SOUTH PLAINFIELD, N.J., Aug. 4, 2016  -- PTC Therapeutics, Inc. (PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2016.

 

"Making Translarna available to all Duchenne muscular dystrophy patients globally who may benefit continues to be our top priority," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc.  "Global sales are on a strong growth trajectory as we continue to expand access outside of the U.S. We are excited patients in England can now access reimbursed Translarna and have received our first commercial order in England following NICE's final guidance recommending Translarna. On the regulatory front, we are optimistic that our interactions with the EMA will support the renewal of Translarna's marketing authorization coupled with an obligation to conduct an agreed upon clinical trial, and we look forward to our next steps in the appeal process of the FDA's Refuse to File letter."

BEDFORD, Mass.-- Ocular Therapeutix, Inc. (OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today provided an update on the status of its New Drug Application (NDA) for DEXTENZA™ (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

 

On July 25, 2016, Ocular Therapeutix announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its NDA for DEXTENZA that identified issues pertaining to deficiencies in the manufacturing process and controls identified during a pre-NDA approval inspection of the Company’s manufacturing facility. The CRL for DEXTENZA did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA.

SAN DIEGO -- AmpliPhi Biosciences Corporation (APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced it has completed enrollment of its Phase 1 clinical trial to evaluate the safety of AB-SA01, its proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Army Institute of Research (Walter Reed) Clinical Trials Center in Silver Spring, Maryland. AmpliPhi expects to report topline results by the end of the third quarter of 2016.

 

Bacteriophages, or, more simply, “phages”, are naturally-occurring viruses that have evolved to be highly selective for the bacterial species they must infect in order to replicate. Successful infection enables a single phage to hijack a bacterial host’s protein production machinery to rapidly produce hundreds of progeny phages, at which point the phage instructs the bacterial cell to burst, scattering the highly selective progeny into the surrounding environment to attack nearby bacteria and repeat the reproduction process until the bacterial population is depleted.

THOUSAND OAKS, Calif. and PRINCETON, N.J., Aug. 2, 2016 -- Amgen (AMGN) and Advaxis, Inc. (ADXS) today announced a global agreement for the development and commercialization of Advaxis' ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor. This collaboration brings together Amgen's development expertise in immuno-oncology with Advaxis' MINE™ (MyImmunotherapy Neo-Epitopes) program, which is uniquely positioned to develop a customized approach to cancer treatment.

 

Under the terms of the agreement, Amgen receives exclusive worldwide rights to develop and commercialize ADXS-NEO. Amgen will make an upfront payment to Advaxis of $40 million and purchase $25 million of Advaxis common stock. Amgen will be fully responsible for funding clinical and commercial activities. Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales.