Pfizer Inc. (Pfizer), incorporated on June 2, 1942, is a research-based global biopharmaceutical company. The Company is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio includes medicines and vaccines, as well as consumer healthcare products. The Company manages its commercial operations through two business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients' lives, as well as products for consumer healthcare. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology, rare diseases and consumer healthcare. EH includes legacy brands, branded generics, generic sterile injectable products, biosimilars and infusion systems. EH also includes a research and development (R&D) organization, as well as its contract manufacturing business. As of December 31, 2016, the Company sold its products in over 125 countries. On December 19, 2018, Pfizer announced a joint merger of their consumer healthcare division with UK pharma giant GlaxoSmithKline; the British company will maintain a controlling share (listed at 68%). 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.
Pfizer’s Drug Safety R&D group develops and applies the skills, experience and scientific tools necessary for safety assessment and risk management of targets and compounds across the research, development and commercial phases of drug development. We seek to enhance our capabilities for target safety assessment, selection of safer compounds, toxicity risk management and translation of preclinical models. <reference/https://www.pfizer.com/partnering/areas_of_interest/drug_safety/>
|Type||Public / Private|
Pfizer is named after German-American Charles Pfizer who co-founded the company with his cousin Charles F. Erhart. Originally from Ludwigsburg, Germany, they launched a chemicals business, Charles Pfizer and Company, from a building at the intersection of Harrison Avenue and Bartlett Street in Williamsburg, Brooklyn, in 1849. Their first product is a palatable form of santonin — an antiparasitic used to treat intestinal worms, a common affliction in mid-19th century America. Combining their skills, Pfizer, a chemist, and Erhart, a confectioner, blend santonin with almond-toffee flavoring and shape it into a candy cone. 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. Pfizer's original administrative headquarters was at 81 Maiden Lane in Manhattan.
After its launch in 1849, Pfizer grew during the Civil War selling painkillers, preservatives, disinfectants and solutions like iodine, morphine, chloroform, camphor and mercurial. As the company expanded, the headquarters moved to Manhattan in 1868, and a warehouse opened in Chicago in 1882. The company’s next major discovery was pioneering the mass production of citric acid, which is used in Coca-Cola, Dr. Pepper and Pepsi. This became their mainstay for many years, laying the basis for their continued growth. Also, when supply of tartaric acid was disrupted due to the civil war and increased tariffs, Pfizer developed its production to become the leading supplier of chemicals in the US. Pfizer’s studies of citric acid and fermentation technology later would assist the company in penicillin production.
By the 20th century, Pfizer had established itself as an industry leader. It celebrated its 50th anniversary and continued to increase profits, exceeding sales of $3 million in 1906. In 1941, Pfizer began mass production of penicillin, responding to the U. S. government’s request to provide World War II soldiers with the new antibiotic. By taking an active role in dispersing this antibiotic, Pfizer cemented its place in medical history.
Another major discovery for Pfizer around this time was a fermentation-free method of producing vitamin C. Researchers noted that the vitamin could be used as a defense against scurvy and the common cold. Pfizer built a new plant dedicated to nonstop production and quickly became the world’s top producer of vitamin C.
Pfizer in India
Pfizer came to India in 1950 through a company named Dumex. Its first production unit was set up at Darukhanna in Mumbai. It manufactured products like Protinex, Isonex, Becosules and Corex.In the year 1960, the company set up one more plant at Thane, near Mumbai for manufacturing and conducting product research. In 1965 Pfizer entered into a licence agreement with Pfizer Corporation for the use of Pfizer?s processes, technical know–how, etc to manufacture its existing products. Later in the year 1992, Dumex was amalgamated with Pfizer. In India, Pfizer instituted the first ever Disease Management Programme –– Healthy Heart in Cardio Vascular Disease (Hypertension, Chronic Stable Angina and Dyslipidemia), in partnership with Apollo Hospital, Hyderabad and Apollo Hospital, Chennai Six Pfizer brands feature among the Top 100 pharmaceutical brands in India, while two of Pfizer India's brands –– Corex (Cough Formulation) and Becosules (Multivitamin) –– continue to rank among the Top 15 pharmaceutical drug brands The company?s manufacturing plant was ISO 14001 certified for its Environment Management System awarded by DNV Certification B.V, Netherlands. In 2013 Pfizer Ltd and Wyeth Ltd decided to merge, creating a single Pfizer Brand. Pfizer Limited has a turnover of Rs. 1827.74 crores for the year ended March 31, 2015. The company was awarded the FICCI SEDF (Socio Economic Development Foundation) Certificate of Commendation for its social responsibility efforts. Pfizer has won several awards including that for the multinational pharmaceutical company of the year and the most respected MNC.
The Company's IH brands include Prevnar 13, Xeljanz, Eliquis, Lyrica (the United States, Japan and certain other markets), Enbrel (outside the United States and Canada), Viagra (the United States and Canada), Ibrance, Xtandi and various over-the-counter (OTC) consumer products (Advil and Centrum). Its EH brands include Lipitor, Premarin family, Norvasc, Lyrica (Europe, Russia, Turkey, Israel and Central Asia countries), Celebrex, Pristiq and various sterile injectable products. Its Internal Medicine products include Lyrica (outside all of Europe, Russia, Turkey, Israel and Central Asia countries), Viagra (United States and Canada), Chantix/Champix and Eliquis. Its vaccine products include Prevnar 13/Prevenar 13. Its oncology products include Ibrance, Sutent, Xalkori, Inlyta and Xtandi. Its inflammation and immunology products include Enbrel (outside the United States and Canada) and Xeljanz. Its rare diseases products include BeneFix, Genotropin, and Refacto AF/Xyntha.
The Company's categories and product lines in its consumer healthcare business include dietary supplements, such as Centrum brands (including Centrum, Centrum Silver, Centrum Men's and Women's, Centrum MultiGummies, Centrum VitaMints, Centrum Specialist, Centrum Flavor Burst and Centrum Kids), Caltrate and Emergen-C; pain management, such as Advil brands (including Advil, Advil PM, Advil Liqui-Gels, Advil Film Coated, Advil Menstrual Pain, Children's Advil, Infants' Advil and Advil Migraine) and ThermaCare; gastrointestinal, such as Nexium 24HR/Nexium Control and Preparation H, and respiratory and personal care, such as Robitussin, Advil Cold and Sinus, Advil Sinus Congestion and Pain, Dimetapp and ChapStick.
The Company's Legacy Established Products include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri- Loss of Exclusivity (LOE) Products), and Peri-LOE Products primarily include Lyrica in certain developed Europe markets, Pristiq globally, Celebrex, Zyvox and Revatio; Vfend and Viagra in certain developed Europe markets and Japan, and Inspra in the European Union (EU). Its Sterile Injectable Pharmaceuticals include generic injectables and specialty injectables (excluding Peri-LOE Products). Its Infusion Systems include Medication Management Systems products composed of infusion pumps and related software and services, as well as intravenous infusion products, including large volume intravenous solutions and their associated administration sets. As of December 31, 2016, the Company had 96 projects in clinical research and development.
The Company's Biosimilars include Inflectra/Remsima (biosimilar infliximab) in the United States and certain international markets, Nivestim (biosimilar filgrastim) in certain European, Asian and Africa/Middle East markets, and Retacrit (biosimilar epoetin zeta) in certain European and Africa/Middle East markets. Its Pfizer CentreOne includes revenues from legacy Pfizer's contract manufacturing and active pharmaceutical ingredient sales operation, including revenues related to its manufacturing and supply agreements with Zoetis Inc., and revenues from legacy Hospira, Inc.'s One-2-One sterile injectables contract manufacturing operation.
Amid its successes, Pfizer faced a growing number of scandals involving some of its most popular drugs. Pfizer has agreed to multiple settlements over charges of illegal marketing.
In 2002, Pfizer paid a $49 million fine based on claims that it defrauded the Medicaid program and overcharged consumers for Lipitor. Other settlements varied in size — the Neurontin settlement in 2004 cost $430 million, and Detrol in 2011 cost $14.5 million.
In 2009, the company paid $2.3 billion to settle civil and criminal allegations and setting a record at the time for the largest health-care fraud settlement and the largest criminal fine of any kind. Pfizer drugs involved in the historic settlement include Bextra, Geodon, Zyvox and Lyrica.
The U.S. Department of Justice (DOJ) filed the criminal charges because of Pfizer’s marketing for Bextra. Although the FDA only approved the drug for arthritis and menstrual cramps, Pfizer reportedly told sales representatives to tell doctors it could be used for unapproved indications, like acute pain and surgical pain, and that it could be taken in high doses. However, the drug came with serious heart and skin risks, which caused Pfizer to withdraw it in 2005 and face a criminal investigation for misbranding the drug.
In 2012, it paid $164 million to settle a lawsuit that claimed it misled investors about the clinical results of Celebrex, used to treat arthritis. A month after that case was finalized, Pfizer settled a class action lawsuit filed by investors claiming they were misled about the risks associated with the antidepressant drug Pristiq. The Pristiq case cost the company $67.5 million.
In 2016, Wyeth and Pfizer agreed to pay $784.6 million to settle allegations that Wyeth knowingly underpaid drug rebates to Medicaid. Wyeth reported false prices to the government for Protonix Oral and Protonix IV, according to the DOJ.
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|September 3rd, 2019||@Pfizer||https://twitter.com/pfizer/status/1168959845409742848?s=20|
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|September 2nd, 2019||@PatientSafe3||https://twitter.com/patientsafe3/status/1168445269794545664?s=20|
Top 5 Recent News Headlines
Pfizer Inc. PFE announced that the FDA has approved a label expansion for its janus kinase (JAK) inhibitor, Xeljanz (tofacitinib), for two doses - 5 mg twice daily and 11 mg once-daily extended-release (XR) formulation.
With this latest approval, Xeljanz can now be administered for treating adult patients with active psoriatic arthritis (PsA), who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and tumor necrosis factor inhibitors, respectively.
Notably, Xeljanz (5 mg twice daily) is approved in the United States as a second-line treatment option for patients with moderate-to-severely active rheumatoid arthritis ("RA"), who have had an inadequate response to or cannot tolerate methotrexate (MTX). The drug was approved in Europe and China in March for RA. Significantly, this is the first and only JAK inhibitor approved in the United States for both moderate to severe RA and an active PsA.
The approval was based on encouraging data from two phase III OPAL (Oral Psoriatic Arthritis TriaL) studies - Broaden and Beyond - on Xeljanz.
Both OPAL Broaden and OPAL Beyond trials evaluated the efficacy and safety of Xeljanz on adult patients with PsA. The programs achieved the primary efficacy endpoint of a statistically significant improvement with twice-daily Xeljanz 5 mg compared with placebo at three months as per measurement by American College of Rheumatology 20 response and the change from baseline in the Health Assessment Questionnaire Disability Index score.
Overall safety results from these studies were found to be consistent with those observed in the broader rheumatology development program for Xeljanz.
We remind investors that the company is also looking to get the drug's label expanded to include treatment of adult patients suffering from moderate-to-severe active ulcerative colitis. A response from the FDA is expected in March next year.
Additionally, Pfizer is conducting a phase IIIb/IV head-to-head study comparing Xeljanz with AbbVie's ABBV Humira. In February, the company announced top-line results from the assessment. Outcomes from the trial demonstrated non-inferiority of combo therapy comprising Xeljanz plus MTX compared with the other combo agents Humira plus MTX, thus meeting the primary endpoint.
We are interested in establishing alliances to develop and access:
- Mechanisms, translatable and monitorable biomarkers, and screening approaches related to target organ toxicity
- Cardiovascular safety including vascular injury and early detection of cardiotoxicity
- CNS biomarkers including peripheral neuropathy
- Liver injury in particular immune-mediated DILI and transporters
- Immunostimulation, including hypersensitivity, autoimmunity, cytokine release
- Nephrotoxicity – glomerular and tubular
- Skeletal and cardiac muscle toxicity
- Pancreatic toxicity
- Ocular safety
- Screening for abuse potential
- Animal models, biomarkers and screening approaches for preclinical immuno-oncology investigation, supporting mono- and combination-therapy approaches (interpretation and translatability)
- Immune system components and responses comparability between preclinical species and human
- Biotherapeutics-related analytical technologies
- Immunogenicity and other safety-relevant assays
- Assays related to aggregation, subvisible particles
- 3D and complex models including stem cell approaches and microfluidics
- Deeper knowledge of targets and pathways
- Knock-in, knock-out technologies
- Novel technologies and increased throughput for target localization studies
- Novel technologies and increased throughput for target localization studies
- Safety biomarker technologies/enablers
- Emerging platforms, including miRNA-based multiplex; analytical approaches
- Academic collaborations to leverage annotated biofluid collections to understand target organ toxicities and enable clinical translation
- Advancing Regulatory Science
- Systems pharmacology approaches for prediction of adverse events
- Novel in silico modelling approaches for pro-arrhythmia detection
Top 5 Lifetime Tweets
1- ❃ Kassandra Seven ❃
@KassandraSeven Aug 9
These are some Laura Ingraham /@IngrahamAngle sponsors. I have them tagged so they will get notifications everytime you LIKE and RETWEET @Applebees @BASF @Bayer @Cabelas @redlobster @Procter_NGamble @CapitalOne @Dell @Ford @Novartis @ODFL_Inc @pfizer @SERVPRO @STIHLUSA @USAA
@OzzieChambers Aug 9
$atrs Interesting thought. Rumors are that Mylan is putting itself up for sale, Epi-pen shortages, Pfizer makes a deal with ATRS. Maybe ATRS is in the crosshairs of something big.
@Toekomst4 Aug 12
#Monsanto #Bayer #Wyeth #Pfizer, World health with #Roundup, #Hormonen, #17betaoestradiol We go to European Court of Human Rights. . (#EHRM, #ECHR) To much off people have #kanker, #diabetes and more danger to #health. Transparancy #FOODSAFETY are not in the Netherlands. !
4- Tony Barrett
Verified account @TonyBarrett Aug 10
Tony Barrett Retweeted Pelé
Always knew Pfizer was good stuff.
5- Gerald L. Maatman, J
@g_maatman 5m5 minutes ago
Illinois federal judge rejects pharmaceutical company's attempt to dismiss a large consumer #classaction via @CookRecord
Top 5 Lifetime News Headlines