About
- Merged with Pfizer in 2009. Financial advisors: Morgan Stanley and Evercore Partners. Legal advisor: Simpson Thacher & Bartlett LLP.
- Wyeth Pharmaceuticals: 37 manufacturing facilities in 17 countries and markets products in over 60 nations.
- Deutsche Bank Healthcare Conference (2004, 2006, 2007).
- Goldman Sachs Healthcare Conference (2007, 2008, 2009).
- JP Morgan Healthcare Conference (2005, 2006, 2007, 2008, 2009).
- Citigroup Health Care Conference (2005, 2006, 2007, 2008).
- Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference (2005, 2006, 2007).
- Morgan Stanley Pharmaceutical Unplugged Conference (2005, 2006, 2008).
- Net revenue: $22.8 billion in 2008; $22.4 billion in 2007; $20.4 billion in 2006; $18.8 billion in 2005; $15.9 in 2003; $14.6 in 2002.
- Net income: $4,417.8 million in 2008; $4,810.4 million in 2007; $4,280.8 million in 2006; $3,656.3 million in 2005; $3,258.9 million in 2003; $2,962.6 million in 2002.
Business
1860-1960
- 1860: John Wyeth and his younger brother, Frank, open a retail drugstore with a small research lab in Philadelphia. Both had attended the Philadelphia College of Pharmacy, first school of pharmacy in the U.S. (1822).
- 1862: The Wyeth brothers manufacture medicines in large quantities for doctors and publish their first catalog of drug preparations for wholesale distribution.
- 1864: John Wyeth & Brother supplies medicines and beef extract to the Union Army during the Civil War.
- 1872: Employee Henry Bower develops one of the first rotary compressed tablet machines in the U.S. for mass-producing medicines with unprecedented precision and speed.
- 1876: 4 awards at the U.S. Centennial Exhibition for its compressed pills, pharmaceutical preparations, suppositories, and food for infants and invalids.
- 1883: First foreign facility in Montreal, Canada.
- 1885: Vaccine production begins.
- 1907: John Wyeth dies and his only son Stuart, 1884 Harvard College graduate, becomes President.
- 1926: American Home Products Corporation is founded.
- 1929: Kolynos brand toothpaste becomes a major player in building global sales. Stuart Wyeth dies and leaves controlling interest of John Wyeth & Brother to Harvard University.
- 1930: Anacin (aspirin and caffeine) is purchased and quickly becomes the Company's leading product. Anacin is also one of the earliest and best examples of concerted television marketing campaign.
- 1931: Harvard sells Wyeth to American Home Products for $2.9 million.
- 1935: Alvin G. Brush, Certified Public Accountant, CEO of the entire organization (1935-1965) launches a diversification and acquisition strategy, acquiring 34 new companies in 15 years, including Chef Boy-Ar-Dee and Wizard Inc.
- 1936: Acquisition of a bacterial antigen for arthritis vaccine research.
- 1938: The S.M.A. Corporation, a pharmaceutical firm specializing in innovative infant formulas, is acquired and folded into John Wyeth & Brother.
- 1941: The United States enters War World II and Wyeth ships sulfa drugs (an early bacteriostatic), blood plasma, typhus vaccine, quinine, and atabrine tablets for malaria to the Armed Forces.
- 1942: Wyeth launches penicillin research program with G. Raymond Rettew, founder of the Chester Country Mushroom Laboratories.
- 1943: Army-Navy E Award for contribution to the war effort. Merger with Ayerst, McKenna and Harrison Ltd. of Canada brings with Premarin, world's first conjugated estrogens product. 6 companies are merged into Wyeth Laboratories, bringing Tetanus, typhus, diphtheria, smallpox, and sera vaccines, the Tubex method of allergy treatment, a line of antacids and laxatives, a beef extract called Bovinine, and SMA.
- 1944: One of the 22 companies selected by the government to manufacture penicillin, first for the armed forces and then for the general public.
- 1945: Acquisition of Fort Dodge Serum Company.
- 1951: Antabuse is launched for the treatment of alcoholism and the antihistamine Phenergan (promethazine HCI) is introduced.
- 1952: Ansolyen is launched as a high blood pressure medication.
- 1953: Lederle Japan Ltd., 50-50 joint venture between American Cyanamid Company and Takeda Chemical Industries Ltd.
- 1954: Wyeth supplies polio vaccine for critical Salk trials and subsequently becomes a leading U.S. vaccine producer. The anticonvulsant Mysoline is introduced.
- 1955: Headquarters moved from Philadelphia to Radnor, Pennsylvania.
- 1958: Dristan Tablets and the non-narcotic sleeping aid, Sleep-Eze, are launched.
- 1959: Strategic alliance with Rhone-Poulenc for pharmaceutical drug research and development. The labs at Ives Cameron produce Isordil, vasodilator for the treatment of angina.
1961-1999
- 1961: Dryvax, freeze-dried smallpox vaccine, is launched.
- 1966: Oral contraceptive Ovral (norgestrel and ethinyl estradiol tablets), first totally synthetic progestational steroid, is launched.
- 1967: The Global Smallpox Eradication Program is initiated by WHO and approaches Wyeth to develop a better injection system for smallpox to be used in the field. The partnership with Imperial Chemical Industries (Akzo Nobel N.V. subsidiary) pays off with the launch of Inderal, the first beta-blocker for arrhythmia.
- 1968: Patent royalties on innovative new bifurcated needle. Delivery of 200 million smallpox vaccine per year. Ovral becomes the most frequently prescribed oral contraceptive on the market.
- 1970: Wyeth improves infant formula S-26 by developing a physiologic fat blend that closely resembles the fatty acid content of human milk.
- 1975: Lo/Ovral (norgestrel and ethinyl estradiol tablets) is released and becomes the most frequently prescribed low-dose contraceptive in the US.
- 1982: American Home Products acquires Sherwood Medical, capturing a share of the growing medical devices market.
- 1983: Inderal becomes the most frequently prescribed medicine in the US.
- 1984: Whitehall Laboratories markets Advil, first nonprescription ibuprofen in the US and most famous prescrption to over the counter switch in history.
- 1985: Ives Laboratories merges with Wyeth.
- 1987: Wyeth and Ayerst merge into Wyeth-Ayerst Laboratories. The animal health business of Bristol-Myers is acquired and assimilated into Fort Dodge.
- 1988: Acquisition of Parke-Davis animal health business, making Fort Dodge the country's 3rd largest manufacturer of animal health products. First Haemophilus b conjugate vaccine against bacterial meningitis licensed in the United States for use in infants.
- 1989: Acquisition of A.H. Robins Company, makers of popular consumer brands Robitussin, ChapStick and Dimetapp.
- 1991: The first diphtheria/tetanus/acellular pertussis vaccine in the US and Norplant (levonorgestrel), the first new contraceptive in the US in more than 30 years, are introduced.
- 1992: Building biotechnology capacity, a majority interest in Genetics Institute is acquired. Premarin becomes the number one prescribed drug in the US.
- 1993: The Women's Health Research Institute is established, the first such pharmaceutical laboratories dedicated entirely to women's health.
- 1994: Acquisition of American Cyanamid and its subsidiary Lederle Laboratories. Effexor (venlafaxine HCI) is introduced, the first serotonin and norepinephrine reuptake inhibitor for the treatment of depression.
- 1995: Combined sales top $13 billion. Acquisition of the remaining interest in Genetics Institute.
- 1997: BeneFIX Coagulaion Factor IX (Recombinant), novel genetically engineered blood-clotting protein, is introduced for the treatment of hemophilia B. Premarin becomes the first Company product to reach $1 billion in sales. Solvay's worldwide animal health business is purchased and folded into Fort Dodge.
- 1998: Enbrel (etanercept), first in class biological treatment for moderate to severe rheumatoid arthritis, is launched by Wyeth and Immunex Corp. (Amgen). Solgar Vitamin and Herb Company is acquired by Whitehall-Robins Healthcare.
- 1999: Meningitec (meningococcal Group C conjugate vaccine) is launched ahead of schedule to help the UK battle an epidemic of meningococcal Group C disease. Rapamune (sirolimus), novel immunosuppresant for kidney transplantation, is launched.
2000
- Cyanamid Agricultural Products is spun-off, marking the final step in the transformation into a research-driven, global pharmaceutical company.
- Collaboration with Elan Corporation to discover, develop and commercialize immunotherapeutic approaches to prevent and treat Alzheimer's disease.
- Wyeth Pharmaceuticals purchases the Collegeville property from Aventis.
2002
- Designed and tested new animal model in rats to study amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, in a partnership with researchers at leading medical institutions across the United States. The new model is in transgenic rats, which are modified to carry a human gene and develop a neuromuscular disease similar to human amyotrophic lateral sclerosis.
- American Home Products changes its name to Wyeth.
- Wyeth appoints PricewaterhouseCoopers as auditor.
- Immunex Corporation is sold to Amgen.
- Wyeth ceases production of FluShield, injectable influenza virus vaccine, and Pnu-Imune, injectable polysaccharide pneumococcal vaccine for adults, and pursues new flu immunization technologies, specifically through partnership with MedImmune, to develop and market FluMist, an intranasal influenza vaccine.
- FDA approves Wyeth manufacturing site for hemophilia A treatment.
2004
- Wyeth at the Bear Stearns 17th Annual Healthcare Conference, the UBS Global Life Sciences Conference, the CIBC World Markets 15th Annual Healthcare Conference, the Credit Suisse First Boston Healthcare Conference.
- Co-development and co-commercialization agreements with Solvay Pharmaceutical B.V. for bifeprunox and other neuroscience compounds.
- Dissolution of collaboration with MedImmune Inc. for the nasal flu vaccine FluMist (Influenza Virus Vaccine Live, Intranasal) and an investigational second-generation liquid formulation, Cold Adapted Influenza Vaccine-Trivalent. Worldwide rights, manufacturing, marketing, and selling of FluMist by MedImmune Inc., that acquire Wyeth's distribution facility in Louisville, Kentucky.
- Collaboration with the World Health Organization on clinical trial to investigate the safety and efficacy of moxidectin in onchocerciasis (river blindness) infected individuals. Culmination of an informal 3-year cooperative effort to develop an oral formula for moxidectin and to conduct the pre-clinical analyses and regulatory filings required before initiating a clinical trial in patients.
- 5 oncology researchers who led the development of the first antibody-targeted chemotherapy awarded the Heroes of Chemistry Award from the American Chemical Society.
- Elan Corporation plc and Wyeth Pharmaceuticals announce that the United States Patent and Trademark Office issued Neuralab Limited, subsidiary of Elan, 7 patents for the companies' joint research on immunotherapeutic approaches to the prevention and treatment of Alzheimer's disease.
- Manufacturing agreement with Genentech Inc. for Herceptin (Trastuzumab).
- Collaboration with the WHO on a clicnical trial for the study of moxidectin as a possible alternative treatment for onchocerciasis, the world's second leading infectious cause of blindness.
- Wyeth supports the National Osteoporosis Foundation and the Surgeon General's focus on prevention of osteoporosis and promotion of bone health.
- Agreement with an affiliate of PBM Products Inc. for the sale of Georgia, Vermont infant nutrition manufacturing facility.
- The Research & Development Council of New Jersey honors Wyeth Research with the Annual Thomas Alva Edison Patent Award in the "Emerging Technology" category for rapamycin hydroxyesters, a derivative of rapamycin known as temsirolimus (CCI-779). Temsirolimus is an investigational drug, which specifically inhibits mTOR (mammalian target of rapamycin) kinase, an enzyme required to control a cell's life cycle, preventing cell division into new cells.
2005
- Wyeth at the SG Cowen & Co. 25th Annual Healthcare Conference, the Canadian Imperial Bank of Commerce World Markets' 16th Annual Heathcare Conference.
- Wyeth purchases additional equity of Wyeth K.K., 70% ownership providing full management control over the joint venture with Takeda Pharmaceutical Company Limited.
- Wyeth opens Grange Castle, one of the world's largest integrated biotech manufacturing facilities in the South Country Dublin, Ireland.
- Applied Neurotherapeutics Research Group, partnership between Wyeth Neuroscience Research, the Conway Institute at University College Dublin and Trinity College, awarded "Best Partnership Alliance" for its collaborative research approach and its significant contributions to the Irish economy.
- The Chamber of Commerce of Cambridge grants "Leading Edge Award" to the Wyeth Research Campus.
- $32 million contract with National Institutes of Health for ongoing HIV vaccine research.
- Worldwide collaboration with Progenics Pharmaceuticals to develop and commercialize Methylnaltrexone.
2006
- Wyeth at the SG Cowen & Co. 26th Annual Healthcare Conference, the Lehman Brothers 9th Annual Global Healthcare Conference, the Bank of America Health Care Conference.
- Strategic Collaboration with Trubion Pharmaceuticals.
- The American Veterinary Medical Association and Fort Dodge Animal Health announce new educational initiative designed to raise consumer awareness about preventing diseases that can be spread from pets, and other animals, to people, as well as those that can infect both people and pets. These diseases, called zoonotic diseases, include leptospirosis, Lyme disease, rabies, ringworm and giardia.
- Collaboration with the Health Ministry of Scotland to enhance translational medicine research.
- Wyeth purchases an additional 10% stake in Wyeth K.K. bringing Wyeth's ownership interest in the Wyeth/Takeda Pharmaceutical Company Limited joint venture to 80%.
- Plans with Progenics Pharmaceuticals Inc. for the further development of methylnaltrexone, investigational drug studied as a treatment for the peripheral side effects of opioid analgesics, without interfering with pain relief. In 3 dosage forms: subcutaneous and oral forms as treatment platforms for opioid induced-bowel dysfunction, and an intravenous form for post operative bowel dysfunction.
- Amended and restated co-promotion agreement regarding King Pharmaceuticals's product ALTACE (ramipril), an angiotensin converting enzyme inhibitor.
2007
- Wyeth at the Bear Stearns 20th Annual Healthcare Conference, the UBS Global Life Sciences Conference.
- Team of Wyeth scientists involved in the discovery, development and manufacture of PREVNAR, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), first and only vaccine available to help protect infants and toddlers against invasive pneumococcal disease caused by vaccine serotypes, awarded the 2005 National Medal of Technology, nation's highest honor for technological achievement, by President George W. Bush at a White House ceremony.
- New neuroscience discovery, co-development, and co-commercialization agreement with Solvay Pharmaceutical B.V. targeting the identification of small molecules as potential anti-psychotic medications.
- Collaboration with Nautilus Biotech to develop hemophilia therapies.
- Kylin Therapeutics Inc., biotechnology company, signs collaboration with Fort Dodge Animal Health to develop new RNAi therapeutics for the treatment of cancer. Under this contract, Kylin uses its patented RNA nanoparticle technology called "pRNA" to explore the enormous potential of RNA interference (RNAi), and develop new RNA-based therapeutics for the treatment of cancer, Fort Dodge receives an exclusive license to the pRNA/RNAi therapeutic compounds for the treatment of cancers in companion animals and Kylin retains rights to the therapies for human use.
- Research partnership with MediVas to develop advanced hemophilia therapies.
- Wyeth purchases final 20% stake of Wyeth K.K. from Takeda Pharmaceuticals Company Limited.
2008
- Wyeth at the Credit Suisse Healthcare Conference.
- Pristiq (desvenlafaxine), new serotonin-norepinephrine reuptake inhibitor approved to treat adult patients with major depressive disorder, available in U.S.
- Wyeth Consumer Healthcare purchases ThermaCare, a leading over-the-counter heat wrap, from Procter & Gamble.
- Wyeth Pharmaceuticals acquires Thiakis Limited, privately held biotechnology company based in the United Kingdom.
2009
- Strategic alliance with Santaris Pharma to develop RNA-based medicines.
- FDA approves new indication for TYGACIL (tigecycline) for the treatment of adult patients with community-acquired bacterial pneumonia.
- National pneumococcal immunisation programme to vaccinate nearly all Rwandan children younger than one and all Rwandan infants on a routine basis. To help make this program possible in Rwanda and Gambia Wyeth contributed more than 3 million doses of the pneumococcal vaccine through GAVI Alliance. To ensure the sustainable supply of pneumococcal vaccines to countries in the future, GAVI launched a unique financing mechanism known as the Advance Market Commitment (AMC). The governments of Italy, the United Kingdom, Canada, Norway, and Russia, and the Bill & Melinda Gates Foundation launched a pilot AMC against pneumococcal disease with a collective $1.5 billion commitment.
- $100,000 donation to ASCO Cancer Foundation to support cancer prevention and care.
- Exclusive worldwide collaboration with Catalyst Biosciences Inc. for the discovery, development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions.
- Wyeth Consumer Healthcare announces availability of new, scientifically advanced, gender-and age-specific adult multivitamin line, Centrum Ultra Women's and Men's and Centrum Silver Ultra Women's and Men's.
- Worldwide alliance with Ambrx Inc. to discover, develop, and commercialize protein drug candidates for three undisclosed targets in multiple therapeutic areas.
- Pfizer and Wyeth divest certain animal health assets to Boehringer Ingelheim.
- Progenics Pharmaceuticals Inc. regains all worldwide rights to the RELISTOR franchise from Wyeth Pharmaceuticals.
Products
2009
- Enbrel (etanercept) approved for the treatment of chronic severe plaque psoriasis in children aged 8 years and above, making it the only biologic treatment approved for use in children.
- CONBRIZA is approved in the European Union for treatment of postmenopausal osteoporosis in women at increased risk of fracture.
- Chilean Ministry of Health becomes first government agency to approve Prevenar 13 Valent, Pneumococcal Conjugate Vaccine 13 Valent (Diphtheria CRM197 Protein), for infants and young children aged 6 weeks through 5 years.
- Productos de prescripción facultativa de Wyeth Pharmaceuticals en España: Benefix, Clanzoflat, Enbrel, Harmonet, Isovorin, Lederfolin, Loette, Meningitec, Metotrexato, Minesse, Minulet, Orfidal, Ovoplex, Prevenar, Rapamune, ReFacto, Relistor, Tazocel, Torisel, Triciclor, Tri-Minulet, Tygacil, Vandral, Vandral Retard.
2008
- Launch of generic version of PROTONIX tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA Inc.
- New recombinant XYNTHA available for patients with hemophilia A, a rare, inherited blood-clotting disorder.
- Wyeth and Progenics Pharmaceuticals Inc. receive approval from European Commission and The Therapeutic Goods Administration division of the Australian Government for Relistor for opioid-induced constipation in advanced illness patients. Wyeth has worldwide rights to commercialize all forms of RELISTOR, except in Japan, where Progenics has granted Ono Pharmaceutical Co. Ltd. an exclusive license to the subcutaneous form of RELISTOR for development and commercialization.
- FDA approvals of low-dose regimen of premarin vaginal cream to treat moderate to severe postmenopausal dyspareunia painful sexual intercourse, and TYGACIL, for the treatment of patients with community-acquired pneumonia, and Bazedoxifene, for the treatment of postmenopausal osteoporosis.
- FDA grants Fast Track designation to the investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The vaccine includes 6 new serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the 7 serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
- Fort Dodge Animal Health announces reintroduction of ProHeart 6, a unique heartworm preventative, to the U.S. veterinary market.
- South Africa begins introduction of PREVENAR into childhood immunization program. 27 countries have included PREVENAR in their national immunization programs. PREVENAR, the only licensed pneumococcal conjugate vaccine, is available in 88 countries around the world, with more than 180 million doses distributed.
2007
- The Environmental Protection Agency approves ProMeris for cats and dogs, a low-volume, topical spot-on, to effectively control existing flea and tick infestations and prevent re-infestations on dogs and puppies eight weeks and older.
- Marketing and distribution of BeneFIX in Europe.
- FDA approves Lybrel, first low dose combination oral contraceptive offering women the opportunity to be period-free over time; Bazedoxifene, for the prevention of postmenopausal osteoporosis; Protonix (pantoprazole sodium), for delayed-release oral suspension; new dosing recommendations for Rapamune in high immunologic risk renal transplant patients; new BeneFIX features that provide hemophilia B patients a simpler and more convenient preparation process for recombinant factor IX.
- FDA and European Commission approve Torisel for the treatment of advanced kidney cancer.
2006
- Launch of unique spanish-language patient education and support program for EFFEXOR XR depression patients.
- National Agency of Veterinary Medicine (France) temporary approval for Poulvac FluFendTM i H5N3 RG, inactivated virus reverse genetics avian vaccine to aid in prevention of avian influenza caused by H5N1 virus. Fort Dodge developed the vaccine in collaboration with St. Jude Children's Research Hospital and the University of Wisconsin. The French Ministry of Agriculture and Fisheries requested an initial supply of 7 million doses of this vaccine for use in ducks as part of an avian influenza control program. In several different countries, Fort Dodge's products have been supplied as vaccine banks for use in the event of an outbreak. In addition to H5N3 RG, Fort Dodge has approvals for vaccines including H5N9, H5N2, H7N1, H7N2 and H7N3 strains.
- Tygacil (tigecycline), first antibiotic in a new class called glycylcyclines approved in Europe.
- Availability of Advil PM, which combines the multi-pain relieving power of Advil with a gentle sleep aid.
2005
- Wyeth Japan and Takeda Pharmaceutical Company Limited (Takeda Pharmaceutical) announce Enbrel (etanercept) approval by the Japan Ministry of Health, Labour and Welfare for the treatment of rheumatoid arthritis.
- Wyeth and Astellas BV announce European Commission approval of InductOs (recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge) for the treatment of single level (L4-S1) anterior lumbar spine fusions as a substitute for autogenous bone graft in adults with degenerative disc disease.
- Fort Dodge Animal announces approval of West Nile-Innovator DNA, innovative vaccine for horses to aid in the prevention of viremia caused by the potentially deadly West Nile virus.
- FDA approval of Tygacil (tigecycline), novel I.V. antibiotic indicated for the treatment of complicated skin and intra-abdominal infections in adults, and Effexor XR, for the treatment of panic disorder.
2004
- Widespread availability of the lowest effective dose of Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, that contains 52% less estrogen and 40% less progestin than Prempro 0.625 mg/2.5 mg, and has been shown to be as effective in relieving menopausal symptoms with less breakthrough bleeding and less breast tenderness.
- Fort Dodge Animal Health announces approval of Duramune Adult, first USDA licensed vaccine with 3 year virus challenge data against a trio of deadly canine diseases, canine parvovirus, canine distemper and canine adenovirus.
- FDA approves reformulation of the stomach acid suppressant, Protonix I.V. (pantoprazole sodium) for Injection, first and only proton pump inhibitor in the United States to be offered in both oral and intravenous formulations. The existing Protonix I.V. formulation used clinically for 7 years in more than 5 million patients worldwide.
- FDA approves rhBMP-2/ACS (recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge), novel protein device that enhances bone healing, for use in the treatment of acute, open tibia shaft fractures in adults.
- Enbrel (25 mg twice weekly) recieves FDA approval for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and European Commission approval for the treatment of adults with severe active ankylosing spondylitis and for monotherapy in the treatment of active rheumatoid arthritis and for use in combination with methotrexate in adults when the response to disease-modifying antirheumatic drugs (including methotrexate unless contraindicated) has been inadequate.
- National advertising campaign, 60-second television commercial and a consumer print advertisement, featuring Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg educates women about the appropriate use of hormone therapy and encourages dialogue between women and their health care professionals about the treatment of menopausal symptoms, according to Wyeth Pharmaceuticals.
- FDA grants "fast track" designation for temsirolimus in the first-line treatment of poor-prognosis patients with advanced renal cell carcinoma.
- Enbrel (atanercept) recieves FDA and European Commission approval for the treatment of chronic moderate to severe plaque psoriasis in adult patients. Amgen Inc. and Wyeth Pharmaceuticals announce Enbrel (etanercept) is the first and only biologic to receive an indication by the FDA to induce a Major Clinical Response in patients with rheumatoid arthritis. 50 mg/mL prefilled syringe approved by the FDA as the recommended dosing form for treatment in all approved adult indications.
- FDA approvals of supplemental New Drug Application, for room temperature shipping and storage of PROTONIX I.V. (pantoprazole sodium) for Injection; and ReFacto Antihemophilic Factor (Recombinant) R2 Kit, first needle-less reconstitution device with a prefilled diluent syringe for hemophilia.
2003
- MedImmune Vaccines Inc. and Wyeth Vaccines announce that FluMist (Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist approved in the United States for healthy people, is available in doctors' offices and pharmacies nationwide for the influenza season.
- FluMist, Influenza Virus Vaccine Live, Intranasal, incorporated into the influenza vaccine recommendations by the Advisory Committee on Immunization Practices as an option for the vaccination of healthy people aged 5 to 49 years.
- Amgen and Wyeth Pharmaceuticals announce FDA approval of 50 mg once-weekly dosage of Enbrel (etanercept), for adult patients across all indications, including moderately-to-severely active rheumatoid arthritis, active arthritis in patients with psoriatic arthritis and active ankylosing spondylitis, and a 0.8mg/kg once-weekly dosage (maximum 50 mg per week) for patients ages four to 17 years with moderately-to-severely active juvenile rheumatoid arthritis. Instead of taking two 25 mg injections 3 to 4 days apart, can be taken both injections on the same day.
- Protonix I.V. (pantoprazole sodium) for Injection approved by the FDA for intravenous administration over a period of at least 2 minutes, in addition to its current 15 minute infusion regimen. Protonix I.V. is indicated for short-term treatment (7 to 10 days) of patients having gastroesophageal reflux disease with a history of erosive esophagitis, as an alternative to oral therapy in patients who are unable to continue taking PROTONIX Delayed-Release Tablets. Protonix is the first and only proton pump inhibitor in the U.S. to be offered in both oral and intravenous formulations.
- FDA approvals of prescribing information for postmenopausal hormone therapies; Effexor XR (venlafaxine HCI), for the treatment of Social Anxiety Disorder; Ropamune (sirolimus), for a new indication which calls for the withdrawal of cyclosporine from the immunosuppressive regimen; new lower-dose versions of Prempro and Premarin; and CYPHER Stent from the Cordis Corporation, product coated with sirolimus to reduce reblockage in patients recieving stents during coronary procedures.
2002
- Final judicial approval of diet drugs Redux and Pondimin.
- Enbrel (etanercept), first therapy approved by FDA for treatment of psoriatic arthritis.
- FDA approval of Alavert, non-sedating antihistamine, and Advil Allergy Sinus, the first 3 ingredient product containing ibuprofen.
- European Commission marketing authorization of Enbrel (etanercept), for Psoriatic Arthritis, and InductOs (rhBMP-2 on an absorbable collagen sponge), for treatment of open tibial fractures as an adjunct to standard of care.
- Fel-O-Vax FV is launched for the prevention of a serious immunodeficiency disease in cats.
2001
- FDA approval of Effexor XR (venlafaxine HCI) for use in preventing relapse and recurrence of depression.
2000
- Prevnar pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 protein), for the prevention of invasive pneumococcal disease in infants and children, and Protonix (pantoprazole sodium), proton pump inhibitor for the treatment of gastroesophageal reflux disease, are launched.
- Altace (ramipril), sponsored by King Pharmaceuticals Inc. and co-marketed by Wyeth, is the first and only angiotensin-converting-enzyme inhibitor to receive FDA approval for reduction of the risk of stroke, myocardial infarction, and death from cardiovascular diseases in patients 55 or older at high risk of developing a major cardiovascular event.