Furiex Pharmaceuticals (NASDAQ:FURX) must wait until April to learn whether the type 2 diabetes compound it licensed to a drug partner will secure regulatory approval and a $25 million milestone payment for the company.
The U.S. Food and Drug Administration has notified drug partner Takeda Pharmaceuticals that review of investigational diabetes drug alogliptin has been delayed and an approval decision is now expected by April 25, 2012. The delay also affects the fixed-dose combination drug alogliptin/pioglitazone. Regulators had previously expected to make a decision by Jan. 25, 2012.
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The alogliptin partnership between Morrisville, North Carolina-based Furiex and Japanese pharma company Takeda dates to 2005, when Furiex was the drug development unit of clinical research organization PPD (NYSE:PPDI). At that time, PPD licensed to Takeda development and commercialization rights to a compound that helps manage blood glucose levels. That compound is now the drug candidate alogliptin, which is being studied to treat type 2 diabetes in addition to diet and exercise. Japan’s regulators approved alogliptin in 2010 and the drug is currently marketed there as Nesina. Furiex receives royalty payments from Nesina’s Japan sales.
Takeda is also seeking U.S. approval for a combination drug that pairs alogliptin with its diabetes drug pioglitazone. Pioglitazone, which targets insulin resistance, was approved in the United States in 1999 and is currently marketed as Actos. The combination drug was approved by Japanese regulators in July and it is now available in that market under the name “Liovel.”
Alogliptin has had a longer than planned journey on the U.S. regulatory path. The drug was expected to secure approval in 2009, but Takeda received a complete response letter from the FDA. The agency in late 2008 issued new cardiovascular guidance and Takeda needed to conduct additional cardiovascular safety studies. The company in July resubmitted its new drug applications for the compound.
“Takeda is confident in alogliptin and alogliptin/pioglitazone as potential therapeutic options for the millions of patients living with type 2 diabetes,” Dr. David Recker, senior vice president, clinical science, Takeda Global Research & Development Center said in a statement. “We will work closely with the FDA to determine the appropriate next steps and are dedicated to continuing our efforts to bring these important therapies to market in the U.S.”
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