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Pfizer Incorporated ( ) is a pharmaceutical company, ranking number one in sales in the world. The company is based in New York Citymarker, with its research headquarters in Groton, Connecticutmarker. It produces Lipitor (atorvastatin, used to lower blood cholesterol); the neuropathic pain/fibromyalgia drug Lyrica (pregabalin); the oral antifungal medication Diflucan (fluconazole), antibiotic Zithromax (azithromycin), Viagra (sildenafil citrate), and the anti inflammatory Celebrex (celecoxib) (also known as Celebra in some countries outside USAmarker and Canadamarker, mainly in South America).

Pfizer's shares were made a component of the Dow Jones Industrial Average on April 8, 2004.

Pfizer pleaded guilty in 2009 to the largest health care fraud in U.S. history and received the largest criminal penalty ever levied for illegal marketing of four of its drugs. Called a repeat offender, this was Pfizer's fourth such settlement with the U.S.marker Department of Justicemarker in the previous ten years.

On January 26, 2009, Pfizer agreed to buy pharmaceutical giant Wyeth for US$68 billion, a deal financed with cash, shares and loans. The deal was completed on October 15, 2009.

History

Pfizer is named after German-American cousins Charles Pfizer and Charles Erhardt (they were originally from Ludwigsburg, Germany) who launched a fine chemicals business, Charles Pfizer and Company, from a building at the intersection of Harrison Avenue and Bartlett Street in Williamsburg, Brooklynmarker in 1849. There, they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that really kick-started Pfizer's growth in the 1880s. Pfizer continued to buy property to expand its lab and factory on the block bounded by Bartlett Street; Harrison Avenue; Gerry Street; and Flushing Avenue. That facility was used by Pfizer until 2005, when Pfizer closed its original plant along with several others. Pfizer established its original administrative headquarters at 81 Maiden Lane in Manhattan. By 1906, sales totaled nearly $3 million.

World War I caused a shortage of calcium citrate that Pfizer imported from Italy for the manufacture of citric acid, and the company began a search for an alternative supply. Pfizer chemists learned of a fungus that ferments sugar to citric acid and were able to commercialize production of citric acid from this source in 1919. As a result Pfizer developed expertise in fermentation technology. These skills were applied to the mass production of penicillin during World War II, in response to a need from the U.S. government. The antibiotic was needed to treat injured Allied soldiers. In fact, most of the penicillin that went ashore with the troops on D-Day was made by Pfizer.

Following the success of penicillin production in the 1940s, penicillin became very inexpensive and Pfizer made very little profit for its efforts. As a result, in the late 1940s Pfizer decided to search for new antibiotics with greater profit potential. The discovery and commercialization of Terramycin by Pfizer in 1950 moved the company on the path of change from a manufacturer of fine chemicals to a research-based pharmaceutical company. To augment its research in fermentation technology, Pfizer began a program to discover drugs through chemical synthesis. Pfizer also established an animal health division in 1959 with an 700-acre farm and research facility in Terre Haute, Indianamarker.

By the 1950s, Pfizer was established in Belgium, Brazil, Canada, Cuba, Iran, Mexico, Panama, Puerto Rico, Turkey and the United Kingdom. In 1960, the Company moved its medical research laboratory operations to a new facility in Groton, Connecticut. In 1980 Pfizer launched Feldene , a prescription anti-inflammatory medication that became Pfizer's first product to reach a total of a billion United States dollars in sales.

During the 1980s and 1990s Pfizer underwent a period of growth sustained by the discovery and marketing of Zoloft, Lipitor, Norvasc, Zithromax, Aricept, Diflucan, and Viagra. Pfizer has recently grown by mergers, including those with Warner-Lambert (2000), with Pharmacia (2003), and with Wyeth (2009).

Corporate structure

Pfizer world headquarters
Current members of the board of directors of Pfizer are: Michael S. Brown, M. Anthony Burns, Robert Burt, Don Cornwell, William H. Gray, Frances D. Fergusson, Constance Horner, William R. Howell, Stanley Ikenberry, Jeff Kindler (chairman), George Lorch, John P. Mascotte, Dana Mead, Ruth J. Simmons, and William Steere.



Pfizer has four divisions: Human Health ($44.28B in 2005 sales), Consumer Healthcare ($3.87B in 2005 sales), Animal Health ($2.2B in 2005 sales), and Corporate Groups (which includes legal, finance, and HR). On June 26, 2006, Pfizer announced that it would sell its Consumer Healthcare unit (manufacturer of Listerine, Nicorette, Visine, Sudafed and Neosporin) to Johnson & Johnsonmarker for $16.6B.

Warner-Lambert / Parke-Davis / Agouron

In 2000, Pfizer merged with Warner-Lambert and acquired full rights to Lipitor (atorvastatin), which was previously jointly marketed by Warner-Lambert and Pfizer. Warner-Lambert was based in Morris Plainsmarker, New Jerseymarker, where former headquarters became a major base of operations for Pfizer. The majority of the facility, and Pfizer's consumer healthcare department, was sold to Johnson and Johnsonmarker in 2006 for $16.6 billion.

Parke-Davis was acquired by Warner-Lambert in 1970, which in turn was merged into Pfizer in 2000. The headquarters of Parke-Davis was sold several years ago. Pfizer sold the near-174-acre Parke-Davis research complex in Ann Arbor, Michigan to the University of Michiganmarker in 2008 for $108 million. It would 'accelerate the expansion' of the university's research activities. Some renovations would be needed' and create 2,000 new research jobs, the university said.

Agouron Pharmaceuticals was acquired by Warner Lambert in 1999 and is now a subsidiary of Pfizer. Nelfinavir (Viracept), an antiretroviral drug used in the treatment of the human immunodeficiency virus (HIV), was developed by Agouron Pharmaceuticals as part of a joint venture with Japan Tobacco, Inc.

Pharmacia / Upjohn / Searle

Searle was founded in Omaha, Nebraska, in 1888. The founder was Gideon Daniel Searle. In 1908, the company was incorporated in Chicago. In 1941, the company established headquarters in Skokie, Illinois. It was acquired by the Monsanto Company, headquartered in St. Louismarker, in 1985.

The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Kalamazoo, Michiganmarker by Dr. William E. Upjohn, an 1875 graduate of the University of Michiganmarker medical school. The company was originally formed to make friable pills, which were specifically designed to be easily digested.

In 1995, Upjohn merged with Pharmacia, to form Pharmacia & Upjohn. Pharmacia was created in April 2000 through the merger of Pharmacia & Upjohn with the Monsanto Company and its G.D. Searle unit. The merged company was based in Peapack, New Jersey. The agricultural division was spun off from Pharmacia, as Monsanto, in preparation for the close of the acquisition by Pfizer.

In 2002, Pfizer merged with Pharmacia. The merger was again driven in part by the desire to acquire full rights to a product, this time Celebrex (celecoxib), the COX-2 selective inhibitor previously jointly marketed by Searle (acquired by Pharmacia) and Pfizer. In the ensuing years, Pfizer commenced with a massive restructuring resulting in numerous site closures and loss of jobs including: Terre Haute, IN; Holland, MI; Groton, CT; Brooklyn, NY; Sandwich, UK and Puerto Rico.

In 2008, Pfizer announced 275 job cuts at the Kalamazoo manufacturing facility. Kalamazoo was previously the world headquarters for the Upjohn Company.

SUGEN

SUGEN, customarily written with capital letters, was founded in 1991 in Redwood Citymarker, Californiamarker, as a partnership between the laboratories of Joseph Schlessinger at New York University Medical School and Axel Ullrich at the Max Planck Institute of Biochemistrymarker, with Steven Evans-Freke as a third co-founder. The name, SUGEN, is derived from combining the first "S" in Schlessinger followed by the "U" in Ullrich with "GEN" - a commonly used suffix by biotech companies (short for "GENetics" or "GENesis"). The focus of the enterprise was to develop drugs targeting intracellular signaling pathways to treat cancer. Specifically, the company sought to discover competitive ATP small-molecule kinase inhibitors which block common cancer pathways. Pharmacia acquired SUGEN in 1999, which merged with the pharmaceutical division of Monsanto Company in 2000 and was purchased by Pfizer in 2003. In 1999, Pharmacia advanced two of SUGEN's lead compounds into clinical trials for colon cancer: SU5416 (Semaxanib) and SU6668; the trials were discontinued but a third and closely related compound named SU11248 was pursued. SUGEN's laboratories were closed in 2003 as part of the reorganization following Pfizer's purchase of Pharmacia. From the acquisition, SUGEN compounds SU11248 and SU14813 entered Pfizer's pipeline. In January 2006, SU11248 was approved by the FDA for treatment of GIST and RCC, and it is now marketed as Sutent (sunitinib). Sutent is packed by Plant in Ascoli Picenomarker, Italy.

Wyeth

On 26 January 2009, after more than a year of talks between the two companies, Pfizer agreed to buy pharmaceuticals rival Wyeth for a combined US$68 billion in cash, shares and loans, including some US$22.5 billion lent by five major Wall Street banks. The deal would cement Pfizer's place as the largest pharmaceutical company in the world, with the merged company generating over US$20 billion in cash each year, and represents the largest corporate merger since AT&T and BellSouth's US$70 billion deal in March 2006. Wyeth's management team is expected to depart following the merger. The combined company could save US$4 billion annually through the streamlining of operations; however, as part of the deal, both companies must repatriate billions of dollars in revenue from foreign sources to the United States, which will result in higher tax costs. The acquisition was completed on October 15, 2009 making Wyeth a wholly-owned subsidiary of Pfizer.

Critics of the merger

The merger received a vast array of criticism. Harvard Business Schoolmarker’s Gary Pisano told the Wall Street Journal:
The record of big mergers and acquisitions in Big Pharma has just not been good.
There’s just been an enormous amount of shareholder wealth destroyed.


The Warner-Lambert and Pharmacia mergers do not appear to have achieved gains for shareholders so it is unclear who will benefit from the Wyeth-Pfizer merger to many critics.

Development of torcetrapib

Development of torcetrapib, a drug that increases production of HDL, or "good cholesterol", which reduces LDL thought to be correlated to heart disease, was cancelled in December 2006. During a Phase III clinical trial involving 15,000 patients there were more deaths than expected in the group that took the medicine, and a 60% increase in deaths was seen among patients taking torcetrapib plus Lipitor versus Lipitor alone. There was no suggestion these results called into question the safety of Lipitor. Pfizer lost nearly $1 billion invested developing the failed drug, and the market value of the company plummeted in the aftermath.

Pharmaceuticals

The following is a list of key prescription pharmaceutical products. The names shown are all registered trademarks of Pfizer Inc.



Animal health brands

The following is a partial list of Animal Health brands manufactured by Pfizer:



Legislation and litigation

Pfizer is party to a number of suits stemming from companies it has acquired or merged with, including asbestos litigation as well as litigation stemming from its medicinal products.

Kelo case

Pfizer's interest in obtaining property in New Londonmarker, Connecticutmarker, for expanded facilities led to the Kelo v.marker New Londonmarker case before the U.S.marker Supreme Courtmarker.

The Supreme Court's 2005 decision in Kelo v. City of New London handed local governments the right to seize private property for economic development, i. e.,offices, a hotel to enhance Pfizer Inc.'s nearby corporate facility. Now Pfizer has announced it will close its research and development headquarters in New London, Connecticut.

Quigley Co.

Pfizer acquired Quigley in 1968, and the division sold asbestos-containing insulation products until the early 1970s. Asbestos victims and Pfizer have been negotiating a settlement deal which calls for Pfizer to pay $430 million to 80 percent of existing plaintiffs. It will also place an additional $535 million into an asbestos settlement trust that will compensate future plaintiffs as well as the remaining 20 percent of current plaintiffs with claims against Pfizer and Quigley. The compensation deal is worth $965 million all up. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million will come from insurance policies.

Bjork-Shiley heart valve

Pfizer purchased Shiley in 1979 at the onset of its Convexo-Concave valve ordeal, involving the Bjork-Shiley heart valve. Approximately 500 people died when defective valves failed and, in 1994, the United Statesmarker ruled against Pfizer for ~$200 million.

Tort reform legislation contributions

Pfizer proposed a ban on all lawsuits against manufacturers of body implant parts which was proposed in the United States Congress as part of tort reform legislation.

Off-label promotional practices

Access to pharmaceutical industry documents has revealed marketing strategies used to promote Neurontin for off-label use. In 1993, the US Food and Drug Administration (FDA) approved gabapentin (Neurontin, Pfizer) only for treatment of seizures. Warner-Lambert, which merged with Pfizer in 2000, used activities not usually associated with sales promotion, including continuing medical education and research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within 5 years the drug was being widely used for the off-label treatment of pain and psychiatric conditions. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses, and paid $430 million to resolve criminal and civil health care liability charges. Today it is a mainstay drug for migraines, even though it was not approved for such use in 2004.

Bextra Settlement of Off-Label Marketing Investigation

In September 2009, the United States Department of Justicemarker announced that Pfizer had agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed four drugs: Bextra, Geodon, Zyvox, and Lyrica "with the intent to defraud or mislead" by promoting the drugs for non-approved uses; this marks Pfizer's fourth such settlement in a decade. Pharmacia & Upjohn Company, Inc., a Pfizer subsidiary, agreed to plead guilty to mis-branded promotion of Bextra, a felony violation of the Food, Drug and Cosmetic Act. The criminal fine accounts for $1.3 billion of the settlement, and is the largest criminal penalty ever imposed by the United States. Pfizer has entered an extensive corporate integrity agreement (CIA) with the Office of Inspector General and will be required to make substantial structural reforms within the company, and maintain the Pfizer website (www.pfizer.com/pmc) to track the company's post marketing commitments. Pfizer must also put a searchable database of all payments to physicians the company has made on the Pfizer website by March 31, 2010. In addition, two former employees were separately indicted and sentenced for their role in marketing of Bextra. A former District Sales manager was found guilty of obstruction of justice for destroying documents pertinent to the investigation, and a Regional Sales Manager pled guilty to the distribution of a mis-branded product.

The case is the largest civil settlement against a pharmaceutical company as well. Pfizer paid a $1 billion civil fine to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration and caused false claims to be submitted to Federal and State programs including but not limited to Medicare and Medicaid. Under the False Claims Act, damages can be assessed for violations of the federal Anti-Kickback statute, 42 U.S.C. § 1320a-7b(b) and the off-label marketing provision within the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§301-97. Six whistle-blowers will receive $102 million for their participation in the civil investigation, and John Kopchinski, a former sales representative, will receive $51.5 million for his allegations involving the marketing of Bextra.

Nigeria

In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to assist in treating the affected population. An experimental antibiotic, trovafloxacin, was administered to approximately 200 children. Local Kano officials report that more than 50 children died from infection, while many others developed mental and physical deformities. In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment. According to the lawsuits, Pfizer administered the trovafloxacin (now marketed as Trovan) without parental consent. The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee; the Nigerian government claims it is a fake.

In 2007, Pfizer published a Statement of Defense letter. The letter makes several claims which deserve mention:

18 million in Nigerian Naira (NGN) in donations.
The figure in NGN is approximately $216,000 in 1996 US dollars (USD).

The drug's oral form was presented as safer and easier to administer.
The more likely reason for Pfizer's insistence on the oral form is the result of testing trovafloxacin intravenously in 1995, which found that the drug precipitated in saline, making it ineffective in patients receiving IV fluids. This is inferred from an FDA communication to ex-CEO William C. Steere, regarding Trovan's compatibility with saline etc., which was omitted from Trovan's labeling until January 1999.

The administration of Trovan saved lives.
According to the figures given by their own defense, 94.4% of patients receiving Trovan survived, while only 89.3% of untreated Nigerians survived. This is not a statistically significant difference, i.e. the success of the drug was negligible and possibly circumstantial.

No unusual side effects, unrelated to meningitis, were observed after 4 weeks.
In June 1999, the FDA released a public health statement warning against the use of Trovan except in life-or-death situations, due to high risk of liver failure. In some cases, liver damage occurred after only two days of treatment.

Research and development

Pfizer's human research and development organization is headquartered in New London, CT while their animal health research and development organization is headquartered in Kalamazoomarker, Michiganmarker. The company has R&D labs in the following locations:Grotonmarker, Connecticutmarker;Sandwichmarker, Englandmarker;La Jollamarker, Californiamarker;Cambridgemarker, Massachusettsmarker;Kalamazoomarker, Michiganmarker;St. Louismarker, Missourimarker. In La Jolla, Pfizer has 1,000 people with plans to create cancer drugs, a departure from the company's cardiovascular specialties.

Spending $8.1 billion in research & development (R&D) in 2007, Pfizer has the industry's largest pharmaceutical R&D organization: Pfizer Global Research and Development.

In 2007, Pfizer announced plans to close or sell on the Loughbeg API facility, located at Loughbeg, Ringaskiddy Co.Cork Ireland by mid to end of 2008

In 2007, Pfizer announced plans to completely close the Ann Arbor, Nagoya and Amboise Research facilities by the end of 2008, eliminating 2,160 jobs and idling the $300-million dollar Michigan facility, which had seen millions of dollars of expansion in recent years.

On June 18, 2007 Pfizer announced it will move the Sandwich, Englandmarker Animal Health Research (VMRD) division to Kalamazoo, Michiganmarker.

Pipeline:



Environmental record

According to the EPA, Pfizer is among the top ten companies in America with the most numerous emissions sources. A landfill and two wastewater lagoons in Ledyard, CT near the Pfizer plant in Groton, Connecticut, are a source of groundwater pollution in the area. According to the Connecticut Department of Environmental Protection (CT DEP), the Pfizer site is active under the CT DEP Site Remediation program. In June 2002, a chemical explosion at the Groton plant injured seven people and caused the evacuation of over 100 homes in the surrounding area.

Pfizer has provided funding to the Competitive Enterprise Institute

Employment and diversity

Pfizer received a 100% rating on the Corporate Equality Index released by the Human Rights Campaign starting in 2004, the third year of the report. In 2007, Pfizer's Canadian division was named one of Canada's Top 100 Employers, as published in Maclean's magazine, the only research-based pharmaceutical company to receive this honor. In 2008, there was controversy, including inquiries from members of Congress, around Pfizer's practice of replacing US workers with H-1b guest workers

AIDS involvement

Pfizer has been involved in controversies over the medicine Diflucan (generic name fluconazole). In 1998, a campaign by Thai public health groups led to the elimination of the Pfizer monopoly on selling fluconazole in Thailand, and the price of the antifungal drug decreased from 200 baht to 6.5 baht in nine months, vastly expanding access to the medicine for AIDS patients. Faced with pressure for compulsory licenses to the Pfizer patent on this drug, Pfizer later established a program for limited access to the medicine in Africa.

"In the United States, 46 percent of all new HIV/AIDS cases occur in the South. From 2003–2006 the Pfizer Foundation has funded 23 innovative HIV/AIDS prevention programs and strengthened the capacity of community-based organizations to reach and serve their communities." Since 2003, Pfizer has committed a $3 Million grant toward supporting the Southern HIV/AIDS Prevention Initiative.

However, there are criticisms of the way Pfizer is testing its AIDS drug. "The European AIDS Treatment Group (EATG), collection of activists from 31 European Countries, said the design of the trial for Pfizer's CCR5 inhibitor Maraviroc (previously known as UK-427,857) is putting people with HIV infection at unnecessary risk of developing AIDS."

On June 20, 2007, Maraviroc received an approvable letter from the FDA advisory board. The letter was a product of expedited review of the novel HIV compound.

In 2001, Pfizer asked the U.S. government to pressure the Brazilian government against issuing compulsory licenses for the patents on the AIDS drug nelfinavir.

AIDS drugs manufactured by Pfizer



See also



Notes and references

Notes




External links




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