OPKO, Pfizer Partner On Long-Acting Human Growth Hormone
By Cyndi Root
OPKO Health and Pfizer have partnered on OPKO's long-acting hGH-CTP. The companies announced the deal in a press release, stating that the agent is for the treatment of growth hormone deficiency (GHD) in adults and children. The treatment shows promise in reducing the dosing frequency from one injection per day in the current standard of care to one injection per week. The agent is an Orphan Drug in the U.S. and the EU, and is currently in Phase 2 and 3 trials. OPKO's CEO, Phillip Frost, M.D., said, “We believe that the global growth hormone market is currently valued at more than $3 billion, and believe that hGH-CTP has the potential to be the best in class long-acting growth hormone product. By reducing the number of injections, our technology can improve patient compliance.”
OPKO and Pfizer Agreement
The agreement between OPKO and Pfizer is a worldwide development and commercialization alliance for hGH-CTP. OPKO will lead and fund development activities in the specified indications while Pfizer will fund development for other indications and fund any post-marketing studies. Pfizer will also be responsible for marketing activities and costs and will lead the manufacturing effort. Pfizer has agreed to make an upfront payment of $295 million to OPKO as well as an additional $275 million in milestone payments. In return, Pfizer earns the exclusive license to market hGH-CTP worldwide, conferring royalties to OPKO for the adult indication. Upon regulatory approval in the pediatric indication, royalties will transition to gross profit sharing.
Geno Germano, Group President of Pfizer Global Innovative Pharma (GIP), also commented on the new partnership, "Long-acting growth hormone is the first innovation in the GHD space in 20 years. hGH-CTP would be complementary to our existing Genotropin franchise.”
hGH-CTP
hGH-CTP is a recombinant human growth hormone analog that treats children who fail to grow or adults with GHD. The formulation is long acting, engineered to reduce the patient’s burden of daily injections. Reducing the patient’s responsibility may lead to improved compliance and better treatment outcomes. OPKO has extended the hormone’s half-life using a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin (hCG). Currently, hGH-CTP is in Phase 3clinical trials for adults and in Phase 2 for pediatric patients.