Kamada Files BLA for Post-Exposure Rabies Treatment- Kamada (KMDA) and its collaboration partner Kedrion S.p.A. announced the filing of a Biologics License Application (BLA) in the U.S. seeking approval of Kamada's post-exposure rabies treatment human anti-rabies immune globulin (IgG). A decision is expected in mid-2017. If approved, Kedrion expects to commence commercial launch in mid-2017.
Roche Announces Results from Phase 3 Clinical Trial OAK- Swiss drug maker Roche (RHHBY) announced that results from a Phase 3 trial, OAK, showed that its TECENTRIQ (atezolizumab) statistically significantly improved overall survival (OS) compared to docetaxel chemotherapy in patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemo. The data will be presented at an upcoming medical conference. OAK is one of eight ongoing Phase 3 studies assessing TECENTRIQ in lung cancer. It has Breakthrough Therapy status in the U.S. for the treatment of PD-1-positive NSCLC whose disease has progressed after platinum-based chemo (and after targeted therapy for those with EGFR-positive or ALK-positive tumors).
AstraZeneca Announces Results From A Five-Year Study of SYMBICORT- AstraZeneca (AZN) announced results from a five-year safety study comparing its asthma med SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol to budesonide (an inhaled corticosteroid) alone showed a comparable risk of serious asthma-related events and lower risk of asthma exacerbations. Specifically, the trial showed statistical non-inferiority (7.3% higher risk) of SYMBICORT to budesonide in the time to first asthma-related event (hazard ratio: 1.073) and a 16.5% lower risk (hazard ratio: 0.835) of asthma exacerbations versus budesonide.
GenVec Says Novartis Committed to Developing CGF166- GenVec (GNVC) disclosed in a regulatory filing that its licensee Novartis (NVS) remains fully committed to developing gene therapy candidate CGF166, GNVC’s lead product candidate, for the treatment of severe-to-profound hearing loss. Earlier this week, Novartis announced that it was dissolving its internal cell and gene therapy unit as a result of the evolution of its internal organizational design. Novartis had licensed CGF166 back in January 2010.
Amgen’s Collaboration Partner Servier Exercises Option to Commercialize Omecamtiv Mecarbil- Amgen (AMGN) announced that its cardiovascular collaborator Servier exercised its option to commercialize omecamtiv mecarbil for the treatment of chronic heart failure in Europe and the Commonwealth of Independent States, including Russia. In addition, the Phase 3 development program will move forward in collaboration with omecamtiv mecarbil discoverer Cytokinetics (CYTK).
Amgen also announced that it has obtained global development and commercialization rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager (BiTE) to a potential target for multiple myeloma called B-cell maturation antigen (BCMA). Phase 1-stage BI 836908 was originally licensed to Boehringer by Micromet before it was acquired by Amgen in 2012. Financial terms of the deal have not been disclosed.
OncoMed Completes Enrollment in Mid-Stage Study of Demcizumab- OncoMed Pharmaceuticals (OMED) announced that it has completed the enrollment of 207 subjects in its Phase 2 clinical trial, YOSEMITE, evaluating demcizumab as first-line treatment of metastatic pancreatic cancer. Top-line data from the study is expected to be announced in the first half of next year. The study will compare the safety and efficacy of demcizumab, in combination with standard-of-care (SOC) therapy to SOC alone. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, response rate and biomarker analyses.