|FDA Approves Sanofi's Nasacort Allergy 24HR Nasal Spray; Auxilium Announces License Agreement with Vivus for Marketing Rights to STENDRA|
|By Staff and Wire Reports|
|Friday, 11 October 2013 19:02|
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.
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.
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.
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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.