Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genentech Inc. (South San Francisco; a unit of Roche AG) |
Actemra |
Subcutaneous formulation of IL-6 receptor inhibiting antibody |
Rheumatoid arthritis |
Met its primary endpoint, showing comparable efficacy at 162 mg subcutaneously weekly compared to 8 mg/kg intravenously every four weeks |
5/4/12 |
CANCER | |||||
ArQule Inc. (Woburn, Mass.) |
Tivantinib |
c-MET inhibitor |
Non-small-cell lung cancer |
Completed patient recruitment in the Phase III pivotal study |
5/21/12 |
BioAlliance Pharma SA (Paris) |
Livatag |
Doxorubicin Transdrug |
Hepatocellular carcinoma |
Started its Phase III ReLive trial in nearly 400 patients |
5/15/12 |
Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.) |
Revlimid |
Lenalidomide |
Multiple myeloma |
Three Phase III trials supported the growing body of evidence for use of the drug in newly diagnosed patients and in maintenance treatment following autologous stem cell transplant |
5/11/12 |
Celsion Corp. (Lawrenceville, N.J.) |
ThermoDox |
Heat-activated liposomal encapsulation of doxorubicin |
Hepatocellular carcinoma |
Reached its enrollment objective of 700 patients in its Phase III study of ThermoDox in combination with radiofrequency ablation |
5/31/12 |
Dendreon Corp. (Seattle) |
Provenge |
Sipuleucel-T |
Prostate cancer |
Phase III data showed that a subgroup of African-American men had a median overall survival benefit of 45.3 months vs. 14.6 months in the control arm |
5/22/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
GS-1101 |
P13K inhibitor |
Chronic lymphocytic leukemia |
Began a Phase III trial with a primary efficacy endpoint of progression-free survival |
5/3/12 |
Millennium (unit of Takeda Pharmaceutical Co. Ltd.; Cambridge, Mass.) and Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
CD30-expressing cutaneous T-cell lymphoma |
Started a pivotal Phase III trial |
5/8/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) and Bayer HealthCare Pharmaceuticals (unit of Bayer AG, Leverkusen, Germany) |
Nexavar |
Sorafenib |
Non-small cell lung cancer |
Failed to meet the primary endpoint of improving overall survival in the Phase III trial |
5/23/12 |
Photocure ASA (Oslo, Norway) |
Hexvix/Cysview |
Drug-device combination procedure |
Bladder cancer |
Significantly improved time to recurrence of bladder cancer in a long-term follow-up study in 551 patients |
5/23/12 |
CARDIOVASCULAR | |||||
Actelion Ltd. (Allschwil, Switzerland) |
Macitentan |
Dual endothelin receptor antagonist |
Pulmonary arterial hypertension |
Hit the primary endpoint in a pivotal Phase III trial |
5/1/12 |
Sosei Group Corp. (Tokyo) |
NVA237 |
Glycopyrronium bromide; long-acting muscarinic antagonist |
Chronic obstructive pulmonary disease |
NVA237 beat placebo at improving lung function, symptom relief and quality of life in the Phase III GLOW2 trial |
5/18/12 |
CENTRAL NERVOUS SYSTEM | |||||
Adamas Pharmaceuticals Inc. (Emeryville, Calif.) |
Arimenda |
Memantine HCl extended-release and donepezil HCl capsules |
Alzheimer's dementia |
FDA agreed to its proposed Phase III safety studies |
5/16/12 |
Ceregene Inc. (San Diego) |
CERE-120 |
AAV2-neurturin |
Parkinson's disease |
Demonstrated biologically active expression of neurturin and enhanced dopamine activity |
5/18/12 |
PharmaNeuro-Boost NV (Alken, Belgium) |
PNB01 |
Selective serotonin reuptake inhibitor combined with low-dose pipamperone |
Major depression |
Recruited the first 250 patients in its Phase III program |
5/25/12 |
RedHill Biopharma Ltd. (Tel Aviv, Israel) and IntelGenx Corp. (Saint Laurent, Quebec) |
RHB-103 |
An oral thin-film formulation of rizatriptan |
Acute migraine |
Data from a pivotal bioequivalence study showed it met its specified endpoints, meeting bioequivalence parameters when tested against Maxalt-MLT |
5/30/12 |
DIABETES | |||||
Andromeda Biotech Ltd. (Yavne, Israel) |
DiaPep277 |
Immunothera-peutic agent |
Type I diabetes |
Achieved primary endpoint in its pivotal Phase III study |
5/10/12 |
MISCELLANEOUS | |||||
Aastrom Biosciences Inc. (Ann Arbor, Mich.) |
Ixmyelocel-T |
Stem cell therapy |
Critical limb ischemia |
First patient was enrolled in the REVIV Phase III trial |
5/11/12 |
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab |
Nonexudative age-related macular degeneration |
Soliris did not meet its primary endpoints |
5/8/12 |
Clarus Therapeutics Inc. (Northbrook, Ill.) |
CLR-610 |
An oral testosterone replacement therapy |
Testosterone deficiency |
Enrollment has been completed in its pivotal Phase III trial |
5/2/12 |
Clinuvel Pharmaceuticals Ltd. (Melbourne, Australia) |
Scenesse |
Afamelanotide |
Erythropoietic protoporphyria |
Started a confirmatory Phase III U.S. study |
5/23/12 |
Genentech Inc. (South San Francisco) |
Avastin and Lucentis |
Bevacizumab and ranibizumab |
Wet age-related macular degeneration |
A head-to-head study found Avastin and Lucentis are equally effective and safe |
5/8/12 |
Histogenics Corp. (Waltham, Mass.) |
NeoCart |
An autologous bioengineered neocartilage grown outside the body using a patient's own cells |
Osteoarthritis of the knee |
Showed significant improvement in the mean measures of all patient-reported outcomes across all time points for up to four years |
5/15/12 |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Gattex |
Teduglutide |
Short bowel syndrome |
Phase III data of seven patients showed three achieved independence of parenteral fluids |
5/22/12 |
Pulmatrix Inc. (Lexington, Mass.) |
iCALM |
Inhaled cationic airway lining modulatory therapy |
Asthma |
A crossover trial of seven patients showed that the product attenuated allergen-induced bronchitis |
5/22/12 |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) |
Amitiza |
Lubiprostone |
Irritable bowel syndrome |
Pivotal Phase III studies showed the drug provides a statistically significantly higher proportion of patients with consistent relief compared to placebo |
5/22/12 |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) |
Amitiza |
Lubiprostone |
Opioid-induced bowel dysfunction |
Additional Phase III data showed the proportion of patients with a first spontaneous bowel movement at four, eight, 12, 24 and 48 hours post-dose was found to be statistically significant over placebo |
5/23/12 |
Tranzyme Pharma Inc. (Research Triangle Park, N.C.) and Norgine BV (Amsterdam, the Netherlands) |
Ulimorelin |
An intravenous ghrelin agonist |
Postoperative ileus |
Top-line Phase III data showed it failed to meet the primary and secondary endpoints, with no statistical difference from the placebo groups |
5/30/12 |
Ventrus Biosciences Inc. (New York) |
VEN 307 |
Diltiazem hydrochloride cream |
Anal fissures |
Pivotal Phase III data showed improvements in three measures of efficacy |
5/15/12 |
Ventrus Biosciences Inc. (New York) |
VEN 309 |
Iferanserin; a selective peripheral 5-HT2A receptor antagonist |
Hemorrhoids |
Completed enrollment in a Phase III trial |
5/1/12 |
|
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. SPA = Special Protocol Assessment. | |||||