Somaxon to explore strategic options, cut jobs; Alkermes Initiates Phase 3 Clinical Study of ALKS 9070 Print E-mail
By Staff and Wire Reports   
Monday, 19 December 2011 19:17
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 19, 2011.

Somaxon Pharmaceuticals Inc (NASDAQ:SOMX) said it was exploring strategic alternatives, including a sale, and will cut jobs to conserve cash.

The company, which hired Stifel Nicolaus Weisel as its financial advisor, said it will cut about 60 percent of its current non-field-based employees.

"This process will focus on strategic alternatives, which may include one or more of a sale of the company or assets relating to Silenor, or partnering or other collaboration transactions relating to U.S. or ex-U.S. prescription or over-the-counter rights to Silenor," Chief Executive Richard Pascoe said.

Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

Somaxon shares closed at 60 cents on Friday on Nasdaq.

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Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes (ALKS) molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY® for the treatment of a number of central nervous system (CNS) disorders. The multicenter, double-blind, placebo-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acute exacerbation of schizophrenia. The clinical data from this study, expected mid-calendar 2013, will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 9070 for the treatment of schizophrenia, a chronic brain disease.

Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs, stated Dr. Herbert Meltzer, Professor of Psychiatry at Feinberg School of Medicine and Director of the Division of Neuropsychopharmacology at Northwestern University. An extended-release injectable medication that incorporates the unique clinical properties and established safety and efficacy of aripiprazole would represent a significant treatment advancement for patients and physicians to manage this serious, chronic disease.

In June 2011, Alkermes announced data from a phase 1b double-blind, randomized, placebo-controlled clinical study of ALKS 9070 in 32 patients with schizophrenia. Data from the study showed that ALKS 9070 was generally well tolerated and achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing.

Alkermes expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly atypical antipsychotic medication that delivers aripiprazole, a widely prescribed oral product with an established safety and efficacy profile, stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. The advancement of ALKS 9070 into pivotal development marks an important milestone for the program, and we look forward to seeing the results in mid-2013.


Also Monday:


Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC)
, a leader in the field of regenerative medicine, responded to investor inquiries in connection with the significant increase in trading and volatility of its common stock over the past few days.

BioElectronics Corporation. (OTCQB: BIEL) (PINKSHEETS: BIEL)
, the maker of inexpensive, disposable drug-free topical pain devices, announced today that the Peoples Republic of China State Intellectual Property Office has issued a Utility Model Patent Number ZL20112008635.4 for its unique Pulsed Electromagnetic Field Device and its affixing methods.

BioMedical Technology Solutions Holdings, Inc. (OTCBB: BMTL)
is pleased to announce that it has executed a national distribution agreement with McKesson Medical-Surgical, Inc.

Cannabis Science, Inc. (OTCBB: CBIS)
a pioneering US biotech company developing pharmaceutical cannabis products, is very pleased to report that two former US Attorneys, and the former head of Seattle FBI, are in favor of Washington State Initiative 502 to legalize marijuana.

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has deposited $11.2 million in cash as trust funds with U.S. Bank National Association, as the trustee of the outstanding 5.75% convertible senior notes (the "Notes"), which is an amount sufficient to pay and discharge the entire amount due on the Notes, including accrued and unpaid interest. CTI has now retired all of its outstanding convertible debt.

Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that it has received written, scientific advice from the European Medicines Agency (EMA) confirming that the Company's Phase III HEAT Study, a multinational, double-blind, placebo controlled pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, is acceptable as a basis for submission of a marketing authorization application (MAA).

Galectin TherapeuticsInc. (OTC: GALT), the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins, today issued the following corporate update to its shareholders.

InSite Vision Incorporated (OTCBB:INSV) today announced that Tim McInerney has been elected Chairman of its Board of Directors.

After obtaining confirmatory opinions from multiple experts in patent law, Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio) today reaffirms that its lead program, applying DCVax®-L for treatment of brain cancer, continues to have clear freedom to operate with respect to US Patent 7,939,090 (the '090 patent), recently issued to Cedars Sinai, and licensed to Immunocellular Therapeutics (IMUC) (collectively, Cedars Sinai/IMUC).

Pall Corporation (NYSE: PLL), a global leader in filtration, separation and purification, today announced it has entered into a definitive merger agreement to acquire ForteBio®, Inc., a leading provider of advanced analytical systems that accelerate the discovery and development of biotech drugs. The transaction is expected to close by February of 2012.

Pharmacyclics, Inc. (Nasdaq: PCYC), a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer and immune mediated diseases, announced today issue notification from the United States Patent & Trademark Office (USPTO, www.uspto.gov) of a patent entitled "Inhibitors of Bruton's Tyrosine Kinase" and specifically claiming "an inhibited tyrosine kinase comprising an irreversible BTK inhibitor having a covalent bond to a cysteine residue of a Bruton's tyrosine kinase (BTK)". This U.S. patent 8,088,781 is set to issue on January 3, 2012.

Power3 Medical Products, Inc. (OTCBB: PWRM), a biotechnology company, announced today the assembly of the foundational elements of its initiative to enter the adult stem cell arena, including: 1. A body of work on proof of concept, i.e. protein biomarkers: in human adult stem cells from patient's bone marrow and in stem cells and in media in culture.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that it has entered into a Share Transfer Agreement with certain purchasers, pursuant to which it has sold all of the ordinary shares of Rosetta Green Ltd. ("Rosetta Green") it held.

Unigene Laboratories, Inc. (OTCBB: UGNE) today highlighted its significant accomplishments in 2011 and announced that its management team has put key elements in place to begin addressing the capital structure and eliminating the inherited debt.

Varian Medical Systems (NYSE: VAR) announced today that it will report results for the first quarter of fiscal year 2012 following the close of regular trading on Wednesday, January 25, 2012.

Vermillion, Inc.(NASDAQ: VRML), a leading molecular diagnostics company, has completed the purchase of substantially all of the assets associated with the ovarian cancer diagnostics business of Correlogic Systems, Inc. for $435,000 in cash.



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