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TAP Pharmaceuticals was formed in 1977 as a
joint venture A joint venture (JV) is a business entity created by two or more parties, generally characterized by shared ownership, shared returns and economic risk, risks, and shared governance. Companies typically pursue joint ventures for one of four rea ...
between the two global
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field an ...
companies, Abbott Laboratories and
Takeda Pharmaceutical Co. The is a Japanese multinational pharmaceutical company, with partial American and British roots. It is the largest pharmaceutical company in Asia and one of the top 20 largest pharmaceutical companies in the world by revenue (top 10 followin ...
and was dissolved in 2008; its two most lucrative products were proton-pump inhibitor
lansoprazole Lansoprazole, sold under the brand name Prevacid among others, is a medication which reduces stomach acid. It is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. Effectiveness is similar to ...
(Prevacid) and the prostate cancer drug,
leuprorelin Leuprorelin, also known as leuprolide, is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, as part of transgender hormone therapy, for early puberty, or to perform chemical cas ...
(Lupron). The intention of the joint venture was to get products that Takeda had discovered developed, approved, and marketed in the US and Canada. The company was established at a time when Japanese pharmaceutical companies were seeking partnerships to access the US market. These efforts were supported by the Japanese government at the time to help the national economy compete in higher technology, as countries like South Korea, Taiwan were beginning to catch up with Japan in commodity production. Japanese pharmaceutical companies were especially strong in the fields of generating analogs of known cephalosporin antibiotics, cancer drugs, and cardiovascular drugs. The first products TAP file new drug applications for, were two cephalosporins,
cefmenoxime Cefmenoxime is a third-generation cephalosporin antibiotic An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic ...
(Cefmax) and cefsulodin (Cefonomil),
estazolam Estazolam, sold under the brand name Prosom among others, is a tranquilizer medication of the triazolobenzodiazepine (TBZD) class, which are benzodiazepines (BZDs) fused with a triazole ring . It possesses anxiolytic, anticonvulsant, hypnotic, s ...
for sleep disorders, and leuprorelin; leuprorelin was the first one approved, in 1985. In 1998 Takeda established its own US R&D and sales force, for the diabetes drug
pioglitazone Pioglitazone, sold under the brand name Actos among others, is an anti-diabetic medication used to treat type 2 diabetes. It may be used with metformin, a sulfonylurea, or insulin. Use is recommended together with exercise and diet. It is not re ...
(Actos). In 2000, TAP's withdrew its new drug application for
apomorphine Apomorphine, sold under the brand name Apokyn among others, is a type of aporphine having activity as a non- selective dopamine agonist which activates both D2-like and, to a much lesser extent, D1-like receptors. It also acts as an antag ...
(branded as "Uprima") as a treatment for erectile dysfunction after an FDA review panel raised questions about the drug's safety, due to many clinical trial subjects fainting after taking the drug. In 2001, the US Department of Justice, states attorneys general, and TAP Pharmaceutical Products settled criminal and civil charges against TAP related to federal and state
medicare fraud In the United States, Medicare fraud is the claiming of Medicare health care reimbursement to which the claimant is not entitled. There are many different types of Medicare fraud, all of which have the same goal: to collect money from the Medicare ...
and illegal marketing of the drug
leuprorelin Leuprorelin, also known as leuprolide, is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, as part of transgender hormone therapy, for early puberty, or to perform chemical cas ...
. TAP paid a total of $875 million, which was a record high at the time. The $875 million settlement broke down to $290 million for violating the Prescription Drug Marketing Act, $559.5 million to settle federal fraud charges for overcharging Medicare, and $25.5 million reimbursement to 50 states and Washington, D.C., for filing false claims with the states' Medicaid programs. The case arose under the
False Claims Act The False Claims Act (FCA), also called the "Lincoln Law", is an American federal law that imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. It is the federal government's primary litigat ...
with claims filed by Douglas Durand, a former TAP vice president of sales, and Joseph Gerstein, a doctor at
Tufts University Tufts University is a private research university on the border of Medford and Somerville, Massachusetts. It was founded in 1852 as Tufts College by Christian universalists who sought to provide a nonsectarian institution of higher learning. ...
's HMO practice. Durand, Gerstein, and Tufts shared $95 million of the settlement. When the settlement was announced, the Department of Justice also announced that seven people were indicted on criminal charges by a grand jury; the DoJ also said that four doctors had already pled guilty for receiving kickbacks. As of 2003 around 12 TAP employees had been indicted and were contested the charges, and one had pled guilty. However, in July 2004 a federal jury in Boston declared all the defendants not guilty. Abbott and Takeda agreed to end the partnership in 2008, with Abbott keeping the rights to leuprorelin, which had sales in 2007 of $600 million and a patent expiring in 2015 and the approximately 300 employees who worked on the product, and Takeda keeping the rights to lansoprazole, which had sales of $2.3 billion in 2007 but was facing imminent generic competition, along with 800 employees in the U.S. and all the drugs in the TAP pipeline. Takeda was also obligated to pay Abbott about $1.5 billion over several years. By 2008, Takeda's own sales in the US outside of TAP had grown to $3 billion, mostly from sales of pioglitazone which by then was the best-selling diabetes drug in the world.


References

{{DEFAULTSORT:Tap Pharmaceutical Products Pharmaceutical companies disestablished in 2008 Pharmaceutical companies of the United States Life sciences industry