|Viking Therapeutics Reports Will Conduct Phase 2 Trial of VK2809; Mylan Receives Unconditional Clearance from EC on Acquisition of Perrigo|
|By Josh Gee|
|Wednesday, 29 July 2015 19:15|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 29, 2015.
Viking Therapeutics, Inc. (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced plans to conduct a Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population. Viking intends to file an investigational new drug (IND) application and initiate the clinical development program in the fourth quarter of 2015.
The planned Phase 2 study will be a randomized, double-blind, parallel group, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of VK2809 in approximately 100 patients with elevated LDL cholesterol and fatty liver disease. Viking expects to complete the study in 2016.
VK2809 has demonstrated an encouraging preliminary efficacy, safety and tolerability profile in previous clinical studies. In a Phase 1b study in patients with mild hypercholesterolemia, treatment with VK2809 resulted in placebo-adjusted reductions in low-density lipoprotein that exceeded 40% at high doses. Patients also experienced significant reductions in triglycerides, as well as the atherogenic proteins lipoprotein-a and apolipoprotein B. Consistent with its liver- and receptor-selective mechanism of action, treatment with VK2809 has also demonstrated rapid reduction of liver fat in animal models of hepatic steatosis. Further animal data have shown that VK2809 has additive cholesterol lowering activity in combination with statins. These characteristics combine to suggest a highly differentiated therapeutic profile relative to existing oral options for patients with hypercholesterolemia and fatty liver disease, such as nonalcoholic steatohepatitis (NASH).
"We look forward to advancing VK2809 into clinical development, as we believe the compound's novel mechanism-of-action and impressive data to date position it as an exciting, first-in-class approach to the dual challenge of hypercholesterolemia and hepatic steatosis," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "Importantly, our ability to target the therapeutic activity of the compound specifically to liver tissue presents a unique opportunity to develop a product that simultaneously addresses the large population of patients suffering from both disorders."
Mylan N.V. (NASDAQ: MYL) announced that it received regulatory clearance from the European Commission under the European Union Merger Regulation (EUMR) for its proposed acquisition of Perrigo Company plc (NYSE: PRGO; TASE).
Mylan's Executive Chairman Robert J. Coury commented, "Today marks yet another important milestone in the process of completing our acquisition of Perrigo and serves as further affirmation of the sound industrial logic of this compelling combination. We look forward to continuing on this path and completing the transaction in the coming months."
As previously announced, on April 24, 2015, Mylan issued a Rule 2.5 announcement (amended on April 29, 2015) under the Irish Takeover Rules setting forth its legally-binding commitment to commence an offer directly to the Perrigo shareholders for the entire issued and to be issued share capital of Perrigo. The proposed transaction remains subject to certain conditions and other terms set forth in the formal Rule 2.5 announcement.
Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the company's scientific founder, Yvonne Paterson, Ph.D., Professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania, will give a presentation titled "HER-2/neu as a target for Listeria-based cancer immunotherapy for breast cancer" on Tuesday, August 4 at 9:00 a.m. BST, at the 2015 World Congress on Breast Cancer in Birmingham, UK.
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today announced that it will report its second quarter 2015 financial and operating results after the close of U.S. financial markets on Wednesday, August 5, 2015.
AXIM Biotechnologies, Inc. (OTC:AXIM) CEO George E. Anastassov, MD, DDS, MBA, proudly shared the Company's cannabinoid delivery methods – including the world's first patented cannabinoid release chewing gum - at the My Compassion Chicago Cannabis Conference.
BioMark Diagnostics Inc. (CNSX:BUX) (FSE:20B) (OTCQB:BMKDF) announces the award of a grant from the Natural Sciences and Engineering Research Council of Canada (NSERC) to partner with David Chen, Ph.D., Professor, Department of Chemistry at the University of British Columbia, to develop a novel sample enrichment method for surface-enhanced Raman spectrometry (SERS) detection.
ChemoCentryx, Inc. (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced that the Company's second quarter 2015 financial results will be released after market close on Thursday, August 6, 2015.
Enzymotec Ltd. (NASDAQ:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that the Company will release financial results for the second quarter ended June 30, 2015 on Wednesday, August 12, 2015, before the market opens.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced that the Company will host a conference call and live audio webcast on Wednesday, August 5, 2015 at 5:00 p.m. ET to report its second quarter 2015 financial results and provide a corporate update.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that it has completed enrollment of 486 patients in the Phase 3 clinical trial of its lead compound FX006 approximately three months earlier than anticipated, and the company now plans on reporting topline data from this trial in the first quarter of 2016.
FutureWorld Corp. (OTC: FWDG), a cannabis technology accelerator and a leading provider of advanced technologies and solutions to the global cannabis industry, announces today that its subsidiary, CB Scientific, has concluded three months of R&D, design and manufacturing of the next generation Cannabis (Hemp) THC and CBD detection kits with ISO lab certified seal of approval.
iKang Healthcare Group, Inc. (Nasdaq:KANG), China's largest private preventive healthcare services provider, today announced that it will release its unaudited financial results for the first quarter ended June 30, 2015 on August 24, 2015 after the US market closes.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization is a major sponsor and key participant in the Society for Clinical Research Sites (SCRS) Asia/Pacific Site Solutions Summit, taking place July 30-31, 2015, in Melbourne, Australia. Senior Vice President, Corporate Strategy Jean Chitwood will present "Collaborating for the Future: Developing Effective CRO, Site and Sponsor Relationships in a Changing Healthcare Environment" on Friday, July 31.
IPC Healthcare, Inc. (NASDAQ:IPCM), a leading national acute hospitalist and post-acute provider group practice, today announced financial results for the second quarter ended June 30, 2015. All operating results referred to as "adjusted" exclude the change in fair market value of contingent consideration ("net change in fair value") for acquisitions. See "Reconciliation of Non-GAAP Financial Measures" below for explanations of these non-GAAP financial measures and reconciliation to GAAP financial measures.
MannKind Corporation (Nasdaq:MNKD) today announced that it has entered into separate, privately-negotiated exchange agreements with select holders of its existing 5.75% Senior Convertible Notes due 2015 (the "2015 notes") to exchange up to an aggregate principal amount of $84.6 million of the 2015 notes.
Parnell Pharmaceuticals Holdings Ltd. (NASDAQ:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, announced today that on August 11, 2015 at 7:00 a.m. ET it will report financial results for the six-month period ended June 30, 2015.
Spark Therapeutics (NASDAQ:ONCE) today announced that it will host a conference call on Wednesday, August 5, 2015 at 8:30 a.m. Eastern to report corporate and financial results for the three and six months ended June 30, 2015.
The Spectranetics Corporation (NASDAQ:SPNC) today announced it has completed enrollment of 300 subjects in the ILLUMENATE Pivotal clinical study, a prospective, randomized controlled, multicenter study designed to assess the clinical performance of the Stellarex™ drug-coated angioplasty balloon used to restore and maintain blood flow to above-the-knee arteries of the leg in patients with peripheral arterial disease (PAD).
The Spectranetics Corporation (Nasdaq:SPNC) today announced that its management will be presenting at the Canaccord Genuity Growth Conference on August 12, 2015 in Boston.
Sutherland Healthcare Solutions, a subsidiary of Sutherland Global Services, has opened a Healthcare Robotic Process Automation (RPA) Center of Excellence in Hyderabad, India.
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime® Abdominal Stent Graft System, today announced that its management will be presenting at the Canaccord Genuity Growth Conference on August 12, 2015 in Boston.
Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the following webcast and conference call: What: Vericel Corporation Second-Quarter 2015 Earnings Call -- When: Wednesday, August 12, 2015 at 8:00am (ET), Where: http://investors.vcel.com/events.cfm , How: The conference call will be available live in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm.
Wright Medical Group, Inc. (NASDAQ:WMGI) today reported financial results for its second quarter ended June 30, 2015.