IRVINE, Calif., Nov. 07, 2017 (GLOBE NEWSWIRE) — Biomerica Inc. (NASDAQ:BMRA) today announced that it has extended its exclusive license agreement with Celtis Pharm Co. Ltd of South Korea. Celtis has changed its name to Telcon Pharmaceuticals (“Telcon”). The License Agreement grants Telcon an exclusive license to market and sell Biomerica’s new InFoods® IBS (Irritable Bowel Syndrome) products in Korea for five years. The Biomerica InFoods® IBS product identifies patient specific foods that, when removed, can alleviate an individual’s IBS symptoms.
Under the terms of the previously announced agreement, Telcon shall pay up to $1.25 million in exclusivity fees to Biomerica based on certain milestones, including receipt of US FDA clearance. In addition to the exclusivity fees, a royalty fee shall be paid to Biomerica based on a percentage (in the mid-teens) of net sales of the products in Korea. The minimum royalty payments required to retain the exclusivity in Korea for the term of the agreement are $7.25 million over five years. The exclusive territory under this license agreement is the Republic of Korea (South Korea) with a possibility of future expansion into other territories in Asia if mutually agreed upon terms are reached. The term of the exclusivity agreement is five years with an additional two years for Telcon to receive Korean FDA clearance and begins with the date Biomerica receives final clearance for sale of the InFoods® IBS products in the United States. The amended agreement may now be cancelled if Biomerica has not obtained final clearance for sale of the Products in the United States from the United States FDA on or before December 31, 2019.
The ability to manage IBS by identifying and eliminating patient specific foods from patient’s diets could help tens of millions suffering from the disorder worldwide. It is estimated that over 45 million Americans are affected by IBS. Since the InFoods® product is a diagnostic guided therapy and not a drug, it has no drug type side effects. In addition, the InFoods® technology is applicable for patients with IBS-M (mixed or alternating between Diarrhea and Constipation). This variant of the disease constitutes approximately 33% of the IBS market and currently no FDA approved therapeutics are available. Biomerica’s Scientific Advisory Board is assisting and guiding the Company with the FDA regulatory process. The Scientific Advisory Board is being chaired by Douglas A. Drossman, M.D. (President of the Rome Foundation), and also includes three other key opinion leaders in the field of gastroenterology and Irritable Bowel Syndrome. The Company expects to announce the beginning of US clinical trials soon.
Zackary Irani, Chairman and Chief Executive Officer of Biomerica, stated, “We are very pleased today to announce the extension of our license agreement with Telcon in the Korean market. It is estimated that 10-15% of the world’s population and over 45 million Americans suffer from IBS.”
Mr. Hong Gye Lim, Chief Executive Officer of Telcon, commented, “We believe Biomerica’s innovative IBS therapy can alleviate suffering and improve the lives of so many people. We look forward to continuing our collaboration with Biomerica and seeing the Company achieve the regulatory milestones that can bring this breakthrough product to market.”
About Biomerica (NASDAQ:BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians’ offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company’s products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.
The Biomerica InFoods® IBS product identifies patient specific foods that when removed may alleviate an individual’s IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product will be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians’ offices is available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects.
About Telcon Pharmaceuticals
Telcon Pharmaceuticals is focused on transforming the lives of patients with Gastrointestinal Diseases. Telcon Pharma specializes in liquid suspension therapies and manufactures its own brands in Korea which are used in hospitals and patients throughout the country. In addition, Telcon Pharma also provides contract manufacturing for other pharmaceutical companies in Korea.
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking; such as statements relating to intended launch dates, sales potential, significant benefits, market size, prospects, new products, favorable outlook, new distributors, expansion, increases in productivity and margins, expected orders, leading market positions, anticipated future sales or production volume of the Company, the launch or success of product and new product offerings. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The potential risks and uncertainties include, among others, fluctuations in the Company’s operating results due to its business model and expansion plans, downturns in international and or national economies, the Company’s ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company’s dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.