| Feuerstein’s 2007 Biotech Calendar |
| Company |
Drug |
Indication |
Event |
Timeline |
| Acadia Pharmaeceuticals |
ACP-103 |
schizophrenia |
top-line phase 2 data |
First Quarter 2007 |
| Acorda |
Famipridine-SR |
multiple sclerosis |
phase III trial start |
2007 |
| Adolor |
Entereg |
opioid-induced constipation |
phase III data |
First half 2007 |
| Advanced Life Sciences |
Cethromycin |
community-acquired pneumonia |
phase III data |
First quarter 2007 |
| Aeterna Zentaris |
ozarelix |
benign prostatic hyperplasia |
phase IIB data |
third quarter 2007 |
| Alexion Pharmaceuticals |
Soliris |
Paroxysmal Nocturnal Hemoglobinuria |
FDA approval decision |
March 20, 2007 |
| Alkermes |
AIR Insulin |
diabetes |
phase III data |
June 22-26, 2007 |
| Allos Therapeutics |
PDX |
non-hodgkin's lymphoma |
phase II data |
Second half 2007 |
| Altus Pharmaceuticals |
ALTU-238 |
human growth hormone |
phase II trial start |
Second quarter 2007 |
|
ALTU-135 |
exocrine pancreative insufficiency |
phase III trial start |
Second quarter 2007 |
| Amarin |
Miraxon |
huntington's disease |
phase III data |
mid-2007 |
| Amgen |
AMG 531 |
immune thrombocytopenic purpura |
phase III data |
first quarter 2007 |
|
Denosumab |
osteoporosis |
phase III data |
Second half 2007 |
| Amylin Pharmaceuticals |
Exenatide LAR |
diabetes type II |
phase II data |
second half 2007 |
| Ariad Pharmaceuticals |
AP23573 |
prostate cancer |
phase II data |
June 2007 |
| Arqule |
ARQ-501 |
various cancers |
phase II data |
mid-2007 |
| Atherogenics |
AGI-1067 |
coronary artery disease |
phase III data |
first quarter 2007 |
| Avanir |
Zenvia |
diabetic peripheral neuropathy |
phase III data |
mid-2007 |
| Biogen Idec/Elan |
Tysabri |
Crohn's disease |
FDA/EMEA approval decision |
Oct. 15, 2007/first half 2007 |
| Biomarin Pharmaceuticals |
phenoptin |
phenylketonuria |
NDA filing |
Second quarter 2007 |
| Cardiome |
Vernakalant |
cardiac arrhythmia |
FDA approval decision |
Oct. 18, 2007 |
| Celgene |
CC-10004 |
psoriasis |
phase II data |
mid-2007 |
|
Revlimid |
MDS/multiple myeloma |
EMEA approval decision |
First half 2007 |
|
Revlimid |
multiple myeloma (newly diagnosed) |
phase III data |
second half 2007 |
| Cephalon |
Fentora |
neuropathic pain |
phase III data |
May 2-5, 2007 |
|
Nuvigil |
narcolepsy, sleep apnea, shift work disorder |
FDA approval decision |
March 31, 2007 |
| Coley Pharmaceuticals |
Promune |
non-small cell lung cancer |
phase III data |
late 2007 |
| Combinatorx |
CRX-150 |
rheumatoid arthritis |
phase II data |
spring 2007 |
|
CRX-139 |
rheumatoid arthritis |
phase II data |
spring 2007 |
| CV Therapeutics |
Ranexa |
Acute coronry syndrome |
phase III data |
March 27, 2007 |
| Cypress BioScience |
milnacipran |
fibromyalgia |
phase III data |
Second quarter 2007 |
| Dendreon |
Provenge |
Prostate cancer |
FDA approval decision |
May 15, 2007 |
| Encysive Pharmauceuticals |
Thelin |
pulmonary arterial hypertension |
FDA approval decision |
June 15, 2007 |
| Epix Pharmaceuticals |
PRX-03140 |
Alzheimer's |
phase IIA data |
Second half 2007 |
| Exelixis |
XL999 |
solid tumors (cancer) |
phase II data |
fourth quarter 2007 |
|
XL647 |
solid tumors (cancer) |
phase II data |
June 2007 (ASCO) |
|
XL880 |
solid tumors (cancer) |
phase II data |
June 2007 (ASCO) |
|
XL784 |
diabetic nephropathy |
phase II data |
Second half 2007 |
| Genentech/Biogen Idec |
Rituxan |
multiple sclerosis |
phase II data |
Arpril/May 2007 |
| Genentech |
Herceptin |
adjuvant breast cancer |
FDA approval decision |
Second half 2007 |
|
Avastin |
breast cancer |
FDA filing |
mid-2007 |
| Genzyme General |
Renvela |
end-stage renal disease |
FDA approval decision |
Oct. 21, 2007 |
|
Mozobil |
multiple myeloma |
phase III data |
mid-2007 |
| Gilead Sciences |
ambrisentan |
pulmonary arterial hypertension |
FDA approval decision |
June 18, 2007 |
|
Atripla |
HIV |
EMEA approval decision |
Second half 2007 |
|
aztreonam lysine |
cystic fibrosis |
phase III data |
First half 2007 |
|
GS9137 |
HIV |
phase III trial start |
First half 2007 |
|
tenofivir |
Hepatitis B |
phase III data |
second half 2007 |
| GlaxoSmithKline |
Tykerb |
breast cancer |
FDA approval decision |
March 18, 2007 |
| ImClone Systems |
Erbitux |
colon, lung, head/neck, pancreatic |
phase III data |
throughout 2007 |
| Incyte |
INCB13739 |
diabetes type II |
phase II data |
June 22-26, 2007 |
| Idenix |
valopicitabine |
hepatitis C |
phase II data |
first quarter 2007 |
| Idev Pharmaceuticals |
Nebido |
hypogonadism |
phase III data |
May-June 2007 |
|
Sanctura |
overactive bladder |
FDA approval decision |
Aug. 13, 2007 |
| Medarex |
Ipilimumab |
melanoma (second line) |
phase II data |
mid-late 2007 |
|
Ipilimumab |
melanoma (first line combination) |
phase III data |
mid-late 2007 |
| Medicines Company |
Cleviprex |
systemic hypertension |
phase III data |
first half 2007 |
| Medivation |
Dimebon |
Alzheimer's |
phase II data |
Second quarter 2007 |
| Memory Pharmaceuticals |
MEM 1003 |
Alzheimer's |
phase IIA data |
first half 2007 |
| MGI Pharmaceuticals |
Acquavan |
anesthesia (bronchoscopy) |
phase III |
First quarter 2007 |
| Millennium Pharmaceuticals |
MLN 1202 |
atherosclerosis/multiple sclerosis |
phase II data |
first half 2007 |
| Neurochem |
Alzhemed |
Alzheimer's |
phase III data |
first half 2007 |
| Omrix |
Thrombin |
hemostasis |
FDA approval decision |
Sept. 6, 2007 |
| Point Therapeutics |
talabostat |
non-small cell lung cancer |
phase III data |
fourth quarter 2007 |
| Roche |
CERA |
anemia |
FDA approval decision |
May 20, 2007 |
| Spectrum Pharmaceuticals |
ozarelix |
benign prostatic hyperplasia |
phase IIB data |
third quarter 2007 |
| Vertex Pharmaceuticals |
Telaprevir |
hepatitis C |
phase II data |
throughout 2007 |
| Wyeth |
Torisel |
renal cell cancer |
FDA approval decision |
April 5, 2007 |
| Zymogenetics |
rh Thrombin |
hemostasis |
FDA approval decision |
Oct. 8, 2007 |