Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Abbott (NYSE:ABT) Humira (FDA-approved) Adalimumab Moderate to severe plaque psoriasis CHMP recommended approval (11/16)
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) Tysabri (FDA-approved) Natalizumab Crohn's disease CHMP recommended rejecting marketing authorization (11/16)
Genmab A/S (Denmark; CSE:GEN) Ofatumumab Binds to the B-cell receptor CD20 Rhuematoid arthritis Started a Phase III trial in Europe (11/20)
UCB SA (Belgium; BR:UCB) Cimzia Certolizumab pegol Crohn's disease CHMP issued a negative opinion on the MAA in the European Union (11/16)
CANCER
Aeterna Zentaris Inc. (Canada; AEZS) Perifosine A first-in-class, oral signal transduction inhibitor Non-small-cell lung cancer Completed enrollment in a European multicenter Phase II trial (11/14)
Celgene International Sarl (Switzerland; CELG) Revlimid (FDA-approved) Lenalidomide Multiple myeloma The Australian Drug Evaluation Committee recommended approval of Revlimid in combination with dexamethasone in patients whose cancers have progressed after one therapy (11/12)
Celgene International Sarl (Switzerland; CELG) Revlimid (FDA-approved) Lenalidomide Chronic lymphocytic leukemia European Commission granted orphan drug status (11/30)
Introgen Therapeutics Inc. (INGN) Advexin A targeted p53 tumor suppressor therapy Li-Fraumeni syndrome cancers Submitted an MAA in Europe (11/13); regulatory authorities accepted the MAA (11/27)
Peregrine Pharmaceuticals Inc. (PPHM) Bavituximab A monoclonal antibody designed to target and bind to phophatidylserine Metastatic breast cancer A Phase II protocol of the drug in combination with the chemotherapy drug docetaxel was approved in Georgia (11/16)
Wyeth Pharmaceuticals Torisel Temsirolimus; an mTOR (mammalian target of rapamycin kinase) inhibitor Advanced renal-cell carcinoma European Commission approved Torisel (11/26)
CARDIOVASCULAR
The Medicines Co. (MDCO) Angiox (FDA-approved) Bivalirudin Adult coronary syndrome CHMP adopted a positive opinion to extend the indication to adult patients planned for urgent or early intervention, specifically patients with unstable angina or non-ST segment elevation myocardial infarction (11/19)
CENTRAL NERVOUS SYSTEM
Neurochem Inc. (Canada; NRMX) Alzhemed Tramiprosate Alzheimer's disease Discontinued its European Phase III trial and said it instead plans to commercialize the product as a branded nutraceutical (11/8)
DIABETES
Generex Biotechnology Corp. (GNBT) Oral-lyn Oral insulin spray, a non-injectable buccal insulin Diabetes Received approval in India (11/1)
INFECTION
Avant Immunotherapeutics Inc. (AVAN) and GlaxoSmithKline plc (UK) Rotarix Rotavirus vaccine Rotavirus Avant said new data from a European trial showed the vaccine is effective against the five most commonly circulating rotavirus types (11/26)
Crucell NV (the Netherlands; CRXL) Rabies monoclonal antibody cocktail Rabies An Indian Phase Ib study indicated the treatment is well tolerated (11/30)
Samaritan Pharmaceuticals Inc. (AMEX:LIV) Amphocil An injection; a lipid form of amphotericin B Invasive aspergillosis The company's subsidiary received notification from the Cyprus Ministry of Health that its MAA was approved in Cyprus (11/9)
ViroPharma Inc. (VPHM) Camvia Maribavir; a benzimidazole riboside To prevent cytomegalo-virus Granted orphan drug status in Europe (11/12)
MISCELLANEOUS
BioMarin Pharmaceutical Inc. (BMRN) and Merck Serono (Germany) Sapropterin dihydrochloride Oral treatment Hyperphenyl-alaninemia Submitted an MAA (11/8)
Biopure Corp. (BPUR) Hemopure A purified hemoglobin blood substitute for surgery patients Acutely anemic orthopedic surgery patients Submitted a complete response to questions from the UK Commission on Human Medicines regarding potential marketing approval (11/8)
Cangene Corp. (Canada; TSX:CNJ) WinRho SDF Rho(D) immune globulin (human); a hyperimmune antibody preparation Hemolytic disease in newborns and immune thrombocytopenic purpura Health Canada approved the liquid formulation (11/29)
Novogen Ltd. (Australia; NVGN) NV-52 A synthetic flavonoid Inflammatory bowel disease Phase Ia and Phase Ib data showed it may be useful for maintaining remission (11/13)
StemCells Inc. (STEM) HuCNS-SC cells Purified human neural stem cells Batten disease One patient has completed the Phase I trial; of the five patients transplanted so far, there have been no safety issues (11/30)
Sucampo Pharma Ltd. (Japan; SCMP) Amitiza (FDA-approved) Lubiprostone Adult chronic constipation Started a Phase IIb study in Japan (11/29)
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; BR = Brussels Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; TSX = Toronto Stock Exchange.