Somaxon

Somaxon secures cash for Silenor marketing

Fri, 23 May 2008 06:59:56 -0400

As Somaxon waits for the FDA okay on insomnia treatment Silenor, the company has lined up funding for marketing and commercialization of the drug. The company inked a $15 million secured loan agreement with Oxford Finance Corporation and Silicon Valley Bank. In addition, Kingsbridge Capital has committed to provide up to $50 million of capital through the purchase of newly-issued shares of Somaxon's common stock.

"The the availability of these funds will support our financial position as we continue to move forward in discussions with a number of companies regarding a potential strategic collaboration relating to the commercialization of Silenor," said Somaxon's interim CEO David F. Hale.

- check out the Somaxon release

Somaxon CEO resigns

Fri, 07 Dec 2007 06:59:55 -0500

Somaxon CEO Kenneth M. Cohen has announced this resignation, effective December 31, 2007. The company's non-executive board chairman David F. Hale will serve as interim CEO until a permanent replacement for Cohen is hired. Specific reasons for Cohen's resignation were not outlined in the announcement, though the company noted that "management changes are part of a transition plan." Somaxon is based in San Diego, CA and is developing psychiatry and neurology treatments.

- see Somaxon's release

Related Articles:
Somaxon touts latest Phase III results for Silenor. Report
Somaxon reveals mid-stage data on smoking cessation. Report

Insomnia market attracts drug developers

Mon, 08 Oct 2007 06:59:54 -0400

The market for insomnia drugs in the U.S. is growing at a whopping 29 percent per year, hitting $4.6 billion in 2006 and attracting the attention of a wide range of drug developers. More than a dozen compounds are in mid- to late-stage clinical trials in a race to capture a market that includes some 70 million Americans who suffer from chronic or occasional insomnia. Among the leaders in that race, according to analysts, are Somaxon and Neurocrine Biosciences, both of which are looking for near-term FDA approvals on late-stage drugs. Somaxon researchers believe that their therapy, which relies on an old antidepressant, will work by blocking the release of histamine at the H1 receptor in the brain.

- here's the report from BusinessWeek

Related Articles:
Somaxon touts latest Phase III results for Silenor. Report
FDA wants more data on Neurocrine's indiplon. Report
Arena Pharma produces positive insomnia data. Report

C&L: Bradbury takes reins at Amylin

Tue, 30 Jan 2007 19:01:32 -0500

Amylin Pharmaceuticals President and COO Daniel Bradbury is taking over as CEO from Ginger L. Graham on March 1. Bradbury has been president and COO since last June.

Jitendra N. Doshi is leaving his positions as COO and CFO of Caraco Pharmaceutical Laboratories to devote his efforts to managing and overseeing Sun Pharmaceutical's development projects and overall operations at its New Jersey and Ohio facilities.

Bernard Poussot has been promoted to the position of president, COO and vice chairman at Wyeth.

Jacques van Kimmenaede has been appointed president of Diosynth Biotechnology.

Gilead Sciences has promoted Jim Meyers to senior vice president, commercial operations, North America.

Metabolon has added these three members to its executive staff: Tim Germann, the new vice president of sales; Dr. Bruce McCreedy has been appointed vice president of strategic development; and Dr. Dan Stevens is the new director of marketing. MonoGen has hired James D. Cureton for the position of vice president, sales and marketing.

Archimedes Pharma has appointed Simon Collins as U.K. country manager.

Aize Smink has joined Chiltern International as global head of project management.

BioVerdant has named Dr. Berkeley W. Cue to its scientific advisory board.

Exelixis has named Jose Baselga, M.D., to its scientific advisory board.

John Leo has resigned from his position as a member of the China Aoxing board of directors.

NexMed has named David S. Tierney, M.D. to the board of directors.

Somaxon Pharmaceuticals has appointed Robert Jones as vice president, human resources.

J. Michael Millis, M.D., has been appointed to the board of Vital Therapies.

CuraGen has appointed James Noble, M.A., C.F.A. to its board of directors.

Dr. Andrew Pecora, FACP, has joined TetraLogic Pharmaceuticals board.

ALSO NOTED: Silenor positive in Phase III; BioSante wins FDA approval;and much more...

Sun, 17 Dec 2006 19:01:30 -0500

> A late stage trial of Somaxon's insomnia drug Silenor produced positive results for elderly patients with chronic pulmonary insomnia. Report

> BioSante has won FDA approval of Bio-E-Gel, which will be marketed under the name Elestrin for hot flashes. Release

> The FDA has approved SkyePharma's asthma spray Foradil Certihaler. Release

> Merck has won the latest trial over Vioxx, bringing its total score to eight wins and four losses. Report

> The Wall Street Journal examines the way investors deal with a biotech company's nasty trial surprises: dumping their stock and sending prices down 40 percent to 60 percent. Neurochem CEO Francesco Bellini says that investors need to learn to diversify. Article (sub. req.)

> NovaDel Pharma has agreed to sell 9.8 million shares for $14 million. Report

> MedImmune has completed the sale of CytoGam to ZLB Behring. Report

> How useful is animal testing for predicting human outcomes? A new report from the British Medical Journal attempts to answer that question. Report

And Finally…The big push to make sure there was plenty of flu vaccine available for the season has created a glut. And next year, manufacturers may respond by making less. Article

Gambling therapy flunks Phase II trial

Mon, 04 Dec 2006 19:01:35 -0500

A Phase II/III trial of Somaxon Pharmaceuticals' nalmefene for the treatment of pathological gambling failed to demonstrate a statistically significant difference compared to placebo. The trial evaluated 20 mg and 40 mg of oral nalmefene hydrochloride. Both doses missed the secondary endpoints as well. Ken Cohen, Somaxon's President and CEO, noted, "The results of this clinical trial for nalmefene are disappointing. We will now perform a careful analysis of all of our nalmefene data and our assumptions underlying that program to determine what the next steps should be." Earlier this year Somaxon touted Phase II data for oral nalmefene hydrochloride for smoking cessation.

- check out this press release on the study results

Related Article:
BioTie drug helps blunt thrill of gambling. Report
Somaxon touts mid-stage data on smoking cessation. Report

Press Release: Somaxon Reports Results From Trial of Oral Nalmefene in Pathological Gambling

Maureen Martino — Mon, 04 Dec 2006 12:15:15 -0500

Somaxon Reports Results From a Clinical Trial of Oral Nalmefene in Pathological Gambling

SAN DIEGO -- Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) today announced results from the company’s Phase 2/3 clinical trial evaluating 20 mg and 40 mg of oral nalmefene hydrochloride, an opiate antagonist, in patients with a diagnosis of pathological gambling.

Nalmefene did not demonstrate a statistically significant difference compared to placebo on the primary endpoint, mean PG-YBOCS (Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling) as measured at week twelve of the treatment period, for either of the doses studied. In addition, neither dose achieved statistical significance on the secondary endpoints in the trial. The most frequently reported adverse events were insomnia, nausea and dizziness. Elevation in liver enzymes was observed in some nalmefene-treated patients.

Somaxon intends to further assess the results from this clinical trial, both internally and with its licensor. Somaxon also intends to assess the previously-reported results from its Phase 2 clinical trial evaluating nalmefene for smoking cessation before making determinations regarding the future of the nalmefene program.

Ken Cohen, Somaxon’s President and CEO, said, “The results of this clinical trial for nalmefene are disappointing. We will now perform a careful analysis of all of our nalmefene data and our assumptions underlying that program to determine what the next steps should be.”

“At the same time, we remain focused on completing and reporting the results from our fourth and final Phase 3 trial for SILENOR™ for the treatment of insomnia,” Mr. Cohen added. “We expect to announce those results later this month.”

Somaxon has previously reported positive results of three Phase 3 clinical trials evaluating SILENOR™ for the treatment of insomnia. The company expects results from its remaining Phase 3 clinical trial for SILENOR™ in December of this year. Assuming that this final ongoing Phase 3 clinical trial and the planned preclinical studies for SILENOR™ are successful and proceed as currently scheduled, Somaxon expects to file a New Drug Application (NDA) with the FDA for SILENOR™ in the third quarter of 2007. This timing assumes that the initial NDA submission will include all of the data from the company’s completed genotoxicity and ongoing reproductive toxicology studies requested by the FDA, but that the FDA will allow the company to submit the data from the requested carcinogenicity studies at a later date. The FDA has previously indicated to Somaxon that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment. The company has submitted the results of the genotoxicity studies to the FDA and is awaiting a response; as the company previously reported, no signal indicative of genotoxicity was observed in any of those studies.

About Somaxon Pharmaceuticals, Inc.

Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is 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. Somaxon’s lead product candidate, SILENOR™ (doxepin HCl), is in Phase 3 clinical trials for the treatment of insomnia. Somaxon has completed a successful pilot Phase 2 trial for nalmefene in smoking cessation and an unsuccessful Phase 2/3 clinical trial for nalmefene for the treatment of pathological gambling, and will evaluate the results from these trials before making determinations regarding the future of the nalmefene program. Acamprosate Ca, a potential treatment for movement disorders, is currently in formulation development.

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 about the potential future of the nalmefene program, the pending clinical trial and required preclinical studies for SILENOR™ and the potential filing of an NDA for 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, the potential for Somaxon’s product candidates to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to require additional preclinical work or other clinical requirements to support an NDA submission for SILENOR™ or Somaxon’s other product candidates, or to be completed after regulatory approval; unexpected adverse side effects or inadequate therapeutic efficacy of SILENOR™ or Somaxon’s other product candidates that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing or marketing of and obtaining regulatory approval for SILENOR™, nalmefene or Somaxon’s other product candidates; the scope and validity of patent protection for SILENOR™ or Somaxon’s other product candidates; the market potential for Somaxon’s target markets, and Somaxon’s ability to compete in those markets; Somaxon’s ability to attract and retain key personnel; and other risks detailed in Somaxon’s prior press releases as well as in 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 news 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.

Somaxon touts latest Phase III results for Silenor

Sun, 19 Nov 2006 19:01:34 -0500

Another Phase III trial of Somaxon's insomnia drug Silenor has produced more data supporting its statistically significant results in patients. In a late-stage trial of 255 elderly volunteers with a minimum three-month history of insomnia, the drug met its primary and secondary endpoints. The primary endpoint was total sleep time. Silenor also proved a winner in a Phase III trial last April. Somaxon was a 2005 Fierce 15 company.

"With this positive Silenor data we are nearing completion of our Phase III clinical development program. We look forward to the results of our final Phase III clinical trial, which we expect in December, the continuation of ongoing strategic collaboration discussions and a New Drug Application filing targeted for the third quarter of 2007."

- see the release on the trial results

Related Article:
Somaxon touts mid-stage data on smoking cessation. Report

Press Release: Silenor demonstrates positive results in third Phase 3 trial

Maureen Martino — Sun, 19 Nov 2006 10:36:35 -0500

Somaxon Pharmaceuticals' SILENOR(TM) Demonstrates Positive Results in Its Third Phase 3 Clinical Trial in Insomnia

Nov 20 2006, 2:00 AM EST
PRNEWSWIRE

SAN DIEGO, Nov. 20 /PRNewswire-FirstCall/ -- Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced positive results from the company's Phase 3 clinical trial evaluating SILENOR(TM) (doxepin HCl) in elderly patients with primary sleep maintenance insomnia. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo in the primary endpoint of this trial, subjective Total Sleep Time (sTST) as measured at week one. Statistical significance was maintained for all timepoints measured throughout the four week treatment period.

This Phase 3 trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group outpatient trial designed to assess the efficacy and safety of 6mg of SILENOR(TM) in elderly patients with primary sleep maintenance insomnia. The trial enrolled 255 elderly subjects with at least a three month history of insomnia. Safety and efficacy were evaluated over a four week period.

With respect to secondary endpoints, SILENOR(TM) achieved statistically significant results compared to placebo in subjective Wake After Sleep Onset (sWASO) and Sleep Quality (SQ) as measured at week one. Each of these effects was maintained at the four week timepoint. SILENOR(TM) also demonstrated improvements relative to baseline in subjective Latency to Sleep Onset (LSO). This improvement was sustained throughout the four week treatment period, but statistical significance relative to placebo was not demonstrated.

This clinical trial demonstrated again that SILENOR(TM) was well tolerated. The incidence of adverse events was generally comparable to placebo. There were no reports of amnesia, memory impairment or weight gain.

Phil Jochelson, M.D., Somaxon's Chief Medical Officer, said: "We are extremely pleased with the results of this important Phase 3 clinical trial. As in all of our prior trials, SILENOR(TM) achieved statistically significant improvements compared to placebo for the primary endpoint. We have now reported results from five randomized, placebo-controlled clinical trials of SILENOR(TM), with consistent and reproducible effects shown in both the adult and the elderly insomnia populations, and in both outpatient and sleep laboratory settings."

Ken Cohen, Somaxon's President and CEO, added, "With this positive SILENOR(TM) data we are nearing completion of our Phase 3 clinical development program. We believe that the data continue to support an attractive product profile for both adults and elderly patients with insomnia, if approved by the FDA. We look forward to the results of our final Phase 3 clinical trial, which we expect in December, the continuation of ongoing strategic collaboration discussions and a New Drug Application filing targeted for the third quarter of 2007."

Somaxon has previously reported the results of two Phase 3 clinical trials evaluating SILENOR(TM) for the treatment of insomnia. The company reported the results from the first of these clinical trials, which evaluated SILENOR(TM) in the treatment of adults with chronic insomnia, in April. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo on the primary endpoint of objective Wake After Sleep Onset (WASO), as well as a range of secondary endpoints including Latency to Persistent Sleep (LPS), at both the 3mg and 6mg doses.

Somaxon reported results from its second Phase 3 clinical trial, which evaluated SILENOR(TM) in healthy adults experiencing transient insomnia in a sleep laboratory setting, last month. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo on the primary endpoint of LPS, as well as a range of secondary endpoints including WASO, objective Total Sleep Time and LSO, at the 6mg dose.

The company expects results from its remaining Phase 3 clinical trial for SILENOR(TM) in December of this year. This trial is a three month polysomnography (PSG) trial in elderly patients. Assuming that this final ongoing Phase 3 clinical trial and the planned preclinical studies for SILENOR(TM) are successful and proceed as currently scheduled, Somaxon expects to file a New Drug Application (NDA) with the FDA for SILENOR(TM) in the third quarter of 2007. This timing assumes that the initial NDA submission will include all of the data from the company's completed genotoxicity and ongoing reproductive toxicology studies requested by the FDA, but that the FDA will allow the company to submit the data from the requested carcinogenicity studies at a later date. The FDA has previously indicated to Somaxon that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment. The company has submitted the results of the genotoxicity studies to the FDA and is awaiting a response; as the company previously reported, no signal indicative of genotoxicity was observed in any of those studies.

About Insomnia

Nearly 70 million American adults are affected by insomnia -- characterized by difficulty falling asleep, waking frequently during the night, waking too early and not being able to return to sleep, or waking up not feeling refreshed. The prevalence of insomnia is greater in the elderly than in adults, particularly sleep maintenance insomnia.

Results from a 2005 National Sleep Foundation Sleep in America poll reported that respondents experienced the following insomnia symptoms:

* 54% experience insomnia symptoms a few nights a week;
* 21% have difficulty falling asleep (sleep onset);
* 32% awake often during the night (sleep maintenance); and
* 21% wake up too early and can not get back to sleep (premature final
awakening).
An estimated 20 to 40% of all adults complain of acute, or transient, insomnia, generally defined as a complaint lasting several days up to a couple of weeks, while 10 to 15% complain of chronic insomnia, generally defined as a complaint lasting approximately 4 weeks or longer.

About SILENOR(TM)

SILENOR(TM) is a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin HCl that is patent protected for its use in insomnia. Doxepin has been prescribed for more than 35 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. At the currently prescribed high doses, doxepin is known to have a range of undesirable side effects. However, at the doses used in SILENOR(TM) in controlled clinical trials completed by Somaxon to date, SILENOR(TM) has been well tolerated.

Unlike most approved insomnia medications, SILENOR(TM) does not act via a set of brain receptors known as the benzodiazepine, or GABA, receptors. Drugs that act on these receptors have been associated with amnesia, hallucinations, dependency and addiction. The U.S. Drug Enforcement Agency classifies these products as Schedule IV controlled substances and carefully monitors and controls their prescribing and use. Although the mechanism of action for the sleep-promoting effects of SILENOR(TM) is not definitively known, it differs from the leading prescription insomnia treatments which act via GABA receptors in that the effects of SILENOR(TM) are mediated through the histaminergic system. Histamine blocking has been demonstrated to reduce wakefulness and is thought to promote the initiation and maintenance of sleep.

Conference Call Information

Somaxon management will host a conference call today at 9:00 a.m. Eastern Time to review the results of this Phase 3 trial. Callers may participate in the conference call by dialing (800) 240-4186 (domestic) or (303) 262-2138 (international). The conference call also will be available to interested parties through a live audio Internet broadcast at www.somaxon.com and www.opencompany.info.

A telephonic replay will be available for approximately one week following the conclusion of the call by dialing (800) 405-2236 (domestic) or (303) 590- 3000 (international), and entering passcode 11077311#. The call will be archived and accessible at www.somaxon.com and www.opencompany.info for approximately one year.

About Somaxon Pharmaceuticals

Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is 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. Somaxon's lead product candidate, SILENOR(TM) (doxepin HCl), is in Phase 3 clinical trials for the treatment of insomnia. Nalmefene HCl is in a Phase 2/3 clinical trial for pathological gambling and has completed a pilot Phase 2 trial for smoking cessation. Acamprosate Ca, a potential treatment for movement disorders, is currently in formulation development.

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. 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, the results which may be observed in the pending preclinical studies and pending clinical trials for SILENOR(TM); the potential for SILENOR(TM) to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to require additional preclinical work or other clinical requirements to support an NDA submission for SILENOR(TM) or to be completed after regulatory approval; the timing of receipt of trial results and any NDA submission; unexpected adverse side effects or inadequate therapeutic efficacy of SILENOR(TM) that could delay or prevent regulatory filings, approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing or marketing of and obtaining regulatory approval for SILENOR(TM); the scope and validity of patent protection for SILENOR(TM); the market potential for insomnia, and Somaxon's ability to compete; Somaxon's ability to attract and retain key personnel; and other risks detailed in Somaxon's prior press releases as well as in periodic filings with the Securities and Exchange Commission.

This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.

Somaxon touts mid-stage data on smoking cessation

Tue, 25 Jul 2006 20:01:36 -0400

Somaxon is touting new Phase II data for oral nalmefene hydrochloride for smoking cessation. Researchers said that a statistically superior number of patients taking a 40 milligram dose reported higher abstinence rates compared to a placebo. Patients in the 80 milligram group did not demonstrate a significantly higher rate of abstention.

"We are encouraged by the results of our first smoking cessation clinical study which was designed to be exploratory in nature," said Chief Medical Officer Phil Jochelson. "We are intrigued with the observation that the nalmefene 40 mg treated patients maintained higher abstinence rates relative to placebo."

- see the report on the data from Trading Markets

ALSO NOTED: Perlegen files $115M IPO; Pharmacyclics acquires cancer treatment candidates from Celera; and much more...

Sun, 09 Apr 2006 20:00:50 -0400

> Preliminary Phase III data of Myogen's Ambrisentan demonstrated that the drug improved the ability of patients suffering from pulmonary arterial hypertension to exercise. Report

> Bayer Healthcare and Nuvelo have initiated a second Phase III trial of Alfimeprase. Release

> Atlanta-based Corautus Genetics has terminated enrollment in its Phase IIb clinical trial based on the recommendation of its independent Data Monitoring Committee. The DMC saw little chance for significant efficacy compared to the safety risk involved. Release

> Perlegen Sciences is planning an IPO of as much as $115 million in common stock. Report

> Pharmacyclics has acquired multiple small molecule drug candidates for the treatment of cancer and other diseases from Celera Genomics. Report

> Somaxon Pharmaceuticals announced positive results from its initial Phase III clinical trial Silenor, a treatment for chronic insomnia. Release

And Finally... A fat-burning laser could offer some hope to those with cellulite and acne. Article

Somaxon unveils $86.2M IPO

Thu, 06 Oct 2005 20:01:37 -0400

San Diego-based Somaxon Pharmaceuticals has filed to sell $86.2 million of stock in an upcoming IPO. Much of that money is earmarked for three drug development projects. Somaxon is advancing drug candidates for psychiatry and neurology. Morgan Stanley, JPMorgan, Piper Jaffray and Thomas Weisel Partners are listed as underwriters.

- read this Dow Jones report for more

VC: San Diego biotechs raise $143M

Wed, 15 Jun 2005 20:01:32 -0400

San Diego biotechs raise $143M.

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Verus Pharmaceuticals San Diego	$78M/$20M loan first round	Domain Associates, Prospect Venture Partners	Verus plans to in-license pediatric drugs and move quickly to Phase III.
Somaxon Pharmaceuticals San Diego	$65M third round	MPM Capital Partners	Somaxon has an insomnia drug -- Silenor -- in Phase III.
Osiris Therapeutics Baltimore	$50M undisclosed	Friedli Corporate	Osiris is in a race to become the first biotech to commercialize stem cell products.
Ziopharm Charlestown, MA	$18.1M first round	Paramount BioCapital	Ziopharm is looking to in-license cancer products.