Novartis Reports Nine New Analyses Show Co.'s LCZ696; Trevena Announces Positive Top-Line Results From Phase 2a/b Study Of TRV130 Print E-mail
By Josh Gee   
Monday, 17 November 2014 20:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 17, 2014.
New data on Novartis` investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients[1],[2]. In August 2014 Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization[4].

The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly[1],[2]:

  •     reduced the risk of dying suddenly by 20%[2] - in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden[2]
  •     reduced first and subsequent HFrEF hospitalizations by 21% and 23% respectively[1]
  •     reduced hospitalizations for a cardiovascular reason or for any reason both by 16%[1]
  •     reduced the need for more intense treatment at home by 16%[1]
  •     reduced emergency room visits because of rapid symptom worsening by 30%[1]

When hospitalized, LCZ696 and enalapril patients remained under care for approximately the same time, but those on LCZ696 had 18% fewer stays in intensive care and were 31% less likely to need IV drugs to help their heart pump. Patients` reports of how well they felt and doctors` assessments of disease severity were also significantly better with LCZ696 than enalapril[1].

"These results provide strong evidence that we may be able to do more than reduce risk of death or hospitalization with LCZ696 versus enalapril. This therapy offers hope to millions of people living with HFrEF that they can also reduce or slow the decline in their heart function, potentially altering the progression of their disease," said David Epstein, Division Head, Novartis Pharmaceuticals.

Analysis of cardiac biomarkers (NTpro-BNP and troponin), substances that indicate the progression of cardiac disease and risk, showed levels were consistently lower with LCZ696 than enalapril, reflecting reduced heart stress and subsequent damage[1],[2].

LCZ696, a twice a day medicine being investigated for heart failure, acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS). Currently available medicines for HFrEF only block the harmful effects and mortality remains very high with up to 50% of patients dying within 5 years of a diagnosis of heart failure[4],[5],[6].

Novartis plans to complete the file for marketing authorization with the US FDA by the end of 2014 and in the European Union in early 2015.


 
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Trevena, Inc. (NASDAQ: TRVN)
, announced positive top-line data from its randomized, double-blind, placebo- and active-controlled Phase 2a/b trial of TRV130 in moderate-to-severe postoperative acute pain. At doses of 2 mg and 3 mg TRV130 administered every 3 hours, the study achieved its primary endpoint of statistically greater pain reduction than placebo over 48 hours, successfully demonstrating proof of concept for TRV130.

The trial was designed with key secondary endpoints to evaluate the differentiation of TRV130 from gold-standard morphine at a standard reference dose of 4 mg every 4 hours. Over the 48 hour study period, TRV130 3 mg every 3 hours showed statistically superior analgesic efficacy compared to morphine. Additionally, the 2 mg and 3 mg doses of TRV130 demonstrated statistically superior analgesic efficacy compared to 4 mg morphine in the first 3 hours of dosing, when study pain was most severe. For these doses, patients also reported maximum pain relief during the first dosing period that was statistically superior compared to morphine. Notably, in this study TRV130 at 2 mg and 3 mg demonstrated similar tolerability to morphine 4 mg over 48 hours. TRV130 and morphine were both associated with opioid-related adverse events, including dizziness, headache, somnolence, nausea, vomiting, flushing, and itching.

“The data from this trial are impressive, suggesting that TRV130 may offer a superior product profile versus morphine, which frequently causes dose-limiting adverse events and often fails to fully manage post-surgical pain,” said Lynn Webster, M.D., past president of the American Academy of Pain Medicine. “Importantly, the study data demonstrate that treatment with TRV130 significantly improved analgesia versus a standard dose of morphine particularly in the early hours after surgery, when pain levels are at their highest. This increased efficacy was achieved with tolerability similar to morphine over the study period. TRV130 may therefore represent an important advance in pain management.”



 
Also Monday:


 
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a diversified biotechnology company focused on the development of diagnostic and therapeutic products in the areas of neurology, psychiatry and ophthalmology announced today that it plans to host a conference call with the investment community on Tuesday, November 18, 2014.

 Amicus Therapeutics (Nasdaq:FOLD),
a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced it has commenced a $75 million underwritten public offering of its common stock.

Anavex Life Sciences Corp. (OTCQB:AVXL)
announced full data results from the Phase 1 clinical trial of ANAVEX 2-73, the Company's lead investigational oral treatment for Alzheimer's, which has shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that it will present two posters on diffuse large B-cell lymphoma (DLBCL) at the 56th annual meeting of the American Society of Hematology (ASH), in San Francisco, CA.

ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today reported additional data from a Phase II clinical trial (the CLEAR trial) with CCX168, an inhibitor targeting the receptor for the complement protein known as C5a (C5aR), in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Corium International, Inc. (Nasdaq:CORI)
, a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited financial results for the fiscal year ended September 30, 2014 and reported on recent corporate developments.

DS Healthcare Group, Inc. (NASDAQ: DSKX)
, a leading developer of personal care products, today announced financial results for the three and nine months ended September 30, 2014.

Elbit Vision Systems Ltd. (OTCBB:EVSNF)
, a global provider of vision technology for automatic surface inspection and in-line quality monitoring systems, today announced its consolidated financial results for the three month period ending September 30, 2014.

Flexion Therapeutics, Inc. (Nasdaq:FLXN)
today announced that CFO Frederick Driscoll will present at the Stifel Healthcare Conference 2014 on Wednesday, November 19, 2014 at 2:25 p.m. Eastern Time.

FutureWorld Corp. (OTCQB: FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, today announced financial results for the three and nine months ended September 30, 2014.

GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that Justin Gover, GW's Chief Executive Officer, is scheduled to present at the Jefferies 2014 Global Healthcare Conference in London, England on Wednesday, 19 November, 2014 at 4:20 p.m. GMT/11:20 a.m. EST time.

Intercept Pharmaceuticals (Nasdaq:ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, announced today the appointment of Lisa Bright as Senior Vice President and Head of Europe, effective November 17, 2014.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
, a biopharmaceutical company focused on bringing innovative therapies to market for patients with renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the trade name Auryxia™ (ferric citrate) for its FDA-approved ferric citrate.

Kite Pharma, Inc., (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).

mCig®, Inc. (OTCQB:MCIG)
, a technology company that owns, manufactures, and distributes the mCig®, VitaCig®, and Vapolution products, today introduced its 8th consumer product in less than a year of operations.

MergeWorthRx Corp. (Nasdaq:MWRX)
, a special purpose acquisition company focused on the U.S. healthcare services market, and privately-held AeroCare Holdings, Inc. (AeroCare), a national leader in home respiratory therapy services, announced today that Steve Griggs, Founder, Chairman & CEO of AeroCare and Charles Fistel, CEO of MergeWorthRx Corp., are scheduled to present at the Oppenheimer 25th Annual Healthcare Conference in New York on Wednesday, December 10, 2014 at 1:00 p.m. EST.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced the election of Vivian S. Lee, Ph.D., M.D., M.B.A. to its Board of Directors. Lee currently serves as the Senior Vice President for Health Sciences at the University of Utah, Dean of the University's School of Medicine, and CEO of University of Utah Health Care, overseeing 15,000 employees.

NeoStem, Inc. (Nasdaq:NBS)
, a biopharmaceutical company developing novel cell based therapeutics, today announced initial positive data from its 161 patient Phase 2 PreSERVE AMI (or acute myocardial infarction) clinical trial.

NewLink Genetics Corporation (Nasdaq:NLNK)
today announced that it will present at the following conferences:  At 9:45 am on Tuesday, November 18, 2014, NewLink will present at the Stifel Healthcare Conference in New York; At 2:20 pm on Thursday, November 20, 2014, NewLink will present at the Jeffries Global Healthcare Conference in London; At 11:10 am on Tuesday, December 2, 2014, NewLink will present at the Piper Jaffray Annual Healthcare Conference in New York.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).

Nuo Therapeutics (OTCQX:NUOT)
, a pioneer in biodynamic therapies, today announced that it is sponsoring the 35th National Veterans Wheelchair Games Business & Community Leaders' Breakfast, co-presented by the Paralyzed Veterans of America (PVA) and the U.S. Department of Veterans Affairs (VA), taking place November 18, 2014 at Southern Methodist University in Dallas, Texas.

OXiGENE, Inc. (Nasdaq:OXGN)
, a biopharmaceutical company developing novel cancer therapeutics, today announced that the company has been granted a patent by the European Patent Office related to its current clinical product candidate, OXi4503.

Portola Pharmaceuticals (Nasdaq:PTLA), Bristol-Myers Squibb Company (NYSE:BMY)
and Pfizer Inc. (NYSE:PFE) today announced results from the first part of the Phase 3 ANNEXA™-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Apixaban) studies.

Prosensa Holding N.V. (Nasdaq:RNA),
the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today reported financial results for the third quarter ending September 30, 2014 and provided an update on the regulatory plans and re-dosing for drisapersen, our lead exon-skipping drug candidate, and next steps for our follow-on exon skipping compounds for the treatment of Duchenne muscular dystrophy (DMD).

Proteon Therapeutics Inc. (Nasdaq:PRTO)
, a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, announced today that Company management will present at the Stifel Nicolaus 2014 Healthcare Conference in New York City on Tuesday, November 18, 2014 at 2:25 pm ET.

Radius Health, Inc. (Nasdaq:RDUS)
today announced that President and CEO, Robert Ward, is scheduled to present at the Jefferies Global London Healthcare Conference at 11:20 a.m. GMT (6:20 a.m. ET) on November 20 at the Waldorf Hilton in London.

Radius Health, Inc. (Nasdaq:RDUS)
has been chosen by Informa and Kantar Health as one of the 2014 Top 10 Most Interesting Oncology Projects to Watch for its investigational compound RAD1901.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today announced that data from clinical trials of the company's lead product candidate, Patiromer for Oral Suspension (Patiromer FOS), were presented at the American Society of Nephrology (ASN) Annual Meeting held last week in Philadelphia. Among the data presented were two key posters related to long-term chronic treatment of hyperkalemia (HK) as well as data on the early onset of action of Patiromer FOS.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that Peter D. Suzdak, PhD, the Company's Chief Executive Officer, and Ted Jeong, Chief Financial Officer will participate in the Brean Capital 2014 Life Sciences Summit.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today its intention to offer up to $55 million of its common shares in an underwritten public offering.

The Spectranetics Corporation (Nasdaq:SPNC)
will host an Analyst & Investor meeting in New York City on Thursday, December 4, 2014 beginning at 8:00 a.m. ET and concluding at 11:30 a.m. ET.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that Thomas J. Sullivan, President and Chief Executive Officer, is scheduled to present at the Stifel 2014 Healthcare Conference in New York, NY.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
a leading developer of RNA interference (RNAi) therapeutics, today announces a licensing and collaboration agreement with Dicerna Pharmaceuticals, Inc. Tekmira has licensed its proprietary lipid nanoparticle (LNP) delivery technology for exclusive use in Dicerna's primary hyperoxaluria type 1 (PH1) development program.

ZS Pharma (Nasdaq:ZSPH)
, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today presented detailed results from HARMONIZE (ZS004) at the late-breaking Clinical Science Special Reports Session of the American Heart Association Scientific Sessions.



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