Furiex Confirms Takeda Receives Positive CHMP Opinion for VIPIDIA™ (alogliptin) and Fixed-Dose Combi
Furiex Confirms Takeda Receives Positive CHMP Opinion for VIPIDIA™ (alogliptin) and Fixed-Dose Combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone)
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Furiex Pharmaceuticals, Inc. (NAS: FURX) today confirmed that Takeda Pharmaceutical Company Limited (Takeda) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIPIDIA™ (alogliptin) and Fixed-Dose Combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone) for the treatment of Type 2 diabetes patients who are uncontrolled on existing therapies. This opinion is a key step toward getting marketing authorization in EU countries, Norway and Iceland.
The CHMP opinion was based on data from a clinical trial program involving more than 11,000 patients treated for up to four years, including the one-year data from the ENDURE* trial and interim data from the cardiovascular outcomes trial EXAMINE†.
The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (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.
Under its agreement with Takeda, Furiex is entitled to receive a $10 million regulatory milestone payment for the first EU marketing authorization of an alogliptin product, plus royalties on all alogliptin product sales in the EU and potential sales-based milestones.
"This positive opinion is an important achievement for Furiex and our partner, Takeda, in our mutual efforts to meet the needs of this growing patient population," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "These treatment options should further assist clinicians to tailor treatment to individual patient needs and help improve outcomes."
* Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus;
†EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
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).
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 a DPP-4 inhibitor that has been recommended by CHMP to be indicated for the treatment of Type 2 diabetes in adults aged 18 years and older to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.
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
Alogliptin and metformin is a fixed dose combination therapy for the treatment of Type 2 diabetes, which combines alogliptin and metformin in a single tablet. Vipdomet has been recommended by CHMP to be indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycaemic 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 glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
About Incresync (alogliptin and pioglitazone) fixed dose combination
Alogliptin and pioglitazone is a fixed dose combination therapy for the treatment of Type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Incresync has be recommended by CHMP to be indicated as a second or third line treatment in adult patients aged 18 years and older with Type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycaemic 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 glycaemic 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: failure of our partner to successfully obtain regulatory approval to market and sell its alogliptin products in the individual EU countries; time required to gain regulatory approvals in the individual EU countries; the demand for our partner's potential alogliptin products, if and when approved; the risks and expense of continuing the research and development activities of alogliptin products; the progress of the alogliptin products in commercialization as it relates to receiving future milestone and royalty payments; 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
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