SOMX - Sector: Healthcare --- Industry: Drug Manufacturers - Other

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One to watch now...

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Somaxon Jumps on Heavy Volume...
01/07/10 - 12:51 PM EST


SAN DIEGO (TheStreet) -- Somaxon Pharmaceuticals (SOMX Quote) shares rallied Thursday on a surge in volume after the company's CEO said in an interview that it would continue to seek approval for its insomnia drug.

Somaxon Pharmaceuticals CEO Richard Pascoe told BNet.com that data collected for its sleep drug Silenor, which was contained in the company's new drug application, demonstrated sustained subjective efficacy in the adult population and that the drug effect wasn't lost over the treatment period of 30 days. "We believe Silenor has an important differentiated product profile and we are committed to working with the FDA to seek approval for Silenor and commercialize the product," Pascoe said during the interview.

The Food and Drug Administration has sent two complete response letters to Somaxon in February and December, stating that Silenor could not be approved in its present form. Somaxon will meet with the FDA on Jan. 20 to discuss the new drug application.
"When we meet with the FDA later in January we'll have additional insights into a potential path forward," Pascoe said during the interview with Bnet.com. "It would not be advisable to presume anything in advance of our meeting. We'll listen closely to their position and manage our course thereafter accordingly."

Shares of Somaxon Pharmaceuticals were jumping by 31 cents, or 25.4%, to $1.53. Earlier in the session, the stock touched an intraday high of $1.68. More than 6.47 million shares changed hands by 12:30 p.m. EST Thursday, compared to the stock's 50-day average daily volume of 2.16 million, according to the Nasdaq.
Somaxon Pharmaceuticals has a 11.8 million-share float with 449,000 shares short as of Dec. 15, according to Yahoo! Finance. Insiders hold 30% of the company's shares, with another 24% owned by institutions.

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Moves big in the after hours...

Somaxon Pharmaceuticals, Inc.(NasdaqCM: SOMX)
After Hours: 2.66  1.34 (101.52%) 7:42pm ET



52wk Range: 0.18 - 4.80
Volume: 3,414,844
Avg Vol (3m): 2,087,200

Technicals
Last Price Quote is:
-4.71%below 13-day MA
-19.45%below 50-day MA
RS Rating: 5 

Fundamentals
Earnings Expected on Mar 11

Key Data:
Market Cap (M): $34.04 
P/E Ratio: N/A 
PEG Ratio: N/A 
Next Earnings: 03/11/2010
Last Analyst Rating: Hold

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Somaxon Provides Update on New Drug Application for...

SAN DIEGO, Jan 21, 2010 (BUSINESS WIRE) -- Somaxon Pharmaceuticals, Inc. (SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor(R) (doxepin) for the treatment of insomnia.

Somaxon held a meeting with senior leadership at the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the issues raised by the FDA in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA. The only remaining efficacy issue was related to the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. In the meeting, the FDA and the company discussed this issue, and the agency instructed Somaxon to resubmit the contents of its January 20, 2010 pre-meeting briefing package to the FDA. The agency acknowledged that this resubmission would be considered a complete response to the Complete Response Letter Somaxon received in December. The FDA also agreed that this would be considered a Class 1 resubmission with a two-month review cycle. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA on January 21, 2010. As a result, the company anticipates a decision from the FDA by March 21, 2010.

"We believe that the dialogue we had with the FDA was constructive," said Richard W. Pascoe, Somaxon's president and chief executive officer. "We intend to continue to work diligently with the FDA during the two-month review cycle toward a potential approval for Silenor."

In the meeting the FDA also reiterated that a revised Risk Evaluation and Mitigation Strategy (REMS), including a Medication Guide to be distributed with the product, will be required.

About Silenor(R)

Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride that is patent protected for use in insomnia. Physicians have prescribed doxepin for more than 35 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. Based upon the controlled clinical trials of Silenor completed by Somaxon, the company believes that Silenor may be well tolerated by patients. In addition, the FDA has indicated that it will recommend that Silenor not be scheduled as a controlled substance.

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 for the treatment of diseases and disorders in the central nervous system therapeutic area.

For more information, please visit the company's web site at www.somaxon.com .

Somaxon cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. For example, statements regarding the review process for the NDA for Silenor, the content of the NDA resubmission and the potential approval or commercialization of Silenor are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, Somaxon's interpretations of its communications and interactions with the FDA relating to the regulatory review process and requirements for approval of the NDA for Silenor, and the FDA's agreement with such interpretations; Somaxon's interpretation of the results of its clinical trials for Silenor, the timing of the interpretation of such results and the FDA's agreement with such interpretation; the potential for Silenor to receive regulatory approval for one or more indications on a timely basis or at all; Somaxon's ability to raise sufficient capital to meet FDA requirements and otherwise fund its operations, and to meet its obligations to parties with whom it contracts relating to financing activity, and the impact of any such financing activity on the level of Somaxon's stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including the potential to be required to restructure the company or to be unable to continue as a going concern; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor; Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate prior to the submission of the results of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor, and the FDA's agreement with Somaxon's interpretation of such results; Somaxon's ability to successfully commercialize Silenor, if it is approved by the FDA; the potential to enter into and the terms of any commercial partnership or other strategic transaction relating to Silenor; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether any approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon's ability to operate its business without infringing the intellectual property rights of others; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for Silenor; the market potential for insomnia treatments, and Somaxon's ability to compete within that market; and other risks detailed in Somaxon's prior press releases as well as in its periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.

SOURCE: Somaxon Pharmaceuticals, Inc.


Investor Inquiries
PondelWilkinson, Inc.
Rob Whetstone, 310-279-5963
or
Media Inquiries
Biocomm Network
Michele Parisi, 925-429-1850

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updated chart look...

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Somaxon receives FDA approval for insomnia drug
Somaxon Pharmaceuticals receives FDA approval for insomnia drug; shares soar

SAN DIEGO (AP) -- Development-stage biotech company Somaxon Pharmaceuticals Inc. said Thursday the Food and Drug Administration approved its delayed insomnia drug Silenor, sending shares skyrocketing.

The stock rose $2.34, or 59.4 percent, to $6.28 in afternoon trading. The stock earlier set a new year high of $7.98, dwarfing a prior peak of $4.88 set March 3.

The FDA approved the drug to treat short term and long term insomnia. FDA decisions on the drug were delayed in 2008 and again in February of 2009. The latter delay came as the FDA asked for more information on the drug.

Silenor is a low-dose oral tablet form of doxepin for use in insomnia. Doxepin has been long prescribed as a treatment for depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. The FDA did not schedule Silenor as a controlled substance, as expected. The company has described the drug as abuse resistant.

The company expects to launch the drug in the second half of 2010.

Separately, Somaxon reported a fourth-quarter loss of $1.9 million, or 8 cents per share, compared with a loss of $9.5 million, or 52 cents per share, during the same period a year prior. The company had no revenue in either period.

The narrower loss was due to a plunge in costs as the company completed development of Silenor.

For the full year, the company lost $14.4 million, or 69 cents per share, compared with a loss of $37.2 million, or $2.04 per share, in 2008.

The company had $5.2 million in cash, cash equivalents and marketable securities as of Dec. 31 and said it has sufficient funds to operate through the second quarter.

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Somaxon receives FDA approval for insomnia drug
Somaxon Pharmaceuticals receives FDA approval for insomnia drug; shares soar


52wk Range: 0.22 - 10.01
Volume: 47,045,894
Avg Vol (3m): 2,329,270

Technicals
Most Actives
Percentage Gainer
Price Gainer

Last Price Quote is:
136.01%above 13-day MA
198.50%above 50-day MA
RS Rating: 99 

Fundamentals
Earnings Surprise

Key Data:
Market Cap (M): $93.14 
P/E Ratio: N/A 
PEG Ratio: N/A 
Next Earnings: 05/06/2010
Last Analyst Rating: Hold

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SOMX - News - Alert
http://www.chartmoney.com/stockquotes.php?ticker=somx
Somaxon Pharmaceuticals, Inc. today announced that Somaxon and Procter & Gamble have entered into a co-promotion agreement for Silenor (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance.

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Profile: 

Somaxon Pharmaceuticals, Inc.
3570 Carmel Mountain Road
Suite 100
San Diego, CA 92130
United States - Map
Phone: 858-876-6500
Fax: 858-509-1761
Website: http://www.somaxon.com

Details   
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 24


Business Summary   
Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the in-licensing, development, and commercialization of proprietary branded products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. Its principal product Silenor (doxepin) has been approved by the United States Food and Drug Administration for the treatment of insomnia characterized by difficulty with sleep maintenance. Somaxon Pharmaceuticals, Inc. was founded in 2003 and is headquartered in Solana Beach, California.


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