Company* |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Active Biotech (Sweden) and Teva Pharmaceutical Industries Ltd. |
Laquinimod |
Oral therapy |
Relapsing-remitting multiple sclerosis |
Hit the primary endpoint in its two-year Phase III study, demonstrating significant reduction in annualized relapse rate compared to placebo (12/10) |
Immunomedics Inc. and UCB SA (Belgium) |
Epratuzumab |
A monoclonal antibody targeting CD22 |
Moderate to severe systemic lupus erythematosus |
Launched two Phase III studies (12/15) |
CANCER | ||||
Amgen Inc. |
Xgeva |
Denosumab |
Skeletal-trelated events in bone metastases; prostate cancer |
Xgeva was superior to Zometa in delaying the time to first on-study skeletal-related event by 18% and time to first and subsequent on-study event by 22% (12/14); it improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer vs. placebo (12/15) |
Bavarian Nordic AS (Denmark) |
Prostvac |
Therapeutic vaccine |
Castration-resistant prostate cancer |
Reached an SPA with the FDA for a Phase III registration study (12/9) |
Biogen Idec Inc. and Roche AG (Switzerland) |
Rituxan |
Rituximab |
Follicular lymphoma |
Phase III data showed that patients who are given two years of maintenance therapy with Rituxan after immunochemotherapy have significantly better progression-free survival and higher response rates compared to those who do not receive that intervention (12/22) |
BioVex Inc. |
OncoVEXGM-CSF |
Oncolytic virus designed to selectively kill tumor cells |
Advanced squamous cell carcinoma of the head and neck |
Started a Phase III pivotal study, which will enroll 528 previously untreated patients (12/13) |
Cel-Sci Corp. |
Multikine |
Immunotherapy |
Head and neck cancer |
Started a Phase III trial (12/30) |
Eli Lilly and Co. |
Tasisulam |
A small-molecule anticancer compound |
Unresectable or metastatic melanoma |
Suspended its global Phase III study (12/15) |
EpiCept Corp. |
Ceplene |
Histamine dihydrochloride |
Acute myeloid leukemia |
Results of a new subset analysis of 190 patients showed a difference in overall survival was in favor of Ceplene plus IL-2 compared to the standard of care, with a median overall benefit of 36 months (12/13) |
Halozyme Therapeutics Inc. |
Herceptin |
Subcutaneous formulation |
HER2-positive breast cancer |
Completed enrollment for a Phase III study with 595 patients (12/8) |
Medivation Inc. and Astellas Pharma Inc. (Japan) |
MDV3100 |
A triple-acting oral androgen receptor antagonist |
Advanced prostate cancer |
Completed patient enrollment in the Phase III study (12/1) |
Sunesis Pharmaceuticals Inc. |
Vosaroxin |
A first-in-class quinolone derivative |
Acute myeloid leukemia |
Launched its Phase III trial (12/22) |
CARDIOVASCULAR | ||||
Amarin Corp. plc (Ireland) |
AMR101 |
Prescription grade omega-3 fatty acid drug; ethyl icosapentate |
For high triglycerides |
Completed randomization for its ANCHOR Phase III trial (12/17) |
Gilead Sciences Inc. |
Letairis |
Ambrisentan |
Idiopathic pulmonary fibrosis |
Phase III data showed a lack of efficacy so Gilead is halting work on Letairis (12/27) |
Pfizer Inc. |
Thelin |
Sitaxentan |
Pulmonary arterial hypertension |
Pfizer is voluntarily pulling it from the market in Europe, Canada and Australia and is discontinuing clinical studies worldwide due to a potential life-threatening idiosyncratic risk of liver injury associated with Thelin (12/13) |
Shire plc (Ireland) |
Firazyr (icatibant) |
Bradykinin B2 recptor antagonist |
Hereditary angioedema (HAE) |
Top-line results from Phase III FAST-3 showed that patients receiving treatment experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to placebo (12/2) |
CENTRAL NERVOUS SYSTEM | ||||
BioDelivery Sciences International Inc. |
Buprenor-phine |
Opioid analgesic delivered with BEMA |
Chronic pain |
Enrolled and dosed the first patient in its Phase III trial (12/10) |
Medivation Inc. |
Dimebon |
Latrepirdine |
Alzheimer's disease |
Completed enrollment in its Phase III trial evaluating dimebon plus Aricept (12/8) |
QRxPharma Ltd. (Australia) |
MoxDuo IR |
A fixed-dose combination of morphine plus oxycodone |
Pain in patients who have undergone total knee replacement surgery |
Completed patient enrollment in a pivotal Phase III trial (12/7) |
Sunovion Pharmaceuticals Inc. |
Latuda |
Lurasidone HCL |
Schizophrenia |
Phase III data showed statistically significant improvement compared to placebo (12/10) |
UCB SA |
Vimpat |
Lacosamide |
Uncontrolled partial-onset seizures |
After a year of Vimpat treatment, patients reported significant improvements in all aspects of seizure severity and across almost all health-related quality-of-life assessments (12/7) |
DIABETES | ||||
Generex Biotechnology Corp. |
Generex Oral-lyn |
A buccal insulin spray product |
Diabetes |
A 31-subject study showed that treatment with an aggregate of 12 sprays resulted in a 29.6% decrease in plasma glucose at two hours and a 26.8% decrease at three hours (12/14) |
INFECTION | ||||
Anacor Pharmaceuticals Inc. |
AN2690 |
A topical antifungal candidate |
Onychomycosis |
Started enrollment in its Phase III program (12/17) |
Medivir AB (Sweden) and Meda AB (Sweden) |
Xerese |
Acyclovir and hydrocortisone cream |
Cold sores |
Phase III data showed it was well tolerated and did not give rise to acyclovir-resistant virus (12/9) |
Topaz Pharmaceuticals Inc. |
Ivermectin |
Topical cream |
Head lice |
Completed its two pivotal Phase III trials, and Topaz plans to submit an NDA in 2011 (12/8) |
MISCELLANEOUS | ||||
Adamis Pharmaceuticals Corp. |
Savvy |
Contraceptive |
To prevent pregnancy |
Completed its Phase III trial, which met its primary endpoint showing the gel was not inferior to Conceptrol; it also was well tolerated (12/8) |
Aeterna Zentaris Inc. (Canada) |
Solorel |
AEZS-130, macimorelin |
Adult growth hormone deficiency |
Reached agreement with the FDA on a Phase III trial (12/21) |
Auxilium Pharmaceuticals Inc. |
Xiaflex |
Collagenase clostridium histolyticum |
Dupuytren's contracture |
Phase III data showed that 67% of patients experienced a clinically significant result (12/7) |
Bellus Health (Canada) and Celtic Therapeutic LLLP |
Kiacta |
Eprodisate |
AA amyloidosis |
Started a confirmatory Phase III study (12/16) |
Corcept Therapeutics Inc. |
Corlux |
Mifepristone; a cortisol receptor antagonist |
Cushing's syndrome |
Phase III data showed a response rate of 60% for glucose-intolerant patients and 43% for patients with hypertension (12/23) |
Ikaria Inc. |
Lucassin |
Terlipressin |
Hepatorenal syndrome type 1 |
Enrolled the first patients in a pivotal Phase III trial (12/1) |
Incyte Corp. |
INCB18424 |
JAK1/2 inhibitor |
Myelofibrosis |
Hit the primary endpoint of reducing spleen size in patients in a Phase III trial (12/22) |
Inspire Pharmaceuticals Inc. |
Denufosol |
Inhaled therapy |
Cystic fibrosis |
Patients, age 5 and older, had better lung exhalation rates than those in the placebo group at the end of 24 weeks in a Phase III trial (12/20) |
Keryx Biopharma-ceuticals Inc. |
Zerenex |
Ferric citrate |
Hyperphospha-temia |
Met the primary and key secondary endpoints in a short-term Phase III trial in dialysis patients (12/1) |
PTC Therapeutics Inc. |
Ataluren |
An oral small molecule |
Nonsense mutation cystic fibrosis |
Completed enrollment in a Phase III trial (12/22) |
Regeneron Pharmaceuticals Inc. and Bayer AG (Germany) |
VEGF Trap-Eye |
Aflibercept |
Macular edema |
Phase III trials met the primary endpoint, with 56.1% of patients on drug gaining at least 15 letters of vision from baseline, compared to 12.3% of patients on placebo (12/21) |
Vivus Inc. |
Avanafil |
A phosphodiesterase 5 inhibitor |
Erectile dysfunction |
It met all primary endpoints in a Phase III study (12/7) |
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. |