Arbutus’ LNP Licensee Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Patisiran

On November 16, 2017 Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that the Company’s lipid nanoparticle (LNP) licensee Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy (Press release, Arbutus Biopharma, NOV 16, 2017, View Source [SID1234522117]). This submission allows the FDA to review completed portions of the NDA on an ongoing basis. Alnylam expects to submit final clinical data by year end.

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"Our LNP licensing partner continues to make great progress towards achieving final regulatory approval for patisiran. This is a testament to the value of our proprietary LNP platform, which is the most widely adopted RNAi delivery technology to date," said Dr. Mark J. Murray, Arbutus’ President and CEO. "Arbutus is entitled to receive single digit royalties on global sales of patisiran, pending final regulatory approvals."