VeroScience Presents Data on Newly FDA Approved Drug Cycloset at American Diabetes Association Annual Scientific Sessions

Data on Novel Therapy Demonstrate Sustained HbA1c Improvements for Patients
Failing Thiazolidinediones (TZDs)
NEW ORLEANS--(Business Wire)--
VeroScience, in collaboration with S2 Therapeutics, today announced the
presentation of clinical and preclinical data at the American Diabetes
Association (ADA) 69th Scientific Sessions on Cycloset, a novel treatment for
patients with Type 2 diabetes. FDA-approved in May 2009, Cycloset is the first
therapy directly targeting the body`s dopamine activity to improve glycemic
control. It is also the only drug to be approved subsequent to the FDA`s new
guidelines that require studies demonstrating that diabetes drugs do not
increase cardiovascular risk.

The data presented today reviewed the impact of adding Cycloset to the treatment
regimen of patients with Type 2 diabetes who are failing thiazolidinedione
(TZDs), as indicated by a baseline HbA1c of greater than or equal to 7.5
percent. The study found that patients taking Cycloset with TZDs demonstrated a
statistically significant improvement after 52 weeks on therapy, compared to
those taking TZDs (Rosiglitazone or Pioglitazone) with or without other oral
anti-diabetes medications. The post-hoc study, from the Company`s 3,070-patient
Cycloset Safety Trial, evaluated 79 patients failing TZD therapies at baseline.

The Cycloset with TZD treatment group demonstrated a 0.76 percent decrease in
A1c compared to a 0.25 percent reduction in the placebo group (p<0.05). Improved
glycemic control persisted throughout the 52-week trial. Additionally, greater
A1c reductions were observed for Cycloset and TZD subjects with higher baseline
A1c levels-1.1 and 1.3 percent decreases were achieved for baseline A1c of
greater than or equal to 8.0 and 8.5 percent, respectively. Taking Cycloset and
TZDs led to a statistically significant 22 mg/dl reduction in fasting plasma
glucose levels from baseline (p<0.05). Additionally, patients taking Cycloset
and TZDs had a 0.7-pound weight loss, compared to a 4.5-pound weight gain for
the placebo group. "The current FDA labeling for Cycloset combination use with
TZDs states that there are limited efficacy data in combination with
thiazolidinediones, and these new post-hoc analyses suggest that further studies
on the beneficial interactions of these anti-diabetes agents are warranted,"
said Richard E. Scranton, M.D., M.P.H., Chief Medical Officer, VeroScience.

"Among the 23 million patients with Type 2 diabetes today, a growing number
cannot adequately control their blood sugars with current therapies," said J.
Michael Gaziano, M.D., Cardiologist, Professor, Division of Aging, Brigham &
Women`s Hospital and principal investigator of the Cycloset Safety Trial. "This
study suggests sustained benefits of Cycloset as an add-on therapy for patients
failing a commonly prescribed therapy class."

"The data presented today contribute to the Company`s momentum and offer further
insights into ascertaining Cycloset`s full mechanism of action, which enables
its use in a wide spectrum of Type 2 diabetics to improve glycemic control
without increasing cardiovascular risks," said Anthony H. Cincotta, Ph.D.,
President and Chief Scientific Officer, VeroScience. "We are working diligently
to procure a distribution partner, to ensure the benefits of Cycloset will be
available to Type 2 diabetes patients as soon as possible."

Cycloset is indicated 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. Unlike many currently available
drugs that stimulate insulin release, Cycloset improves glycemic control without
increasing circulating insulin levels. Instead, it is designed to improve
responsiveness to insulin`s blood-sugar lowering effects, though the precise
mechanisms by which Cycloset improves glycemic control have not been fully
delineated.

Preclinical data presented at ADA

Two preclinical presentations further demonstrate how Cycloset impacts
metabolism in hypertensive (high blood pressure) rat models.

The research studies entitled, "Sympatholytic dopamine agonist therapy reduces
insulin resistance and protein levels of pro-inflammatory mediators in liver of
SHR rats," and "Bromocriptine treatment improves insulin sensitivity, attenuates
hepatic expression of multiple protein mediators within several inflammatory
pathways that potentiate insulin resistance, and increases hepatic PGC-1 levels
in SHR rats," show that the active agent in Cycloset leads to statistically
significant reductions in plasma insulin, glucose and HOMA-IR, a common measure
of insulin responsiveness, as well as significant reductions in modulators of
liver and systemic inflammation, in an insulin-resistant animal model. Most
importantly, according to the two studies, the active agent in Cycloset
decreased the levels of liver pro-inflammatory pathway proteins that contribute
to hepatic insulin resistance and also ultimately, potentiate cardiovascular
disease risk. These findings add important new information to the growing body
of data regarding Cycloset`s mechanism of action and its beneficial impact on
glycemic control, and potentially, cardiovascular disease.

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 (after-meal) 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.

Safety

The Cycloset Safety Trial, a 3,070 person, 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.
Additionally, 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 (Hazard Ratio: 0.58; Confidence Interval: 0.35-0.96). 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.

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, an FDA approved
treatment for patients with Type 2 diabetes. The Company 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.

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
Company Inquiries
VeroScience, LLC
Anthony H. Cincotta, Ph.D., 401-816-0525
Anthony_Cincotta@veroscience.com
or
Clinical Inquiries
VeroScience, LLC
Richard Scranton, M.D. M.P.H., 401-816-0525
Richard_Scranton@veroscience.com

Copyright Business Wire 2009