Furiex Pharmaceuticals shares soared in value Monday by 66.4 percent as news spread about regulatory approval for three diabetes drugs it has partnered with a Japanese firm to bring to market.
Furiex also is headed for a big payday – $25 million as a milestone payment plus royalties to come – after the FDA approved on Friday three new drugs to treat type 2 diabetes.
In pre-market trading Monday, shares are up a whopping 27 percent, or $5.76, to a new 52-week high of $27. The previous high was $25.
Shares ended the day at $35.34 after a day-long frenzy of buying. Shares peaked at $35.75.
Some 1.4 million shares were traded. Its daily average is some 48,000 shares.
Furiex (Nasdaq: FURX) announced late Friday that the U.S. Food and Drug Administration had approved the treatments from Takeda Pharmaceutical Company.
Takeda, based in Osaka, Japan, and the Furiex partner, saw its shares advance 1.4 percent at the close of Tokyo trading.
The Food and Drug Administration cleared Takeda and Furiex’s alogliptin and two combinations of the treatment 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 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.
Other Sales Had Peaked for Takeda
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 at the time.
Alogliptin is in the same class of drugs as Merck & Co. (MRK)’s Januvia, which generated $3.3 billion in 2011, and Bristol-Myers Squibb Co. (BMY)’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 diabetics 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.
Pleased at Furiex
“We are pleased to see these important therapies become available for patients with type 2 diabetes,” said June Almenoff, president and chief medical officer of Furiex. “Type 2 diabetes is a complex disease, requiring careful long-term disease management. We believe these new treatments in the U.S. offer patients additional therapeutic options for managing the disease.”
Fufriex is partnered with Takeda for the drugs’ development and is already receiving royalty payments from two that are already being sold in Japan.
The approved drugs include Nesina (alogliptin), Oseni and Kazano. The latter two include alogliptin in combination with other compounds.
Furiex also could receive additional milestone payments based on sales.
The company is based in Morrisville.
(Bloomberg contributed to this report.)