FDA Approves Sanofi's Nasacort Allergy 24HR Nasal Spray; Auxilium Announces License Agreement with Vivus for Marketing Rights to STENDRA Print
By Staff and Wire Reports   
Friday, 11 October 2013 19:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 11, 2013.

Sanofi (NYSE: SNY)
announced the U.S. FDA approved Nasacort® Allergy 24HR nasal spray as an over-the-counter (OTC) treatment for seasonal and year-round nasal allergies in adults and children 2 years of age and older. Nasacort is the first and only medicine in its class to be available without a prescription and will be marketed by Sanofi's consumer healthcare division, Chattem, Inc.

"We believe there is significant value in making certain types of medicines, like Nasacort, directly available to consumers," said Anne Whitaker, President, North America Pharmaceuticals, Sanofi US.  "Allergy sufferers will benefit from having an additional treatment option and it's a strong addition to our existing consumer health portfolio."

Up to 60 million Americans suffer from seasonal and year-round nasal allergies annually.  This can have a major disruption to the quality of life of both adults and children, interfering with sleep, outdoor activities, and for children their performance at school. Nasacort and nasal sprays in the same medication class are considered the most effective treatment for hay fever and other upper respiratory allergies.



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Auxilium Pharmaceuticals (NASDAQ: AUXL)
announced the signing of an agreement with VIVUS (NASDAQ: VVUS) providing Auxilium with the exclusive right to market VIVUS's product, STENDRA (avanafil), in the United States and Canada.  The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be initially responsible for the manufacture and supply of STENDRA to Auxilium.

STENDRA is an oral therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).

Under the license, Auxilium will pay VIVUS a one-time license fee of $30 million.  Auxilium may make a $15 million regulatory milestone payment to VIVUS if the FDA approves the STENDRA label to reflect a 15 minute or less onset of action efficacy claim and up to $255 million in potential milestone payments based on the achievement of certain sales targets. VIVUS will also receive royalties on product sales.



Also Friday:



On October 8, 2013, a class action lawsuit was filed in the United States District Court for the District of Connecticut against Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN).

Advanced Medical Isotope Corporation (OTCBB:ADMD)
, a company engaged in the production and distribution of medical isotopes, today announced that Kenin M. Spivak has been elected to its board of directors as vice-chairman of the board.

Agilent Technologies Inc. (NYSE:A)
today announced it is sponsoring a free scientific symposium on exposomics and the etiology of disease.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
, a specialty biopharmaceutical company, announced today the signing of an agreement with VIVUS, Inc. (Nasdaq: VVUS) providing Auxilium with the exclusive right to market VIVUS's product, STENDRA (avanafil), in the United States and Canada.

Brazil Interactive Media, Inc. (OTCQB: BIMI)
, a Brazil-based, interactive TV entertainment, production and broadcasting Company, today announced a 148% increase in minutes billed to its customers during the month ended September 30, 2013 vs. the same period 2012.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, is exhibiting its next generation FORE-SIGHT ELITE™ Cerebral Oximetry product at the American Society of Anesthesiologists (ASA) Annual Meeting, being held October 12-16, 2013, at the Moscone Center in San Francisco.

CEL-SCI Corporation (NYSE MKT: CVM)
, a late-stage oncology company, today announced the closing of its previously announced underwritten public offering.

Fuse Science, Inc. (OTCQB: DROP)
, a consumer products and delivery technology company that is developing new, patent-pending technologies poised to redefine how consumers receive energy, medicines, vitamins and minerals, is pleased to announce Stanley Cup champion Kris Versteeg of the Florida Panthers is now "Powered By Fuse®" and whose story will be told as part of the regional and national advertising campaigns currently being produced by Fuse Science®.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company’s supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair® (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc. – is honored to announce that HempMedsPX™ has retained Cheryl Shuman as a brand ambassador.

Otsuka Holdings Co., Ltd. announced today that its wholly-owned subsidiary, Otsuka Pharmaceutical Co., Ltd. (“Otsuka Pharmaceutical”), successfully completed, through its wholly-owned indirect subsidiary Autumn Acquisition Corporation, its acquisition of Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) for US $8.50 per share, net to the seller in cash, without interest and less any required withholding taxes.

Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS)
and its wholly owned subsidiary Alkame Water Inc. are pleased to announce the appointment of Mr. Eric McClure to the new positions of Director of Cause Related Marketing & Creative Director.

Press Ventures Inc. (OTCQB: PVEN)
, through its wholly-owned Polish subsidiary Biosafety Systems, Inc. Sp z o.o. ("BSI"), is pleased to announce that it has launched an online systems engineering application for its patented natural Cedar Leaf Oil Diffusion ("CLO-D") bacteria and virus biosafety system on the BSI website.

Seattle Genetics, Inc. (Nasdaq: SGEN)
today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 9th International Symposium on Hodgkin Lymphoma (ISHL) being held October 12-15, 2013 in Cologne, Germany. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

SK3 Group, Inc. (OTC Pink: SKTO)
announced that it plans to release 3rd quarter results by month's end.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
, an emerging leader in the Local search space, today announced that it will host an investor conference call after the market close on Thursday October 17, 2013 to discuss the Company's recent acquisition, financing and pending audit.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health delivery system, today announced that it will host an investor conference call at 11:15 a.m. EDT on Thursday, October 17, 2013, to discuss the information contained in the Company's Form 10-K for the year ended December 31, 2013.

Vaccinogen, Inc. (OTC:VGEN) a pioneer in cancer immunotherapy, today announced that its cofounder, Chairman, and CEO Michael G. Hanna, Jr., Ph.D., will deliver a keynote address on the impact of genomic sequencing data in cancer immunotherapy at the 2nd International Conference on Clinical & Cellular Immunology (the Immunology Summit-2013) on October 15, 2013.



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