Pfizer

Charles Pfizer (1824–1906)

Charles Pfizer and his cousin Charles F. Erhart, both of German descent, founded Pfizer in New York City in 1849. They launched the chemicals business, Charles Pfizer and Company, at Bartlett Street[11] in Williamsburg, Brooklyn, where they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that led to Pfizer's growth in the 1880s. Pfizer continued to buy property to expand its lab and factory. Pfizer's original administrative headquarters was at 81 Maiden Lane in Manhattan.[11] By 1906, sales totaled $3.4 million.[12]

World War I caused a shortage of calcium citrate, which 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 they were able to commercialize production of citric acid from this source in 1919. The company developed expertise in fermentation technology as a result. These skills were applied to the mass production of the antibiotic penicillin during World War II in response to the need to treat injured Allied soldiers. "Pfizer, succeeded in producing large quantities of penicillin using deep-tank fermentation. Its success helped make penicillin available to Allied soldiers by the end of the war."[13]

Penicillin became very inexpensive in the 1940s, and Pfizer searched for new antibiotics with greater profit potential. They discovered Terramycin (oxytetracycline) in 1950, and this changed the company from a manufacturer of fine chemicals to a research-based pharmaceutical company. Pfizer developed a drug discovery program focused on in vitro synthesis in order to augment its research in fermentation technology. The company also established an animal health division in 1959 with a 700-acre (2.8 km²) farm and research facility in Terre Haute, Indiana.

By the 1950s, Pfizer had established offices in Belgium, Brazil, Canada, Cuba, Mexico, Panama, Puerto Rico, and the United Kingdom. In 1960, the company moved its medical research laboratory operations out of New York City to a new facility in Groton, Connecticut. In 1980, they launched Feldene (piroxicam), a prescription anti-inflammatory medication that became Pfizer's first product to reach one billion dollars in total sales.[14] During the 1980s and 1990s, Pfizer Corporation growth was sustained by the discovery and marketing of Zoloft, Lipitor, Norvasc, Zithromax, Aricept, Diflucan, and Viagra.[15][16]

Pfizer logo from 1990 to 2009

In this decade, Pfizer grew by mergers, including those with Warner–Lambert (2000),[17] Pharmacia (2003),[18] and Wyeth (2009).[19]

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, more deaths occurred in the group that took the medicine than expected, and a sixty percent increase in mortality was seen among patients taking the combination of torcetrapib and Lipitor versus Lipitor alone. Lipitor alone was not implicated in the results, but Pfizer lost nearly $1 billion developing the failed drug and the market value of the company plummeted afterwards.[20][21][22] That same year, the company also announced it would acquire PowerMed and Rivax.[23]

In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the U.S. Food and Drug Administration (FDA), and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time.[24]

A July 2010 article in BusinessWeek, reported that Pfizer was seeing more success in its battle against makers of counterfeit prescription drugs by pursuing civil lawsuits rather than criminal prosecution. Pfizer has hired customs and narcotics experts from all over the globe to track down fakes and assemble evidence that can be used to pursue civil suits for trademark infringement. Since 2007, Pfizer has spent $3.3 million on investigations and legal fees and recovered about $5.1 million, with another $5 million tied up in ongoing cases.[25]

Pfizer acquired Warner–Lambert in 2000 for $111.8 billion.[26] This created what was, at the time, the second-largest pharmaceutical company in the world.[27] Warner–Lambert was founded as a Philadelphia drug store in 1856 by William R. Warner. Inventing a tablet-coating process gained Warner a place in the Smithsonian Institution. Parke–Davis was founded in Detroit in 1866 by Hervey Parke and George Davis. Warner–Lambert took over Parke–Davis in 1976, and acquired Wilkinson Sword in 1993, and Agouron Pharmaceuticals in 1999.

In 2003, Pfizer merged with Pharmacia.[18]

The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Kalamazoo, Michigan, by Dr. William E. Upjohn. The company was originally formed to make friable pills, which were designed to be easily digested. Greenstone was founded in 1993 by Upjohn, as a generics division.[28] 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-Gladstone, New Jersey. The agricultural division was spun off from Pharmacia, as Monsanto, in preparation for the close of the acquisition by Pfizer.[29]

SUGEN, a company focused on protein kinase inhibitors, was founded in 1991 in Redwood City, California, and acquired by Pharmacia in 1999. The company pioneered the use of ATP-mimetic small molecules to block signal transduction. After the Pfizer merger, the SUGEN site was shut down in 2003, with the loss of over 300 jobs, and several programs were transferred to Pfizer. These included sunitinib (Sutent), which was approved for human use by the FDA in January 2006, passed $1 billion in annual revenues for Pfizer in 2010.[30] A related compound, SU11654 (Toceranib), was also approved for canine tumors, and the ALK inhibitor Crizotinib also grew out of a SUGEN program.[31]

In 2003, the new Pfizer made Greenstone (originally established as a division of Upjohn) its generic division, and focused on selling authorized generics of Pfizer's products.[28][32]

In 2008, Pfizer announced 275 job cuts at the Kalamazoo manufacturing facility. Kalamazoo was previously the world headquarters for the Upjohn Company.[33]

Pfizer logo from 2009 to 2021

On January 26, 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 cemented Pfizer's position as the largest pharmaceutical company in the world, with the merged company generating over US$20 billion in cash each year, and was the largest corporate merger since AT&T and BellSouth's US$70 billion deal in March 2006.[34] The combined company was expected to save US$4 billion annually through streamlining; 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.[35]

The merger was broadly criticized. Harvard Business School'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."[36] Analysts said at the time, "The Warner–Lambert and Pharmacia mergers do not appear to have achieved gains for shareholders, so it is unclear who benefits from the Wyeth–Pfizer merger to many critics."[37]

In October 2010, Pfizer agreed to buy King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King's closing share price October 11, 2010.[38]

In February 2011, it was announced that Pfizer was to close its UK research and development facility (formerly also a manufacturing plant) in Sandwich, Kent, which at the time employed 2,400 people.[39] However, as of 2014, Pfizer has a reduced presence at the site;[40] it also has a UK research unit in Cambridge.[41]

On September 4, 2012, the FDA approved a Pfizer pill for a rare type of leukemia. The medicine, called Bosulif, treats chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.[42]

In July 2014, the company announced it would acquire Innopharma for $225 million, plus up to $135 million in milestone payments, in a deal that expanded Pfizer's range of generic and injectable drugs.[43]

On January 5, 2015, the company announced it would acquire a controlling interest in Redvax for an undisclosed sum. This deal expanded the company's vaccine portfolio targeting human cytomegalovirus.[44] In March 2015, the company announced it would restart its collaboration with Eli Lilly surrounding the phase III trial of Tanezumab. Pfizer is expected to receive an upfront sum of $200 million.[45] In June 2015, the company acquired two meningitis drugs from GlaxoSmithKline—Nimenrix and Mencevax—for around $130 million, expanding the company's meningococcal disease portfolio of drugs.[46]

In May 2016, the company announced it would acquire Anacor Pharmaceuticals for $5.2 billion, expanding the company's portfolio in both inflammation and immunology drugs areas.[47] On their final trading day, Anacor shares traded for $99.20 each, giving Anacor a market capitalisation of $4.5 billion. In August, the company made a $40 million bid for the assets of the now bankrupt BIND Therapeutics through the U.S. Bankruptcy Court.[48] The same month, the company announced it would acquire Bamboo Therapeutics for $645 million, expanding the company's gene therapy offerings.[49] Later, in August, the company announced the acquisition of cancer drug-maker – Medivation – for $14 billion.[50][51] On Medivation's final day of trading, its shares were valued at $81.44 each, giving an effective market capitalisation of $13.52 billion. Two days later, Pfizer announced it would acquire AstraZeneca's small-molecule antibiotics business for $1.575 billion[52] merging it into its Essential Medicines business[53] In the same month the company licensed the anti-CTLA4 monoclonal antibody, ONC-392, from OncoImmune.[54]

In May 2019, the company announced it would acquire Therachon for $810 million, expanding its rare disease portfolio through Therachon's recombinant human fibroblast growth factor receptor 3 compound, aimed at treating conditions such as achondroplasia.[55] In June, Pfizer announced it would acquire Array Biopharma for $10.6 billion boosting its oncology pipeline.[56]

In September 2020, the company announced it had purchased a 9.9% stake in CStone Pharmaceuticals for $200 million (HK$1.55 billion), helping to commercialise its anti-PD-L1 monoclonal antibody, CS1001.[57] In October, Pfizer announced it had acquired Arixa Pharmaceuticals.[58]

Plans to spin out Zoetis, the Agriculture Division of Pfizer and later Pfizer Animal Health, were announced in 2012. Pfizer filed for registration of a Class A stock with the U.S. Securities and Exchange Commission on August 13, 2012.[59] Zoetis's IPO on February 1, 2013, sold 86.1 million shares for US$2.2 billion.[60] Pfizer retained 414 million Class B shares, giving it an 83% controlling stake in the firm.[61] The offering's lead underwriters were JPMorgan Chase, Bank of America, Merrill Lynch, and Morgan Stanley.[60] Most of the money raised through the IPO was used to pay off existing Pfizer debt.[62]

In February 2015, Pfizer and Hospira agreed that Pfizer would acquire Hospira for $15.2 billion,[63] a deal in which Hospira shareholders would receive $90 in cash for each share they owned.[64][65] News of the deal sent Hospira share prices up from $63.43 to $87.43 on a volume of 60.7 million shares.[66] Including debt, the deal is valued at around $17 billion.[63] Hospira is the largest producer of generic injectable pharmaceuticals in the world.[67] On the final day of trading, Hospira shares traded for $89.96 each, giving a market capitalization of $15.56 billion.

On November 23, 2015, Pfizer and Allergan, plc announced their intention to merge for an approximate sum of $160 billion, making it the largest pharmaceutical deal ever, and the third largest corporate merger in history. As part of the deal, the Pfizer CEO, Ian Read, was to remain as CEO and chairman of the new company, to be called "Pfizer plc", with Allergan's CEO, Brent Saunders, becoming president and chief operating officer. As part of the deal, Allergan shareholders would receive 11.3 shares of the company, with Pfizer shareholders receiving one. The terms proposed that the merged company would maintain Allergan's Irish domicile, resulting in the new company being subject to corporation tax at the Irish rate of 12.5%--considerably lower than the 35% rate that Pfizer paid at the time.[68] The deal was to constitute a reverse merger, whereby Allergan acquired Pfizer, with the new company then changing its name to "Pfizer, plc".[69][70] The deal was expected to be completed in the second half of 2016, subject to certain conditions: US and EU approval, approval from both sets of shareholders, and the completion of Allergan's divestiture of its generics division to Teva Pharmaceuticals (expected in the first quarter of 2016).[69] On April 6, 2016, Pfizer and Allergan announced they would be calling off the merger after the Obama administration introduced new laws intended to limit corporate tax inversions (the extent to which companies could move their headquarters overseas in order to reduce the amount of taxes they pay).[71]

In October 2017, reports emerged that Pfizer was undertaking a strategic review of its consumer healthcare division, with possible results ranging from a partial or complete spin-off or a direct sale.[72] The divestment was expected to raise approximately $15 billion.[73] Reckitt Benckiser expressed interest in bidding for the division earlier in October[74] with Sanofi, Johnson & Johnson, Procter & Gamble[75] and GlaxoSmithKline also being linked with bids for the business.[76] On March 22, Reckitt Benckiser pulled out of the deal, a day later GlaxoSmithKline also pulled out.[77]

In December 2018, GlaxoSmithKline announced that it, along with Pfizer, had reached an agreement to merge and combine their consumer healthcare divisions into a single entity. The combined entity would have sales of around £9.8 billon ($12.7 billion), with GSK maintaining a 68% controlling stake in the joint venture. Pfizer would own the remaining 32% shareholding. The deal builds on an earlier 2018 deal where GSK bought out Novartis' stake in the GSK-Novartis consumer healthcare joint business.[78][79] The transaction closed in August 2019 and gives GSK three years to publicly list the business in the UK.[80]

In July 2019, Pfizer announced that it would merge its off-patent branded and generic established medicines business, known as Upjohn, with Mylan. The transaction created a new company, Viatris, using a reverse Morris trust structure.[81] The new business will trade on the NASDAQ stock exchange under the ticker NASDAQ: VTRS.[81] Pfizer shareholders would own 57% of the new combined business. The Board of Viatris will be composed of Robert J. Coury as Executive Chairman, Michael Goettler as CEO, eight people chosen by Mylan and three chosen by Pfizer. In December 2019, Pfizer chose former CEO and Chairman, Ian Read and Director of Pfizer, James Kilts. In February 2020, Pfizer announced W. Don Cornwell and their final Board selection with Mylan selecting JoEllen Lyons Dillon, Neil Dimick, Melina Higgins, Harry A. Korman, Rajiv Malik, Richard A. Mark, Mark W. Parrish and Pauline van der Meer Mohr as their Board nominees – all directors of Mylan.[81]

In October 2020, the US Federal Trade Commission approved the combination.[82]

Pfizer–BioNTech COVID-19 vaccine

In May 2020, Pfizer began testing four different COVID-19 vaccine variations. It planned to expand human trials to thousands of test patients by September 2020. The pharma company injected doses of the potential vaccine BNT162b2, which was developed by the German biotechnology company BioNTech, and into the first human participants in the U.S. in early May. Based on the results, Pfizer said they "will be able to deliver millions of doses in the October time frame" and expects to produce hundreds of millions of doses in 2021.[83]

In July 2020, Pfizer and BioNTech announced that two of the partners' four mRNA vaccine candidates had won fast track designation from the FDA.[84][85] The company began Phase III testing in the last week of July 2020, on 30,000 people and was slated to be paid $1.95 billion for 100 million doses of the vaccine by the United States government.[86] The U.S. deal priced two doses at $39 and the company stated that it would not lower the rates for other countries until the outbreak is no longer a pandemic.[87] Pfizer's CEO stated the companies in the private sector producing a vaccine should make a profit.[88]

In September 2020, Pfizer and BioNTech announced that they had completed talks with the European Commission to provide an initial 200 million vaccine doses to the EU, with the option to supply another 100 million doses at a later date.[89][90]

In October 2020, it was reported that Pfizer would start testing the COVID-19 vaccine developed by BioNTech on a broader range of subjects including children as young as 12. This would be the first coronavirus vaccine trial to include children in the United States.[91]

On November 9, 2020, Pfizer announced that the vaccine had a nearly 95% efficacy rate with no serious side effects.[92] On November 20, 2020, Pfizer applied for Emergency use authorization from the Food and Drug Administration for the vaccine.[93] On December 2, 2020, the United Kingdom granted emergency use authorization to Pfizer-BioNTech's vaccine, becoming the first country to approve a COVID-19 vaccine that had been tested in a "large clinical trial" of "43,000 people".[94][95]

On December 4, 2020, Bahrain became the second country to approve emergency use of the Pfizer–BioNTech COVID-19 vaccine for high-risk groups and later announced that the vaccine would be provided free to the public.[96][97]

On December 8, 2020, Britain began initial distribution of the Covid-19 vaccine.[98] On December 9, 2020, British regulators told hospitals not to give the Pfizer–BioNTech COVID-19 vaccine to people prone to "serious" allergic reactions, after two National Health Service staffers had symptoms of "anaphylactoid reaction".[99]

Also on December 9, 2020, Canada became the third country to approve the Pfizer–BioNTech COVID-19 vaccine, initially purchasing 20M doses and preserving the option to purchase up to 56M additional doses. An initial delivery of 249,000 doses was planned for December with up to 4M more doses planned for delivery by March 2021.[100][101]

On December 10, 2020, the United States Food and Drug Administration (FDA) held an advisory committee meeting to discuss authorization of the vaccine.[102] An independent panel voted 17-4 in support of the FDA approving the vaccine.[102] On the same day, Saudi Arabia approved the vaccine, becoming the 4th country to do so.[97] The next day, December 11, 2020, the United States officially became the 5th country to approve use of BioNTech's Covid-19 vaccine.[103] The FDA granted Emergency Use Authorization (EUA) and under the United States agreement with Pfizer, Pfizer agreed to an initial distribution of 2.9 million doses on an immediate basis and 100 million doses through March 2021, with the United States providing the vaccine free to the public.[104] On December 14, 2020, Singapore became one of the first in Asia to approve the vaccine through the Health Sciences Authority.[105]

On December 21, 2020, the European Union European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the vaccine "Comirnaty" developed by BioNTech and Pfizer.[106] On December 27, 2020, the European Union launched a co-ordinate measure to rollout the Pfizer–BioNTech COVID-19 vaccine, which was distributed to all the 27 member states. The top officials of the Union called it a “touching moment of unity”.[107]

Pfizer introduced a new logo in January 5, 2021.[108]

In May 2015, Pfizer and a Bar-Ilan University laboratory announced a partnership based on the development of medical DNA nanotechnology.[110]

Pfizer's research and development activities are organized into two principal groups: the PharmaTherapeutics Research & Development Group, which focuses on the discovery of small molecules and related modalities; and the BioTherapeutics Research & Development Group, which focuses on large-molecule research, including vaccines.[109] In 2007, Pfizer invested $8.1 billion in research and development, the largest R&D investment in the pharmaceutical industry.[111]

In 2018, Pfizer announced that it would end its work on research into treatments for Alzheimer's disease and Parkinsonism (a symptom of Parkinson's disease and other conditions). The company stated that approximately 300 researchers would lose their jobs as a result.[112]

In 2018, Pfizer signed an agreement with the German biotechnology company BioNTech, to conduct joint research and development activities, to further the advance of mRNA-based flu vaccines. Under the agreement, following BioNTech’s completion of a first in-human clinical study, Pfizer would assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines.[113]

In 2020, Pfizer partnered again with BioNTech, to study and develop COVID-19 mRNA vaccine candidates. On July 27, 2020, the companies announced the start of a global (except China) Phase 2/3 safety and efficacy clinical study to evaluate the mRNA vaccine candidate BNT162b2.[114] The companies plan to use Pfizer facilities to manufacture the vaccine if they receive FDA approval.[115][116]

In November 2020, Pfizer announced that BioNTech's COVID-19 vaccine, tested on 43,500 people, was found 90% effective, which was described as a "milestone."[117]

In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children.[171] Local Kano officials reported that more than 50 children died in the experiment, while many others developed mental and physical deformities.[172] The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa.[173] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[174] According to the news program Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[175] 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. While the specific facts of the case remain in dispute, both Nigerian medical personnel and at least one Pfizer physician have stated that the trial was conducted without regulatory approval.[176][177]

In 2007, Pfizer published a Statement of Defense letter.[178] The letter states that the drug's oral form was safer and easier to administer, that Trovan had been used safely in over 5000 Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.

In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[179]

In December 2010, WikiLeaks released US diplomatic cables, which indicate that Pfizer had hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[180] The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail."[175] In response, the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith.[181] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[182] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[183][184]