January 13, 2017
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – Despite ending 2016 with a Phase III failure of its long-acting human growth hormone product, Miami-based Opko Health rolled into the annual J.P. Morgan Healthcare conference with a game plan for growth in 2017–a plan that includes the growth hormone.
Referencing humorist Mark Twain, Steve Rubin, Opko’s executive vice president, told investors that rumors of hGH-CTP are “greatly exaggerated.” Rubin said the company has identified “one of more outliers that may have affected the primary outcome” of the Phase III trial, Keith Speights reported in The Motley Fool. On Dec, 30. Opko revealed the Phase III trial failed to see statistically significant change in trunk fat mass from the baseline to 26 weeks of dosing. Opko’s hCH-CTP had a satisfactory satisfactory safety profile, and “more patients on hCH-CTP had normalized serum concentrations of insulin-like growth factor-I compared to those on placebo,” BioSpace reported in December.
This week, Speights said Rubin revealed Opko’s scientists discovered “an exceptional value of trunk fat mass reduction in the placebo group.” That means, Speights said, that Opko will take another look at evaluating treatment in the adult patient population.
Opko and Pfizer partnered on the drug development. The two companies will be seeking approval from the U.S. Food and Drug Administration for another crack at the drug, Speights reported. Rubin is expecting the FDA to give the nod for a late-stage study in adults. With a better understanding of those outliers, Rubin seemed optimistic that Opko and Pfizer could submit the drug for FDA approval.
It’s not just renewed hope for hCH-CTP that is part of Opko’s 2017 game plan. Speights also reported the company initiated a Phase I trial for its Claros 1 prostate-specific antigen. Opko will look to file for modular pre-market approval of the test within the first half of this year. A second testosterone tests will be sought in the second half of 2017, according to reports.
Opko is also seeing growth from its recently approved kidney disease drug, Rayaldee, extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease. Speights said the company secured contracts with multiple insurance payers, including Medicare Part D to cover “half or all Americans.” The company thinks that between 70 percent and 80 percent of individuals will be covered for Rayaldee by mid-2017, Speights said.
Shares of Opko are down slightly this morning, trading at $9.18. Since the Dec. 30 report of the Phase III failure, shares of Opko have been down about 20 percent.
