Furiex Confirms Takeda Receives European Marketing Authorization for VIPIDIA™ (alogliptin), VIPDOMET™ (alogliptin and

  Furiex Confirms Takeda Receives European Marketing Authorization for
  VIPIDIA™ (alogliptin), VIPDOMET™ (alogliptin and metformin) and INCRESYNC™
  (alogliptin and pioglitazone)

Business Wire

MORRISVILLE, N.C. -- September 24, 2013

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed Takeda
Pharmaceutical Company Limited (Takeda)’s announcement that the European
Commission has granted Marketing Authorization (MA) for VIPIDIA™ (alogliptin)
for the treatment of Type 2 diabetes patients who are uncontrolled on existing
therapies and for the fixed-dose combinations VIPDOMET™ (alogliptin and
metformin) and INCRESYNC™ (alogliptin and pioglitazone). The Committee for
Medicinal Products for Human Use (CHMP), of the European Medicines Agency
(EMA), issued a positive opinion for these products on July 26, 2013.

Under its agreement with Takeda, the MA triggers a $10 million milestone
payment to Furiex. Furiex is also eligible to receive tiered royalties on
product sales in the EU and potential sales-based milestones.

The MA was based on data from a clinical trial program involving more than
11,000 patients treated for up to four years and two key studies, the ENDURE^1
trial and the interim data from the cardiovascular safety outcomes trial
EXAMINE^2.

The ENDURE study demonstrated that alogliptin 25 mg, in addition to metformin,
offered superior durability of glycemic control at two years with notably
fewer hypoglycemic episodes and no negative impact on weight compared to a
sulphonylurea (SU), (glipizide). Results also showed that when alogliptin was
given in combination with metformin, significantly more patients achieved
target hemoglobin A1c (HbA[1c]) of ≤ 7% compared with an SU in combination
with metformin.

Takeda completed the EXAMINE  trial in June 2013 and the results were
published in The New England Journal of Medicine (NEJM). Alogliptin is the
first DPP-4 inhibitor with demonstrated cardiovascular safety outcomes data in
Type 2 diabetes patients with recent acute coronary syndrome (ACS).

The efficacy of alogliptin was also studied as an adjunct to diet and exercise
as an add-on therapy to several other classes of anti-diabetic medications,
including metformin, thiazolidinediones (TZDs), insulin and SUs. In these
studies, alogliptin 25 mg tablets taken once-daily demonstrated clinically and
statistically significant reductions in HbA1c, with a good overall
tolerability profile and low incidence of hypoglycemia compared with active
control or placebo. Previous trials indicated that alogliptin co-administered
with either metformin or pioglitazone produced significant improvements in
glycemic control compared with the respective monotherapies.

“We are pleased Takeda has received marketing authorizations in Europe for
these three new Type 2 diabetes therapies," said June Almenoff, MD, Ph.D.,
president and chief medical officer of Furiex. "With rising incidence of Type
2 diabetes in Europe, these approvals provide clinicians with what we believe
are important options to tailor treatment to meet the individual needs of this
growing patient population."

"Receiving these marketing authorizations in Europe marks another important
milestone for Furiex and our partner, Takeda," said Fred Eshelman, Pharm.D.,
chairman of Furiex. "We believe Takeda’s continued success in obtaining
regulatory approvals in key markets and building its alogliptin product
franchise is a significant value driver for Furiex."

As previously announced, on January 25, 2013 these three new Type 2 diabetes
therapies were approved by the U.S. Food and Drug Administration under the
brand names Nesina^® (alogliptin), Kazano^® (alogliptin and metformin) and
Oseni^® (alogliptin and pioglitazone). In addition to the U.S., alogliptin is
approved in Japan and China under the brand name Nesina and the fixed-dose
combination, alogliptin and pioglitazone, is approved in Japan under the brand
name Liovel^®.

Please see accompanying Full Prescribing Information, including Medication
Guide, for NESINA.

Please see accompanying Full Prescribing Information, including Medication
Guide, for KAZANO.

Please see accompanying Full Prescribing Information, including Medication
Guide, for OSENI.

^1 Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus
Metformin in Subjects with Type 2 Diabetes Mellitus

^2 EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in
Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome

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 Vipidia (alogliptin)

  *Alogliptin is indicated for the treatment of Type 2 diabetes in adults
    aged 18years and older to improve glycemic control in combination with
    other glucose lowering medicinal products including insulin, when these,
    together with diet and exercise, do not provide adequate glycemic control.
  *The usual recommended daily dose is 25 mg once daily (OD), with dose
    flexibility for all stages of renal disease (no dose adjustment for mild
    renal impairment, 12.5 mg OD for moderate renal impairment, 6.25 mg OD for
    severe renal impairment or ESRD).
  *DPP-4 inhibitors address insulin deficiency by slowing the inactivation of
    incretin hormones GLP-1 (glucagon-like peptide-1) and GIP
    (glucose-dependent insulinotropic peptide). 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.

About Vipdomet (alogliptin and metformin) fixed-dose combination

Vipdomet is a fixed-dose combination therapy for the treatment of Type 2
diabetes which combines 12.5 mg alogliptin and 1000 mg metformin in a single
tablet, taken twice daily. Vipdomet is indicated in the treatment of adult
patients aged 18years and older with Type2 diabetes mellitus:

  *as an adjunct to diet and exercise to improve glycemic control in adult
    patients, inadequately controlled on their maximal tolerated dose of
    metformin alone, or those already being treated with the combination of
    alogliptin and metformin;
  *in combination with pioglitazone (i.e. triple combination therapy) as an
    adjunct to diet and exercise in adult patients inadequately controlled on
    their maximal tolerated dose of metformin and pioglitazone; and
  *in combination with insulin (i.e. triple combination therapy) as an
    adjunct to diet and exercise to improve glycemic control in patients when
    insulin at a stable dose and metformin alone do not provide adequate
    glycemic control.

About Incresync (alogliptin and pioglitazone) fixed-dose combination

Incresync is a fixed-dose combination therapy for the treatment of Type 2
diabetes, which combines 25 mg alogliptin and 45 mg pioglitazone in a single
tablet, taken twice daily. Incresync is indicated as a second or third line
treatment in adult patients aged 18years and older with Type2 diabetes
mellitus:

  *as an adjunct to diet and exercise to improve glycemic control in adult
    patients (particularly overweight patients) inadequately controlled on
    pioglitazone alone, and for whom metformin is inappropriate due to
    contraindications or intolerance; and
  *in combination with metformin (i.e. triple combination therapy) as an
    adjunct to diet and exercise to improve glycemic control in adult patients
    (particularly overweight patients) inadequately controlled on their
    maximal tolerated dose of metformin 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: our continuing
losses and potential need for additional capital; failure of our partner to
successfully obtain regulatory and/or pricing approval to market and sell its
alogliptin products in the individual EU countries; time required to gain
regulatory and/or pricing approvals in the individual EU countries; failure by
our partner to build demand for the alogliptin products thereby impacting our
receipt of future milestone and royalty payments; the risks and expense of
continuing the research and development activities, and continuing to seek
additional regulatory approvals 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:

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