Biotechnology PRESENTED by AMERICA’ S PHARMACEUTICAL COMPANIES 324 Biotechnology Medicines in Testing Promise to Bolster the Arsenal Against Disease
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2004Survey M EDICINES IN D EVELOPMENT Biotechnology PRESENTED BY AMERICA’ S PHARMACEUTICAL COMPANIES 324 Biotechnology Medicines in Testing Promise to Bolster the Arsenal Against Disease illions of people have already benefited from B IOTECHNOLOGY M EDICINES IN D EVELOPMENT— medicines and vaccines developed through B Y T HERAPEUTIC C ATEGORY* Mbiotechnology, and a new survey offers hope that many more will benefit in the future. The survey AIDS/HIV Infection/Related Conditions 17 found 324 biotechnology medicines in development for Autoimmune Disorders 26 Blood Disorders 2 nearly 150 diseases. These include 154 medicines for Cancer/Related Conditions 154 cancer, 43 for infectious diseases, 26 for autoimmune dis- Cardiovascular Disease 19 eases and 17 for AIDS/HIV and related conditions. These Diabetes/Related Conditions 10 potential medicines, all of which are either in human Digestive Disorders 11 clinical trials or under review by the Food and Drug Eye Conditions 5 Genetic Disorders 9 Administration, will bolster the list of 108 biotechnology Growth Disorders 3 medicines already approved and available to patients. Infectious Diseases 43 Neurologic Disorders 16 Approved biotechnology medicines treat or help prevent Respiratory Disorders 14 heart attacks, stroke, multiple sclerosis, leukemia, hepatitis, Skin Disorders 7 rheumatoid arthritis, breast cancer, diabetes, congestive Transplantation 3 heart failure, lymphoma, kidney cancer, cystic fibrosis, Other 17 and other diseases. These medicines are based on several *Some medicines are listed in more than one category. cutting-edge technologies. For example, most early biotechnology medicines were protein drugs, produced an epidermal growth factor inhibitor, which targets and by splicing genes into bacteria. They include recombi- blocks signaling pathways that are implicated in the growth nant insulin, human growth hormone, clotting factor for and survival of cancer cells. Monoclonal antibody medicines hemophilia patients, and erythropoietin to stimulate the in the pipeline target asthma, Crohn’s disease, rheumatoid production of red blood cells in kidney dialysis and arthritis, lupus, and various types of cancer. Therapeutic cancer patients. Another type of biotechnology medicine, vaccines, designed to jump-start the immune system to the monoclonal antibody, is a laboratory-made version of fight disease, are in development for AIDS and several the naturally occurring protein that binds to and neutral- types of cancer. Medicines based on antisense technol- izes foreign invaders. The first recombinant monoclonal ogy are potential treatments for AIDS, several types of antibody that inhibits angiogenesis—the formation of new cancer, Crohn’s disease and heart disease. Gene thera- blood vessels that feed tumors—was approved this year pies, which augment normal gene functions or replace for the treatment of metastatic colorectal cancer. or inactivate disease-causing genes, are being tested for Interferons, proteins that interfere with the ability of a cell several cancers, cystic fibrosis and heart disease. to reproduce, are the basis of existing medicines for These are only a few examples of new ways pharma- osteoporosis, chronic granulomatous disease, genital ceutical and biotechnology companies are attacking warts, multiple sclerosis, hairy cell leukemia and other disease. The 324 biotechnology medicines in develop- diseases. Antisense drugs are medicines that interfere ment promise to push the frontiers of science and bring with the communication process that tells a cell to more and better treatments to patients. produce an unwanted protein. The first antisense drug, for the treatment of cytomegalovirus retinitis in AIDS patients, was approved in 1998. The biotechnology medicines in development make Alan F. Holmer use of these and other state-of-the-art technologies. For President and CEO example, one medicine in the pipeline for lung cancer is PhRMA Biotechnology Medicines in Development AIDS/HIV INFECTION AND R ELATED C ONDITIONS Product Product Development Name Sponsor Category Indication Status Alferon LDO® Hemispherx Biopharma interferon HIV infection Phase I/II New Brunswick, NJ (888) 253-3766 Philadelphia, PA ALVAC E120TMG Aventis Pasteur vaccine HIV infection Phase III Swiftwater, PA (Thailand) (570) 839-4267 ALVAC MN120 Aventis Pasteur therapeutic HIV disease Phase I/II TMGMP Swiftwater, PA vaccine (570) 839-4267 Ampligen® Hemispherx Biopharma immune HIV infection/AIDS Phase II New Brunswick, NJ modulator (see also autoimmune) (215) 988-0080 Philadelphia, PA AVR 118 Advanced Viral Research immune-based cachexia associated with Phase I/II Yonkers, NY therapy AIDS (914) 376-7383 (see also cancer) Doxovir™ Redox Pharmaceutical HIV infection Phase I New York, NY (see also infectious) (212) 543-4530 GEM® 92 Hybridon antisense HIV infection Phase I completed Cambridge, MA (617) 679-5500 HE2000 Hollis-Eden Pharmaceuticals cellular therapy HIV infection/AIDS Phase I/II completed San Diego, CA (see also genetic, (858) 587-9333 infectious) HIV vaccine Chiron vaccine HIV infection Phase I Emeryville, CA www.hvtn.com National Institutes of Health Bethesda, MD HIV vaccine GlaxoSmithKline recombinant HIV infection prophylaxis Phase I Philadelphia, PA vaccine (888) 325-5249 Rsch. Triangle Park, NC HIV vaccine Merck vaccine treatment and prevention Phase I Whitehouse Station, NJ of HIV infection/AIDS (800) 672-6372 IL-2 Bayer interleukin HIV infection Phase I West Haven, CT (see also cancer) (203) 812-2000 MDX-010 Medarex MAb HIV infection Phase I/II Princeton, NJ (see also cancer) (609) 430-2880 Prosaptide™ Savient Pharmaceuticals neurostimulatory HIV-associated Phase II prosaptide East Brunswick, NJ peptide neuropathic pain (800) 284-2480 Remune® Immune Response immune-based HIV seropositive Phase II HIV-1 immunogen Carlsbad, CA therapy (760) 431-7080 Serostim® Serono recombinant HIV-related adipose Phase III somatropin Rockland, MA growth redistribution syndrome (800) 283-8088 (rDNA origin) hormone for injection 2 M EDICINES IN D EVELOPMENT Biotechnology 2004 AIDS/HIV INFECTION AND R ELATED C ONDITIONS Product Product Development Name Sponsor Category Indication Status VRC-HIVADV GenVec vaccine HIV infection Phase I 014-00-VP Gaithersburg, MD (240) 632-0740 Vaccine Research Center/ NIAID/NIH Bethesda, MD A UTOIMMUNE D ISORDERS Product Product Development Name Sponsor Category Indication Status ABT-874 Abbott Laboratories MAb autoimmune disease Phase II Abbott Park, IL (847) 936-1189 AMG108 Amgen MAb arthritis Phase II Thousand Oaks, CA (805) 447-1000 AMG531 Amgen platelet immune thrombocytopenic Phase II Thousand Oaks, CA stimulating purpura (ITP) (805) 447-1000 factor AMG714 Amgen MAb rheumatoid arthritis Phase II Thousand Oaks, CA (805) 447-1000 Ampligen® Hemispherx Biopharma immune chronic fatigue syndrome Phase III New Brunswick, NJ modulator (see also AIDS/HIV) (215) 988-0080 Philadelphia, PA anti-CD20 Immunomedics MAb autoimmune disease Phase I humanized Morris Plains, NJ (see also cancer) (973) 605-8200 anti-clonal antibody anti-TGF beta Genzyme MAb diffuse scleroderma Phase II (Orphan Drug) Cambridge, MA (800) 745-4447 Avonex® Biogen Idec interferon chronic inflammatory Phase II interferon beta-1a Cambridge, MA demyelinating (617) 679-2000 polyneuropathy (CIDP) CDP 870 Nektar Therapeutics pegylated rheumatoid arthritis Phase III San Carlos, CA antibody (650) 631-3100 fragment eculizumab Alexion Pharmaceuticals MAb lupus nephritis, Phase II (Orphan Drug) Cheshire, CT membranous nephritis, (203) 272-2596 rheumatoid arthritis (see also skin) humanized Genentech MAb rheumatoid arthritis Phase I/II anti-CD20 South San Francisco, CA (650) 225-1000 (PRO70769) Humira Abbott Laboratories MAb ankylosing spondylitis, Phase III adalimumab Abbott Park, IL juvenile rheumatoid (847) 936-1189 arthritis, psoriatic arthritis (see also digestive, skin) interferon InterMune interferon idiopathic pulmonary Phase III gamma Brisbane, CA fibrosis (415) 466-2200 (see also cancer) M EDICINES IN D EVELOPMENT Biotechnology 2004 3 A UTOIMMUNE D ISORDERS Product Product Development Name Sponsor Category Indication Status interleukin-1 Regeneron Pharmaceuticals interleukin rheumatoid arthritis Phase II trap Tarrytown, NY (914) 345-7400 ISIS 104838 Isis Pharmaceuticals antisense rheumatoid arthritis Phase II Carlsbad, CA (800) 679-ISIS LymphoStat-B™ Human Genome Sciences MAb rheumatoid arthritis, Phase II Rockville, MD systemic lupus www.hgsi.com erythematosus MDX-018 Medarex MAb autoimmune disease Phase I/II Princeton, NJ (609) 430-2880 MLN 1202 Millennium MAb rheumatoid arthritis Phase II Pharmaceuticals (800) 589-9005 Cambridge, MA MM-093 Merrimack Pharmaceuticals recombinant rheumatoid arthritis Phase II (recombinant Cambridge, MA protein (617) 441-1000 human alpha-fetoprotein) R1569 MRA Roche MAb juvenile idiopathic Phase II (tocilizumab) Nutley, NJ arthritis, rheumatoid (973) 235-5000 arthritis Rituxan® Genentech MAb anti-TNF refractory Phase III rituximab South San Francisco, CA rheumatoid arthritis (650) 225-1000 Biogen Idec (see also cancer) Cambridge, MA --------------------------------------------------------------- primary progressive Phase II/III multiple sclerosis (650) 225-1000 --------------------------------------------------------------- moderate to severe Phase II rheumatoid arthritis (650) 225-1000 TACI-lg Serono recombinant lupus Phase II Rockland, MA protein (see also cancer) (800) 283-8088 --------------------------------------------------------------- rheumatoid Phase I arthritis (800)