Company* (Country; Symbol) Product Description Indication Status (Date)
CANCER
Celgene International Sarl (Switzerland; CELG) Revlimid Lenalidomide; oral drug Multiple myeloma Approved by the Swiss Agency for Therapeutic Products for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy (9/4)
Genmab A/S (Denmark; CSE:GEN) HuMax-EGFr Zalutumumab Head and neck cancer The Danish Head and Neck Cancer Group is starting a Phase III trial in previously untreated patients (9/13)
Imclone Systems Inc. (IMCL) and Merck KGaA (Germany) Erbitux (FDA-approved) Cetuximab Metastatic colorectal cancer Submitted an application to the EMEA for broader use of Erbitux as a first-line therapy (9/4)
Immutep SA* (France) ImmuFact IMP321 A natural human T-cell immunostimulatory factor that amplifes the T-cell immune response in vaccines Metastatic melanoma Started a Phase I trial (9/4)**
Oncolytics Biotech Inc. (Canada; ONCY; TSX:ONC) Reolysin Formulation of the human reovirus Metastatic cancers Interim Phase Ia/Ib results from a UK trial showed that three of 11 patients experienced significant partial responses (9/28)
Pharmion Corp. (PHRM) MGCD0103 A histone deacetylase inhibitor Hodgkin's lymphoma EMEA granted orphan medicine status to MGCD0103 (9/24)
CENTRAL NERVOUS SYSTEM
GW Pharmaceuticals plc (UK; LSE:GWP) Sativex Cannabis-based drug Central neuropathic pain in multiple sclerosis Completed patient recruitment in its pivotal Phase III trial (9/5)**
NeurogesX Inc. (NGSX) NGX-4010 A dermal patch that contains capsaicin, a TRPV1 agonist Peripheral neuropathic pain The EMEA accepted for review its MAA (9/27)
INFECTION
Cubist Pharmaceuticals Inc. (CBST) and Novartis AG (Switzerland) Cubicin (FDA-approved) Daptomycin for injection Right-sided infective endocarditis due to S. aureus, and S. aureus bacteremia Approved in the European Union (9/6)
Cubist Pharmaceuticals Inc. (CBST) Cubicin (FDA-approved) Daptomycin for injection Complicated skin and skin structure infections Approved for marketing in Canada (9/25)
Medivir AB (Sweden; SSE:MVIRB) Lipsovir (ME-609) Formulation of the antiviral drug acyclovir and the steroid cortisone Labial herpes The Phase III program has enrolled 240 children and adolescents in Sweden and Russia (9/13)
MISCELLANEOUS
Basilea Pharmaceuticals Ltd. (Switzerland; SWX:BSLN) Alitretinoin Once-daily oral treatment Severe refractory chronic hand eczema Submitted an MAA to Swissmedic (9/28)
Ocera Therapeutics Inc.* AST-120 Oral spherical adsorptive carbon Nonconstipating irritable bowel syndrome Started a Phase II trial in Belgium (9/20)
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.
CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.