The agreement grants Medicox an exclusive license to apply for regulatory approval for and distribute Oramed’s oral insulin candidate (ORMD-0801) for ten years in the Asian country.
Oramed says the deal allows it to participate in the large and growing Korean market, leveraging the commercialization strength of a partner, while freeing it up to focus on other key markets, including the US.
Medicox will purchase ORMD-0801 at an agreed upon transfer price and will additionally pay Oramed up to $18m, $2m of which have already been received by Oramed to date, in developmental milestones, and up to 15% royalties on gross sales.
The Korean company will be responsible for gaining regulatory approval of the drug in the Republic of Korea.
ORMD-0801 is currently in two pivotal Phase 3 studies, with top-line results of the first Phase 3 study expected in January next year.
The company says the drug has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.
Boosting patient compliance
Nadav Kidron, CEO of Oramed, told this publication previously that oral insulin has a number of potential benefits, including a more natural method of delivery.
“Oramed’s oral insulin – recombinant human insulin – unlike the injectable insulin, mimics the body’s endogenous insulin and regulates glucose from the liver. In addition, with an oral insulin pill, patient compliance will likely be much higher – studies have shown that people would prefer a pill to a shot.
“Today, for type 2 patients, insulin is often a last resort medication, but with an oral insulin pill, insulin could be prescribed earlier on in the treatment paradigm which should have a positive impact on the patient’s overall health.”
Oramed’s delivery platform includes technology that protects the protein from being broken down by enzymes in the GI tract and includes absorption enhancers to help the insulin cross over the intestinal wall, explained the company.
NASH trial data
The company also recently released additional positive data from its Phase 2 double-blind, fully randomized, placebo-controlled, multicenter clinical trial (ORA-D-N02) to assess the safety and efficacy of ORMD-0801 to reduce liver fat content in Type 2 diabetes patients with non-alcoholic steatohepatitis (NASH).
The Phase 2 trial enrolled 32 patients, with 30 patients completing, over a treatment period of 12-weeks.
Oramed said the study showed that ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for it compared to placebo. The oral insulin candidate also demonstrated consistent trends across key secondary endpoints with reduction of liver fat, liver stiffness and lipids, said the developer.
