C5 complement inhibitor; humanized monoclonal antibody designed to inhibit complement activation and reduce inflammation over prolonged period of time
Systemic lupus erythematosus
Filed IND (1/12)
Alexion Pharmaceuticals Inc.
Apogen MP4
MP4 is recombinant molecule designed to eliminate T cells that target nerves in the brain (based on Apogen technology)
Multiple sclerosis
Filed IND (2/23)
AltaRex Corp. (Canada)
BrevaRex
Anti-idiotype induction therapy; murine monoclonal antibody that is developed from, and specifically binds to, MUC1 tumor-associated antigen
Metastatic cancers that express MUC1 antigen
Filed IND for Phase I trial (10/13)
AltaRex Corp. (Canada)
OvaRex
Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen
Late-stage ovarian cancer in patients with elevated serum CA125 levels who have completed 1st-line treatments
Filed IND for 2nd Phase IIb trial (11/4); filed IND for open-label North American Phase II trial (11/4); fast-track designation conferred (12/21)
AMDL Inc. (OTC Bulletin Board:AMDD)
PyloriProbe
Direct enzyme immuno-assay (EIA) that detects presence of Helicobacter pylori antibodies in blood
Diagnostic test for H. pylori infection
Filed 510(k) (4/30)
Anergen Inc. and NV Organon (the Netherlands)
AnergiX
Product incorporating an Organon peptide derived from human cartilage-derived glycoprotein; intended to selectively inactivate T cells that cause specific inflammatory autoimmune response
Rheumatoid arthritis
Filed IND (3/17)
Anthra Pharmaceuticals Inc.*
AD32
Lipophilic anthracycline analogue
Superficial bladder cancer in patients who have failed 1st-line therapy
Filed NDA (1/9)
The Ares-Serono Group (Switzerland)
Rebif
Recombinant interferon beta-1a
Multiple sclerosis (relapsing-remitting; also transitional)
Submitted BLA (2/27)
Aronex Pharmaceuticals Inc.
Atragen
Injectable formulation of all-trans retinoic acid
Acute promyelocytic leukemia
Filed NDA (12/7)
Avigen Inc.
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Gene therapy; use of adenoassociated viral (AAV) vector to deliver gene for Factor IX to muscle
Hemophilia B
Filed IND for Phase I trial (11/10)
Aviron
FluMist
Nasal spray formulation of influenza vaccine; attenuated, cold-adapted live virus vaccine
Prevention of influenza infection in children and adults, as well as in high-risk adults (when co-administered with inactivated vaccine)
FDA notified company that its PLA/ELA was not accepted for filing; FDA requires additional information on manufacturing and process validation (8/31)
Axsys Pharmaceuticals Inc.
APC-366
Tryptase inhibitor (synthetic small molecule); dry-powder inhaler formulation
Zanamivir; neura-minidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form
Treatment and prevention of influenza A and B
Glaxo submitted NDA (10/27)
Boston Life Sciences Inc.
Therafectin
Synthetic carbohydrate-based drug (oral formulation)
Rheumatoid arthritis
Submitted amendment to pending NDA (contains results of Phase III trial and manufacturing data) (7/1)
Exisulind; orally active drug designed to induce apoptosis in precancerous cells
Adenomatous polyposis coli in children (precancerous colonic polyps)
FDA granted product fast-track status (7/9)
Cell Pathways Inc.*
CP461
Compound to induce apoptosis in abnormal cells
Potential therapy for cancer
Filed IND (12/29)
Celltech Group plc (U.K.)
CDP 571
Human monoclonal antibody that binds to and neutralizes tumor necrosis factor
Crohn¿s disease
FDA granted product fast-track status (9/2)
Chiron Corp. and Berlex Laboratories Inc. (subsidiary of Schering AG; Germany)
Betaseron (FDA-approved)
Recombinant human interferon beta-1b (injection)
Secondary progressive multiple sclerosis
Submitted supplement to BLA (6/30)
Chiroscience Group plc (U.K.)
Chirocaine
Levobupivacaine; chiral version of approved drug bupivacaine
Broad usage in local, regional or spinal anesthesia
Submitted NDA (4/29)
Connetics Corp.
Betamethasone mousse
Foam formulation of corticosteroid betamethasone-17-alpha valerate
Treatment of all steroid-responsive dermatoses, including scalp psoriasis
Submitted NDA (1/6); Accepted by FDA (2/25)
Coulter Pharmaceutical Inc.
I-131 Anti-B1 Antibody
Monoclonal antibody against B cells conjugated to radioactive iodine
Treatment of non-Hodgkin¿s lymphoma
Received fast-track designation (12/7)
Creative BioMolecules Inc. and Stryker Corp. (NYSE:SYK)
OP-1 Device
Device that combines genetically engineered bone morphogenic protein (OP-1) with resorbable collagen scaffold that is surgically implanted in bone fractures and defects
Bone graft; to induce normal bone regeneration in tibial non-union fractures
Stryker initiated modular PMA submission in 4/98
Cypros Pharmaceutical Corp.
Ceresine
Small molecule; acts during and after ischemia by maintaining cellular ATP levels or accelerating their restoration
Closed head injury
FDA granted product expedited review status (7/7)
Cypros Pharmaceutical Corp.
Cordox
Natural sugar phosphate which provides energy to ischemic tissues
Sickle cell anemia crisis
FDA granted product expedited review status (12/14)
Cygnus Inc. and Wyeth-Ayerst (unit of American Home Products; NYSE: AHP)
E2III
7-day estrogen transdermal patch
Hormone replacement therapy
Wyeth-Ayerst filed NDA (12/1)
Discovery Laboratories Inc.
Surfaxin
Sinapultide; lung surfactant containing the peptide KL4 (a 21-amino-acid peptide modeled after the SP-B protein in the human surfactant system)
Acute respiratory distress syndrome from direct causes (i.e., non-sepsis causes such as pneumonia)
FDA granted product fast-track status (10/15)
Discovery Laboratories Inc.
Surfaxin
Sinapultide; lung surfactant containing the peptide KL4 (a 21-amino-acid peptide modeled after the SP-B protein in the human surfactant system)
Meconium aspiration syndrome (severe respiratory disease in infants)
FDA granted product fast-track status (10/21)
Digene Corp.
Hybrid Capture II CT and GC DNA Tests
Assays detect DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhea (GC)
Diagnostic assays for sexually transmitted diseases
Filed 3 510(k)s: 1 for each test individually and 1 for simultaneous testing (4/30)
Dusa Pharmaceuticals Inc. (Canada)
Levulan
Photodynamic therapy; 20% solution of aminolevulinic acid HCl (topical)
Multiple actinic keratoses of the face and scalp (sun-induced precancerous skin lesions)
Submitted NDA (combination drug/device; includes applicator and light source) (6/30)
Generex Biotechnology Corp. (NASDAQ:GNBT; Canada)
Oralgen
Oral insulin (liquid; administered with metered-dose aerosol applicator)
Types I and II diabetes
Filed IND for Phase II and III trials (10/28)
Genetics Institute Inc. and Wyeth-Ayerst (both units of American Home Products Corp.; NYSE:AHP)
Topical gel formulation of hyaluronic acid and diclofenac
Actinic keratosis
FDA accepted NDA (12/21)
Immunex Corp. and Wyeth-Ayerst Laboratories (unit of American Home Products Corp.; NYSE:AHP)
Enbrel
Recombinant, soluble p75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1
Moderate to severe active rheumatoid arthritis in juveniles (ages 4-17)
Submitted supplemental BLA (11/25)
Immunex Corp. and Ivax Corp. (AMEX:IVX)
Paclitaxel Injection
Generic paclitaxel; inhibits cancer cell division by blocking microtubule assembly/ disassembly; extracted from all parts of 5 to 7 year-old cultivars of Pacific yew trees
2nd-line therapy for metastatic breast and ovarian cancer
FDA confirmed that Immunex¿s ANDA (submitted 8/97; accepted for review 10/97) is the 1st filed ANDA for paclitaxel (8/13)
Interferon Sciences Inc.
Alferon N Injection (FDA-approved)
Highly purified, multi-species, natural-source human alpha interferon
HIV infection
FDA advised company that results of Phase III trial were insufficient to file for approval and that additional trial will be necessary to evaluate product¿s efficacy (4/2)
Interneuron Pharmaceuticals Inc.
CerAxon
Citicholine sodium; organic molecule consisting of brain cell membrane components cytidine and choline
Reduction of infarct size and improvement in neurological function in patients with ischemic stroke
FDA granted product fast-track status (4/3); company withdrew NDA due to results of Phase III trial, which showed that product did not outperform placebo (4/20)
Lifecore Biomedical Inc.
Intergel
Hyaluronate gel
Prevention of adhesion formation following abdominal surgical procedures performed by laparotomy
Initiated PMA application process (modular) (6/30)
Ligand Pharmaceuticals Inc. and Wyeth-Ayerst Laboratories (division of American Home Products Corp.; NYSE:AHP)
TSE-424
Tissue-selective estrogen
Post-menopausal osteoporosis
Wyeth-Ayerst filed IND (3/26)
The Liposome Co. Inc.
Evacet
Liposomal formulation of chemotherapeutic agent doxorubicin
Treatment of advanced breast cancer
Filed NDA (12/15)
LXR Biotechnology Inc.
CP-Cardiosol
Cardioplegia solution (intended to suppress pathways that initiate apoptosis; heart protectant solution)
To reduce long-term heart damage in connection with coronary artery bypass graft surgery
Product put on clinical hold; FDA wants additional preclinical data, especially for potential delayed adverse effects (4/14)
Submitted PLA and supplement to ELA (8/17); granted priority review (9/17); filed expanded access IND (11/16)
NeoPharm Inc.
Neomark
Broxiuridine; a radio-sensitizer that is incorporated into DNA of tumor cells
Prognostic test to measure tumor cell proliferation in breast cancer
Company will provide FDA with additional information and analysis on its product application (2/2)
Neurogen Corp. and Wyeth-Ayerst Laboratories (unit of American Home Products Corp.; NYSE:AHP)
ADC1
Mild NMDA receptor antagonist and use-dependent blocker of voltage-gated sodium channels
Epilepsy
Wyeth-Ayerst filed IND for Phase II trials (6/24)
Neurogen Corp. and Pfizer Inc. (NYSE:PFE)
NGD 96-1
Small molecule that modulates specific gamma amino butyric acid (GABA) neurotransmitter subtypes
Insomnia
Pfizer submitted IND (9/16)
Novopharm Biotech Inc. (TSE:NVO; Canada)
GPI-2A
Antisense therapy; use of antisense oligonucleotide that blocks HIV replication, delivered via cationic liposomes (intravenous and subcutaneous)
HIV infection and AIDS in patients who have failed or are resistant to available HIV therapies
Company voluntarily withdrew its IND for Phase Ib trial and will resubmit once supplementary animal data on higher doses intended for this trial are available (5/11)
Nexell Therapeutics Inc. (majority-owned subsidiary of Vimrx Pharmaceuticals Inc.)
Isolex 300 and Isolex 300i
Stem-cell selection systems; devices that separate CD34+ stem cells from peripheral blood (Isolex 300 is semi-automated; Isolex 300i is fully automated)
To support enrichment of CD34+ cells and reduction of non-target cells (including tumor cells) in autologous transplants in breast cancer, non-Hodgkin¿s lymphoma and other B-cell malignancies
Submitted all information in support of PMA application requested by FDA (8/31)
NeXstar Pharmaceuticals Inc.
NX 1838
Small-molecule inhibitor of vascular endothelial growth factor, developed via NeXstar¿s SELEX combinatorial chemistry process
Age-related macular degeneration
Submitted IND (7/22)
OraVax Inc. (OTC Bulletin Board: ORVX)
Colitis vaccine
Clostridium difficile toxoid vaccine (prepared from inactivated bacterial toxins)
Prevention and treatment of C. difficile colitis
Filed IND for Phase I trial (11/24)
Pacific Pharmaceuticals Inc.
BOPP
Boronated porphyrin compound (light-activated drug for photodynamic therapy)
Malignant brain tumors
Filed IND for clinical trial (to be conducted in Australia) (3/3)
Roche Molecular Systems Inc. (unit of Roche Holding AG; Switzerland)
Amplicor HIV-1 Monitor
Ultrasensitive assay; quantitates HIV-1 RNA levels down to 50 copies per milliliter of plasma (uses PCR amplification)
Measurement of viral load (circulating virus) in HIV-infected patients (used to prove efficacy of antiretroviral drug therapies)
Filed 510(k); requested expedited review status (6/26)
Schering-Plough Corp. (NYSE:SGP)
Intron A (FDA-approved)
Recombinant human interferon alfa-2b (injection)
Combination therapy with Ara-C (cytarabine arabinoside) for initial treatment of chronic myelogenous leukemia
Submitted supplement to PLA and requested priority review status (4/13)
Scios Inc.
Natrecor
Nesiritide; human B-type natriuretic peptide (BNP; naturally occurring hormone produced in heart)
Acute congestive heart failure
Submitted NDA (4/27)
Shaman Pharmaceuticals Inc.
Provir
Oral formulation of SP-303 compound, which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells
Diarrhea in AIDS patients
FDA granted product fast-track status (5/7)
Sheffield Pharmaceuticals Inc.
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Albuterol sulfate delivered via metered solution inhaler
Asthma
Filed IND (1/6)
Sonus Pharmaceuticals Inc.
EchoGen Emulsion
Fluorocarbon-based ultrasound contrast agent
Contrast radiography
Company submitted an amendment to NDA (8/26) after receiving a non-approvable letter (2/26)
SUGEN
SU6668
Drug targeted to the Flk-1/KDR platelet derived growth factor and fibroblast growth factor receptors
Potential cancer therapy
Filed IND (12/23)
SunPharm Corp.
DEHOP
Diethylhomospermine; analogue of naturally occurring essential intracellular polyamine compound
AIDS-related diarrhea
FDA told company that it needs to conduct another Phase II trial prior to pivotal trials (10/26)
SuperGen Inc.
MitoExtra
Mitomycin reformulated with ¿shielding¿ drug delivery technology
Various cancers
FDA accepted NDA for filing (2/24)
SuperGen Inc.
Paclitaxel
Generic paclitaxel
Cancer
Submitted ANDA (8/18)
Techniclone Corp.
TNT
Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131 (targets necrotic center of tumor)
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