Thread: SOMX - Somaxon Pharmaceuticals, Inc.

Although the stock has been in a confirmed uptrend for a while now (since early May, todays jump IMO is due to the recent PR the security has seen. While the rise may continue, SOMX is also nearing the land of overbought, which may indicate a retraction.

=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=

From stockshaven.com (abridged)

Second Time’s a Charm for Somaxon (NASDAQ:SOMX)

July 22, 2009

Somaxon Pharmaceuticals, Inc.

(Public, NASDAQ:SOMX)

StocksHaven Investments profiles one of the most promising biomedical pharmaceutical company involved with a PDUFA with regards to a drug which could quite possibly revolutionize the treatment for insomnia, a condition affecting over 70 million Americans. The company has been making waves the past few months as investors and institutions gain confidence from the highly positive clinical trials, and the recent exclusive meeting with the FDA with regards to their NDA. Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. The lead product candidate is Silenor® (doxepin) for the treatment of insomnia. The FDA decision date on Silenor has been set to 12/4/09 for their NDA resubmission, the importance of this is discussed further in the article.

Insomnia Overview

Sleep is essential for human performance, general health and well-being. Insomnia, the most common sleep complaint across all stages of adulthood, is a condition characterized by difficulty falling asleep, waking frequently during the night or too early, or waking up feeling unrefreshed. Approximately 70 million Americans have insomnia according to the National Sleep Foundation (NSF). About 40 million people in the United States suffer from chronic sleep disorders and an additional 20-30 million are affected by intermittent sleep related disorders. According to the 2007 Sleep in America Poll, 65% of respondents reported experiencing insomnia symptoms a few nights a week.

In fact, insomnia has become a problematic issue as of late, receiving publicity from various worldwide publications and news outlets. Adding to the growing pains of this phenomenon, celebrities have been struggling to deal with it as well. Michael Jackson was so distraught over persistent insomnia in recent months that he pleaded for a powerful sedative despite warnings it could be harmful, says a nutritionist who was working with the singer as he prepared his comeback bid.

The Mechanism of Action - What Makes Silenor® Unique

At the doses used in Silenor® (doxepin) (3 mg and 6 mg), doxepin’s most potent pharmacological response, histamine H1 blockade, appears to define the action of the drug. Doxepin has long been known as a potent H1 antagonist; receptor binding and functional studies conducted by Somaxon confirm that doxepin has high affinity at human H1 receptors and good selectivity against other central nervous system targets. The receptor binding profile of doxepin suggests that the drug is at least 10-fold more potent as an H1 antagonist than for its other clinically relevant targets. The potency of doxepin at the H1 receptor, coupled with its selectivity versus other central nervous system targets, makes this drug an ideal candidate for use in insomnia when used at low doses. Silenor’s low doses avoid much of the pharmacology of doxepin at antidepressant doses, as supported by the very low incidence of adverse events associated with Silenor.

Doxepin has activity at re-uptake sites for norepinephrine and serotonin, although it is essentially inactive at the dopamine transporter or at dopamine receptor subtypes studied to date. Studies conducted by Somaxon suggest little or no relevance for 5-HT or dopamine re-uptake in the pharmacology of Silenor, although some functional role for the norepinephrine transporter cannot be definitively ruled out. The finding that doxepin is a functional antagonist at 5-HT2a sites suggests that this activity could play a role in doxepin’s sleep promoting effects, as this receptor has been proposed to contribute to the expression of restorative sleep.

Market Opportunity

Silenor® (doxepin) is highly differentiated from currently available insomnia treatments and will have competitive advantages in a large and growing market, if it is approved by the FDA. According to IMS Health, in 2008 the prescription market for the treatment of insomnia grew approximately 6% to more than 63 million prescriptions compared the prior year. In 2008, the insomnia market accounted for more than $2.0 billion in sales despite the introduction in April 2007 of generic versions of Ambien, which was the leading prescription product at the time.

While there are a number of products currently available for the treatment of insomnia, the market remains under-served due in part to the limitations of current therapies. It is estimated that only about 20 percent of those who suffer from insomnia are on prescription therapy. Somaxon-sponsored market research indicates that less than one third of patients being treated for insomnia with prescription medications claimed they were very satisfied with their current treatment, and only 12% of patients claimed that their insomnia was well controlled.

Competitive Advantage

In addition, the insomnia market is driven primarily by the clinical experience of patients. Patient trial is seen as the most useful tool by physicians to determine the clinical utility of any insomnia agent. Importantly, because Silenor will not be designated as a Schedule IV controlled substance (unlike GABA-ergic products), it can be freely sampled in all jurisdictions. This will facilitate critical initial physician and patient trial and usage and provide Silenor with an important competitive advantage.

Based on Somaxon’s clinical results and market research, they believe that initial trial will lead to prescription usage. In their market research 9 out of 10 physicians indicated a willingness to try Silenor. In fact, when presented with the Silenor product profile as part of our market research, the surveyed physicians indicated that Silenor could become a leading product for treating insomnia in their practice.

FDA Regulatory Status Timeline & Resubmission

On January 31, 2008, the company submitted its NDA for Silenor® (doxepin) to the U.S. Food and Drug Administration (FDA), and the FDA accepted the NDA for review as of March 31, 2008.
On November 24, 2008 the company received notification that the FDA required additional time and would not be able to complete its review of the company’s NDA for Silenor by the Prescription Drug User Fee Act (PDUFA) date of December 1, 2008. The FDA indicated that the review would be extended for up to three additional months, resulting in a new PDUFA date of February 28, 2009.
On February 25, 2009, the company received a Complete Response Letter from the FDA relating to the NDA. The FDA stated that based on its review the NDA could not be approved in its present form. In the Complete Response Letter the FDA raised issues relating to the interpretation of the efficacy data contained in the NDA. The Agency indicated that they did not find sufficient evidence to support the inclusion of sleep onset in the indication statement of the label and similarly, that the 1mg dose did not show sufficient efficacy to warrant approval. The FDA did not specifically request the company to conduct additional clinical trials of Silenor.
The FDA indicated that they were open to a discussion of these concerns.
The company met with the FDA on April, 6, 2009 to discuss the items raised by the Agency in the Complete Response Letter. The Agency focused their concern on the durability of the sleep maintenance effect of Silenor in the adult population. The Agency agreed that Silenor demonstrated significant and durable (defined as at least one month) sleep maintenance effects on objective measures (sleep laboratory assessments) across all populations and subjectively in the elderly population at the 6mg dose. The Agency indicated an openness to review any further analysis we submit of the data on the durability of the sleep maintenance effect in the adult population.
The company believes that based on the totality of the data package, which is supported by its further analysis of this data, there is sufficient evidence to support a determination by the FDA that Silenor can be approved for the treatment of insomnia characterized by sleep maintenance and the prevention of early morning awakenings.
As a result of the meeting with the FDA and the further analysis of the data, the company resubmitted the Silenor NDA in June, 2009. That filing included additional statistical analyses of the company’s clinical efficacy data in adults that the company believes demonstrate sustained subjective sleep maintenance efficacy. It also included the results from the company’s completed clinical trial of doxepin that evaluated the potential for ECG effects. The anticipated PDUFA action date relating to the resubmission is December,4, 2009.

Institutional & Mutual Fund Holders

Nothing reeks confidence for private individual investors moreso than seeing the big players throwing their own money at the respective companies. Somaxon Pharmaceuticals has been one of the hottest stocks in July, 2009 with regards to this, take a look for yourself. (Image courtesy of MFFAIS)

When you have top institutional and mutual fund holders with the likes of Morgan Stanley, Bank of America Corporation, Franklin Resources Inc., Merrill Lynch & Co. Inc., Vanguard, you know you are part of an elite group of companies within any given industry.

=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=

Longest post ever.

Let at it go this morning!

Looks like it was wrong about the overbought retraction, for now.

I ended up buying some at $4.4 and then more at $3.83. Now I am going to wait and see what happens. I am sure there is some news out there due to which there is a lot of buying. I wish I was a little patient this morning since it had dropped all the way to $3.15 now. If any news comes out after hours today that can have an impact to this stock tomorrow AM either positive or negative, that is the risk we take !

Originally Posted by edh

I ended up buying some at $4.4 and then more at $3.83. Now I am going to wait and see what happens. I am sure there is some news out there due to which there is a lot of buying. I wish I was a little patient this morning since it had dropped all the way to $3.15 now. If any news comes out after hours today that can have an impact to this stock tomorrow AM either positive or negative, that is the risk we take !

As a gerenal rule I don't buy stocks withing the first hour of trading, this way you are not caught in the opening run up only to see it dip an hour later. It took me a while to learn this lesson, always second guessing myself and pulling the trigger too early.