Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX) jumped $1.39 (41.25%) to $4.76 today on news that the biopharma company had signed a deal with Procter & Gamble to market the company’s new insomnia drug, Silenor. In return for helping Somaxon sell the drug, which is a low-dose from of doxepin, P & G will gain first rights to develop and market the drug as an over-the-counter medication. The pact will run through the end of 2012, but it is renewable.
Somaxon deals primarily with the treatment of diseases and disorders in the central nervous system. Silenor will be the company’s principal product.
-Michael B. Sauter
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) was up $0.48 (15%) to $3.69 as biotech continued to correct from a major dropoff at the beginning of the month.
Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the in-licensing, development, and commercialization of treatments of diseases and disorders in the central nervous system, as well as solutions for sleep disorders.
There is a new weapon in the war on insomnia, and one which does not appear to have the drug dependence and the nasty side-effects associated with many other sleep aids. Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) announced this morning that the FDA has approved the New Drug Application for Silenor as a treatment of insomnia characterized by difficulty with sleep maintenance. Somaxon calls this the “First and Only Prescription Sleep Aid to Provide a Full Night’s Sleep Without Abuse Potential.”
The company said it will focus on seeking a U.S. commercial partnership and will then build a U.S. commercial presence and will prepare to launch Silenor in the second half of 2010.
Silenor binds with high affinity to histamine (H1) receptors, which is believed to be the mechanism to promote the maintenance of sleep. The company noted that this mechanism of action is different from any other prescription medication currently approved for the treatment of insomnia.
- Sanofi Aventis (NYSE: SNY) makes Ambien. Drugs.com noted that Ambien CR was the #43 drug with sales of $865 million. Sepracor Inc. makes LUNESTA, but this company has been acquired. Drugs.com notes that in 2008 Lunesta was the #47 drug with $771 million in sales.
- Sleep maintenance difficulty is defined as waking frequently during the night and/or waking too early and being unable to return to sleep. The company noted that this is the most commonly reported nighttime symptom of insomnia.
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) has soared in after-hours trading as we have noted over and over how micro-cap and low-priced biotech stocks are seeing trophy hunters trying to find the next 1,000% move… That is the quest for the ten-bagger in investor slang. The company provided an update on the status of its New Drug Application for Silenor for the treatment of insomnia. It held a meeting with senior leadership at the FDA on January 20, 2010 to discuss the issues raised in the FDA’s Complete Response Letter Somaxon from December 2009.
According to Somaxon, the FDA acknowledged that this resubmission would be considered a complete response and noted that no additional safety or efficacy data was needed. Furthermore, the company now sees a decision from the FDA due by March 21, 2010. Somaxon has no stock options, so no binary trading event opportunity exists here other than being long or short. The short interest as of December 31 was a mere 522,000 shares.
The company noted that the only remaining efficacy issue was over the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. The FDA has instructed Somaxon to resubmit the contents of its pre-meeting briefing package to the FDA and the agency has reportedly acknowledged that the resubmission would be considered a complete response to the Complete Response Letter Somaxon received from the FDA back in December.
Somaxon Pharmaceuticals (SOMX) collapsed today, with shares down over two-thirds. It will be interesting to see if the company can recover from a major blow to its prospects.
The company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor (doxepin) for the treatment of insomnia. Based on its review, the FDA has determined that the NDA cannot be approved in its present form. Somaxon previously received a Complete Response Letter for the NDA in February 2009, and it resubmitted the NDA in June 2009.
In the most recent Complete Response Letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy due to a lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia.
For the third quarter of 2009, net loss applicable to common stockholders was $1.8 million, or $0.08 per share, compared with $10.3 million, or $0.56 per share, for the third quarter of 2008. The company had no revenue and had only $5.4 million in revenue at the end of the quarter.
The firm’s share price is down to $1.80 and its market cap down to $31 million.
Douglas A. McIntyre
The appetite for biotech and emerging pharmaceutical companies to raise cash is almost a never ending line of companies. We have some offerings today and have seen many offerings and filings from companies to offer shares. These are just some of the filings and offerings we have seen.
MannKind Corporation (NASDAQ: MNKD) priced a secondary offering this morning of 7,400,000 shares of its common stock, and while the press release did not say what price the deal came at the syndicate group told us this went out at $7.35 per share. Chairman, CEO, and principal stockholder Alfred E. Mann is purchasing 1,000,000 of these shares from the underwriters, which brought in over $54 million before fees and commissions. MannKind shares are down 9.5% at $7.37. Its 52-week trading range is $2.00 to $9.25.
Idenix Pharmaceuticals Inc. (NASDAQ: IDIX) priced a secondary offering this morning of 7,248,936 shares of common stock at $3.14 per share to clear roughly $22 million before fees and commissions. Its shares are down over 14% at $3.15 today and its 52-week range is $1.86 to $10.10.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) priced a 22.2 million share secondary offering of common stock this morning at a price of $4.50 per share. This raised close to $100 million. Share are down 6% at $4.66 and the 52-week trading range is $1.68 to $5.80.
Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) on Tuesday priced its public offering of 19,000,000 shares of common stock at $1.75 per share; the company said net proceeds after fees and commissions was roughly $30.9 million.
Oncothyreon Inc. (Nasdaq: ONTY) announced on Tuesday that it had obtained commitments from several investors for $15 million in a direct offering. The agreement was to purchase approximately 2.28 million shares of common stock and warrants to purchase approximately 684,000 shares of common stock for gross proceeds of approximately $15.0 million. The company noted that investors agreed to purchase the shares and warrants for $6.5775 per unit with each unit being one share of common stock and a warrant to purchase 0.30 shares of common stock and an exercise price of $6.5775 per share.
NovaBay Pharmaceuticals, Inc. (NYSE: NBY) filed this week with the SEC to offer up to $20,000,000 of any combination of common stock or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock, preferred stock or debt securities upon the exercise of warrants. It market cap is a mere $48 million.
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) filed this week to cover for the resale of up to 10,212,750 shares of common stock (roughly $23 million) from time to time for existing security holders and certain transferees of the selling security holders. Roughly 5.1 million of these shares were issued in a private placement that closed on July 8, 2009; the additional 5.1 million shares are issuable upon a warrant exercise sold in the private placement which expire on July 8, 2016. If sold, none of the proceeds go back to NovaBay.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) filed on Monday to allow the resale from time to time of up to 28,000,000 shares of common stock by the selling stockholders from a July private placement. We will not receive any of the proceeds from the sale of these shares. If sold, none of the proceeds go back to Arena.
OXiGENE, INC. (NASDAQ: OXGN) filed this week for the resale of up to 10,000,000 shares of common stock from time to time by Symphony ViDA Holdings LLC. This was via an amendment dated as of July 2, 2009. If sold, none of the proceeds go back to OXiGENE.
JON C. OGG
AUGGUST 5, 2009