Company* |
Product | Description |
Indication | Status |
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AUTOIMMUNE | ||||
Abbott |
Humira |
Adalimumab; fullyhuman antibody designed to block TNF-alpha |
Psoriatic arthritis and rheumatoid arthritis |
The EMEA recommended approval of the product for treating PA and as a first-line treatment for moderate to severe early RA (6/27) |
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Chelsea |
CH-1504 |
Orally available inert antifolate |
Various diseases |
Began a Phase I trial in the UK to evaluate safety and tolerability in healthy volunteers (6/9) |
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Cytochroma |
CTA018 |
Vitamin D analogue |
Plaque psoriasis |
Phase Ia trial in Canada in 17 patients demonstrated safety and efficacy (6/2) |
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Isotechnika |
ISA247 |
Immunosuppressive agent |
Psoriasis |
Phase II trial in Canada met its primary endpoint of a two-point reduction in global assessment, and met secondary endpoints (6/30) |
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CANCER | ||||
American |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection;albumin-bound |
Metastatic breast cancer |
The company filed for approval of the product in Canada (6/15) |
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Antigenics Inc. |
Oncophage |
Personalized cancer vaccine based on heat-shock protein technology |
Renal-cell carcinoma |
The product was granted orphan status in Europe in that indication (6/7) |
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Antisoma plc |
AS1404 |
Vascular-disrupting agent |
Recurrent ovarian cancer |
Began Phase II trial to test the drug with other agents in about 70 patients in Europe, Australia and New Zealand (6/7) |
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Bioenvision |
Clofarabine (FDA-approved) |
Second-generation purine nucleoside analogue |
Leukemias |
Encouraging data from various trials in various indications were presented (6/6) |
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Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Acute myeloid leukemia |
Phase II trial in the UK in older patients demonstrated an overall response rate of 67% (6/3) |
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Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Metastatic melanoma |
Filed letter of intent seeking app- roval of the product in Europe for use with dacarbazine (6/30) |
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GPC Biotech |
1D09C3 |
Anti-major histocompatibility complex Class II monoclonal antibody |
Hodgkin's lymphoma |
The product was granted orphan designation in Europe in that indication by the EMEA (6/2) |
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Favrille Inc.* |
FavId |
Vaccine designed to stimulate immune responses |
Indolent B-cell non-Hodgkin's lymphoma |
Began a Phase II trial in Europe that will evaluate activity in several disease subtypes (6/6) |
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Lorus |
Virulizin |
Immunotherapy agent designed to stimulate the immune system |
Pancreatic cancer |
The product was granted orphan status in Europe in that indication (6/7) |
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Onyvax |
Onyvax-P |
Cell vaccine; an immunotherapy |
Metastatic, hormone- resistant prostate cancer |
Published data confirmed results from the first cohort in a Phase II trial showing drug may delay dis- ease progression (6/17) |
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OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced non- small-cell lung cancer |
European regulators recommended approval for use after failure of at least one regimen; partner F. Hoffmann-La Roche Ltd. made the filing (6/27) |
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Peregrine |
Tarvacin |
Chimeric monoclonal antibody that binds to the phospholipid phosphatidylserine |
Refractory solid tumors |
Began Phase I trial to evaluate safety, tolerability, pharmaco- kinetics and dosing in up to 28 patients (6/10) |
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pSivida Ltd. |
BrachySil |
Micron-sized particle in which the isotope 32 phosphorus is immobilized |
Advanced liver cancer |
Phase IIa trial in eight patients in Singapore showed safety and tolerability, as well as reductions in tumor size (6/21) |
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TopoTarget |
Savene |
Dexrazoxane; inhibitor of topoisomerasde II poisons |
For use in cancer treatments |
Phase II/III trial in 35 patients demonstrated a 97% success rate in treating accidental extravasation of anthracycline chemotherapeutics and avoidance of surgical interventions (6/28) |
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Viragen Inc. |
Multiferon |
Multisubtype, natural human alpha interferon |
Various diseases |
Drug was approved in Chile as a second-line treatment in cases in which recombinant interferon therapy failed (4/25) |
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Viventia |
Proxinium |
Antibody fragment conjugated with a cancer-killing payload |
Head and neck cancer |
The product was granted orphan designation in Europe in that indication by the EMEA (6/1) |
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CENTRAL NERVOUS SYSTEM | ||||
CeNeS |
CNS 5161 |
Selective NMDA antagonist |
Neuropathic pain |
Phase IIa proof-of-concept study showed agent was well tolerated and a trend toward an improvement in pain levels (6/8) |
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CeNeS |
M6G |
Morphine-6-glucuronide peptide vector |
Post-operative pain |
Presented data on oral bioavailability and its potential in that indication (6/1) |
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Durect Corp. |
SABER-Bupivacaine |
Sustained-release formulation of bupivacaine delivered by SABER system |
Post-operative pain |
Second cohort of hernia patients in Phase II trial in Australia reported improved pain relief vs. commercial bupivacaine (6/20) |
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GW |
Sativex |
Spray formulation of cannabis extract |
Spasticity in multiple sclerosis |
UK regulators denied an appeal to allow marketing of the product without additional trials (6/10) |
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DIABETES | ||||
Depomed Inc. |
Glumetza |
Once-daily, extended- release formulation of metformin hydrochloride |
Type II diabetes |
The product was approved in Canada; Biovail plans to launch it there in 4Q:05 (6/1) |
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Generex |
Orallyn |
Oral insulin spray formulation |
Diabetes |
Small study in volunteers in Israel showed a shorter time to maximum insulin concentration vs. subcutaneous insulin (6/7) |
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Metabolex |
Metaglidasen |
Oral insulin sensitizer |
Type II diabetes |
Phase II trial in 217 patients demonstrated statistically significant reduction of hemoglobin A1c and other endpoints (6/10) |
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TolerRx Inc.* |
TRX4 |
Humanized monoclonal antibody that binds to the CD3 receptor on T cells |
Type I diabetes |
Phase II trial in 80 patients in Europe showed insulin-producing beta cells were preserved and a reduction in the amount of insulin needed to control blood glucose levels (6/23) |
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INFECTION | ||||
Arpida Ltd. |
Iclaprim |
Broad-spectrum antibiotic |
Infections |
Phase I trial in the UK showed achievement of high concentrations of drug in specific lung compartments, paving the way for a trial in pneumonia (6/22) |
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BioInvent |
BI-201 |
Human antibody that binds to the TAT protein |
HIV |
Began Phase I/II trial in the UK to assess safety, tolerability and pharmacokinetics, as well as viral load (6/20) |
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Human Genome |
Albuferon |
Long-acting form of interferon alpha that uses albumin fusion technology |
Hepatitis C |
Began Phase IIb trial with ribavirin in Europe and elsewhere to evaluate efficacy and safety in 440 patients with HCV genotype 1 (6/1) |
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Nabi Bio- |
Civacir |
Antibody-based hepatitis C immune globulin |
Hepatitis C |
The product was granted orphan status in Europe for preventing recurrent HCV-induced liver disease in liver transplant recipients (6/22) |
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MISCELLANEOUS | ||||
Cambridge |
CAT-354 |
Human anti-IL-13 monoclonal antibody |
Severe asthma |
Preliminary data from Phase I trial in the UK demonstrated tolerability with no safety concerns identified (6/23) |
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Karo Bio |
KB2115 |
Compound that stimulates the thyroid hormone receptor |
Obesity and dyslipidemia |
Began Phase I trial in overweight subjects to evaluate tolerability, safety and pharmacokinetics as well as effects on high blood lipids and other risk factors (6/20) |
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Revotar Biophar- |
Bimosiamose |
Topical formulation of pan-selectin antagonist |
Acute lung injury |
The product was granted orphan designation in Europe in that indication (6/9) |
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Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London 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. |