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The ERP Biomarker Qualification Consortium was launched by pharmaceutical industry members with the goal of qualifying event-related potential biomarkers to aid the development of new investigational therapies for people with schizophrenia in accordance with FDA guidelines. The Consortium, which brings together industry, academic and regulatory stakeholders, also aims to standardize ERP measurements so they are consistent across treatment centers and can be used to stratify patient populations and evaluate the effects of new treatments. Principal industry members of the Consortium include Alkermes (ALKS), Anavex Life Sciences Corp. (AVXL), Cadent Therapeutics, H. Lundbeck A/S (HLUYY), Merck (MRK), Neuronetrix Solutions, Sage Therapeutics (SAGE) and Takeda Pharmaceutical Company Limited (TAK). Central nervous system disease experts Daniel C. Javitt, M.D., Glytech, Inc.; David P. Walling, Ph.D., CNS Network, LLC; Larry Ereshefsky, PharmD, Follow the Molecule, LLC; and Richard Keefe, Ph.D., VeraSci, will serve as advisory members. The ERP Biomarker Qualification Consortium will run clinical studies to support qualification of the ERP biomarker. The studies are designed to evaluate ERP levels in patients with schizophrenia and healthy adults. Key objectives are to determine baseline measures and evaluate how these measures change in response to pharmaceutical interventions.

Merck has exercised its option to extend the research phase of the strategic collaboration with NGM Biopharmaceuticals for an additional two-year period from March 2020 to March 2022. The collaboration, originally announced in February 2015, is focused on discovering, developing and commercializing novel biologic therapeutics across a wide range of therapeutic areas. Merck retains one additional two-year extension option that is exercisable in 2021. During the two-year extension period, Merck will continue to fund NGM's research and development efforts at similar levels to the original collaboration terms and, in lieu of the $20M extension fee payable to NGM, Merck will make additional payments totaling up to $20M in support of NGM's research and development activities in 2021 and 2022. In January 2019 Merck exercised its option to license NGM313, an investigational monoclonal antibody agonist for the treatment of nonalcoholic steatohepatitis discovered by NGM. Merck's one-time option to license NGM313 was triggered by NGM's completion of a proof-of-concept clinical study of NGM313. Merck intends to advance MK-3655 into a Phase 2b study to evaluate the effect of MK-3655 on liver histology and glucose control in NASH patients with or without diabetes. NGM's fibroblast growth factor 19 program is excluded from the agreement and remains wholly owned by NGM. Merck will terminate its license to NGM's growth differentiation factor 15 receptor agonist program being developed for the treatment of obesity, effective May 31. Merck's decision to terminate the GDF15 program, a right stipulated in the agreement, does not impact the remainder of the collaboration arrangement.