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Furiex Confirms Alogliptin Cardiovascular Safety Outcomes Trial (EXAMINE) Met Primary Endpoint



  Furiex Confirms Alogliptin Cardiovascular Safety Outcomes Trial (EXAMINE)
  Met Primary Endpoint

Clinical Data Published in New England Journal of Medicine and Presented at
the ESC Congress 2013

Business Wire

MORRISVILLE, N.C. -- September 3, 2013

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda
Pharmaceutical Company Limited (Takeda) announced top line results of the
EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of
CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome)
cardiovascular (CV) safety outcomes trial showing the primary endpoint of
non-inferiority compared to placebo in addition to standard of care was met
with no increase in CV risk in a Type 2 diabetes patient population at
high-risk for cardiovascular events. These data, published in the New England
Journal of Medicine (NEJM) and also presented at the ESC 2013 Congress,
demonstrate that alogliptin does not increase CV risk in Type 2 diabetes
patients at high risk for major adverse cardiac events (MACE) due to a recent
acute coronary syndrome (ACS). The trial’s primary objective was to evaluate
non-inferiority with respect to CV risk based on a primary composite endpoint
of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary
endpoint occurred at similar rates in the alogliptin and placebo groups (11.3%
vs. 11.8% during a median follow-up period of 18 months; hazard ratio, 0.96;
one sided repeated confidence interval bound, 1.16).

“The EXAMINE trial is an important evaluation as it assesses cardiovascular
safety in patients known to be at high risk for cardiovascular disease,” said
June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
“Cardiovascular disease is very common in patients with Type 2 diabetes and
the results of this study provide clinicians with assurance that alogliptin is
effective and well-tolerated in these patients, and does not adversely affect
cardiovascular health outcomes.”

EXAMINE was a large, randomized, double-blind, placebo-controlled global
clinical trial, designed to evaluate CV safety following treatment with
alogliptin in addition to standard of care, versus placebo in addition to
standard of care alone, in patients with type 2 diabetes and a recent ACS.
During the trial, patients were randomly assigned to receive alogliptin or
placebo in addition to standard of care medications for diabetes and CVD. A
total of 5,380 patients were randomly assigned and followed for a median of 18
months and up to 40 months. The rate of premature discontinuation of the study
drug was similar in the alogliptin and placebo groups. Patients also received
high levels of standard of care for treatment of Type 2 diabetes and CV risk
factors.

“We are pleased to see the results from the EXAMINE study,” added Fred
Eshelman, PharmD., chairman of Furiex, “the trial provides key insights to
clinicians treating diabetes patients and reinforces Takeda’s ongoing
commitment to the diabetes community.”

The principal secondary safety endpoint was the primary composite with the
addition of hospitalization for unstable angina that required coronary
revascularization within 24 hours of hospital admission. Testing of the
secondary composite endpoint showed no difference in rates on alogliptin
versus placebo (12.7% vs. 13.4%, hazard ratio, 0.95, one-sided repeated CI
bound, 1.14).

Other secondary endpoints included cardiovascular death alone and death from
any cause. Cardiovascular death, occurred in 112 patients treated with
alogliptin (4.1%) and 130 patients treated with placebo (4.9%) for a hazard
ratio of 0.85 (95% confidence limits of 0.66 to 1.10, p = 0.21). Death from
any cause occurred in 153 patients treated with alogliptin (5.7%) and 173
patients treated with placebo (6.5%) for a hazard ratio of 0.88 (95%
confidence limits of 0.71 to 1.09, p = 0.23). Overall, rates of death from any
cause and cardiovascular death were not statistically significant different
between alogliptin and placebo groups.

Additional safety end points included angioedema, hypoglycemia, pancreatitis,
malignancy and results of laboratory testing. Rates of hypoglycemia,
malignancy, pancreatitis, dialysis and serum aminotransferase elevations were
similar for alogliptin and placebo groups. No events of pancreatic cancer were
reported during the trial. The alogliptin and placebo groups also did not
differ significantly with regard to rates of serious adverse events (33.6% and
35.5%, respectively, p = 0.14)

About EXAMINE

EXAMINE was a large, randomized, double-blind, placebo-controlled global
clinical trial designed to evaluate CV safety following treatment with
alogliptin in addition to standard of care, versus placebo in addition to
standard of care alone, in patients with type 2 diabetes and a recent ACS
(within 15 to 90 days prior to randomization). The trial had primary endpoint
of non-inferiority with a composite of CV death, nonfatal myocardial
infarction and nonfatal stroke.

In the alogliptin group, 71.4% of patients received 25 mg, 25.7% received 12.5
mg, and 2.9% received 6.25 mg daily. Alogliptin doses were adjusted according
to renal function: estimated glomerular filtration rate (eGFR) by the
Modification in Diet in Renal Disease formula ≥ 60 ml/min, 25 mg daily; < 60
ml/min but ≥ 30 ml/min, 12.5 mg daily; and < 30 ml/min, 6.25 mg daily.
Premature discontinuation of the study drug was similar in the alogliptin and
placebo groups (20.9% of patients versus 22.6%). The median duration of
exposure to study drug was 533 days (interquartile range, 280 to 751 days). By
the end of the study, the mean change from baseline in HbA1c was -0.33% and
0.03% in the alogliptin and placebo groups, and the least square means
difference in HbA1c between alogliptin and placebo was -0.36% (95% CI, -0.43,
-0.28, p < 0.001). In the analysis of the components of the primary end point,
the hazard ratios were consistent with the overall result. Hazard ratios for
death from any cause and cardiovascular death were consistent with the primary
composite end point.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic
proportions globally. The global health care expenditures to treat and prevent
diabetes and its complications were estimated at $471 billion in 2012. By
2030, this number is projected to exceed $595 billion. In addition to diet and
exercise, patients often need to take multiple medications to help manage
blood glucose. Due to the chronic nature of this disease, combination therapy
is often required to maintain diabetic control over many years of therapy.

About Alogliptin

Alogliptin is a dipeptidyl peptidase-4 inhibitor for the treatment of Type 2
diabetes in adults as an adjunct to diet and exercise. DPP-4 inhibitors are
designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a
result, an increased amount of active incretins enables the pancreas to
secrete insulin in a glucose-dependent manner, thereby assisting in the
management of blood glucose levels. A New Drug Application (NDA) for NESINA®
(alogliptin) was approved in April 2010 by the Japanese Ministry of Health,
Labour and Welfare for the treatment of Type 2 diabetes, and the therapy is
available under the same brand name in Japan. In July 2011 the fixed-dose
combination LIOVEL® (alogliptin and pioglitazone) was approved by the Japanese
Ministry of Health, Labor and Welfare. NESINA (alogliptin) was approved by the
U.S. Food and Drug Administration as a monotherapy and also in fixed-dose
combination with pioglitazone (OSENI®) and metformin HCl (KAZANO®) in January
2013 for the treatment of Type 2 diabetes in adults as adjuncts to diet and
exercise. On July 26, 2013, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) issued a positive opinion for
VIPIDIA™ (alogliptin) and Fixed-Dose Combinations VIPDOMET™ (alogliptin and
metformin) and INCRESYNC™ (alogliptin and pioglitazone).

About Furiex

Furiex Pharmaceuticals is a drug development collaboration company that uses
innovative clinical development design to accelerate and increase value of
drug development programs by advancing them through the drug discovery and
development process in a cost-efficient manner. Our drug development programs
are designed and driven by a core team with extensive drug development
experience. The company collaborates with pharmaceutical and biotechnology
companies and has a diversified product portfolio and pipeline with multiple
therapeutic candidates, including one Phase III-ready asset, two compounds in
Phase III development, one of which is with a partner, and four products on
the market. The company’s mission is to develop innovative medicines faster
and at a lower cost, thereby improving profitability and accelerating time to
market while providing life-improving therapies for patients. For more
information, visit www.furiex.com.

Except for historical information, all of the statements, expectations and
assumptions contained in this news release are forward-looking statements that
involve a number of risks and uncertainties. Although Furiex attempts to be
accurate in making these forward-looking statements, it is possible that
future circumstances might differ from the assumptions on which such
statements are based. In addition, other important factors which could cause
actual results to differ materially include the following: the market
acceptance of and demand for our partner’s marketed alogliptin products; the
progress of the alogliptin products in commercialization as it relates to
receiving future milestone and royalty payments; our continuing losses and
potential need for additional capital; failure of our partner to successfully
obtain regulatory approval to market and sell its alogliptin products in
countries where these products are not yet approved; time required to gain
regulatory approvals in individual countries where alogliptin products are not
yet approved; the risks and expense of continuing the research and development
activities of alogliptin products; and the other risk factors set forth from
time to time in the SEC filings for Furiex, copies of which can be found on
our website.

Contact:

Media/Analysts/Investors:
Furiex Pharmaceuticals, Inc.
Sailash Patel, 919-456-7814
sailash.patel@furiex.com
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