Company

Product

Description

Indication

Action

Alexion Pharmaceuticals Inc.

5G1.1

Monoclonal antibody

Rheumatoid arthritis

Filed IND (12/30) for 5G1.1 which inhibits C5 complement factor

American Biogenetic Sciences Inc.

FiF Test

In vitro assay for functional intact fibrinogen (quantitated in plasma)

For cardiovascular risk assessment

Filed 510(k) (2/4)

Atrix Laboratories Inc.

Atridox

Biodegradable polymer incorporating doxycycline

Periodontal disease

Submitted NDA (4/1); FDA accepted NDA (6/6)

Bio-Technology General Corp.

Androtest SL

Sublingual testosterone

Hypogonadism in men (testosterone deficiency)

FDA accepted NDA for filing (1/14)

Boston Life Sciences Inc.

Altropane

Radio-imaging agent for dopamine transporter system in the brain

Diagnostic agent for Parkinson's disease

Filed IND (1/13)

Celgene Corp.

Thalomid (was Synovir)

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

Treatment of Behcat's disease and complex aphthosis (chronic autoimmune disorders)

Filed IND for Phase II trials (9/26)

Cell Genesys Inc.

T cell cancer gene therapy

Patient's own T cells are genetically modified with the CC49 zeta gene (which targets cancer cells expressing TAG-72 surface protein)

Colon cancer

Filed IND (5/5)

CellPro Inc.

Ceprate SC System

Stem cell concentration device: separates cells of interest from other cells of bone marrow or peripheral blood using an avidin/biotin immunoaffinity selection system

For selection and purification of peripheral blood stem cells

Submitted data from Phase III trial to FDA as part of PMA supplement (to expand label indication) (10/9)

CollaGenex Pharmaceuticals Inc.

Periostat

Orally administered drug consisting of sub-antibiotic dose of doxycycline (inhibits production of collagenase)

Treatment of periodontitis

FDA sent company an action letter on NDA, requesting clarification of statistical methods used in NDA (9/2)

Cortecs Inter- and Boehringer Mannheim Corp. (unit of Corange Ltd.; Bermuda)

Helisal One-Step

Whole-blood diagnostic kit that detects antibodies to Helicobacter pylori; rapid, 5-minute test can be used in doctor's office

Diagnostic for H. pylori infection (causes gastritis and ulcers; linked to a stomach cancer)

Boehringer Mannheim national Ltd. (U.K.) filed 510(k) (9/25)

CSL Ltd. (Australia) and Merck & Co. Inc.


Multivalent vaccine consisting of a virus-like particle engineered to create an immune response to the E7 protein in the human papillomavirus

Prevention of human papillomavirus infection (causes genital warts and cervical cancer)

Merck filed IND (8/19)

Diatide Inc.

AccuTect

Synthetic peptides, designed to attach to targeted disease molecules, labeled with technetium 99m

In vivo imaging agent for acute deep vein thrombosis

Submitted NDA (8/21)

Digene Corp.

Hybrid Capture II HPV DNA Test

Assay detects DNA from 18 different human papillomavirus (HPV) types

Used in conjunction with Pap smear testing to detect HPV (cause of cervical cancer)

Submitted PMA (10/1)

Dusa Pharmaeuticals Inc.

Levulan (ALA) Photo- Detection

5-aminolevulinic acid (ALA) for photodynamic therapy

Bladder cancer test

Filed IND to begin a Phase I/II trial (8/14)

Ergo Science Corp.

Ergoset Tablets

Formulation of bromocriptine (ergot alkaloid; generic dopamine agonist)

Type II diabetes

Submitted NDA (8/25); FDA accepted filing (10/7)

GelTex Pharmaceuticals Inc. and Genzyme Corp.

RenaGel

Non-absorbed polymer-based compound that binds to and eliminates target substances from the intestinal tract

Control of elevated phosphorus levels in chronic kidney failure (administered in conjunction with dietary calcium supplement)

Submitted NDA (11/3)

Gliatech Inc.

Adcon-L

Anti-adhesion barrier gel (semisynthetic carbohydrate polymer)

To inhibit post operative peridural scars (following lumbar disc surgery)

FDA accepted PMA for filing (2/13)

ImmuLogic Pharmaceutical Corp.


Peptide therapeutic vaccine; consists of peptides of mylein basic protein administered subcutaneously to induce immune tolerance

Multiple sclerosis

Filed IND (1/6)

Immunomedics Inc.

LymphoCide

Humanized lymphoma antibody consisting of murine binding sites linked to human immunoglobulin backbone (both radiolabeled and unconjugated forms)

Advanced non-Hodgkin's lymphoma

Filed IND (5/1)

Immunex Corp.

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

Second-line therapy for metastatic breast and ovarian cancer

Submitted abbreviated NDA 8/8/97; accepted for review by FDA 10/7/97

INSMED Pharmaceuticals Inc.

INS-1 (D-chiro inositol)

Small, carbohydrate-based molecule, orally delivered

Insulin resistance

Submitted IND (7/8)

Lidak Pharmaceuticals Inc.

Lidakol

Long chain fatty alcohol that inhibits herpes virus from entering cells

Oral herpes virus infection

Filed NDA (12/23)

LXR Biotechnology Inc.

HK-Cardiosol

Heart preservation solution

Heart transplant (for donor organ prior to transplant)

Filed investigational device exemption (IDE) for open-label random- ized pivotal trials (10/2)

Matritech Inc.

NuMA Test Kit

Diagnostic blood test that detects a nuclear matrix protein present at elevated levels in colon cancer cells

Aid in monitoring and management of patients diagnosed with colon cancer

Filed 510(k) (10/16)

Matrix Pharmaceutical Inc.

AccuSite Injectable Gel

Formulation for localized sustained drug release (biodegradable protein matrix contain ing 5-FU and epinephrine)

Treatment of genital warts

Submitted amendment to NDA (to address concerns expressed by FDA in its 12/96 action letter) (3/20)

Maxim Pharmaceuticals Inc.

Maxamine

Immunotherapeutic; H2 receptor agonist that blocks phagocyte signal that leads to death of natural killer cells

Combination therapy with interleukin-2

Filed IND for Phase III trial (2/10) for treating advanced malignant melanoma

MedImmune Inc. and BioTransplant Inc.

MEDI-507

Humanized monoclonal antibody that binds to CD2 antigen receptor found on T cells and natural killer cells

Broad applications in autoimmune diseases and transplantation; initially for preventing renal transplant rejection

Filed IND (4/15) for a dose escalating Phase I trial in psoriasis (11/25)

MedImmune Inc.

Synagis (MEDI 493)

Monoclonal antibody aimed at the respiratory syncytial virus

To prevent pneumonia in high-risk infants and children

Filed BLA (12/22)

NeoPharm Inc.

Neomark-BU

Broxiuridine; a radiosensitizer that is incorporated into DNA of tumor cells

In vivo prognostic test to measure tumor cell proliferation in breast cancer

FDA accepted NDA for filing (3/3)

NeoTherapeutics Inc.

AIT-082

Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors

Alzheimer's disease

Filed IND (4/2)

Neurobiological Technologies Inc.

Xerecept

Synthetic preparation of peptide hormone corticotropin-releasing factor

To prevent cerebral edema (swelling of brain tissue) following traumatic brain injury

Filed IND to begin Phase II trials (9/3)

Neurogen Corp. and Pfizer Inc.

NGD 91-2

Non-sedating GABA receptor or subtype specific small molecule

Anxiety

Pfizer filed IND (6/19)

North American Vaccine Inc.

Certiva DTaP vaccine

Acellular pertussis vaccine; combined diphtheria, tetanus and acellular pertussis vaccine (contains detoxified pertussis toxoid)

Adolescent and adult booster shots

Requested expanded indication (6/6)

North American Vaccine Inc.

DTaP-IPV vaccine

Combines Certiva, a DTP vaccine, with injectable inactivated polio vaccine

Infants and children; vac- cination for pertussis, diph- theria, tetanus and polio

Filed IND (6/23)

Novopharm Biotech Inc.

Antibody 4B5

Fully human monoclonal antibody

Vaccine for melanoma

Filed IND to begin Phase I trials (9/16)

Novartis Pharma- ceuticals Corp. (unit of Novartis AG; Switzerland)

Simulect

Basiliximab; selective high-affinity monoclonal antibody that blocks receptor for interleukin-2

Prevention of acute rejection episodes after kidney transplantation

Submitted BLA (11/14)

Oncor Inc.

Inform

Genetic test for Her-2/neu gene amplifications

Breast cancer (identifies more aggressive malig- nancies)

Submitted amendment to PMA (6/10)

Oxis International Inc.

BXT-51072

Mimic of natural anti- oxidant enzyme gluta- thione peroxidase; designed to control levels of free radicals and re- active oxygen species in cells; oral formulation

Inflammatory bowel disease

Filed IND (1/9)

Palatin Technologies Inc.

LeuTech

Radiolabeled infection imaging system; pro- duct binds specifically to white blood cells

Imaging of infection sites (via conventional planar imaging tech- nologies)

Filed IND (10/15)

SangStat Medical Corp. and the Imtix division of Pasteur Merieux Connaught (member of the Rhone-Poulenc Group; France)

Thymo- globulin

Rabbit anti-human thymocyte polyclonal antibody

Treatment and prevent- ion of acute graft reject- ion episodes in kidney transplant recipients

Submitted PLA (1/6) FDA accepted (2/20)

Sepracor Inc.

Levalbuterol

Purified active isomer form of bronchodilator racemic albuterol

To improve lung function in patients with asthma

Initiated NDA (7/1); FDA accepted filing (9/2)

Sonus Pharmaceuticals Inc.

EchoGen Emulsion

Fluorocarbon-based ultrasound contrast agent

To improve ultrasound images of heart, liver, kidney, vascular system and other organs

FDA notified company that Medical Imaging Drugs Advisory Commit- tee meeting is not neces- sary to complete its review of NDA (10/2)

Spiros Develop- ment Corp. and Dura Pharma- ceuticals Inc.

Albuterol Spiros

Powder aerosol form- ulation of albuterol delivered to lungs via Spiros inhaler

Asthma

Dura submitted NDA (11/10)

Sugen Inc.

SU 101

Small-molecule signal transduction inhibitor; specifically inhibits platelet-derived growth factor receptor signaling

Front-line treatment of malignant glioma in combination with BCNU (carmustine)

Filed IND amendment to initiate Phase I/II trial of SU 101 in combination with BCNU (7/22)

Sugen Inc.


Synthetic small-molecule signal transduction inhibitor of Flk-1/KDR that has poten- tial as an anti-angiogenesis and antimetastasis agent

Solid tumors

Filed IND (7/2)

Sugen Inc.

SU 5271

Synthetic small mole- cule signal transduction inhibitor that blocks growth of keratinocytes

Psoriasis (topical formu- lation)

Filed IND (1/6)

Techniclone Corp.

TNT

Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with 311-I (targets necrotic center of tumor)

Malignant glioma (brain cancer)

Filed IND (9/29)

Texas Biotechnology Corp.

Novastan

Synthetic small molecule (argatroban) derived from arginine; acts as direct inhibitor of thrombin

Anticoagulant therapy in patients with heparin- induced thrombocytopenia

Initiated submission of NDA (7/2)

Xoma Corp.

hu1124

Anti-CD11a humanized monoclonal antibody; targets CD11a receptor on surface of T cells

To prevent organ reject- ion in renal transplant patients (used in combina- tion with standard immunosuppressive drugs)

Filed IND (1/21)


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