Wednesday, March 20, 2019
EastGate Biotech Corp., a pharmaceutical company that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of Type 2 diabetes, entered into a long term strategic alliance with MJ Biopharm (www.mjgroup.co.in) for the supply of human recombinant insulin.
One of the key terms of the strategic alliance agreement between EastGate and MJ Biopharm is to provide EastGate with human insulin active pharmaceutical ingredient (API) for clinical trial purposes AT NO COST in order to formulate its liquid insulin mouth rinse in the South East Asian (SEA) territory. The SEA countries included in the agreement are Pakistan, Bangladesh, Malaysia, Philippines, India, Vietnam, Indonesia, Thailand, Singapore, Cambodia, Laos, Myanmar, Brunei, Sri Lanka and Nepal. MJ Biopharm also agrees to provide all regulatory support required to achieve regulatory approval in each country. After approval, MJ Biopharm agreed to provide human insulin API for commercial purposes in the same territory for a period of 10 years. In exchange for the free insulin during the trials, EastGate has agreed to pay MJ Biopharm a royalty after the countries in the territory have received regulatory approval and have launched their marketing campaigns.
In addition, EastGate has given MJ Biopharm a First Right of Refusal on the liquid insulin mouth rinse for the country of India.
According to the International Diabetes Federation (IDF) Diabetes Atlas 8th Edition an estimated 82 million adults aged 20-79 years were living with diabetes in the SEA region in 2017; representing a regional prevalence of 8.5%. About 45.9% of these diabetes cases were undiagnosed.
"This strategic agreement will allow EastGate to quickly roll out our liquid insulin mouth rinse in the SEA territory," said Anna Gluskin, CEO of EastGate Biotech. "Securing a dominant supplier of insulin in this region was the final piece we needed for our go to market strategy. We now have strong regulatory support. We are delighted to see such strong regulatory support from both of our partners in this region. MJ Biopharm has an excellent reputation and standing within the regulatory community, and this is of great value to EastGate. We believe that this represents a new era in the treatment of diabetes," concludes Anna Gluskin.
Rose C. Perri, President of EastGate Biotech, added, "Early on we realized that procuring an exclusive source of insulin was key to our strategic plans for the development and future commercialization of our liquid insulin mouth rinse for Type 2 diabetes patients; particularly in light of the fact that there are very few insulin manufacturers around the world. Together with my colleague, Bill Abajian, in charge of Global Licensing and Business Development, we mapped out a plan to execute our needs specifically in our initial targeted market of South East Asia. This strategic agreement is a direct result of our attendance at the Arab Health Conference at the end of January. Together with the MJ Executive team we were able to reach agreeable terms in order to finalize the agreement expeditiously. We anticipate that this will jump start more licensing agreements in the coming months. Our pathway to regulatory approval in the SEA region is now well defined ahead of our forthcoming clinical trial results."
Amol Shah, Managing Director of MJ Biopharm, says, "MJ has focused on insulin based therapy. Despite its proven efficacy and safety, per capita usage of insulin is low in emerging markets due to "needle fear". We are delighted to work with EastGate as they offer just what we were looking for: development of an innovative delivery system for insulin. This type of collaborative effort will help in providing access to insulin to a larger number of the needle adverse population. MJ Biopharm with its strong capability in manufacturing insulin drug substance will support EastGate's initiative in reversing the tide of Diabetes through an innovative, yet easy-to-administer system for non-invasive drug product."