MORRISVILLE, N.C.--(EON: Enhanced Online News)--Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed Takeda Pharmaceutical Company Limited (Takeda)’s announcement that the European Commission has granted Marketing Authorization (MA) for VIPIDIA™ (alogliptin) for the treatment of Type 2 diabetes patients who are uncontrolled on existing therapies and for the fixed-dose combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone). The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), issued a positive opinion for these products on July 26, 2013.
“With rising incidence of Type 2 diabetes in Europe, these approvals provide clinicians with what we believe are important options to tailor treatment to meet the individual needs of this growing patient population.”
Under its agreement with Takeda, the MA triggers a $10 million milestone payment to Furiex. Furiex is also eligible to receive tiered royalties on product sales in the EU and potential sales-based milestones.
The MA was based on data from a clinical trial program involving more than 11,000 patients treated for up to four years and two key studies, the ENDURE1 trial and the interim data from the cardiovascular safety outcomes trial EXAMINE2.
The ENDURE study demonstrated that alogliptin 25 mg, in addition to metformin, offered superior durability of glycemic control at two years with notably fewer hypoglycemic episodes and no negative impact on weight compared to a sulphonylurea (SU), (glipizide). Results also showed that when alogliptin was given in combination with metformin, significantly more patients achieved target hemoglobin A1c (HbA1c) of ≤ 7% compared with an SU in combination with metformin.
Takeda completed the EXAMINE trial in June 2013 and the results were published in The New England Journal of Medicine (NEJM). Alogliptin is the first DPP-4 inhibitor with demonstrated cardiovascular safety outcomes data in Type 2 diabetes patients with recent acute coronary syndrome (ACS).
The efficacy of alogliptin was also studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, thiazolidinediones (TZDs), insulin and 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. Previous trials indicated that alogliptin co-administered with either metformin or pioglitazone produced significant improvements in glycemic control compared with the respective monotherapies.
“We are pleased Takeda has received marketing authorizations in Europe for these three new Type 2 diabetes therapies," said June Almenoff, MD, Ph.D., president and chief medical officer of Furiex. "With rising incidence of Type 2 diabetes in Europe, these approvals provide clinicians with what we believe are important options to tailor treatment to meet the individual needs of this growing patient population."
"Receiving these marketing authorizations in Europe marks another important milestone for Furiex and our partner, Takeda," said Fred Eshelman, Pharm.D., chairman of Furiex. "We believe Takeda’s continued success in obtaining regulatory approvals in key markets and building its alogliptin product franchise is a significant value driver for Furiex."
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). In addition to the U.S., alogliptin is approved in Japan and China under the brand name Nesina and the fixed-dose combination, alogliptin and pioglitazone, is approved in Japan under the brand name Liovel®.
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.
1 Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects with Type 2 Diabetes Mellitus
2 EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
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 indicated for the treatment of Type 2 diabetes in adults aged 18 years and older to improve glycemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.
- The usual recommended daily dose is 25 mg once daily (OD), with dose flexibility for all stages of renal disease (no dose adjustment for mild renal impairment, 12.5 mg OD for moderate renal impairment, 6.25 mg OD for severe renal impairment or ESRD).
- 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
Vipdomet is a fixed-dose combination therapy for the treatment of Type 2 diabetes which combines 12.5 mg alogliptin and 1000 mg metformin in a single tablet, taken twice daily. Vipdomet is 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 glycemic 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 glycemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycemic control.
About Incresync (alogliptin and pioglitazone) fixed-dose combination
Incresync is a fixed-dose combination therapy for the treatment of Type 2 diabetes, which combines 25 mg alogliptin and 45 mg pioglitazone in a single tablet, taken twice daily. Incresync is 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 glycemic 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 glycemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
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: our continuing losses and potential need for additional capital; failure of our partner to successfully obtain regulatory and/or pricing approval to market and sell its alogliptin products in the individual EU countries; time required to gain regulatory and/or pricing approvals in the individual EU countries; failure by our partner to build demand for the alogliptin products thereby impacting our receipt of future milestone and royalty payments; the risks and expense of continuing the research and development activities, and continuing to seek additional regulatory approvals of alogliptin products; 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.