Company* (Country; Symbol)ProductDescriptionIndicationStatus (Date)

AUTOIMMUNE
Abbott (NYSE:ABT)Humira (FDA-approved)Adalimumab; an inhibitor of tumor necrosis factorModerate-to-severe plaque psoriasisReceived marketing authorization from the European Commission for Humira (12/20)
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN)AlitretinoinOral drugSevere refractory chronic hand eczemaFiled its new drug submission with Health Canada (12/21)
CANCER
Amgen Inc. (AMGN)VectibixPanitumumab; a fully human anti-EGFR monoclonal antibodyEGFR-expressing metastatic colorectal cancerEuropean Commission approved Vectibix (12/6)
Epeius Biotechnologies Corp.*Rexin-GTumor-targeted cancer agentIntractable cancersReceived approval in the Philippines (12/18)
Genentech Inc. (NYSE:DNA), Biogen Idec Inc. (BIIB) and F. Hoffmann-La Roche Ltd. (Switzerland)MabThera (FDA-approved)Rituximab (Rituxan)Follicular non-Hodgkin's lymphomaCHMP issued a positive recommendation to extend the label for MabThera to include its use with any chemotherapy as a first-line treatment (12/14)
Provectus Pharmaceuticals Inc. (OTC BB:PVCT)PV-10ProvectaStage III and Stage IV metastatic melanomaStarted recruiting patients in its Phase II trial in Australia (12/18)
CENTRAL NERVOUS SYSTEM
Genzyme Corp. (GENZ)Synvisc-OneSingle-injection version of the marketed drug Synvisc (hylan G-F 20)Pain associated with osteo-arthritis of the kneeReceived a European CE Mark for Synvisc-One (12/19)
Lexicon Pharmaceuticals Inc. (LEXG)LX6171Inhibits a central nervous system membrane proteinCognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia and vascular dementiaStarted a Phase IIa European trial (12/5)
INFECTION
Napo Pharmaceuticals Inc. (LSE:NAPL) and Glenmark Pharmaceuticals Ltd. (India)CrofelemerAgent extracted from the rainforest plant Croton lechleriAcute infectious diarrheaStarted a Phase II trial in India (12/6)
MISCELLANEOUS
BioMimetic Therapeutics Inc. (BMTI)GEM OS1 Bone GraftCombines platelet derived growth factor with the bone matrix beta tricalcium phosphateFoot and ankle fusionsA pivotal Canadian study showed 90% of patients gained benefit (12/14)
Hospira Inc. (NYSE:HSP)RetacritEpoetin zeta; a follow-on, or biosimilar, erythropoietinAnemia associated with chronic renal failure and chemotherapyEuropean Commission has authorized it to market Retacrit (12/20)
Neurochem International Ltd. (Switzerland; NRMX)KIACTAEprodisateAmyloid A amyloidosisCHMP recommended refusal of the MAA, concluding that another study is needed to demonstrate effectiveness (12/14)
Oculus Innovative Sciences Inc. (OCLS) and China Bao Tai (China)MicrocynNonirritating small-molecule oxychlorine compoundWound and burn careChina Bao completed two randomized, controlled trials (12/18)

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.
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange.

No Comments