Shares of Amgen, Inc. (NASDAQ:AMGN) ended Monday session in red amid volatile trading. The shares closed down -0.92 points or -0.57% at $160.18 with 2.46 million shares getting traded. Post opening the session at $161.36, the shares hit an intraday low of $160.00 and an intraday high of $162.32 and the price vacillated in this range throughout the day. The company has a market cap of $123.80 billion and the numbers of outstanding shares have been calculated to be 751.22 million shares.
Amgen, Inc. (AMGN) on July 11, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body’s natural system for eliminating “bad” cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.1 Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.
“The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.”
Shares of Opko Health Inc. (NASDAQ:OPK) ended Monday session in red amid volatile trading. The shares closed down -0.05 points or -0.51% at $9.82 with 1.93 million shares getting traded. Post opening the session at $9.91, the shares hit an intraday low of $9.80 and an intraday high of $10.02 and the price vacillated in this range throughout the day. The company has a market cap of $5.38 billion and the numbers of outstanding shares have been calculated to be 547.44 million shares.
On June 30, 2016 Opko Health Inc. (OPK) and Transition Therapeutics Inc. (NASDAQ:TTHI, TSX:TTH) announced the signing of a definitive agreement under which OPKO will acquire Transition Therapeutics, a clinical stage biotechnology company.
Under the terms of the agreement approved by the Boards of Directors of both companies, Transition Therapeutics security holders will receive approximately 6.4 million shares of OPKO common stock. Based on the moving average price of OPKO common stock for the five trading days preceding the signing of the agreement, the transaction is valued at approximately US$60 million, or US$1.55 per share of Transition Therapeutics common stock, based on current outstanding shares. The companies expect the transaction to close during the second half of 2016, subject to approval of Transition Therapeutics stockholders and other customary conditions.
The Transition Therapeutics clinical portfolio includes:
- TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity. We believe TT401 to be the most clinically advanced drug candidate among the new class of GLP1-glucagon receptor dual agonists. In a recently completed phase 2 study of 420 patients with type 2 diabetes, subjects receiving the highest dose of TT401 peptide once weekly demonstrated significantly superior weight loss compared with currently approved extended release exenatide and placebo after 12 and 24 weeks of treatment. TT401 also provided a reduction in HbA1c, a marker of sugar metabolism, similar to exenatide at weeks 12 and 24. TT401 strengthens OPKO’s existing pipeline of oxyntomodulin drug candidates for the treatment of type 2 diabetes and obesity. OPKO’s MOD-6031, currently in a phase 1 study, is a once weekly oxyntomodulin with a proprietary delivery system to slowly release the natural oxyntomodulin, which allows the molecule to penetrate the blood brain barrier. The potential of MOD-6031 to interact with CNS, as well as peripheral receptors, is expected to mimic the natural effect of oxyntomodulin for its effects on satiety and weight loss.
- TT701 is a once daily oral selective androgen receptor modulator for patients with androgen deficiency. In a 12-week study of 350 male subjects, it resulted in significantly decreased fat mass and increased lean body mass and muscle strength without significantly changing prostate specific antigen levels. The selective and antagonistic properties of TT701 appear to be well suited to provide anabolic therapeutic benefits to specific patient populations, while potentially avoiding, or even reducing, prostate hypertrophy.
- ELND005, a neuropsychiatric drug candidate. ELND005 is an orally administered small molecule that has completed phase 2 clinical studies in Alzheimer’s disease and Down syndrome patients.
“This acquisition provides OPKO with two late stage drug candidates, each of which holds exceptional market potential,” stated Phillip Frost, M.D., CEO and Chairman of OPKO. “We believe TT401, a once-weekly dual GLP1/Glucagon agonist that recently showed success in a 420-patient phase 2 study, will complement OPKO’s existing oxyntomodulin product candidate (MOD-6031), which may provide enhanced therapeutic benefit through targeted delivery.”