FDA Unanimously Recommends Approval of Gattex; FDA Tentatively Approves Perrigo's OTC Version Of Omeprazole And Sodium Bicarbonate Capsules Print E-mail
By Staff and Wire Reports   
Tuesday, 16 October 2012 18:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 16, 2012.

NPS Pharmaceuticals (NASDAQ: NPSP)
, announced the U.S. FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex® (teduglutide) for adults with short bowel syndrome (SBS). The committee's recommendation will be considered by the FDA in its review of the company's New Drug Application (NDA) for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, 2012.

NPS also today reported that five additional patients have successfully achieved independence from parenteral nutrition (PN) and intravenous (IV) fluids while on long-term Gattex® (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult SBS. To date, 12 patients or 14 percent have achieved independence from PN/IV fluids while on Gattex therapy in the ongoing STEPS 2 study.

“The results of today's advisory committee reinforced our belief in the favorable benefit-risk profile of Gattex,” said Francois Nader, MD. “The unique mechanism of Gattex could make it the first and only long-term therapy that treats the underlying cause of this rare disorder by helping patients increase their ability to absorb nutrients and fluids to reduce or even eliminate their dependence on parenteral support. With 14 percent of patients completely eliminating the need for parenteral support in STEPS 2, we believe Gattex could be a life-changing therapy for patients with short bowel syndrome.”

SBS is a serious, complex disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal track to sustain life. SBS is typically treated with PN/IV fluids that do not treat the underlying disorder, which is the body's inability to absorb nutrients and fluids. In addition, long-term use of PN/ IV fluids can be associated with life-threatening complications such as liver damage, serious bloodstream infections, and blood clots.


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The Perrigo Company (NASDAQ: PRGO)
announced it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) to market over-the-counter (OTC) omeprazole and sodium bicarbonate capsules 20mg/1100mg, the store brand equivalent to Merck & Co.'s Zegerid OTC®. Perrigo expects to launch the product on the date when market formation occurs.

Zegerid OTC® (omeprazole and sodium bicarbonate capsules 20mg/1100mg), a proton pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the last 12 months.

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "Our research and development group worked diligently to achieve this milestone. This is another excellent example of Perrigo's investment and commitment to making quality healthcare more affordable for our customers."



Also Tuesday:



ReliaBrand® Inc. (OTCBB:RLIA)
officially introduced its new Adiri® NxGen® brand of baby bottles and infant feeding accessories at the ABC KIDS EXPO in Louisville, Kentucky this week.

AeroGrow International, Inc. (OTCQB: AERO)
("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, announced today the effectiveness of a 1-for-100 reverse split of its common stock.

Alexandria Real Estate Equities, Inc. (NYSE: ARE)
is pleased to announce its renowned panel of thought leaders at the prestigious annual Galien Forum being held today at the Alexandria Center for Life Science – New York City.

EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF)(MUN:EY6)
("EasyMed" or the "Company") reports the publication by the University Hospital of Geneva (UHG) of a large-scale study performed by the Division of Primary Care Medicine using EasyMed's technology.

Hadasit Bio-Holdings Ltd. (OTC: HADSY, TASE: HDST)
a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced today that Ophir Shahaf, the Company's Chief Executive Officer, will be a member of the Hadassah Centennial Convention's Business Session panel on Thursday, October 18th in Jerusalem.

Heska Corporation (NASDAQ: HSKA)
, a provider of advanced veterinary diagnostic and other specialty veterinary products, announced today that it is further extending the expiration date for its tender offer for the purchase for cash of all shares of its common stock held by stockholders that owned 99 or fewer shares as of the close of business on August 21, 2012 and that continue to own such shares through the expiration date of the offer.

Johnson & Johnson (NYSE: JNJ)
today announced sales of $17.1 billion for the third quarter of 2012, an increase of 6.5% as compared to the third quarter of 2011.

La Jolla Pharmaceutical Company (OTCQB: LJPC)
(the "Company" and "La Jolla") announced today that researchers at UCLA's Jonsson Comprehensive Cancer Center have discovered the mechanism by which the Company's lead drug candidate, GS-100, makes lymphoma cells more responsive to chemotherapy.

MediaTechnics Corporation (PINKSHEETS: MEDT)
is pleased to announce that it executed an agreement to purchase MedLaw Capital LLC. of Fountain Hills, Arizona ("MEDLAW") in exchange for restricted preferred stock on Labor Day, September 3, 2012.

OPTIMIZERx Corp. (OTCBB: OPRX)
DrFirst, the nation's leading e-prescribing and solutions platform provider, announced today the launch of Patient Advisorsm, a medication adherence solution that works within DrFirst's Rcopia e-prescribing platform, or any EMR or HIT solution.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it will report financial results for the third quarter ended September 30, 2012 after market closes on Tuesday, October 30, 2012.

Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS)
today announced the development of two new breakthrough platform technologies for targeted drug delivery that can enable and enhance patient outcomes for many acute and chronic conditions where there are high rates of occurrence but limited treatment options available.

VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA)
, a biotechnology company applying stem cell technology for drug rescue and novel pharmaceutical assays for predictive heart and liver toxicology and drug metabolism screening, today announced the completion of the previously announced $3.25 million financing commitment with Platinum Long Term Growth VII, LLC (Platinum) and approximately $3.0 million strategic debt restructuring.

World Health Energy Holdings, Inc. (PINKSHEETS: WHEN)
, a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today the results of 3 water desalination & water purification tests.



"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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