Nitto BioPharma Press Releases
IND application of ND-L02-s0201 allowed to proceed for idiopathic pulmonary fibrosis indication by the FDA / 2018/Mar/06
Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; “Nitto”, hereafter) (6988: Tokyo), today announced that investigational new drug (IND) application for ND-L02-s0201, an RNAi-based investigational drug, for idiopathic pulmonary fibrosis (IPF) indication was allowed to proceed by the US Food and Drug Administration (FDA). Upon the IND allowance, Nitto plans to promptly initiate a Phase 2 study of ND-L02-s0201 for IPF. Nitto has been developing an RNAi-based drug for treating fibrosis in the liver and other organs since 2008, and in June 2013, Nitto initiated a clinical study for advanced liver fibrosis. In November 2016, Nitto signed a license agreement with Bristol-Myers Squibb (“BMS”, hereafter) giving BMS exclusive rights to develop the drug for liver diseases. BMS has exclusive options for additional licenses to Nitto’s IPF program and also for other fibrosis disease.
Under the slogan of “Innovation for Customers”, Nitto plans to continue expanding their business reach in the Green (Environment) / Clean (New Energy) / Fine (Life Sciences) domains in order to contribute to our customer’s value creation. Nitto continues to make significant efforts towards delivering new drugs for fibrosis and other intractable diseases to patients in need.
Idiopathic Pulmonary Fibrosis: IPF
Idiopathic pulmonary fibrosis (IPF) is a disease of unmet medical need that results in accumulation of collagen and thickening of interstitium, which is the tissue and space around the air sacs of the lungs, due to continuous inflammatory stimuli and lack of repair. IPF is associated with poor prognosis and is designated as one of the intractable diseases in Japan.
ND-L02-s0201 (BMS Code: BMS-986263)
It is an oligonucleotide drug using HSP47 (Heat Shock Protein 47) siRNA, which moderates collagen synthesis and secretion that causes fibrosis.
View Nitto Global press release here.
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 / 2016/Nov/10
- 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
(NEW YORK and OSAKA – November 10, 2016) - 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 https://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.
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.
View Nitto Global press release here.
Initiation of Drug Development for Oncology Using Nitto's Proprietary DDS Platform / 2016/Jul/11
Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; "Nitto", hereafter) is engaged in drug discovery and development for intractable diseases. In January 2016 Nitto BioPharma, Inc. ("Nitto Biopharma", hereafter) was established with a focus on pharmaceutical research and development and has now initiated operations in San Diego, CA, USA.
Nitto's drug development programs are progressing as planned; the first program for liver fibrosis (ND-L02-s0201) is in preparation for phase-2b clinical study. Nitto is also planning to file a regulatory submission for initiation of clinical studies in fiscal year 2016 for lung fibrosis.
Additionally, Nitto is expanding its pipeline and moving forward with oncology programs based on newly identified therapeutic target molecules and DDS (Drug Delivery Systems). Nitto is well situated to utilize its drug development expertise including nucleic acid and DDS design, bio-evaluation, and clinical study management which have been cultivated during progression of the fibrosis program.
The new programs have been initiated at Nitto's Hokkaido Laboratory in Japan and Nitto Biopharma, planning to submit a new IND application in fiscal year 2017. Nitto plans to announce more details in April 2017.
Under the slogan of "Innovation for Customers", Nitto plans to continue expanding their business reach in the Green (Environment) / Clean (New Energy) / Fine (Life Sciences) domains in order to contribute to our customer's value creation. Taking the opportunity of establishing this new company, Nitto will promote drug development for treating intractable diseases, such as fibrosis and cancers, which are activities in Fine (Life Sciences) domain.
Establishment of Nitto BioPharma, Inc. / 2016/Jan/25
Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; "Nitto", hereafter) established a new company, Nitto BioPharma, Inc., with a focus on pharmaceutical development. Nitto has been conducting their first anti-liver fibrosis drug program (ND-L02-s0201), which is now in clinical trials in the US, Europe
and Japan, and has several other pipelines of intractable diseases in the discovery stage.
Along with the establishment of the new company, Nitto plans to set up a new facility mid-2016 in the center of the Life Sciences hub in San Diego, California.
Going forward, drug discovery and development ventures, such as an anti-fibrosis and other drugs will be conducted by Nitto and the new company. By establishing this new company with a focus on pharmaceutical development, Nitto will be able to further expand its future business options and opportunities for Nitto groups.
Under the slogan of "Innovation for Customers", Nitto plans to continue expanding their business reach in the Green (Environment) / Clean (New Energy) / Fine (Life Sciences) domains in order to contribute to our customer's value creation. Taking the opportunity of establishing this new company, Nitto will promote drug discovery for intractable
diseases, such as fibrosis, which are activities in Fine (Life Sciences) domain.
New Company Outline
Company Name: Nitto BioPharma, Inc.
President: Kageshi Maruyama (Senior Vice President of Nitto Denko Corporation)
Company Address: 10628 Science Center Drive, Suite 100, San Diego, CA 92121, USA(Planning from June, 2016)
Date of Establishment: January 11, 2016