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Boston Therapeutics and Advance Pharmaceutical Company (APC) announced today the expansion of their sugardown® licensing agreement to Japan, a move that increases the number of Asian countries covered by the agreement to 16. Advance Pharmaceutical further reiterated its commitment to collaborate with Boston Therapeutics for funding of clinical trials for sugardown®. Upcoming product development trials are expected to include a pre-diabetes study of sugardown® at the Chinese University of Hong Kong and a U.S. Phase II study at the Joslin Diabetes Center in Boston for Boston Therapeutics’ BTI-320 candidate (a new generation of alpha glucosidase inhibitor that is designed to reduce post-meal elevation of blood glucose).
The complete press release is included below.
MANCHESTER, NH--(Marketwired - Mar 17, 2015) - Boston Therapeutics, Inc. (OTCQB: BTHE), a leading developer of complex carbohydrates to treat diabetes and inflammatory diseases, and Advance Pharmaceutical Company Ltd. (APC), via its subsidiary Sugardown Company Ltd.(SDCL) of Hong Kong, have agreed to expand their licensing and marketing agreement for Boston Therapeutics' sugardown® to include Japan. The territory expansion comes as a result of the continued regulatory filings and marketing clearance authorizations that are being granted as APC continues its market registration expansion.
APC received a signed certificate from the Department of Health to initiate a clinical trial at the Chinese University of Hong Kong (CUHK) evaluating sugardown® in subjects with pre-diabetes. The clinical trial is expected to start this month. APC also will collaborate with Boston Therapeutics who signed an agreement with the Joslin Diabetes Center in Boston to be the lead clinical site of a Phase II study of BTI-320.
Under the terms of the original agreement, SDCL can market sugardown® in China, Hong Kong and Macau. In 2014, the agreement was expanded to include Korea, Taiwan, Singapore, Thailand, Malaysia, Vietnam, Philippines, Myanmar, Indonesia, Laos, Brunei and Cambodia. APC already has been granted marketing approval in Singapore, Macau, and Korea and Hong Kong as well. The mainland China registration will enter the clinical testing phase this year with a projected approval tentatively set for 2016.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "As a result of this major expansion of our marketing approval efforts across Asia, we expect to attract a substantial number of new potential sugardown® consumers. Concerns about blood sugar levels exist in every country worldwide, and we are confident that the benefits of our product will resonate with the populations of these nations where carbohydrate and excessive processed sugar components have been and continue to be a major impact on future national healthcare. We are pleased to expand our agreement and our clinical development with APC and SDCL, and we look forward to expanding our sugardown® distribution and, potentially, our revenues."
In the fourth quarter of 2014, Boston Therapeutics received a purchase order from SDCL for 60,000 bottles of sugardown®. It expects to ship this order in the second quarter of 2015.
About sugardown®
Boston Therapeutics' plan for sugardown® is to out-license marketing rights to strategic partners in their jurisdictions of expertise. The Company entered into an agreement with Advance Pharmaceutical Co. Ltd. (APC), our Hong Kong-based strategic partner to develop markets in Asia. As part of the plan to increase sales, the Company entered into a strategic marketing collaboration with Benchworks SD, LLC, a leading branding and marketing agency, aimed at driving brand awareness and growing sales of sugardown® in North America.
sugardown® is Boston Therapeutics' over-the-counter, natural dietary supplement product that helps people maintain healthy blood sugar levels. sugardown® is the first chewable tablet of its kind. It was designed to help people keep their blood sugar levels healthy. The main ingredients in sugardown® are made from naturally occurring plant-based mannans (galactomannans) that have the ability to regulate digestive enzymes which in turn promotes healthy digestion, optimal sugar absorption and supports healthy glucose levels. sugardown® is available in a bottle of 60 tablets or a convenient 10-tablet tube. For more information, visit sugardown® on Facebook. To order, visit www.sugardown.com.
About Advance Pharmaceutical Company, Ltd.
Advance Pharmaceutical Company is a leading Hong Kong-based pharmaceutical company. Advance Pharmaceutical Company currently sells over 400 types of licensed pharmaceutical products, consisting of prescription and over the counter products to local dispensaries, medicine shops, clinics and hospitals, as well as chain stores, such as 7-11, Wellcome, Park-N-Shop, Manning's and Watson's. Outside of Hong Kong, APC has been building and maintaining its marketing network in Macau since 1983 and has many years of experience in exporting and distributing pharmaceutical products to China. SugarDown Co Ltd of Hong Kong is an affiliate of Advance Pharmaceuticals Company (APC), organized under the laws of Hong Kong. Boston Therapeutics has entered into an agreement with APC to develop markets for sugardown® in Hong Kong, China and Macau in addition to 13 other countries in Asia. Additional information is available at http://www.apc.com.hk/aboutus.php.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug designed initially to treat lower limb ischemia associated with diabetes. The company also developed and markets sugardown®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "May," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding our clinical development of sugardown® are subject to factors beyond our control. We can provide no assurance we or our commercial partner will be able to generate market demand for sugardown®, and thus we may not be able to generate revenue from sugardown® sales.
Moreover, we have incurred operating losses since our inception, and our ability to successfully develop, market, manufacture, distribute and sell drugs or over-the-counter products may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC.
You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.