Navigation Links
Dainippon Sumitomo Pharma and Intercept Pharmaceuticals Announce Agreement to Develop and Commercialize Obeticholic Acid (INT-747) for Chronic Liver Disease
Date:3/30/2011

OSAKA, Japan and NEW YORK, March 30, 2011 /PRNewswire/ -- Dainippon Sumitomo Pharma Co, Ltd. (DSP) and Intercept Pharmaceuticals, Inc. (Intercept) today announced that they have entered into an exclusive licensing agreement for the development and commercialization of Intercept's first-in-class FXR agonist obeticholic acid (OCA, also known as INT-747). DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, with an initial focus on primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH). Intercept is currently preparing for the initiation of a Phase III PBC program in the US and Europe and, under the company's cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a large placebo-controlled trial of OCA in NASH patients recently started enrolling in the US.

Under the terms of the licensing agreement, Intercept will receive an initial payment from DSP of $15 million and will be eligible to receive approximately $300 million in additional milestone payments associated with the successful development and commercialization of OCA. Upon launch of OCA, Intercept will be entitled to receive tiered double-digit royalties from DSP based on sales in its territory. DSP has the exclusive option to add several other Asian countries to its territory, including Korea and Taiwan, and to pursue additional indications. DSP will be responsible for the costs of developing and commercializing OCA in its territory.

"OCA is an important strategic addition to our growing pipeline of hepatology drugs and reflects DSP's strong commitment to specialty therapeutic areas," said Masayo Tada, President and CEO of DSP. "There is a very high unmet medical need in the hepatology area in Asia and DSP's marketed products SUMIFERON®, a natural alpha interferon, and MIRIPLA®, a therapeutic agent for hepatocellular carcinoma, benefit many thousands of liver patients in Japan. We strongly believe that OCA has the potential to significantly add to the treatment options DSP can make available to these patients and are looking forward to working with Intercept to bring OCA to the market as an important new therapy for PBC and the first drug approved for NASH."

"This agreement is an important milestone for our OCA program and provides additional confirmation of our drug's potential," said Mark Pruzanski, MD, President and CEO of Intercept. "We are excited to be partnering in Asia with DSP, given its proven track record in the development and commercialization of drugs in the hepatology area. This collaboration with DSP will provide important development support as we advance OCA in parallel for PBC, NASH and possibly other indications."

About Obeticholic Acid (OCA or INT-747)

OCA is a potent, first-in-class farnesoid X receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist.  Intercept has previously announced positive Phase II results from randomized clinical trials in patients with primary biliary cirrhosis (PBC) and in type 2 diabetics with nonalcoholic fatty liver disease.  The clinical data and mechanism of action support OCA's potential as a novel, hepatoprotective agent in a broad range of chronic liver diseases.  

About Primary Biliary Cirrhosis (PBC)

PBC is the most common autoimmune chronic liver disease that primarily afflicts women over the age of 40. PBC causes substantial loss of intrahepatic bile ducts, resulting in impaired bile flow (cholestasis) and progressive fibrosis that leads eventually to cirrhosis. It is estimated that there are approximately 50,000 PBC patients in Japan and more than 400,000 in China.  Given inadequate treatment options, up to 50% of such patients worldwide continue to be at significant risk of progression to liver transplant or death.

About Nonalcoholic Steatohepatitis (NASH)

NASH is a more serious form of nonalcoholic fatty liver disease (NAFLD) and occurs in patients who drink little or no alcohol. NASH occurs most commonly in obese and insulin resistant patients, but is also seen in lean individuals. In a report of a 5-10 year follow-up study, up to 25% of NASH patients progressed to cirrhosis of the liver.  The prevalence of NASH in Japan is estimated to be at least 1% of the adult population and pediatric disease is also becoming more common, while in the US it is estimated that 3-5% of the population has the disease in association with higher obesity rates. There is currently no approved treatment for NASH.

About Intercept Pharmaceuticals, Inc.

Intercept is a biotechnology company focused on discovering and developing small molecule drugs for the treatment of chronic liver and metabolic diseases.  The company's most advanced programs are focused on the development of modified bile acids that are selective for FXR, a nuclear receptor, and TGR5, a G protein-coupled receptor. Bile acid signaling through these receptors regulates key aspects of lipid, glucose and overall energy metabolism, while also serving to maintain the functional integrity of the liver, intestine and kidneys, organs that are exposed to bile acid flux. For more information about Intercept, please go to www.interceptpharma.com. CONTACT: Mark Pruzanski, M.D. or Barbara Duncan, both of Intercept, +1-646-747-1000. For information about Intercept's majority shareholder Genextra S.p.A., please go to www.genextra.it.

About Dainippon Sumitomo Pharma Co., Ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical products. DSP aims to produce innovative pharmaceutical products in the central nervous system (CNS) field and other specialty areas. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at http://www.ds-pharma.com/


'/>"/>
SOURCE Intercept Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Codexis Signs First Japanese Biocatalysis Collaboration With Dainippon Sumitomo Pharma
2. Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia
3. Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia
4. Pharmasset Initiates Phase 2b ATOMIC Trial of PSI-7977 for Multiple HCV Genotypes
5. Isis Pharmaceuticals to Present at the 10th Annual Needham Healthcare Conference
6. Konica Minolta Sensing Announces CM-5 Spectrophotometer to Pharmaceutical Industry at Interphex 2011
7. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
8. SCOLR Pharma, Inc. Reports 2010 Financial Results, Provides Updates on Advances in Nutritionals, OTC Drugs
9. ViroPharma Initiates Phase 2 Study of C1 Esterase Inhibitor [Human] for Treatment of Antibody-Mediated Rejection (AMR)
10. New Survey Emphasizes Value of Biopharmaceutical Company Engagement With Healthcare Providers
11. LodgeNet Healthcare Partners With American Society of Health-System Pharmacists to Improve Clinical Outcomes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... SAN DIEGO , Feb. 5, 2016 Aethlon ... Jim Joyce , Chairman and CEO, will be presenting at ... New York, NY at 2:15 p.m. ... participate in an Immunotherapy Panel discussion taking place at 3:15 ... available for replay approximately one hour after the conclusion of ...
(Date:2/5/2016)... India , February 5, 2016 ... a new market research report "Fetal (Labor & Delivery) ... & Antepartum), Warmer, Incubator, Pulse Oximeter, Phototherapy/Jaundice Management Devices, ... published by MarketsandMarkets, This report studies the global market ... market is estimated at USD 6.28 Billion in 2015 ...
(Date:2/4/2016)... Ohio , Feb. 4, 2016 For ... Program, or those already participating in the program, the ... often referred to as the , Mega-Guidance , could ... final guidance is published in September 2016. ... Product and Service Marketing , summarizes the Mega-Guidance,s key ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... February 06, 2016 , ... With the FCPX LUT: Summer pack ... their footage. A LUT is a Lookup Table that contains a mathematical formula for ... by the table. By manipulating each pixel, LUT's can change each color range differently, ...
(Date:2/5/2016)... ... 2016 , ... Steven Tonkinson, 36, of Coconut Grove, Florida, ran the Miami ... in 2003. This year, he ran all 26.2 miles with a green 25-pound ShelterBox ... Miami Heat. , This Sunday, while many are watching the Superbowl, Steven Tonkinson will ...
(Date:2/5/2016)... City, UT (PRWEB) , ... February 05, 2016 , ... ... Whole-Food Nutrition , announced that the much-anticipated feature with author Jahnavi Foster, specialist in ... Humans Amateur TV Network. , Each week, on his weekly Whole-Food Warrior TV show, ...
(Date:2/5/2016)... ... 05, 2016 , ... The Muscular Dystrophy Association and Sailormen ... the 14th annual “Appetite for a Cure” campaign on Feb. 1 to raise ... related diseases that severely limit strength and mobility. , Now through March ...
(Date:2/5/2016)... Dickson, Tennessee (PRWEB) , ... February 05, 2016 ... ... State Community College President George H. Van Allen have signed a joint enrollment ... semester, provides a seamless pathway toward associate and baccalaureate degrees at FHU|Dickson. ...
Breaking Medicine News(10 mins):