Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Active Biotech
AB
(Sweden;
SSE:ACTI)

Laquinimod (SAIK-MS)

Immunomodulatory substance

Multiple sclerosis

Presented Phase II data on 209 patients showing a statistically significant reduction in the number of active lesions (4/27)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (infliximab; FDA-approved)

Monoclonal antibody that targets and binds to tumor necrosis factor-alpha

Rheumatoid arthritis

European regulators issued a positive option on application to expand labeling to include early RA patients with severe, active and progressive disease; Schering-Plough Corp. has European rights (4/23)

GW Pharma-ceuticals
plc
(UK; LSE:GWP)

Sativex

Cannabis-based medicinal extract product

Multiple sclerosis

UK regulators asked for additional information on marketing application, pushing expected action past earlier guidance of the end of the second quarter 2004 (4/30)

CANCER

A.P. Pharma
Inc.
(APPA)

APF530

Agent combining Biochronomer delivery system with granisetron, a 5-HT3 antagonist

Chemotherapy- induced nausea and vomiting

Began Phase I trial in the UK to test safety and tolerability in 18 healthy volunteers (4/16)

Australian Cancer
Technology Ltd.
(Australia; ASX:ACU)

Pentrys (formerly Pentrix)

Vaccine designed to trigger immune response against cancer cells with mutated p53 gene

Hormone- refractory prostate cancer

Began Phase II trial that will include 40 patients at three sites in Australia (4/30)

Bioenvision
Inc.
(AMEX:BIV)

Clofarabine

Next-generation purine nucleoside antimetabolite

Acute myeloid leukemia

Interim data from European Phase II trial showed complete responses in nine of 14 patients; the single- agent study is being expanded (4/21)

MediGene AG
(Germany; FSE:MDG)

Polyphenon E Ointment

Product from green tea leaves designed to block virus binding to cells

Aktinic keratosis

Began Phase II trial in Germany and Switzerland to test efficacy and safety in 60 patients (4/6)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

European Commission approved the drug for treating patients who have progressed despite two prior therapies; it will be sold there by Johnson & Johnson companies (4/27)

Oxigene Inc.
(OXGN)

Combretastatin A4 Prodrug

Vascular-targeting drug designed to block flow of blood to tumor

Anaplastic thyroid cancer

The product gained orphan designation in Europe as a treatment for ATC (4/19)

ProMetic Life
Sciences Inc.
(Canada; TSE:PLI)

PBI-1402

Orally active agent designed to activate neutrophils

Chemotherapy and radiotherapy side effects

Began Phase I trial in Canada to assess compound in healthy volunteers (4/1)

CARDIOVASCULAR

Forbes
Medi-Tech Inc.
(FMTI)

FM-VP4

Amphipathic analogue of phytostanols

Cholesterol management

European Phase II trial showed lowering of cholesterol levels by 11% compared to placebo, a statistically significant result but lower than seen by other agents (4/5); released additional data supporting decision to move drug forward (4/19)

Sangart Inc.*

Hemospan (MP4)

Hemoglobin-based oxygen carrier

Alternative to blood transfusions

Received approval for Phase II trial in up to 90 patients at six sites in Sweden (4/12)

CENTRAL NERVOUS SYSTEM

Pharming Group
NV
(the Netherlands;
Euronext:PHARM)

rhC1INH

Recombinant human C1 inhibitor

Hereditary angioedema

Began pivotal Phase III trial at multiple centers in Europe (4/28)

INFECTION

Phanuel Pursuits*
LLC
(British
Virgin Islands)

--

Topical formulation designed to knock down relevant proteins

Herpes I and II

Phanuel plans to begin trials in India of the product licenced from CytoGenix Inc. (4/30)

SciClone
Pharmaceuticals
Inc.
(SCLN)

Zadaxin

Synthetic preparation of thymosin alpha-1

Hepatitis B

Began trial in Taiwan comparing treatment with lamivudine vs. lamivudine alone (4/14)

Sinovac Biotech
Ltd.
(China;
OTC BB:SNVBF)

--

Vaccine for severe acute respiratory syndrome

SARS

Said World Health Organization agreed to company's Phase I trial design, and that trial would start soon (4/30)

MISCELLANEOUS

Anika
Therapeutics
Inc.
(ANIK)

Incert-S

Bioabsorbable, chemically modified form of hyaluronic acid

Adhesion and scarring after spinal surgery

Began pilot study in 45 patients in the UK to test safety and effectiveness (4/20)

Isotechnika
Inc.*
(Canada)

Trans-ISA247

Immunosuppresive agent

Psoriasis and renal transplantation

Got approval in Canada for dose-finding trial in 36 subjects (4/21)

NicOx SA
(France; OTC BB:
NICXF)

NCX 1022

Nitric oxide-releasing steroid; ointment formulation

Seborrheic dermatitis

Phase IIa trial in 40 patients showed statistically significant improvement in clinical efficacy symptoms (4/29)


Notes:

* Privately held.

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