Boston Therapeutics Signs Agreement With Patheon to Manufacture Pharmaceutical-Grade BTI-320 Tablets
Agreement Secured in Preparation of International Phase III Trial of BTI-320 Slated for 2015
MANCHESTER, NH--(Marketwired - May 6, 2014) - Boston Therapeutics, Inc. (OTCQB: BTHE), a clinical stage developer of innovator compounds that address diabetes and inflammatory diseases using complex carbohydrate chemistry, along with its Hong Kong-based strategic partner Advance Pharmaceutical Company, have together signed an agreement with pharmaceutical manufacturing company Patheon Inc. to manufacture pharmaceutical-grade tablets of the company's lead product candidate BTI-320, a compound designed to reduce post-meal elevation of blood glucose.
This agreement was secured in anticipation of Boston Therapeutics' anticipated IND filing in late 2014, as well as the company's planned international Phase III trial for BTI-320 that is scheduled to be initiated in 2015. One batch of BTI-320 will be manufactured within a six-month timeframe during which all methods development, analytical, stability and other necessary tests will be performed under the IND requirements.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "The manufacturing of pharma-grade BTI-320 tablets is essential to the preparation for our upcoming IND submission and our planned international Phase III trial. We are pleased to have secured the services of Patheon for this important project, a key step in our BTI-320 development efforts and our continued growth as a company."
Patheon is a leading provider of drug development and manufacturing services to global pharmaceutical, biotechnology and specialty pharmaceutical companies. Its global manufacturing network includes approximately 6,000 employees providing services at 12 commercial contract manufacturing facilities, and nine development centers across North America and Europe.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose in Type 2 diabetic patients. BTI-320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
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 (formerly PAZ320), 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 produces and sells SugarDown(R) , 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 the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from our approved products. Plans regarding development, approval and marketing of any of our compounds, including BTI-320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. We have incurred operating losses since our inception, and our ability to successfully develop and market drugs 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.