Company
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

GeneLabs
Technologies
Inc. (GNLB)

Anastar

Prasterone, GL701;
the synthetic equivalent of
dehydroepiandrosterone

Systemic lupus
erythematosus

European Agency for Evaluation of Medicinal Products determined that the marketing authorization application is complete; the review process has begun (1/9)

CANCER

Aphton Corp.
(APHT)

G17DT

Anti-gastrin immunogen

Pancreatic
cancer and
gastric cancer

The Committee for Orphan Medicinal Products recommended to the European Commission that G17DT be granted orphan drug status (1/22)

CARDIOVASCULAR

Dyax Corp.
(DYAX)

DX-88

A small protein that inhibits
an enzyme in the blood called kallikrein

Angiodema

The European Commission granted orphan medicinal product designation for DX-88 (1/8)

CENTRAL NERVOUS SYSTEM

Labopharm Inc.
(Canada; TSE:DDS)

Tramadol

A once-daily formulation
of the analgesic tramadol

Moderate to
severe pain

Phase III results in Europe showed Labopharm's formulation achieved the primary endpoint of the study (1/22)

INFECTION

NeuTec Pharma
plc
(UK; LSE:NTP)

AuroGrab

A recombinant antibody based on natural antibodies isolated from patients who recovered from MRSA

Methicillin-
resistant
Staphylococcus aureus (MRSA)

Company will start a Phase IIb trial this quarter (1/22**)

OraPharma
nc.
(OPHM)

Arestin

Time-released antibiotic
encapsulated in microspheres

Periodontal
disease

Arestin was approved for sale in Sweden (1/22)

Triangle
Pharmaceuticals

Inc.
(VIRS)

Coviracil

Emtricitabine; a nucleoside
reverse transcriptase inhibitor

HIV

Company submitted a marketing authorization application in Europe (1/7)

MISCELLANEOUS

MoliChem
Medicines Inc.

(OTC BB:MLCM)

Moli
1901

Duramycin; a muco-active
polypeptide that may normalize the mucus composition in the lung by activating an alternative chloride and water channel

Cystic
fibrosis

Company received orphan drug designation in Europe for Moli1901 (1/8)

Oxford Glyco-
Sciences
plc (UK; OGSI; LSE:OGS) and Teva Pharmaceu- tical Industries Ltd. (Israel)

Zavesca

Oral capsule formulation
of a glucosyltransferase
inhibitor

Type I
Gaucher's
disease

Companies submitted an approval application in Israel (1/17)

SangStat Medical
Corp.
(SANG)

Acceptine

Cylosporine capsules

To prevent
organ trans-
plant rejection

Company filed a marketing authorization application in an undisclosed European country (1/22)


Notes:

** Denotes the date the item ran in BioWorld International.

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