Company* (Country; Symbol) | Product |
Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Serono SA (Switzerland; NYSE:SRA) |
Raptiva (FDA- approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis | Moderate to severe plaque psoriasis |
The product was approved in Switzerland; Serono has a license to Raptiva outside the U.S. and Japan from Genentech Inc. and XOMA Ltd. (3/16) |
CANCER | ||||
Active Biotech |
CD2 |
Product from company's Tumor Targeted Super- antigens program |
Pancreatic cancer |
Final Phase IIa trial data showed five of 19 patients achieved stable disease after two months (3/25) |
Aegera |
AEG35156/ GEM640 |
Antisense inhibitor of X- linked inhibitor of apoptosis protein |
Cancers |
Aegera and Cancer Research UK began a Phase I trial; the drug was developed in collaboration with Hybridon Inc. (3/29) |
Atrix |
Eligard (FDA-approved) |
Leuprolide acetate for injectable suspension; four-month formulation |
Prostate cancer |
Sanofi-Synthelabo Canada, Atrix's licensee, received approval of the product in Canada (3/2) |
Celgene Corp. (CELG) |
Revimid |
Immunomodulatory drug |
Myelodysplastic syndromes |
The drug was granted orphan designation in Europe for that indication (3/3) |
Debiopharm SA* (Switzerland) |
Pamorelin LA |
Long-acting formulation of triptorelin pamoate based on polylactic glycolic acid copolymers |
Prostate cancer |
The three-month formulation was approved in Germany, where a one-month form already is sold; Ipsen SA will market the product in Germany (3/23) |
ImClone Systems Inc. (IMCL) |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Metastatic colorectal cancer |
Merck KGaA got an approval recommendation for the drug in Europe to treat EGFR-expressing cancers in combination with irinotecan after an irinotecan-based treatment failure (3/25) |
Immuno-Designed |
Bexidem |
Cell therapy product with activated macrophages from a patient's white blood cells |
Bladder cancer |
IDM started a Phase II/III trial in Europe; half the patients will get Bexidem and half will get BCG, the standard treatment (3/23) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins (XIAP, c-FLIP) |
Prostate cancer |
Phase Ib/IIa trial in Australia showed dose-dependent effects on serum PSA levels in late-stage patients (3/31) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins (XIAP, c-FLIP) |
Renal carcinoma |
Company began a study in Australia in late-stage patients who are not responding to chemotherapy (3/8) |
Micromet AG* (Germany) |
MT201 |
Fully human antibody targeting the EpAM antigen |
Metastatic breast cancer |
Micromet began a Phase II trial in Europe in 100 patients to assess clinical response to two different doses (3/9) |
Munich Biotech AG* (Germany) |
MBT-0206 |
Anti-neovascular agent containing paclitaxel and a lipid-based carrier |
Cancers |
Patients continuing with Phase I trial showed quality- of-life improvements, stabilization and some tumor regression (3/25) |
PharmaMar SA* (Spain) |
Aplidin |
Cyclodepsipeptide derived from the marine tunicate Aplidium albicans |
Cancers |
Company began Phase I trial in Europe in pediatric solid tumors and leukemias to find doses for Phase II trials (3/22) |
Wilex AG* (Germany) |
Rencarex (WX-G250) |
Chimeric monoclonal IgG1 antibody that binds to MN cell surface antigen |
Renal-cell carcinoma |
Follow-up Phase II data showed encouraging long- term survival results in 36 patients (3/1) |
CARDIOVASCULAR | ||||
Amsterdam |
-- |
Adeno-associated viral vector expressing lipoprotein lipase |
Lipoprotein lipase deficiency |
European regulators designated orphan designation to the product in that indication (3/17) |
CV Therapeutics |
Ranolazine (Ranexa) Hemospan (MP4) |
Partial inhibitor of fatty- acid oxidation Hemoglobin-based oxygen carrier |
Chronic angina Alternative to blood transfusions |
Company filed a marketing approval application in Europe (3/30) Company said Phase Ib/II trial in Sweden in patients undergoing orthopedic surgical procedures showed no serious adverse events (3/11) |
United Therapeutics Corp. (UTHR) |
Remodulin (FDA- approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Long-term data presented from European trial showed improved functional class and exercise tolerance over study period (3/11) |
CENTRAL NERVOUS SYSTEM | ||||
Celltech Group plc (UK; NYSE:CLL) and Orphan Medical Inc. (ORPH) |
Xyrem (FDA- approved) |
Sodium oxybate oral solution |
Narcolepsy |
The NDA on Xyrem was accepted for review in Europe, where the product has orphan status (3/31) |
Neuro3D* (France) |
Ocaperidone |
Atypical antipsychotic |
Schizophrenia |
Neuro3D began two Phase II trials in an attempt to demonstrate therapeutic efficacy at low doses (3/11) |
INFECTION | ||||
Cangene Corp. (Canada; TSE:CNJ) |
WinRho SDF (FDA-zpproved) |
Antibody to certain types of red blood cells |
Dengue hemorrhagic fever |
Company is planning a study in the Philippines after pilot study there showed young patients rapidly improved (3/22) |
Genome |
Factive (FDA- approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Acute bacterial exacerbations of chronic bronchitis |
The product gained approval in Canada (3/11) |
Innogenetics NV (Belgium; Euronext:INNX) |
-- |
HCV E1-based therapeutic vaccine |
Hepatitis C |
Three-year data from Phase IIa trial demonstrated improvement from baseline (3/25) |
MediGene AG (Germany; FSE:MDG) |
Polyphenon E Ointment |
Product from green tea leaves designed to block virus binding to cells |
Genital warts |
Phase III trial in 500 patients in Europe demonstrated statistical significance (3/31) |
Microscience Ltd.* (UK) |
-- |
Vaccine consisting of Salmonella bacteria modified to carry an ETEC antigen |
Travelers' diarrhea (E. coli infection) |
UK trial in 36 volunteers showed the vaccine was safe and highly immunogenic (3/7) |
The Immune Response Corp. (IMNR) |
Remune |
Immune-based therapy comprised of a whole- killed virus and an adjuvant |
HIV |
Remune will be included in a trial in Canada evaluating the delay rebound in plasma viremia after scheduled interruption of anti- retroviral therapy (3/31) |
Transgene SA (France; TRGNY) |
MVA-HPV-IL2 |
Product using the MVA virus to carry and express two HPV antigens found in HPV 16 |
Human papillomavirus- related infections |
Phase II data showed responses in five of 15 patients treated with the high dose, but no regression from the low dose; also, a simultaneous study in vulvar intra-epithelial neoplasia showed no benefit vs. placebo (3/18) |
Vetrtex Pharmaaeuticals Inc. (VRTX) |
Telzir (FDA- approved as Lexiva) |
Fosamprenavir calcium; protease inhibitor |
HIV |
Vertex and partner GlaxoSmith- Kline plc received a positive opinion on the European marketing application for use of the drug in combination therapies (3/25) |
MISCELLANEOUS | ||||
Aastrom Biosciences Inc. (ASTM) |
Tissue Repair Cells |
Stem and progenitor cells produced from a patient's own bone marrow |
Bone grafting |
A Phase I trial in Spain is expected to enroll up to five patients and combine TRCs with a commercial synthetic matrix (3/30) |
AnorMED Inc. (Canada; TSE:AOM) |
Fosrenol |
Lanthanum carbonate; phosphate binder |
High phosphate levels |
The product gained approval in Sweden, the first in Europe, for patients who require dialysis for severe kidney disease; Shire Pharmaceuticals Group plc has marketing rights (3/24) |
Antares Pharma Inc. (OTC BB:ANTR) |
Twin-Jector EZ |
Needle-free technology for use with human growth hormone |
Human growth hormone deficiency |
Japanese licensee JCR Pharma- euticals Co. Ltd. obtained approval to market the product there (3/25) |
Antares Pharma Inc. (OTC BB:ANTR) |
-- |
Transdermal gel formulation of oxybutynin |
Overactive bladder |
Phase I trial in healthy female volunteers in Germany showed that therapeutic doses were delivered (3/11) |
Biofrontera AG* (Germany) |
BF-Derm1 |
Histidine decarboxylase inhibitor |
Severe chronic urticaria |
Interim Phase II data showed a 30% to 40% reduction in symptoms (3/30 |
DevCo Pharmaceuticals Ltd.* (UK) |
Lexipafant |
Platelet-activating factorantagonist |
Various indications |
A study in the UK confirmed safety and 70% inhibition of PAF- activated neutrophil function (3/15) |
NexMed Inc. (NEXM) |
Femprox |
Alprostadil cream |
Female sexual arousal disorder |
Company is initiating a Phase III trial in 400 patients in China to test safety and efficacy (3/2) |
Xcellentis (subsidiary of Innogenetics NV; Belgium) |
LyphoDerm |
Freeze-dried cultured human keratinocytes |
Venous leg ulcers |
Phase II trial in 193 patients in Europe showed an 11% improvement over the standard of care (3/2) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
