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Laboratory Focus May/June 2017
Pharma Notes Valeant Pharmaceuticals International, Inc. (Laval, Que) has entered into an agreement to sell its iNova Pharmaceuticals business for $930 million in cash to a company jointly owned by funds advised and managed by Pacific Equity Partners and The Carlyle Group. iNova’s diversified portfolio includes prescription and over-the-counter products in several areas, such as weight management, pain management, cardiology and cough and colds. It operates in more than 15 countries around the world. iNova holds market positions in Australia and South Africa and also has an established platform in Asia. Valeant will maintain a strong footprint in these countries primarily through its Bausch + Lomb franchise. Valeant will use proceeds from the sale to permanently repay term loan debt under its Senior Secured Credit Facility. The transaction is expected to close in the second half of 2017, subject to customary closing conditions, including receipt of applicable regulatory approvals. Oncolytics Biotech Inc., (Calgary) announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for Reolysin, the company’s proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer. The company is gearing to conduct an End-of-Phase 2 meeting with the FDA as soon as is practical and obtain scientific guidance, said Dr. Matt Coffey, president and CEO of Oncolytics Biotech. In April 2017, data from an open-label, randomized, Phase 2 study assessing the therapeutic combination of intravenously-administered Reolysin given in combination with the chemotherapy agent paclitaxel versus paclitaxel alone, in patients with advanced or metastatic breast cancer (IND 213) was presented at the American Association of Cancer Research Annual Meeting. The combined treatment demonstrated a statistically significant increase in median overall survival. Based on Oncolytics’ evolving understanding of Reolysin’s mechanism of action, along with the positive overall survival data generated to date, the company is pursuing metastatic breast cancer as its primary focus for late-stage clinical testing. Sanofi (Laval, Que.) reported that that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combina-
tion of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The 15-member panel voted 12 to 2 (1 panelist did not vote due to travel) to approve the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. The U.S. NDA submission for the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide is based on data
from two Phase 3 studies, which enrolled more than 1,900 adults worldwide to evaluate the efficacy and safety of the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints. The full results of both studies will be presented in June 2016 at the
American Diabetes Association’s 76th Scientific Sessions. Lixisenatide is currently approved in more than 60 countries worldwide under the proprietary name Lyxumia. The fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was submitted for regulatory review in the European Union in March 2016 and has not yet been approved for use by any health authority.
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GREER 6 YEARS OLD
Greer’s remarkable recovery from a horseback riding accident was helped by community donations. Children’s Miracle Network® dollars provided a private PICU room and also purchased the pediatric CT scanner which analyzed her traumatic brain injury. Showing no fear of the animal that crushed the right side of her face, Greer is happy to be “back in the saddle” and now wears a special helmet for added safety during her weekly riding lessons. Children’s Miracle Network raises funds and awareness for 170 member hospitals, 14 of which are in Canada. Donations stay local to fund critical treatments and healthcare services, pediatric medical equipment and research. Its various fundraising partners and programs support the nonprofit’s mission to save and improve the lives of as many children as possible. Find out why children’s hospitals need community support, find your member hospital and learn how you can Put Your Money Where the Miracles Are, at childrensmiraclenetwork.ca and facebook.com/CMNHospitals.
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