Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Celgene International Sarl (Boudry, Switzerland; subsidiary of Celgene Corp.) |
Apremilast |
An oral small-molecule inhibitor of phosphodiesterase 4 |
Psoriatic arthritis |
The compound achieved statistical significance for the primary endpoint of ACR20 in a Phase III trial |
7/13/12 |
Genentech Inc. (South San Francisco) |
Actemra |
Tocilizumab |
Rheumatoid arthritis |
Met its primary endpoint in the BREVACTA study |
7/30/12 |
Savient Pharmaceuticals Inc. (East Brunswick, N.J.) |
Krystexxa |
Pegloticase |
Gout |
Data showed patients had statistically significant improvements in quality of life, pain and physical function |
7/3/12 |
CANCER | |||||
A.P. Pharma Inc. (Redwood City, Calif.) |
APF530 |
A long-acting formulation of granisetron |
Chemotherapy-induced nausea and vomiting |
Phase III data showed it was comparable to palonosetron |
7/2/12 |
Argos Therapeutics Inc. (Durham, N.C.) |
AGS-003 |
An Arcelis dendritic cell immunotherapy candidate |
Metastatic renal cell carcinoma |
Secured an SPA for a Phase III study |
7/3/12 |
Ariad Pharmaceuticals Inc. (Cambridge, Mass.) |
Ponatinib |
A pan-Bcr-Abl inhibitor |
Chronic myeloid leukemia |
Started a Phase III trial |
7/30/12 |
Debiopharm Group (Lausanne, Switzerland) |
Debio 8206 |
Triptorelin pamoate |
Advanced prostate cancer |
First patient was treated in a Phase III study |
7/25/12 |
Depomed Inc. (Menlo Park, Calif.) |
Gralise |
Gabapentin; once-daily 1,800 mg |
Postherpetic neuralgia |
Phase III data showed it reduced intensity of pain compared to placebo, with a statistically significant difference after one week |
7/24/12 |
OncoGenex Pharmaceuticals Inc. (Bothell, Wash.) |
Custirsen |
Designed to block production of cell survival protein clusterin |
Non-small-cell lung cancer |
Company is planning a Phase III trial to start later this year |
7/11/12 |
OncoSec Medical Inc. (San Diego) |
OMS Electo-Chemo-therapy |
Electrochemo-therapy |
Squamous cell carcinoma of the head and neck |
An interim analysis from two Phase III trials showed it achieved the primary endpoint of preserving quality of life, compared to surgery |
7/24/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Kyprolis |
Carfilzomib |
Relapsed multiple myeloma |
Began enrollment in a Phase III trial |
7/3/12 |
Onyx Pharmaceuticals Inc. (South San Francisco), Bayer HealthCare Pharmaceuticals Inc. (Wayne, N.J.) and Astellas Pharma Inc. (Tokyo) |
Tarceva |
Erlotinib |
Unresectable hepatocellular carcinoma |
Tarceva with Nexavar failed to improve overall survival, compared to Nexavar alone, in a Phase III trial |
7/24/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Zevalin |
Ibritumomab tiuxetan |
Non-Hodgkin's lymphoma |
Data of Zevalin following fludarabine, cyclophosphamide and Rituxan conditioning and nonmyeloablative allogeneic stem cell transplantation resulted in a significantly improved six-year overall survival estimate of 80% |
7/27/12 |
CARDIOVASCULAR | |||||
Amarin Corp. plc (Dublin, Ireland) |
AMR101 |
Icosapent ethyl |
High triglycerides |
Phase III data showed it met all primary and secondary endpoints |
7/25/12 |
Biogen Idec Inc. (Weston, Mass.) and Swedish Orphan Biovitrum AB (Stockholm, Sweden) |
rFVIIIFc and rFIXFc |
Long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins |
Hemophilia A and B |
Started two global pediatric trials |
7/6/12 |
Ipsen SA (Paris) and Inspiration Biopharma-ceuticals Inc. (Cambridge, Mass.) |
IB1001 |
An intravenous recombinant Factor IX therapy |
Hemophilia B |
FDA placed on hold both Phase III studies, due to a potential safety concern |
7/11/12 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) |
REGN727 |
An antibody |
To lower LDL cholesterol |
Began enrolling patients for several trials within its Phase III program |
7/23/12 |
Theravance Inc. (South San Francisco) and GlaxoSmithKline plc (London) |
Umeclidinium bromide and vilanterol |
LAMA/LABA bronchodilator combination |
Chronic obstructive pulmonary disease |
Phase III data showed superiority against placebo and current standard of care |
7/3/12 |
ViroPharma Inc. (Exton, Pa.) |
Cinryze |
C1-esterase inhibitor |
Hereditary angioedema |
Subjects in the study experienced a 93.7% reduction in attacks while taking Cinryze compared with the median historical rate at baseline |
7/30/12 |
CENTRAL NERVOUS SYSTEM | |||||
Hemispherx Biopharma Inc. (Philadelphia) |
Ampligen |
A Toll-like receptor 3 modulator |
Chronic fatigue syndrome |
Reached an agreement with the FDA on the submission of new data |
7/12/12 |
Human Genome Sciences Inc. (Rockville, Md.) and GlaxoSmithKline plc (London) |
Albiglutide |
Glucagon-like peptide 1 receptor agonist |
Obesity |
Phase III data demonstrated significant reductions in HbA1c levels from baseline |
7/12/12 |
Spinal Restoration Inc. (Austin, Texas) |
Biostat System |
An intradiscal biologic therapy consisting of Biostat Biologx Fibrin Sealant |
Chronic discogenic low back pain |
Completed enrollment in its Phase III study |
7/12/12 |
INFECTION | |||||
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
CB-315 |
Oral novel lipopeptide |
Clostridium difficile-associated diarrhea |
The first patient has been enrolled in a pair of pivotal Phase III studies |
7/13/12 |
Gilead Sciences Inc. (Foster City, Calif.) |
Elvitegravir |
Integrase inhibitor |
HIV |
Two-year Phase III data showed elvitegravir dosed once daily is noninferior to Isentress dosed twice daily |
7/25/12 |
Shionogi-ViiV Healthcare LLC (joint venture between Shionogi and Co. Ltd., of Osaka, Japan, and ViiV Healthcare Ltd.) |
Dolutegravir |
An integrase inhibitor designed to block HIV replication by preventing viral DNA from being integrated into the cellular genome |
HIV |
It beat Gilead Sciences Inc.'s Atripla in a Phase III trial, with 88% virological suppression rate, compared with 81% for Atripla |
7/12/12 |
MISCELLANEOUS | |||||
Acucela Inc. (Seattle) |
Rebamipide |
Ophthalmic suspension |
Drye eye syndrome |
Began a Phase III trial |
7/20/12 |
AMAG Pharmaceuticals Inc. (Lexington, Mass.) |
Feraheme |
Ferumoxytol |
Iron-deficiency anemia |
Phase III data demonstrated superiority on all primary efficacy endpoints, with patients achieving a statistically significant mean increase in hemoglobin at week five of 2.7 g/dL, compared to 0.1 g/dL in placebo patients |
7/19/12 |
BHR Pharma LLC (Phoenix) |
BHR-100 |
An intravenous progesterone infusion formulation |
Severe traumatic brain injury |
Reached its clinical trial enrollment midpoint of 590 patients in a Phase III trial |
7/26/12 |
Lux Biosciences Inc. (Jersey City, N.J.) |
Voclosporin |
Oral therapy |
Noninfectious uveitis |
Completed patient enrollment in a new Phase III study, which is being done to respond to the the FDA's complete response letter issued nearly two years ago |
7/10/12 |
Nymox Pharmaceutical Corp. (Hasbrouck Heights, N.J.) |
NX-1207 |
Administered by intraprostatic injection |
Benign prostatic hyperplasia |
Patient recruitment for a Phase III study is almost complete ; |
7/10/12 |
Protalix BioTherapeutics Inc. (Carmiel, Israel) |
Elelyso |
Taliglucerase alfa |
Gaucher disease |
Clinical data at 36 months showed patients had significant improvement in bone marrow fat fraction from baseline |
7/3/12 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Androxal |
Enclomiphene; oral therapy |
Hypogonadism |
Reached an agreement with the FDA for the design of pivotal efficacy studies |
7/10/12 |
|
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. | |||||