Company

Product

Description

Indication

Action

Alexion Pharmaceuticals Inc.

5G1.1

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.

-

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

Asthma

Filed IND for Phase IIb trial (6/2)

Bayer Corp. (unit of Bayer Group; Germany)

Kogenate SF

2nd-generation recombinant Factor VIII; sucrose-formulated (albumin-free)

Hemophilia A

Submitted amendment to BLA (6/11)

Biocircuits Corp. (NASDAQ:BIOC; company has since gone out of business)

PSA Assay

Point-of-care assay for prostate-specific antigen

Aid in diagnosing and monitoring prostate cancer

Filed 510(k) (5/11)

Biota Holdings Ltd. (ASX:BTA; Australia) and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Relenza

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)

Celgene Corp.

CDC 801

Selective cytokine inhibitory drug; inhibits overproduction of tumor necrosis factor (oral)

Crohn¿s disease

Filed IND for Phase II trials (11/24)

Cell Pathways Inc.*

FGN-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)

ReFacto

Recombinant Factor VIII; albumin-free formulated product

Hemophilia A

FDA accepted BLA for review (5/17)

Hyal Pharmaceutical Corp. (Canada)

Solarase

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)

Magainin Pharmaceuticals Inc.

Pexiganan (formerly Cytolex)

Pexiganan acetate (1% cream); broad-spectrum anti-infective; synthetic magainin (natural host-defense peptide isolated from frogs)

Infection in diabetic foot ulcers

FDA accepted NDA for filing (9/23)

NABI

H-BIG

Reformulated hepatitis B immune globulin (human)

Prevention of hepatitis B virus infection

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)

Ribozyme Pharmaceuticals Inc.

Angiozyme

Chemically synthesized ribozyme; specifically inhibits formation of vascular endothelial growth factor receptor (VEGFr)

Various cancers

Submitted IND (9/22)

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.

-

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)

Malignant glioma (brain tumor; interstitial delivery system)

Submitted Phase II trial protocol to FDA (9/14)

Therapeutic Antibodies Inc.

CroTAb

Polyclonal antibody (produced in sheep) designed to neutralize poisonous effect of bites from North American pit vipers

Anti-venom product for treating snake bites

FDA accepted PLA and ELA for review (7/13)

Vertex Pharmaceuticals Inc. and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Agenerase

Amprenavir; 2nd-generation HIV protease inhibitor; twice-daily dosage

Combination therapy with antiretroviral drugs for HIV and AIDS

Glaxo submitted NDA (10/16)


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