OPKO Health (OPK) is a medical test and medication company focused on diagnostics and pharmaceuticals. The company develops treatments for secondary hyperparathyroidism, and has recently finished the patient recruitment for a Phase III trial against insufficiency in Vitamin D. The company is a publicly traded company on NYSE under the symbol "OPK". It acquired Laboratorio Arama de Uruguay in 2014 and is seeking to expand its presence in Uruguay and Argentina.
OR31-6 2nd Year Efficacy Results of Once-Weekly Administration of CTP-Modified Human Growth Hormone (MOD-4023): A Phase 2 Study in Children with Growth Hormone Deficiency Program: Abstracts - Orals, Poster Previews, and Posters Session: OR31-Growth and Puberty Disorders II Clinical/Translational Sunday, April 3, 2016: 11:45 AM-1:15 PM Presentation Start Time: 1:00 PM Room 104 (BCEC) Nataliya Zelinska1, Julia Skorodok2, Oleg Malievsky3, Ron G Rosenfeld4, Zvi Zadik5, Ronit Koren6, Leanne Amitzi6, Oren Hershkovitz6, Gili Hart*6 and Klaudziya Radziuk7 1Children Specialized Clinical Hospital, Kiev, Ukraine, 2St. Petersburg State Pediatric Medical Academy, St. Petersburg, Russia, 3Bashkir State Medical University, Ufa, Russia, 4Oregon Health and Science University, Portland, OR, 5Kaplan Medical Center, Rehovot, Israel, 6OPKO Biologics, Nes Ziona, Israel, 72nd Children City Clinic, Minsk, Belarus Objective: Growth hormone (GH) replacement therapy currently requires daily injections. This may cause poor compliance, inconvenience and distress for patients. CTP-modified hGH (MOD-4023) has been developed for onceweekly administration in growth hormone deficient (GHD) adults and children. The 18 and 24 month efficacy of once-weekly subcutaneous (SC) administration of MOD-4023 was evaluated in a Phase 2 study in children with GH deficiency. Design and methods: A one year, randomized, controlled Phase 2 study was conducted in 53 prepubertal children with GHD receiving once-weekly SC injections of one of three MOD-4023 doses (0.25, 0.48, and 0.66 mg/kg/week) vs. daily hGH (34 µg/kg/day). Forty-six subjects were rolled over to continue with the same MOD-4023 dose in an open-label extension (OLE), which will routinely assess growth until marketing approval. Height velocity (HV) results during the 2nd year of MOD-4023 treatment for 45 patients were compared to historical controls1. IGF-1 and IGFBP-3 were monitored as well. Results: The analysis included 2nd year height velocity data for 45 patients. All 3 doses of MOD-4023 demonstrated promising 2nd year growth, while the two higher doses of MOD-4023 resulted in better growth in comparison to the lower dose of MOD-4023 (0.25 mg/kg/week), and in line with reported age- and GHD severity-matched historical controls1. Conclusions: The efficacy of single weekly administration of MOD-4023 for the treatment of pediatric GHD patients was further confirmed during the 2nd year of treatment as part of the OLE of a Phase 2 study. This further affirms that a single weekly injection of MOD-4023 has the potential to replace daily hGH injections in children with GHD and provides additional efficacy data to support dose selection for OPKO's upcoming Phase 3 trial. (1) Ranke MB, Lindberg A, KIGS International Board, J Clin Endocrinol Metab. 2010; 95:1229–37. Disclosure: OM: Investigator, Ascendis Pharma. RGR: Advisory Group Member, OPKO Biologics. KR: Investigator, Ascendis Pharma. Nothing to Disclose: NZ, JS, ZZ, RK, LA, OH, GH *Please take note of The Endocrine Society's News Embargo Policy at www.endocrine.org/news-room/endo-annual-meeting/pr-resources-for-endo
FDA accepted OPKO's resubmission however they went with the later date option which is 6 months from now. At least the market reaction was not as bad as I expected. Hopefully, we can get away with the current 2-3% drop. OPKO Health (OPK) Announces FDA Acceptance of RAYALDEE NDA Resubmission OPKO Health, Inc. (NYSE:OPK) announced the U.S. Food and Drug Administration (FDA) has accepted OPKO’s resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. OPKO resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the FDA indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO’s third party manufacturer. The observations were not specific to RAYALDEE manufacturing, and the CRL did not cite any safety, efficacy or labeling issues with regard to RAYALDEE, nor did it request any additional studies to be conducted prior to FDA approval. A six month review period has been assigned for the resubmitted NDA, and the new Prescription Drug User Fee Act (PDUFA) date will be October 22, 2016. "We have worked closely with our third party manufacturer to ensure the FDA’s inspection observations are promptly and fully addressed, and we believe that our resubmission reflects OPKO’s strong commitment to providing a new treatment for SHPT in CKD patients as soon as possible,” stated Phillip Frost, M.D., Chairman and CEO of OPKO. “If approved, RAYALDEE will be the first drug approved for this important indication.”
of course it would be the 6 month variety, man i am very angry with cltl right now, we shareholders of opk are pretty much held hostage by this crappy company. the whole thing that makes me angry is their own stock didnt even get hit for the crl.
PRESS RELEASE + OPKO Form 8K Vifor Fresenius Medical Care Renal Pharma and OPKO Health Enter into Agreement for OPKO’s RAYALDEE® Monday, 9 May 2016 ______ - Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE® in Europe, Canada and certain other international markets - OPKO to receive up to USD 282 million in upfront and milestone payments, plus tiered double-digit royalties - OPKO and Vifor Fresenius Medical Care Renal Pharma to jointly develop RAYALDEE® for dialysis patients ______ Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a common company of Galenica and Fresenius Medical Care, and OPKO Health (NYSE: OPK), have entered into a collaboration and license agreement for the development and commercialization of RAYALDEE® inEurope, Canada, Mexico, Australia, South Korea and certain other international markets for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) and vitamin D insufficiency. Under the terms of the agreement, the parties will also collaborate to develop and commercialize RAYALDEE® for the treatment of SHPT in dialysis patients, and OPKO has granted VFMCRP an option to acquire rights to the US market for treatment of dialysis patients. "Vifor Fresenius Medical Care Renal Pharma is a leader in chronic kidney disease and we believe they are the ideal partner to bring RAYALDEE® to patients across Europe and other territories," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "We believe further developing RAYALDEE® for dialysis patients is an important additional step in the care of chronic kidney disease patients," Dr. Frost continued. “Managing bone and mineral disorders in CKD patients remains a challenge for physicians despite the treatment options already available to them. The clinical data for RAYALDEE® show promising safety and efficacy and we strongly believe that once approved, RAYALDEE® will become a cornerstone therapy to better address this key co-morbidity and improve the well-being of chronic kidney disease patients,” said Stefan Schulze, Chief Executive Officer of VFMCRP. SHPT is a common disorder in CKD patients triggered by vitamin D insufficiency, which can cause reduced vitamin D hormone production, decreased intestinal absorption of dietary calcium, increased secretion of parathyroid hormone (PTH), and metabolic bone disease. Using current treatment options, most patients underachieve control of both vitamin D insufficiency and SHPT, leading to a range of bone and mineral disorders. RAYALDEE® is an oral vitamin D prohormone treatment in a modified release capsule being developed by OPKO. VFMCRP has entered into an exclusive license agreement with OPKO to co-develop and commercialize RAYALDEE® in leading markets around the world, including Europe (except Russia), Canada, Mexico, Australia and South Korea. OPKO retains all rights in the US, Latin America (excluding Mexico), Russia, China, Taiwan and Japan. The two companies will also collaborate to prepare the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA). Under the agreement, VFMCRP will make an upfront payment to OPKO of USD 50 million, plus up to an additional USD 52 million in regulatory and launch milestones, and USD 180 million in sales-based milestones. In addition, VFMCRP will pay OPKO tiered, double-digit royalties on sales of the product. In the event VFMCRP exercises its option for rights to the US dialysis market, VFMCRP will pay OPKO additional commercial-based milestones, as well as double-digit royalties. OPKO submitted a New Drug Application (NDA) for RAYALDEE® to the US Food and Drug Administration (FDA) in 2015 for the treatment of SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency. On 29 March 2016, the FDA indicated in a Complete Response Letter (CRL) that observations of deficiencies at OPKO's third-party contract manufacturer were issued on March 25, 2016, as a result of an FDA field inspection initiated on March 14, 2016. The observations were not specific to RAYALDEE® manufacturing. The CRL did not cite any safety, efficacy or labelling issues with regard to RAYALDEE®, nor did it request that additional studies be conducted prior to FDA approval. OPKO subsequently resubmitted its NDA to the FDA, and the FDA accepted OPKO’s resubmission on April 22, 2016. The new Prescription Drug User Fee Act (PDUFA) date is October 22, 2016. The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open label extension study conducted in the targeted patient population at 105 US sites. These studies met all primary efficacy and safety endpoints, confirming the anticipated product profile of RAYALDEE’s ability to correct vitamin D insufficiency and treat SHPT without meaningfully increasing serum calcium or phosphorus levels. Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. Source: www.viforpharma.com/en/Media/mediareleases/2016/20160509_5739766795-message.php#pdf Read more: http://opkodd.proboards.com/thread/1052/vifor-fresenius-opko-rayaldee-license#ixzz48ALEkqUK
OPKO Health beats by $0.01, beats on revenue OPKO Health (NYSE:OPK): Q1 EPS of -$0.02 beats by $0.01. Revenue of $291M (+866.8% Y/Y) beats by $24.7M. Shares +4.9%. Press Release
https://opkodd.wordpress.com/2016/0...ayaldee-there-are-no-therapeutic-equivalents/ There is some movement going on I am confused though. Thought it wouldnt be approved until october
october is the deadline, if the FDA for whatever reason can review it earlier, than of course it would be approved earlier.
Frost will never stop buying this now. All his work has now come together. It's harvest season. PT of $20 by next year. Easy!
frost is really building an empire, when everything starts to come together this stock will be alot higher in a few years.
I am probably going to jinx it but look at the beauty of its recent chart. I sold half of my position but will keep rest for a bit more. I still trust DR Frost.
i still have all my shares. some news is probably coming up with the run this thing has had. rayaldee release is supposed to be around november.
