Teva Presents Positive Safety and Efficacy Data for QNASL®; Avanir Announces Preliminary Feedback from the FDA on AVP-825 Print E-mail
By David Fowler   
Friday, 07 November 2014 18:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 7, 2014.

Teva Pharmaceutical Industries Ltd., (NYSE:TEVA)
announced positive findings from a Phase III clinical study which examined the safety and efficacy of QNASL® (beclomethasone dipropionate) Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial – or “year round” – allergic rhinitis (PAR). QNASL is a waterless aerosol intranasal corticosteroid spray currently available for the treatment of PAR and seasonal allergic rhinitis (SAR) in patients 12 years of age and older. The data will be presented at the 2014 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Atlanta, Georgia on Saturday, November 8 and Sunday, November 9.

“As a company deep-rooted in its commitment to helping people living with respiratory conditions, such as allergic rhinitis, we look forward to the potential for bringing this new, specially formulated treatment option to market,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “It is our goal at Teva to address patients’ unmet needs and we believe these findings support QNASL as a prospective treatment for children suffering from the symptoms associated with nasal allergies.”

On May 13, 2014, the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for a lower dose QNASL for the treatment of PAR and SAR in children 4-11 years of age. The submission was based on a comprehensive clinical development program consisting of three Phase III clinical trials designed to evaluate the safety and efficacy of QNASL 80 μg/day in children with allergic rhinitis (AR). If approved, QNASL will be the first and only waterless HFA nasal allergy treatment available for patients as young as four years of age.

“Since there are limited new treatment options available to help manage allergic rhinitis in the pediatric patient population, it is certainly exciting to see these results for QNASL,” said study investigator Dr. William Berger of the Allergy and Asthma Associates of Southern California in Mission Viejo, California. “This treatment features a low-dose formulation and ‘waterless’ aerosol delivery, making it a promising option for children with allergic rhinitis.”

The 12-week, Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trial enrolled 547 patients ages 4 to 11 to receive two actuations (one 40 μg/actuation per nostril) of QNASL or placebo nasal aerosol once daily. Symptoms were measured at 6 weeks and 12 weeks using average morning (AM) and evening (PM) reflective and instantaneous nasal symptom scores. Results indicate that patients treated with QNASL experienced a significantly greater improvement in PAR symptoms than patients treated with placebo. Overall, QNASL was well tolerated throughout the duration of the study with a safety profile comparable to placebo.




Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
announced the U.S. FDA has issued preliminary written feedback to its New Drug Application (NDA) for AVP-825. AVP-825 is a drug-device combination product consisting of low-dose sumatriptan powder, delivered intranasally utilizing a novel Breath Powered delivery technology. The FDA has raised questions regarding the human factor validation study data submitted as part of the NDA. Human factor testing focuses on the interactions between people and devices. The goal of human factor testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.  Although the NDA review is ongoing, Avanir has concluded, at this time, that approval of AVP-825 may be unlikely by the PDUFA date of November, 26, 2014.

The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle to convey early thoughts on possible deficiencies of an application.  In the letter, the FDA requested that the company optimize the product-user interface and conduct additional human factor testing. In addition, the FDA commented that the NDA review is not complete and that they may have additional comments regarding the application.

"We are currently reviewing the correspondence from the FDA and are awaiting the final feedback when the full NDA review cycle is complete on November 26th," said Joao Siffert, MD, chief medical officer of Avanir. "We plan to work closely with the FDA to answer the agency's questions and satisfy their requirements. We remain confident that AVP-825 will be an important new treatment option for migraine patients who are in need of alternative, fast acting and well tolerated medications."

About AVP-825  --  AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. AVP-825 is an investigational drug-device combination product not approved by the FDA. Sumatriptan is the most commonly prescribed migraine medication. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.

The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing or inhalation of sumatriptan powder into the lungs.

About Migraine  --  Migraine represents an area of significant unmet medical need. According to the Centers for Disease Control and Prevention, over 37 million Americans suffer from migraine headaches. The triptan class of medications is generally considered the standard of care with over 13 million prescriptions written annually. Sumatriptan is the class leader with a market share of over 50% making it the most commonly prescribed migraine drug in the U.S. 100 mg tablets are the most commonly prescribed form of sumatriptan.  In a clinical study, over 40% of patients were not satisfied with the degree of relief they experienced from their current prescription migraine medications and nearly 80% of them were willing to try another medication.  As a result, many migraine sufferers are seeking new fast-acting, well tolerated treatment options.

Also Friday:

3D Systems Corporation (NYSE:DDD)
announced today that it named Kevin McAlea Executive Vice-President & Chief Operating Officer for its healthcare business.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the Company will hold a conference call to discuss the data from the laboratory of Eduardo Marbán, M.D., Ph.D., Capricor's Scientific Advisory Board Chairman and the Director of the Cedars-Sinai Heart Institute.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced that Krisztina Zsebo, Ph.D., Chief Executive Officer, will present a corporate overview at the Credit Suisse Healthcare Conference, being held at the Arizona Biltmore Hotel, Scottsdale, Arizona.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today reported financial results and a corporate update for the third quarter 2014.

The House Veterans Affairs Subcommittee on Health has invited CNS Response  (OTCBB:CNSO) Chairman Tom Tierney and CEO George Carpenter to submit testimony on November 19, 2014 for hearing in consideration of HR 5059, the Clay Hunt Suicide Prevention Act.

Coronado Biosciences, Inc. (Nasdaq:CNDO)
announced today that it raised $3,501,750 through the sale of restricted common stock.

ERBA Diagnostics, Inc. (NYSE MKT:ERB)
will be featuring two new fully automated diagnostic testing instruments, the Hb-Vario diabetes monitoring system and the Laura XL urinalysis processer, at MEDICA 2014 in Dusseldorf Germany, November 12-15. 

Fibrocell Science, Inc. (Nasdaq:FCSC)
, an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today reported financial results for the third quarter 2014.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 1/2a trial of GALE-301, a Folate Binding Protein (FBP)-derived immunotherapy, will be presented today at the upcoming Society for Immunotherapy of Cancer (SITC) 29th Annual Meeting.

Golden Hour Data Systems, Inc. announces it has entered into a historic Patent Royalty Licensing Agreement with PHI Air Medical LLC, a PHI Company (PHII:NASDAQ).

GrowBLOX Sciences, Inc., (OTCQB:GBLX)
, a company that merges state-of-the-art technologies in plant biology, cultivation technology and post-production processes in order to optimize our safe and consistent medicinal cannabis, has joined forces with cannabis industry enterprise software leader MJ Freeway to develop a breakthrough app which will enhance the medical cannabis patient experience.

Idera Pharmaceuticals (Nasdaq:IDRA)
and Parent Project Muscular Dystrophy (PPMD) today announced a collaboration to advance Idera's proprietary Toll-like receptor (TLR) technology for the treatment of Duchenne muscular dystrophy.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that the Company was honored by the Research & Development Council of New Jersey with their coveted Edison Patent Award, in recognition of the Company's significant achievements in the biotechnology category for its novel linker technology in building paradigm-changing antibody-drug conjugates (ADCs).

INC Research Holdings, Inc. (Nasdaq:INCR)
, a leading, global Phase I to IV contract research organization, will visit the Nasdaq MarketSite in Times Square in celebration of its initial public offering (IPO) which will occur today, November 7.

Loxo Oncology, Inc. (Nasdaq:LOXO)
, a biopharmaceutical company focused on developing targeted cancer therapies for genetically-defined populations, will announce financial results for the third quarter ended September 30, 2014 on November 14, 2014 before the NASDAQ market open.

MedAssets (Nasdaq:MDAS) recently held its 13th annual Business and Technology Forum in Dallas, Texas.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate in two investor conferences this month.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill.

NanoString Technologies, Inc. (Nasdaq:NSTG)
, a provider of life science translational research and molecular diagnostic products, today announced that its management is scheduled to present at the Canaccord Genuity Medical Technology and Diagnostics Forum in New York City.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has submitted, through its subsidiary Nuvilex Australia, an application to the Therapeutic Goods Administration (TGA) in Australia to obtain the Orphan Drug Designation for its pancreatic cancer treatment.

OraSure Technologies, Inc. (Nasdaq:OSUR)
today announced that Douglas A. Michels, President and CEO, will speak to the investment community at the Stephens 2014 Fall Investment Conference in New York City, New York.

SAGE Therapeutics (Nasdaq:SAGE)
, a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced that six abstracts have been accepted for poster presentations at Neuroscience 2014, the Society for Neuroscience's 44th Annual Meeting.

Swisher Hygiene Inc. (Nasdaq:SWSH)
, a leading service provider of essential hygiene and sanitizing solutions, today announced that it will report its third quarter 2014 results after market close on Monday, November 10, 2014 and will host a conference call and live webcast to discuss the results on Tuesday, November 11, 2014 at 8:30 AM Eastern time.

TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG)
today announced the appointment of Mary Ann Gray, Ph.D. and Mr. Michael D. Kishbauch as Class I directors to fill two board slots that have been vacant since January 2014.

ViaDerma, Inc. (OTCQB:VDRM)
, a specialty pharmaceutical company devoted to bringing new products to market, has recently released a revolutionary new wound care drug called TetraStem.

"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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