Alliance with MJ Biopharm of Mumbai, India positions the company to further its plans for SEA countries for its liquid insulin mouth rinse
WEST CALDWELL, NJ and TORONTO, ON, March 19, 2019 (GLOBE NEWSWIRE) -- via NEW MEDIAFIRE -- Eastgate Biotech Corp. (OTC PINK: ETBI), 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 the 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 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 the easy-to-administer system for the non-invasive drug product."
About MJ Biopharm
MJ Biopharm is headquartered in Mumbai, India and is a subsidiary of the much larger MJ Group of companies. The company's vision is to improve access to life-sustaining therapies and to discover, develop and commercialize quality bio-similar products through technology transfer. Their mission to bring value-added cost-effective solutions for diabetes is in complete alignment with Eastgate. They have 14,000 square meters of manufacturing space that has been built to European Medicines Evaluation Agency (EMEA) and Food and Drug Administration (FDA) standards. Their microbial unit is devoted to the production of recombinant human insulin and analogs and represents one of their three manufacturing facilities. They are one of the largest manufacturers of human insulin formulations in different forms.
About Eastgate Biotech
Eastgate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that take difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increases the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that those trying to attain and maintain a healthy lifestyle. Eastgate's wholly-owned subsidiary OMNI Surgery and Anti-Aging Centre is the first of many surgery centers to come under the OMNI umbrella as we plan to roll up existing businesses under the OMNI brand and expand our footprint globally.
Cautionary statement n forward-looking information
All statements, other than statements of historical fact, contained or incorporated by reference in this news release constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws, including the provisions for "safe harbor" under the United States Private Securities Litigation Reform Act of 1995 and are based on expectations, estimates, and projections as of the date of this news release.
The words "anticipates", "plans", "expects", "indicate", "intend", "scheduled", "estimates", "forecasts", "focus", "guidance", "initiative", "model", "methodology", "outlook", "potential", "projected", "pursue", "strategy", "study", "targets", or "believes" or variations of or similar such words and phrases or statements that certain actions, events or results "may", "could", "would" or "should", "might" or "way forward", "will be taken", "will occur" or "will be achieved" and similar expression identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies. The risks, estimates, models, and assumptions contained or incorporated by reference in this release, including those identified from time to time in the reports filed by Eastgate with the SEC, which should be considered together with any forward-looking statement. Eastgate undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Rose C. Perri