Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Argenes Inc.* ARG098 An anti-Fas IgM monoclonal antibody that specifically targets the Fas molecule Rheumatoid arthritis Started a Phase I trial (10/5)
ZymoGenetics Inc. (ZGEN) and Merck Serono (Switzerland; NYSE:SRA) Atacicept Antagonist protein that binds to the TNF cytokines BLyS and APRIL Lupus nephritis Companies agreed with FDA on an SPA to conduct a pivotal trial (10/4)
CANCER
Abraxis BioSciences Inc. (ABBI) and Biocon Ltd. (India) Abraxane (FDA-approved) Paclitaxel protein-bound particles for injectable suspension; albumin-bound Breast cancer Received approval in India (10/18)
Adherex Technologies Inc. (AMEX:ADH) STS Sodium thiosulfate Hepatoblastoma Initiated enrollment in the UK for a Phase III trial to prevent hearing loss in children treated for hepatoblastoma (10/30)
Metabasis Therapeutics Inc. (MBRX) MB07133 A HepDirect prodrug of cytarabine monophosphate Hepatocellular carcinoma European Commission granted orphan designation (10/3)
Micromet Inc. (MITI) MT103 A BiTE antibody targeting the CD19 antigen Acute lymphoblastic leukemia Received approval to begin a German Phase II trial (10/18)
Onyx Pharmaceuticals Inc. (ONXX) Nexavar (FDA-approved) Sorafenib tablets Hepatocellular carcinoma European Commission granted marketing authorization (10/30)
OSI Pharmaceuticals Inc. (OSIP) and F. Hoffmann-La Roche Ltd. (Switzerland) Tarceva (FDA-approved) Erlotinib Recurrent non-small-cell lung cancer Received approval in Japan (10/22)
Poniard Pharmaceuticals Inc. (PARD) Picoplatin Intravenous picoplatin; a new generation platinum chemotherapy agent Small-cell lung cancer European Commission granted orphan designation (10/17)
Xanthus Pharmaceuticals Inc.* Xanafide Amonafide malate Acute myeloid leukemia Received orphan drug designation in Europe (10/26)
CENTRAL NERVOUS SYSTEM
Javelin Pharmaceuticals Inc. (AMEX:JAV) Dyloject Diclofenac sodium; an injectable nonsteroidal anti-inflammatory drug Pain Received marketing authorization approval in the UK (10/31)
INFECTION
Gilead Sciences Inc. (GILD), Bristol-Myers Squibb Co. and Merck & Co. Inc. Atripla Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg HIV-1 infection Health Canada approved Atripla (10/17); CHMP recommended the drug for treating HIV-1 infection in adults with virologic suppression to HIV-1 RNA levels of less than 50 copies/ml on their current combination antiretroviral therapy for more than three months (10/18)
Inovio Biomedical Corp. (AMEX:INO) ChronVac-C DNA vaccine administered using Inovio's MedPulser DNA delivery system Hepatitis C virus Began enrolling patients for a Phase I/II study in Sweden (10/30)
Transgene SA (France; Paris:TNG) TG4040 MVA-HCV; vaccine Chronic hepatitis C virus infection Enrolled the first patients in a Canadian Phase I trial (10/1)
MISCELLANEOUS
Actelion Ltd. (Switzerland; SWX:ATLG) Zavesca Miglustat Niemann Pick type C CHMP issued a negative opinion about extending the use of Zavesca (10/19)
Genzyme Corp. (GENZ) Elaprase Idursulfase Hunter syndrome Gained approval in Japan (10/5)
Hospira Inc. (NYSE:HSP) Retacrit Epoetin zeta Anemia associated with chronic renal failure Received a positive opinion from the CHMP recommending approval (10/19)
NexMed Inc. (NEXM) Alprostadil Topical drug Erectile dysfunction Filed a new drug submission seeking approval in Canada (10/22)
NPS Pharmaceuticals Inc. (NPSP) Cinacalcet hydrochloride Secondary hyperparathyroidism Approved in Japan (10/25)
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; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange.