Company* |
Product | Description |
Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel (FDA- approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Plaque psoriasis |
The product was approved in Europe for treating adults with moderate to severe disease who failed to respond to other therapies (9/30) |
Serono SA |
Raptiva (FDA-approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Chronic plaque psoriasis |
Gained marketing approval in the European Union for treating moderate to severe disease when other treatments were ineffective or inappropriate (9/23) |
CANCER | ||||
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia from chemotherapy |
European regulators approved extended dosing regimens for the drug (9/20) |
Austrianova* |
NovaCaps |
Retroviral vector-based delivery system |
Inoperable pancreatic cancer |
European regulators issued a positive opinion on company's proposed pivotal trial in 200 patients (9/8) |
Clavis |
CP-4055 |
Fatty-acid derivative |
Advanced solid tumors |
Phase I trial in 24 patients confirmed safety and showed some signs of efficacy (9/24) |
Guilford |
Gliadel Wafer (FDA-approved) |
Wafer comprised of a biodegradable polymer incorporating carmustine |
Malignant glioma |
Extended marketing authorization was granted in Europe to include use in newly diagnosed patients with high-grade glioma as an adjunct to surgery and radiation (9/14) |
Medarex Inc. |
MDX-010 and GVAX |
Fully human anti-CTLA-4 antibody; whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Advanced prostrate cancer |
Companies began a Phase I trial of the combination of the products in 45 patients in the Netherlands to test safety, dosing and efficacy endpoints (9/13) |
MethylGene |
MG98 |
Second-generation antisense compound designed to inhibit the expression of DNA methyltransferase |
Solid tumors |
Data from seven patients in Phase I trial in the UK showed reduction of DNMT1 mRNA by 52% after one cycle and 65% after two (9/30) |
Oxford |
TroVax |
Vaccine that delivers an antigen (5T4) using a poxvirus vector |
Colorectal cancer |
Interim analysis of Phase II trial in 13 Stage IV patients showed safety with chemotherapy and specific immune responses to the 5T4 antigen (9/1) |
OxiGene Inc. |
Combrestatin A4 Prodrug |
Vascular-targeting agent designed to block flow of blood to a tumor |
Cervical cancer |
Began Phase I trial in combination with cisplatin in 18 patients in Denmark with advanced or recurrent disease (9/14) |
Pharmion |
Vidaza (FDA-approved) |
Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions |
Myelodysplastic syndromes |
European regulators accepted for review the marketing authorization application (9/21) |
Salmedix Inc.* |
SDX-101 |
Single component of the anti- inflammatory drug etodolac |
Chronic lymphocytic leukemia |
Began Phase II trial in Europe to evaluate responses of drug and chlorambucil in 80 patients (9/30) |
ViRexx |
Occlusin Injection |
Embolotherapeutic agent; designed to lead to clot formation |
Liver cancer |
Began Phase I trial in 12 patients in Canada to test safety when used as an embolizing agent as part of transcatheter arterial chemoembolization (9/23) |
CARDIOVASCULAR | ||||
Sangart Inc.* |
Hemospan |
Hemoglobin-based oxygen carrier |
Blood substitute |
Began Phase II trial to test the product in 90 Swedish patients undergoing elective orthopedic surgeries (9/8) |
The Medicines |
Angiox (Angiomax; FDA-approved) |
Bivalirudin; direct thrombin inhibitor |
Anticoagulant |
The product was approved in the European Union for use as an anticoagulant in patients under- going percutaneous coronary interventions (9/22) |
CENTRAL NERVOUS SYSTEM | ||||
Acadia |
ACP-103 |
5-HT2A inverse agonist |
Schizophrenia |
Trial in 18 healthy volunteers in Sweden showed the drug reduced the motor disturbances and hyperprolactinemia caused by haloperidol treatment (9/15) |
CeNeS |
M6G |
Morphine metabolite |
Postoperative pain |
Phase III trial in 167 patients who had knee-replacement surgery demonstrated statistically significant analgesia (9/20) |
ExonHit |
Ikomio |
Small molecule believed to have neuroprotective effects |
Amyotrophic lateral sclerosis |
Phase III trial in 400 patients in Europe taking drug and Rilutek failed to demonstrate a survival benefit vs. placebo (9/27) |
IDEA AG* |
IDEA-033 |
Analgesic product delivered by ultra-deformable carriers |
Joint and musculoskeletal pain |
Began open-label Phase III trial to evaluate safety, efficacy and compliance in 400 patients with osteoarthritis of the knee (9/16) |
Lyfjathroun hf |
-- |
Sumatriptan nasal spray |
Acute migraine |
Phase Ib study in eight healthy volunteers showed the product was safe and well tolerated (9/10) |
Newron |
Safinamide |
Molecule believed to have multiple mechanisms of action |
Parkinson's disease |
Began multinational Phase III trial in 240 patients to test drug vs. placebo as an add-on therapy to a dopamine agonist (9/13) |
INFECTION | ||||
ID Biomedical |
Fluvira S/F |
Vaccine comprised of the A/New Caledonia, A/ Wyoming and B/Jiangsu strains |
Influenza |
Canadian regulators cleared the vaccine for shipping and use throughout Canada (9/10) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
African sleeping sickness |
All patients evaluated from Phase IIb trial in the Congo were parasite-free in follow-on testing; the drug was well tolerated (9/28) |
Micrologix |
MBI-3253 (celgosivir) |
Oral a-glucosidase I inhibitor |
Hepatitis C |
Began Phase IIa trial in 60 patients |
Sinovac Biotech |
-- |
Split flu vaccine |
Influenza |
Filed for approval of the vaccine in China (9/16) |
Sinovac Biotech |
-- |
Vaccine for severe acute respiratory syndrome |
SARS |
Phase I trial in 18 healthy volunteers in China showed no adverse reactions after two inoculations (9/7) |
The Immune |
Remune |
Immune-based therapy comprised of a whole- killed virus and an adjuvant |
HIV |
Interim results from a Phase II trial in Italy showed HIV-specific immunity in drug-naive patients (9/14) |
MISCELLANEOUS | ||||
APT Pharmaceuticals* |
-- |
Aerosolized hydroxy- chloroquine that uses the Aradigm Corp. AERx pulmonary delivery system |
Various diseases |
Began Phase I trial in Australia to test safety and tolerability (9/13) |
Auxilium |
Testim |
Topical 1% testosterone gel |
Hypogonadism |
Phase IV study in 151 hypogonadal men showed better results in sexual endpoints for Testim group than those who remained on AndroGel therapy (9/15) |
BioXell SpA* |
BXL-628 |
Inhibitor of growth factor phosphorylation and bcl-2 |
Benign prostatic hyperplasia |
Phase II trial in 120 patients demonstrated a statistically significant reduction in reducing prostate volume (7.2%) vs. placebo (9/27) |
Cambridge |
CAT-354 |
Human anti-IL-13 monoclonal antibody |
Severe asthma |
Began Phase I trial in the UK to study the safety, tolerability and pharmacokinetics of the product (9/8) |
Cellegy |
Rectogesic (Cellegesic) |
Nitroglycerin ointment |
Pain from anal fissures |
UK authorities approved the product there and will act as a reference member state for other Europeancountries (9/13) |
Cytos |
CYT003-QbG10 |
Virus-like particle packaged with an immunostimulatory sequence |
Various diseases |
Phase I trial in 35 healthy volunteers showed QbG10 was safe, well tolerated and highly immunogenic (9/16) |
Eyetech |
Macugen |
Pegaptanib sodium injection; pegylated anti-VEGF aptamer |
Age-related macular degeneration |
European regulators accepted for review the approval application; companies also completed filing in Canada (9/20) |
Protherics |
DigiFab (FDA-approved) |
Polyclonal antibody designed to neutralize digoxin |
Digoxin toxicity |
The company filed for approval in the UK (9/2) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
