Okpo Health - Früherkennung bei Prostatakrebs ?
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Thomson Reuters completed its industry survey and following that it has given a 52-week price estimate of $16.60 to Opko Health Inc (NYSE:OPK) stock. It is the average of the price estimates given by the brokerages during First Call survey. Last year, the company posted average EPS of $-0.06, and for the upcoming quarter year, the EPS is expected at $-0.05. The analysts are projecting next quarter earnings at $-0.01, and for next fiscal at $0.17.
EirGen Pharma owner is to expand facility and create a product development centre
http://www.irishtimes.com/business/technology/...-waterford-1.2619239
'Jim is uniquely qualified to establish and execute our commercial plans for RAYALDEE in the US. His deep knowledge of the chronic kidney disease market will help bring RAYALDEE to Stage 3 and 4 CKD patients,' said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. Dr. Frost continued, 'We look forward to rapidly moving through the final regulatory steps with the FDA and securing an approval.'
Sehr ärgerlich das ganze...
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.
Und später kommen noch die Zahlen.
OPKO Health Reports First Quarter Financial and Operating Results
Consolidated Revenue Increased to $291.0 Million From $30.1 Million for the First Quarter of 2016 as compared to the 2015 period
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and OPKO Health Entered into Agreement for OPKO's RAYALDEE®; OPKO to Receive up to $282 Million in Upfront and Milestone Payments, Plus Tiered Double-Digit Royalties; Vifor Fresenius also Acquired an Option for Rights to the U.S. Dialysis Market for a New Dosage Form of RAYALDEE Which Provides for Payment to OPKO of up to $555 Million in Additional Milestone Payments Plus Double-Digit Royalties if Exercised
RAYALDEE PDUFA Date Set for October 22, 2016
New Leadership at Bio Reference Laboratories and Senior Vice President of Pharmaceutical Sales for RAYALDEE launch appointed
4Kscore® Recommended in 2016 European Association of Urology Prostate Cancer Guidelines
First Patient Dosed in Phase 2a Clinical Trial of Long Acting Factor VIIa
First Patient Dosed in Phase 1 Clinical Trial of Long-Acting Subcutaneous Oxyntomodulin for Obesity and Diabetes
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE:OPK), a multinational biopharmaceutical and diagnostics company, today reported financial and operating results for the three months ended March 31, 2016.
Dialyse
(https://de.wikipedia.org/wiki/Dialyse)
Weltweit leiden mehr als 2,8 Millionen Menschen an Nierenversagen. Mit innovativen Produkten und Therapien setzen wir für die Dialysebehandlung von Patienten mit chronischem Nierenversagen den höchstmöglichen Standard.
http://www.freseniusmedicalcare.com/de/startseite/
Daher auch das große Interesse an Rayaldee....
Aus dem Übersetzer: Man kann sich den orginal conference call unter " listen to this transcript" im englischen Orginalton anhören
Ich stelle fest, dass es keine derzeit erhältliche Produkte sind, die zuverlässig Stufe D 25-Hydroxy-Vitamin bei Patienten mit Stadium 3 oder 4 chronischen Nierenerkrankung auf die für eine bessere Steuerung des sekundären Hyperparathyreoidismus erforderlich erhöhen können. Die Marktchancen für US RAYALDEE übersteigt 12 Milliarden $ und es gibt auch eine erhebliche globale Marktchancen. Folglich sind wir mit dieser Zusammenarbeit Entwicklungs- und Vermarktungsvereinbarung mit Vifor Fresenius sehr zufrieden.
MOD-6031 ist unsere langwirkenden subkutane oxyntomodulin, die ein natürlicher Appetitzügler zur Behandlung von Fettleibigkeit und Typ-2-Diabetes. Im März sind wir das erste Thema in einer Phase 1 Einzeldosis-Eskalations-Studie zur Dosis erfreut, die Sicherheit und Pharmakokinetik von MOD-6031 gesund, übergewichtig oder fettleibig Probanden zu bewerten. Die Studie soll 40 Fächer einschreiben und je nach Einschulungsraten erwarten wir Topline-Daten bis Ende des Jahres zu haben. Vorklinische Tier Daten zeigten, dass unsere Verbindung verringert die Nahrungsaufnahme und das Körpergewicht und zur Verbesserung der glykämischen Kontrolle Lipidprofil geführt.
Die pharmakokinetischen Studien zeigten eine erweiterte kinetische Profil im Vergleich zu nativen oxyntomodulin und wir glauben, dass Oxyntomodulin das Potenzial hat, eine sichere, langfristige Therapie bei Adipositas und Typ-2-Diabetes, von denen jede stellen eine bedeutende (technische Schwierigkeiten) Gelegenheit zu sein. Mehr als 380 Millionen Menschen mit Diabetes weltweit leben, von denen ca. 90% Typ-2-Diabetes haben. Nach Angaben der Weltgesundheitsorganisation gibt es mehr als 500 Millionen stark übergewichtig oder fettleibig Menschen in der Welt
Mr. Nusbickel has over 25 years of pharmaceutical experience with established large companies, such as Hospira, Amgen and Abbott, with a career long focus on specialty products and nephrology. He has been involved in numerous product launches including serving as the global lead for Amgen’s launch of Sensipar, and has deep connections with managed care organizations and with key nephrology opinion leaders. Prior to joining OPKO, Mr. Nusbickel served as Hospira’s Head of U.S. Market Access, Biologics and as Amgen’s Executive Director, Value Access and Advocacy.
“OPKO is proud to add Tom to our growing management team responsible for commercializing RAYALDEE in the U.S. Tom has extensive, successful experience in launching new products in the U.S. chronic kidney disease market,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, “and we are confident that he will help drive Rayaldee to great success.”
July 28, 2015
Brand name: Rayaldee
Generic name: calcifediol
Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism
Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.
The safety and efficacy of Rayaldee was established from the results of two 26 week placebo controlled, double blind phase 3 trials of 213 patients with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels between 10 and 30 ng/mL. Data demonstrated that a larger proportion of patients achieved at least 30 percent 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.
Rayaldee is an extended release capsule taken orally, once daily at bedtime. The most common side effects reported in clinical trials were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
Charles Bishop (CEO OPKO’s Renal Division) stated at the Q1 2015 Conference Call:
“There are no other drugs currently on the market or under development that simultaneously control secondary hyperparathyroidism pre-dialysis patients and correct the most frequent underlying cause of the disease which is vitamin D insufficiency.”
“Rayaldee™ is going to be the first with the indication of treating Secondary Hyperparathyroidism that arises from Vitamin D Insufficiency in this patient population. No other product has this indication.”
OPKO Executive Vice President – Steven D. Rubin at RBC 2016 Healthcare Conference:
“There is really nothing else in that space that effectively treats a Stage 3 & 4 Chronic Kidney Disease Patient with those indications.”
As reiterated in an OPKO Conference Call, the market for Rayaldee™ is large. Millions of patients that OPKO targets with Stage 3 & 4 CKD, one quarter are treated with active Vitamin D Hormones and one third are treated with Nutritional Vitamin D. Because neither of these options are very good about one half of the patients are not treated at all. OPKO believes Rayaldee™ can take share from all three of these categories and in fact expand the market.