Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone.
Takeda recently provided post-marketing data from outside the U.S. and has been in discussions with the FDA. The FDA has requested additional data, which Takeda believes it can supply from post-marketing data from outside the U.S., as well as data from its ongoing clinical trial program.
Takeda intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues.
“We are disappointed with the FDA decision,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “Our partner Takeda has extensive Phase III data, including interim findings from a cardiovascular outcomes trial and we remain confident in the future potential of alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes.”Currently, Furiex receives royalty payments from Takeda for the sale of these alogliptin products, trade names NESINA® and LIOVEL®, in Japan. About Type 2 Diabetes Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. More than 23 million Americans currently live with the disease. Type 2 diabetes is a progressive and chronic condition, and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. 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. About alogliptin and alogliptin and pioglitazone 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. An 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 and pioglitazone is a fixed-dose combination therapy, which combines alogliptin and pioglitazone in a single tablet, in development for the treatment of type 2 diabetes in adults. Pioglitazone is a TZD that directly addresses insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved 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. 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 strong, diversified product portfolio and pipeline with multiple therapeutic candidates, including two Phase III-ready assets, one compound in Phase III development 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 time required to gain regulatory approvals; failure of our partner to successfully obtain regulatory approval to market and sell its product; the demand for our potential products, if and when approved; the risks and expense of continuing the research and development activities of our existing candidates; progress of product candidates in clinical trials as it relates to receiving future milestone payments; 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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