WASHINGTON, Jan. 5 /PRNewswire/ -- Former Pennsylvania congressman James Greenwood has assumed the post of president of the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 member organizations across three major areas of research and development: healthcare, food and agriculture, and industrial and environmental biotechnology. Carl B. Feldbaum, president of BIO from its inception in 1993, has retired.
"The biotechnology industry is dedicated to solving humanity's toughest problems; it's creating cures for heartbreaking diseases, improved crops for better nutrition, and clean biofuels for a better environment," said Greenwood. "In 2004, the industry delivered on all fronts, with dozens of new products reaching consumers."
The future looks bright for the next generation of companies and products as well. Investment in private biotechnology companies -- almost all of them small research-and-development firms funded by venture capitalists -- hit a record $5 billion in 2004, while the industry as a whole raised more than $20 billion.
"These investments are funding discovery and development of products across the biotech spectrum -- new crops, new industrial processes for consumer goods, and new therapies in virtually every major disease category, including infection, diabetes, obesity, cardiovascular disease, neurodegenerative disorders and cancer," said Greenwood. "This industry has never been financially stronger or scientifically more innovative. Our momentum as we enter 2005 is impressive."
FDA Approves Breakthrough Therapies
The FDA in 2004 approved 32 new therapeutic products discovered, developed or marketed by biotechnology and related companies, according to a BIO analysis. The approvals include the first cancer drug designed to stop the growth of the blood vessels that feed tumors (Avastin), two cancer drugs targeting a cancer growth factor (Erbitux and Tarceva), and new medicines for multiple sclerosis, macular degeneration, and pain. (See chart that follows for details.)
"More than 800 million patients have benefited from biotech medicines and vaccines already, and millions more will benefit in the future," said Greenwood. "Literally hundreds of products are in the development queue."
Biotech companies also are leading a revolution in molecular diagnostics, including pharmacogenomic products that get the right drugs to the right patients. 2004 ended with the FDA's approval of a first-of-its-kind genotyping test that helps doctors and patients select medications and doses for treatment of cardiac disease, psychiatric disease and cancer.
At the earlier end of the pipeline, two critical fields of research -- biodefense and embryonic stem cells -- both got a boost in 2004. The new federal BioShield law provides $5.6 billion over 10 years to procure vaccines, therapies and other products critical to protecting against bioterrorism. At the state level, California voters passed a $3 billion, 10-year initiative to fund embryonic stem cell research. Because embryonic stem cells can become any type of body cell, they have great potential for replacing cells, tissues and organs ravaged by disease and injury. Already, these cells have reversed paralysis in animal models.
Biotech Agriculture Expands
Biotech crop adoption continued to soar in 2004, nine years after the introduction of the first biotech staple crops. In the United States, biotech varieties accounted for 85 percent of soybeans, 76 percent of cotton, and 45 percent of corn. Six biotech crops (canola, corn, cotton, papaya, soybean and squash) were found to increase U.S. grower incomes by $1.9 billion and crop yields by 5.3 billion pounds, while reducing pesticide use by 46.4 million pounds, according to a new study from the National Center for Food and Agricultural Policy.
The impact of biotech crops is rapidly expanding in the rest of the world. A December study from food and trade policy analyst C. Ford Runge found that biotech crops are now being grown in 18 countries, and research and development is being conducted in another 45 countries. The global commercial value of biotech crops grown in the 2003-2004 crop year was $44 billion, according to the study.
"Biotechnology lifts farmer income and cuts erosion and pesticide use, benefits that farmers both here in the U.S. and in developing countries appreciate," said Greenwood. "Moreover, growth will continue: The pipeline is packed with agricultural products that will further increase yields -- and deliver health and safety benefits to consumers."
Those products include drought-tolerant wheat, crops with higher levels of protein and antioxidants, livestock free of E. coli and immune to mad cow disease, and fish with higher levels of healthy fat and lower levels of contaminants such as mercury.
Milestones for Industrial & Environmental Biotech
A third major sector of biotechnology -- industrial and environmental (I&E) biotech -- is making giant strides in clean energy production and green manufacturing, bringing biotech to everyday products such as clothing, plastic cups, laundry detergent and vitamins. I&E replaces conventional manufacturing techniques with bioprocesses that generate less waste, consume less energy and, in many cases, save money.
"With these applications, biotechnology is providing the tools for sustainable, environmentally sound economic growth," said Greenwood. "That's revolutionary, not evolutionary, and the future impact could be of an even greater magnitude than biotech's contributions to healthcare and agriculture."
That impact starts with energy. April 2004 brought the first commercial production of bioethanol -- ethanol made from agricultural wastes and grasses with the help of biotech enzymes. BIO member Iogen Corp. of Ottawa, Canada, produced the fuel using wheat straw. According to the Natural Resources Defense Council, bioethanol could supply half of America's transportation fuel needs by 2050 if development is aggressive.
"We could cut both greenhouse emissions and our dependence on imported oil, all while boosting income for America's farmers and creating new jobs in the nation's heartland," said Greenwood. "The future will bring energy security and economic growth, thanks to biotechnology."
2004 brought other milestones in industrial and environmental biotechnology. DuPont joined forces with a British sugar producer, Tate & Lyle, to make a synthetic polymer for textiles using corn instead of petroleum. And Maxygen subsidiary Codexis signed an agreement with Pfizer to provide access to its technology for finding biotech solutions to improve small-molecule drug manufacturing processes.
Also in 2004, BIO published New Biotech Tools for a Cleaner Environment, a report analyzing the potential impact of industrial biotech on conventional manufacturing. Among other things, the study found that biotech processes can reduce toxic sludge waste volumes and energy requirements in paper bleaching by 40 percent; slash water usage for textile finishing by up to 60 percent and air emissions by almost 50 percent; and can cut air emissions associated with production of vitamin B2 and the antibiotic cephalexin by 50 to 80 percent.
Outlook Bright
With a spate of new products hitting the market, Ernst & Young projects industry revenues will rise almost 20 percent, to $51.4 billion, in 2005. That growth is driving employment gains that are expected to outpace the general economy at least through 2012, according to calculations based on U.S. Labor Department statistics.
"Growth is accelerating in dozens of regions in America, and it encompasses both startups and large-cap firms," said Greenwood. "That record of growth will help BIO in the coming months as we pursue a policy agenda designed to ensure the financial markets and regulatory system continue to support this innovative industry, which has come so far, so fast, but still has a long way to go."
About BIO
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.
Selected Biotechnology and Biotech-Related FDA Approvals, 2004*
New Products
Product Company Indication Approval
Date
Avastin(TM) Genentech First-line treatment of 2/26/04
(bevacizumab) metastatic colorectal cancer,
in combination with 5-
fluorouracil-based chemotherapy
Captique(TM) Genzyme Corp. Facial wrinkle correction 11/12/04
Injectable and Inamed
Gel (non- Corp.
animal
stabilized
hyaluronic
acid)
CLOLAR(TM) Genzyme Corp. Refractory or relapsed acute 12/24/04
(clofarabine) lymphoblastic leukemia in
children
Codeprex(TM) Celltech Cough relief; 12-hour dosing 6/21/04
Extended- Group plc
Release
Suspension
CIII (codeine
polistirex/
chlorpheniramine
polistirex)
DepoDur(TM) Endo Pharma- Pain following major surgery 5/18/04
(morphine ceuticals
sulfate Inc. and
extended- SkyePharma plc
release
liposome
injection)
ERBITUX(TM) ImClone Combination treatment with 2/12/04
(cetuximab) Systems Inc. irinotecan for metastatic
and Bristol- colorectal cancer that is
Myers Squibb refractory to irinotecan alone
and that expresses the epidermal
growth factor receptor; for use
as a single agent in patients of
intolerant irinotecan and whose
cancer expresses EGFR
Evoclin(TM) Connetics Acne vulgaris 10/22/04
(clindamycin) Corp.
Foam, 1%
(formerly
Actiza(TM))
FOSRENOL AnorMED Inc. Reduction of blood phosphate 10/26/04
and Shire levels in patients undergoing
Pharmaceuticals kidney dialysis
Group
Hylaform(R) Genzyme Corp. Correction of moderate to 4/22/04
(Hylan-B gel) and Inamed severe facial wrinkles and
Corp. folds (such as nasolabial
folds)
Hylaform(R) Genzyme Corp. Correction of moderate to 10/13/04
Plus (Hylan-B and Inamed severe facial wrinkles and
gel; large- Corp. folds
particle size
hyaluronic
acid-based
dermal filler)
ISTOLOL(TM) ISTA Glaucoma 6/4/04
(timolol) Pharmaceu-
ticals and
Senju
Pharmaceutical
Co.
Kepivance(TM) Amgen Severe oral mucositis in cancer 12/15/04
(palifermin) patients with hematologic blood
cancers undergoing high-dose
chemotherapy, with or without
radiation, followed by a bone
marrow transplant
LUNESTA(TM) Sepracor Insomnia 12/15/04
(eszopiclone; Inc.
formerly
Estorra)
Luveris(R) Serono For concomitant use with 10/8/04
(lutropin Gonal-f(R) (follotropin alfa
alfa for for injection) for stimulation
injection) of follicular development in
infertile hypogonadotropic
hypogonadal women with profound
luteinizing hormone deficiency
Macugen(R) Eyetech Neovascular (wet) age-related 12/17/04
(pegaptanib Pharmaceu- macular degeneration
sodium ticals Inc.
injection) and Pfizer***
Metvixia PhotoCure Photodynamic treatment of 7/27/04
(methyl ASA and actinic keratosis
aminoleyulinate; Galderma SA
developed under
the trade name
Metvix(R))
NeutroSpec(TM) Palatin Diagnosis of appendicitis in 7/2/04
(Technetium Technologies patients with equivocal signs
[99m Tc] and
fanolesomab; Mallinckrodt
formerly Imaging (Tyco
LeuTech(R)) Healthcare)
Nuflexxa(TM) Savient Pain associated with 12/7/04**
(1% sodium Pharma- osteoarthritis of the knee in
hyaluronate) ceuticals patients who have failed
Inc. to respond adequately to
conservative non-pharmacologic
therapy and simple analgesics
ORTHOVISC(R) Anika Pain in patients suffering from 2/4/04
(high Therapeutics osteoarthritis of the knee who
molecular Inc. and have failed to respond
weight Ortho Biotech adequately to conservative non-
hyaluranon) Products LP pharmacologic therapy and to
simple analgesics
PRIALT(R) Elan Corp. Management of severe chronic 12/28/04
(ziconotide plc pain in patients for whom
infusion) intrathecal therapy is
warranted and who are
intolerant of or refractory to
other treatment, such as
systemic analgesics, adjunctive
therapies or IT morphine
SANCTURA(TM) Indevus Overactive bladder with symptoms 5/28/04
(trospium Pharmaceu- of urge urinary incontinence,
chloride) ticals Inc. urgency and urinary frequency
and Odyssey
Pharma-
ceuticals
Inc. (sub-
sidiary of
PLIVA)
Sensipar(R) NPS Pharmaceu- Secondary hyperparathyroidism 3/8/04
(cinacalcet ticals Inc. in chronic kidney disease
HCl) and Amgen patients on dialysis and for
the treatment of elevated
calcium levels (hypercalcemia)
in patients with parathyroid
carcinoma
Tarceva(TM) OSI Locally advanced or metastatic 11/18/04
(erlotinib) Pharmaceu- non-small-cell lung cancer
ticals Inc. after failure of at least one
and Genentech prior chemotherapy regimen
Taxus(TM) Angiotech Improving luminal diameter in 3/4/04
Express2(TM) Pharmaceu- native coronary arteries for
(paclitaxel- ticals Inc. treatment of de novo lesions
eluting and Boston
coronary Scientific
stent) Corp.
Truvada(TM) Gilead HIV (as part of combination 8/2/04
(emtricitabine Sciences therapy)
and tenofovir
disoproxil
fumarate)
TYSABRI(R) Biogen Idec Reduction of clinical relapse 11/23/04
(natalizumab; and Elan frequency in relapsing forms
formerly Corp. of multiple sclerosis
ANTEGREN(R))
Ventavis(TM) CoTherix Inc. Pulmonary arterial hypertension 12/29/04
(iloprost) and Schering in patients with NYHA Class III
Inhalation AG or IV symptoms
Solution
Vidaza(TM) Pharmion Myelodysplastic syndromes 5/19/04
(azacitidine) Corp. (all five subtypes)
Vitrase(R) ISTA Spreading agent to facilitate 5/5/04
(hyaluronidase Pharmaceu- facilitate dispersion and
for injection; ticals Inc. absorption of other drugs
(lyo-philized,
ovine)
XIFAXAN(TM) Salix Travelers' diarrhea caused 5/25/04
(rifaximin) Pharmaceu- by noninvasive strains of
ticals Ltd. E. coli in patients 12
years of age and older
ZEGERID(TM) Santarus 20 mg dose approved for 6/15/04;
(omeprazole Inc. short-term treatment of 12/22/04**
powder for active duodenal ulcer,
oral for heartburn and other
suspension) symptoms associated with
gastro-esophageal reflux
disease (GERD), for the
short-term treatment of
erosive esophagitis that
has been diagnosed by
endoscopy, and for the
maintenance of healing
of erosive esophagitis;
40 mg formulation
subsequently approved for
reduction of risk of upper
GI bleeding in critically
ill patients and the
short-term treatment
of benign gastric ulcers
Zylet(TM) Pharmos Corp. Steroid-responsive 12/14/04
(loteprednol and inflammatory ocular
etabonate and Bausch & conditions for which a
superficial Lomb corticosteroid is
tobramycin indicated and where
ophthalmic superficial bacterial or
suspension) a risk of ocular
infection exists
New Indications
BOTOX(R) Allergan Primary axillary 7/19/04
(botulinum hyperhidrosis
toxin type A) inadequately managed
with topical agents
Enbrel(R) Amgen New indication for the 4/30/04;
(etanercept) treatment of adults with 9/24/04
chronic moderate to severe
plaque psoriasis who are
candidates for systemic therapy
or phototherapy; FDA approved
new labeling allowing an
indication of induction of
major clinical response in
patients with rheumatoid
arthritis
Hectorol(R) Bone Care Additional indication of 4/23/04
(doxercal- International secondary hyperparathyroidism
icferol) Inc. that develops in earlier stages
Capsules of chronic kidney disease
prior to dialysis
INFUSE(R) Wyeth and Acute, open tibia shaft 4/30/04
Bone Graft Medtronic fractures in adults
(recombinant Sofamor Danek
human bone
morphogenetic
protein-2/
absorbable
collagen
sponge)
HUMIRA(R) Cambridge Expanded indication to include 7/30/04
(adalimumab) Antibody improvement in physical
Technology function for adult patients with
and Abbott moderately to severely active RA
Laboratories
PROVIGIL(R) Cephalon Inc. Excessive sleepiness 1/23/04
(modafinil) associated with obstructive
Tablets sleep apnea/hypopnea syndrome
and shift-work sleep disorder
REMICADE(R) Centocor FDA approved expanded label 9/29/04
(infliximab) (subsidiary for Remicade in combination
of Johnson with methotrexate as first-
& Johnson) line regimen in patients with
moderate to severe rheumatoid
arthritis
Saizen(R) Serono Replacement of endogenous 8/26/04
(somatropin) growth hormone in adults
with growth hormone deficiency
Other FDA Approvals of Interest
Campath(R) Genzyme Corp. FDA approved single-use vial 10/18/04**
(alemtuzumab) and Belex Inc. (drug is used for chronic
(unit of B-cell lymphocytic leukemia in
Schering AG) patients who have been treated
with alkylating agents and who
have failed fludarabine therapy)
Eligard 45 mg QLT Inc. and Six-month sustained release 12/14/04
(leuprolide) Aventis formulation (drug is used
Sanofi-Group for palliative treatment of
advanced prostate cancer)
Enbrel(R) Amgen Updated radiographic data 9/24/04;
(etanercept) demonstrating more than half 9/27/04
of Enbrel patients in an
open-label, long-term study
experienced no progression
of joint damage for up to five
years; new 50 mg/ml prefilled
syringe for use in all approved
adult indications
FUZEON(R) Trimeris Inc. Product granted traditional 10/15/04
(enfuvirtide) and Roche approval (HIV drug previously
granted accelerated approval
in March 2003)
Gonal-f(R) Serono Inc. FDA approved prefilled device 5/25/04
RFF Pen (drug is used for infertility)
(follitropin
alfa
injection)
Norditropin Novo Nordisk Prefilled pen (treats adults 10/1/04
Nordiflex(R) A/S growth hormone deficiency)
(somatropin
[rDNA]
injection)
Pegasys(R) Nektar Prefilled syringes approved for 1/8/04**
(peginterferon Therapeutics treatment of chronic hepatitis C
alfa-2a) Inc. and Roche
Rebif(R) Serono Inc. New-patient dosing of multiple 12/22/04
Titration sclerosis drug
Pack
(interferon
beta-1a)
Remodulin(R) United FDA approved intravenous use 11/24/04
(treprostinil Therapeutics of pulmonary arterial
sodium) Corp. hypertension drug
Injection
Renagel(R) Genzyme Corp. FDA approved new labeling 3/9/04
(sevelamer showing the product's
hydrochloride) phosphorous and calcium-
phosphorous control are
consistent with the National
Kidney Foundation's aggressive
guidelines
Synagis(R) MedImmune Inc. FDA approved liquid formulation 7/26/04**
(palivizumab) (drug prevents serious lower
respiratory tract disease
caused by respiratory syncytial
virus in patients at high risk
of RSV disease)
Vitrase(R) ISTA FDA approved single-use vial 12/2/04
(hyaluronidase Pharma- (product is used as a spreading
injection) ceuticals agent for other drugs)
Ovine Inc.
* Note: This list includes small-molecule products developed by
biotechnology companies, and other selected small-molecule, biologic and
device products. This list covers new approvals, selected new
indications and other selected approvals (e.g., new formulations or
modes of administration). For a complete listing of FDA approvals from
1996 to the present, visit the agency's Web site at http://www.fda.gov.
** Date of company announcement.
*** Macugen also incorporates technology from Nektar Therapeutics.
