Takeda Pharmaceutical Co. (4502), whose best-selling diabetes drug Actos lost patent protection in August, won U.S. regulatory approval for a new treatment five years after its initial application.
Takeda and Furiex Pharmaceuticals Inc. (FURX:US), its partner on the drug, received clearance from the Food and Drug Administration for alogliptin and two alogliptin combinations to use with diet and exercise for patients with Type 2 diabetes. “Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control,” the FDA said Jan. 25 in a statement.
The approval gives Osaka, Japan-based Takeda a new revenue source as cheaper generics erode earnings from Actos, its largest sales contributor and once the world’s biggest diabetes drug. Takeda, whose application for alogliptin was twice rejected by the FDA, has projected net income would fall to a 13-year low of 120 billion yen ($1.3 billion) in the 12 months through March 2015. The company said it plans to sell the medicines beginning in mid-2013.
“Millions of people are affected by diabetes and, as a leader in the diabetes arena, Takeda is dedicated to working to advance patient care and helping to meet the needs of this growing patient population,” Douglas Cole, president of Takeda’s U.S. subsidiary, said in a statement.
Actos sales peaked in the year ended March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company’s revenue.
Alogliptin is in the same class of drugs as Merck & Co. (MRK:US)’s Januvia, which generated $3.3 billion in 2011, and Bristol-Myers Squibb Co. (BMY:US)’s Onglyza, which sold $473 million that year, according to data compiled by Bloomberg.
The first rejection of alogliptin came in June 2009, when the FDA said clinical data was insufficient based on new guidelines on diabetes treatments and cardiovascular risks released in December 2008. Takeda conducted additional studies for its resubmission. In April last year, the FDA asked for more information on the use of the medicine in other countries.
In the U.S., 25.8 million children and adults, or 8.3 percent of the population, have diabetes, including 7 million people who are undiagnosed, according to figures from the American Diabetes Association’s website.
Diabetes is caused by the body’s inability to use or produce the hormone insulin. It can lead to heart disease, kidney failure, blindness or amputations. Most people have the Type 2 form linked to being overweight or inactive.
Alogliptin is approved in Japan and sold under the brand name of Nesina. The tablets will go by the same name in the U.S. The other products will be called Oseni and Kazano, Takeda said in the statement.
Furiex will receive a $25 million payment as a result of the approval as well as royalties based on U.S. sales, the Morrisville, North Carolina-based company said in a statement.
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