Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira |
Adalimumab; fully human antibody designed to block TNF-alpha |
Crohn's disease |
The EMEA's CMPH recommended approval (4/27) |
CANCER | ||||
Allos |
PDX |
Antifolate pralatrexate; a small-molecule chemo- therapeutic agent designed to inhibit dihydrofolate reducatase |
Peripheral T-cell lymphoma |
European Commission granted orphan drug designation to PDX (4/19) |
Genta Inc. (GNTA) |
Genasense |
Oblimersen sodium injection |
Advanced melanoma |
Company is requesting a review of a negative opinion for market-ing authorization in Europe of its application for Genasense plus dacarbazine (4/27) |
Hybrigenics |
Inecalcitol |
A synthetic vitamin D analogue |
Prostate cancer |
Phase I data showed no adverse side effects at the initial dose (4/18)** |
Northwest |
DCVax-Brain |
A personalized dendritic cell vaccine |
Malignant brain cancers |
Filed for authorization in Switzerland (4/17) |
CARDIOVASCULAR | ||||
Alexion |
Soliris (FDA-approved) |
Eculizumab; monoclonal antibody designed to selectively block terminal complement activation |
Paroxysmal nocturnal hemoglobinuria |
European regulators recommended approval, calling for a broad label(4/27) |
Encysive |
Thelin |
Sitaxentan sodium 100 mg tablets; selective endothelin A receptor antagonist |
Pulmonary arterial hypertension |
Launched Thelin in Ireland (4/2) |
Proteo Biotech |
Elafin |
Recombinant human protein |
Pulmonary arterial hypertension |
Received orphan drug status from the European Commission (4/4) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. |
Vivitrol (FDA-approved) |
Naltrexone for extended-release injectable suspension |
Alcohol dependence |
Submitted marketing authorization in the UK and Germany for once- monthly treatment (4/2) |
SkyePharma plc |
Requip |
Ropinirole; prolonged-release tablets |
Parkinson's disease |
French officials approved the product (4/23) |
INFECTION | ||||
Crucell NV |
|
Rabies monoclonal antibody |
Rabies |
Began a Phase I study in India (4/4) |
Idenix |
Sebivo |
Telbivudine; once-a-day tablet |
Hepatitis B virus |
European Commission approved Sebivo (4/30) |
MediGene AG |
Polyphenon E Ointment |
A concentrate of catechines |
Genital warts |
Regulatory authorities in Germany, Austria and Spain have accepted the MAA for review (4/18) |
Schering-Plough |
Pegintron (FDA-approved for hepatitis C) |
Peginterferon alfa-2b |
Chronic hepatitis B virus |
It was approved in China (4/5) |
MISCELLANEOUS | ||||
Clinuvel |
CUV1647 |
Agent designed to stimulate production of eumelanin |
Erythropoietic protoporphyria |
Received Swiss regulatory clearance to begin a Phase III trial (4/11) |
Pharmaxis Ltd. |
Bronchitol |
Inhalable dry powder formulation of mannitol delivered twice daily |
Cystic fibrosis |
Began a Phase III trial in Australia, the UK and Ireland to support eventual approval in the EU, Australia and elsewhere (4/11) |
QLT Inc. |
Visudyne (FDA- approved) |
Light-activated therapy |
Occult subfoveal choroidal neo- vascularization secondary to age-related macular degeneration |
The CMPH recommended deletion of the indication due to missed primary endpoints in a confirmatory trial (4/25) |
Notes: | ||||
* Privately held. ** Denotes the date the item ran in BioWorld International. | ||||
CMPH = 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. | ||||
ASX = Australian Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||