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Takeda Pharmaceuticals

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Japanese pharmaceutical company Takeda Pharmaceuticals is the manufacturer of one of the most popular Type 2 diabetes medications, Actos. The drug is linked to an increased risk of bladder cancer. In April 2015, the company settled about 9,000 bladder cancer lawsuits for $2.4 billion.

Takeda Pharmaceuticals is the U.S. subsidiary of Takeda Pharmaceutical Company Limited, Japan’s largest drug company. The spinoff was founded in 1998 and ranks among the top 15 drug companies in America, largely because of the Type 2 diabetes drug Actos, which had $3.4 billion in U.S. sales in 2011.

The parent company was founded as a single medicine shop in 1781 in Osaka, Japan. It became a cooperative union in 1871 to import Western medicine and bought its first factory in 1895. By 1925, Chobei Takeda & Company Limited, as it was known then, was worth about $1 million.Takeda pharmaceuticals company logo

After World War II, Takeda manufactured penicillin and vitamin B. It became a publicly traded company in 1949, with its shares listed on the Tokyo and Osaka stock exchanges. From 1956 to 1970, the parent company grew at annual rates as high as 20 percent.

Takeda began marketing its cancer-fighting drug Lupron in the United States in 1985. Lupron Depot, the successor to Lupron, and Prevacid (lansoprazole) helped the company expand its U.S. and European markets. These drugs are now sold in more than 79 countries, with worldwide sales of more than $1 billion.

One focus of Takeda Pharmaceuticals is Actos, which has made the company a target of lawsuits because of its dangerous side effects and which the company is trying to replace as a revenue generator. Actos earned more than $8 billion of the company's $17 billion in net sales in 2011. That same year, the drug became the target of a number of lawsuits filed by patients who said the drug caused their bladder cancer after studies surfaced linking the Type 2 diabetes drug to the cancer.

After several long years of litigation, the Japanese drug maker agreed to settle about 9,000 bladder cancer lawsuits for $2.37 billion in April 2015. In September of that year, the company increased the settlement to $2.4 billion after more than 97 percent of claimants agreed to settle.

Takeda and Actos

After Actos earned Takeda a foothold in the United States, studies showed that growing numbers of long-term users of Actos developed life-altering side effects. Those side effects included congestive heart failure and bladder cancer.

As more and more Actos users suffered from these effects, some of them filed lawsuits against Takeda and Eli Lilly, a company that helped Takeda market the drug in the United States. Takeda faced up to 10,000 bladder cancer lawsuits in the U.S. from Actos users.

A second threat to Takeda's profitability is time. In August 2012, generic forms of Actos were allowed on the market. Those generic drugs are more affordable for consumers, although the side effects of those generics may not be known for some time.

Takeda is trying to develop another hit drug to treat lifestyle diseases such as diabetes. Takeda had planned for its new diabetes drug alogliptin to replace Actos when its patent expired in August 2012, but the drug failed to gain marketing approval from the FDA in time. Alogliptin was finally approved in January 2013.

Takeda clinical trials are in progress for a weight loss drug, as well as a new class of diabetes drug known as TAK-875.

Actos History

When Actos received approval from the FDA in 1999, it was heralded as the latest, greatest diabetes drug. Like its successful predecessor, Avandia, Actos is part of the thiazolidinedione class of drugs. Actos was initially marketed as a drug with all of the benefits of Avandia and none of the dangerous heart risks.

Since Actos entered the market in 1999, more than 10 million people worldwide have taken the drug. That means tens of thousands of people could be suffering from the dangerous side effects of Actos.

In 2007, after studies showed that some users of Actos and Avandia had an increased risk of congestive heart failure, the FDA added a black-box warning to both drugs. Avandia's sales began to shrink, and it is no longer available in U.S. pharmacies. Actos, on the other hand, became more widely prescribed. It remains available in the United States despite more evidence of increased risk to those who take the drug.

In 2011, a study revealed that Actos causes a 40 percent increased risk of bladder cancer in patients who take it for more than a year. A study in 2012 found the increased risk could be as high as 83 percent. Actos has also been linked to a serious eye disorder called macular edema and an increased risk of bone fracture in women.

France and Germany pulled Actos from their shelves in 2011. The FDA, however, has chosen not to pull the drug in the United States, preferring instead to rely on warnings for consumers on the drug's labeling. That warning, however, helped lay the groundwork for an increasing number of lawsuits by Actos users against Takeda. Plaintiff said the company hid the bladder cancer risks of the drug and failed to warn the public.

In April 2015, the company offered thousands of patients over $2 billion to settle claims, though it did not admit liability. More than 97 percent of claimants had agreed to the settlement by September that year.

Actos Lawsuits against Takeda

Takeda is facing multidistrict litigation (MDL), a process in which multiple federal lawsuits are grouped in a single court for pretrial proceedings. Injured patients wishing to join the Multidistrict Litigation No. 2299 against Takeda can file directly with the U.S. District Court for the Western District of Louisiana or with a lawyer who specializes in Actos litigation. Takeda also faces numerous Actos lawsuits in state courts.

Former Takeda employee Dr. Helen Ge filed a separate lawsuit, accusing the company of hiding Actos’ side effects from the FDA. As a safety consultant, Ge’s job was to send the FDA side effect reports when Actos patients and doctors told Takeda about bad reactions to the diabetes drug. During her time working for Takeda, Ge says she received many reports of delirium, suicide, bladder cancer and congestive heart failure caused by Actos.

In her claim, Ge said Takeda executives asked her to ignore and under-report side effects. She said that in Takeda’s database, more than 100 cases of bladder cancer were recorded but only 72 were sent to the FDA.

Ge's suit has since been dismissed.

Takeda Looks Forward

The FDA initially rejected alogliptin’s marketing application based on insufficient data about the new drug’s heart risks. Takeda first applied to sell alogliptin in the U.S. market in 2007, the same year Actos’ congestive heart failure side effects were uncovered. Alogliptin received approval in January 2013.

Takeda's sales on Actos are expected to drop dramatically after generics were allowed on the market in 2012. Actos sales peaked at $4.5 billion in the year ending in March 2011, accounting for 27 percent of the company's revenue that year.

The company took an historic profit loss in the 2014 fiscal year, the first since 1946, because of legal woes, Bloomberg reported.

Since Actos, the company developed several new diabetes drugs, but so far, none have achieved the same blockbuster status. Development of one new drug was scraped in 2014 because of a potential link with liver damage.