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    Features

    Doing It Right At Back Bay Scientific

    Clinical trials support company's flagship product; other science-based products in pipeline.

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    Solid science before marketing is the mantra at Back Bay Scientific, Boston, MA. Formed in September of 2000, the company is led by four individuals who provide the various components of a science-based nutra­­ceuticals producer. Drs. Ri­chard and Judith Wurtman are scientists at MIT and Harvard, while Eli Wurtman and Marc Tobin provide the entrepreneurial perspective; both men worked in the high tech industry previously, while Mr. Tobin also has experience in the food, OTC drug and nutraceuticals industries.

    The company's flagship product is PMS Escape®, a patented carbohydrate drink that also includes vitamins C, B6, calcium and magnesium. The patented PMS Escape formulation manages PMS-related disturbances in mood and ap­petite and has three clinical trials backing up its efficacy. Mr. Tobin explained PMS Escape's evolution. "The product was co-developed by Dr. Judith Wurtman and marketed through Internutria, a subsidiary of a company called Interneuron Pharmaceuticals, with which Dr., Wurtman was affiliated in the late 1990s. Interneuron chose to stop marketing the product for internal reasons but the response from users was overwhelming and continued after the product left the market. As a result," he said, "in January 2000, the Wurtmans bought the rights for the product back from Interneuron and last September Back Bay Scientific-a re­search-oriented company based on a biotech model-was formed to market PSM Escape and other nutraceuticals invented by the Wurtmans." The product was relaunched in April of this year and is available on the Internet (www.pmsescape.com) or via a toll-free number. Additionally, said Mr. Tobin, the company expects to have the product available in the mass market channel during the first half of next year.

    Back Bay Scientific is also working on additional products, including two that should launch in the next few months. The first is Serotrim™, an appetite control beverage and weight loss plan. The development of Serotrim was based on research discoveries made by the Wurtmans in basic and clinical research labs at MIT and is also based on a proprietary carbohydrate combination, said Mr. Tobin. "We still have some additional clinicals to do on Serotrim, but the product has been shown to promote weight loss in extensive testing conducted-for more than two years-as part of a weight loss treatment program run by Dr. Judith Wurtman at the TRIAD Weight Management Center of Harvard University's McLean Hospital."

    In addition, Nature's Sleep™, a patented low-dosage melatonin product, is far along the development chain. Na­ture's Sleep is meant to promote and sustain natural sleep and specifically targets individuals over the age of 50. A recent publication describing an NIH-funded study showed the effectiveness of the active ingredient in Nature's Sleep. "The dosage of melatonin in Nature's Sleep is much lower than current melatonin products on the market," explained Mr. Tobin. "Usually, melatonin products are sold in 3 mg dosages; ours is 0.3 mg. The recently published study showed that the 'sleep efficiency' of previously insomniac older people who took the 0.3 dose was undifferentiable from people without insomnia. In contrast," he continued, "people who took the usual health food store dose of melatonin (3 mg or more) had less of a beneficial response and also de­veloped unacceptable side effects like hypothermia."

    Also in the works are products for brain health, which, according to Mr. Tobin, is Dr. Richard Wurtman's area of expertise. "We have patented a unique combination of uridine and choline, as well as resveratrol, that we believe will help 'strengthen' the ability of the brain to form and retrieve memories. These products will not help Alzheimer's disease patients who are already affected, but can help the brain before Alzheimer's hits." The products are the subject of a license agreement signed in March with Royal Numico, Zeotermeer, The Netherlands. Under terms of the agreement, Numico will fund additional research, including clinical development, regulatory review, manufacturing and marketing. The product is currently in the early stages of laboratory testing.

    Farther down the product development pipeline are several other products. One is a 5HTP-based constituent that helps control stress-related overeating and a similar constituent that facilitates tobacco withdrawal. Other products in development include line extensions of PMS Escape for menopausal symptoms and for the "blues" sometimes associated with pregnancy or the postpartum state.

    "Our expertise lies in our science background and the fact that our products are safe natural compounds and mixtures, not drugs," said Mr. Tobin. "Our philosophy is to approach these products as an OTC drug company would. We have a step by step way of doing this. We invent a product, we do laboratory testing, we do human testing, we run clinical trials and we obtain patent licenses. Then we look at bringing the finished product to market in a quick, cost-efficient manner either directly or with established distribution partners. We do not intend to market commodity products," he emphasized. "Our products are all patented and all undergo clinical testing to support marketing claims. But they are not drugs, so we do not have to deal with NDAs and long periods to market. The products are safe and efficacious. Our tagline," said Mr. Tobin, "is, 'Enhancing the lives of healthy people through innovative products supported by proven science.'"- E.S.
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