clinical trials to evaluate Silenor for the treatment of insomnia.

If the trials are successful, Somaxon plans to file a New Drug Application seeking U.S. marketing approval for this product candidate.

Although Somaxon is not required to purchase any minimum quantity of Silenor under the agreement, Somaxon has agreed to purchase from Patheon not less than specified percentages of Somaxon's total annual commercial requirements from all suppliers of Silenor, which vary depending upon annual volume.

The agreement provides for an initial five-year term beginning upon commencement of the manufacturing services and thereafter automatically continues for successive 12-month terms unless terminated by written notice at least 18 months prior to the end of the then-current term.

Somaxon is a San Diego-based biotechnology company.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.