Biotechnology Industry Posts 37 FDA Approvals, $16.4 Billion in Financing in 2003
WASHINGTON, Jan. 5 /PRNewswire/ -- The biotechnology industry enters 2004 stronger than ever after earning 37 FDA approvals, raising $16.4 billion in new financing and winning significant battles on Capitol Hill in 2003.
"Biotechnology is a performance-driven industry," said BIO President Carl B. Feldbaum. "In 2003, the biotechnology's results at the FDA were terrific, driving an industry recovery on Wall Street and further boosting the industry's political credibility."
The FDA approved 25 new biotechnology drugs and biologics in 2003, up 25 percent from 2002. The new approvals include first-in-class medicines for genetic disorders, HIV/AIDS, Alzheimer's disease, psoriasis, asthma and cancer. The agency also cleared 12 new indications for previously approved biotech products.
"The results that matter most in this industry are the ones that benefit patients, and the biotech products approved this past year will help many whose needs would otherwise be unmet," said Feldbaum. "The upswing in approvals in part reflects new energy at the FDA under the leadership of Commissioner Mark McClellan, who brought a deep commitment to innovation and sensible risk-benefit analysis to the agency in 2003."
FDA approvals, combined with stellar earnings performances at companies with marketed products, drove the Nasdaq biotech index up 46 percent in 2003 and helped biotech companies to raise $16.4 billion in new financing, up 56
percent from 2002.
"It's not just the industry's established companies that have done well," noted Feldbaum. "Small-cap stock gains outpaced those of the industry's top tier, and venture capitalists poured $3.3 billion into privately held biotechs. In fact, the life sciences eclipsed software in the third quarter to become the number one destination for venture capital funding."
Industry Advances Political Agenda:
* BIO's pro-innovation principles were incorporated into the Medicare drug coverage law, which also reversed deep cuts in biotech products that were already covered under the program.
* Bills to allow biotechnology companies to take advantage of net operating losses were introduced in both the House and Senate.
* The comprehensive energy legislation that passed the House and is now pending in the Senate includes more than $800 million in bioenergy incentives and sets mandatory requirements for usage of biofuels.
* Efforts to ban therapeutic applications of cloning technology were defeated in Congress, at the United Nations, and in several states.
* The international food safety organization Codex Alimentarius approved science-based risk-assessment rules for foods derived from biotechnology.
In 2004, BIO's legislative priorities include passage of tax reform and energy legislation, as well as Project BioShield, the Patent and Trademark Office fee bill and small business legislation that would ensure venture-backed biotech firms qualify for Small Business Innovation Research grants.
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.
Note: A list of biotech drug approvals follows.
2003 Biotech Drug Approvals
Note: Recombinant proteins and monoclonal antibodies are underlined. This list includes monoclonal antibodies and recombinant proteins developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule or tissue-engineered products considered relevant to the biotechnology industry.
New Products
Product Description Company Indication
ADVATE Recombinant Baxter Hemophilia A
------ antihemophilic Healthcare
factor produced Corp.
without any added
human or animal
plasma proteins
and albumin
ALDURAZYME(R) Laronidase; BioMarin Mucopolysac-
------------ recombinant Pharmaceuticals charidosis-1
enzyme Inc. and
replacement Genzyme
Aloxi Palonosetron HCl MGI Pharma and Prevention of
injection; 5-HT3 Helsinn acute nausea and
receptor antagonist Healthcare vomiting in
chemotherapy
patients
AMEVIVE(R) Alefacept; Biogen Moderate to severe
--------- recombinant, chronic plaque
dimeric fusion psoriasis
protein; targets
CD45RO+ T-cells
BEXXAR(R) Tositumomab Corixa Corp. CD20-positive,
--------- and I-131 and follicular non-
tositumomab; GlaxoSmithKline Hodgkin's lym-
monoclonal phoma whose
antibody disease is
targeting the refractory
CD20 antigen to Rituxan and
and radiolabeled has relapsed
version of the following
antibody chemotherapy
Cialis(R) Tadalafil; Lilly ICOS LLC Erectile
oral PD55 (joint venture dysfunction
inhibitor of Eli Lilly
and Co. and
ICOS Corp.)
CosmoDerm(TM)/ Dermal fillers Advanced Wrinkle
CosmoPlast(TM) containing human- Tissue injections
based collagen Sciences Inc.
and Inamed
Corp.
Cubicin(TM) Daptomycin Cubist Bacterial
for injection Pharmaceut- infections
icals Inc.
and Chiron
Corp.
Elestat(TM) Epinastine HCl Inspire Persistent itching
ophthalmic Pharmaceu- associated with
solution ticals Inc., allergic
0.05% Inc. Allergan Inc conjunctivitis
(Inspire signed
a co-promotion
agreement
following
approval of
the Allergan
drug) and
Boehringer
Ingelheim
Emtriva(TM) Emtricitabine; Gilead Treatment of HIV
once-daily Sciences Inc. infection in adults
nucleoside as part of
reverse combination
transcriptase
inhibitor
(capsule)
ESTRASORB(TM) Estradiol topical Novavax Inc. Short-term use
emulsion and King to reduce
Pharmaceuticals moderate to
Inc. severe vasomotor
symptoms
("hot flashes") in
menopausal women
Fabrazyme(R) Algasidase beta; Genzyme Fabry's disease
----------- recombinant enzyme
replacement
FACTIVE(R) Gemifloxacin GeneSoft Mild to moderate
mesylate Pharmaceu- community-acquired
ticals Inc. pneumonia and acute
bacterial exacerba-
tion of chronic
bronchitis
FluMist(TM) Nasally delivered MedImmune Inc. Prevention of flu
influenza vaccine
FUZEON(TM) Enfuvirtide; Trimeris Inc. Component of
fusion inhibitor and Roche combination
(subcutaneous therapy for HIV-1
injection) infection in
treatment-
experienced
patients
with evidence of
HIV-1 replication
despite ongoing
antiretroviral
therapy
Ganite(TM) Gallium nitrate Genta Inc. Cancer-related
injection hypercalcemia
Lexiva(TM) Fosamprenavir Vertex Treatment of HIV
calcium; protease Pharmaceuticals infection in adults
inhibitor (tablet) and in combination with
GlaxoSmithKline other
antiretrovirals
NAMENDA(TM) Memantine HCl; Neurobiological Mild to moderate
N-methyl-D- Technologies Alzheimer's
aspartate receptor Inc. and Forest
antagonist (tablet) Laboratories
Plenaxis(TM) Abarelix Praecis Palliative
(injectable Pharmaceuticals treatment of
suspension); Inc. men with advanced
gonadotropin symptomatic
releasing hormone prostate cancer
antagonist under certain
conditions
RAPTIVA(TM) Efalizumab; Xoma Ltd. and Chronic moderate
----------- selective, Genentech Inc. to severe plaque
reversible psoriasis in adults
T-cell blocker
(subcutaneous
injection; self-
administered)
RISPERDAL(R) Risperidone, Alkermes Inc. Schizophrenia
CONSTA(TM) long-acting and
injection Johnson &
formulation; Johnson
uses Medisorb(R)
drug delivery
technology that
encapsulates active
medication in slow-
degrading, polymer-
based microspheres
SOMAVERT(R) Pegvisomant; Nektar Acromegaly
----------- pegylated version Therapeutics
of a recombinant and Pfizer Inc.
human growth
hormone analog
structurally altered
to act as a GH
receptor antagonist
VELCADE(TM) Bortezomib for Millennium Relapsed and
injection; Pharmaceuticals refractory multiple
proteasome inhibitor Inc. myeloma
Xolair(R) Omalizumab; Genentech, Moderate to severe
--------- recombinant DNA- Tanox Inc. persistent asthma
derived humanized and Novartis in adults and
monoclonal antibody Pharmaceuticals adolescents
targeting
immunoglobin-E
(subcutaneous)
Zavesca(TM) Miglustat; substrate Celltech Mild to moderate
reduction therapy Group plc Gaucher's Disease
(capsule) and Actelion patients for whom
Ltd. enzyme replacement
therapy is not an
option
New Indications
Product Description Company Indication
AVONEX(R) Interferon beta-1a; Biogen Treatment after
--------- recombinant initial multiple
sclerosis attack if
a brain MRI scan
shows abnormalities
characteristic of
the disease
Betaseron(R) Interferon beta-1b; Chiron and New labeling
------------ recombinant Berlex includes data from
Laboratories studies in patients
Inc. with secondary
progressive
multiple sclerosis,
and the indications
section reflects
Betaseron is
indicated for
treatment of
relapsing forms of
MS to reduce the
frequency of
clinical
exacerbations
ENBREL(R) Etanercept; Amgen and Ankylosing
--------- recombinant Wyeth spondylitis;
product; dimeric improvement of
fusion protein physical function
consisting of tumor in patients with
necrosis factor moderately to
receptor linked to severely
the Fc portion of active rheumatoid
human IgG1 arthritis;
expanded psoriatic
arthritis label
claiming blockage
of progression
FACTIVE(R) Gemifloxacin GeneSoft Community-acquired
mesylate Pharmaceuticals pneumonia due to
Inc. multi drug
resistant
Streptococcus
pneumoniae
GLIADEL(R) Polifeprosan 20 Guilford Newly diagnosed
Wafer with carmustine Pharmaceuticals patients with
implant Inc. high-grade
malignant glioma as
an adjunct to
surgery and
radiation
Humatrope(R) Somatropin; Eli Lilly Long-term treatment
------------ recombinant and of children of
Company short stature
(unknown cause)
PHOTOFRIN(R) Porfimer sodium; Axcan Ablation of high-
PhotoDynamic photodynamic Pharma Inc grade dysplasia
Therapy therapy in Barrett's
esophagus patients
who do not undergo
esophagectomy
REMICADE(R) Infliximab; Centocor Inc. Reduction of
----------- tecombinantly draining
produced, chimeric enterocutaneous and
monoclonal antibody recto-vaginal
fistulas and for
maintaining fistula
closure in patients
with fistulizing
Crohn's disease
Synagis(R) Palivizumab; MedImmune FDA cleared
---------- recombinantly Inc. addition of new
produced, humanized safety and efficacy
monoclonal antibody data supporting the
drug's use in young
children with
hemodynamically
significant
congenital heart
disease
Zorbtive(TM) Somatropin; Serono Short bowel
(Serostim(R)) recombinant syndrome (product
previously approved
under the trade
name Serostim(R)
for AIDS wasting)
Sources: BioCentury, BioWorld, company reports and prescribing
information for individual products.
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