Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genzyme Corp. (Cambridge, Mass.) |
Aubagio |
Teriflunomide; once-daily oral drug |
Multiple |
Hit the two main clinical endpoints in a confirmatory pivotal Phase III trial: an annualized reduction in relapse rate and a reduction in the risk of sustained accumulation of disability |
6/4/12 |
Immunomedics Inc. (Morris Plains, N.J.) |
Epratuzumab |
A humanized anti-CD22 antibody |
Systemic lupus erythematosus |
Data showed clinically meaningful improvements in health-related quality of life; it is in Phase III |
6/11/12 |
CANCER | |||||
Ariad Pharmaceuticals Inc. (Cambridge, Mass.) |
Ponatinib |
Pan-BCR-ABL inhibitor |
Chronic myeloid leukemia or Philadelphia-positive acute lymphoblastic leukemia |
Pivotal data showed that 54% of chronic-phase CML patients, including 70% with the T315I mutation, achieved a major cytogenetic response |
6/19/12 |
Celgene Corp. (Summit, N.J.) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension |
Metastatic pancreatic cancer |
Completed enrollment in a Phase III study, with 861 patients randomized to receive Abraxane plus gemctiabine vs. gemcitabine alone |
6/7/12 |
Cell Therapeutics Inc. (Seattle) |
Pixuvri |
Pixantrone; aza-anthracenedione |
Aggressive non-Hodgkin B-cell lymphomas |
Phase III data were the basis for conditional marketing authroziation in the European Union |
6/1/12 |
Genentech Inc. (South San Francisco; part of the Roche Group) |
Perjeta |
Pertuzumab |
HER2-positive metastatic breast cancer |
Patients lived significantly longer when treated with the combination of Perjeta, Herceptin and docetaxel chemotherapy, compared to Herceptin and docetaxel alone in the Phase III study |
6/25/12 |
Genta Inc. (Berkeley Heights, N.J.) |
Tesetaxel |
Oral chemotherapy |
Metastatic breast cancer |
Reached an SPA agreement with the FDA for the proposed Phase III trial |
6/19/12 |
Medivation Inc. (San Francisco) and Astellas Pharma Inc. (Tokyo) |
MDV3100 |
Enzalutamide |
Advanced prostate cancer |
Completed enrollment of 1,680 patients in the Phase III study |
6/7/12 |
Millennium: The Takeda Oncology Co. (Cambridge, Mass.) |
MLN9708 |
An oral proteasome inhibitor |
Relapsed and/or refractory multiple myeloma |
Started a Phase III trial |
6/29/12 |
NewLink Genetics Corp. (Ames, Iowa) |
Algenpan-tucel-L |
Hyperacute pancreas immunotherapy product candidate |
Pancreatic cancer |
Passed the midpoint in enrollment in its Phase III candidate |
6/20/12 |
NovaRx Corp. (San Diego) |
Lucanix |
Belagenpuma-tucel-L |
Non-small-cell lung cancer |
Completed enrollment in its Phase III trial |
6/21/12 |
Polynoma LLC (San Diego; subsidiary of CK Life Sciences International Inc.) |
POL103A |
A melanoma vaccine |
Melanoma |
Started a Phase III trial |
6/5/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
Relapsed or refractory Hodgkin lymphoma |
Pivotal data showed that the median overall survival has not been reached after a 26.5-month median follow-up |
6/15/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Zevalin |
Ibritumomab tiuxetan injection |
Refractory/relasped aggressive lymphoma |
Updated clinical data for Zevalin injection for intravenous use showed it resulted in a 91% two-year overall survival rate when administered in combination with BCNU, etoposide, cytarabine, melphalan therapy |
6/19/12 |
Taiho Pharmaceutical Co. Ltd. (Tokyo) |
TAS-102 |
Combination antimetabolite; oral nucleoside |
Advanced recurrent colorectal cancer |
It will initiate a global Phase III trial |
6/1/12 |
Talon Therapeutics Inc. (San Mateo, Calif.) |
Marqibo |
Vincristine sulfate liposome injection |
Philadelphia-chromsome-negative acute lymphoblastic leukemia |
Talon reported enrollment and dosing of the first patient in a confirmatory Phase III trial |
6/4/12 |
Ziopharm Oncology Inc. (New York) |
Zymafos |
Palifosfamide |
Metastatic soft tissue sarcoma |
Enrollment was completed in the Phase III trial of palifosfamide with doxorubicin vs. doxorubicin alone |
6/5/12 |
Ziopharm Oncology Inc. (New York) |
Zymafos |
Palifosfamide |
Small-cell lung cancer |
Dosed its first patient in the Phase III pivotal trial |
6/12/12 |
CARDIOVASCULAR | |||||
Chelsea Therapeutics (Charlotte, N.C.) |
Northera |
Droxidopa |
Neurogenic orthostatic hypotension |
Phase III data showed patients experienced improvements in their symptoms of neurogenic orthostatic hypotension and a number of individual symptoms |
6/22/12 |
Orexigen Therapeutics Inc. (San Diego) |
Contrave |
Naltrexone SR/bupropion SR |
Weight loss |
Started enrollment in its long-term research study |
6/7/12 |
Theratechnologies Inc. (Montreal) |
Tesamorelin |
A synthetic analogue of human growth hormone-releasing factor |
Muscle wasting in chronic obstructive pulmonary disease |
Data presented at the ENDO 2012 meeting in Houston showed it selectively reduced visceral adipose tissue in the abdominal area, without significant effects on subcutaneous adipose tissue; it also was shown to improve triglycerides, C-reactive protein and carotid intima medial thickness, without aggravation glucose |
6/28/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alkermes plc (Dublin, Ireland) and Janssen Research & Development LLC (unit of Johnson & Johnson) |
Invega Sustenna |
Paliperidone palmitate; once-monthly injectable |
Schizophrenia |
Initiated a Phase III program |
6/13/12 |
DIABETES | |||||
Amylin Pharmaceuticals Inc. (Houston) |
Metreleptin |
Analogue of leptin |
Diabetes and/or hypertriglyceridemia |
Ongoing expanded access protocol clinical study showed treatment reduced blood glucose and triglyceride levels |
6/26/12 |
MISCELLANEOUS | |||||
Aeterna Zentaris Inc. (Quebec City) |
AEZS-130 |
Oral ghrelin agonist |
Adult growth hormone deficiency |
Phase III data showed it was safe and effective |
6/27/12 |
AMAG Pharmaceuticals Inc. (Lexington, Mass.) |
Feraheme |
Ferumoxytol |
Iron deficiency anemia |
The global Phase III program will conclude this year |
6/27/12 |
Amgen Inc. (Thousand Oaks, Calif.) |
Sensipar/Mimpara |
Cinacalcet |
Secondary hyperparathyroidism and chronic kidney disease |
Top-line Phase III data showed patients experienced numerically fewer composite events when compared to placebo, though the study fell short of statistical significance |
6/11/12 |
Auxilium Pharmaceuticals Inc. (Malvern, Pa.) |
Xiaflex |
Collagenase clostridium histolyticum |
Peyronie's |
Top-line Phase III data showed that the co-primary endpoints met statistical significance, with a 37.6% mean reduction in penile curvature deformity |
6/5/12 |
Canyon Pharmaceuticals Inc. (Parsippany, N.J.) |
Desirudin |
Anticoagulant |
Orthopedic surgery in chronic kidney disease |
Results of an analysis comparing enoxaparin with desirudin found that blood clots and postoperative bleeding were reduced with use of desirudin |
6/21/12 |
Cleveland Biolabs Inc. (Cleveland) |
CBLB502 |
Polypeptide derived from the flagellin protein |
Radiation exposure |
Showed a nearly threefold increase in overall survival among rats exposed to a 70% lethal dose of radiation; this is being developed under the FDA's animal rule and the next step is a BLA filing |
6/5/12 |
Finox Biotech AG (Burgdorf, Switzerland) |
Afolia |
A biosimilar recombinant follicle-stimulating hormone |
For assisted reproduction technology |
Pivotal Phase III data showed it met its primary endpoint, demonstrating clinical and statistical equivalence to reference product Gonal-f |
6/7/12 |
Furiex Pharmaceuticals Inc. (Morrisville, N.C.) |
MuDelta |
JNJ-27018966 |
Diarrhea-predominant irritable bowel syndrome |
The first patient has been dosed in its Phase III placebo-controlled studies |
6/21/12 |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Natpara |
Recombinant human parathyroid hormone |
Hypoparathyroidism |
Phase III data showed it resulted in significant reductions in calcium and active vitamin D supplements |
6/26/12 |
Omeros Corp. (Seattle) |
OMS302 |
PharmacoSurgery candidate |
For use in lens replacement surgery |
Began a pharmacokinetic substudy in its Phase III program |
6/1/12 |
ProFibrix BV (Leiden, the Netherlands) |
Fibrocaps |
A dry powder topical tissue sealant |
For spine, liver and soft-tissue surgery |
Began a Phase III trial |
6/7/12 |
PTC Therapeutics Inc. (South Plainfield, N.J.) |
Ataluren |
An investigational new drug |
Nonsense mutation cystic fibrosis |
Phase III data demonstrated positive trends in lung function |
6/11/12 |
Veloxis Pharmaceuticals A/S (Horsholm, Denmark) |
LCP-Tacro |
A once-daily formulation of the immunosuppressive drug tacrolimus |
Kidney transplant |
A Phase III subgroup analysis showed that African-American stable kidney transplant patients may be safely converted from twice-daily Prograf to once-daily LCP-Tacro |
6/1/12 |
Ventrus Biosciences Inc. (New York) |
VEN 309 |
Iferanserin ointment |
Hemorrhoidal disease |
Phase III trial failed to demonstrate improvement over placebo in either treatment arm, for any of the endpoints |
6/26/12 |
XOMA Corp. (Berkeley, Calif.) |
Gevokizumab |
Monoclonal antibody that allosterically modulates its target, interleukin-1 beta |
Noninfectious uveitis |
Enrollment is open in a Phase III study in noninfectious uveitis and a Phase II trial in erosive osteoarthritis of the hand |
6/28/12 |
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. |