Israeli weekly growth-hormone therapy edges closer to market

A weekly growth-hormone injection developed in Israel by multinational healthcare firm OPKO Health is moving closer to market entry shortly after announcing positive Phase 3 results. The long-acting somatrogon formulation first developed by Israel's Prolor Biotech (now OPKO Biologics), acquired for $480 million by OPKO in 2013, promises improved quality of life and enhanced treatment success rates for children who require growth-hormone injection treatment on a daily basis. The Nasdaq-listed company is now expected to submit its positive Phase 3 results to the US Food and Drug Administration (FDA) in the second half of 2020. It hopes to receive FDA approval to launch the long-acting product in mid-2021. Daily injections are required for children with growth-hormone deficiency (GHD), a rare medical condition characterized by inadequate secretion of growth hormone from the pituitary gland. Deficiencies may be either congenital or acquired and can be a symptom of genetic diseases, including Turner syndrome and Prader-Willi syndrome. As with all daily injections, the treatment is often associated with poor levels of adherence. “Somatrogon is a new molecular entity incorporating OPKO's proprietary long-acting technology,” OPKO CEO and chairman Dr. Phillip Frost told The Jerusalem Post. “We believe somatrogon represents a significant advance in the treatment of children with GHD compared to the current standard of one injection per day that could enhance a patient's adherence to treatment and quality of life.” Frost, a well-known biotech entrepreneur, served as chairman of Israeli drugmaker Teva from March 2010 until December 2014. He also served as chairman and CEO of IVAX Corporation from 1987 until 2006, when it was acquired for $7.4b. by the Israeli drug giant. According to Phase 3 trial results announced in October 2019, once-weekly doses of somatrogon in prepubertal children with GHD was non-inferior to daily doses of growth hormone somatropin, as measured by height velocity after 12 months of treatment. In 2014, OPKO entered into a worldwide agreement with Pfizer for the development and commercialization of somatrogon – set to target an expanding growth hormone-therapy market worth approximately $3.5b. In addition to an advance of $295m. paid by Pfizer in 2015, and additional pre-commercial regulatory milestones, the New York-headquartered corporation will enter into a profit-sharing mechanism following receipt of FDA approval based on all existing and future sales of growth-hormone products. The current dominance of Pfizer in the growth-hormone therapy market should ensure a short time to market for their weekly injection. “Growth hormone (GH) therapy has been available for over 50 years and has proven to be essential to the management of children who are GH deficient,” said Dr. Ron Rosenfeld, professor and chair of pediatrics (emeritus) at Oregon Health & Science University. “Such therapy, unfortunately, has required daily injections, typically for many years. With the successful completion of their Phase 3 studies of somatrogon, OPKO Biologics has demonstrated that therapy with their GH derivative can be given by weekly injection, rather than daily,” he said. “We anticipate that such a schedule will prove enormously appealing to children and parents and should lead to improved adherence to the prescribed course of treatment and optimization of the growth potential of children with GH deficiency.”

Israeli weekly growth-hormone therapy edges closer to market

As with all daily injections, the treatment is often associated with poor levels of adherence.

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Israeli weekly growth-hormone therapy edges closer to market

As with all daily injections, the treatment is often associated with poor levels of adherence.

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