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Company** Product Description Indication Type Action (Date)
Name
CANCER
Chiron Corp. Proleukin Recombinant human Single-agent therapy FDA's Oncologic Drugs
(FDA- interleukin-2 for metastatic melanoma Advisory Committee
approved) in adults (Stage IV) recommended approval
(12/19)
CollaGenex Metastat Chemically modified Inhibition of cancer National Cancer Institute
Pharmaceuticals tetracycline (stripped of metastasis filed IND (12/5)
Inc. antimicrobial proper-
ties) that acts as a
matrix metalloprotein-
ase inhibitor
DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis FDA's Oncologic Drugs
and Chiron Corp. release formulation of arising from solid tumors Advisory Committee
chemotherapeutic agent declined to recommend
cytarabine (uses Depo- approval when it found
Foam, lipid-based drug no evidence that drug works
delivery) better than current thera-
py (methotrexate) (12/18)
Genzyme Corp. Thyrogen Recombinant human For use in diagnostic Submitted NDA (12/17)
thyroid stimulating procedures (radio-iodine
hormone whole-body scanning)
used to monitor patients
for recurrence of
thyroid cancer
Human Genome MPF-1 Human myeloid pro- Protection of hemato- Filed IND for Phase I
Sciences Inc. genitor inhibitory poietic progenitor cells trial (12/18)
factor-1 (genomics- in human bone marrow
derived) from toxic effects of
chemotherapy
NaPro Paxene Paclitaxel; compound AIDS-related Kaposi's FDA tentatively approved
BioTherapeutics extracted from needles sarcoma (2nd-line NDA, but because Bristol-
Inc. and Ivax Corp. and limb stock of therapy) Myers Squibb Co.'s Tax-
(AMEX:IVX) ornamental yew trees ol was approved in 8/97
for this indication (and
has marketing exclusivity
for 7 years), NaPro/Ivax's
drug might not get final
approval until 8/4/04 (12/26)
NeoPharm Inc. Neomark Broxiuridine; a radio- In vivo prognostic test FDA's Oncologic Drugs
sensitizer that is incor- to measure tumor cell Advisory Committee
porated into DNA of proliferation in breast voted not to recommend
tumor cells cancer for approval (12/19)
Neoprobe Corp. RIGScan I-125-labeled mono- Surgical detection and FDA notified company
CR49 clonal antibody for use management of primary that approval of BLA
with hand-held isotope and metastatic colorectal cannot be considered
detector for radioimmu- cancer without additional clinical
noguided surgery and manufacturing infor-
mation (12/29)
Oncor Inc. Inform Genetic test designed to Prediction of recurrence Approved for marketing
HER-2/neu identify HER-2/neu of breast cancer (identi- (12/31)
gene amplification in fies more aggressive
breast cancer tissue malignancies)
Seragen Inc. (OTC DAB389IL-2 Denileukin diftitox; Cutaneous T cell lymph- Submitted BLA, request-
Bulletin Board:SRGN) interleukin-2 (IL-2) oma that recurs or per- ing expedited review
fusion protein consisting sists after prior therapy (12/8)
of diphtheria toxin frag- (i.e., as 2nd-line therapy)
ment A-fragment B
genetically fused to
human IL-2 (targets high-
affinity IL-2 receptors
on activated T cells)
SuperGen Inc. Nipent Pentostatin for injection; Hairy cell leukemia FDA approved supple-
(FDA- chemotherapeutic drug mental NDA for commer-
approved) that inhibits adenosine cial scale manufacturing
deaminase (blocks DNA (12/29)
synthesis)
Vion Triapine Ribonucleotide reduc- Treatment of solid Filed IND (12/12)
Pharmaceuticals tase inhibitor (inhibits tumors
Inc. DNA synthesis)
CARDIOVASCULAR
BioTime Inc. Hextend Blood plasma volume Replacement of blood Initiated submission of
expander volume during surgery NDA (12/18)
in which substantial
amounts of blood are lost
Collateral Gene Intra-arterial delivery of Patients suffering from Schering filed IND for
Therapeutics Inc.* therapy gene that promotes stable exertional angina Phase I/II trial (12/23)
and Schering AG angiogenesis (gene not due to atherosclerosis
(Germany) identified) via adeno- (coronary artery disease)
viral vector
Interneuron CerAxon Citicholine; membrane Ischemic stroke Submitted NDA (12/15)
Pharmaceuticals resynthesis facilitator;
Inc. organic molecule that
consists of cytidine and
choline (components of
brain cell membranes)
Molecular Optison 2nd-generation ultra- For use in patients with Approved for marketing
Biosystems Inc. and sound contrast imaging suboptimal echocardio- (12/31)
Mallinckrodt Inc. agent; contains perflu- grams to improve imag-
(NYSE:MKG) orocarbon ing of left ventricle of
heart
CENTRAL NERVOUS SYSTEM
Cephalon Inc. Provigil Modafinil; oral formu- Sleep disorders narco- FDA sent company an
lation of synthetic com- lepsy and idiopathic approvable letter (12/30)
pound that is thought to hypersomnia
affect alpha-adrenergic
receptors in the brain
DIABETES
Chiron Corp. and Regranex Becaplermin; gel form Wound healing in Approved for marketing
Johnson & Gel of recombinant human diabetic foot ulcers (12/17)
Johnson (NYSE:JNJ) platelet-derived growth
factor-beta
INFECTION
Enzo Therapeutics Gene Use of StealthVector To stop viral progression Filed IND (12/18)
Inc. (subsidiary of therapy gene delivery system in HIV-infected patients
Enzo Biochem Inc.) to treat patient's blood
stem cells ex vivo (to
render them HIV-resis-
tant), then reinfuse cells
back into patient
Lidak Lidakol Long-chain fatty Recurrent outbreaks of Submitted NDA (12/23)
Pharmaceuticals (n-docosanol) alcohol believed to oral herpes (cold sores
Inc. work by interfering or fever blisters caused
with viral entry into by herpes simplex virus)
cells (topical)
MedImmune Inc. Synagis Palivizumab; human- Prevention of serious Submitted BLA (12/19)
(formerly ized monoclonal anti- RSV disease in certain
MEDI-493) body to respiratory high-risk infants and
syncytial virus (RSV); young children (causes
binds to fusion protein pneumonia, bronchio-
on viral surface litis)
PathoGenesis TOBI Tobramycin for Chronic lung infections Approved for marketing
Corp. inhalation (Pseudomonas aerugi- (12/23)
nosa) in patients with
cystic fibrosis
Penederm Inc. Mentax Butanefine HCl, 1% 1-week dosing regi- Approved for marketing
(FDA- cream (benzylamine, men for treating Tinea (label expansion) (12/3)
approved) antifungal agent; topical) pedis (athlete's foot)
Schering-Plough Intron A Recombinant human Combination therapy Schering-Plough submit-
Corp. (NYSE:SGP) plus interferon alfa-2b for chronic hepatitis ted NDA and requested
and ICN Pharma- Rebetol (Intron-A) plus C virus infection in priority review status
ceuticals Inc. (both FDA- oral form of ribaverin patients 18 years of age (12/9)
approved) (Rebetol; synthetic or older with compen-
nucleoside with sated liver disease who
broad-spectrum anti- have relapsed following
viral activity) alpha-interferon therapy
Siga Strep throat Vaccine uses vector Strep throat (caused by National Institutes of
Pharmaceuticals vaccine system that presents many strains of Group A Health filed IND (12/18)
Inc. disease-associated Streptococcus)
antigens to body's
mucosal surfaces to
stimulate immune
system response
MISCELLANEOUS
Alexion 5G1.1 C5 complement inhib- Rheumatoid arthritis Filed IND (12/24)
Pharmaceuticals itor; humanized mono-
Inc. clonal antibody designed
to inhibit complement
activation and reduce
inflammation over pro-
longed period of time
Alza Corp. Testoderm Testosterone trans- Treatment of hypogo- Approved for marketing
dermal drug delivery nadism (testosterone (12/19)
system deficiency) in males
Alza Corp. Ditropan XL Oxybutynin chloride Urge urinary incon- Alza submitted NDA
and Crescendo extended-release tablets tinence (12/22)
Pharmaceuticals (via OROS osmotic drug
Inc. delivery technology)
Anika Orthovisc Ultra-pure, high molecu- Osteoarthritis of the Submitted PMA (12/31)
Therapeutics Inc. lar-weight naturally knee
derived hyaluronic acid
(intra-articular injection)
Centocor Inc. Avakine Infliximab; chimeric Moderate-to-severe Submitted BLA (12/30)
(formerly cA2 monoclonal antibody Crohn's disease, includ-
or Cen-TNF) to tumor necrosis factor- ing fistulizing Crohn's
alpha disease
Genentech Inc. Nutropin Powder (lyophilized) Replacement of endo- Approved for marketing
(FDA- formulation of recombi- genous growth hormone (expanded label) (12/17)
approved) nant human growth in adults with growth
hormone hormone deficiency
Nutropin AQ Aqueous formulation of Replacement of endo- Approved for marketing
(FDA- recombinant human genous growth hormone (expanded label) (12/18)
approved) growth hormone in adults with growth
hormone deficiency
Gliatech Inc. Adcon-L Anti-adhesion barrier To inhibit postopera- FDA's Orthopedic and
gel (semisynthetic tive peridural scars Rehabilitation Devices
carbohydrate polymer) (following lumbar disc Advisory Committee
surgery) voted 8 to 1 to recommend
approval, with conditions
regarding labeling (12/12)
Eli Lilly and Co. Evista Raloxifene HCl; Prevention of post- Approved for marketing
(NYSE:LLY) selective estrogen menopausal osteo- (12/10)
receptor modulator porosis
MedImmune Inc. MEDI-507 Humanized monoclonal Steroid-resistant MedImmune filed IND
and BioTransplant antibody that binds to graft-vs.-host disease for Phase I/II trial (12/24)
Inc. CD2 antigen receptor
found on T cells and
natural killer cells
Protein Design Zenapax Daclizumab; human- Prevention of organ Approved for marketing
Labs Inc. and ized monoclonal anti- rejection following (12/11)
Hoffmann-La Roche body (SMART Anti- kidney transplantation
Inc. Tac) that binds to the
interleukin-2 receptor
on activated T cells
NOTES:
Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products.
* Private companies are indicated with an asterisk.
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 10-11.

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