Company* |
Product | Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Antisense |
ATL1102 |
Second-generation antisense inhibitor of VLA-4, an immune system protein |
Multiple sclerosis |
Received approval to restart trial in Europe, a Phase IIa study to assess safety and activity in 80 patients(1/18) |
Biogen Idec |
BG-12 |
Oral fumarate derivative with an immunomodulatory mechanism of action |
Multiple sclerosis |
Phase II trial in 250 patients in Europe demonstrated statistically significant reductions in gadolinium-enhancing brain lesions (1/9) |
Novagali |
Nova22007 |
Ophthalmic formulation of cyclosporine A |
Sjogren syndrome |
Phase II trial demonstrated safety, as well as efficacy trends, in patients suffering SS associated with keratoconjunctivitis sicca (1/11) |
CANCER | ||||
Affymax Inc.* |
Hematide |
Synthetic, peptide-based erythropoiesis-stimulating agent |
Anemia in cancer patients |
Began Phase II trial in Europe to evaluate safety and pharmacokinetics in cancer patients (1/30) |
AmpliMed |
Amplimexon |
Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria |
Ovarian cancer |
The product was granted orphan designation in Europe in that indication; the drug is in Phase I/II trials (1/11) |
Ark |
Vitor |
Small molecule originally developed for high blood pressure |
Muscle wasting in cancer patients |
Full data from 200-patient trial showed statistical significance was reached in colorectal and non-small-cell lung cancers but not in pancreatic cancer(1/16) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced malignant melanoma |
Completed MAA filing in Europe seeking approval for use in combination with chemotherapy (1/3) |
Proacta Inc.* |
PR-104 |
Hypoxia-targeted small-molecule prodrug |
Hypoxic tumors |
Began Phase I trial in Australia and New Zealand to evaluate the agent (1/24) |
SuperGen Inc. |
Orathecin |
Rubitecan; topoisomerase-I inhibitor in capsule formulation |
Pancreatic cancer |
Withdrew MAA seeking approval in Europe after discussions with the EMEA; future plans will depend on ongoing trials (1/20) |
Vion Pharmaceuticals |
Cloretazine |
Sulfonylhydrazine DNA alkylating agent |
Acute myeloid leukemia |
The product was granted orphan designation in Europe in that indication (1/23) |
Xanthus |
Symadex (C-1311) |
Next-generation product based on the existing cancer drug mitoxantrone |
Metastatic colorectal cancer |
Began trial in Europe to evaluate responses in 49 patients who failed oxaliplatin and/or irinotecan regimens (1/17) |
Xanthus |
Symadex (C-1311) |
Next-generation product based on the existing cancer drug mitoxantrone |
Metastatic breast cancer |
Began trial in Europe in 49 women who relapsed following treatment with an anthracycline and taxane regimen (1/3) |
CARDIOVASCULAR | ||||
Gentium SpA |
efibrotide |
Single-stranded DNA designed to protect vascular endothelial cells |
Veno-occlusive disease |
Began Phase II/III trial in Europe and Israel to evaluate the product in 270 pediatric patients under-going stem cell transplantation (1/20); data from study in Japan showed three of four patients responded to therapy; two remained alive at 100 days (1/30) |
GPC Biotech |
1D09C3 |
Major histocompatibility complex class II monoclonal antibody |
Chronic lymphocytic leukemia |
The product was granted orphan designation in Europe in that indication for which Phase I trials are ongoing (1/27) |
Speedel Holding |
SPP100 (aliskiren; Rasilez) |
Oral renin inhibitor |
Hypertension |
Partner Novartis AG reported positive Phase III data of drug when used as a monotherapy and with a calcium channel blocker and an ACE inhibitor (1/19) |
United |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Israeli officials expanded the label there to include treatment of PAH associated with connective tissue disorders (1/10) |
CENTRAL NERVOUS SYSTEM | ||||
Trophos* |
TRO19622 |
Compound believed to promote the survival of a range of neurons |
Neuro- degenerative diseases |
Phase I trial in France showed the agent was safe, well tolerated and achieved the desired dose (1/31) |
Vectura |
VR040 |
Inhaled formulation of apomorphine |
Parkinson's disease |
The product was granted orphan designation in Europe for treating "off episodes" in PD patients (1/18) |
YM BioSciences |
AeroLEF |
Aerosolized liposome- encapsulated fentanyl |
Pain |
YM subsidiary Delex Therapeutics Inc. began Phase IIb trial in Canada in 120 post-surgical patients following orthopedic surgeries (1/26) |
DIABETES | ||||
Generex |
Oral-lyn |
Oral insulin buccal spray formulation |
Type I diabetes |
Began trial in 27 juvenile patients in Ecuador (1/9); began trial in 60 patients in Europe to evaluate metabolic efficacy vs. regular insulin therapy |
Nektar |
Exubera |
Dry-powder, inhaled insulin formulation that uses Nektar technology |
Type I and II diabetes |
The product was approved in the European Union, where it will be marketed by Pfizer (1/26) |
INFECTION | ||||
Chiron Corp. |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
Complicated skin and soft-tissue infections |
The product was approved in Europe for treating cSSTIs caused by Gram-positive bacteria (1/23) |
Intercell AG |
IC41 |
Hepatitis C vaccine |
Hepatitis C |
Optimization trial demonstrated improved immunogenicity when delivered via optimized route (1/31) |
Intercell AG |
-- |
Inactivated vaccine for immunizing against Japanese encephalitis virus |
Japanese encephalitis virus |
The vaccine was granted orphan designation in the European Union (1/30) |
Intercell AG |
-- |
Inactivated vaccine for immunizing against Japanese encephalitis virus |
Japanese encephalitis virus |
Monitors saw no safety concerns in Phase III trial, allowing for completion of recruitment for the program (1/12) |
MISCELLANEOUS | ||||
BioMarin |
Naglazyme (FDA-approved) |
Galsulfase; an enzyme- replacement therapy |
Mucopoly- saccharidosis-VI |
The product was approved in the European Union, where it has orphan status (1/30) |
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Pompe disease |
A regulatory committee in the European Union recomended full approval of the drug (1/27) |
Inspire |
Denufosol tetrasodium |
P2Y2 receptor agonist |
Cystic fibrosis |
The EMEA granted orphan designation to the product in Europe (1/10) |
ISTA |
Vitragan (Vitrase; FDA- approved) |
Ovine hyaluronidase formulation |
Vitreous hemorrhage |
The EMEA accepted for review the MAA seeking European market approval (1/12) |
LAB |
LAB CGRP |
Calcitonin gene related peptide; vasodilative agent |
Asthma |
Phase I trial demonstrated safety, with no adverse events (1/24) |
Serono SA |
Gonal-f (FDA-approved) |
Recombinant human follicle-stimulating hormone |
Hypogonadism |
The product was approved in Japan for inducing spermatogenesis in men with hypogonado- tropic hypogonadism (1/24) |
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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange ; VSE = Vienna Stock Exchange. | ||||
