OPKO Rayaldy News:

OPKO Health Inc

Surpasses 50% enrollment in second phase III trials

OPKO Health IncOPKO Health, Inc. has surpassed 50 per cent enrollment in the second phase III trial of Rayaldy to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. This trial is the second of two identical randomized, double-blind, placebo controlled, multi-site studies intended to establish the safety and efficacy of Rayaldy as a new treatment for SHPT in the targeted population.

The endpoints of both studies, which are being conducted in parallel, include vitamin D status and changes in serum calcium, serum phosphorus and plasma intact parathyroid hormone (PTH).

Each of the two phase III trials will involve 210 patients recruited at approximately 40 sites in the US. These patients are being stratified by CKD stage and randomized in a 2:1 fashion to receive six months of treatment with either Rayaldy or placebo. Dosing with Rayaldy is titrated, as necessary, to achieve the desired blood concentration and the targeted reduction in PTH.

“I am pleased to report that these pivotal trials with Rayaldy Capsules are progressing as planned toward completion in the first half of 2014,” stated Phillip Frost, MD, OPKO’s chairman and chief executive officer. “Top-line data are expected in mid-2014. We believe Rayaldy will prove to be superior to high monthly doses of prescription vitamin D2, a common therapeutic approach which has been shown unreliable in correcting vitamin D insufficiency in patients with chronic kidney disease and generally ineffective in controlling elevated levels of parathyroid hormone. We look forward to advancing the standard of care for this patient population when Rayaldy is ultimately approved for marketing.”

Rayaldy is a first-in-class oral vitamin D prohormone treatment being developed for SHPT in stage 3 and 4 CKD patients with vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces the PTH lowering potency of current vitamin D supplements. Activation of the product by the kidney is tightly regulated, preventing excessive elevation of serum calcium and related side effects which encumber current vitamin D hormone therapies and promote vascular and renal calcification. Once approved, Rayaldy will address the approximately four million CKD stage 3 and 4 patients in the US and many more, elsewhere, with SHPT and vitamin D insufficiency.

CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five different stages — mild (stage 1) to severe (stage 5) disease — as measured by the kidney’s glomerular filtration rate.

Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormones, collectively known as 25-hydroxyvitamin D.

SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH. SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormones to properly regulate calcium and phosphorus metabolism, and PTH secretion. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues.

OPKO is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.

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OPKO – News

opko-160x160

Second Quarter 2013 Financial Highlights

opko-160x160MIAMI — OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial highlights for the second quarter of 2013.

OPKO Health Inc. (OPK: Quote) on Friday said that its second quarter net loss improved as revenue more than doubled compared to the year-ago quarter.

TESARO_OPKO_DAYTRADERPICKSTop-line results from a phase III trial of Rolapitant, which OPKO out-licensed to biopharmaceutical company TESARO Inc., are anticipated in the second half of 2013. Rolapitant is under phase III testing for the treatment of chemotherapy-induced nausea and vomiting.

OPK closed Friday ( 8/9/13)  trading at $7.49. In after-hours, the stock was up 0.53% to $7.53.

Second Quarter 2013 Financial Highlights

Consolidated revenues more than doubled to $23.8 million during the three months ended June 30, 2013, from $10.2 million in the prior year period and nearly tripled to $55.2 million for the six months ended June 30, 2013, from $19.0 million in the prior year period. Revenue for the six months ended June 30, 2013, includes $12.5 million of revenue resulting from a strategic partnership in the field of RNA interference with RXi Pharmaceuticals Corporation.

Net loss for the three months ended June 30, 2013, was $ 3.4 million, compared to a net loss of $10.8 million for the 2012 period. Net loss for the three months ended June 30, 2013, includes the impact of:

$9.9 million non-cash benefit related to the change in fair value of embedded derivatives which are part of our January 2013 convertible senior notes due in 2033 (the “2033 Senior Notes”). This non-cash benefit resulted principally from the decrease in the closing market price of our common stock as of June 30, 2013, as compared to the previous quarter end; and

$8.5 million related to other income from the sale of available for sale securities.

Net loss for the six months ended June 30, 2013, was $38.0 million, compared to a net loss of $20.0 million for the 2012 period. Net loss for the six months ended June 30, 2013, includes the impact of:

$14.9 million in net non-cash charges related to the change in fair value of embedded derivatives which are part of our 2033 Senior Notes, principally as a result of the increase in the closing market price of our common stock as of June 30, 2013, as compared to the date of issuance of such notes; and

$10.8 million related to other income from the sale of available for sale securities.

Cash, cash equivalents and marketable securities were $169.1 million as of June 30, 2013.

Business Highlights

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Our Spanish subsidiary, Pharmadiet, S.L.U., received regulatory approval for commercialization of its oral and injectable formulations of citicoline to treat memory disorders and behavior related to stroke, head injury, chronic disease, as well as degenerative brain disorders.

The two Phase 3 trials of Rayaldy™, our vitamin D prohormone to treat patients with secondary hyperparathyroidism with stage 3 or 4 chronic kidney disease and vitamin D insufficiency, are progressing on schedule. We anticipate top-line data from this pivotal program in mid-2014.

Prolor-Biotech_OPKOOur acquisition of PROLOR Biotech, Inc. (NYSE MKT: PBTH), a biopharmaceutical company focused on developing longer-acting proprietary forms of presently marketed therapeutic proteins and peptides, is expected to close during the third quarter of 2013. PROLOR has reported that its long-acting version of human growth hormone, hGH-CTP, can reduce the dosing frequency from one injection per day to a single weekly injection. A Phase 2 trial in children with GHD is currently ongoing, and a Phase 3 trial in adults with GHD was initiated in June 2013. PROLOR also recently announced results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia. The data indicate that Factor VIIa-CTP can be administered by subcutaneous (SC) injection in contrast to presently used products which must be given intravenously; this would facilitate its prophylactic at home use.

Enrollment, now surpassing 90%, continues by our licensee, TESARO, Inc. in each of three Phase 3 trials of Rolapitant for the prevention of chemotherapy induced nausea and vomiting. TESARO anticipates that top-line data from this pivotal program will be announced by year end. TESARO also presented results from a pharmacokinetic study of Rolapitant at the recent Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support concomitant administration of Rolapitant with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product.

The U.S. commercial launch of the OPKO 4Kscore™ prostate cancer test as a laboratory developed test will be through our CLIA-certified laboratory based in Nashville, TN.

“We continue to build and strengthen the foundation for a sound profitable business,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. “We are pleased that Pharmadiet, our Spanish subsidiary, has received regulatory approval for our oral and injectable formulations of citicoline, and we are beginning the process for marketing them in Spain as well as through our Latin American units. These products will be sold by prescription to improve memory in certain patients,” continued Dr. Frost. “We are also very proud of the pipeline of new products in various stages of development in OPKO and soon to be acquired PROLOR. They can provide the basis for an important health care company.”

About OPKO Health, Inc.

A  multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.

About Absolute Day Trader Picks

This is a site sponsored and driven by content supplied and aggregated  by Frank Magliochetti and Parcae Capital Corporation.  It will highlight emerging growth companies and picks made by Frank Magliochetti and his team of professionals.

If you have a company interested in having our team review for our Day Trading Pick please contact us by clicking here.

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