Plunkett's Biotech & Genetics Industry Almanac 2003-2004 (Plunkett's Biotech & Genetics Industry Almanac)

539 Pages·2004·4.32 MB·English

by  Jack W. Plunkett

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Plu nkett's Biotech & Genetics Industry

Almanac 2003-2004

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PLUNKETT’S
BIOTECH &
GENETICS
INDUSTRY
ALMANAC
2003-2004

The Only Comprehensive

Guide to Biotech Companies and Trends

Jack W. Plunkett

Published by:
Plunkett Research, Ltd., Houston, Texas
www.plunkettresearch.com
PLUNKETT’S
BIOTECH & GENETICS
INDUSTRY
ALMANAC 2003-2004

Editor and Publisher:
Jack W. Plunkett

Executive Editor and Database Manager: Web Page Design:
Martha Burgher Plunkett Darren Smith

Senior Editors and Researchers: Cover Design:
Elisa Gabbert Kim Paxson, Just Graphics
Ghazal Siddiqi Junction, TX

Editors, Researchers and Assistants: Special Thanks to:
Christie Manck Burrill & Company
Ray Marumahoko San Francisco, CA
Mariya Paterwic Food and Drug Administration
Suzanne Zarosky U.S. Dept. of Health and Human Services
National Human Genome Research Institute
Information Technology Director: U.S. National Institutes of Health
Alex Preskovsky Patent and Trademark Office
U.S. Department of Commerce
E-Commerce Manager: Pharmaceutical Research and Manufacturers of
Robert Daniel America
Washington, D.C.

Plunkett Research, Ltd.
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Copyright  2003 by Plunkett Research, Ltd.
All rights reserved. No part of this book may be reproduced or transmitted in any form by any means, electronic
or mechanical, including by photocopying or by any information storage or retrieval system, without the written
permission of the publisher.

Published by:
Plunkett Research, Ltd.
P. O. Drawer 541737
Houston, Texas 77254-1737 USA

Phone: [phone]
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ISBN # 1-891775-98-7

Disclaimer of liability
for use and results of use:
The editors and publishers assume no responsibility for your own success in making an investment or business
decision, in seeking or keeping any job, in succeeding at any firm or in obtaining any amount or type of benefits
or wages. Your own results and the job stability or financial stability of any company depend on influences
outside of our control. All risks are assumed by the reader. Investigate any potential employer or business
relationship carefully and carefully verify past and present finances, present business conditions and the level of
compensation and benefits currently paid. Each company's details are taken from sources deemed reliable;
however, their accuracy is not guaranteed. The editors and publishers assume no liability, beyond the actual
payment received from a reader, for any direct, indirect, incidental or consequential, special or exemplary
damages, and they do not guarantee, warrant nor make any representation regarding the use of this material.
Trademarks or tradenames are used without symbols and only in a descriptive sense, and this use is not authorized
by, associated with or sponsored by the trademarks’ owners. Ranks and ratings are presented as an introductory
and general glance at corporations, based on our research and our knowledge of businesses and the industries in
which they operate. The reader should use caution.
PLUNKETT'S
BIOTECH & GENETICS
INDUSTRY ALMANAC 2003-2004

CONTENTS

A Short Biotech & Genetics Glossary i
Introduction 1
How To Use This Book 3
Chapter 1: Major Trends & Technologies Affecting the Biotech & Genetics Industry 7
Chapter 2: Biotech & Genetics Industry Statistics 25
Chapter 3: Biotech & Genetics Industry Contacts 41
Addresses, Telephone Numbers and World Wide Web Sites
Chapter 4: THE BIOTECH & GENETICS 400:
Who They Are and How They Were Chosen 53
Industry List, With Codes 54
Index of Rankings Within Industry Groups 55
(The Biotech & Genetics 400 grouped by industry and ranked
for sales and profits)
Alphabetical Index 64
Index of Headquarters Location by State 67
Index of Headquarters Location by Country 71
Index by Regions Where the Biotech & Genetics 400 Have Locations 72
Index by Firms With International Operations 78
Individual Profiles on each of THE BIOTECH & GENETICS 400 81
Appendix: Biotech Research Techniques & Genetic Illustrations 477
Additional Indexes
Index of Hot Spots for Advancement for Women/Minorities 498
Index of Subsidiaries, Brand Names and Selected Affiliations 500

List of Major Tables and Charts
Biotechnology Industry Profile, 2001: U.S., Europe and Canada 26
Total R&D Investments by Research-Based Pharmaceutical Companies: 1970-2001 27
Domestic R&D as a Percentage of Sales, U.S. Research-Based Pharmaceutical
Companies: 1970-2001 28
Annual Percent Change in U.S. Research & Development by Research-Based
Pharmaceutical Companies: 1980-2001 29
U.S. Biotech Industry Financing, 2001 30
U.S. Biotech Industry Fundraising, 1996-Third Quarter 2002 31
Top 20 Global Biotech and Pharmaceutical Companies, 2001 32
Major Biotechnology Company Consolidations, 1st through 3rd Quarter 2002 33
The U.S. Drug Discovery, Development and Approval Process 34
Total U.S. Biotechnology Patents Granted Per Year, 1985-2000 35

Continued on Next Page
Continued from Previous Page

New U.S. Biotech Drug and Vaccine and Indication Approvals, 1982-2001 36
U.S. Drug Development Times 37
U.S. FDA Approval Times for New Drugs, 1987-2001 38
Average Salaries in the U.S. Pharmaceutical and Biotechnology Industries: 2002 39
Global Agricultural Biotech At A Glance, 2001 40

List of Illustrations
Andenovirus 481
Amino Acid 482
Antibody 482
Base Pair 483
Blastocyst 484
Chromosome 485
Cytogenetic Map 486
DNA 487
DNA Replication 488
Enzyme 489
Gene 489
Microarray Technology 490
Nucleotide 491
Protein 493
RNA 494
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A Short Biotech & Genetics Industry systems, such as microarrays, multiple detectors
(probes) are positioned in an array in order to best do
Glossary
research. See “Microarray” below.

Assay: A laboratory test to identify and/or measure
510 K: The application filed with the FDA for a new the amount of a particular substance in a sample.
medical device to show that the apparatus is Types of assays include: endpoint assay, in which a
“substantially equivalent” to one that is already single measurement is made at a fixed time; kinetic
marketed. assay, in which increasing amounts of a product are
formed with time and are monitored at multiple
ADME: Absorption, Distribution, Metabolism and points; microbiological assay, which is a
Excretion. In clinical trials, the bodily processes measurement of the concentration of antimicrobials
studied to determine the extent and duration of in biological material; and immunological assay, in
systemic exposure to a drug. which an analysis or measurement is based on
antigen-antibody reactions.
AE (Adverse Event): In clinical trials, a condition
not observed at baseline or worsened if present at Baseline: A set of data used in clinical studies for
baseline. Sometimes called Treatment Emergent control or comparison.
Signs and Symptoms (TESS).
Basic Research: Attempts to discover compounds,
Amino Acid: Any of a class of 20 molecules that materials, processes or other items that may be
combine to form proteins. largely or entirely new and/or unique. Basic research
may start with a theoretical concept that has yet to be
ANDA (Abbreviated New Drug Application): An proven. The goal is to create discoveries that can be
application filed with the FDA for a drug showing moved along to “applied research.” Basic research is
that the substance is the same as an existing, sometimes referred to as “blue sky” research.
previously approved drug (i.e., a generic version).
Bioavailability: In pharmaceuticals, the rate and
Angiogenesis: Blood vessel formation, typically in extent to which a drug is absorbed or is otherwise
the growth of malignant tissue. available to the treatment site in the body.

Antibody: A protein produced by white blood cells Bioequivalence: In pharmaceuticals, the
in response to a foreign substance (see “Antigen”). demonstration that a drug’s rate and extent of
Each antibody can bind only to one specific antigen. absorption are not significantly different from those
of an existing drug that is already approved by the
Antigen: A foreign substance that causes the immune FDA.
system to create an antibody (see “Antibody”).
Bioinformatics: Computer-simulated generation and
Antisense Technology: The use of RNA-like testing of new chemical compounds for possible drug
oligonucleotides that bind to RNA and inhibit the use. This method is much faster and more cost-
expression of a gene. effective than manual methods.

Apoptosis: A normal cellular process leading to the Biologic: Any virus, therapeutic serum, toxin,
termination of a cell’s life. antitoxin, vaccine, blood, blood component or
derivative, allergenic or analogous product or
Applied Research: The application of compounds, arsphenamine or one of its derivatives (or any other
processes, materials or other items discovered during trivalent organic arsenic compound) applicable to the
“basic research” to practical uses. The goal is to prevention, treatment or cure of disease or injury.
move discoveries along to the final development
phase. Biopharmaceuticals: That portion of the
pharmaceutical industry focused on the use of
Array: An orderly arrangement, such as a biotechnology to create new drugs.
rectangular matrix of data. In some laboratory
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Biotechnology: A set of powerful tools that employ Class II Device: An FDA classification of medical
living organisms (or parts of organisms) to make or devices. Performance standards and special controls
modify products, improve plants or animals are sufficient to ensure safety and efficacy.
(including humans) or develop microorganisms for
specific uses. Early uses of biotechnology included Class III Device: An FDA classification of medical
traditional animal and plant breeding techniques and devices. Pre-market approval is required to ensure
the use of yeast in making bread, beer, wine and safety and efficacy, unless the device is substantially
cheese. Today, biotechnology is most commonly equivalent to a currently marketed device. (See “510
thought of to include the development of human K” above.)
medical therapies and processes using recombinant
DNA, cell fusion, other genetic techniques and Clone: A group of identical genes, cells or organisms
bioremediation. derived from one ancestor; an identical copy. “Dolly”
the sheep is a famous case of cloning a replica of an
Blastocyst - A fertilized embryo, aged four to eleven animal. (Also see "Cloning-Reproductive" and
days, which consists of multiplying cells both outside "Cloning-Therapeutic.")
and inside a cavity. It is the blastocyst that embeds
itself in the uterine wall and ultimately develops into Cloning-Reproductive: A method of reproducing an
a fetus. Blastocysts are utilized outside the womb exact copy of an animal, or potentially an exact copy
during the process of stem cell cultivation. of a human being. A scientist removes the nucleus
from a donor's unfertilized egg, inserts a nucleus
CANDA (Computer-Assisted New Drug from the animal to be copied and then stimulates the
Application): An electronic submission of a new nucleus to begin dividing to form an embryo. In the
drug application (NDA) to the FDA. case of a mammal, such as a human, the embryo
would then be implanted in the uterus of a host
CAPLA (Computer-Assisted Product License female. Also see "Cloning-Therapeutic."
Application): An electronic submission of a
biological product license application (PLA) to the Cloning-Therapeutic: A method of reproducing
FDA. exact copies of cells needed for research or for the
development of replacement tissue or organs. A
CBER (Center for Biologics Evaluation and scientist removes the nucleus from a donor's
Research): The branch of the FDA responsible for unfertilized egg, inserts a nucleus from the animal, or
the regulation of biological products, including human, whose cells are to be copied and then
blood, vaccines, therapeutics and related drugs and stimulates the nucleus to begin dividing to form an
devices, to ensure purity, potency, safety, availability embryo. However, the embryo is never allowed to
and effectiveness. www.fda.gov/cber grow to any significant stage of development.
Instead, it is allowed to grow for a few hours or days
CDER (Center for Drug Evaluation and and stem cells are then removed from it for use in
Research): The branch of the FDA responsible for regenerating tissue. Also see "Cloning-
the regulation of drug products. www.fda.gov/cder Reproductive."

CDRH (Center for Devices and Radiological Combinatorial Chemistry: After researchers
Health): The branch of the FDA responsible for the determine which protein is involved in a specific
regulation of medical devices. www.fda.gov/cdrh disease, they use combinatorial chemistry to find the
molecule that controls the protein. This advanced
Chromosome: A structure that contains genes and is computer technique enables scientists to use
found in the nucleus of a cell. Chromosomes are automatic fluid handlers to mix chemicals under
found in pairs. specific test conditions at extremely high speed.
Combinatorial chemistry can generate thousands of
Class I Device: An FDA classification of medical chemical compound variations in a few hours.
devices. General controls are sufficient to ensure Previously, traditional chemistry methods could have
safety and efficacy. required several weeks to do the same work.

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Complementary-DNA: cDNA, also called “copy Device: In medical product development, according
DNA,” is a sequence acquired by copying a to the FDA, an instrument, apparatus, implement,
messenger RNA (mRNA) molecule back into DNA. machine, contrivance, implant, in vitro reagent or
In contrast to the original DNA, mRNA codes for an other similar or related article, including any
expressed protein without non-coding DNA component, part or accessory, that 1) is recognized in
sequences (“introns”). Therefore, a cDNA probe can the official National Formulary or United States
also be used to find the specific gene in a complex Pharmacopoeia or any supplement to them, 2) is
DNA sample from another organism with different intended for use in the diagnosis of disease or other
non-coding sequences. conditions, or in the cure, mitigation, treatment or
prevention of disease, in man or animals or 3) is
Coordinator: In clinical trials, the person at an intended to affect the structure of the body of man or
investigative site who handles the administrative animals and does not achieve any of its principal
responsibilities of a clinical trial acts as a liaison intended purposes through chemical action within or
between the investigative site and the sponsor and on the body of man or animals and is not dependent
reviews data and records during a monitoring visit. upon being metabolized for the achievement of any
of its principal intended purposes.
CPMP (Committee on Proprietary Medicinal
Products): A committee, composed of two people Diagnostic Radioisotope Facility: In medicine, the
from each EU member state (see “EU” below) that is use of radioactive isotopes (radiopharmaceuticals) as
responsible for the scientific evaluation and tracers or indicators to detect an abnormal condition
assessment of marketing applications for medicinal or disease in the body.
products in the EU. The CPMP is the major body
involved in the harmonization of pharmaceutical Distributor: Distributors do not manufacture but
regulations within the EU and receives administrative may be involved in sales, marketing, warehousing or
support from the European Medicines Evaluation shipping of drugs and/or medical devices. In
Agency. (See “EMEA” below.) medicine, distributors are subject to medical device
incident reporting, record keeping, tracking and
CRA (Clinical Research Associate): An individual registration and certification requirements under the
responsible for monitoring clinical trial data to ensure Safe Medical Devices Act (see “SMDA” below).
compliance with study protocol and FDA GCP
regulations. DMB (Data Monitoring Board): A committee that
monitors the progress of a clinical trial and carefully
CRF (Case Report Form): In clinical trials, a observes the safety data.
standard document used by clinicians to record and
report subject data pertinent to the study protocol. DNA: (Deoxyribonucleic Acid): The carrier of the
genetic information that cells need to replicate and to
CRO (Contract Research Organization): An produce proteins.
independent organization that contracts with a
sponsor of a clinical investigation to conduct part of DNA Chip: The DNA microchip is a revolutionary
the work on a clinical study. Drug makers and tool used to identify mutations in genes like BRCA1
medical device makers frequently outsource work to and BRCA2. The chip, which consists of a small
CROs. glass plate encased in plastic, is manufactured using a
process similar to the one used to make computer
CRT (Case Report Tabulation): In clinical trials, a microchips. On the surface, each chip contains
tabular listing of all data collected on study case synthetic single stranded DNA sequences identical to
report forms. a normal gene.

Development: The phase of research and Drug Utilization Review: A quantitative assessment
development in which researchers attempt to create of patient drug use and physicians’ patterns of
new products from the results of discoveries and prescribing drugs in an effort to determine the
applications created during basic and applied usefulness of drug therapy.
research.

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