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Biotech Medicines on the Market Top 110 With Hundreds More in the Pipeline

Washington, D.C. – A record 32 biotechnology drugs, vaccines and new indications for existing medicines were approved by the U.S. Food and Drug Administration (FDA) in 2000.

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.




Application (use)

Approval Date




Pharmaceuticals and GlaxoSmithKline

topical treatment of recurrent cold sores (herpes simplex infection)

July 2000



Texas Biotechnology

and GlaxoSmithKline

anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia

June 2000


(interferon gamma-1b)

Genentech and InterMune Pharmaceuticals Inc.

treatment of chronic granulomatous disease; treatment of severe, malignant osteopetrosis

Dec. 1990

Feb. 2000


(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


(living, human skin substitute from collagen, fibroblasts and keratinocytes)


treatment of venous leg ulcers; treatment of diabetic foot ulcers

May 1998

June 2000


(crotalidae polyvalent immune Fab, ovine)

Protherics and Altana

rattlesnake anti-venom

Oct. 2000



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



(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


(recombinant antihemophilic factor)


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)


factor VII for treatment of hemophilia A; second-generation factor VIII formulated with sucrose for treatment of hemophilia A

Sept. 1989

June 2000


(insulin glargine)


biosynthetic basal insulin for adult and pediatric patients with type 2 diabetes

April 2000


(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


(botulinum toxin type B)

Elan Pharmaceuticals

treatment of cervical dystonia

Dec. 2000

Novantrone (mitoxantrone hydrochloride)


treatment of acute nonlymphocytic leukemia; hormone refractory prostate cancer; secondary progressive multiple sclerosis


Nov. 1996

Feb. 2000


(insulin aspart)

Novo Nordisk

insulin analog for adults with diabetes mellitus

May 2000


(clobetasol proprionate .05% foam)


short-term topical treatment of moderate to severe dermatoses of the scalp

May 2000


(recombinant human chorionic gonadotropin)

Serono Laboratories

treatment of infertility in women

Sept. 2000


(live attenuated Bacillus Calmette-Guerin)

BioChem Pharma

and UroCor

bladder cancer immunotherapy

Mar. 2000


(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


(fluoxetine hydrochloride

Interneuron Pharmaceuticals and Eli Lilly and Co.

treatment of premenstrual dysphoric disorder

July 2000


(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




treatment of acute myocardial infarction

June 2000


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


(arsenic trioxide)

Cell Therapeutics

treatment of acute promyelocytic leukemia

Sept. 2000



QLT Photo Therapeutics and CIBA Vision

treatment of wet form of age-related macular degeneration

Apr. 2000


(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,