Glaxo, Theravance Confirm Positive CHMP Opinion for Relvar Ellipta; Repros Issues Added Info Confirming Success for Study ZA-302 Print E-mail
By Staff and Wire Reports   
Thursday, 19 September 2013 19:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 19, 2013.

GlaxoSmithKline plc (NYSE: GSK) (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name RELVAR(TM) ELLIPTA(TM) for;

Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:  -- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists

COPD: the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1 < 70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy

Relvar is a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long-acting beta2-agonist (LABA) vilanterol "VI". Two strengths of FF/VI are proposed for asthma (92/22 mcg and 184/22 mcg) and one strength is proposed for COPD (92/22 mcg). All strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).



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Repros Therapeutics Inc.® (Nasdaq: RPRX)
reported additional topline results for study ZA-302, the second pivotal efficacy study for Androxal®. The results of both pivotal studies, ZA-301 and ZA-302, have met the SPA co-primary endpoints as defined by the FDA.

Study ZA-302 had no detected site anomalies. Additional data which may be of interest to investors are provided below for informational purposes. It should be noted that these results are topline and not fully audited. However, the Company does not believe any changes will occur that will affect the conclusions that can be drawn.

The Company has conducted several placebo controlled trials of Androxal in the treatment of secondary hypogonadism. In every study Androxal achieved highly statistically significant and clinically relevant improvement in testicular function as evidenced by improved endogenous production of the male hormone. Importantly, Androxal improves pituitary secretions of important hormones necessary to maintain normal testicular function including both testosterone synthesis and spermatogenesis. This feature distinguishes Androxal from all of the testosterone replacement therapies which, via the negative feedback on the pituitary of exogenous testosterone, result in suppression of pituitary signaling and testicular function.



Also Thursday:



AtheroNova Inc. (OTCBB: AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Chairman and CEO, Thomas W. Gardner, will present a corporate overview at the 2013 Aegis Capital Healthcare Conference.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, will display its ForeCYTE Breast Health Test at the Pri-Med East 2013 Conference & Exhibition from September 19 through September 22, 2013, in Boston, MA.

Ambit Biosciences (Nasdaq: AMBI)
, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the Company's participation at the BioCentury NewsMakers in the Biotech Industry conference at the Millennium Broadway Hotel in New York City on Friday, September 27, 2013.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first-in-class collagenase-based products marketed as XIAFLEX® in the U.S and XIAPEX® in the EU, today announced that BioSpecifics' President, Tom Wegman, will present a corporate overview at the Aegis Capital 2013 Healthcare Conference.

Cempra, Inc. (Nasdaq:CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra, will present at the NewsMakers in the Biotech Industry conference at 1:30 p.m. EDT, Friday, Sept. 27, at the Millennium Broadway Hotel & Conference Center in New York.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
today announced updated data showing that sapacitabine has activity against a majority of ovarian cancer samples taken from patients, including resistant tumors.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced that Herb C. Cross will join the company as of September 23, 2013, and transition into the Chief Financial Officer role in coordination with Jeffrey H. Cooper, the company's current CFO.  

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced it has named F. Michael (Mike) Ball, Chief Executive Officer (CEO) of Hospira, Inc. (NYSE:HSP) to its Board of Directors.

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry, today announced that the Company has received purchase orders in excess of eight thousand units (8000) for Vancouver, Canada and Washington state based dispensaries to provide its Hemp based beverages and energy drink Chillo and C+ Swiss Teas for the month of September.

Nuvilex, Inc. (OTCQB: NVLX)
made another subtle but significant move this week that seems to signal the company is in "go-mode" on its future Phase III pancreatic cancer clinical trials.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is proud to announce that the Corporate Directors Forum (CDF) named the Company's long-standing board member, Jack Blair, as Director of the Year for Corporate Governance at an awards ceremony on September 18th.

Omeros Corporation (NASDAQ: OMER)
today announced initiation of enrollment in a Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor.

Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that SAFC® Commercial,its custom manufacturing services business unit, has engineered additional traits into its CHOZN®  Platform cell line, increasing the utility of the CHOZN® portfolio of products and services.



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