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Bristol-Myers Squibb Signs Exclusive Worldwide License Agreement with Nitto Denko for Targeted siRNA Therapy in Advanced Non-alcoholic Steatohepatitis (NASH) and Cirrhosis Due to NASH
  ⋅Exclusive license to develop, manufacture and commercialize lead Phase 1b asset ND-L02-s0201 in development for advanced liver fibrosis
⋅Advances Bristol-Myers Squibb's development program in fibrotic diseases
⋅Agreement includes options for exclusive licenses for lung fibrosis and other organ fibrosis

Thursday, November 10, 2016 6:59 am EST
NEW YORK & OSAKA, Japan--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Nitto Denko Corporation (Nitto) (6988:Tokyo) today announced the companies have entered into an agreement granting Bristol-Myers Squibb exclusive worldwide rights for the development and commercialization of Nitto's investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations, which includes Nitto's lead asset ND-L02-s0201, currently in Phase 1b study for the treatment of advanced liver fibrosis. The agreement also grants Bristol-Myers Squibb the option to receive exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis and other organ fibrosis. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
"Addressing the significant unmet need in fibrotic diseases is a key part of Bristol-Myers Squibb's strategy to build a sustainable and diversified portfolio of transformational medicines," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer of Bristol-Myers Squibb. "We continue to invest in innovative approaches both internally and externally that may halt or slow the progression of fibrotic diseases and are pleased to partner with Nitto Denko to advance the development of therapies for patients living with advanced NASH and cirrhosis due to NASH who currently have limited treatment options."
"We believe our investigational anti-fibrosis drug has the potential to make a significant contribution to help patients with advanced liver fibrosis. We are very excited that Bristol-Myers Squibb joins our effort, as this will provide an accelerated development for this compound," said Hideo Takasaki, chief executive officer, Nitto Denko Corporation. "From now on, Nitto group will support Bristol-Myers Squibb for further development and will continue our efforts to develop other organ fibrosis treatments including Idiopathic Pulmonary Fibrosis (IPF) through our newly established Nitto BioPharma Inc."
Nitto's lead product, ND-L02-s0201, is a targeted siRNA therapy that is designed to inhibit HSP47, a collagen specific chaperone which regulates collagen synthesis and secretion, and prevent further collagen deposition as well as enable resolution of existing fibrosis. Nitto is currently conducting a 5-week open-label Phase 1b study in patients with advanced fibrosis (F3-F4c) due to NASH or hepatitis C. The U.S. Food and Drug Administration granted fast track designation to ND-L02-s0201 for two indications, liver fibrosis and cirrhosis secondary to NASH and liver fibrosis and cirrhosis secondary to HCV.
Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $100 million to Nitto. Bristol-Myers Squibb will be responsible for the development, manufacture, and commercialization of HSP47 siRNAs in vitamin A containing formulations for all liver diseases. Nitto is also eligible to receive subsequent clinical and regulatory milestone payments, royalties, sales based milestone payments as well as option exercise payments for lung and other organ fibrosis.
About Fibrosis and NASH
Fibrotic diseases are characterized by inflammation and subsequent formation of excess collagen in an organ or tissue, compromising function and ultimately leading to organ failure. Non-alcoholic steatohepatitis (NASH) is characterized by fatty infiltration of the liver not caused by alcohol. NASH may progress to liver fibrosis, cirrhosis, hepatocellular carcinoma and liver failure, and is expected to be the leading cause of liver transplant by 2030. The severity of liver fibrosis (scar tissue in the liver) is measured on a scale of F0 (normal) to F4 (cirrhosis) in a liver biopsy specimen. F3 and F4-compensated ("F4c) are considered advanced NASH. Approximately 20 million patients in the U.S. have NASH with three to four million of those patients being F3 or F4c. No approved pharmacologic therapies for NASH exist.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Nitto Denko Corporation
Founded in 1918, Nitto is Japan's leading materials manufacturer offering over 13,500 diversified industrial products to more than 70 business fields as electronics, automobiles, ecology and life science. We aim to offer value to Green (environment), Clean (new energy) and Fine (life science) markets. For more information about Nitto, visit us at http://www.nitto.com/jp/en/
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the investigational compounds discussed in this release will be successfully developed or approved for any of the indications described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bristol-Myers Squibb
Lisa McCormick Lavery, 609-252-7602
Ken Dominski, 609-252-5251
Tim Power, 609-252-7509
Bill Szablewski, 609-252-5894
Nitto Denko Corporation
Brand Strategy Dept., Corporate Strategy Management Div.

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