Company* |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Paladin Labs Inc. (Canada) and Isotechnika Pharma Inc. (Canada) |
Voclera |
Voclosporin |
Psoriasis |
Submitted a dossier for approval for the Canadian market (12/21) |
CANCER | ||||
Allos Therapeutics Inc. |
Folotyn |
Pralatrexate injection |
Peripheral T-cell lymphoma |
EMA accepted the MAA for review (12/22) |
EpiCept Corp. |
Ceplene |
Histamine dihydrochloride |
Acute myeloid leukemia |
The Israeli Ministry of Health has approved the marketing application for Ceplene (12/22) |
Johnson & Johnson (which acquired developer Cougar Biotechnology Inc.) |
Abiraterone acetate |
An oral androgen biosynthesis inhibitor |
Metastatic, advanced prostate cancer |
Submitted a marketing application in Canada (12/27) |
Lytix Biopharma A/S (Norway) and KAEL-GemVax Co. Ltd. (South Korea) |
LTX-315 |
An adjuvant for the GV1001 peptide cancer vaccine |
Cancer |
Enrolled the first patient in the companies' joint study, which will include 20 patients total (12/7) |
Pfizer Inc. |
Sutent |
Sunitinib malate |
Pancreatic neuroendocrine tumors |
European Commission has approved Sutent (12/3) |
CARDIOVASCULAR | ||||
InterMune Inc. |
Esbriet |
Pirfenidone |
Idiopathic pulmonary fibrosis |
CHMP issued a positive opinion, positioning the company for a European approval in early 2011 (12/20) |
CENTRAL NERVOUS SYSTEM | ||||
Vivus Inc. |
Qnexa |
Phentermine/topiramate controlled-release capsules |
Obesity |
Filed an MAA with the EMA (12/21) |
Zogenix Inc. and Desitin Pharmaceuticals GmbH (Germany) |
Sumavel DosePro |
Sumatriptan injection needle-free delivery system |
Migraine attacks and cluster headache |
The Danish Medicines Agency has approved the MAA for Sumavel DosePro (12/3) |
INFECTION | ||||
BioMarin Pharmaceutical Inc. |
BMN 110 |
N-acetylgalac-tosamine 6-sulfatase |
Mucopoly-saccharidosis IVA |
The Medicines and Healthcare Products Regulatory Agency in the UK accepted a Phase III trial (12/15) |
Intercell AG (Austria) |
Vaccine |
Patch-based vaccine to protect against enterotoxigenic Escherichia coli strains |
Traveler's diarrhea |
Failed to demonstrate efficacy in two studies, a Phase III trial in Central America and a Phase II pilot study in India; company is discontinuing development (12/14) |
Mymetics Corp. (Switzerland) |
MYMV101 |
Vaccine |
HIV |
Phase I data showed the vaccine was well tolerated and immunogenic at low and high doses; the trial was conducted in Belgium (12/1) |
MISCELLANEOUS | ||||
Shire plc (UK) |
Vpriv |
Enzyme replacement therapy |
Gaucher's disease |
Health Canada approved Vpriv for long-term use in pediatric and adult Type I Gaucher's disease (12/2) |
Sucampo Pharmaceuticals Inc. and Abbott |
Amitiza |
Lubiprostone |
Chronic idiopathic constipation |
Phase III data in Japanese patients showed it was safe and well tolerated and showed a statistically significant increase from baseline in the number of spontaneous bowel movements at the end of week one and a statistically significant increase from baseline in the number of rhythmic SBMs at the end of week one (12/1) |
Notes: CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. # The date indicated refers to the BioWorld Today issue in which the news item can be found. |