The Medicines Company Announces FDA Approval of KENGREAL™; Boston Scientific Initiates Global Study To Assess EMBLEM Print E-mail
By Josh Gee   
Monday, 22 June 2015 18:49
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 22, 2015.
The Medicines Company (NASDAQ:MDCO) announced the approval of KENGREAL™ (cangrelor) by the U.S. Food and Drug Administration as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
 
“The approval of KENGREAL provides a new option for PCI”  The Medicines Company expects KENGREAL to be available in the U.S. in July.
 
KENGREAL is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI that, in clinical trials, has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.
   
“The approval of KENGREAL provides a new option for PCI,” said Clive A. Meanwell, MD, PhD, Chairman and Chief Executive Officer, The Medicines Company. “This novel drug will potentially decrease thrombotic risk in the acute care setting, deliver value to the healthcare system alongside Angiomax®, and help us to increase our commercial offerings in the cath lab.”
   
The CHAMPION PHOENIX study provided the primary evidence of efficacy for the approval of KENGREAL™. The results of this trial, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing KENGREAL to oral clopidogrel in patients undergoing PCI, were published in The New England Journal of Medicine. Co-principal investigators for the CHAMPION clinical program were Robert A. Harrington, MD, Professor and Chair of the Department of Medicine, Stanford University Medical School, Stanford, CA and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and
Women’s Hospital, Boston, MA and Professor, Harvard Medical School, Boston, MA.
   
“In the U.S., the vast majority of PCI procedures are done on an ad hoc basis because clinicians want to define the coronary anatomy prior to making a treatment decision,” said J. Jeffrey Marshall, MD, FACC, FSCAI, Director, Cardiac Catheterization Lab, Northeast Georgia Medical Center and

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Past President, Society for Cardiovascular Angiography and
Interventions (SCAI). “Cangrelor provides a benefit because it allows for antiplatelet therapy to be initiated just after the decision for PCI has been made.”
  
PCI, commonly known as coronary angioplasty, is a non-surgical procedure used to treat narrowed arteries found in coronary heart disease. More than 700,000 PCI procedures each year in the U.S. require effective antithrombin and antiplatelet therapy. KENGREAL has the potential to address the unmet needs of these patients and is well-suited for contemporary U.S. practice in the cath lab.
   
“I believe that intravenous cangrelor has the potential to substantially improve outcomes for patients with cardiovascular disease because of its immediate onset of near complete platelet inhibition with rapid reversibility,” said Gregg Stone, MD, Director of Cardiovascular Research and Education, Columbia University Medical Center, New York-Presbyterian Hospital. “With decreasing door-to-procedure times and the limitations of all oral anti platelet agents, I believe cangrelor will be widely embraced by the interventional community.”
   
Conference Call -- The Company will discuss this approval during a call on June 23rd at 8:30 am ET. The conference call will be available via phone and webcast. Dial-in information is listed below:
   
Domestic Dial-in: +1 (877) 359-9508
International Dial-in: +1 (224) 357-2393
Passcode for both Dial-in numbers: 69887586
   
Replay is available from 11:30 am Eastern time following the conference call through July 1, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 69887586.
   
   
    
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 Boston Scientific (NYSE: BSX) has initiated a worldwide study to evaluate the rate and causes of shocks for patients implanted with the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death in the setting of severely reduced cardiac function (left ventricular ejection fraction
   
In order to further demonstrate the usefulness of the S-ICD System in this particular patient population, the UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria derived from the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) study. The landmark MADIT-RIT study evaluated shock rates in 1,500 patients implanted with TV-ICD devices and is one of the largest randomized trials to assess shock reduction strategies for TV-ICD devices.i
   
"The MADIT-RIT trial demonstrated that standardized programming using higher rate cutoffs and longer delays to therapy reduces the incidence of inappropriate shocks for TV-ICDs," said Dr. Lucas Boersma, EU principal investigator and electrophysiologist at St. Antonius Hospital, The Netherlands. "The UNTOUCHED trial will examine the incidence of all-cause shocks when using the EMBLEM S-ICD System with standardized therapy settings similar to MADIT-RIT."
   
The first patient enrolled in the global, multi-site, prospective, non-randomized study received an EMBLEM S-ICD System implant by Dr. Craig Barr, cardiologist at Russells Hall Hospital in Dudley, England. The study will enroll a minimum of 2,015 patients at up to 200 sites worldwide. Enrollments in the U.S. will begin later this summer.
    
"In the published data to date, we have observed S-ICD devices demonstrate comparable inappropriate shock rates for arrhythmias to TV-ICDs," said Michael Gold, M.D., Ph.D., U.S. principal investigator and chief of cardiology and the Michael E. Assey professor of medicine at Medical University of South Carolina, Charleston. "Ideally, this trial will demonstrate S-ICD devices can either meet or improve upon the inappropriate shock rates experiences with TV-ICDs in MADIT-RIT within this large patient population."
    
The EMBLEM S-ICD System – the next generation of the Boston Scientific S-ICD System – received CE mark earlier this year, was approved by the Food & Drug Administration (FDA) in March of 2015, launched in Europe starting in May, and became commercially available in the U.S. earlier this month in preparation for a planned full U.S. launch during the third quarter of 2015.
   
   
   
Also Monday:
   
    
   
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company developing specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced that it has entered into a loan and security agreement with Oxford Finance LLC for up to $21 million.
    
Aptose Biosciences Inc. (Nasdaq:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will present at the upcoming 10th Annual JMP Securities Life Sciences Conference on Wednesday, June 24th at 10:30 a.m. ET at the St. Regis New York.
    
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage orphan disease-focused biotechnology company, announced today positive preclinical in vitro and in vivo proof-of-concept study results for its Read-through drug candidate (BBrm02) for Spinal Muscular Atrophy (SMA). BBrm02 is a proprietary, intrathecal formulation of azithromycin.
   
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the appointment of Mason M. Yamashita, M.D., Ph.D., as Vice President, Pharmacovigilance, reporting to David T. Hagerty, M.D., Executive Vice President, Clinical Development.
   
Healthways, Inc. (Nasdaq:HWAY) today announced that its financial results for the second quarter ending June 30, 2015, will be released after market close on Thursday, July 23, 2015, followed the same day by a conference call and live webcast scheduled for 5:00 p.m. ET.
    
Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced the appointment of Jonathan Lieber as its Chief Financial Officer, effective July 2, 2015. 
    
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, such as primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH), today announced the appointment of Juan Carlos Lopez-Talavera, M.D., Ph.D. as Senior Vice President of Medical Affairs.
    
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the presentation of positive clinical and preclinical data for its lead product candidate, selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound, at the 13th International Conference on Malignant Lymphoma (ICML) 2015 held June 17-20, 2015 in Lugano, Switzerland.
   
Kite Pharma, Inc. (Nasdaq:KITE) and bluebird bio, Inc. (Nasdaq:BLUE) today announced that they have entered into a collaboration agreement to co-develop and co-commercialize second generation T cell receptor (TCR) product candidates directed against the human papillomavirus type 16 E6 (HPV-16 E6) oncoprotein incorporating gene editing and lentiviral technologies.
    
MedAssets, Inc. (Nasdaq:MDAS) is pleased to announce that Kevin Twomey has joined the company's board of directors, and will also serve as an independent member of the compensation committee as well as the governance and nominating committee.
   
MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain, today announced that the neurological surgical team at University of Kansas Medical Center performed the first stereotactic laser ablation of the hippocampus (SLAH) procedure in their MRI suite, utilizing the ClearPoint Neuro Navigation System.
    
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that seven studies evaluating the performance and clinical impact of select Verigene® multiplex infectious disease tests were presented at the 115th General Meeting of the American Society for Microbiology (asm2015), held last month in New Orleans, Louisiana.
    
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that it has been selected to be included in the broad-market Russell 3000® and Russell Global indexes. 
     
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize energy to treat cancer, today announced that it will effect a one-for-ten reverse stock split at the opening of market trading on June 23, 2015.
   
Portola Pharmaceuticals (Nasdaq:PTLA), Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced full results from the second part of the Phase 3 ANNEXA™-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors – Apixaban) study. 
   
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced the appointment of Peter Brandt as Chairman of the Board. 
   
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced it has appointed Jayson Dallas, M.D., as its Chief Commercial Officer, effective August 3, 2015. 
   
Vical Incorporated (Nasdaq:VICL) today announced top-line results from an ongoing randomized, double-blind, placebo controlled Phase 1/2 clinical study of its therapeutic genital herpes vaccine, designed to reduce viral shedding and genital herpes lesions in herpes simplex virus type 2 (HSV-2) infected patients. 



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