Oramed Pharmaceuticals (NASDAQ:ORMP), a global leader in oral drug delivery technology, saw its out-licensed technology succeed in Entera Bio’s (NASDAQ:ENTX) Phase 2 study. Entera’s EB613, which is based on oral protein delivery technology in-licensed from Oramed, achieved its primary endpoint in a Phase 2 study by significantly increasing new bone formation in osteoporosis patients.
Royalties of 3% are owed to Oramed on Entera’s net revenue for the osteoporosis indication.
Entera saw a significant value increase in its shares on very heavy trading volume following the Phase 2 results.
Positioned to be the first oral bone building product to treat osteoporosis, EB613 is an orally delivered human parathyroid hormone (1-34). The Phase 2 trial met its primary endpoint with 3-month results showing a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation and the change at 3-months is the primary endpoint of the trial.
A pivotal Phase 3 registration trail of EB613 in osteoporosis is expected to start enrolling patients next year.
In addition to royalties on osteoporosis, Oramed is also entitled to 3% of royalties from Entera’s collaboration deal with Amgen (NASDAQ:AMGN). Entera is eligible to receive up to $270 million in aggregate payments and royalties from Amgen upon achievement of clinical and commercial milestones.
Oramed is conducting a pivotal Phase 3 study for its lead product ORMP-0801 which, if approved, would become the world’s first oral insulin drug to serve the $59 billion type 2 diabetes market. The technology out-licensed by Oramed to Entera differs from its main delivery technology used for oral insulin and is subject to different patent applications.