Company* |
Product |
Description |
Indication |
Status |
CANCER | ||||
AltaRex Corp. |
OvaRex MAb |
Modified murine monoclonal antibody that binds to CA 125 cancer antigen |
Ovarian cancer |
Company reported positive reresults in which 56% of German patients who received the therapy survived more than one year, 34% survived more than two and 11% out of the 34% survived more than five years (7/12) |
British Biotech |
E21R |
A granulocyte macrophage- colony stimulating factor antagonist |
Acute myeloid leukemia |
Company received approval to start a Phase II trial at University College London (7/26) |
CancerVax |
Canvaxin |
Allogeneic; whole cell vaccine that expresses over 20 antigens |
Melanoma |
Company said it plans to prepare a new drug submission seeking marketing approval in Canada (7/25) |
Cephalon |
Actiq |
Oral transmucosal fentanyl citrate |
Cancer |
Actiq was granted marketing approval in 16 European countries (7/2) |
Inex |
INX-3280 |
Anticancer therapeutic that targets the c-myc gene, believed to be a factor in the uncontrolled cell growth characteristic of tumors |
Cancer |
The final patient was enrolled in a Phase I trial of INX-3280 in combination with cisplatin (7/23) |
Millennium |
MabCampath |
Humanized monoclonal antibody; alemtuzumab |
B-cell chronic lymphocytic leukemia |
European Commission granted marketing authorization to the MabCampath antibody (7/12) |
Oxford |
MetXia |
Gene-activated prodrug therapy |
Breast cancer |
Company received approval in the UK to start a further trial (7/18**) |
SciClone |
Zadaxin |
Immune system enhancer; synthetic immunostimulant peptide |
Cancer |
Zadaxin was approved in the Philippines as an adjuvant to chemotherapy to treat various cancers (7/23) |
CARDIOVASCULAR |
||||
Cerus Corp. |
Intercept Platelet System |
A system to inactivate bacteria, viruses and other pathogens and white blood cells in platelets intended for transfusion |
Thrombo- |
Results from a Phase III European trial showed the safety and efficacy was comparable to the first cycle of Intercept platelets, with comparable increases in platelet counts following transfusion (7/16) |
CENTRAL NERVOUS SYSTEM |
||||
Biovail Corp. |
d-methyl- |
Chirally pure version of dl-methylphenidate |
Attention deficit disorder |
Companies filed a new drug submission in Canada (7/10) |
Immunex |
Enbrel (FDA- approved) |
Etanercept; tumor necrosis factor receptor |
Psoriatic arthritis |
Company filed for regulatory approval in Canada (7/17) |
INFECTION |
||||
Biosearch Italia |
Ramoplanin |
Naturally occurring antibiotic |
Infections due to vancomycin- resistant Enterococci |
Company received orphan drug status in Europe for Ramoplanin (7/12) |
SciClone |
Zadaxin |
Immune system enhancer; synthetic immunostimulant peptide |
Hepatitis B and C |
Company received expanded indications in Mexico (7/10) |
Trinity Medical |
Remune |
HIV-1 immunogen |
HIV |
Companies filed an NDA in Thailand (7/30) |
MISCELLANEOUS | ||||
Atrix |
Atridox |
8.5% doxycycline combined with the Atrigel drug delivery system |
Periodontal disease |
Atrix received approval in Switzerland to market Atridox in the Atrigel drug delivery system (7/3) |
AVAX |
¿ |
Treatment consisting of introducing the normal gene into stem cells of patients through gene therapy |
Severe combined immunodeficiency disease |
Product gained orphan medicinal product status in Europe (7/19) |
Axcan Pharma |
Photofrin (FDA-approved) |
Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated) |
High-grade dysplasia associated with Barrett's esophagus |
Company filed a new drug submission in Canada (7/5) |
Enzo Biochem |
¿ |
Immune regulation medicine |
Crohn's disease |
Company received approval in Israel to being a Phase I trial (7/12) |
Inhale |
¿ |
Inhalable form of alpha-1-antitrypsin |
Hereditary emphysema |
Aventis received orphan medicinal product designation from the European Commission (7/26) |
Lilly ICOS |
Cialis |
Oral drug; a PDE5 inhibitor |
Erectile dysfunction |
Company filed an application in Europe for the approval of Cialis (7/12) |
Oxford |
Vevesca |
Oral capsule formulation of a glucosyl transferase inhibitor |
Type I Gaucher disease |
Company submitted a marketing authorization application to the European Medicines Evaluation Agency (7/12) |
QLT Inc. |
Visudyne |
Verteporfin for injection |
Predominately subfoveal choroidal neovascularization |
Health Canada granted approval (7/26) |
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. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange | ||||
NDA = New Drug Application |