Ligand Presents Preclinical Data on HepDirect™; VIVUS Announces Positive Recommendation From CHMP Print E-mail
By Staff and Wire Reports   
Friday, 26 April 2013 19:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 26, 2013.

Ligand Pharmaceuticals Incorporated (LGND: NASDAQ) announced that data from preclinical studies evaluating Ligands HepDirect" liver-targeting technology platform will be featured in a poster presentation at the 48th Annual International Liver Congress hosted by the European Association for the Study of the Liver (EASL) in Amsterdam. The data show highly targeted liver delivery of a clinically active NS5B polymerase inhibitor utilizing the HepDirect technology platform, and demonstrated that HepDirect liver targeting of active nucleosides may be an effective method to improve efficacy while reducing systemic side effects in HCV treatment.

In preclinical studies, Ligand evaluated the pharmacokinetics and liver targeting of LGD-7501, a HepDirect prodrug designed for increased liver targeting compared to other phosphoramidate prodrugs of the same active nucleoside. The compound using HepDirect technology efficiently targeted the liver with greatly reduced systemic distribution in preclinical models, providing further proof-of-concept of the value and utility of the HepDirect technology platform.

Our HepDirect technology is an important example of Ligands diverse portfolio of internal and un-partnered assets and technologies, and has applicability for liver-targeting for a wide range of therapeutic areas, including HCV, commented Matthew W. Foehr, Chief Operating Officer of Ligand Pharmaceuticals. These positive findings represent the first preclinical example of HepDirects delivery efficiency when directly compared to other prodrugs of the same active nucleoside that have been previously tested clinically.

About Ligands HepDirect HCV Inhibitor Program--HepDirect is a pro-drug technology that targets delivery of certain drugs to the liver by using a proprietary chemical modification that renders a drug biologically inactive until cleaved by a liver-specific enzyme. Antiviral therapies for the treatment of HCV often have significant undesired side effects related to systemic exposure of the compounds. The HepDirect technology may improve the efficacy and/or safety of certain drugs and can be applied to marketed or new drug products.


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 VIVUS, Inc. (VVUS: NASDAQ) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorization for avanafil (SPEDRA") for the treatment of erectile dysfunction (ED) in the European Union. The CHMP recommendation will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. A final decision from the EC regarding the SPEDRA Marketing Authorization Application (MAA) is expected within approximately two months.

"We are pleased with the positive recommendation of the CHMP to support the approval of SPEDRA," said Peter Tam, president of VIVUS, Inc. "This positive opinion marks another important milestone in the drug development history of VIVUS. We could not have accomplished this without the longstanding collaboration and support of our partner Mitsubishi Tanabe Pharma Corporation and our European team of advisors and consultants, all of whom have worked diligently on the application. If approval of the MAA is granted by the EC, we expect to complete our partnering discussions on a timely basis to allow for the commercialization of SPEDRA in the EU."

"SPEDRA is the first next-generation PDE5 inhibitor and offers a unique profile for the treatment of ED," said Prof. Francesco Montorsi, FRCS, Professor and Chairman, Department of Urology and Director, Urological Research Institute, Università Vita Salute San Raffaele, Milan, Italy. "Its onset of action, PDE5 inhibition selectivity and absorption profile make it an important new treatment option for the more than 20 million ED sufferers in Europe. We look forward to the launch of SPEDRA and to providing patients with this important new medication."



Also Friday:




Anacor Pharmaceuticals (NASDAQ:ANAC)
announced today that it has priced an underwritten public offering of 3,129,890 shares of its common stock at a price to the public of $6.39 per share for gross proceeds of $20.0 million.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announcedtoday that it will provide a corporate update and discuss first quarter 2013 financial results after the NASDAQ Global Select Market closes on Thursday, May 2, 2013.

Astellas Pharma Europe Ltd., the European Headquarters of Tokyo-based Astellas Pharma Inc. (TSE:4503), and Medivation, Inc. (Nasdaq: MDVN) have received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission (EC) approval for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a specialty biopharmaceutical company, will release results for the first quarter 2013 on Monday, April 29, 2013 before the opening of the U.S. financial markets.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced that it will release its first quarter ended March 31, 2013 financial results on Thursday, May 2, 2013.

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX)
announced today that it will release its first quarter 2013 results after the market closes on Thursday, May 2, 2013.

Cytomedix, Inc. (OTCQX: CMXI)
, a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Martin Rosendale, the Company's Chief Executive Officer, will present at the 12th Annual Needham Healthcare Conference, on Wednesday, May 1, 2013 in New York.

eHealth, Inc. (NASDAQ: EHTH)
, America's first and largest private health insurance exchange, announced today its financial results for the first quarter ended March 31, 2013.

Fibrocell Science, Inc. (OTC: FCSC)
today announced that LAVIV® (azficel-T) was recognized as the Silver Winner in aesthetics of the science/medical category at the 2013 Edison Awards Ceremony and Gala in Chicago.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) antibody-drug conjugate (ADC) technology, today reported financial results for the three-month period ended March 31, 2013 – the third quarter of the Company’s 2013 fiscal year – and provided an update on the Company.

Immunotech Laboratories, Inc. (PINKSHEETS: IMMB)
today announced the company has initiated the Pre-IND and IND process with the US Food & Drug Administration (FDA).

Life Technologies Corporation (NASDAQ: LIFE) today announced that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is the sole platform cleared for use under the Centers for Disease Control and Prevention (CDC) protocol created for emergency screenings of patients suspected of harbouring the Avian influenza (H7N9) virus, which to date has led to 23 deaths in China and Taiwan.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced that data from preclinical studies evaluating Ligand’s HepDirect™ liver-targeting technology platform will be featured in a poster presentation at the 48th Annual International Liver Congress hosted by the European Association for the Study of the Liver (EASL) in Amsterdam.

Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS) announced today that Kips Bay will release operating and financial results for the first quarter ended March 30, 2013 on Thursday, May 9, 2013 prior to market open and will hold a conference call to discuss those results at 9:00 A.M. (Eastern Time).

Nanosphere, Inc. (NASDAQ: NSPH)
, a leader in the development and commercialization of advanced molecular diagnostics systems, today announced the appointment of Ken Bahk, Ph.D. to the newly created position of Chief Strategy Officer and the departures of Tim Patno as Chief Technology Officer and Chad Mirkin, Ph.D. as a Member of the Board of Directors.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, has been named one of the Best Places to Work in New Jersey.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the Company's first quarter 2013 financial results will be released on Thursday, May 2, 2013, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.

Regarding the report "The Long Term Returns of Obesity Prevention Policies" unveiled this week by the Campaign to End Obesity (CEO), Orexigen Therapeutics, Inc. (Nasdaq: OREX) issued the following statement:  Orexigen commends CEO as well as the author of the report, Alex Brill, and the Robert Wood Johnson Foundation (RWJF) who funded the report, for this new research illustrating the importance of long-term budget impact analyses on preventive health policies, specifically those aimed at obesity.

Simulations Plus, Inc. (NASDAQ:SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that its Board of Directors has decided to distribute a cash dividend in May.

SpectraScience, Inc. (OTCQB: SCIE)
announced today that the Company's first in a series of endoscopy workshops featuring the WavSTAT4, which was originally scheduled for April 25, 2013 in Erlangen, Germany, has been rescheduled.

Tauriga Sciences, Inc. (OTCQB: TAUG)
("the Company"), a life sciences holding company creating a diversified portfolio of medical technology assets, has today announced that the Company has taken meaningful steps to enhance its corporate governance protocols and gain compliance with Sarbanes Oxley ("SOX") regulations.

Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)(FRANKFURT:V3T)
(the "Company" or "Verisante"), a leader in cancer detection technology, announced today that Verisante Aura™, a non-invasive skin cancer detection device, was voted a Bronze Edison Award winner for innovation at the April 25th event at Navy Pier in Chicago.



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