About Takeda Pharmaceuticals
In the U.S., Takeda is a subsidiary company of Takeda Pharmaceutical Company Limited. They are the largest drug company in Japan. Takeda Pharmaceuticals was founded in 1998, and with estimated revenue of about $20 Billion annually, is ranked as one of the top pharmaceutical companies of the U.S. and one of the top 10 pharma companies in the world.
A substantial amount of Takeda’s success has come from their drug for treating type 2 diabetes, Actos but the company is focused in several areas of medicine including blood-based therapies, cancer, immunizations and gastroenterology.
History of Takeda
Takeda Pharmaceutical Company was originally founded in Osaka, Japan in 1781 as Chobei Takeda & Company Limited, a seller of traditional Japanese and Chinese herbal medicines. The company began importing pharmaceutical supplies from the west in 1871 to produce western medicines like quinine for malaria and phenol for cholera.
Import agreements with companies in Europe, including an exclusive deal with Bayer in Germany, allowed the company to increase its supplies of Western medicine, before shifting the entire business. Uchibayashi Drug Works was acquired in 1895 and the company began producing bismuth, quinine, and other products such as saccharin.
A research division was established as Takeda Pharmaceutical Company around 1914 when World War I blocked the import of medicines from Germany and other areas, allowing the company to develop and sell their own products, even exporting them to the U.S., Russia and China. In 1925 the divisions of Chobei Takeda, and Takeda Pharmaceutical Company merged with a value of approximately $1 million.
During World War II Takeda Pharmaceuticals supplied penicillin and B vitamins. Shortly after World War II, a second factory was established, and the company began trading stock internationally. In 1953, Takeda formed a joint venture known as Lederle, a company which would go on to become Wyeth Pharmaceuticals.
Sales from Takeda expanded into other parts of Asia in 1962, and further into Europe in 1978 with the establishment of marketing and manufacturing facilities. In 1985, Takeda formed TAP Pharmaceuticals as a joint venture with Abbott Laboratories to market their anti-cancer medication, Lupron Depot.
Takeda became Takeda Pharmaceuticals in 1998 on the tail of a number of expansions into the UK, Ireland and the U.S. and in 1999, Takeda launched a new Type 2 diabetic agent, Actos (pioglitazone) which would go on to become a blockbuster drug but also the target of hundreds of drug injury lawsuits.
Between 2008 and 2018, the company acquired a number of pharmaceutical ventures including Millenium Pharmaceuticals and a portion of Amgen which allowed further expansion into cancer treatment and blood-based therapies. Takeda also acquired or integrated a number of other companies including Syrrx, Inc., Paradigm Therapeutics Limited, TAP Pharmaceutical Products, Nycomed, URL Pharma, LigoCyte Pharmaceuticals, Multilab Indústria e Comércio de Produtos Farmacêuticos Ltda., Ariad Pharmaceuticals, and Envoy Therapeutics.
The company has also divested all of its non-pharmaceutical businesses including animal health, vitamin, chemical, food and agricultural divisions. In 2019, Takeda acquired Shire Pharmaceuticals, increasing its medication portfolio with expansion further into neuroscience and continues to expand through acquisition of cancer and immunotherapy companies.
Takeda Lawsuits and Challenges
As Takeda became a major global player in the pharmaceutical industry, some of its products caused major concerns. The most notable issues have arisen over the blockbuster drug, Actos (pioglitazone), however other medications have also caused concern and resulted in hundreds or even thousands of lawsuits including the ulcer medication Prevacid (lansoprazole) and gout medication Uloric (febuxostat).
In addition, newer medications in some of the more specific therapeutic areas may be prone to high-risk treatment including cancer and blood-based therapies but the company has faced a number of non-injury related issues as well. In November of 2010, after Takeda had acquired Millennium Pharmaceuticals, the company was forced to recall certain lots of the cancer medication Velcade from the U.S., Japan, Malaysia, and Europe after white particles were found to be present in vials.
In February of 2013, the company was forced to recall all manufacturing lots of Omontys, a drug used to treat anemia which was jointly produced with Affymax, after 19 reports of anaphylaxis were reported in dialysis patients. The partnership with Affymax was subsequently dissolved.
In July of 2015, a number of bottles of the obesity medication, Contrave were recalled as the tablets may have been poorly manufactured and may split into the two components. The cooperative agreement with the manufacturer Orexigen was dissolved after a clinical trial involving Contrave was badly conducted, costing $ Millions but leaving Takeda free of liability when the FDA added the medication to a watch list in April 2017.
Takeda’s type 2 diabetes medication, Actos (pioglitazone), was approved by the FDA in 1999. Actos is a thiazolidinedione, or TZD compound similar to other type 2 diabetes medications including Avandia.
In 2007, the U.S. Food and Drug Administration issued a “black box warning,” or “black label warning,” after studies had shown congestive heart failure as an increased risk from Actos treatment. Despite the warning, Actos became the most widely prescribed drug for treating type 2 diabetes.
Actos has been prescribed to over 10 million type 2 diabetes patients around the world and was the best-selling diabetes medication in the U.S. for a number of years. In 2010, the drug brought about $4.5 billion in revenue to Takeda, but serious problems started to emerge.
In 2011, a study was released that claimed Actos may increase the risk of bladder cancer by as much as 40 percent and showed that the risk was more substantial for patients that were prescribed Actos for longer than a year. A separate study was published claiming that the bladder cancer risk may be increased by as much as 83 percent.
Separately, other health complications from Actos were also identified including lactic acidosis, bone fracture, and macular edema and during the same year, 2011, the FDA began requiring that additional warnings about cancer risk be included on prescribing information. By 2012, when Actos’ patent expired, thousands of lawsuits had been filed for injuries caused by the medication.
Takeda Pharmaceuticals was accused of hiding information regarding Actos. A safety consultant from the FDA filed suit against Takeda Pharmaceuticals because of bad reactions that were not being reported to necessary officials. In 2014, Takeda agreed to settle about 9,000 lawsuits for $2.4 billion.
Prevacid PPI Lawsuits
One of Takeda’s primary therapeutic areas, gastrointestinal disease, led to the development of anti-ulcer medications, Prevacid (lansoprazole), Protonix (pantoprazole), and Dexilant (dexlansoprazole). These medications are proton-pump inhibitor (PPI) medications which are used to treat diseases including gastroesophageal reflux disease (GERD) and other acid-related conditions such as ulcers but may increase the risk of serious injuries such as kidney disorders, stroke, and bone fractures.
PPIs are available over the counter but have come under fire as many people have used them for longer than they were designed for. Thousands of PPI lawsuits have been filed against companies who manufacture PPI medications including over 1,300 lawsuits against Takeda for Prevacid-related injuries.
In 2014, Takeda settled a number of Prevacid bone fracture lawsuits for undisclosed amounts. Other lawsuits for injuries caused by Prevacid may also have been settled or may still be pending in federal, state, and local courts.
Takeda is also facing lawsuits filed for injuries caused by its gout medication, Uloric (febuxostat). Uloric works to treat gout by lowering the amount of uric acid in the bloodstream and is one of only a few gout medications available in the U.S. Though the medication is popular, a 2018 study found that it may increase the risk of cardiac-related death when compared to another gout medication, allopurinol.
The FDA began requiring a black box warning on Uloric but allowed the medication to remain on the market for people who cannot take or do not respond to allopurinol. Despite these precautions, multiple people have and continue to suffer cardiovascular events and even death due to use of Uloric. Some of these people have filed Uloric lawsuits against Takeda but no settlements or large-scale announcements have been made about lawsuit dispositions.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.