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FDA Approves Cycloset

VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes

First-in-class antidiabetic drug is first to receive FDA approval under new cardiovascular safety guidelines

TIVERTON, R.I. & BRISTOL, Tenn.--(BUSINESS WIRE)--May 6, 2009 - VeroScience, in collaboration with S2 Therapeutics, Inc. (S2), announced today that the U.S. Food and Drug Administration (FDA) approved its first-in-class drug Cycloset for the treatment of Type 2 diabetes. Cycloset improves glycemic control across a broad patient population as a monotherapy or as an adjunctive therapy to sulfonylurea, metformin plus sulfonylurea, and single or dual oral hypoglycaemic agent therapies.

Cycloset is the first drug to be approved subsequent to the FDA's new guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk. A 52 week, double-blind safety trial of 3,000 patients treated with Cycloset did not show an increase in pre-specified and independently adjudicated adverse cardiovascular outcomes—a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure, and revascularization surgery—compared to patients taking a placebo (HR 0.58; CI 0.35-0.96).

"For patients newly diagnosed with Type 2 diabetes or those who cannot adequately control their blood sugar with currently available medications, Cycloset provides a completely new approach to treating diabetes," said J. Michael Gaziano, M.D., Cardiologist, Associate Professor, Division of Aging, Brigham & Women's Hospital and principal investigator of the Cycloset Safety Trial. "In addition, patients with Type 2 diabetes are at high-risk for cardiovascular events, so it's important that Cycloset has been demonstrated not to increase the risk of cardiovascular events such as heart attacks, and may actually have potential to lower this risk."

Cycloset represents a new therapeutic approach in the management of Type 2 diabetes. It is the first drug for patients with diabetes that targets the body's dopamine activity, a chemical messenger between neurons, or nerve cells, within the nervous system. A dopamine agonist, Cycloset increases dopamine activity. While the specific mechanism by which Cycloset improves glycemic control in humans is unknown, the development of Cycloset for the treatment of Type 2 diabetes was based upon preclinical studies that have shown brain dopamine activity to be low in metabolic disease states and that this factor contributes to multiple metabolic dysfunctions such as insulin resistance—the loss of the body's ability to respond to the blood sugar lowering effects of insulin—observed in Type 2 diabetes. Moreover, preclinical studies of diabetic animals have shown that treatment with a dopamine agonist as in Cycloset acts upon the central nervous system to reset and improve control of peripheral metabolism.

"This approval is a major milestone for VeroScience and also represents the culmination of many years of intense research and development activities. We're very pleased that these prodigious efforts will now translate to provide patients with a new approach to treating Type 2 diabetes," said Anthony H. Cincotta, Ph.D., President and Chief Scientific Officer, VeroScience.

Charles P. Sutphin, President and CEO of S2 Therapeutics, Inc. said, "We are extremely happy to have been able to support and work with VeroScience to bring this diabetes therapy to the U.S. market. With the United States approval, we will collectively initiate efforts to complete applications globally with an immediate focus in Europe and Canada." S2 Co-chairman and co-founder Brian Schrader said "S2 Therapeutics and VeroScience intend to seek a partner to commercialize Cycloset in order to bring this important new therapy to patients as soon as possible."

About Cycloset and the Biological Clock

Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in "resetting" the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial glucose without increasing plasma insulin concentrations and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.

The Cycloset Safety Trial, a 3,000 patient, one-year study, demonstrated that Cycloset at doses up to 4.8 mg per day used to treat Type 2 diabetes was not different from placebo regarding the rate of occurrence of all-cause serious adverse events. None of the serious adverse events grouped by System-Organ-Class occurred more than 0.3 percentage points higher with Cycloset than with placebo. Cycloset can cause hypotension, including orthostatic hypotension, and syncope, particularly upon dose initiation or escalation. The primary reason for discontinuation from clinical trials of Cycloset was nausea, which was mild to moderate and transient during the beginning of therapy.

"Cycloset represents a new treatment paradigm for Type 2 diabetes. The clinical development of Cycloset involved the collection of a vast amount of safety data prior to the drug's approval. The information compiled to date has demonstrated that this novel therapy is both safe and effective in treating Type 2 diabetes alone or in combination with other drugs used to treat Type 2 diabetes," said Richard Scranton M.D., M.P.H., Chief Medical Officer, VeroScience.

About VeroScience

VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, R.I. VeroScience holds the NDA and related intellectual property for Cycloset and has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.

About S2 Therapeutics

S2 Therapeutics, a privately held specialty pharmaceutical company headquartered in Bristol, Tennessee, is the commercialization partner for Cycloset and is the holder of an exclusive global license for the manufacture, marketing, sale, and distribution of Cycloset.

Contact: Media Inquiries
Schwartz Communications, Inc.
Andrew Law, 781-684-0770
veroscience@schwartz-pr.com
or
Investor Inquiries
S2 Therapeutics, Inc.
Charles P. Sutphin, 540-818-4415
pat.sutphin@vatring.net
or
VeroScience, Inc.
Anthony Cincotta, 401-816-0525
Anthony_cincotta@veroscience.com

Posted: May 2009

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