MORRISVILLE, N.C. (June 19, 2012) - Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation from the European Medicines Agency (EMA) of the acceptance of submissions of Marketing Authorization Applications (MAAs) for alogliptin and pioglitazone combined in a single tablet and alogliptin and metformin combined in a single tablet. The EMA has confirmed that these submissions have been validated for assessment.
Under Furiex's agreement with Takeda, these submissions do not trigger a milestone payment to Furiex. However, if approved, Furiex is entitled to receive royalty payments on sales of these products.
"We are pleased that the EMA has accepted to review Takeda's MAA submissions for the two fixed dose combination therapies using alogliptin, which follow close behind the acceptance to review the MAA for alogliptin", said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, "These filings represent another important milestone for alogliptin and brings us one step closer to offering two more treatment options for patients with type 2 diabetes."
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 $376 billion in 2010. By 2030, this number is projected to exceed $490 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 almost uniformly required to maintain diabetic control over many years of therapy.
Alogliptin is a DPP-4 inhibitor being investigated in the U.S., as an adjunct to diet and exercise, for the treatment of type 2 diabetes. 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 (NDA) for 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 currently available under the brand name NESINA® in this market.
Alogliptin/pioglitazone is a fixed dose combination therapy indicated for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Pioglitazone is a thiazolidinedione or TZD, marketed by Takeda as ACTOS®, 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. An NDA for the alogliptin/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 the therapy is currently available under the brand name LIOVEL® in this market.
Alogliptin/metformin is a fixed-dose combination therapy which combines the benefits of alogliptin with metformin in a single tablet, for the treatment of type 2 diabetes. Metformin is a member of the biguanide class of oral hypoglycemic and is the usual first-line therapy in addition to diet and exercise. It acts primarily by reducing the amount of glucose produced by the liver. Alogliptin and metformin work in combination to help patients with type 2 diabetes manage their blood glucose levels.
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 strong, 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 two 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 risk of the EMA not approving the MAA filings; inability of our existing collaborators to effectively market approved products for which we receive royalty and sales milestone payments; progress of product candidates in regulatory approvals as it relates to receiving future milestone payments; changes in the safety and efficacy profile of our existing candidates as they progress through research and development; potential EMA changes to its regulatory guidance; continuing losses and our potential need for additional financing; 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.