Archive for the ‘Pfizer’ Category

Wyeth – Products



– 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.
– 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.


– Enbrel (etanercept) is 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.

– 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.

– 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.
– Wyeth begins marketing and distributing 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.

– 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.

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.

– 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.

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.

– 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.

FDA approval of Effexor XR (venlafaxine HCI) for use in preventing relapse and recurrence of depression.

– 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.