Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Biogen Idec Inc. (Weston, Mass.) |
BG-12 |
Dimethyl fumarate |
Relapsing-remitting multiple sclerosis |
Phase III data showed statistically significant and clinically relevant effects of BG-12 in reducing MS relapses and progression of disability |
10/15/12 |
CANCER | |||||
AB Science SA (Paris) |
Masitinib |
An oral tyrosine kinase inhibitor |
Pancreatic cancer |
Phase III data showed that masitinib in combination with Gemzar significantly extended overall survival by six months in pancreatic cancer patients |
10/31/12 |
ArQule Inc. (Woburn, Mass.) |
ARQ 197 |
c-Met-targeted cancer drug tivantinib |
Nonsquamous non-small-cell lung cancer |
An independent data safety monitoring committee terminated the Phase III MARQUEE trial, following data that the statistically significant improvement in progression-free survival did not extend to overall survival |
10/3/12 |
ArQule Inc. (Woburn, Mass.) |
Tivantinib |
A selective MET inhibitor |
Hepatocellular carcinoma |
Reached an SPA agreement with the FDA for a pivotal Phase III trial |
10/17/12 |
Cancer Research UK (London) |
Tarceva |
Targeted therapy; erlotinib |
Advanced non-small-cell lung cancer |
Phase III data showed that elderly patients who developed a rash within 28 days of receiving Tarceva survived an average of 6.2 months, compared to 4. 1 months for patients who received placebo |
10/16/12 |
Celgene Corp. (Summit, N.J.) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension |
Metastatic melanoma |
Met the primary endpoint of progression-free survival in a Phase III trial |
10/3/12 |
Celgene Corp. (Summit, N.J.) |
Pomalidomide |
Immunomod-ulatory agent |
Multiple myeloma |
Phase III study met the primary endpoint of progression-free survival |
10/24/12 |
NewLink Genetics Corp. (Ames, Iowa) |
Algenpan-tucel-L |
HyperAcute Pancrease immunotherapy |
Pancreatic cancer |
Launched a Phase III study with 280 subjects who will receive standard-of-care FOLFIRINOX plus or minus algenpantucel-L |
10/11/12 |
OncoGenex Pharmaceuticals Inc. (Bothell, Wash.) |
Custirsen |
Based on Isis Pharmaceuticals Inc.'s second-generation antisense technology |
Non-small-cell lung cancer |
Entered another Phase III study, this one in NSCLC patients whose disease has progressed despite chemotherapy |
10/1/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Carfilzomib |
Single-agent |
Relapsed and refractory myeloma |
Completed enrollment in the Phase III study |
10/16/12 |
Pharmacyclics Inc. (Sunnyvale, Calif.) |
PCI-32765 |
Ibrutinib |
Chronic lymphocytic leukemia/small lympocytic lymphoma |
Phase III trial of ibrutinib in combination with bendamustine and rituximab enrolled the fifth patient |
10/16/12 |
Threshold Pharmaceuticals Inc. (South San Francisco) |
TH-302 |
A hypoxia-targeted drug |
Metastatic or locally advanced unresectable pancreatic cancer |
FDA reached agreement with Threshold's partner, Merck KGgA, for an SPA for a Phase III trial |
10/17/12 |
XBiotech Inc. (Austin) |
Xilonix |
Antibody (MABp1) |
Cachexia in cancer and other diseases |
Launched its first Phase III trial |
10/5/12 |
CENTRAL NERVOUS SYSTEM | |||||
Omeros Corp. (Seattle) |
OMS302 |
Designed to be added to standard irrigation solution used during intraocular lens replacement procedures |
To maintain intraoperative mydriasis and reduce postoperative pain |
Enrolled the last patient in its second Phase III trial |
10/4/12 |
TauRx Therapeutics Ltd. (Singapore) |
LMTX |
Tau aggregation inhibitor |
Alzheimer's disease |
Recruited the first patients to two Phase III trials |
10/31/12 |
DIABETES | |||||
Dompe Group (Milan, Italy) |
Reparixin |
Shown to improve efficacy of transplantation of insulin-producing pancreatic islets |
Type I diabetes |
Enrolled the first patient in a Phase III trial |
10/24/12 |
MannKind Corp. (Valencia, Calif.) |
Afrezza |
Insulin human [rDNA origin] |
Diabetes |
Finished recruiting patients for two Phase III studies |
10/8/12 |
Reata Pharmaceuticals Inc. (Irving, Texas) |
Bardoxolone methyl |
An antioxidant inflammation modulator |
Stage IV chronic kidney disease and Type II diabetes |
Ended a Phase III trial after an independent data monitoring committee pointed to safety signals in the treatment arm |
10/19/12 |
INFECTION | |||||
Circassia Ltd. (Oxford, UK) |
ToleroMune |
T-cell vaccine |
Rhinoconjuc-tivitis |
Started a pivotal Phase III study |
10/5/12 |
Durata Therapeutics Inc. (Morristown, N.J.) |
Dalbavancin |
A long-acting intravenous lipoglycopeptide |
Acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria |
Reached its target enrollment in a Phase III trial |
10/26/12 |
Trius Therapeutics Inc. (San Diego) |
Tedizolid |
Tedizolid phosphate |
Acute bacterial skin and skin structure infections |
Data showed that the incidence of platelet counts below the lower limit of normal was significantly lower in patients receiving tedizolid vs. Zyvox |
10/22/12 |
MISCELLANEOUS | |||||
Amgen Inc. (Thousand Oaks, Calif.) |
Prolia |
Denosumab |
To increase bone mineral density (BMD) |
Phase III data showed continued increases in BMD and low fracture incidence over six years |
10/16/12 |
Depomed Inc. (Menlo Park, Calif.) |
Serada |
Nonhormonal extended-release formulation of gabapentin |
Menopausal hot flashes |
Phase III data suggested it may help manage menopausal hot flashes |
10/4/12 |
Genzyme Corp. (Cambridge, Mass.) |
Eliglustat tartrate |
Oral therapy |
Gaucher disease Type I |
Met its primary endpoint in previously untreated patients in a Phase III trial |
10/3/12 |
Millennium: The Takeda Oncology Co. (Cambridge, Mass.) |
MLN9708 |
Once-weekly oral therapy |
Relapsed or refractory light chain AL amyloidosis |
Started a Phase III trial |
10/22/12 |
NPS Pharmaceuticals Inc. (Bedminister, N.J.) |
Gattex |
Teduglutide therapy |
Short bowel syndrome |
Data suggested patients achieving independence from intravenous fluids tend to have colon in continuity and lower baseline needs than typical patients |
10/23/12 |
NPS Pharmaceuticals Inc. (Bedminister, N.J.) |
Natpara |
Recombinant human parathyroid hormone |
Hypopara-thyroidism |
Phase III data showed Natpara initiated bone remodeling as demonstrated by significant increases in bone turnover markers |
10/16/12 |
Noven Pharmaceuticals Inc. (Miami; subsidiary of Hisamitsu Pharmaceutical Co. Inc.) |
LDMP |
Low-dose mesylate salt of paroxetine |
Severe vasomotor symptoms associated with menopause |
Data from two Phase III trials showed it achieved statistical significance for all co-primary endpoints testing weekly reductions in the frequency and severity of symptoms |
10/4/12 |
SARcode Bioscience Inc. (Brisbane, Calif.) |
Lifitegrast |
Ophthalmic solution 5% |
Dry eye syndrome |
Phase III data showed it hit its primary endpoint |
10/23/12 |
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. |