Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases Report
M2 - Fri May 23, 2:03AM CDT
Research and Markets (http://www.researchandmarkets.com/research/bfcxg8/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for liver diseases" report to their offering. Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases. Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension. This initiation report explores these programs in depth, including the underlying rationale for use and a review of the phase II data in the lead PBC and NASH indications. It also explores issues related to the later phase trials for those indications, including the selection of endpoints. In PBC and especially in NASH, the ability to identify those who will have poor long-term outcomes (and thus would benefit from therapy) is difficult. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success. The report also reviews the rationale and available data from the other programs and also looks at the competitive landscapes for each. Key Topics Covered: 1. Primary biliary cirrhosis (PBC) - The disease - Phase II, including long-term extension data (ICPT 2013 10-K) - POISE - Accelerated Approval in PBC and surrogates of transplant-free survival - Will one study be enough? - In summary 2. Non-alcoholic steatohepatitis (NASH) - NAFLD and NASHa brief review - Phase II study in diabetic NAFLD - The FLINT study - Endpoint issues and approval pathways for NASH - Update on lipid changes in phase II studies of fatty liver 3. Update on other indications 4. Summary opinion - PBC - NASH - Other indications Companies Mentioned - Albireo - Antipodean Pharmaceuticals - Intercept Pharmaceuticals - Johnson & Johnson - Kotobuki Pharmaceuticals - NovImmune - Phenex For more information visit http://www.researchandmarkets.com/research/bfcxg8/intercept About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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Business Wire - Thu May 22, 1:09PM CDT
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Nucynta ER/Palexia SR (Neuropathic Pain) - Forecast and Market Analysis to 2022
M2 - Thu May 22, 10:18AM CDT
Research and Markets (http://www.researchandmarkets.com/research/fbpdns/nucynta) has announced the addition of the "Nucynta ER/Palexia SR (Neuropathic Pain) - Forecast and Market Analysis to 2022" report to their offering. Nucynta ER/Palexia SR (tapentadol) is an opioid analgesic that was developed by Gr?nenthal in conjunction with Johnson & Johnson (J&J), first as an immediate-release formulation indicated for acute pain, and later as an ER formulation for the management of chronic pain. Tapentadol has a dual mechanism of action as an agonist of the ?-opioid receptor and as a norepinephrine reuptake inhibitor, and was developed as an improvement to tramadol, which has weak opioid activity, but also inhibits the reuptake of both serotonin and norepinephrine (Tzschentke et al., 2007). Scope - Overview of Neuropathic pain, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape. - Detailed information on Nucynta ER/Palexia SR including product description, safety and efficacy profiles as well as a SWOT analysis. - Sales forecast for Nucynta ER/Palexia SR for the top six countries from 2012 to 2022. - Sales information covered for the US, France, Germany, Italy, Spain and the UK. Key Topics Covered: 1 Tables & Figures 2 Introduction 3 Disease Overview 4 Disease Management 5 Competitive Assessment 6 Nucynta ER/Palexia SR 7 Appendix For more information visit http://www.researchandmarkets.com/research/fbpdns/nucynta
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