Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
4SC AG |
SC12267 |
New type of small-molecular active agent from the class of disease-modifying anti-rheumatic drugs; works as a selective inhibitor in the biosynthesis of pyrimidine |
Rheumatoid arthritis |
Started a Phase IIa study in 120 patients in Germany, Poland and Serbia (12/4) |
Centocor Inc. |
Remicade |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Rheumatoid arthritis |
European Commission approved a label extension allowing for a shortened infusion time (12/14) |
Isotechnika Inc. |
ISA247 |
Immunosuppressive drug |
Psoriasis |
Enrolled its first patient in a European/Canadian Phase III trial for moderate to severe patients (12/5) |
CANCER | ||||
Ardana plc |
Teverelix |
Gonadotropin-releasing hormone antagonist |
Benign prostatic hyperplasia |
Phase II data showed it induced symptomatic improvement from as early as week two and the duration of the effect appeared to last around eight weeks (12/27)** |
Advanced |
Combidex |
Imaging agent for use with magnetic resonance imaging |
To diagnose metastatic lymph nodes |
Company's European partner, Guerbet SA, submitted an MAA (12/6) |
BioAlliance |
Doxorubicin |
Nanoparticle formulation of doxorubicin |
Primary liver cancer |
Received the go-ahead from French authorities to start a Phase II/III trial (12/20)** |
Oncolytics |
Reolysin |
A formulation of the reovirus |
Advanced cancer |
Started patient enrollment in its UK Phase II study (12/22) |
Onyvax Ltd.* |
Onyvax-P |
Cell vaccine; an immuno-therapy |
Prostate cancer |
Phase IIb trial is under way in the UK and the Baltic States (12/13)** |
OSI |
Tarceva |
Once-daily therapy |
Metastatic pancreatic cancer |
European Committee for Medicinal Products for Human Use recommended approval (12/15) |
QLT USA Inc. |
Eligard |
45 mg, six-month formulation |
Advanced prostate cancer |
Approved in Germany (12/1) |
SkyePharma |
Solaraze |
Diclofenac; topical gel |
Actinic keratosis |
Australian regulators approved Solaraze (12/6)** |
CARDIOVASCULAR | ||||
Alliance |
Oxygent |
Perfluorochemical emulsion |
To prevent post- operative ileus |
Received approval from French authorities (12/18) |
BioTime Inc. |
Hextend |
Plasma volume expander |
To expand plasma volume |
A Japanese Phase II trial is under way (12/7) |
CV |
Ranexa |
Ranolazine |
Chronic angina |
Filed for European approval (12/21) |
Northern |
|
Engineered cell-based therapy |
Idiopathic pulmonary arterial hyper-tension |
Began the first human trial, a Phase IIa study in 18 patients at two sites in Canada (12/12) |
CENTRAL NERVOUS SYSTEM | ||||
Trophos* |
TRO19622 |
Compound believed to promote the survival of a range of neurons |
Amyotrophic lateral sclerosis |
Completed a Phase Ib trial and plans to start a pivotal Phase II/III trial (12/13)** |
DIABETES | ||||
Speedel Group |
SPP301 |
Once-a-day oral endothelin A receptor antagonist |
Diabetic nephropathy |
Company halted a pivotal Phase III trial following the development of excessive fluid retention in patients receiving the drug (12/20)** |
INFECTION | ||||
Dynavax |
Heplisav |
Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9 |
Hepatits B virus |
Started a pivotal Phase III trial in Canada (12/21) |
Helix |
Topical interferon alpha-2b |
Ano-genital warts associated with human papillomavirus infection |
Started patient enrollment in a Phase II trial in Sweden (12/11) |
|
Inovio |
ChronVac-C |
DNA vaccine administered using Inovio's MedPulse DNA Delivery System |
Hepatitis C virus |
Filed an application for a Phase I study in healthy volunteers (12/5) |
InterMune Inc. |
ITMN-191 |
An NS3/4A protease inhibitor |
Chronic hepatitis C virus |
Received approval in Europe to start a Phase Ia trial (12/19) |
Ipsat |
P1A |
Product designed to inactivate beta-lactam antibiotics in the lower intestinal tract |
Upper and lower respiratory tract infections |
Recruited the first patient in a Phase IIb study of P1A in combination with Ampicillin (12/4) |
Pevion |
Virosome-based therapeutic hepatitis C vaccine that combines PevitTER and PeviPRO |
Hepatitis C |
Began a Phase I trial in 30 healthy volunteers (12/20)** |
|
SciClone |
Zadaxin |
Thymalfasin or thymosin alpha 1 |
Hepatitis C |
Completed enrollment in a Phase III trial of Zadaxin in combination with pegylated interferon alpha and ribavirin; trial conducted in Europe has enrolled 553 patients (12/28) |
Tibotec |
Prezista |
Darunavir |
HIV |
Committee for Human Medicinal Products recommended conditional approval of Prezista based on a pooled analysis of two Phase II trials (12/15) |
MISCELLANEOUS | ||||
Vernalis plc (UK; |
V24343 |
A cannabinoid-1 antagonist |
Obesity, Type II diabetes and related disorders |
Started a Phase I trial (12/11) |
Notes: | ||||
* Privately held; ** The date the item ran in BioWorld International. MAA = Marketing authorization application. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange. |