Buy: BIOPHARMA: Biopharmaceutical Products in the U.S. Market 3rd Edition

Table of Contents

Table of Content - alphabetical order

Sample monographs (full text):

RSV Mab, rDNA (Synagis from MedImmune)

EPO rDNA Amgen

FDA Approvals

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2005:

• Meningococcal Conjugates Vaccine* [Menactra; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; MCV-4] - granted on 1/17/2005 to Sanofi Pasteur Inc. for protection against meningococcal disease in adolescents and adults aged 11-55 years

2004:

• Keratinocyte growth factor, rDNA* [Palifermin - Kepivance; des1-23 KGF; 24-163 fibroblast growth factor 7 (human)] granted on 12/15/2004 to Amgen Inc. for treatment of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, followed by a bone marrow transplant.
   
• Integrin Mab, rDNA* [Tysabri - natalizumab; Antegren; integrin alpha(4) humanized monoclonal antibody] granted on 11/24/2004 to Biogen Idec for treatment of multiple sclerosis [formerly Antegren (trade name), now Tysabri; changed at FDA request].
   
• Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] full approval (upgraded from accelerated approval granted 3/2003) granted on 10/15/2004 to Hoffmann-La Roche Inc. for the treatment of HIV-1 infection in in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy [synthetic peptide, not a biopharmaceutical].
• Immune Globulin (IGIV)/Octapharm [Octagam; Immune Globulin Intravenous (Human)] - granted on 5/21/2004 to Octapharma AG for treatment of primary immune deficiency.
• Hyaluronidase, ovine [Vitrase; hyaluronate 4-glycanohydrolase] granted on 5/4/2004 to ISTA Pharmaceuticals Inc. for use as a spreading agent to facilitate the dispersion and absorption of drugs, particularly local anesthetics, during ophthalmic surgery; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents
• Insulin glulisine, rDNA [Apidra; [LysB3, GluB29] insulin; insulin (human), 3B-l-lysine, 29B-l-glutamic acid-, recombinant] - granted on 4/16/2004 to Aventis Pharma for use as a rapid-acting insulin for treatment of diabetes.
• VEGF Mab, rDNA [Avastin; bevacizumab; vascular endothelial growth factor monoclonal antibody, recombinant] - granted on 2/26/2004 to Genentech, Inc. for use in combination with 5-fluorouracil for treatment of metastatic cancer of the colon or rectum.
• EGF receptor Mab, rDNA [Cetuximab - Erbitux; IMC-C225; epidermal growth factor receptor monoclonal antibody, recombinant] - granted on 2/12/2004 to ImClone Systems Inc. (for marketing by Bristol-Myers Squibb Co.) for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy, and for monotherapy treatment of patients with EGFR-expressing metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
• Rho(D) Immune Globulin/ZLB [Rho(D) Immune Globulin Intravenous (Human) - Rhophylac] - granted on 2/12/2004 to ZLB Bioplasma AG for antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women.
• Hyaluronic acid/Anika [ORTHOVISC High Molecular Weight Hyaluronan] - granted on 2/5/2004 to Anika Therapeutics, Inc. for U.S. marketing by Ortho Biotech Products, L.P. (Johnson & Johnson) for the treatment of pain associated with osteoarthritis of the knee. [Derived from rooster combs; considered a borderline biopharmaceutical product]

2003:

• Immune Globulin Intravenous (Human) [Flebogamma] - granted on 12/18/2003 to Instituto Grifols (Probitas Pharma) for treatment of primary immune deficiency.
• Hyaluronic acid/Medicis [Restylane] - granted on 12/12/2003 to Medicis Pharmaceutical Corp. for correction of moderate to severe facial wrinkles and folds, e.g., nasolabial folds (lines/folds near the nose and mouth). [bacterial fermentation-derived; considered a mainstream biopharmaceutical product]
• CD11a Mab, rDNA [Efalizumab - Raptiva; CD11a monoclonal antibody, recombinant] - granted on 10/27/2003 to Genentech, Inc. and Xoma Ltd. for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic or phototherapy.
• Botulism Immune Globulin Intravenous (Human) [BabyBIG] - granted on 10/23/2003 to the California Department of Health Services for treatment of infant botulism caused by type A or type B Clostridium botulinum.
• Somatropin, rDNA/Serono [Somatropin (rDNA origin) - Serostim; human growth hormone, recombinant] - full approval granted on 8/29/2003 to Serono Inc. for the treatment of HIV patients with wasting or cachexia [upgraded from accelerated approval granted in 1996]
• Factor VIII, rDNA, PFM [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method - Advate; Factor VIII, recombinant; rAHF-PFM] - granted on 7/25/2003 to Baxter Hyland Immuno for treatment of hemophilia A.
• TNF Receptor-IgG Fc, rDNA [Etanercept - Enbrel; tumor necrosis factor receptor2-immune globlulin G1 Fc fusion protein, recombinant] - supplemental BLA granted on 7/24/2003 to Amgen Inc. for treatment of active ankylosing spondylitis.
• Antitrypsin, alpha-1/Aventis [Alpha-1-Proteinase Inhibitor (Human) - Zemaira] - granted on 7/8/2003 to Aventis Behring LLC for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema.
• CD20 Mab, rDNA--I 131 radioconj. [Iodine I 131 tositumomab - Bexxar; CD20 monoclonal antibody--Iodine I 131 radioimmune conjugate] - granted on 6/27/2003 to Corixa Corp. (formerly Coulter Pharmaceutical) with marketing by GlaxoSmithKline (GSK) for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.
• Immunoglobulin E Mab, rDNA [Omalizumab - Xolair; rhuMab-E25; immunoglobulin E25 monoclonal antibody, recombinant; IgE Mab, rDNA] - granted on 6/20/2003 to Genentech, Inc. (with manufacture by Tanox, Inc. and co-marketing by Novartis Pharmaceutical Corp.) for treatment of moderate-to-severe allergic asthma.
• Hirudin, desulfato- rDNA/Aventis [Iprivask; Desirudin; Revasc; desulfatohirudin; hirudin, desulfato- recombinant] - granted on 4/3/2003 to Aventis Pharma for approved for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.
• Influenza Vaccine, Live Intranasal [FluMist] - granted on 6/17/2003 to MedImmune Vaccines, Inc. (subsidiary of MedImmune, Inc.) for influenza prophylaxis in healthy persons from 5-50 year of age.
• Iduronidase, rDNA [laronidase; Aldurazyme; alpha-L-iduronidase] - granted on 4/30/2003 to Biomarin Pharmaceutical Inc. (and Genyzme Corp.) for treatment of Mucopolysaccharidosis I (MPS I)
• Galactosidase, beta rDNA [Agalsidase beta - Fabrazyme; alpha-galactosidase A] - granted on 4/24/2003 to Genzyme Corp. for treatment of Fabry disease
• Somatropin antagonist, PEG-, rDNA [Pegvisomant - Somavert; somatropin antagonist, pegylated, recombinant] - granted on 3/25/2003 to Pharmacia Corp. for treatment of acromegaly
• Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] - granted on 3/15/2003 to Hoffmann-La Roche Inc. for treatment of HIV-infection [synthetic; not a biopharmaceutical]
• LFA-3/IgG1, rDNA [Alefacept; Amevive; leukocyte function-associated antigen-3/immune globulin G (IgG) fusion protein, recombinant] - granted on 1/30/2003 to Biogen Corp. for treatment of moderate-to-severe chronic plaque psoriasis
• Antitrypsin, alpha-1/Baxter [alpha-1 Proteinase Inhibitor (Human); Aralast; alpha-1 antitrypsin; AAT; A1P1] - granted on 1/9/2003 to Alpha Therapeutic Corp. (for marketing by Baxter) for enzyme replacement therapy in patients with heredity emphysema (AAT deficiency)

2002:

• TNF Mab, rDNA, human [Adalimumab; Humira; D2E7; tumor necrosis factor-alpha human monoclonal antibody] - granted on 12/30/2002 to Abbott Laboratories for treatment of rheumatoid arthritis
• DTaP & Hepatitis B & Polio Vaccine [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix; Infanrix + Engerix-B + IPOL] - a combination vaccine; approval granted on 12/13/2002 to GlaxoSmithKline Inc. for prevention of diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio; Poliovirus vaccine (mixture of three inactivated strains) is the only component not previously approved.
• Parathyroid hormone (1-34), rDNA [teriparatide (rDNA origin); Forteo; LY333334; parathyroid hormone (1-34), recombinant] - granted on 11/26/2002 to Eli Lilly & Co. for treatment of osteoporosis
• Interferon alfa-2a, rDNA, PEG- [Peginterferon alfa-2a; Pegasys; interferon alpha-2a, recombinant, pegylated] - granted on 10/16/2002 to Hoffmann-La Roche Inc. for first-line treatment of chronic hepatitis C
• Urate oxidase, rDNA [uric acid oxidase, recombinant; rasburicase; re-Uox; Elitek; Fasturtec] - granted on 7/16/2002 to Sanofi-Synthelabo for control of plasma uric acid levels (hyperuricaemia) in pediatric patients receiving cancer chemotherapy resulting in tumor lysis and elevation of uric acid
• Bone morphogenic protein-2, rDNA [bone morphogenetic protein-2, recombinant; BMP-2; INFUSE Bone Graft] - PMA granted on 7/2/2002 to Medtronic Sofamor Danek using recombinant bmp-2 (from Genetics Institue/Wyeth) as part of the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device for treatment of certain types of spinal degenerative disc disease (lumbar spinal fusion)
• DTaP Vaccine/Aventis Canada Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) [DAPTACEL] - BLA granted on 5/14/2002 to Aventis Pasteur, Ltd. for the first 4 doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks up to 7 years
• Botulinum Toxin Type A Purified Neurotoxin Complex [BOTOX COSMETIC] - supplemental BLA granted on 4/12/2002 to Allergan, Inc. for temporary improvement in the appearance of moderate to severe glabellar lines ["frown lines"] associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age
• Secretin, synthetic [SecreFlo; porcine secretin] - not a biopharmaceutical product (synthetic); granted on 4/5/2002 to Repligen Corp. for diagnosis of gastrinoma (tumors that secrete gastrin) and pancreatic disorders
• Interferon beta-1a, rDNA/Serono [Rebif] - granted on 3/7/2002 to Serono, Inc. for treatment of relapsing forms of multiple sclerosis
• CD20 Mab/Y-90 radioconj. [Ibritumomab Tiuxetan; Zevalin; a CD20 monoclonal antibody-chelating group conjugate] - granted on 2/29/2002 to IDEC Pharmaceuticals Corp. for treatment of B-cell non-Hodgkin's lymphoma; regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan
• G-CSF, rDNA, PEG- [Pegfilgrastim; Neulasta; pegylated granulocyte-colony stimulating factor] - granted on 1/31/2002 to Amgen, Inc. for treatment of febrile neutropenia in patients receiving chemotherapy for non-myeloid malignancies

[*Approved since publication of the 3rd edition, which presents full monographs for these products reported as applications pending].