Shares of Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) ended Wednesday session in green amid volatile trading. The shares closed up +0.21 points or 0.41% at $51.19 with 5.75 million shares getting traded. Post opening the session at $50.96, the shares hit an intraday low of $50.80 and an intraday high of $51.96 and the price vacillated in this range throughout the day. The company has a market cap of $51.79 billion and the numbers of outstanding shares have been calculated to be 1.02 billion shares.
Teva Pharmaceutical Industries Ltd (ADR) (TEVA) on June 13, 2016 announced that it will voluntarily suspend sales, marketing and distribution of ZECUITY® (sumatriptan iontophoretic transdermal system). Teva has received post-marketing reports of application site reactions described as burns and scars in patients treated with ZECUITY, and is working in full cooperation with the U. S. Food and Drug Administration (FDA) to better understand these adverse events. In addition to this voluntary suspension, Teva has initiated a pharmacy-level recall of the product.
“At Teva, the wellbeing of people using our products is always the first priority. Given our deep commitment to patient safety, we will engage in a voluntary suspension of marketing while we continue our investigation into the root cause of these adverse skin reactions,” said Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines at Teva. “We will continue to work closely with the FDA to resolve any remaining questions.”
Patients are advised to discontinue the use of ZECUITY and discuss alternative treatment options with their physicians. Teva has issued a Dear Health Care Provider Letter to alert the prescribing community.
Shares of Opko Health Inc. (NYSE:OPK) ended Wednesday session in red amid volatile trading. The shares closed down -0.34 points or -3.51% at $9.36 with 4.97 million shares getting traded. Post opening the session at $9.67, the shares hit an intraday low of $9.30 and an intraday high of $9.67 and the price vacillated in this range throughout the day. The company has a market cap of $5.41 billion and the numbers of outstanding shares have been calculated to be 547.44 million shares.
Opko Health Inc. (OPK) on June 21, 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.”