FDA Approves 20 New Biotech Products, 15 New Indications

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Washington, D.C. (January 9, 2003) - The Food and Drug Administration (FDA) approved 35 new biotechnology-based drugs and vaccines as well as new indications for previously approved products in 2002, up slightly from 2001, according to an analysis by the Biotechnology Industry Organization (BIO).

“More than half of the 155 biotech medicines available to patients and on the market today, were approved in just the last five years, demonstrating the steadily accelerating growth of the biotech industry,” said Carl B. Feldbaum, BIO president.

Of the 35 FDA approvals issued last year, 20 were for new medicines designed to treat such diseases as osteoporosis, hepatitis C, pulmonary arterial hypertension, cancer and multiple sclerosis.

“The increase in the number of FDA biotechnology product approvals last year means that many patients with debilitating and life-threatening illnesses now have their first-ever therapies and cures, and many others have vastly improved medical options available to them,” Feldbaum said. “More than 350 biotech products are in late-stage development for 200 serious diseases, and many of these represent significant medical advancements for patients suffering from conditions such as asthma, diabetes and HIV infection.”

“The Prescription Drug User Fee Act, which was renewed last year, should help reduce review and approval times at the FDA. With that law in place and a new Commissioner leading the agency, the drug approval process will continue to improve,” Feldbaum concluded.

The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. For more information on BIO, visit our Web site at www.bio.org.

Approved Biotechnology Drugs by Year

Biotech Drug Approvals 2002*
Total: 35
New products: 20
New indications: 15

New Products

Product   Company   Application (use)   Approval Date

AVINZA TM
(extended-release morphine sulfate)
  Ligand Pharmaceuticals and Elan Corp. plc   Once-daily treatment of moderate to severe pain in patients who require continuous opioid therapy for an extended period of time   March 2002

Eligard TM
(slow-release formulation of leuprolide acetate)
  Atrix Laboratories and Sanofi-Synthelabo   Advanced prostate cancer   January 2002 (additional formulation cleared in July 2002)

Elitek ®
(rasburicase)
  Sanofi-Synthelabo   Management of plasma uric acid levels in pediatric chemotherapy patients   July 2002

FortaFlex TM
(bioengineered collagen matrix)
  Organogenesis Inc. and Biomet Inc.   Rotator cuff repair   April 2002

FORTEO ®
(teriparatide, recombinant)
  Eli Lilly and Company   Treatment of osteoporosis in postmenopausal women at high risk of fracture, and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture   November 2002

Hepsera TM
(adefovir dipivoxil)
  Gilead Sciences Inc.   Chronic hepatitis B   September 2002

HUMIRA TM
(adalimumab)
  Cambridge Antibody Technologies and Abbott Laboratories   Patients with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more traditional disease modifying antirheumatic drugs   December 2002

Imagent ®
(perflexane lipid microspheres)
  Alliance Pharmaceutical Corp., Cardinal Health Inc. and InChord Communications Inc.   Imaging agent for use in echocardiography   June 2002

INFUSE TM
Bone Graft/LT-CAGE TM (device utilizing recombinant human bone morphogenetic protein [rhBMP-2])
  Wyeth and Medtronic Sofamor Danek   For use in spinal fusion surgery to treat certain types of spinal degenerative disease   July 2002

Mitozytrex
(MitoExtra TM proprietary version of mitomycin)
  SuperGen Inc.   Disseminated adenocarcinoma of the stomach or pancreas   November 2002

Neulasta TM
(pegfilgrastim)
  Amgen   Reduction of incidence of infection as manifested by febrile neutropenia in non-myeloid cancer patients receiving certain chemotherapies   January 2002

Orfadin ®
(nitisinone)
  Swedish Orphan International AB and Rare Disease Therapeutics Inc.   Hereditary tyrosinemia type 1   January 2002

Pediarix TM
(diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B [recombinant] and inactivated polio-virus vaccine combined)
  GlaxoSmithKline   Prevention of diphtheria, tetanus, pertussis, hepatitis B and polio   December 2002

Pegasys ®
(peginterferon alfa-2a)
  Roche and Inhale Therapeutics Inc.   Chronic hepatitis C patients with compensated liver disease who have not been previously treated with alpha interferon   October 2002

Rebif ®
(interferon beta 1-a)
  Serono SA and Pfizer Inc.   Relapsing forms of multiple sclerosis   March 2002

Remodulin TM
(treprostinil sodium)
  United Therapeutics Corp.   Treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise   May 2002

RESTASIS TM
(cyclosporine ophthalmic emulsion)
  Allergan Inc.   Chronic dry eye disease in patients whose tear production is presumed to be suppressed due to ocular inflammation   December 2002

SecreFlo TM
(synthetic porcine secretin)
  Repligen Corp.   Pancreatic assessment   April 2002

Xyrem ®
(sodium oxybate)
  Orphan Medical Inc.   Cataplexy associated with narcolepsy   July 2002

Zevalin TM
(ibritumomab tiuxetan)
  IDEC Pharmaceuticals Corp.   Relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma   February 2002

New Indications

Aranesp TM
(darbepoietin alfa)
  Amgen   Chemotherapy-induced anemia in patients with non-myeloid malignancies   July 2002

Argatroban   Texas Biotechnology Corp. and GlaxoSmithKline   Anticoagulant for use in patients with or at risk of heparin-induced thrombocytopenia undergoing percutaneous coronary interventions   April 2002

AVAGE TM
(tazarotene; also marketed as Tazorac ®)
  Allergan Inc.   Topical treatment of facial fine wrinkling, mottled hypo- and hyperigmentation, and benign facial lentigines   October 2002

BOTOX ® COSMETIC
(botulinum toxin type A)
  Allergan Inc.   Temporary improvement in appearance of moderate to severe glabellar lines (frown lines) in adults 65 or younger   April 2002

ENBREL ®
(etanercept)
  Amgen and Wyeth   Reduction of signs and symptoms of active arthritis in patients with psoriatic arthritis   January 2002

FOLLISTIM TM
(follitropin-beta)
  Organon (unit of Akzo Nobel)   Induction of spermatogenesis in men with primary and secondary hypo-gonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure   February 2002

Gleevec TM
(imatinib mesylate)
  Novartis AG   Treatment of Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal tumors; first-line treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia   February 2002;
December 2002

INTEGRA ®
Dermal Regeneration Template
  Integra Life Sciences Holding Corp and Ethicon Inc. (a unit of Johnson & Johnson)   Repair of scar contractures   April 2002

OLUX ® Foam
(clobetasol proprionate)
  Connetics Corp.   Short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas   December 2002

Pegasys ®
(peginterferon alfa-2a)
  Roche and Inhale Therapeutics Inc.   Combination therapy with ribavirin in patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with alpha interferon   December 2002

Prevnar ®
(pneumococcal 7-valent conjugate vaccine [diphtheria CRM-197 protein])
  Wyeth   Immunization of infants and toddlers against otitis media caused by vaccine serotypes   October 2002

REMICADE ®
(infliximab)
  Centocor Inc. (subsidiary of Johnson & Johnson)   Improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate; reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy   February 2002;
June 2002

SecreFlo TM
(synthetic porcine secretin)
  Repligen Corp.   Aid in location and cannulation of pancreatic ducts in patients undergoing endoscopic retrograde cholangiopancreatography   November 2002

Sources:
BioCentury Publications, BioCentury
BioWorld Publishing Group, BioWorld Today
CenterWatch.com
Recombinant Capital, Inc./Signalsmag.com
U.S. Food and Drug Administration (FDA)

* Note: This list includes novel biologics developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule, delivery-enhanced or tissue-engineered products. For a complete listing of FDA approvals from 1996 to the present, visit the agency's Web site at www.fda.gov. If you have questions about this list, please contact Debbie Strickland, BIO's director of publications, at (202) 962-9233.

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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.