Company* |
Product | Description |
Indication | Status (Date) |
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Early rheumatoid arthritis |
Filed a Type II variation with the EMEA seeking approval in early RA (12/22) |
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Psoriatic arthritis |
Filed an MAA with the EMEA seeking approval in the additional indication of PA (12/16) |
BioMS |
MBP8298 |
Synthetic peptide |
Multiple sclerosis |
Began pivotal Phase III trial in Canada and Europe in up to 553 patients to assess time to disease progression vs. placebo (12/8) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
Psoriasis |
Company began a Phase III trial in Canada to test efficacy and other endpoints in 400 patients with severe disease (12/1) |
CANCER | ||||
Active Biotech |
TASQ |
Tumor angiogenesis suppression by quinolines |
Prostate cancer |
Began a Phase I trial in Sweden to study safety and tolerability (12/13) |
Australian |
RP101 |
Antiviral drug marketed in Europe that down-regulates the STAT3 and APEX genes |
Metastatic pancreatic cancer |
Began Phase II trial in Germany to test drug and gemcitabine in 22 patients (12/14) |
Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Acute myeloid leukemia |
Trial in Europe demonstrated a threefold greater overall response rate in older patients than current standard of care (ASH) |
Cell |
Trisenox (FDA-approved) |
Arsenic trioxide |
Myelodysplatic syndromes |
Phase II trial in Europe showed the drug produced a hematologic response rate of 27% (ASH) |
Diatos SA* |
DTS-201 |
Doxorubicin conjugated to a peptide technology |
Advanced solid tumors |
Got regulatory clearance for a Phase I trial in France and Belgium (12/16) |
Flamel |
-- |
Medusa formulation of long-acting interleukin-2 |
Renal cancer |
Began Phase I/II trial in France to compare drug to Proleukin (12/8) |
GPC Biotech |
1D09C3 |
Anti-MHC Class II monoclonal antibody |
B-cell lymphomas |
Got OK for a Phase I trial in Switzerland to test safety, tolerability and dosing in patients with relapsed or refractory disease (12/9) |
ILEX |
Campath (FDA-approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
Peripheral T-cell non-Hodgkin's lymphoma |
Trial in Germany showed an over- all response rate of 62% in 21 patients in first-line treatment (ASH) |
ILEX |
Campath (FDA- approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
B-cell chronic lymphocytic leukemia |
Phase II trial with Fludara in Germany showed an overall response rate of 85% in the relapsed/refractory patients (ASH) |
ILEX |
Campath (FDA-approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
Chronic lymphocytic leukemia |
Trial in Germany showed an overall response rate of 36% in 44 patients refractory to fludarabine (ASH) |
OxiGene |
OXi4503 |
Ortho-quinone prodrug |
Advanced cancers |
Began Phase I trial in the UK that will assess safety and gain further insight into the mechanism of action (12/21) |
QLT Inc. |
Eligard (FDA-approved) |
Leuprolide acetate for injectable suspension; LHRH agonist |
Prostate cancer |
Gained approval in 24 of 26 countries in Europe through the mutual recognition procedure for the one- and three-month formulations (12/21) |
Vaxon-Biotech* |
VX-001 |
Vaccine containing a peptide that targets tumors expressing the telomerase antigen |
Tumors |
Phase I trial in Greece produced immune responses in 13 of 14 patients, with disease stabilization in four patients (12/6) |
YM Biosciences |
TheraCIM h-R3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Nasopharyngeal carcinoma |
Phase II pivotal trial in 130 patients showed complete responses of 90.6% with radiation vs. 51.5% in the radiation-only group (12/21) |
CARDIOVASCULAR | ||||
Alexion |
Eculizumab |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Two-year, 11-patient extension study in the UK showed statistically significant reductions in hemolysis and the need for blood transfusions (ASH) |
Cangene Corp. |
WinRho SDF (FDA-approved) |
Antibody to certain types of red blood cells |
Hemolytic disease of the newborn and ITP |
Company completed the European Mutual Recognition Procedure, gaining approval in 10 European countries for hemolytic disease and immune thrombocytopenic purpura (12/20) |
Cytos |
CYT006-AngQb |
Vaccine designed to produce an anti-angiotensin II antibody response |
Hypertension |
Began Phase I/II trial in 88 patients to evaluate safety, tolerability and efficacy (12/7) |
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
Phase III STRIDE-4 trial showed a lower dose was not as effective as a higher dose, and not superior to placebo; trial was in 98 patients in Latin America, Poland and Spain (12/20) |
CENTRAL NERVOUS SYSTEM | ||||
Arena |
APD125 |
Antagonist at the 5-HT2A serotonin receptor |
Insomnia |
Began Phase I trial in France to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (12/1) |
GW |
Sativex |
Spray formulation of cannabis extract |
Spasticity in multiple sclerosis |
UK regulators said another study would be needed because clinical relevance was uncertain (12/3) |
GW |
Sativex |
Spray formulation of cannabis extract |
Spasticity in multiple sclerosis |
Canadian regulators issued a notice saying the product qualified to be considered for approval (12/21) |
KetoCytonyx |
KTX 0101 |
Ketone agent designed to act as an alternative energy system for cells |
Cognitive impairment |
Completed Phase I trial in volunteers undergoing coronary artery bypass graft surgery that showed positive safety and pharmacodynamic effects (12/13) |
Neurobiological |
Ebixa (FDA-approved) |
Memantine; NMDA receptor antagonist |
Alzheimer's disease |
H. Lundbeck A/S gained approval of the product in Canada (12/13) |
DIABETES | ||||
Diamyd |
Diamyd |
Glutamic acid decarboxylase 65- based immunotherapy |
Type I diabetes |
Began a Phase II trial in Sweden in 70 children to test if remaining insulin-producing beta cells can be saved (12/15) |
MannKind |
Technosphere Insulin |
Pulmonary insulin formulation delivered via company's inhaler |
Diabetes |
Began Phase III trial in Europe (12/22) |
INFECTION | ||||
AEterna |
Impavido |
Oral miltefosine, an alkylphospholipid agent |
Visceral and cutaneous leishmaniasis |
The product was approved in Germany (12/6) |
Anadys |
ANA380 (LB80380) |
Oral prodrug of the nucleotide analogue ANA317 (LB80317) |
Hepatitis B |
Interim Phase II data showed a 99.9% reduction in viral load in two dosing groups (12/13) |
Chiron Corp. |
Fluvirin |
Influenza vaccine |
Influenza |
UK officials plan to continue the manufacturing suspension for a further three months, effective Jan. 4, 2005 (12/7) |
Chiron Corp. |
Cubicin (FDA-approved) |
Daptomycin for injection |
Complicated skin and soft-tissue infections |
Companies filed MAA seeking approval in Europe for treating cSSTIs in which susceptible Gram-positive bacteria are confirmed or suspected (12/2) |
Flamel |
-- |
Medusa formulation of long-acting interferon-alpha |
Hepatitis and hepatitis C |
Began Phase I/II trial in France to test safety, and to compare pharmacokinetic profile to Schering-Plough Corp.'s Viraferon (12/17) |
Nabi Bio- |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
To prevent S. aureus bacteremia |
Filed MAA with the EMEA seeking approval in Europe to prevent the condition in patients with end- stage renal disease (12/21) |
SciClone |
Zadaxin |
Synthetic preparation of thymosin alpha-1 |
Hepatitis C |
Partner Sigma-Tau began a Phase III trial to test the drug with pegylated interferon-alpha and ribavirin in 500 patients in Europe (12/23) |
Sinovac Biotech |
-- |
Inactive vaccine for severe acute respiratory syndrome |
Severe acute respiratory syndrome |
Phase I trial showed induction of SARS-neutralizing antibodies in all 36 subjects in a Phase I trial (12/6) |
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Post-operative ileus |
Phase III trial in Europe failed to meet the primary endpoint of gastrointestinal recovery vs. placebo; it did show statistical significance in secondary endpoints (12/23) |
BioMarin |
Aryplase |
Galsulfase; an enzyme- |
Mucopoly- |
The company filed an MAA seeking approval in the European Union (12/6) |
Cellegy |
Tostrex |
Transdermal testosterone gel product |
Hypogonadism |
The product was approved in Sweden; ProStrakan Group Ltd. has European marketing rights (12/30) |
Cytos |
CYT005- AllQbG10 |
Immunodrug carrier mixed with the natural allergen extract of house dust mites |
Allergy |
Began Phase II trial to test safety, tolerability and efficacy of the vaccine in 20 patients (12/2) |
Genzyme |
Myozyme |
Recombinant human acid alpha- lucosidase enzyme |
Pompe disease Europe (12/20) |
The EMEA accepted the MAA that seeks approval of the drug in Europe (12/20) |
Halozyme |
Cumulase |
Ex vivo formulation of recombinant human PH20 hyaluronidase |
Treatment of oocytes |
Received CE Mark approval for treating oocytes to facilitate certain in vitro fertilization procedures, allowing it sell the product in Europe (12/28) |
Manhattan |
Oleoyl estrone |
Oral therapeutic for weight loss |
Obesity |
Got approval in Switzerland to begin a safety and tolerability trial in obese volunteers (12/20) |
Metabolic |
AOD9604 |
Oral peptide modeled on one section of the human growth hormone molecule |
Obesity |
Phase IIb trial demonstrated weight loss, tolerability and an improvement in cholesterol (12/13) |
Pharmagene |
PGN0052 |
Synthetic version of secretin |
Cystic fibrosis |
Phase IIa trial in 18 patients failed to show improvement in the ability of the lungs to clear secretions (12/22) |
Pharming |
rhC1INH |
Recombinant human C1 inhibitor |
Hereditary angioedema |
European trial showed rapid time to beginning of relief and to complete resolution (12/17); also got approval to expand clinical development to the U.S. (12/21) |
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
ASH = Data were presented at the American Society of Hematology meeting. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; | ||||
TSE = Toronto Stock Exchange. | ||||
