OPKO Adds to Growing Tech Portfolio

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Zebra Biologics, Inc

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Opko Press Release:  

MIAMI, Oct 10, 2013 (BUSINESS WIRE) — OPKO Health, Inc. has agreed to make an investment in Zebra Biologics, Inc. (“Zebra”), a privately held biotechnology company focused on the discovery and development of biosuperior antibody therapeutics and complex drug targets. Zebra’s patented platform is an advanced version of a core technology that underlies the discovery and commercial success of AbbVie Inc.’s Humira(TM), developed by Richard Lerner, M.D., at The Scripps Research Institute. The technology allows for the selection of antibodies for function rather than through simple binding. Zebra has already developed an early pre-clinical pipeline of candidate antibodies with significant commercial potential in regulating diabetes and obesity, cancer, and treatment of neurological disease.

In addition to Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer, Zebra’s directors and founders also include Dr. Lerner; Dr. Ronald M. Lindsay, a director and Executive Vice President for Strategic Planning of Sequenom, Inc.  a company providing innovative diagnostic testing and genetic analysis solutions; Mr. Gao Feng, chairman and president of Beijing based Hongye International Investment Group, which operates in the energy, natural resources, finance and bio-pharmaceuticals industries; and Dr. Paul Greengard, Vincent Astor Professor at Rockefeller University and recipient of a 2000 Nobel Prize for his work concerning signal transduction in the nervous system.

“This participation is in keeping with a core strategy of investing in other companies that have valuable proprietary technology and significant future potential for OPKO,” said Dr. Frost. “We are hopeful that our portfolio of investments will continue to appreciate in value as the companies and technologies mature. In some cases, our investments offer opportunities for OPKO to obtain new products; as well as the possibility to monetize them at an appropriate time.”

ABOUT OPKO HEALTH, INC.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com.

SAFE HARBOR STATEMENT

This press release includes forward looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Such statements may relate to OPKO’s plans, objectives and expected financial and operating results, including statements regarding the commercial potential of Zebra’s early pre-clinical pipeline of candidate antibodies, expected benefits from OPKO’s investment in Zebra and other companies with valuable proprietary technology, the value of OPKO’s portfolio of investments and whether the investments will continue to appreciate in value, whether the investments offer opportunities for new products, and whether OPKO will be able to monetize the investments at the appropriate time. The words “may,” “could,” “would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” and similar expressions or variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond OPKO’s ability to control. The risks and uncertainties that may affect forward looking statements include those described in OPKO’s filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors For more details about the risks and uncertainties related to OPKO’s business, refer to OPKO’s filings with the Securities and Exchange Commission. OPKO undertakes no obligation to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise.

SOURCE: OPKO Health, Inc.

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Featured on Media Crush

Absolute Day Trader Picks was recently a featured post on Media Crush!

Many months ago ADTP Frank Magliochetti chose OPKO Health Inc as a featured company to watch.

Lo and behold the pick has been a hot one with OPKO Health Inc heating up many of the trend setting stock analysts sites.

CLICK HERE to take a look at what our marketing company had to say recently on their blog about ADTP.

 

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OPKO to List on Tel Aviv for Prolor Deal

Tel Aviv Stock Exchange

Billionaire Phillip  Frost to List Shares…

Tel Aviv Stock ExchangeOpko Health Inc. (OPK:US), led by billionaire Phillip Frost, is set to list shares on the Tel Aviv Stock Exchange as it seeks to complete the acquisition of Israeli drugmaker Prolor Biotech Inc. (PBTH:US)

 

OPKO Health IncShares of the Miami-based drug developer, which are already listed on the New York Stock Exchange, will begin trading in Tel Aviv on Aug. 21, a bourse spokeswoman said by telephone today. In October, the stock will enter the Tel Aviv 25 Index (TA-25), a gauge of the exchange’s largest companies by market value, she said.

Prolor-Biotech_OPKOOpko’s listing would enable it to pay Prolor shareholders in locally listed stock. The deal announced in April gave them 0.9951 Opko shares for each stock in Prolor. While the share swap valued Prolor at $480 million in April, a 12 percent increase in Opko’s shares since then has boosted the value to about $540 million.

Prolor’s stock, which will be delisted, has gained 27 percent since the deal was announced. The transaction is expected to close in the second half of this year, provided Opko and Prolor shareholders approve the merger in a vote on Aug. 28.

After selling Ivax Corp. to Teva (TEVA) for $7.4 billion in 2006, Frost and his associates began assembling Opko, a health-care holding company for diagnostic equipment and medical products. Frost is the chairman and largest shareholder in both Opko and Prolor and one of Prolor’s early investors. He’s also chairman of Teva.

Sourced From:
http://www.businessweek.com/news/2013-08-19/billionaire-frost-s-opko-to-list-in-tel-aviv-for-prolor-deal
by David Wainer in Tel Aviv – Bloomberg

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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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NEWS: Opko Health Inc. Hits New 52-Week High at $8.00

OPKO Health, Inc - Absolute Day Trader Picks

Absolute Day Trader Picks – Pick Hit!

Back in April OPKO it was decided that OPKO was a pick hit company and a stock to watch.

Yesterday, OPKO Health closed at a 52 Week High at $8.00, this almost doubles the year low of $4.05.   

Frank Magliochetti of Absolute Day Trader Picks and managing partner at Parcae Capital has had this on our watch list for quite a while.  

Opko Health (NYSE:OPK) set a new 52-week high during mid-day trading on Thursday, AnalystRatings.Net reports. The stock traded as high as $8.00 and last traded at $7.85, with a volume of 2,225,379 shares. The stock had previously closed at $7.88.

OPK has been the subject of a number of recent research reports. Analysts at Barrington Research raised their price target on shares of Opko Health from $7.50 to $9.00 in a research note to investors on Monday. They now have an “outperform” rating on the stock. Analysts at Ladenburg Thalmann raised their price target on shares of Opko Health from $8.50 to $10.00 in a research note to investors on Thursday, May 30th. They now have a “buy” rating on the stock.

Opko Health has a one year low of $4.05 and a one year high of $8.00. The stock has a 50-day moving average of $7.46 and a 200-day moving average of $7.15. The company’s market cap is $2.644 billion.

 

About OPKO Health, Inc.

OPKO Health, Inc (NYSE:OPK), incorporated in October 1991, 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.

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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OPKO – News

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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.

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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.

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OPKO Health, Inc – Merger News

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Dr Phillip Frost can vote on Prolor-Opko merger

absolute day trader picks Frank Magliochetti

Jul 28, 2013  –Dr. Phillip Frost, the chairman of both Prolor Biotech Inc. PBTH(tase:PBTH) and Opko Health Inc.  OPK has the right to vote on the merger of the two companies on August 28, states Prolor in the summons to the general shareholders meeting which will vote on the merger. Each company will hold a separate vote on the merger. Frost is also chairman of Teva Pharmaceutical Industries Ltd. TEVA(tase:TEVA).

Frost is the biggest shareholder in both Prolor and Opko, owning 26.5 percent of the former and 50 percent of the latter. In contrast to Israeli law, under US law, Frost and his associates who are parties at interest in the deal are not banned from voting on it. This means that the vote by Opko shareholders is essentially a done deal. As for Prolor, the parties will have to secure a third of the independent shareholders to approve the merger.

“Although Frost initiated the merger, he was not personally involved in the negotiations, which were managed by a team of external directors of each party. The law therefore allows Frost to vote as an ordinary shareholder,” Prolor president Shai Novik.

The description of the negotiations in the proxy statement, which the companies published for the merger, Frost proposed the merger and the price, which were not changed during the negotiations. Prior to this proposed merger, Prolor was in acquisition talks with Teva, but the parties could not agree on terms.

Prolor has a market cap of 442 million, and Opko has a market cap of 2.5 billion. Under the merger terms of 0.9951 Opko shares for each Prolor share, the deal gives Prolor a share price of 7.64, a 9.6 percent premium on Friday’s closing price of 6.96, and a 30 percent premium on its share price when the merger was announced.

Frost has bought Opko shares since the merger was announced. He bought shares in the company in previous years, but picked up the pace following the announcement, helping boost the share price. This also affected the company value of Prolor for the deal, which will be through a share swap. The purchases also boosted Frost’s stake in Opko to over 50 percent, which means that he can decide the vote on the merger by himself.

At the same time, Frost also bought shares in Prolor. “I am buying Opko because it’s a good investment and Prolor because it’s like buying Opko at a discount,” he says.

In the proxy statement, Opko says that, after the merger with Prolor, it is considering a listing on the Tel Aviv Stock Exchange (TASE). It is a diversified life sciences company with diagnostic and drug development operations, most of which it acquired from third parties. It posted a loss of 34 million on 31 million revenue for the first quarter of 2013, compared with a loss of 8.6 million on 8.7 million for the corresponding quarter of 2012.

Besides Frost, Opko has an Israeli connection through two pharmaceutical manufacturing companies which it acquired for small amounts: Nesher-based FineTech Pharmaceutical Ltd. and Rehovot-based SciGen Israel Ltd.

Prolor is developing delayed-release injectable drugs. Its flagship product is a longer acting human growth hormone, which can be delivered once a week or every other week, instead of daily. The company is about to begin a Phase III clinical trial (multicenter efficacy trial) on the drug.

 

About Prolor Biotech

PROLOR Biotech is developing proprietary versions of already-approved therapeutic proteins. The Company’s Carboxyl Terminal Peptide technology can be attached to an array of existing therapeutic proteins, stabilizing the therapy in the bloodstream and extending its lifespan without additional toxicity or loss of desired biological activity.

PROLOR products under development include Human Growth Hormone (“hGH”) for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone (a $3 billion market opportunity). PROLOR’s hGH could potentially be injected once a week or twice per month instead of daily. PROLOR’s hGH is scheduled for Phase III trials in 2013.

PROLOR’s GLP-1 / Glucagon dual receptor agonist for Diabetes Type II (a $2 billion market opportunity) could be injected once a week and may have a dramatically better weight-loss profile than current GLP-1 therapies.

PROLOR is also developing Factor VIIa and Factor IX for Hemophilia (a $2 billion market opportunity); Anti-Obesity Peptide Oxyntomodulin; Interferon ß and Erythropoietin; and Atherosclerosis and Rheumatoid Arthritis long-acting therapies.

PROLOR’s offices and research and development facilities are located in Israel in the Weizmann Science Park, Nes-Ziona.

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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.

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OPKO Health, Inc – World News

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Citicoline Products Approved for Commercialization in Spain

MIAMI--(BUSINESS WIRE)--July 24, 2013--

OPKO Health, Inc. (NYSE:OPK) announced that its Barcelona, Spain subsidiary, Pharmadiet, S.L.U., received regulatory approval from Spain’s health authority (Agencia Española de Medicamentos y Productos Sanitarios) for commercialization of its oral and injectable formulations of citicoline. Final marketing authorization is expected within 60 to 90 days.

Sales of the other citicoline product presently available in Spain, Somazina(R), exceeded $80 million in 2012. Citicoline also enjoys strong sales throughout Latin America, including those countries where OPKO maintains a growing presence.

“OPKO plans to commercialize its oral and injectable citicoline products in Europe, Latin America, and other markets as well,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer.

About Citicoline

Citicoline products are indicated for the treatment of memory disorders and behavior related to stroke, head injury, chronic disease, as well as degenerative brain disorders. Citicoline enhances the level of phosphatidylcholine in the brain.

About OPKO Health, Inc.

We are 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.

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding expected financial performance, the market for and expected sales of citicoline products, our ability to commercialize citicoline products in Spain, Europe, Latin America and other markets, and expectations regarding timing for final marketing authorization for our citicoline products, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

 
    CONTACT: OPKO Health, Inc.

Steven D. Rubin or Juan F. Rodriguez, 305-575-4100

 
    SOURCE: OPKO Health, Inc.

 

OPKO Health, Inc – In The News

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Increased Demand, Fast Track Designations, and Strong Sales Boost Revenue Growth 

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Research Report on Alexion, Baxter International, Align Technology, Transition, and OPKO

NEW YORK, July 23, 2013 /PRNewswire/ —

Today, Analysts’ Corner announced new research reports highlighting Alexion Pharmaceuticals Inc. (NASDAQ: ALXN), Baxter International Inc. (NYSE: BAX), Align Technology, Inc. (NASDAQ: ALGN), Transition Therapeutics Inc. (NASDAQ: TTHI), and OPKO Health Inc. (NYSE: OPK).

opko-160x160OPKO Health Inc. Research Report

On July 16, 2013, OPKO Health Inc. (OPKO) announced the appointment of David Okrongly, Ph.D. as the President of the Company’s Diagnostics Business Unit. According to OPKO, Dr. Okrongly brings extensive experience developing and commercializing advanced diagnostic platforms. Prior to his involvement with OPKO, Dr. Okrongly served as the Chief Operating Officer of Exosome Diagnostics, Inc., where he was responsible for establishing product, platform, and regulatory strategy for the Company’s proprietary technology for purifying RNA derivatives from exosomes. Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, said, “David’s profound industry knowledge will be invaluable as we near the U.S. commercial launch for our 4Kscore prostate cancer diagnostic test, advance the development of our point of care diagnostic platform, and continue to execute our strategy of establishing industry-leading positions in large and rapidly growing medical markets.” The Full Research Report on OPKO Health Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/cd43_OPK]

Alexion Pharmaceuticals Inc. Research Report

On July 16, 2013, Alexion Pharmaceuticals Inc. (Alexion) announced that the Company’s first-in-class terminal complement inhibitor, Soliris (eculizumab) has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMA) for the treatment of neuromyelitis optica (NMO), a life-threatening, ultra-rare neurological disorder. An orphan medicinal product status, granted by the European Commission, provides incentives to develop medicinal products to treat, prevent, or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. The proposed status would provide Alexion with certain benefits and incentives, including a period of marketing exclusivity. According to the Company, the positive opinion of the COMP has now been forwarded to the European Commission for final approval and publication in the community register. The Full Research Report on Alexion Pharmaceuticals Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/4619_ALXN]

Baxter International Inc. Research Report

On July 18, 2013, Baxter International Inc. (Baxter International) announced its financial results for Q2 2013. Worldwide sales of the Company increased 3% YoY to $3.7 billion. According to the Company, BioScience sales rose 6% YoY on constant currency basis and 5% on actual basis to $1.6 billion, due to improved demand for the Company’s hemophilia therapies, including ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] and FEIBA (an inhibitor therapy) as well as accelerated growth of select plasma-based therapeutics and vaccines. The Company reported Medical Products sales of $2.0 billion, reflecting 1% growth, driven primarily by gains in peritoneal dialysis patients, as well as growth of certain injectable therapies and anesthesia products. Further, the Company reported net income of $590 million or $1.07 per diluted share compared to net income of $661 million or $1.19 per diluted share in Q2 2012. These results include after-tax special items totaling $49 million ($0.09 per diluted share) primarily for costs associated with Baxter’s planned acquisition of Gambro AB. Q2 2013 results also included a net after-tax benefit from special items totaling $42 million of income ($0.07 per diluted share). The Full Research Report on Baxter International Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/163d_BAX]

Align Technology, Inc. Research Report

On July 18, 2013, Align Technology Inc. (Align Technology) reported its financial results for Q2 2013. Total net revenues increased 6.6% QoQ to $163.8 million, with Invisalign clear aligner revenues increasing 8.3% QoQ to $153.3 million. Net profit was $29.3 million or $0.36 per diluted share compared to net loss of $42 million or $0.52 per diluted share in Q1 2013 and net profit of $28.5 million or $0.34 in Q2 2012. Commenting on the results, Thomas M. Prescott, President and Chief Executive Officer of Align Technology, said, “Strong second quarter results were driven by higher Invisalign volumes and ASPs, with sequential growth across all customer channels.” The Full Research Report on Align Technology, Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/69b3_ALGN]

Transition Therapeutics Inc. Research Report

On July 17, 2013, Transition Therapeutics Inc. (Transition) announced that the US Food and Drug Administration (FDA) granted Fast Track Designation to the development program for ELND005, which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s disease (AD). According to the Company, ELND005 is an orally bioavailable small molecule that is being investigated by Transition’s licensing partner, Elan Corporation plc (Elan), for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes beta-amyloid anti-aggregation and regulation of brain myo-inositol levels. Elan will be responsible for all development and commercialization activities as well as costs of ELND005. The Full Research Report on Transition Therapeutics Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/09eb_TTHI]

EDITOR NOTES:

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Pharmsynthez

pharmsynthez-logo2

Frank Magliochetti – Absolute Day Trader Picks-

Pharmsynthez is a one to add to your watch list.  Take a look at the information below culled from their company  website

pharmsynthez

Pharmsynthez is an innovative pharmaceutical company developing new medications, technologies of drugs for organ-specific delivery and innovative methods of manufacture for pharmaceutical ingredients.

The company profile is production and sales of both officinal medicines (original OM) and active pharmaceutical ingredients (API). The company has at its disposal a research and production facility, Pharmsyntez, put into operation in 2001.

Pharmsynthez is an international company and our business extends far beyond Russia. Starting from 2000, company-manufactured medicines were made available to the Public Health Services of Ukraine and Georgia, and since 2004 they have been marketed throughout CIS countries. In chemical compounds and API production we are intensely cooperating with North-American, Canadian and European companies.

While developing new medications, creating new technologies of organ-specific delivery of medicines and refining medicines manufacturing methods, we are working in close relations with leading research centres in Russia, Great Britain, France and Germany using the advantages of broad international cooperation to offer our patients safer and more effective medications.

We haven’t been looking for royal roads. Our main resources are assigned to oncology, tuberculosis and other bacterial and viral infections – grave and mortal diseases taking their toll of millions of humans worldwide every year.

In the area of API manufacturing, the company focuses on production of innovative hi-tech expensive substances, until now, for the most part, imported.

Industrially developed countries impose strict quality, effectiveness and safety standards on pharmaceutical industries.

Quality management and assurance in a modern enterprise are essential and quite expensive challenges. We do set ourselves these objectives and are successfully accomplishing them.

An innovative chemical production facility intended for the manufacture of active pharmaceutical ingredients and other chemical substances was built by the Company 10 kilometres north of St. Petersburg. This project provides a good example of the symbiosis of Russian expertise in setting up science intensive chemical production facilities and producing chemicals of traditional German quality.

The facility engineering design was developed in conjunction with the St. Petersburg State Institute of Technology; Linde, German technological company, and Prikladnaya Khimiya (Applied Chemistry) Russian Research Centre, Federal State Unitarian Enterprise. The facility is equipped with new European technological and testing machinery. Upon completion, the construction project was certified by German specialists.

Mission:

The National Standard for pharmaceuticals manufacture and quality control, RF GOST R 52249-2004 (being an authentic translation of EU Pharmaceuticals Good Manufacturing Practices regulations), came into effect on January 1st, 2005. One of the purposes of the pharmaceutical industry switching to international standards is providing the country populace with modern highly effective medications of a quality adequate to that of foreign analogs but at lower retail prices.

Pharmsynthez is an active participant of a nation-wide pharmaceutical business transition to international regulations. In particular, Quality Policy and Objectives for the years 2006-2007 make provisions for preparation to ISO certification and getting enterprise quality management system ISO-certified and attested for conformity with EU GMP. When achieved, these steps will enable the Company to manufacture pharmaceuticals of international quality standard locally and establish cooperation with leading domestic and foreign manufacturers on new dosage forms (ampoules, tablets, capsules, etc.) production.

Manufacturing:

Pharmsynthez Company is an innovative production company operating its own working capital and it has been very successful in the market in recent years.

pharmsythez

The Company, unlike the majority of pharmaceutical production companies in Russia, adheres to international business standards, and having a modern high-tech pharmaceutical substances production facility, we place production orders for official medicines on the nation-best facilities and always fulfill our contractual obligations for production services.

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