Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Rheumatoid arthritis |
Wyeth and Takeda Pharmaceutical Co. Ltd. gained approval in Japan for treating those who inadequattely responded to other drugs (1/27) |
CANCER | ||||
Adherex |
Exherin |
Cadherin antagonist; small-peptide, tumor/vascular-targeting agent |
Advanced cancers |
Began Phase Ib/II trial in Switzerland to test safety and efficacy in up to 40 patients with N-cad- herin-positive tumors (1/18) |
AEterna |
AN-152 |
Cytotoxic conjugate that targets certain types of cancer cells that express LHRH receptors |
Cancers |
Began Phase I trial in Germany to evaluate safety and pharmacokinetics in patients with ovarian, endometrial or breast cancers (1/18) |
Genentech |
Avastin (FDA- approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic colorectal cancer |
F. Hoffmann-La Roche Ltd. gained approval of the drug in Europe as part of combination regimen (1/14) |
YM BioSciences |
h-R3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Brain cancer in children |
Phase II trial achieved the clinical milestone that permits conversion of the study into a pivotal trial, which will enroll 100 children (1/25) |
CENTRAL NERVOUS SYSTEM | ||||
CeNeS |
M6G |
Morphine metabolite |
Post-operative pain |
Final results from 168-patient Phase III trial in Europe showed the drug was an effective analgesic in patients who had knee-replacement surgery (1/21) |
GW Pharmaceuticals plc (UK; LSE:GWP) |
Sativex |
Spray formulation of cannabis extract |
Severe cancer pain |
Phase III trial in 177 patients demonstrated a statistically significant improvement in pain vs. placebo (1/19) |
Labopharm |
-- |
Once-daily formulation of the analgesic tramadol |
Pain |
French authorities approved the drug there, allowing the company to begin the mutual recognition procedure elsewhere in Europe (1/17) |
Phytopharm |
Cogane PYM50028 |
Product based on Asian plant extract believed to have neuroprotective effects |
Alzheimer's disease |
Interim review after first 60 patients in a Phase II trial showed no safety concerns; planned enrollment will increase from 200 to 238 subjects (1/20) |
Pozen Inc. |
MT 100 |
Combination of metoclopramide and naproxen |
Migraine |
An advisory group in the UK recommended approval of the product as long as Pozen provides additional data and meets other conditions (1/26) |
Prana |
PBT-1 (clioquinol) |
Small molecule that binds metal ions; designed to remove zinc bound to amyloid-beta |
Alzheimer's disease |
Got OK for pivotal Phase II/III trial in the UK to test efficacy in a one- year trial in 435 patients, when added to existing therapy (1/4) |
Newron |
Safinamide |
Molecule believed to have multiple mechanisms of action |
Restless legs syndrome |
Phase II trial in 10 patients in Italy showed improvement in all efficacy parameters (1/11) |
Vasogen Inc. |
VP025 |
Agent designed to target chronic inflammation in the brain |
Neurological diseases |
Began Phase I trial in Canada that will evaluate safety and tolerability in up to 24 healthy volunteers (1/24) |
DIABETES | ||||
Prosidion Ltd. |
PSN9301 |
Small-molecule dipeptidyl peptidase-V inhibitor |
Type II diabetes |
Began Phase II proof-of-concept and dose-finding trial in 60 patients in Germany (1/19) |
INFECTION | ||||
Advanced Viral |
AVR118 |
Peptide-nucleic acid complex with immuno- modulatory properties |
Cachexia in AIDS patients |
Presented final data from Phase I/II trial in 30 patients in Israel showing improved weight, strength and fat percentage in all doses (1/24) |
Nabi Bio-pharmceuticals |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
To prevent S. aureus bacteremia |
The MAA was accepted for review by EMEA; Nabi is seeking approval in Europe to prevent bacteremia in patients with end-stage renal disease on hemodialysis (1/26) |
The Immune |
Remune |
Immune-based therapy comprised of a whole-killed virus and an adjuvant |
HIV |
Completed Phase II trials in Italy and Spain; one demonstrated safety and other induction of HIV- specific T cells (1/11) |
Sinovac |
Bilive |
Combined hepatitis A and B vaccine |
Hepatitis A and B |
Received final marketing approval in China (1/12) |
MISCELLANEOUS | ||||
Cerep SA |
-- |
LFA-1 receptor antagonist |
Immuno-inflammatory disorders |
Partner Bristol-Myers Squbb Co. completed Phase I trials showing the oral agent was well tolerated (1/24) |
Kamada Ltd.* |
-- |
Aerosolized version of its alpha-1 proteinase inhibitor product |
Congenital emphysema |
The EMEA granted orphan status to the drug (1/5) |
Pharmagene |
PGN1164 |
Oral 5HT2B antagonist |
Irritable bowel syndrome |
Began a Phase I trial in the UK to evaluate safety, tolerability and pharmacokinetics in 36 healthy volunteers (1/24) |
Serono SA |
-- |
Selective inhibitor of matrix metalloprotease inhibitor-12 |
Inflammatory diseases |
Serono began a Phase I trial to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (1/19) |
ThromboGenics |
-- |
Recombinant microplasmin, a truncated form of the human protein plasmin |
Vitreoretinal disorders |
Began Phase II trial to evalaute safety in up to 50 patients in the Netherlands and Germany (1/18) |
| | ||||
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
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