Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
UCB SA (Brussels, Belgium) |
C-Early |
Certolizumab pegol |
Rheumatoid arthritis |
Started a Phase III trial of C-Early in combination with methotrexate for RA (2/23) |
CANCER | ||||
Dendreon Corp. (Seattle) |
Provenge |
Sipuleucel-T |
Prostate cancer |
Data showed an estimated median overall survival of 7.8 months with the vaccine (2/2) |
Gamida Cell Ltd. (Jerusalem) |
StemEx |
A cell therapy |
Blood cancers |
Enrolled the last of 100 patients in a pivotal, Phase III trial (2/15) |
Medivation Inc. (San Francisco) and Astellas Pharma Inc. (Tokyo) |
MDV3100 |
An oral androgen receptor signaling inhibitor |
Advanced prostate cancer |
MDV3100 extended life by nearly five months vs. placebo in a Phase III trial (2/28) |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Carfilzomib |
A next-generation proteasome inhibitor |
Relapsed multiple myeloma |
Completed enrollment in the Phase III trial (2/24) |
CARDIOVASCULAR | ||||
Gentium SpA (Villa Guardia, Italy) |
Defibrotide |
The sodium salt of a complex mixture of single-stranded oligodeoxribonucleotides derived from procine mucosal DNA |
To prevent hepatic veno-occlusive disease |
Phase III data showed it led to a 40% reduction in the incidence of VOD 30 days after hematopoietic stem cell transplantation (2/28) |
Ikaria Inc. (Hampton, N.J.) |
Nitric oxide |
Inhaled therapy |
Broncho-pulmonary dysplasia |
Enrolled the last patient in its pivotal Phase III trial (2/28) |
Karo Bio AB (Huddinge, Sweden) |
Eprotirome |
Cholesterol-lowering agent |
Heterozygous familial hypercholesterolemia |
Company is terminating a Phase III pivotal trial after a toxicology study in dogs indicated that long-term exposure could result in cartilage damage (2/15) |
CENTRAL NERVOUS SYSTEM | ||||
Forest Laboratories Inc. (New York) and Gedeon Richter plc (Budapest, Hungary) |
RHG-188 |
Cariprazine; antipsychotic agent |
Acute mania associated with bipolar I disorder |
Top-line data from a Phase III trial showed patients experienced significant improvements in symptoms compared to those in the placebo arm (2/9) |
Omeros Corp. (Seattle) |
OMS302 |
Drug that combines an anti-inflammatory agent with one that causes mydriasis |
For use during cataract surgery and to reduce postoperative pain |
Positive clinical developments allowed it to revise the planned analysis for its ongoing Phase III study (2/8) |
Orexigen Therapeutics Inc. (San Diego) |
Contrave |
Naltrexone HCl/bupropion HCl |
Obesity |
Orexigen agreed with the FDA on an SPA for the Contrave cardiovascular outcomes trial (2/7) |
Titan Pharmaceuticals Inc. (South San Francisco) |
Probuphine |
A subcutaneous implant formulation of buprenorphine |
Opioid dependence |
Data from an open-label, six-month safety re-treatment study showed re-treatment was well tolerated (2/10) |
DIABETES | ||||
Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.) |
AVP-923 (Nuedexta) |
Dextromethorphan with quinidine |
Diabetic peripheral neuropathy |
Phase III data showed efficacy, but the company is putting the indication on the back burner to focus on central neuropathic pain in multiple sclerosis (2/9) |
ViroPharma Inc. (Exton, Pa.) |
Plenadren |
Hydrocortisone, modified-release tablet |
Concomitant diabetes mellitus |
Pivotal data suggested the once-daily dual-release tablet provided a more circadian-based serum cortisol profile resulting in reduced body weight, reduced blood pressure and improved glucose metabolism, compared to standard formulations of hydrocortisone (2/17) |
Zealand Pharma A/S (Copenhagen, Denmark) and Sanofi SA (Paris) |
Lixisenatide |
A once-daily glucagon-like peptide 1 agonist |
Type II diabetes |
Top-line data from the GetGoal-P Phase III study showed it hit its primary efficacy endpoint of significantly reducing blood glucose levels compared to placebo (2/9) |
INFECTION | ||||
Dynavax Technologies Corp. (Berkeley, Calif.) |
Heplisav |
HBV-10 vaccine |
Hepatitis B virus |
Pivotal Phase III data showed that a short, two-dose regimen of Heplisav over one month was well tolerated and superior to a three-dose regimen over six months (2/15) |
Intercell AG (Vienna, Austria) |
Ixiaro/Jespect |
Vaccine |
Japanese encephalitis |
Completed a pivotal Phase III study in the Philippines and a second Phase III study in the European Union, U.S. and Australia, showing it was well tolerated and immunogenic in children (2/2) |
MISCELLANEOUS | ||||
Protalix BioTherapeutics Inc. (Carmiel, Israel) |
Taliglucerase alfa |
A plant-cell expressed form of glucocerebrosidase |
Gaucher's disease |
Phase III extension data showed patients continued to demonstrate a statistically significant reduction in mean spleen volume after 24 months, with reductions of 54% in the 60 U/kg group and of 41% in the 30 U/kg group (2/10) |
Salix Pharmaceuticals Ltd. (Raleigh, N.C.) |
Xifaxan |
Rifaximin; antibiotic |
Irritable bowel syndrome with diarrhea |
Started a Phase III trial to test rifaximin 550 mg three times daily for 14 days (2/22) |
Santarus Inc. (San Diego) |
Uceris |
Budesonide tablets 9 mg |
Ulcerative colitis |
Began patient enrollment in a Phase IIIb trial (2/15) |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Amitiza |
Lubiprostone |
Opioid-induced bowel dysfunction |
Met the primary endpoint in a Phase III trial (2/3) |
Tranzyme Pharma Inc. (Research Triangle Park, N.C.) and Norgine BV (Amsterdam, the Netherlands) |
Ulimorelin |
Intravenous ghrelin agonist |
For gastrointestinal recovery in patients undergoing abdominal surgery |
Completed patient enrollment in two Phase III studies (2/29) |
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. |