Takeda President Yasuchika Hasegawa talks to reporters after FDA’s warning about Actos bladder cancer in 2011.
Japanese pharmaceutical company Takeda is dropping plans to develop diabetes drug fasiglifam (TAK-875) because clinical trials showed participants developed dangerous side effects, including possible liver damage.
This comes as a blow for the drugmaker as it scrambles to find another drug to take the place of its once best-selling Type 2 diabetes drug Actos. Takeda lost patent protection for Actos in 2012.
Before TAK-875 was voluntarily scrapped, Takeda executives touted it as a potentially important new treatment in the fight against Type 2 diabetes. But the bad news caused Takeda’s stock to tank in late December 2013 as investors recalled the gaping hole in profits after the Actos patent expired. Many are wondering what the company will do with one less successor.
The pharmaceutical company issued a press release late December stating that after working with three independent expert panels, they decided to discontinue the trials. Panel members found a link between the drug and liver damage.
“The benefits of treating patients with fasiglifam did not outweigh the potential risks,” a company press release showed. Takeda’s stock dropped 8 percent after that announcement.
Fasiglifam drug was supposed to part of a new class of diabetes medications called GPR40 agonists, which would create insulin secretion in the pancreas. The drug was expected to hit the Japanese market in 2015 and possibly Europe and U.S. before 2017.
Takeda officials said the people who took part in the clinical trials would get proper treatment, and also assured stockholders they were looking into more diabetes options. “Takeda remains committed to the development of novel treatment for diabetes,” company officials said in the press release.
Many diabetes drugs have shown dangerous side effects, which has toughened approval in the U.S.
In January 2013, the U.S. Food and Drug Administration announced approval of Takeda’s new treatment called alogliptin, sold under the brand name Nesina. Approval came more than five years after the company applied for approval in 2007. The FDA tightened cardiovascular safety standards for diabetes drugs, and forced Takeda to prove compliance with years of data from several trials.
The company’s projected net income is expected to be the lowest in 15 years, and Takeda is only projecting single-digit percentage revenue growth through 2017.
Takeda is reportedly looking to cut annual costs by 100 billion yen, likely through job cuts.
Actos (pioglitazone) used to be Takeda’s best-seller with global sales of $3.7 billion, and at one time accounted for 25 percent of the pharmaceutical’s revenue.
Losing patent exclusivity severely cut into those profits as other medical companies started rolling out their versions of Actos in August of 2012.
The oral tablet works by making cells more sensitive to insulin, allowing sugar in the blood to travel more easily into the cells. That lets the body properly regulate sugar and glucose levels in the body. People with Type 2 diabetes do not produce insulin which allows glucose regulation.
Declining sales from generic drug competition isn’t the only problem Takeda has faced with Actos.
The FDA warned about the increased risk of bladder cancer in 2011. Actos was also suspended in Germany, France and India due to those dangers. The link to bladder cancer eventually led to thousands of lawsuits from former Actos users.
People who used the drug for extended periods also reported complications such as heart failure, macular edema, bone fractures and lactic acidosis, which is a build-up of lactic acid in the body. It can cause myriad medical issues.
Actos also interacts with a variety of medications that may increase risks of unwanted side effects. Drugs like Actos vary from birth control pills, thyroid medications, aspirin and herbal supplements.