Diabetes is experiencing a heightened awareness with debates in Washington over healthcare costs and pharmaceuticals companies working to develop new therapies for one of the world’s fastest growing diseases.  Presently, one in ten people in the United States is diagnosed with diabetes with that ratio expected to mushroom to one in three by the year 2030, according to the International Diabetes Federation.   Major drug makers like Johnson & Johnson (NYSE: JNJ) and Merck & Co. (NYSE: MRK) are advancing new drug candidates through clinical trials with some success, although sometimes only in specific subsets of diabetes patients.   Also moving towards the end of the regulatory pathway to bring a better drug to the diabetes population is Boston Therapeutics, Inc. (OTCBB: BTHE) with its new version of metformin, arguably the most common drug used by diabetes patients worldwide.

J&J recently announced that its drug, canagliflozin, has shown the potential for efficacy in reducing blood sugar in patients on long-term insulin therapy and at high risk for heart problems, according to data culled from a much larger Phase III trial.

Merck’s MK-3102, an investigational once-weekly treatment for Type 2 diabetes, was shown in a Phase IIb study to significantly lower blood sugar compared with a placebo.  The pharmaceutical giant is initiating a Phase III trial based upon the collected data.

Metformin:  The Good and Bad

For the nearly 26 million people in the States that have diabetes there are many common threads, including most of them taking the oral drug metformin to help process sugar in their bodies.  Metformin is in a class of drugs called biguanides and is used alone or with other medications, including insulin, as a front-line treatment for type 2 diabetes.  The drug acts by increasing the sensitivity of liver, muscle, and fat tissue to the effects of insulin, thereby lowering the level of glucose in the blood.   Metformin is also the only anti-diabetic drug that has been conclusively shown to prevent the cardiovascular complications of diabetes by helping to reduce LDL cholesterol and triglyceride levels with no associated weight gain.

Despite its benefits, metformin users commonly complain about the foul taste and smell of the drug, saying that it smells “fishy” and leaves an unpleasant metallic taste in the mouth.

Metformin has been around for decades and is known for its many generic formulations.  In the States, about 50 million prescriptions of metformin were filled in 2010.

A Better Metformin

Boston Therapeutics, a developer of complex carbohydrate therapeutics to treat diabetes and inflammatory diseases, recently released strong news that could prove a boon to the company and a relief to millions of metformin users.  The company said that the U.S. Food and Drug Administration approved its petition to file an Abbreviated New Drug Application, or ANDA, for a new, chewable tablet formulation of the diabetes drug metformin hydrochloride. The Company plans to market the new formulation under the name PAZAMET™.  An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or FDA-approved drug.

Further, the FDA has ruled that no further clinical investigation is necessary to demonstrate the safety and effectiveness of PAZAMET, citing PAZAMET’s active moiety being that of Bristol-Myers Squibb’s (NYSE: BMY) approved drug Glucophage® (metformin hydrochloride) Tablets.  Additionally, the FDA said that additional clinical trials are not required on PAZAMET to meet requirements of the Pediatric Research Equity Act of 2007, meaning that the new drug could be available to the pediatric population as well upon marketing approval.

As an added component of the new formulation, scientists at Boston Therapeutics have optimized the chemistry of complex carbohydrates known as mannans, a group of complex carbohydrates from plants which possess significant biological activity in moderating blood glucose levels after a meal.

With the ANDA pathway opened, Boston Therapeutics has shaved-off years and millions of dollars in research.  The company still must run a small-scale, Phase III clinical trial to prove bioequivalency (meaning that PAZAMET performs similar to Glucophage®).  In a phone conversation with David Platt, Chief Executive Officer at Boston Therapeutics, he told us that the company would be moving forward “expeditiously” with the trial.

Complex Carb Experts

The company is centered around their team of complex carbohydrate experts.  The BTHE pipeline has five products that are built upon optimizing the chemistry of complex carbohydrates, including SUGARDOWN®, a marketed neutraceutical for the management of blood glucose.

Harnessing the power of mannans, SUGARDOWN® is taken before carbohydrate-containing meals to reduce the absorption of glucose from the intestinal tract.  The proprietary mannan formulation in the chewable tablet binds to carbohydrates and digestive enzymes preventing the breakdown to glucose as the ingredients temporarily coat the digestive tract to slow the absorption of glucose.  In addition, SUGARDOWN® induces a feeling of fullness and can therefore support portion control.  All of these mechanisms combined lead to lowering the rate of glucose absorption from the intestinal tract into the blood.

Solid Front to Back

With a neutraceutical already on the market, Boston Therapeutics presents an opportunity that is not unlike a lot of other upstart biotechs.  But, a closer look shows the company to be an anomaly amongst its smaller biotechnology peers.  Aside from a strong pipeline and scientific team, the company is basically debt-free even though it has a new drug candidate heading into a Phase III clinical trial; a fact that is virtually unheard of in drug development.

Of course, the most appetizing (no pun intended) component of Boston Therapeutics is PAZAMET in the mid-term.  As mentioned, the diabetes population is only growing larger and there is a great area of unmet need simply based upon the taste and smell of current approved therapies.  PAZAMET appears to have not only addressed that issue, but has improved upon metformin on multiple levels as well through mannans.  In addition to the general patient population where market share could be huge, PAZAMET should be particularly beneficial to the pediatric markets because of the drug being a chewable tablet, rather than a swallowed pill.  The geriatric market could also yield a large portion of metformin users immediately to PAZAMET as swallowing, digestive and esophageal problems can be directly overcome with the chewable variation.

By improving a single drug whose sales reach billions of dollars annually, Boston Therapeutics could find itself making a noticeable impact in short order.