Medtronic's Pacifier Trial Study Met Primary Endpoint; Teva's Study of Armodafinil Failed to Meet Primary, Secondary Endpoints Print E-mail
By Staff and Wire Reports   
Wednesday, 23 January 2013 20:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 23, 2013.

Medtronic, Inc. (NYSE: MDT)
,  announced completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries (SFA and PPA).

IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that enrolled 181 patients at more than 40 U.S. sites and randomized them 2:1 to treatment with either the IN.PACT Admiral drug-eluting balloon (study arm) or a traditional, non-coated angioplasty balloon (control arm). Its primary efficacy endpoint is primary patency, a measure of blood flow through the treated arterial segment, at 12 months.

The principal investigators of IN.PACT SFA II are interventional cardiologist Dr. John Laird, professor of medicine at the University of California Davis and medical director of the UC Davis Vascular Center, and vascular surgeon Dr. Peter Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu.

Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I, which previously completed enrollment of 150 patients in Europe, to support a premarket approval (PMA) application to the U.S. FDA.


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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA)
announced top-line results of its Phase III clinical program for armodafinil (NUVIGIL®) as adjunct therapy in adults with major depression associated with bipolar 1 disorder. While study 3072 demonstrated a numerical improvement, it did not reach statistical significance in meeting its primary endpoint -- to determine whether armodafinil treatment, at a dosage of 150 mg per day, is more effective than placebo as adjunct therapy to mood stabilizers and/or atypical antipsychotics. This is the second of three, Phase III studies; results of the first pivotal study 3071 announced in May, 2012 were positive (P=0.0097). Study 3073 and open-label extension study 3074 are ongoing; results are expected for study 3073 later this year.

“While we are disappointed that the second study did not reach statistical significance, we are firmly committed to continuing with the third, Phase III trial based on the promising results of the first study, the trend seen in the second, and comparable safety results between the two studies. Bipolar 1 disorder is a complex disease where there remains a significant unmet patient need to successfully treat associated depressive episodes,” said Michael Hayden, M.D., president of Global R&D and Chief Scientific Officer. “We believe that armodafinil may have a unique mechanism of action in patients with depression associated with bipolar 1 disorder, and we will continue to study it as adjunct therapy in adults with this debilitating disease. At Teva, we are dedicated to advancing the science in serious neuropsychiatric conditions, such as this.”

Bipolar disorder is among the top 20 most severely disabling disorders.i Bipolar 1 disorder is defined by manic or mixed episodes that last at least a week in which an individual feels abnormally euphoric, optimistic, and energetic, and can be so severe as to require hospitalization, followed by depressive episodes typically lasting at least two weeks. The depressive episodes of bipolar 1 disorder can be so severe that the person cannot function normally at work, school, or homeii.



Also Wednesday:




Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that ILUVIEN® is not cost effective for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Amgen (NASDAQ: AMGN)
today announced financial results for the fourth quarter and full year of 2012.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
, a specialty biopharmaceutical company ("Auxilium"), today announced that it intends, subject to market and other conditions, to offer $200.0 million aggregate principal amount of Convertible Senior Notes due 2018 (the "Convertible Notes") in an offering (the "Offering") registered under the Securities Act of 1933, as amended (the "Securities Act").

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that it has launched a website to showcase OCCULASE, a wholly-owned subsidiary of BIOLASE, dedicated to expanding the multiple applications of its proprietary WaterLase technology and other related intellectual property into ophthalmology.

BrainStorm Cell Therapeutics (OTC.QB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that its CEO, Dr. Adrian Harel, has issued an Annual Letter to Shareholders summarizing the company’s extremely significant developments of 2012

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended December 31, 2012 after the market closes on Monday, February 4, 2013 and will host a conference call at 5:00 p.m. ET that day to discuss its results.

eHealth, Inc. (NASDAQ: EHTH)
, parent company of eHealthInsurance and America's first and largest private health insurance exchange, has released a new version of its "eHealth Mobile" mobile application.

GeoVax Labs, Inc. (OTCQB: GOVX)
, an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, unveiled its new website January 23rd.

Given Imaging (NASDAQ: GIVN)
today announced that the company will host a conference call on Wednesday, February 13, 2013 at 9:00am ET, 4:00pm Israel time to discuss fourth quarter 2012 financial results.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that its Magellan™ Robotic System was utilized in two successful live endovascular aortic aneurysm repair (EVAR) cases broadcast at the 25th Annual International Symposium on Endovascular Therapy (ISET), on January 22nd at the Fontainebleau Miami Beach Hotel in Miami, FL.

Hospira, Inc. (NYSE: HSP)
, the world's leading provider of injectable drugs and infusion technologies, today announced that its TheraDoc™ Infection Control Assistant™ has been ranked as the top product in the Infection Control & Monitoring software category in the recently released Best in KLAS Awards 2012: Software and Services Report (more information available at www.theradoc.com).

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the appointment of Tracey H. Wielinski as Vice President, Global Regulatory/Clinical Affairs and Quality Assurance.

Life Technologies Corporation (NASDAQ: LIFE)
announced today it is #33 among the "Global 100 Most Sustainable Corporations."

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced today plans to report fourth quarter 2012 financial results on Wednesday, February 13, 2013.

Lignol Energy Corporation (TSXV: LEC)
("LEC" or "the Company"), a leading technology development company in the advanced biofuels and renewable chemicals sector, today announced that it is currently evaluating various opportunities to increase the value of its investment in Australian Renewable Fuels Ltd. (ASX: ARW) ("ARW") and identify areas for collaboration between the two organizations.

Mannatech, Incorporated (NASDAQ: MTEX)
, the leading innovator and provider of nutritional supplements based on Real Food Technology® solutions, announced today the results of its Founder’s Challenge initiative in December 2012.

Medifocus Inc. (OTCQX: MDFZF) (TSX VENTURE: MFS)
(Medifocus or the Company) is pleased to announce its preliminary results for the fourth quarter of 2012, relative to the accelerated rollout of its recently acquired Prolieve® Thermodilatation System, designed to provide a relatively painless and effective alternative to drug therapy and certain types of surgical procedures used to treat the symptoms of Benign Prostatic Hyperplasia (BPH).

MMR Global (OTCQB: MMRF)
with a current market cap of $10 million, provides secure and easy-to-use online Personal Health Records ("PHRs") and electronic safe deposit box storage solutions, serving consumers, healthcare professionals, employers, insurance companies, financial institutions, retail pharmacies, and professional organizations and affinity groups.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records (PHRs) MyEsafeDepositBox storage solutions and MMRPro document management and imaging systems for healthcare professionals, is featured in a Special Report dated January 22, 2013 (http://michaelbass.com/PDF/Patent_Valuation.pdf), published by the Michael Bass Research Group on the Personal Health Records market, with particular emphasis on MMRGlobal's MyMedicalRecords Health Information Technology Global Patent portfolio.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
announced today that two additional patents have been granted related to the Company's proprietary Vesicular Monoamine Transporter 2 inhibitor (VMAT2) NBI-98854.

Sigma-Aldrich Corporation (NASDAQ: SIAL)
will hold its quarterly conference call to discuss fourth quarter and full-year 2012 results on Thursday, February 7, 2013, at 11:00 AM Eastern Time.

Venaxis, Inc. (Nasdaq: APPY)
, an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its blood-based appendicitis test, APPY1, today announced that it will present at the 2013 BIO CEO and Investor Conference, to be held February 11-12, 2013, at the Waldorf Astoria Hotel in New York.

VistaGen Therapeutics, Inc. (OTCQB: VSTA)
, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, today announced the successful completion of its final Phase 1 safety study of AV-101, a novel orally available prodrug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain.



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