Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda
Pharmaceutical Company Limited announced that it has submitted a New
Drug Application (NDA) to the Japanese Ministry of Health, Labour and
Welfare for trelagliptin succinate (SYR-472), a once weekly dosage
treatment for type 2 diabetes.
Under Furiex’s agreement with Takeda, Furiex is eligible to receive
royalties and sales-based milestones if trelagliptin succinate is
approved and marketed in Japan.
Takeda’s NDA is based on the safety and efficacy results of multiple
Phase III clinical studies in patients with type 2 diabetes in Japan.
The efficacy of once-weekly trelagliptin succinate was confirmed in all
studies, in addition to a good safety and tolerability profile.
Trelagliptin succinate controls blood glucose levels effectively with
single weekly dosing, and is expected to contribute to improvement in
drug adherence of patients.
"We are pleased that Takeda has taken this important step in seeking
approval of trelagliptin succinate in Japan," said Fred Eshelman,
Pharm.D., chairman of Furiex. “This is a significant achievement for
Furiex and Takeda’s type 2 diabetes franchise.”
Added June Almenoff, M.D., Ph.D., president and chief medical officer of
Furiex, "We are excited about the potential for trelagliptin succinate
to provide type 2 diabetes patients with a convenient, once-weekly
treatment option."
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 Takeda’s Trelagliptin
Trelagliptin succinate, discovered by Takeda California, Inc., Takeda's
wholly-owned subsidiary located in San Diego, California, is a
once-weekly dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood
glucose levels by selectively and continually inhibiting DPP-4, an
enzyme that causes the inactivation of glucagon-like peptide-1 and
glucagon-dependent insulinotropic polypeptide, incretin hormones that
play an important role in blood glucose regulation. The inhibition of
DPP-4 increases insulin secretion depending on blood glucose
concentration, thereby controlling blood glucose levels.
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: progress of compounds in
clinical trials and regulatory approvals; potential changes to
regulatory guidance by regulatory agencies such as the Japanese Ministry
of Health, Labour and Welfare; continuing losses and our
potential need for additional financing; inability of collaborators to
effectively market approved products for which we receive royalty and
sales-based milestone payments; changes in the safety and efficacy
profile of our existing compounds as they progress through research and
development; the costs of defending any patent opposition or litigation
necessary to protect our proprietary technologies; 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.
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