insomnia

Vanda shares surge on Phase III insomnia data

John Carroll — Thu, 26 Jun 2008 11:31:38 -0400

Shares of Vanda Pharmaceuticals shot up this morning after researchers announced that its late-stage trial for treating chronic insomnia hit its primary endpoint. The goal was to demonstrate the immediate and intermediate ability of tasimelteon to improve the onset of sleep. The 322 volunteers of the study suffering from chronic primary insomnia received either a 20 mg or 50 mg dose of the drug or a placebo. The study also produced statistically significant data on sleep maintenance. The drug is a melatonin agonist and may be particularly useful treating people who suffer from insomnia due to late shifts.

"The mechanism of action of tasimelteon as a circadian regulator gives Vanda the opportunity to explore its use for the treatment of circadian rhythm sleep disorders as well as chronic primary insomnia," stated Paolo Baroldi, MD, PhD, Vanda's chief medical officer.

- check out Vanda's release
- read the AP story

SPOTLIGHT: Neurogen cuts jobs (again)

Wed, 09 Apr 2008 06:59:53 -0400

Facing a delay of clinical trials for its lead therapy, Neurogen slashed 45 more jobs and announced plans to focus its development programs. The developer also raised $30.6 million in a private placement with institutional investors. That money will be used to advance research for the company's four clinical programs in insomnia, anxiety, restless legs syndrome, and Parkinson's disease. Release

ALSO NOTED: Pharma growth sinking to historic low; Neurocrine gains Japanese partner; OccuLogix suspends development program;an

Thu, 01 Nov 2007 07:59:50 -0400

> Here's statistical confirmation of the gloom-and-doom facing Big Pharma. Worldwide sales growth will slow next year to around 5 percent from 6 to 7 percent this year, according to a new report from IMS Health. Report

> Japan's Dainippon Sumitomo Pharma will pay Neurocrine Biosciences $20 million up front plus an additional milestone payment of $10 million for the Japanese licensing rights to the insomnia drug indiplon, which has been filed for approval by the FDA. The PDUFA action date on indiplon is December 12. Release

> OccuLogix has already put itself up on the sales block as it signals its willingness to do a deal of some sort. Now the company says it is suspending development of its RHEO System for dry, age-related macular degeneration. In early October the company announced that it would consider every option in maximizing shareholder value, including a sale, but couldn't confirm whether or not it could complete a deal. Release

> ZymoGenetics is boosting spending in preparation for launching rThrombin, designed to control bleeding during surgery, causing its losses for the third quarter to go up. Report

> It's a one-two punch for AstraZeneca today. A Canadian drug maker is challenging AZ's patent on the cholesterol drug Crestor, one of its top sellers at $2 billion--and a linchpin of its profits over the next few years. Meanwhile, the company reported a 15 percent drop in profits. Report

> Score one for GlaxoSmithKline. The company won an injunction against the U.S. Patent and Trademark Office, successfully blocking implementation of new rules governing patent continuances, at least temporarily. Report

> What's your pick for the most memorable drug ad of the 2006-2007 season? If you picked that Lunasta moth, you win. Report

And Finally... Nematode worms treated with lithium show a 46 percent increase in lifespan, raising the tantalizing question of whether humans taking the mood affecting drug are also taking an anti-aging medication. Release

Evotec drug extends sleep in mid-stage trial

Tue, 16 Oct 2007 06:59:54 -0400

Evotec has given a thumb's up on its Phase II data on its insomnia drug EVT 201. In the trial of 149 patients over the age of 65 researchers found that the lower dose extended sleep time by nine percent while the higher dose led to a 17 percent increase in sleep time.

- see this release on the trial

Related Articles:
Insomnia market attracts drug developers. Report
PerkinElmer acquires Evotec Tech in cash buyout. Report
Evotec adds drugs in Renovis buyout. Report
Evotec shutters Alzheimer's development program. Report

Read more on: Evotech | Insomnia

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

Arena Pharma produces positive insomnia data

Tue, 25 Sep 2007 06:59:55 -0400

San Diego-based Arena Pharmaceuticals has delivered positive mid-stage data on APD125, an experimental therapy for chronic insomnia. The therapy is being developed for people who have a hard time staying asleep after they go to sleep. Researchers said that the trial provided statistically significant evidence that the therapy helped those people stay asleep. A Phase III trial is slated to begin next year.

"We are very encouraged by the results from the Phase II trial, which demonstrate improved sleep maintenance with an excellent tolerability profile," said Dr. William Shanahan, Arena's Chief Medical Officer. "We look forward to the continued development of APD125, and hope to bring a safe, efficacious and non-scheduled treatment to patients to help them maintain sleep and awake refreshed."

- check out the release on the insomnia data

Related Articles:
Actelion sees positive results in new sleep trial. Report
Arena prepares pivotal trial on obesity drug. Report
Arena reports successful lorcaserin trial. Report

Evotec adds drugs in Renovis buyout

Wed, 19 Sep 2007 06:59:58 -0400

Germany's Evotec is boosting its pipeline to five compounds with the acquisition of Renovis for $152 million in an all-stock transaction. An insomnia drug is slated to begin a human clinical trial by the end of next year. Evotec says it will seek a NASDAQ listing for the merged operation, which should help it buy out more drug developers.

"By combining Evotec's drug discovery and development know-how with Renovis' medicinal chemistry and target validation expertise, we expect to form a global biopharmaceutical company with world-class discovery capabilities," said Evotec Chief Executive Jorn Aldag.

- see the release on the buyout
- read the report from the International Herald Tribune

Related Articles:
Evotec shutters Alzheimer's development program. Report
Evotec touts early data. Report
Renovis pares work force in restructuring. Report
Renovis, Pfizer to collaborate on pain research. Report

ALSO NOTED: GSK to commercialize Lunesta; second headline; and much more...

Tue, 11 Sep 2007 06:59:50 -0400

> GlaxoSmithKline has signed on to commercialize Sepracor's insomnia drug Lunesta, agreeing to pay $20 million up front and up to $155 million in total for milestones and licensing fees. Glaxo gains the rights to all countries except the US, Canada, Mexico and Japan. Glaxo is looking for European approval of the drug--dubbed Lunivia outside the U.S.--in the second half of next year. FiercePharma

> Arena Pharmaceuticals stock got a bump this morning when researchers found no sign of heart valve damage after six months of Phase III testing for its obesity drug Lorcaserin. Release

> Evotec has sold its Chemical Development Business to Aptuit for about $63 million in cash. Release

> As part of its overall restructuring, Pfizer will shut down its 53-year-old manufacturing facilities in Sandwich, England, shedding some 400 jobs in the process. FiercePharma

And Finally... According to new research from the Institute for Safe Medication Practices, the FDA received reports of 89,842 adverse events including 15,107 deaths in 2005, more than double the 1998 numbers of 34,966 reports and 5,519 deaths. Report

Actelion sees positive results in new sleep trial

Thu, 06 Sep 2007 06:59:58 -0400

Actelion says its experimental sleep therapy has performed well in a clinical trial, raising the prospects of a new class of sleep drugs that inhibit orexin, a chemical in the brain believed to keep people awake. The news hits as a variety of Big Pharma players are angling to introduce new sleep meds. Ambien, a blockbuster in the field, has just gone generic. And there's a widespread belief that a new drug can appeal to consumers who don't respond to nonbenzodiazepine drugs. At the World Sleep Congress in Cairns, Australia, Actelion said that almorexant significantly increased sleep time when compared with a placebo. A late-stage trial should get underway by the end of this year.

- see this release from Actelion
- here's the article on the data from The Wall Street Journal (sub. req.)

Related Articles:
Actelion to pay $420M in cash for CoTherix. Report
Roche, Actelion ink $630M pact. Report
Actelion drug gets mixed results. Report

ALSO NOTED: Elbion acquires drug candidates; Vanda looks to raise $96M;and much more...

Thu, 18 Jan 2007 19:01:30 -0500

> Belgium's Elbion NV has acquired some late-stage drug candidates from DrugAbuse Sciences. Two of the therapies are sustained-release forms of currently approved drug. Naltrexone Depot, an antagonist that blocks receptors in the brain and is used in the treatment of opiate and alcohol abuse, is expected to head into Phase III this year. Buprenorphine Depot, a sustained release buprenorphine indicated for the treatment of opiate addiction, is also included in the portfolio. No financial terms were disclosed. Release

> Shares of Vanda Pharmaceuticals were on the rise after it announced that it had priced an offering of 3.8 million shares at $27.29. The offering is designed to raise about $96 million. Vanda has been developing therapies for CNS diseases. Late last year Vanda confirmed positive data from a Phase III trial of its experimental insomnia drug, VEC-162. Report

> Bayer Innovation has licensed the rights to DelSiTech's drug delivery technology for fiber applications in the fields of wound care and certain other applications. Release

And Finally… A number of medical schools are prohibiting their students from taking advantage of the free lunches and other freebies offered by drug reps. Report

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

SPOTLIGHT: Merck touts reorganization efforts

Mon, 11 Dec 2006 19:01:33 -0500

Merck CEO Richard Clark (photo) has been using the company's annual business briefing to tout its reorganization efforts. More than half of the 7,000 announced job cuts have been made and Merck launched five new vaccines this year. Clark added that Merck has eight more products on the horizon, including three receiving regulatory scrutiny. NDAs for HIV, insomnia and heart disease are planned for 2007. Merck also faces 27,200 lawsuits over Vioxx. 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.

Vanda gains on late-stage sleep trial data

Tue, 14 Nov 2006 19:01:38 -0500

Vanda Pharmaceuticals was buoyed by the latest data from a late-stage clinical trial of its experimental insomnia therapy. Its stock jumped more than 30 percent after releasing results for three doses: 25 milligrams, 50 milligrams and 100 milligrams of VEC-162. The 412 patients in the trial experienced a time-to-sound-sleep that ranged from 21.5 to 26.3 minutes faster than a placebo. Total sleep time also improved. One of the keys to Vanda's approach is avoiding a designation as a controlled substance.

"Because VEC-162 is a balanced melatonin receptor agonist that works through the natural sleep/wake cycle, it appears to lack the side effects associated with hypnotics and sedatives and should not be scheduled as a controlled substance," said Paolo Baroldi, M.D., Ph.D., senior vice president and chief medical officer.

- see the company press release on the data
- here's the AP report for more info

Related Article:
Vanda cuts IPO prices. Report

Struggling to save cash, Neurocrine axes sales force

Thu, 27 Jul 2006 20:01:37 -0400

Analysts weren't surprised by yesterday's announcement that Neurocrine is laying off its 200-person sales force in the U.S. After Pfizer terminated its collaboration with Neurocrine to market the anti-insomnia drug indiplon, the company had to find different ways to conserve cash while developing their lead drug. The San Diego-based biotech says the move will save the company $16 million this year. Indiplon has been hit by a series of setbacks that has slowed its path to the market.

- check out the report on Neurocrine from Forbes.com
- and more from TheStreet.com

SPOTLIGHT: Evotec touts early data

Wed, 07 Jun 2006 20:01:33 -0400

Evotec says that a Phase I/II trial of its experimental insomnia therapy, EVT 201, demonstrated that the drug was safe and effective. Researchers say that patients taking the drug experienced a significant increase in untroubled sleep without experiencing adverse side effects. Report

SPOTLIGHT: ReGen acquires Sciencom

Tue, 07 Feb 2006 19:01:33 -0500

London-based ReGen Therapeutics has struck a deal to acquire the outstanding shares of Sciencom, which is developing a new use for the insomnia drug zolpidem. According to Regen, "a significant body of 'open' clinical case observations has shown that zolpidem can normalize areas of brain dormancy secondary to a primary lesion in brain damage conditions such as stroke, traumatic brain injury, vascular dementia and Bell's palsy." ReGen is planning a Phase II trial this year. Report

Demand for sleep drugs soars in U.S.

Mon, 06 Feb 2006 19:01:37 -0500

Prescriptions for sleep drugs have swelled 60 percent in the last five years, leading some experts to speculate that doctors are overprescribing the meds that are available. A chief reason for the growing demand is a steadily rising rate of insomnia, the byproduct of a much more turbulent average work day in America. A new wave of sleep drugs is supposed to have corrected some of the side effects, such as lingering fatigue, associated with older sleep drugs. But reports of short-term amnesia and sleepwalking are raising new concerns. Drug makers, meanwhile, say that the drugs are safe and effective when taken as prescribed, a message that they are promoting with an ad budget that breaks the $300 million-a-year mark.

- read this article from The New York Times for more information

Hypnion bags $20M in second venture round

Sun, 18 Dec 2005 19:01:35 -0500

The neuroscience drug discoverer Hypnion has raised $20 million in an extension of its second round of venture capital. MPM Capital, Advanced Technology Ventures, Forward Ventures, Flagship Ventures, Oxford Bioscience Partners, GIMV, S.R. One Limited, JAFCO, Alexandria Real Estate Equities, and Mintz Levin Investments all participated in the round. Hypnion says the money will move its lead insomnia drug into Phase II trials.

- read this release for more information

FDA staffer reverses course on ADHD patch

Thu, 01 Dec 2005 19:01:37 -0500

An FDA staff scientist has reversed himself on an earlier opinion about a patch used to treat ADHD, telling an agency expert committee that the therapy from Shire Pharmaceuticals and Noven Pharmaceuticals should be approved. On Thursday, the FDA released a document saying the patch should not be approved because it increased the risk of side effects such as muscle twitches, anorexia and insomnia. But FDA staff reviewer Robert Levin says that he now thinks the therapy was not as risky as believed earlier. Risks remain, he added, but at a lower level.

- see this report from The San Diego Union Tribune for more information