Shares of GlaxoSmithKline plc (ADR) (NYSE:GSK) ended Monday session in green amid volatile trading. The shares closed up +1.16 points or 2.88% at $41.49 with 5.77 million shares getting traded. Post opening the session at $42.27, the shares hit an intraday low of $41.42 and an intraday high of $42.28 and the price vacillated in this range throughout the day. The company has a market cap of $98.17 billion and the numbers of outstanding shares have been calculated to be 4.87 billion shares.
On June 1, 2016 Regulus Therapeutics Inc. (RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs (miR), announced that it has expanded its clinical trial collaboration agreement with GSK (GSK) for the development of RG-101, Regulus’ wholly-owned, GalNAc-conjugated anti-miR that targets miR-122. In the expanded collaboration, the companies plan to conduct a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK’s long-acting parenteral (“LAP”) formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV. This study will be conducted outside the United States and is planned to begin in the fourth quarter of 2016. Based on predicted enrollment rates, interim results from this expanded collaboration should be available in the second half of 2017, enabling a potential initiation of a pivotal study in late 2017. As with the initial collaboration, both parties will share equally in the costs associated with the study. Neither Regulus nor GSK has any further obligations or commitments to each other beyond this expanded clinical collaboration agreement.
“We are very pleased to expand our working collaboration with GSK. This is an important next step to advance the scientific understanding of the potential for a combination therapy to achieve a single-visit cure for HCV,” said Paul Grint, M.D., President and CEO of Regulus. “The market research conducted to date indicates that a potential single visit cure would be a highly preferred product profile to existing regimens.”
Zhi Hong, Senior Vice President and Head of the Infectious Diseases Therapy Area, GSK, commented, “We are excited about the potential of this combination to provide people living with HCV a new treatment option that could be delivered in a single visit. Together with Regulus, we are taking another step forward to proving this novel concept.”
Shares of Opko Health Inc. (NYSE:OPK) ended Monday session in green amid volatile trading. The shares closed up +0.14 points or 1.55% at $9.19 with 5.18 million shares getting traded. Post opening the session at $9.23, the shares hit an intraday low of $9.10 and an intraday high of $9.31 and the price vacillated in this range throughout the day. The company has a market cap of $4.91 billion and the numbers of outstanding shares have been calculated to be 547.44 million shares.
Opko Health Inc. (OPK) on 21 June, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved RAYALDEE® (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).
“FDA’s approval of RAYALDEE represents an important milestone for OPKO,” noted Dr. Phillip Frost, CEO and Chairman of OPKO. “RAYALDEE is the first product to receive FDA approval for this important indication and is one of OPKO’s many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options.”
Results from two 26 week placebo controlled, double blind phase 3 trials demonstrated that a larger proportion of stage 3 or 4 CKD patients with SHPT and vitamin D insufficiency achieved ≥30% reductions in plasma intact parathyroid hormone (iPTH) when treated with RAYALDEE than with placebo. Vitamin D insufficiency was corrected in more than 80% of the patients receiving RAYALDEE compared with less than 7% of subjects receiving placebo. Mean serum calcium and phosphorus levels increased by 0.1 mg/dL during RAYALDEE treatment compared to placebo treatment, but these changes were deemed clinically irrelevant. No differences in RAYALDEE’s efficacy or safety were observed between patients with stage 3 CKD or stage 4 CKD.
“RAYALDEE fills a large void in the current treatment options for SHPT in predialysis patients,” commented Dr. Charles W. Bishop, CEO of OPKO’s Renal Division. “The current standard of care is high dose vitamin D supplementation, an approach for treating SHPT that is neither FDA approved nor demonstrated to be safe and effective in this population. SHPT is a progressive disease that becomes increasingly debilitating and difficult to treat, necessitating timely and effective treatment.”
“RAYALDEE is an important new option for treating SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency,” stated Kevin J. Martin, Director of Research, Division of Nephrology at Saint Louis University School of Medicine. “The great majority of SHPT cases in this patient population are associated with vitamin D insufficiency, a problem that RAYALDEE can correct.”