Opko Health Outlines 2017 Plans
Jan 16, 2017 23:19:16 GMT
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Post by gutset on Jan 16, 2017 23:19:16 GMT
January 16, 2017 www.investopedia.com/news/opko-health-outlines-2017-plans-opk/#ixzz4VyAzCnvY
After a disastrous end to 2016, when its Phase 3 study of the long-acting human growth hormone hGH-CTP failed, Opko Health Inc. (OPK) outlined a robust plan for 2017 at the recently concluded 35th annual JP Morgan Heathcare Conference. (For more, see The Synergy From OPKO's Acquisition of Transition Therapeutics.)
On December 30, the Miami, Florida-based health care company said its late-stage GHD clinical trial did not meet the primary endpoints, leading to an 18% decline in its stock price.
Entering the New Year, the company confirmed the discovery. Executive vice president Steve Rubin claimed that researchers have identified "an exceptional value of trunk fat mass reduction in the placebo group," which will now enable the company to re-evaluate the therapy in the adult patients.
The initiation of statistical data analysis will assist in the necessary submission for drug approval. The drug is being developed in partnership with Pfizer Inc (PFE), which owns its registration and commercialization.
Growth hormone deficiency (GHD) is a medical disorder caused by problems arising in the pituitary gland, in which the body does not produce enough growth hormone. Growth hormone is necessary for stimulation of growth and cell reproduction.
Other Targets for 2017
Opko has commenced clinical studies of its Claros 1 prostate-specific antigen (PSA) test, which will be tested on 1,000 patients across 15 different U.S. sites. Opko expects to submit the necessary application for securing modular pre-market approval of the PSA test latest by June 2017.
Opko also expects its secondary hyperparathyroidism drug Rayaldee (calcifediol) sales to increase steadily in coming months. The key drug for treating kidney disease was launched in November last year in the U.S. (For more, see Opko Health Ships Rayaldee Kidney Drug In US.)
With the company actively securing contracts with commercial and Medicare Part D payers, it expects 70% to 80% of U.S. residents to get covered for the drug by mid-2017.
Opko has reported success in securing reimbursement coverage from at least one national-level player for its 4Kscore prostate cancer test, and continues to engage with other Medicare administrative contractors for wider coverage.
The company also looks forward to announcing results from its Phase 2a trial assessing FVIIa replacement therapy for hemophilia patients by end of mid-2017. It plans to initiate Phase 2b clinical trial of oxyntomodulin therapy for treating Type-2 diabetes during later half of 2017. The company also announced a collaboration with AbbVie Inc. (ABBV) to discover agonist antibody therapeutics for inflammatory diseases. (For more, see Opko Health 3Q Loss of 3c/Share Beats Street.)
After a disastrous end to 2016, when its Phase 3 study of the long-acting human growth hormone hGH-CTP failed, Opko Health Inc. (OPK) outlined a robust plan for 2017 at the recently concluded 35th annual JP Morgan Heathcare Conference. (For more, see The Synergy From OPKO's Acquisition of Transition Therapeutics.)
On December 30, the Miami, Florida-based health care company said its late-stage GHD clinical trial did not meet the primary endpoints, leading to an 18% decline in its stock price.
Entering the New Year, the company confirmed the discovery. Executive vice president Steve Rubin claimed that researchers have identified "an exceptional value of trunk fat mass reduction in the placebo group," which will now enable the company to re-evaluate the therapy in the adult patients.
The initiation of statistical data analysis will assist in the necessary submission for drug approval. The drug is being developed in partnership with Pfizer Inc (PFE), which owns its registration and commercialization.
Growth hormone deficiency (GHD) is a medical disorder caused by problems arising in the pituitary gland, in which the body does not produce enough growth hormone. Growth hormone is necessary for stimulation of growth and cell reproduction.
Other Targets for 2017
Opko has commenced clinical studies of its Claros 1 prostate-specific antigen (PSA) test, which will be tested on 1,000 patients across 15 different U.S. sites. Opko expects to submit the necessary application for securing modular pre-market approval of the PSA test latest by June 2017.
Opko also expects its secondary hyperparathyroidism drug Rayaldee (calcifediol) sales to increase steadily in coming months. The key drug for treating kidney disease was launched in November last year in the U.S. (For more, see Opko Health Ships Rayaldee Kidney Drug In US.)
With the company actively securing contracts with commercial and Medicare Part D payers, it expects 70% to 80% of U.S. residents to get covered for the drug by mid-2017.
Opko has reported success in securing reimbursement coverage from at least one national-level player for its 4Kscore prostate cancer test, and continues to engage with other Medicare administrative contractors for wider coverage.
The company also looks forward to announcing results from its Phase 2a trial assessing FVIIa replacement therapy for hemophilia patients by end of mid-2017. It plans to initiate Phase 2b clinical trial of oxyntomodulin therapy for treating Type-2 diabetes during later half of 2017. The company also announced a collaboration with AbbVie Inc. (ABBV) to discover agonist antibody therapeutics for inflammatory diseases. (For more, see Opko Health 3Q Loss of 3c/Share Beats Street.)