Biotech Drug Approvals Top 90 With Hundreds More In Late-Stage Clinical Trials

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    Charles Craig
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WASHINGTON, D.C. (Jan. 18, 2000) Another 22biotechnology drugs, vaccines and new indications for existing medicines were approved by the U.S. Food and Drug Administration (FDA) in 1999.

That brings the number of biotech drugs and vaccines on themarket to 92. Total FDA biotech approvals from 1982 through 1999 reach 143 when adding clearances for new indications of existing medicines. The vast majority of product approvals for the biotech industry, which is only a quarter century old, came in the second half of the 1990s. These medicines benefit hundreds of millions of people worldwide with life-threatening illnesses, such as heart disease, cancer, Alzheimer's and AIDS.

"Our industry and its science have matured to the point that the number of life-saving drugs on the market and in late-stage clinical trials is skyrocketing," observed Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO). "Over the past five years approvals were double that of the previous 13 years combined. Some drugs represent the first effective treatments ever for our most intractable and debilitating diseases.

"Many biotech medicines, for example, target age-relateddiseases, a fact that should not be overlooked in the current discussions by Congress on Medicare reform," Feldbaum said. "Any legislative measures to expand access to drugs for Medicare beneficiaries must recognize that support for a healthy biotechnology industry is essential for making sure new therapies and cures get to patients.

more"With more than 350 biotechnology medicines already inlate-stage clinical trials for heart ailments, cancer, neurological diseases and infections, continued biotechnology innovation is the key not only for improving our health, but also for lowering our health care costs."

Among the approvals in 1999 were medicines for ovarian cancer,rheumatoid arthritis, hemophilia, influenza, and hepatitis C plus a first-of-its kind sustained-release form of growth hormone.

In recognition of the many advancements made by the biotechnology industry in health care, agriculture, manufacturing and environmental management, the U.S. Senate has declared January 2000 National Biotechnology Month.

BIO represents more than 860 biotechnology companies,academic institutions and state biotechnology centers in 46 states and more than 26 nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.


"1999

Product

Company

Application (use)

ApprovalDate

Chiron RIBA HCV 3.0 Strip Immunoblot Assay

 

Chiron/Johnson & Johnson

detection of antibodies to hepatitis C in human serum or plasma.

Feb. 1999

Depocyt

Depotech(SkyePharma)/

Chiron

treatment of lymphomatous meningitis

April 1999

Doxil (liposomal formulation of doxorubicin hydrochloride)

Alza

second-line therapy for Kaposi's sarcoma in AIDS patients (liposomal drug delivery system metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens

Nov. 1995

June 1999

Enbrel (etanercept)

Immunex

reduction in signs and symptoms of moderately 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

Nov. 1998

May 1999

Epogen (epoetin alfa)

Amgen

treatment of anemia associated with chronic renal failure and anemia in Retrovir-treated HIV-infected patients; pediatric use

June 1989

July 1999

Hextend (hetastarch)

BioTime

plasma volume expander for treatment of hypovolemia during surgery

March 1999

Humate-P (antihemophilic factor/von Willebrand factor complex - human)

Centeon Pharma

treatment and prevention of bleeding episodes in hemophilia A adult patients; spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease in adult and pediatric patients, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate

April 1999

Infergen (interferon alfacon-1)

 

Amgen

treatment of hepatitis C

(HCV) in patients 18 years or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA; subsequent treatment of HCV-infected patients who have tolerated an initial course of Interferon therapy

Oct. 1997

Dec. 1999

Integrelin (eptifibatide for injection)

COR Therapeutics /Schering-Plough

treatment of patients with acute coronary syndrome and angioplasty; including patients who are to be managed medically and those undergoing percutaneous coronary intervention

May 1998

Sept. 1999

Luxiq

Connetics

relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp

Feb. 1999

Nabi-HB (hepatitis B immune globulin - human

 

Nabi

treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute hepatitis B

March 1999

NovoSeven (coagulation factor VIIa)

Novo Nordisk

treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX

March 1999

Nutropin/ Nutropin AQ (somatropin rDNA)

 

Genentech

treatment of growth hormone deficiency in children; growth hormone deficiency in adults; growth failure associated with chronic renal insufficiency prior to kidney transplantation; short stature associated with Turner Syndrome; to improve spine bone mineral density observed in childhood onset adult growth hormone deficient patients and to increase serum alkaline phosphatase

Nov. 1993

Jan. 1994 Jan. 1996 Dec. 1996

Dec. 1999

Nutropin Depot (somatropin for injectable suspension)

 

Genentech/Alkermes

long-acting dosage form of recombinant growth hormone (one or two doses a month) for pediatric growth hormone deficiency

Dec. 1999

Ontak

(denileukin diftitox)

Ligand Pharmaceuticals

treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the Interleukin-2 receptor

Feb. 1999

Panretin (alitretinoin)

Ligand Pharmaceuticals

the topical treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma

Feb. 1999

Remicade (infliximab)

Centocor

short-term management of moderately to severely active Crohn's disease including those patients with fistula; treatment of patients with rheumatoid arthritis who have had inadequate response to methotrexate alone

Aug. 1998

Nov. 1999

Roche Amplicor HIV-1 RNA Test

Roche Molecular Systems

in vitro nucleic acid amplification test used for patient monitoring and as an aid in management of patients on anti-viral therapy for HIV disease

March 1999

Tamiflu (oseltamivir phosphate)

 

Hoffmann-La Roche /Gilead Sciences

 

treatment of most common strains of influenza (A&B)

Oct. 1999

Targetin (bexarotene)

Ligand Pharmaceuticals

treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy

Dec. 1999

Ultra-sensitive Amplicor HIV-1 Monitor test

Roche Molecular Systems

quantitative assay for HIV-1 RNA used to assess a patient's prognosis by measuring changes in plasma HIV-RNA levels during the course of antiviral treatment

March 1999

Wellferon (interferon alfa-n1, lymphoblastoid)

Glaxo Wellcome

treatment of chronic hepatitis C in patients 18 years of age or older without decompensated liver disease

March 1999

The medicines and vaccines included on this list are produced and/or developed by companies involved in recombinant DNA research or other biotechnology applications.

Sources:
The Biotechnology Industry Organization
U.S. Food and Drug Administration


Recombinant Capital Inc.

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.