TAP Pharmaceuticals

From Wikipedia, the free encyclopedia

This article or section needs to be wikified to meet Wikipedia's quality standards.
Please help improve this article with relevant internal links. (June 2007)

This article does not cite any references or sources. (November 2006)
Please help improve this article by adding citations to reliable sources. Unverifiable material may be challenged and removed.

TAP Pharmaceuticals is a Japanese pharmaceutical company.

It is a joint venture between Abbott Laboratories and the Japanese Takeda Pharmaceutical Company, formed in 1977. Currently they have only 4 marketed products selling within the United States -- PREVACID (lansoprazole), Lupron Depot (Leuprolide),Rozerem (Ramelteon), & FAMVIR (Famciclovir).

Today TAP works with both Abbott and Takeda and searches the world for in-licensing opportunities, focusing its efforts on rapid, high-quality drug development, and marketing and sales in North America.

From TAP's Company Website:

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.^[1]

TAP settled serious criminal and civil charges in the United States in 2001. According to the Department of Justice press release:

(1) 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:

(a) 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.

(b) 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.

(c) 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.

(d) 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.

...

http://www.usdoj.gov/opa/pr/2001/October/513civ.htm

[edit] Timeline

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 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.

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.

1994 TAPCare introduced.

1993 Lupron Depot-PED (leuprolide acetate for depot suspension) approved for treatment of central precocious puberty.

1990 Lupron Depot 3.75 mg approved for management of endometriosis.

1989 Lupron Depot 7.5 mg approved for palliative treatment of advanced prostate cancer.

1985 LUPRON INJECTION (leuprolide acetate) approved by FDA for palliative treatment of advanced prostate cancer, the first new hormonal treatment for prostate cancer in 40 years.

1977 Takeda Chemical Industries, Ltd. and Abbott form a joint research partnership, Takeda-Abbott Products (TAP).