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April 17, 2017

BMS, Nordic Bioscience to Develop Biomarkers for NASH, Fibrotic Diseases

  • Bristol-Myers Squibb (BMS) and Nordic Bioscience said today they will partner to develop biomarker technology for diagnosis and monitoring of nonalcoholic steatohepatitis (NASH) and other fibrotic diseases.

    Under the collaboration—whose value was not disclosed—the companies agreed to develop translational biomarkers and diagnostics for NASH in preclinical models of fibrotic diseases, as well as in clinical settings.

    The partnership is designed to combine Nordic’s more than 25 years’ expertise in biomarker development and clinical trials, focusing extensively on fibrosis as well as rheumatology, with BMS’ drug-development efforts.

    Fibrosis is one of the pharma giant’s five therapeutic areas of focus, along with oncology, immunoscience, cardiovascular, and “genetically defined” diseases caused by abnormalities in the genome.

    BMS’ pipeline listed six pipeline candidates for fibrotic diseases as of January 1. Three of the six are in Phase II development: BMS-986020, a small-molecule lysophosphatidic acid 1 (LPA1) receptor antagonist; a recombinant human pentraxin-2 protein candidate for idiopathic pulmonary fibrosis and myelofibrosis that BMS acquired last year for up to $1.25 billion; and another biologic, PEG-FGF21 (pegylated human fibroblast growth factor 21), licensed by the pharma from Ambrx in 2011.

    Another fibrosis-related indication for PEG-FGF21 is in Phase I, as are the other two other fibrotic disease candidates, both small-molecule compounds—a galectin-3 inhibitor and ND-L02-s0201, which targets heat shock protein 47 (HSP47).

    ND-L02-s0201 is the lead candidate of Nitto Denko, which in November granted BMS an exclusive license to develop that candidate and other small interfering RNA (siRNA) molecules targeting heat shock protein 47 (HSP47).

    “Addressing the significant need for better diagnostic and monitoring tools in fibrotic diseases is a key element of BMS’  fibrosis strategy to help patients suffering from these debilitating conditions,” said Mike Burgess, M.D., Ph.D., BMS’ head of cardiovascular, fibrosis, and immunoscience development, said in a statement.

    Last week, BMS honed its therapeutic focus further by licensing its progressive supranuclear palsy (PSP) candidate BMS-986168 to Biogen, and its Duchenne muscular dystrophy candidate BMS-986089 to Roche. The deals could generate more than $1 billion for BMS.

    Nordic Bioscience maintains a portfolio of more than 50 biomarkers, and has specialized in measurement, development, and validation of assays for collagens, elastins, and laminins as biomarkers of extracellular matrix (ECM) activity. The company invented C-terminal telopeptide (CTX), a biomarker that noninvasively identifies osteoporosis patients with a high rate of bone loss and can be used to assess response to osteoporosis therapy.

    The company has also developed Protein Fingerprint™ technology, a method designed to identify and quantify disease-specific protein fragments that according to the company exceeds the specificity of gold-standard biomarkers in biological relevance and scientific rationale. The technology has been incorporated into assays that have identified disease-specific protein fragments, shown them to be different from normal intact proteins, and quantified them in body liquids, Nordic Bioscience said.

    “There is a big unmet need in medical and drug development for simple noninvasive diagnostic, early proof-of-efficacy of intervention and prognostic biomarkers in the NASH field,” added Nordic Bioscience CEO Morten Karsdal, Ph.D.

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