Company* |
Product |
Description |
Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha |
Crohn's |
A European advisory committee recommended approval of expanded labeling for Remicade to include maintenance dosing for sustaining clinical response in patients with fistulizing, active Crohn's disease who have responded to infliximab therapy (7/25) |
| ||||
CANCER | ||||
Aphton Corp. |
G17DT |
Anti-gastrin immunogen |
Pancreatic cancer and gastric cancer |
European Union granted orphan drug status (7/8) |
|
||||
Celmed BioSciences Inc. (subsidiary of Theratechnologies Inc.; Canada; TSE:TH) |
Theralux |
A photodynamic therapy being developed to destroy cancer cells in bone marrow or blood ex vivo using Th9402 |
Chronic myeloid leukemia |
Phase I/II data showed it was safe and significantly reduced the absolute number of cancer cells in the graft, while preserving an adequate number of progenitor cells for sustained engraftment; the trial was conducted in Canada (7/7) |
| ||||
ImClone Systems Inc. (IMCL) and Merck KGaA (Germany) |
Erbitux |
Cetuximab; monoclonal antibody that targets the epidermal growth factor receptor |
Colorectal cancer |
Merck filed for marketing clearance in Europe (7/7) |
|
||||
Mologen AG (Germany; FSE:MGNG) |
dSLIM |
Immunomodulating molecule |
Metastasized colon cancer |
Phase II data showed no side effects and higher incidences of complete and partial remission; trial was conducted in Spain (7/23**) |
| ||||
PharmaMar SA* (Spain) |
Aplidin |
Marine-derived |
Acute lymphoblastic leukemia |
PharmaMar received orphan drug status in Europe for Aplidin (7/17) |
|
||||
PharmaMar SA* (Spain) |
Yondelis |
Trabectedin |
Soft tissue sarcoma |
European committee rejected marketing approval (7/29) |
|
||||
Transgene SA (France; TRGNY) |
Adeno-interferon |
Uses an improved version of Transgene's adenovirus vector carrying the interferon-gamma gene |
Cutaneous T-cell lymphoma |
European Commission designated the candidate an orphan drug (7/23) |
|
||||
CARDIOVASCULAR | ||||
Medicure Inc. (Canada; TSE:MPH) |
MC-4232 |
Agent to reduce hyper- tension and the risk of heart attack |
Hypertension |
Company received approval in Canada to begin a Phase II trial (7/23) |
|
||||
DIABETES | ||||
Biotech Holdings |
Sucanon |
An insulin receptor sensitizer |
Type II diabetes |
Biotech Holdings received approval in Mexico (7/30) |
|
|
|||
INFECTION | ||||
Gilead Sciences Inc. (GILD) |
Emtriva |
Emtricitabine; blocks reverse transcriptase |
HIV |
A European advisory committee recommended that regulatory authorities approve Emtriva (7/25) |
|
||||
MISCELLANEOUS | ||||
Debiopharm Corp.* (Switzerland) and |
DX-890 |
Inhibitor of hNE; might act as an anti-inflammatory agent to target neutrophil-related inflammation |
Cystic fibrosis |
Companies received European orphan drug designation (7/29) |
|
|
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| | ||||
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
FSE = Frankfurt Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
