Furiex Confirms Takeda`s Receipt of FDA Approval of NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the Treatment of Type 2 Diabetes

Fri Jan 25, 2013 7:00pm EST

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MORRISVILLE, N.C.--(Business Wire)--
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda
Pharmaceutical Company Limited has received approval from the U.S. Food and Drug
Administration of three new type 2 diabetes therapies, NESINA (alogliptin) and
the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and
KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in
adults as adjuncts to diet and exercise. 

Under its agreement with Takeda, Furiex is entitled to receive a $25 million
milestone payment as a result of this approval, as well as royalties on sales in
the United States and potential sales-based milestones. Furiex has already been
receiving royalty payments from Takeda for the sale of NESINA and LIOVEL in
Japan. 

"Receiving regulatory approvals for NESINA, OSENI and KAZANO in the U.S. marks
an important milestone for Furiex," said Fred Eshelman, Pharm.D., chairman of
Furiex. "These approvals should enable Takeda to build on the success of NESINA
in Japan and leverage its more than 20 years of clinical and patient experience
in the type 2 diabetes therapeutic area." 

"We are pleased to see these important therapies become available for patients
with type 2 diabetes," said June Almenoff, M.D., Ph.D., president and chief
medical officer of Furiex. "Type 2 diabetes is a complex disease, requiring
careful long-term disease management. We believe these new treatments in the
U.S. offer patients additional therapeutic options for managing the disease." 

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. Because of the chronic nature of this disease, combination therapy is
often required to maintain diabetic control over many years of therapy. 

About NESINA, OSENI and KAZANO

NESINA is a DPP-4 inhibitor for the treatment of type 2 diabetes as an adjunct
to diet and exercise. 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. A New Drug
Application for alogliptin was approved in April 2010 by the Japanese Ministry
of Health, Labour and Welfare for the treatment of type 2 diabetes, and Takeda
currently sells the therapy under the brand name NESINA in this market. 

OSENI is a fixed dose combination therapy that combines alogliptin and
pioglitazone in a single tablet for the treatment of type 2 diabetes in adults
as an adjunct to diet and exercise. Pioglitazone is a thiazolidinedione that
directly targets insulin resistance, a condition in which the body does not
efficiently use the insulin it produces to control blood glucose levels. It is
currently approved for use in adults for the treatment of type 2 diabetes as an
adjunct to diet and exercise. A New Drug Application for the alogliptin and
pioglitazone fixed-dose combination was approved in July 2011 by the Japanese
Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and
Takeda currently sells the therapy under the brand name LIOVEL in this market. 

KAZANO is a fixed dose combination therapy for the treatment of type 2 diabetes
that combines alogliptin and metformin in a single tablet. Metformin is a
widely-used diabetes medication that acts primarily by reducing the amount of
glucose produced by the liver. These medications work in combination to help
patients with type 2 diabetes manage their blood glucose levels. 

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. 

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 three 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: reliance on our collaborators to market
our products; the demand for our products; the risks and expense of continuing
the research and development activities of our existing candidates; time
required to gain regulatory approvals; our continuing losses and potential need
for additional capital; 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.

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

Copyright Business Wire 2013

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