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

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.

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