Company* |
Product | Description | Indication |
Status |
| | ||||
|
AUTOIMMUNE | ||||
Biogen Idec |
Tysabri |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
EMEA committee recommended approval of the drug for treating relapsing-remitting MS to delay the progression of disability and reduce the frequency of relapses (4/28) |
Serono SA |
Rebif (FDA-approved) |
Interferon beta-1a |
Multiple sclerosis |
Submitted variation of MAA that seeks European approval of a new formulation of Rebif (4/4) |
CANCER | ||||
Bioenvision |
Evoltra (FDA-approved) |
Clofarabine; second- generation purine nucleoside analogue |
Acute myeloid leukemia |
Phase I/II trial in 30 patients older than 60 showed an overall response rate of 92%; drug was given with danorubicin (4/5) |
Celgene |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Advanced multiple myeloma |
The EMEA accepted for review the MAA filing that seeks approval of the drug in Europe (4/7) |
Genentech |
Herceptin (FDA-approved) |
Trastuzumab; monoclonal antibody against the HER2/neu protein |
Early stage breast cancer |
EMEA committee recommended approval for use as an adjuvant treatment; the filing was made by F. Hoffmann-La Roche Ltd. (4/28) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Advanced head and neck cancer |
Partner Merck KGaA got approval in Europe to expand the label to include use with radiotherapy in advanced head and neck cancer (4/3) |
Onyx Pharmaceuticals |
Nexavar (FDA-approved) |
Sorafenib; RAF kinase and VEGF inhibitor |
Advanced kidney cancer |
European regulators issued a positive opinion on marketing application; separately, the drug was approved in Mexico in that indication (4/28) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; RAF kinase and VEGF inhibitor |
Liver cancer |
The product was granted orphan designation in Europe for treating hepatocellular carcinoma, or liver cancer (4/18) |
OSI |
Tarceva (FDA-approved) |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Advanced non-small-cell lung cancer |
OSI partner Chugai Pharmaceutical Co. Ltd. filed for approval of the product in Japan (4/17) |
Pharmexa |
GV1001 |
Peptide vaccine that targets telomerase |
Pancreatic cancer |
Began Phase III PrimoVax trial to evaluate drug with gemcitabine in 520 patients in Europe and Australia (4/26) |
CARDIOVASCULAR | ||||
Fibrex Medical |
FX06 |
Anti-inflammatory peptide |
Myocardial infarction |
Phase I trial in 30 healthy volunteers in Austria demonstrated safety and tolerability (4/6) |
|
CENTRAL NERVOUS SYSTEM | ||||
BioLineRx |
BL-1020 |
Small-molecule neuro-transmission modulator |
Schizophrenia |
Began Phase I trial in Israel to evaluate safety and pharmacokinetics (4/10) |
CardioVascular |
-- |
Agent containing Cardio Vascu-Grow, a stimulator of angiogenesis |
Chronic back pain |
Began proof-of-concept studies in patients in Russia and Eastern Europe (4/26) |
Debiopharm Pharmaceuticals |
ZT-1 |
Hup A derivative; acetylcholinesterase inhibitor |
Alzheimer's disease |
Phase I monthly sustained-release implant study demonstrated safety and tolerability; Phase II oral study demonstrated efficacy and safety (4/25) |
Faust |
FP001 |
Glutamate release inhibitor |
Amyotrophic lateral sclerosis |
Phase IIa trial in 24 patients in France demonstrated safety and tolerability, and that it could be administered with riluzole (4/26) |
Neuren |
Glypromate |
Naturally occurring peptide fragment with protective qualities found in brain |
Brain protection in CAPG surgery |
Successfully completed Phase II safety trial in Australia and New Zealand in 33 patients undergoing coronary artery bypass surgery (4/27) |
Neuropharma |
NP031112 |
Inhibitor of glycogen synthase kinase 3 |
Alzheimer's disease |
Began Phase I trial in Germany to evaluate safety and dosing (4/24) |
SkyePharma |
DepoDur (FDA-approved) |
Sustained-release, injectable liposomal formulation of morphine |
Postsurgical pain |
The product was approved in the UK; additional approvals in Europe are anticipated (4/28) |
INFECTION | ||||
Biolex |
Locteron |
Controlled-release form of alpha interferon |
Hepatitis C |
Phase I trial in the Netherlands demonstrated the safety and tolerability in healthy volunteers and supported dosing every two weeks (4/27) |
Oxxon |
-- |
Agent from Hi-8 PrimeBoost platform designed to stimulate an immune response |
Hepatitis B |
Phase II trial showed the vaccine was well tolerated and induced HBeAg seroconversion, followed by a viral load decrease (4/27) |
Pharmasset |
Clevudine |
Pyrimidine nucleoside analogue |
Hepatitis B |
Preliminary data from Phase III trial in Korea demonstrated significant viral suppression and bio- chemical improvement (4/27) |
Oncoscience |
Nimotuzumab |
Anti-EGFr monoclonal antibody |
Brain stem glioma |
Began Phase III trial in combination with radiation in 36 children with inoperable pontine glioma (4/27) |
Targeted |
tgAAC09 |
Preventive vaccine based on HIV subtype C; uses a recombinant adeno-associated viral vector |
HIV |
Began clinical trial in Zambia to evaluate safety and immuno-genicity in 16 volunteers (4/26) |
Transgene SA |
TG4001 (MVA-HPV-IL-2) |
Therapeutic vaccine; MVA virus carrying and expressing HPV16 E6 and E7 genes |
Cervical intraepithelial neoplasia |
Phase II trial in France resulted in avoidance of surgery for 9 of 18 women (4/25) |
Tripep AB |
AlphaHGA |
Agent designed to inhibit the spread of the virus from the infected cell |
HIV |
Phase I/II trial in Thailand failed to show a significant decrease of HIV levels in patients (4/4) |
ViRexx |
HepaVaxx B Vaccine |
Molecule containing a hepatitis B viral antigen and a portion of a murine monoclonal antibody |
Hepatitis B |
Is starting a Phase I trial in 15 patients in Canada to evaluate safety (4/27) |
|
MISCELLANEOUS | ||||
AEterna |
Cetrotide (cetrorelix; FDA-approved) |
Luteinizing hormone- releasing hormone antagonist |
For use in in vitro fertilization |
The product was approved in Japan, where it will be made and sold by partners Nippon Kayaku Co. Ltd. and Shionogi & Co. Ltd. (4/20) |
Cellegy |
Tostrex |
Transdermal testosterone gel product |
Hypogonadism |
European licensee ProStrakan Group plc concluded the MRP, paving the way for approvals in EU countries (4/11) |
Chronogen |
CHGN111 |
Topical agent; inhibitor of the mitochondrial enzyme CLK-1 |
Age-related diseases |
Began Phase I/II trial in Canada to prevent cutaneous phototoxicity induced by photodynamic therapy (4/26) |
Clinuvel |
CUV1647 (formerly Melanotan or EPT1647) |
Agent designed to stimulate production of eumelanin |
Sun poisoning |
Phase II trial in 26 patients demonstrated statistically significant reductions in the need for rescue medication vs. placebo (4/18) |
Cytori |
-- |
Adult adipose-derived stem and regenerative cells |
For use in breast reconstruction |
Began open-label study in Japan to test safety and feasibility in 20 breast cancer patients who have had a partial mastectomy (4/20) |
Cytos |
CYT005- AllQbG10 |
Immunodrug carrier mixed with house dust mite allergen |
Dust mite allergy |
Follow-up data from Phase IIa trial showed therapeutic benefit for an extended period of time (4/25) |
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Pompe disease |
The product was approved in Europe for use as a long- term enzyme-replacement therapy (4/3) |
LAB |
LAB CGRP |
Calcitonin gene-related peptide; vasodilative agent |
Asthma |
Began Phase IIa trial in 12 patients to evaluate safety and tolerability, and efficacy vs. salbutamol and placebo (4/18) |
NPS |
Preotact (Preos) |
Recombinant human parathyroid hormone |
Postmenopausal osteoporosis |
The European Commission granted marketing authorization for the product; Nycomed Group has European marketing rights (4/26) |
Nuvo |
Pennsaid |
Topical non-steroidal anti-inflammatory agent |
Osteoarthritis |
52-week data from Phase III trial confirmed safety (4/26) |
Pharmaxis |
Bronchitol |
Mannitol formulation delivered via an inhalation device |
Bronchiectasis |
Began Phase III trial to evaluate the product in 350 patients with the chronic obstructive lung dis- ease(4/19) |
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; MSE = Madrid Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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