Company* |
Product | Description | Indication | Status |
AUTOIMMUNE | ||||
BioMS |
MBP8298 |
Synthetic peptide |
Multiple sclerosis |
Monitors reviewing pivotal Phase II/III trial in secondary progressive MS recommended continuation of the study (2/7) |
GemacBio* |
Agent comprising several molecules in the human body grafted together |
Multiple sclerosis |
Data from 22-patient Phase IIa trial showed a safety profile that could support long-term treatment (2/1) |
|
CANCER | ||||
Advaxis Inc. |
Lovaxin C |
Listeria-based cancer vaccine |
Cervical cancer |
Is starting Phase I/II trials at sites in Israel, Serbia and Mexico (2/21) |
Algeta ASA* |
Alpharadin |
Radiopharmaceutical based on the alpha particle emitter radium-223 |
Bone metastases from prostate cancer |
Follow-up data from Phase II trial in 64 patients in Europe showed a statistically significant decrease of bone-alkaline phosphatase vs. placebo (2/27) |
Antisoma plc |
AS1411 |
Anti-nucleolin aptamer |
Renal and pancreatic cancers |
The product was granted orphan designation in Europe in both cancers (2/21) |
Bioenvision |
Evoltra (FDA- approved) |
Clofarabine; second- generation purine nucleoside analogue |
Acute lymphoblastic leukemia in pediatric patients |
The European Medicines Agency issued a positive opinion on the marketing authorization application (2/23) |
BioVex Inc.* |
OncoVEX-GMCSF |
Oncolytic virus designed to selectively kill tumor cells |
Head and neck cancer |
Began open-label trial in the UK to evaluate the product with chemo- radiotherapy in 16 patients (2/14) |
Chemokine |
CTCE-9908 |
Chemokine CXCR4 |
Cancers |
Is starting a Phase Ib/II trial in Canada to evaluate safety and early efficacy in up to 30 patients with late-stage cancers (2/6) |
Ecopia |
ECO-4601 |
Small-molecule agent derived from soil-dwelling microorganisms |
Cancers |
Began Phase I trial in Canada to evaluate safety and tolerability in up to 30 refractory patients (2/2) |
Gastrotech |
GTP-200 |
Product based on the naturally occurring peptide hormone, ghrelin |
Cancer cachexia |
Began Phase II trial in Sweden in 30 patients with end-stage cancer and significant weight loss (2/9) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced metastatic melanoma |
MAA filed in January in Europe was accepted for review (2/1) |
Genentech |
Herceptin (FDA-approved) |
Trastuzumab; monoclonal antibody against the HER2/neu protein |
Early stage breast cancer |
Partner F. Hoffmann-La Roche Ltd. filed MAA seeking European approval for treating early stage, HER2-positive disease (2/15) |
GPC Biotech |
1D09C3 |
Major histocompatibility complex class II monoclonal antibody |
Multiple myeloma |
The product was granted orphan designation in Europe in that indication (2/14) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
Partner Merck KGaA received a positive opinion from the CHMP on marketing application to use drug with radiation in treating advanced disease (2/23) |
ProMetic Life |
PBI-1402 |
Orally active, low-molecular-weight synthetic compound |
Anemia |
Is starting a Phase Ib/II trial in Canada in up to 30 cancer patients undergoing chemotherapy (2/13) |
TopoTarget |
Savicol |
Histone deacetylase inhibitor |
Colorectal polyps |
Began pivotal Phase II trial in Germany and Russia in 60 patients with familial adenotmatous |
Viragen Inc. |
Multiferon |
Multisubtype, natural human alpha interferon |
Malignant melanoma |
The product was approved in Sweden for first-line adjuvant treatment of MM following dacarbazine after surgical removal of tumors (2/21) |
CARDIOVASCULAR | ||||
Genzyme |
Treatment with autologous skeletal myoblasts |
Heart failure |
Enrollment was stopped in Phase II trial in Europe after monitors concluded there was a low likeli- hood of improvements in heart function (2/23) |
|
GTC |
ATryn |
Recombinant form of human antithrombin |
Hereditary antithrombin deficiency |
Company said EMEA was issuing a negative opinion on marketing application; GTC intends to appeal that finding (2/23) |
Neose |
NE-180 |
Long-acting, GlycoPEG-ylated erythropoietin |
Anemia |
Began Phase I trial in Europe to evaluate safety and pharmaco- kinetics in 40 volunteers (2/13) |
CENTRAL NERVOUS SYSTEM | ||||
Cytos |
CYT002- NicQb |
Therapeutic vaccine that induces nicotine-specific antibodies that bind nicotine |
Smoking cessation |
Study designed to induce high enough antibody levels was succesfully completed (2/2) |
Evotec AG |
EVT 101 |
NR2B subtype selective NMDA receptor antagonist |
Alzheimer's disease |
Phase I trial in 48 young, healthy (Germany; subjects showed agent was well tolerated and had a good pharmacokinetic profile (2/3) |
Memory |
MEM 3454 |
Nicotinic alpha-7 agonist |
Central nervous system disorders |
Phase I trial in Canada in 48 healthy volunteers demonstrated improved memory scores (2/21) |
Neurogen |
NGD-8243 |
Agent targeting the type 1 vanilloid receptor |
Pain |
Partner Merck & Co. Inc. began a Phase I trial in Europe to evaluate safety and pharmacokinetics in healthy volunteers (2/16) |
Pain |
Remoxy |
Abuse-resistant form of long-acting oxycodone |
Pain |
Began Phase III trial under FDA SPA to evaluate the drug in 400 patients with moderate to severe osteoarthritic pain (2/16) |
Prana |
PBT2 |
Small molecule that binds metal ions |
Alzheimer's disease |
Phase I trial in the Netherlands demonstrated suitable safety and pharmacokinetic profiles for continued development (2/7) |
INFECTION | ||||
Avant Immuno- |
Rotarix |
Oral, two-dose, live attenuated vaccine developed from a single human strain |
Rotavirus infection |
Partner GlaxoSmithKline plc received approval to market the product in Europe to prevent gas- troenteritis caused by rotavirus (2/27) |
Biota |
BTA-798 |
Agent targeting the |
The common cold |
Began Phase I trial in the UK that will include up to 48 volunteers (2/16) |
Debiopharm |
Debio-025 |
Synthetic, non-immuno-suppressive cyclosporin |
HIV |
Data from trial in 36 patients |
Idenix |
Telbivudine |
Selective, oral nucleoside analogue |
Hepatitis B |
Partner Novartis AG submitted an MAA seeking approval of the product in Europe (2/7) |
Targeted |
tgAAC09 |
Gene therapy using AAV vector to elicit immune system responses |
HIV |
Began Phase II trial in Uganda to evaluate the safety and immuno- genicity of the preventive vaccine (2/6) |
MISCELLANEOUS | ||||
Allergy |
MPL103 |
Monophosphoryl lipid A; TLR-4 agonist used as an adjuvant |
Allergies |
Began Phase I/II trial in Germany that will evaluate product with sublingual vaccines in 80 patients allergic to grass pollens (2/10) |
BioPartners |
Valtropin |
Recombinant human growth hormone |
Growth hormone deficiency |
The CHMP recommended approval of the product in Europe (2/24) |
Bone Medical |
Oral parathyroid hormone |
Osteoporosis |
Phase I trial demonstrated safety and evidence of biological activity (2/14) |
|
CollaGenex |
Oracea |
Non-antimicrobial tetracycline derivative |
Rosacea |
Filed MAA seeking approval in the UK, which will serve as the reference state for Europe (2/27) |
NPS |
Preotact (Preos) |
Recombinant human parathyroid hormone |
Osteoporosis |
The CHMP recommended approval of the product in Europe, where Nycomed Group has rights (2/23) |
OSI |
Macugen(FDA-approved) |
Pegaptanib sodium; injection; pegylated anti- VEGF-aptamer |
Age-related macular degeneration |
Partner Pfizer Inc. gained approval of the product in Europe (2/2) |
Scil |
MD05 |
Recombinant growth and differentiation factor with a synthetic inorganic carrier |
For use in bone augmentation |
Began Phase II trial in patients requiring bone augmentation prior to implant insertion (2/14) |
Notes: | ||||
* Privately held. | ||||
CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
