Biotech Medicines on the Market Top 110 With Hundreds More in the Pipeline
Of the 32 FDA approvals, 21 were for new medicines to treat illnesses such as pneumococcal diseases in children, diabetes, cancer, heart attacks, hemophilia, high cholesterol and severe skin diseases.
The number of biotech medicines on the market has skyrocketed since 1995. Nearly three times as many biotech products have been approved over the last six years than the previous 13 years combined. The total number of biotech products on the market is now 117.
"The dramatic increase of biotech medicines on the market in 2000 represents hope for patients suffering from debilitating and life-threatening diseases such as heart disease, cancer, and Alzheimer’s," said, Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO).
"The biotech industry is just 25 years old and already more than one-quarter billion people worldwide have been helped by this technology," observed Feldbaum. "Another 350 biotech medicines targeting more than 200 diseases are now in late-stage development. Many of these are potentially life saving drugs and will be approved for patients in the next several years."
Many of the biotech industry’s leading companies will be showcased at BIO’s upcoming CEO & Investor conference in New York, February 20 and 21. "Our conference helps biotech companies find the resources they need to continue bringing innovative medicines to the marketplace," said Feldbaum.
BIO represents more than 960 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and more than 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.
Product | Company | Application (use) | Approval Date |
Abrevaä (docosanol) | AVANIR Pharmaceuticals and GlaxoSmithKline | topical treatment of recurrent cold sores (herpes simplex infection) | July 2000 |
Acova (argatroban) | Texas Biotechnology and GlaxoSmithKline | anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia | June 2000 |
Actimmune (interferon gamma-1b) | Genentech and InterMune Pharmaceuticals Inc. | treatment of chronic granulomatous disease; treatment of severe, malignant osteopetrosis | Dec. 1990 Feb. 2000 |
AmBisome (liposomal amphotericin B) | Gilead Sciences (from NeXstar Pharmaceuticals) and Fujisawa Healthcare | treatment of fungal infections in patients with depressed immune function and with fever of unknown origin; treatment of cryptococcal meningitis in HIV-infected patients | Aug. 1997 June 2000 |
AndroGel (testosterone) | Unimed Pharmaceuticals (subsidiary of Solvay Pharmaceuticals) | testosterone replacement therapy in males with testosterone deficiency | Feb. 2000 |
Angiomax (bivalirudin) | The Medicines Co. | anticoagulant in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty | Dec. 2000 |
Apligraf (living, human skin substitute from collagen, fibroblasts and keratinocytes) | Organogenesis | treatment of venous leg ulcers; treatment of diabetic foot ulcers | May 1998 June 2000 |
CroFab (crotalidae polyvalent immune Fab, ovine) | Protherics and Altana | rattlesnake anti-venom | Oct. 2000 |
Enbrel (etanercept) | Immunex Corp. | treatment of moderate to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs; treatment of polyarticular course juvenile rheumatoid arthritis; treatment as a first-line therapy for moderate to severe active rheumatoid arthritis | Nov. 1998 May 1999 June 2000
|
Gonal-F (follitropin alfa) | Serono Laboratories | treatment of infertility in women not due to primary ovarian failure; treatment of infertility in men and women | Sept. 1998 June 2000 |
Helixate (recombinant antihemophilic factor) | Aventis | factor VIII for treatment of hemophilia A; second-generation factor VIII formulated with sucrose for treatment hemophilia A | Feb. 1994 June 2000 |
Kogenate FS (recombinant antihemophilic factor) | Bayer | factor VII for treatment of hemophilia A; second-generation factor VIII formulated with sucrose for treatment of hemophilia A | Sept. 1989 June 2000 |
Lantus (insulin glargine) | Aventis | biosynthetic basal insulin for adult and pediatric patients with type 2 diabetes | April 2000 |
Mylotarg (gemtuzumab ozogamicin) | Celltech Chiroscience and Wyeth-Ayerst (American Home Products) | human antibody linked to calicheamicin (chemotherapeutic) for treatment of CD33 positive acute myeloid leukemia in patients 60 and older in first relapse who are not considered candidates for cytotoxic chemotherapy | May 2000 |
Myobloc (botulinum toxin type B) | Elan Pharmaceuticals | treatment of cervical dystonia | Dec. 2000 |
Novantrone (mitoxantrone hydrochloride) | Immunex | treatment of acute nonlymphocytic leukemia; hormone refractory prostate cancer; secondary progressive multiple sclerosis | 1987 Nov. 1996 Feb. 2000 |
NovoLog (insulin aspart) | Novo Nordisk | insulin analog for adults with diabetes mellitus | May 2000 |
Olux (clobetasol proprionate .05% foam) | Connetics | short-term topical treatment of moderate to severe dermatoses of the scalp | May 2000 |
Ovidrel (recombinant human chorionic gonadotropin) | Serono Laboratories | treatment of infertility in women | Sept. 2000 |
Pacis (live attenuated Bacillus Calmette-Guerin) | BioChem Pharma and UroCor | bladder cancer immunotherapy | Mar. 2000 |
Prevnar (diptheria CRM 197 protein) | American Home Products – Wyeth Lederle Vaccines | vaccine for infants and toddler, 12-15 months, to prevent invasive pneumococcal disease | Feb. 2000 |
ReFacto (antihemophilic factor) | Genetics Institute (American Home Products) | control and prevention of hemophilia A and short-term prophylaxis to reduce bleeding episodes | Mar. 2000 |
Renagel capsules (sevelamer hydrochloride) | GelTex Pharmaceuticals Inc. | reduction of serum phosphorus in patients with end-stage renal disease (ESRD); reduction of serum phosphorus in hemodialysis patients with end-stage renal disease | Nov. 1998 July 2000 |
Sarafem (fluoxetine hydrochloride | Interneuron Pharmaceuticals and Eli Lilly and Co. | treatment of premenstrual dysphoric disorder | July 2000 |
Tamiflu (oseltamivir phosphate) | Gilead Sciences and Hoffmann-La Roche | treatment of most common strains of influenza in adults; prevention of influenza in adolescents and adults; treatment of acute influenza in children 1 year and older | Oct. 1999 Nov. 2000 Dec. 2000 |
Targretin Gel (bexarotene) | Ligand Pharmaceuticals | topical treatment of cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma | June 2000 |
TNKase (tenecteplase) | Genentech | treatment of acute myocardial infarction | June 2000 |
Tripedia | Aventis Pasteur (formerly Pasteur Merieux Connaught) | diptheria, tetanus and acellular pertussis vaccination of infants 2, 4 and 6 months of age; first booster at 15-18 months; fifth dose at 4-6 years of age after four prior doses | July 1996 Sept. 1996 Aug. 2000 |
Trisenox (arsenic trioxide) | Cell Therapeutics | treatment of acute promyelocytic leukemia | Sept. 2000 |
Visudyne (verteporfin) | QLT Photo Therapeutics and CIBA Vision | treatment of wet form of age-related macular degeneration | Apr. 2000 |
WelChol (colesevelam HCI) | GelTex Pharmaceuticals | reduction of elevated low-density lipoprotein (LDL) cholesterol alone or in combination with HMG-CoA reductase inhibitor (statin) in patients with hypercholesterolemia | May 2000 |
Zonegran (zonisamide) | Elan Pharmaceuticals | adjunctive therapy in treatment of partial seizures in adults with epilepsy | March 2000 |
Sources: Biotechnology Industry Organization, FDA, BioWorld Today, Pink Sheet, Signalsmag.com