Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Elan Corp. plc (Ireland; NYSE:ELN) and Biogen Idec Inc. (BIIB) Tysabri (FDA-approved) Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells Crohn's disease EMEA said the CMPH adopted a negative opinion on the MAA; the companies plan to appeal the opinion (7/19)
MediGene AG (Germany; PK: MDGEF) and CollaGenex Pharmaceuticals Inc. (CGPI) Oracea (FDA-approved) Capsule formulation of doxycycline Rosacea The European marketing authorization has been postponed after the committee of the nine countries involved failed to reach a unanimous decision
CANCER
Active Biotech AB (Sweden; SSE:ACTI) Anyara Antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells Renal cancer Was granted orphan drug status by the Committee for Orphan Medicinal Products of the EMEA (7/26)
Ark Therapeutics plc (UK; PK:ARKTF) Cerepro Gene therapy Malignant glioma Withdrew its application for early marketing approval after learning the EMEA requires data from the ongoing Phase III trial for approval (7/25)**
Bioxel Pharma Inc. (Canada; CDNX:BIP) Docetaxel Active agent in the cancer drug Taxotere Cancer Submitted a drug master file with Health Canada seeking approval of docetaxel (7/31)
EntreMed Inc. (ENMD) MKC-1 An oral, cell-cycle inhibitor Leukemia Started a Canadian Phase I study (7/24)
Genta Inc. (GNTA) Genasense Oblimersen sodium injection Advanced melanoma The requested re-examination by the CMPH reaffirmed a negative opinion for approval, saying there is a need for an additional, confirmatory study (7/20)
Oncolytics Biotech Inc. (Canada; ONCY; TSX:ONC) Reolysin Formulation of the human reovirus Advanced cancers Started enrolling patients in a UK trial of Reolysin in combination with docetaxel (7/23)
Spectrum Pharmaceuticals Inc. (SPPI), Pharmion Corp. (PHRM) and GPC Biotech AG (Germany; GPCB) Satraplatin Oral platinum compound Metastatic hormone- refractory prostate cancer EMEA accepted for review the MAA submitted for satraplatin in combination with prednisone for the treatment of patients who have failed prior chemotherapy (7/27)
CARDIOVASCULAR
Beike Biotechnology Co. Ltd.* Peripheral blood stem cells Peripheral vascular disease 90.1% of patients (7/2) Completed a study showing that lower limb pain and coldness were improved significantly in (China)
CENTRAL NERVOUS SYSTEM
Athersys Inc.* ATHX-105 Oral drug shown to selectively inhibit the 5HT2c receptor agonist without activating 5HT2b Obesity Started a Phase I trial in the UK (7/25)
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) Tysabri (FDA-approved) Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells Relapsing-remitting multiple sclerosis UK officials changed an earlier decision and recommended the use of Tysabri in people with highly active disease (7/2)
GW Pharmaceuticals plc (UK; LSE:GWP) Sativex Cannabis-derived treatment Spasticity in multiple sclerosis Company withdrew its European submission to conduct another trial (7/25)**
Targacept Inc. (TRGT) and AstraZeneca plc (UK) AZD3480 Designed to act selectively on neuronal nicotinic receptors Alzheimer's disease Started a Phase IIb trial with about 500 patients in Western Europe, Eastern Europe and Canada (7/23)
INFECTION
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) Ceftobiprole Broad-spectrum, anti MRSA cephalosporin antibiotic Complicated skin and skin structure infections A new drug submission was filed with Canadian regulatory authorities (7/17); European authorities accepted the filed MAA
Dynavax Technologies Corp. (DVAX) Heplisav A hepatitis B vaccine Hepatitis B Completed enrollment of more than 2,000 subjects in a Phase III trial held in Canada and Germany (7/12)
Pfizer Inc. Celsentri Maraviroc; a CCR5 antagonist HIV CMPH issued a positive opinion recommending marketing authorization for use in combination with other antiretroviral agents (7/20)
MISCELLANEOUS
Omrix Bio-pharmaceuticals Inc. (OMRI) and Ethicon Inc. Evicel Liquid fibrin sealant General hemostasis in surgery Submitted a market authorization application to the EMEA (7/30)
Notes:
* Privately held.
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.
CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.