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Takeda’s Diabetes Drug Alogliptin Rejected by FDA

http://www.bloomberg.com/apps/news?pid=20601101&sid=aFC11q4WMIRs

By Kanoko Matsuyama

June 27 (Bloomberg) -- Takeda Pharmaceutical Co., Asia’s biggest drugmaker, failed to gain U.S. regulatory approval to market its new diabetes drug alogliptin because of insufficient data.

The U.S. Food and Drug Administration issued a so-called complete-response letter saying the company must provide more data on cardiovascular risks, Osaka-based Takeda said today in a statement.

The rejection is a blow to Takeda President Yasuchika Hasegawa’s plan for alogliptin to serve as a new revenue generator when its top seller, diabetes treatment Actos, loses patent protection in 2011.

“We expect to resubmit the application in about two years,” Takeda spokesman Hisashi Tokinoya said by telephone today. “We’re still negotiating the design of the test with the FDA and hope to reach agreement in the near future.”

At least eight analysts, including Mitsuya Sakurai of CLSA Ltd. in Tokyo, had anticipated the delay of alogliptin, a drug for Type 2 diabetes.

“The likelihood of Takeda winning approval is only about 5 percent,” Sakurai said by telephone on June 22. The analyst, who rates the stock “outperform,” expects the drug to be ready for sale during the quarter ending June 2013.

Takeda rose 0.8 percent to 3,790 yesterday on the Tokyo Stock Exchange. The stock has fallen 18 percent this year, against an 11 percent gain by the Nikkei 225 Stock Average.

‘Insufficient’ Data

The FDA told Takeda in March clinical data on alogliptin was “insufficient” based on new guidelines on diabetes treatments and cardiovascular risks released in December. Takeda had applied to the FDA to sell alogliptin, or SYR-322, as a once-daily treatment a year earlier in December 2007.

“SYR-322 is the most important drug development agenda for Takeda,” Tokinoya said. “We expect to lose patent protection on Actos, and with the decision by the FDA it’s difficult to have the drug in time for the patent expiration.’’

Proposed treatments for Type 2 diabetes should follow new testing standards to rule out an “unacceptable increase” in heart problems, according to the FDA’s guidance. The recommendations apply to all experimental diabetes drugs, even if studies are in progress or the medicine has been submitted for approval, the FDA said.

24 Million Patients

In the U.S., 24 million people, or 7.8 percent of the population, have diabetes, according to the American Diabetes Association’s Web site. Cardiovascular disease and stroke are the most life-threatening consequences of diabetes, the association said.

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.

Takeda said on June 4 it delayed submitting an application to seek European approval for alogliptin by at least two years as it conducts additional patient studies on the drug’s efficacy. The company plans to file with European regulators in 2012.

If approved, alogliptin would compete with Merck & Co.’s Januvia as well as saxagliptin from Bristol-Myers Squibb Co. and AstraZeneca Plc. Saxagliptin is under review by the FDA, which will decide by July 30 whether to approve the pill, Bristol- Myers and Astrazeneca said April 23.

All three drugs are in a new class of diabetes treatments known as DPP4 inhibitors that spur the pancreas to produce more insulin and signal the liver to make less glucose, or blood sugar.

Actos generated 387 billion yen ($4 billion), or 25 percent, of Takeda’s revenue last year. Chesney projected global sales of alogliptin at 10 billion yen in 2013.