Jan. 4 (Bloomberg) -- Takeda Pharmaceutical Co., Japan's biggest drugmaker, sought U.S. approval for alogliptin, a diabetes pill it's counting on to replace the bestseller Actos.

Takeda applied to the Food and Drug Administration to sell alogliptin as a once-daily treatment for type-2 diabetes, it said in a statement today. If approved, it will be the Osaka- based company's first new medicine released in the U.S. in more than two years.

The Japanese drugmaker needs to find successors to Actos, the world's bestselling diabetes medicine, to buffer a decline in sales once the pill's patent expires in 2011. Actos, first sold in the U.S. in 1999, generated $2.86 billion, or 26 percent of Takeda's revenue, in the year ended March 31.

``Takeda needs a new source of revenue,'' said Kumi Miyauchi, an equities analyst at Daiwa Research Institute, in a telephone interview. If approved, Takeda may be able to start selling the drug in early 2009, generating as much as $2 billion a year, said Miyauchi, who has a ``buy'' rating on the shares.

Takeda fell 240 yen, or 3.7 percent, to a 23-month low of 6,330 yen on the Tokyo Stock Exchange. Japan's Topix index slumped 4.3 percent, its worst-ever New Year start, after a decline in U.S. vehicle sales stoked concern consumer spending in the region's largest export market is faltering.

Merck, Novartis

The drug, also known as SYR-322, will compete with Merck & Co.'s Januvia and Novartis AG's Galvus, which is also up for approval by the FDA. All three are in a new class of diabetes treatments known as DPP4 inhibitors that spur the pancreas to produce more insulin and signals the liver to make less glucose, or blood sugar.

Takeda's filing was supported by data from six final-stage trials involving more than 2,000 patients conducted in 220 centers worldwide, Takeda said.

Results of second and third stages of clinical studies on alogliptin will be published this year, Takeda spokesman Seizo Masuda said. Patients taking the medicine weren't inclined to gain weight, a potential side effect with Actos, he said.

The drugmaker, which traces its origins to a medicine wholesale business opened in Osaka in 1781, has another DPP4, inhibitor known as SYR-472, in the second of three stages of patient studies usually needed for regulatory review.

Skin Lesions

Novartis's drug, Galvus, was delayed in November 2006 after U.S. regulators sought more data showing that skin lesions in monkey tests hadn't appeared in people. Novartis may not reapply to sell the drug in the U.S. until 2009. In Europe, regulators have approved the medicine.

``I'm not aware of any specific problems with this class of drugs,'' said Duncan Topliss, professor of medicine at Melbourne's Monash University, who hasn't participated in any studies on alogliptin. ``The nuances of drug structure can lead to little glitches that you can't necessarily predict.''

The global market for branded prescription medicines for diabetes is estimated to have grown 17 percent to $21.7 billion in 2007, Lehman Brothers Holdings Inc. said in a Sept. 19 report.

About 20.8 million people in the U.S., or 7 percent of the population, have diabetes, the American Diabetes Association estimates. Most have the type-2 version that's linked to excess weight and lack of exercise. In most patients with type 2 diabetes, the cells don't respond properly to insulin, creating a condition called insulin resistance.

Separately, TAP Pharmaceutical Products Inc., Takeda's U.S. joint venture with Abbott Laboratories, said it applied for FDA approval to sell TAK-390MR, a so-called proton pump inhibitor to treat diseases caused by stomach acid, including reflux. Takeda already sells Takepron for stomach ulcers.

To contact the reporters on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net.

Last Updated: January 4, 2008 01:28 EST