TAP Pharmaceuticals
Encyclopedia
TAP Pharmaceuticals was a Japan
ese pharmaceutical company.
It was a joint venture between Abbott Laboratories
and the Japanese Takeda Pharmaceutical Company
, formed in 1977. The joint venture was dissolved in 2008 and most of the company merged with Takeda Pharmaceutical Co. in 2008.
TAP had four marketed products selling within the United States
press release:
The merger is a result of the conclusion of a 30-year joint venture between Takeda Pharmaceutical Company Limited and Abbott Laboratories, which was announced on March 19, 2008. According to terms previously announced, Takeda received the rights to TAP’s product Prevacid, its non-Lupron related commercial organization, TAP's support organizations, and TAP’s pipeline.
Abbott received the rights to Lupron.
TAP submits New Drug Application(NDA) to the U.S. Food and Drug Administration(FDA) for febuxostat for the management of hyperuricemia in chronic gout.
The U.S. FDA approves several new options for patients using Prevacid:
TAP introduces Lupron Depot (leuprolide acetate for depot suspension) with LuproLocTM, making Lupron Depot the first product in its class to offer a needlestick safety device on its prefilled syringes.
TAP ends agreement with Unimed/Solvay Pharmaceuticals to co-promote Androgel, 1% (testosterone gel).
TAP returns rights to Spectracef (cefditoren pivoxil) to partner Meiji Seika Kaisha, Ltd. of Japan.
TAP enters collaborative research agreement with Ligand Pharmaceuticals.
Spectracef approved by FDA.
Lupron Depot add-back therapy approved by FDA.
Prevacid is the first PPI approved in a packet for oral suspension.
TAP enters a long-term research collaboration with IPF PharmaCeuticals GmbH.
Prevacid approved for new administration options, including sprinkling on cottage cheese, yogurt or Ensure pudding or strained pears, as well as mixing with orange juice and tomato juice.
NDA filed with FDA for Spectracef.
Prevacid in combination with clarithromycin
and amoxicillin
approved for 14-day therapy for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.
Prevpac blister packaging approved for 14-day triple therapy for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.
Lupron Depot-3 Month 11.25 mg approved for treatment of endometriosis and, in combination with iron, for presurgical treatment of anemia caused by uterine fibroids.
Lupron Depot-4 Month 30 mg approved for palliative treatment of advanced prostate cancer.
The Prevacid launch becomes one of the most successful in pharmaceutical history.
Pharmacy Solutions introduced.
Lupron Depot 3.75 approved, in combination with iron, for presurgical treatment of anemia caused by uterine fibroids.
Lupron Depot-3 Month 22.5 mg approved for palliative treatment of advanced prostate cancer.
CaPSURETM introduced.
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
ese pharmaceutical company.
It was a joint venture between Abbott Laboratories
Abbott Laboratories
Abbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
and the Japanese Takeda Pharmaceutical Company
Takeda Pharmaceutical Company
is the largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company. The company has over 19,000 employees worldwide and achieved $15.7 billion USD in revenue during the 2008 fiscal year...
, formed in 1977. The joint venture was dissolved in 2008 and most of the company merged with Takeda Pharmaceutical Co. in 2008.
TAP had four marketed products selling within the United States
- PREVACID (lansoprazoleLansoprazoleLansoprazole is a proton-pump inhibitor which prevents the stomach from producing gastric acid. It is manufactured by a number of companies worldwide under several brand names . It was first approved by the U.S...
) - Lupron Depot (LeuprolideLeuprolideLeuprorelin or leuprolide acetate is a GnRH analog. Proper Sequence: Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt - Mode of action:Leuprolide acts as an agonist at pituitary GnRH receptors...
) - Rozerem (RamelteonRamelteonRamelteon, marketed as Rozerem by Takeda Pharmaceuticals North America, is the first in a new class of sleep agents that selectively binds to the MT1 and MT2 receptors in the suprachiasmatic nucleus , instead of binding to GABA A receptors, such as with drugs like zolpidem, eszopiclone, and...
) - FAMVIR (FamciclovirFamciclovirFamciclovir is a guanine analogue antiviral drug used for the treatment of various herpesvirus infections, most commonly for herpes zoster . It is a prodrug form of penciclovir with improved oral bioavailability...
) - KAPIDEX(DexlansoprazoleDexlansoprazoleDexlansoprazole is a proton pump inhibitor that is marketed by Takeda Pharmaceuticals. Chemically, it is an enantiomer of lansoprazole. The compound was launched in the US for use in the treatment and maintenance of patients with erosive oesophagitis and non-erosive gastro-oesophageal reflux disease...
)
History
"Fourteen years ago, TAP had 200 employees. Today, the company has grown to more than 3,300 employees. As TAP evolves and grows to meet the needs of customers, the challenge will be to maintain the energy and optimism that makes TAP unique. Ultimately, it is not the size of the company that matters—TAP's success will be measured by how well the company meets the challenge of serving patients. TAP believes that the best way to meet that challenge is to live and work by its mission and the Spirit of TAP.
Throughout TAP's history, its efforts have been focused on developing and bringing innovative treatments to the people who need them. LUPRON INJECTION (leuprolide acetate), TAP's first product, was the first new hormonal therapy for the palliative treatment of advanced prostate cancer in 40 years. Prevacid (lansoprazole), a proton pump inhibitor (PPI), quickly became one of the most widely prescribed therapies for acid-related disease in North America. And the focus on innovation continues as the people of TAP work to improve patient convenience with new dosing and packaging advancements, research new indications for existing products, and develop new products in the pipeline."
Criminal Charges
TAP settled serious criminal and civil charges in the United States in 2001. According to the United States Department of JusticeUnited States Department of Justice
The United States Department of Justice , is the United States federal executive department responsible for the enforcement of the law and administration of justice, equivalent to the justice or interior ministries of other countries.The Department is led by the Attorney General, who is nominated...
press release:
- TAP Pharmaceutical Products Inc. ("TAP"), a major American pharmaceutical manufacturer, has agreed to pay $875,000,000 to resolve criminal charges and civil liabilities in connection with its fraudulent drug pricing and marketing conduct with regard to Lupron, a drug sold by TAP primarily for treatment of advanced prostate cancer in men. The global agreement includes:
- TAP has agreed to plead guilty to a conspiracy to violate the PrescriptionDrug Marketing Act and to pay a $290,000,000 criminal fine, the largest criminal fine ever in a health care fraud prosecution. The plea agreement between the United States and TAP specifically states that TAP's criminal conduct caused losses of $145,000,000.
- TAP has agreed to settle its federal civil False Claims Act liabilities and to pay the U.S. Government $559,483,560 for filing false and fraudulent claims with the Medicare and Medicaid programs as a result of TAP's fraudulent drug pricing schemes and sales and marketing misconduct.
- TAP has agreed to settle its civil liabilities to the fifty states and the District of Columbia and to pay them $25,516,440 for filing false and fraudulent claims with the states, as a result of TAP's drug pricing and marketing misconduct, and from TAP's failure to provide the state Medicaid programs TAP's best price for those drugs as required by law.
- TAP has agreed to comply with the terms of a sweeping corporate integrity agreement which, among other things, significantly changes the manner in which TAP supervises its marketing and sales staff, and ensures that TAP will report to the Medicare and Medicaid programs the true average sale price for drugs reimbursed by those programs.
2008
Takeda Pharmaceutical Company Limited announced on July 1, 2008 that Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. merged with TAP Pharmaceutical Products Inc. (TAP), forming one of the top 15 pharmaceutical companies in the United States.The merger is a result of the conclusion of a 30-year joint venture between Takeda Pharmaceutical Company Limited and Abbott Laboratories, which was announced on March 19, 2008. According to terms previously announced, Takeda received the rights to TAP’s product Prevacid, its non-Lupron related commercial organization, TAP's support organizations, and TAP’s pipeline.
Abbott received the rights to Lupron.
2004
TAP names new management team of Alan MacKenzie, President and Glenn Warner, Executive Vice President.TAP submits New Drug Application(NDA) to the U.S. Food and Drug Administration(FDA) for febuxostat for the management of hyperuricemia in chronic gout.
The U.S. FDA approves several new options for patients using Prevacid:
- Labeling for use of Prevacid in adolescents aged 12 to 17.
- New dosing options for Prevacid(lansoprazole) SoluTabTM Orally Disintegrating Tablets.
- Prevacid I.V.(lansoprazole) for Injection was approved for use in the treatment of erosive esophagitis in hospitalized patients.
2003
TAP introduces Prevacid NapraPACTM (lansoprazole delayed release capsules and naproxen tablet kit) a first of its kind combination package containing two widely used medications in one prescription.TAP introduces Lupron Depot (leuprolide acetate for depot suspension) with LuproLocTM, making Lupron Depot the first product in its class to offer a needlestick safety device on its prefilled syringes.
TAP ends agreement with Unimed/Solvay Pharmaceuticals to co-promote Androgel, 1% (testosterone gel).
TAP returns rights to Spectracef (cefditoren pivoxil) to partner Meiji Seika Kaisha, Ltd. of Japan.
2002
Prevacid becomes available through Together RxTM, an innovative program from members of the pharmaceutical industry to provide prescription medication discounts for seniors without prescription drug insurance coverage.2001
TAP enters co-promotion agreement with Unimed/Solvay Pharmaceuticals for AndroGel 1% (testosterone gel).TAP enters collaborative research agreement with Ligand Pharmaceuticals.
Spectracef approved by FDA.
Lupron Depot add-back therapy approved by FDA.
Prevacid is the first PPI approved in a packet for oral suspension.
2000
Prevacid becomes the first PPI approved by the FDA for the treatment and risk reduction of recurrence of NSAID-associated (nonsteroidal anti-inflammatory drug) gastric ulcers in chronic NSAID users.TAP enters a long-term research collaboration with IPF PharmaCeuticals GmbH.
1999
Prevpac (lansoprazole/amoxicillin/clarithromycin) 10-day triple therapy approved for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.Prevacid approved for new administration options, including sprinkling on cottage cheese, yogurt or Ensure pudding or strained pears, as well as mixing with orange juice and tomato juice.
NDA filed with FDA for Spectracef.
1998
Prevacid approved for short-term treatment of symptomatic gastroesophageal reflux disease and, in combination with clarithromycin and amoxicillin, for 10-day therapy for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.1997
Prevacid approved for short-term treatment of active benign gastric ulcers and maintenance of healed duodenal ulcer.Prevacid in combination with clarithromycin
Clarithromycin
Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia , skin and skin structure infections...
and amoxicillin
Amoxicillin
Amoxicillin , formerly amoxycillin , and abbreviated amox, is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral...
approved for 14-day therapy for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.
Prevpac blister packaging approved for 14-day triple therapy for eradication of H. pylori to reduce the risk of duodenal ulcer recurrence.
Lupron Depot-3 Month 11.25 mg approved for treatment of endometriosis and, in combination with iron, for presurgical treatment of anemia caused by uterine fibroids.
Lupron Depot-4 Month 30 mg approved for palliative treatment of advanced prostate cancer.
1996
Prevacid approved for long-term maintenance of healed erosive esophagitis.The Prevacid launch becomes one of the most successful in pharmaceutical history.
Pharmacy Solutions introduced.
1995
Prevacid approved by FDA for short-term treatment of erosive esophagitis, active duodenal ulcers and pathological hypersecretory conditions.Lupron Depot 3.75 approved, in combination with iron, for presurgical treatment of anemia caused by uterine fibroids.
Lupron Depot-3 Month 22.5 mg approved for palliative treatment of advanced prostate cancer.
CaPSURETM introduced.