Biotech President Sees More Medical Breakthroughs And Good Investment Opportunities Ahead

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NEW YORK, N.Y., (February 24, 1999) -- Twenty-one new biotechnology drugs, vaccines and new indications for existing drugs were approved by the Food and Drug Administration (FDA) in 1998.
"Over the past four years there has been a record number of approvals of new biotechnology drugs, vaccines and new indications, demonstrating the strength and commitment of the biotechnology industry to develop innovative products to address widespread unmet medical needs," said Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO).
In the past four years 76 new biotechnology drugs, vaccines and new indications have been approved. This is a significant increase over the previous 14 years. In 1998, the FDA approved new biotechnology medicines for acute coronary syndrome, arthritis, breast cancer, Crohn's disease and for the prevention of Lyme disease.
"Biotechnology leads in medical innovation because of the industry's willingness to attempt to solve the difficult problems, to confront the most intractable, often life-threatening diseases. With our fast-developing knowledge of the genetic causes of disease, and with new discoveries being made virtually everyday, we believe biotechnology will continue to produce significant medical breakthroughs," said Feldbaum.
"Our companies are providing both the tools to produce the next generation of medicines as well as the final products. These represent enormous and expanding markets. With more than 300 biotechnology medicines in Phase II and Phase III clinical trials for AIDS, breast, ovarian and prostate cancers, heart disease, Alzheimer's and other conditions, we believe strongly that investment in biotechnology should yield substantial returns in the years ahead," added Feldbaum.
The Biotechnology Industry Organization (BIO) represents over 835 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 and industrial and environmental biotechnology products.

1998 Approved Biotechnology Drugs


Product

Company

Application (use)

Approval Date

Apligraf«

(graftskin)

Organogenesis, Inc.

for treatment of venous leg ulcers

May 1998

CytoGam«

(CMV immune

globulin IV)

MedImmune, Inc.

prevention of cytomegalovirus (CMV) in kidney transplant patients/

for prophylaxis against CMV disease

associated with kidney, lung, liver, pancreas and heart transplants

April 1990

Dec. 1998

Enbrel«

(etanercept)

Immunex Corporation

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 (DMARDS)

Nov. 1998

Engerix-B«

(recombinant Hepatitis B vaccine)

SmithKline Beecham

hepatitis B vaccine/

adults with chronic Hepatitis C infection

Sept. 1989

Aug. 1998

Herceptin«

(trastuzumab)

Genentech, Inc.

treatment of patients with metastatic breast cancer whose tumors over express the HER2 protein

Sept. 1998

IntegrilinÖ

(eptifibatide for injection)

COR Therapeutics, Inc./Schering-Plough Corp.

treatment of patients with acute coronary syndrome and angioplasty

May 1998

Intron A«

(alpha-interferon)

Schering-Plough Corp.

hairy cell leukemia/

genital warts/

AIDS-related Kaposi's sarcoma/

non-A, non-B hepatitis C/

hepatitis B/

chronic malignant melanoma/

extended therapy for chronic viral hepatitis C/

treatment for follicular lymphoma in conjunction with chemotherapy/

treatment of hepatitis B in pediatric patients

June 1986

June 1988

Nov. 1988

Feb. 1991

July 1992

Dec. 1995

March 1997

Nov. 1997

Aug. 1998

LYMErixÖ

(recombinant OspA)

SmithKline Beecham Biologicals

prevention of Lyme disease

Dec. 1998

Neupogen«

(filgrastim)

Amgen

chemotherapy-induced neutropenia/

bone marrow transplant accompanied neutropenia/

severe chronic neutropenia/

autologous bone marrow transplant engraftment or failure/

mobilization of autologous PBPCs post-chemotherapy/

acute mycloid leukemia

Feb. 1991

June 1994

Dec. 1994

Dec. 1995

April 1998

Proleukin, IL-2«

(aldesleukin)

Chiron

treatment of kidney (renal) carcinoma/

treatment of metastatic melanoma

May 1992

Jan. 1998

PROVIGIL«

(modafinil) Tablets

Cephalon, Inc.

to improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy

Dec. 1998

Pulmozyme«

(dornase, alfa recombinant)

Genentech, Inc.

mild to moderate cystic fibrosis/

advanced cystic fibrosis/

pediatric use in infants 3 months to 2 years and children 2 to 4 years old

Dec. 1993

Dec. 1996

March 1998

Rebetron«

Schering-Plough Corp.

combination therapy for treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha-interferon treatment/

treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy

June 1998

Dec. 1998

Refludan«

(lepirudin (rDNA) for injection)

Hoechst Marion Roussel

for anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic complications

March 1998

Remicade«

(infliximab)

Centocor, Inc.

short-term management of moderately to severely active Crohn's disease including those patients with fistula

Aug. 1998

Renagel« Capsules

(sevelamer hydrochloride)

GelTex Pharmaceuticals, Inc./Genzyme General

reduction of serum phosphorus in patients with end-stage renal disease

Nov. 1998

Simulect«

(basiliximab)

Novartis Pharmaceutical Corporation/

Seragen, Inc.

for the prevention of acute rejection episodes in kidney transplant recipients

May 1998

SYNAGISÖ

(palivizumab)

MedImmune, Inc.

prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease

June 1998

Thyrogen«

(thyrotropin alfa for injection)

Genzyme General

adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer

Dec. 1998

VitraveneÖ

(fomivirsen sodium, injectable)

Isis Pharmaceuticals, Inc./CIBA Vision Corp.

treatment of cytomegalovirus (CMV) retinitis in patients with AIDS

Aug. 1998

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.