Furiex Gets Product Rights for Priligy; Celsion Announces Resubmission of Combined IND/IDE Application Print E-mail
By Staff and Wire Reports   
Monday, 14 May 2012 19:59
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 14, 2012.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX)
announced it has entered into an agreement with ALZA Corporation and Janssen Pharmaceutica, N.V. whereby ALZA and Janssen will transfer worldwide rights for Priligy® to Furiex. Currently Priligy is marketed by Janssen for on-demand treatment of premature ejaculation in 15 countries in Europe, Asia and Latin America, while it is approved for that indication in 43 countries worldwide.


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Celsion Corporation (NASDAQ: CLSN)
announced a joint resubmission with Philips Healthcare of an Investigational New Drug/Investigational Device Exemption (IND/IDE) application with the U.S. FDA for a Phase 2 clinical study of Celsion's ThermoDox® combined with Philips' Sonalleve® MR-HIFU (MR-guided high intensity focused ultrasound) technology for the treatment of prostate cancer metastases to the bone. The companies expect to initiate the clinical study as soon as possible following FDA acceptance of the proposed program.

"Since we began our collaboration, both Celsion and Philips have understood the significant potential of combining ThermoDox® and HIFU," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Many thought leaders believe that a multimodality approach is critical to the effective treatment of a variety of cancers. ThermoDox®, as a 'drop-in' therapy triggered only in the presence of heat, offers the ideal complement to potentially extend the menu of HIFU-based treatments. We look forward to completing our IND/IDE submission and, as we approach the outcome of our pivotal Phase III HEAT Study of ThermoDox® in primary liver cancer later this year, to initiating this Phase 2 study in metastases to the bone."

ThermoDox® combined with MR-HIFU will be investigated for pain palliation in patients with painful bone metastasis. Cancer progresses to the bone in a majority of patients with late-stage breast, prostate or lung cancer, with estimates of between 300,000 to 500,000 cases annually in the United States. Patients may experience excruciating and unrelenting pain, often treated with opiate drugs and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) with only modest benefit. External beam radiation therapy is effective in palliating painful bone metastasis, but is limited by accumulating toxic effects to normal organs. "A non-radioactive single-treatment therapy that acts quickly and brings significant pain relief to these debilitated patients would be a substantial step forward in the palliation of bone pain," said Nicholas Borys, MD, Celsion's Chief Medical Officer.




Also Monday:




Aetna (NYSE: AET)
today announced that it is adding five new capabilities to Aetna Rx Check®, a collection of programs designed to promote safety and prevent the misuse of various prescription drugs such as pain medications and antibiotics.

Array BioPharma Inc. (NASDAQ: ARRY)
announced today that the strategic alliance between Array and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has been honored with the Breakthrough Alliance Award of 2012.

Biogen Idec (NASDAQ: BIIB)
announced that two new dosing innovations designed to help patients receiving once-a-week AVONEX (interferon beta-1a) for relapsing forms of multiple sclerosis (MS) are now available in U.S. pharmacies.

BioScrip (NASDAQ: BIOS)
today announced that the Company will present at the Bank of America Merrill Lynch 2012 Health Care Conference to be held at Encore at the Wynn in Las Vegas, NV on May 15-17, 2012.

BioTime, Inc. (NYSE MKT: BTX)
announced today the publication of a scientific paper demonstrating the effectiveness of HyStem®-C in the transplantation of heart muscle-derived cells in an animal model of heart disease.

Biovest International, Inc. (OTCQB:BVTI)
, a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced that Biovest plans to file for marketing approval in the European Union (EU) for BiovaxID®, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.

Bristol-Myers Squibb Company (NYSE: BMY)
today announced that the company will present 18 abstracts on ORENCIA® (abatacept) at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Berlin, June 6-9.

Celsion Corporation (NASDAQ: CLSN)
, a leading oncology drug development company, today announced a joint resubmission with Philips Healthcare of an Investigational New Drug/Investigational Device Exemption (IND/IDE) application with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Celsion's ThermoDox® combined with Philips' Sonalleve® MR-HIFU (MR-guided high intensity focused ultrasound) technology for the treatment of prostate cancer metastases to the bone.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that the results from the Phase 2 studies of CB-5945 (formerly ADL5945) in patients with chronic non-cancer pain and opioid-induced constipation (OIC) will be presented at the 31st Annual Scientific Meeting of the American Pain Society taking place May 16 to 19, 2012, in Honolulu and during Digestive Disease Week 2012 taking place May 19 to 22, 2012, in San Diego.

Eli Lilly and Company (NYSE: LLY)
will present data from more than 25 studies at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. from June 1 – 5, 2012, including overall survival results from PARAMOUNT, a Phase III study of an ALIMTA® (pemetrexed for injection)-based continuation maintenance regimen for the treatment of advanced nonsquamous non-small cell lung cancer. Lilly presented progression-free survival data from PARAMOUNT at the 2011 ASCO meeting.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced that it has entered into an agreement with ALZA Corporation and Janssen Pharmaceutica, N.V. whereby ALZA and Janssen will transfer worldwide rights for Priligy® to Furiex.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX)
and Menarini Group today announced that they have entered into a license agreement by which Furiex will license to Menarini rights to commercialize Priligy® in Europe, most of Asia, Africa, Latin America and the Middle East.

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK)
today announced that it is scheduled to make an investor presentation at the Bank of America Merrill Lynch 2012 Health Care Conference Tuesday, May 15, 2012, at 10:40 p.m. Pacific Daylight Time.

IDenta Corp. (PINKSHEETS: IDTA)
CEO Yaacov Shoham today announced that IDenta Corp. has signed an agreement with a large drug store chain to sell the General Screening Drug Testing Kits and Marijuana Kits in all of the chains thousands of stores."

Imaging Diagnostic Systems, Inc. (OTCBB: IMDS), a pioneer in laser breast imaging, announced today that it has signed a distribution agreement with Shimadzu Medical to market and sell its Computed Tomography Laser Mammography (CTLM®) System in Australia, New Zealand and the Pacific Islands.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced they will present linaclotide-related data in one oral presentation and 16 poster presentations during Digestive Disease Week (DDW) 2012 being held in San Diego, May 19 through May 22, 2012.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer, and Matt Foehr, Executive Vice President and Chief Operating Officer, will present at the Jefferies 2011 Global Healthcare Conference on Monday, June 4, 2012 at 2:00 p.m. Eastern Time (11:00 a.m. Pacific Time).

Mauna Kea Technologies (NYSE Euronext: MKEA)
, the leader in the endomicroscopy market, today announced highlights of the Fourth Annual International Conference of Cellvizio® Users (ICCU), which took place last month in Rome.

Maxygen, Inc. (Nasdaq:MAXY), a biopharmaceutical company, today announced that it will receive a $30.0 million payment from Bayer HealthCare LLC in connection with Bayer’s continued clinical development of a recombinant factor VIIa product candidate for the treatment of hemophilia.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced financial results for three month ended March 31, 2012, and the filing with the U.S. Securities and Exchange Commission (“SEC”) of the Company’s Quarterly Report on Form 10-Q.

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR"), today announced that it had signed reseller agreements with two nationally known Patient Advocate Organizations: Premier Health Advocates and Patient-Advocate.com.

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained the services of Mr. Andrew Hahn to help with the overall design and construction of its laboratory and cGMP pilot production facility.

NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced that former NxStage® System One™ patient Nikolas Gieske of Mequon, Wisconsin, received a kidney transplant following four successful years of more frequent home hemodialysis with the System One.

Ohr Pharmaceutical Inc. (OTCBB: OHRP)
announced today that its Squalamine Eye Drops, a potent inhibitor of multiple growth factors implicated in angiogenesis, has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of the wet form of macular degeneration (wet-AMD).

Palatin Technologies, Inc. (NYSE Amex: PTN) a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its third quarter ended March 31, 2012.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Gregory S. Weishar, Chief Executive Officer, will make a presentation regarding the Company at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas on Wednesday, May 16, 2012, at 11:20 a.m. Pacific Time.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces the Company has formed an independent board to meet corporate governance requirements like that of NASDAQ, which requires a majority of independent Board Members.

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced the effectiveness of a one-for-fifteen reverse stock split of its share capital.

SANUWAVE Health, Inc. (OTCBB: SNWV) today reported financial results for the three months ended March 31, 2012 and provided a business update.

Senesco Technologies, Inc. (NYSE Amex: SNT), announced today that an oral presentation will be delivered at the 15th Annual Meeting of the American Society of Gene & Cell Therapy. The conference will be held May 16-19th, 2012 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.

Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, has appointed Mr. Danny Chung as Chief Financial Officer, effective immediately.

Solazyme, Inc. (NASDAQ:SZYM), a renewable oil and bioproducts company, announced today that the company will be presenting at the following upcoming financial conferences:  Deutsche Bank Clean Tech, Utilities & Power Conference.

Soligenix, Inc. (OTCBB: SNGX), a development stage biopharmaceutical company, announced today its financial results for the quarter ending March 31, 2012.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF)
today announced the closing of the first of two tranches of a US$6.0 million term loan from Midcap Financial LLC ("Midcap").

SurModics IVD Inc., a wholly owned subsidiary of SurModics, Inc. (NASDAQ:SRDX) and a market leader for immunoassay reagents for diagnostic tests, is pleased to announce it will present a poster entitled “Evaluation of Immunoassay Interference Reduction Technologies” at Biomarker World Congress in Philadelphia, PA from May 21 – 23, 2012.

Syneron Medical Ltd. (NASDAQ: ELOS), www.syneron.com, the global leader in medical aesthetic products and technology, announced today recognition in the Essence Best in Black Beauty Awards 2012 for their elure™ Advanced Lightening Night Cream in the skincare category.

Synthetic Biologics, Inc. (NYSE Amex: SYN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the appointment of Carol Reed, M.D., as Senior Vice President of Clinical & Regulatory Affairs.

Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the quarter ended March 31, 2012 and also commented on certain corporate accomplishments and plans.

VolitionRX Limited (VNRX.OB), a life sciences company focused on developing blood-based diagnostic tests, is pleased to announce the closure of a private placement of 582,510 shares at $1.75 per share (a total of US$$1,019,375.00 raised).

Walgreens (NYSE: WAG) (NASDAQ: WAG) today launched its national Retail Employees with Disabilities Initiative (REDI).



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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