Boston Therapeutics has assembled a team with over six decades of combined experience in complex carbohydrate chemistry and nearly as many decades on the business end of the pharmaceutical industry. The company is able to boast today of a far-reaching applied carbohydrate chemistry technology platform with deep penetration into the diabetes therapy market, as well as applications in ancillary inflammatory diseases.
The company’s current pipeline leverages that vast experience in engineering, developing, and commercializing therapeutic molecules to offer a variety of proprietary formulations that are designed to satisfy unmet medical needs. The company’s first consumer product launched back in June at the 94th Endocrinology Annual Meeting & Expo, a chewable tablet trademarked SUGARDOWN®, which utilizes a proprietary fractioned mannan (a group of plant-derived complex carbohydrates, or polysaccharides known for a range of biological functions from inhibiting cholesterol absorption to stopping tumor growth) for safely and effectively moderating post-meal glucose levels in a non-systemic fashion (primarily in the stomach and intestine).
This ability to go to work in the gastrointestinal tract and block carbohydrate-hydrolyzing enzymes that produce simple sugars offers a powerful, extremely safe means for glycemic control in pre-diabetics/diabetics and thus can be a major factor in managing blood glucose levels. This same technology is behind BTHE’s drug candidate PAZ320, another chewable which saw completion of enrollment for the Phase II clinical trial back in June. The trial is designed to validate safety/efficacy in combination with other oral agents (or insulin) in Type 2 diabetics at the Dartmouth-Hitchcock Medical Center in New Hampshire. This follows fast on the heels of the company’s analysis of extant Phase II clinical trial data that shows significant reductions of post-meal elevation of glucose and very favorable tolerability with no side effects. PAZ320 represents a simple way for individuals to potentially slow the onset of Type 2 diabetes and/or diabetes complications like heart disease and stroke.
The very recent Trust for America’s Health and Robert Wood Johnson Foundation report indicates that half of U.S. adults will be obese by 2030 given current projections, with as many as 7.9M new cases of diabetes each year. Taken into context with broader CDC/ADA data that shows the diabetes rate increasing from around 10% to nearly 34% of the population within that same interval, we have compelling baseline fundamentals for the company’s glucose regulating indications.
Earlier this month, the company won approval from the FDA on their petition to file an Abbreviated New Drug Application (ANDA) for their new chewable tablet formulation of the current oral standard for care in Type 2 diabetes, metformin hydrochloride, called PAZAMET™. Given that the Reference Listed Drug for PAZAMET with the FDA is the established Glucophage® (Bristol-Myers Squibb), the FDA has ruled that no further clinical work needs to be done to validate the proposed product’s safety/efficacy. Huge news for BTHE as this essentially constitutes a green light for an improved form of a drug that has been widely used for several decades, is available in multiple generic formats, and which represents several billion a year in sales (50M prescriptions in 2010 alone). The easy to use format of a chewable tablet should expand usage significantly and because the FDA has further ruled that the proposed product is “PREA-fulfilled” (2007 Pediatric Research Equity Act), no customary safety/efficacy assessment needs to be done for the product to be used in pediatric populations.
PAZAMET again derives significant benefits from the company’s scientific expertise with mannans, and it is worth taking a closer look at the assembled literature on the subject to get a better sense of the true potential of the company’s technological platform for addressing a wide range of unmet needs. This technology platform is based on the pioneering work done by the company’s CEO, David Platt, who himself represents some three decades in the industry and it is remarkable that the company’s management has been able to get one product on the market and another into Phase III clinical trialing for bioequivalency (PAZAMET) without incurring any real debt. This feat should tell investors a great deal about the company’s in-depth knowledge of the development and commercialization process, as well as underscoring the exceptional business model and target space accessed by BTHE’s pipeline.
Also in the development pipeline is Ipoxyn™, the company’s very first CSP™ (carbohydrate shielded protein). Ipoxyn was engineered from the ground up to handle Lower Limb Ischemia associated with diabetes by delivering powerful universal oxygen-carrying performance (glycoprotein drug candidate). Ipoxyn is not a biologic, but a 2nd generation New Chemical Entity HBOC (hemoglobin based oxygen carrier) as defined by the FDA. The potential for this product goes well beyond Lower Limb Ischemia into a range of areas from anemia and blood loss (injury), to cardiovascular disease, and surgical blood supplementation. This extremely stable/consistent intravenous product has a shelf life greater than two years and doesn’t require any refrigeration. Furthermore, the advanced carbohydrate chemistry employed in its design has resulted in a product that is able to take up and off load oxygen much like a red blood cell would, giving the product serious therapeutic strength with the capacity to create hemoglobins in a whole range of different oxygen affinities.
On the pipeline periphery are OxyFex™, an Ipoxyn alternate designed for the veterinary space, and BTI-9, a gastrointestinal anti-inflammatory using a proprietaty formulation of a fractioned pectin that has shown strong binding of tumor necrosis factor alpha, thus shunting the immunological inflammatory mechanism and generally promoting colon health.
Boston Therapeutics is a small company with the technological prowess to carve out a big slice of the pie dominated by big name, juggernaut developers who are currently aggressively trialing what are essentially band-aid solution drug candidates that are only able to address portions of the overall market. With strong leads like SUGARDOWN and PAZAMET tapping directly into this huge market that shows no signs of slowing down, BTHE shareholders have a lot to be excited about.
To learn more about Boston Therapeutics, please visit www.BostonTI.com
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