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News Article | May 25, 2017
Site: www.businesswire.com

MIAMI--(BUSINESS WIRE)--World Fuel Services Corporation (NYSE:INT) announced today that its board of directors has declared a quarterly cash dividend of $0.06 per share payable on July 7, 2017 to shareholders of record on June 9, 2017. Headquartered in Miami, Florida, World Fuel Services is a global energy management company involved in providing supply fulfillment, energy procurement advisory services, and transaction and payment management solutions to commercial and industrial customers, principally in the aviation, marine and land transportation industries. World Fuel Services sells fuel and delivers services to its clients at more than 8,000 locations in more than 200 countries and territories worldwide. For more information, call 305-428-8000 or visit www.wfscorp.com


NEW YORK, May 25, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.  PBC is a rare, progressive, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications, affecting an estimated 11,000 Canadians. PBC impacts people in the prime of their lives and is the leading cause of liver transplantation among women in Canada. Ocaliva is a farnesoid X receptor (FXR) agonist that will fill an important unmet need for patients who have an inadequate response to, or are unable to tolerate, the standard of care, UDCA, and therefore remain at significantly increased risk of liver failure, need for liver transplantation, or death. “A substantial number of PBC patients are not achieving treatment goals with UDCA alone and a few cannot tolerate this standard of care. Until now we have only had experimental adjunctive therapies to help these non-responders with progressive disease,” said Andrew Mason, MBS, FRCPI, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “The introduction of Ocaliva will help to address this critical need and provide an opportunity for physicians to revisit treatment goals with their patients.” Ocaliva has been issued a marketing authorization with conditions (also known as a Notice of Compliance with Conditions or NOC/c) from Health Canada, pending the results of trials to verify its clinical benefit. Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.  Further, Health Canada approval follows an accelerated priority review of the Ocaliva New Drug Submission, recognizing the unmet need for new therapies in PBC. "We are excited to be introducing the first new treatment option for PBC in over 20 years for Canadian patients so closely following regulatory approval in the U.S. and Europe,” said Mark Pruzanski, M.D., President and CEO of Intercept. “Health Canada’s approval is encouraging news for patients and represents another important step in Intercept's mission to improve the lives of people with progressive non-viral liver diseases." Intercept is actively pursuing reimbursement of Ocaliva with private insurance carriers and public drug plans across Canada. Intercept is committed to ensuring patients with PBC can access Ocaliva as quickly and easily as possible and has launched the Navigate™ Patient Support Program to provide comprehensive and personalized support for eligible patients prescribed Ocaliva for PBC. “We are very excited that Canadians living with PBC will now have an important new treatment option,” said Gail Wright, President of the Canadian PBC Society. “It is such a promising time for PBC patients, and the community has been energized by new advances in research, growing disease awareness among the public and clinicians and now the introduction of a much-needed new therapy to help patients better manage their disease.” About Primary Biliary Cholangitis Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population. About Ocaliva™ (obeticholic acid) Ocaliva (obeticholic acid) is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. Ocaliva is indicated in Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva has been issued a marketing authorization with conditions from Health Canada, pending the results of trials to verify its clinical benefit. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC. In December 2016, Ocaliva received conditional marketing authorization in Europe from the European Medicines Authority. Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Ocaliva is contraindicated in patients with complete biliary obstruction. In two 3-month, placebo-controlled clinical trials, a dose-response relationship was observed for the occurrence of liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare with dosages of Ocaliva of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with Ocaliva. Monitor patients during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse reactions. Weigh the potential risks against the benefits of continuing treatment with Ocaliva in patients who have experienced clinically significant liver-related adverse reactions. Discontinue Ocaliva in patients who develop complete biliary obstruction. Pruritus was mostly mild to moderate in severity and generally started within the first month following the initiation of treatment with Ocaliva and decreased in severity over time with continued dosing. Severe pruritus was reported in 23% of patients in the Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm, and 7% of patients in the placebo arm, respectively. Management strategies include the addition of bile acid resins or antihistamines, Ocaliva dosage reduction, and/or temporary interruption of Ocaliva dosing. The most common adverse drug reactions reported in double-blind clinical trials (frequency≥5%) were pruritus, fatigue, constipation, oropharyngeal pain and arthralgia. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets please see the Product Monograph. About Intercept Pharma Canada Inc. Intercept Pharma Canada Inc. is the Canadian subsidiary of Intercept Pharmaceuticals, Inc., founded in 2015 and based in Mississauga, Ontario. Intercept is a proud member of Ontario’s biopharmaceutical community, and is committed to helping support the needs of Canada’s liver health community. About Intercept Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. Intercept’s International headquarters are located in London. For more information about Intercept, please visit www.interceptpharma.com. Safe Harbor Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance and utility of ALP, bilirubin and the surrogate endpoint used in the Phase 3 POISE trial to predict clinical outcomes, the acceptance of OcalivaTM (obeticholic acid) as a treatment for PBC by healthcare providers, patients and payors, the commercial availability of OCA for the treatment of PBC and timelines related thereto, the anticipated prevalence of and other epidemiological estimates and market data related to PBC, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Intercept's ability to successfully commercialize Ocaliva in PBC, and Intercept's ability to maintain its regulatory approval in jurisdictions in which Ocaliva is approved for use in PBC; the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA in PBC in countries outside the ones in which it is approved and in indications other than PBC and any other product candidates it may develop such as INT-767; conditions that may be imposed by regulatory authorities on Intercept's marketing approvals for its products and product candidates such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), and any related restrictions, limitations, and/or warnings in the label of any approved products and product candidates; Intercept's plans to research, develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its products and product candidates; Intercept's ability to successfully commercialize its products and product candidates; the size and growth of the markets for Intercept's products and product candidates and its ability to serve those markets; the rate and degree of market acceptance of any of Intercept's products, which may be affected by the reimbursement received from payors; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, revenues and capital requirements and the accuracy thereof; Intercept's use of cash and short-term investments; Intercept's ability to attract and retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in our annual report on Form 10-K for the year ended December 31, 2016 filed on March 1, 2017 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.


NEW YORK, May 25, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.  PBC is a rare, progressive, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications, affecting an estimated 11,000 Canadians. PBC impacts people in the prime of their lives and is the leading cause of liver transplantation among women in Canada. Ocaliva is a farnesoid X receptor (FXR) agonist that will fill an important unmet need for patients who have an inadequate response to, or are unable to tolerate, the standard of care, UDCA, and therefore remain at significantly increased risk of liver failure, need for liver transplantation, or death. “A substantial number of PBC patients are not achieving treatment goals with UDCA alone and a few cannot tolerate this standard of care. Until now we have only had experimental adjunctive therapies to help these non-responders with progressive disease,” said Andrew Mason, MBS, FRCPI, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “The introduction of Ocaliva will help to address this critical need and provide an opportunity for physicians to revisit treatment goals with their patients.” Ocaliva has been issued a marketing authorization with conditions (also known as a Notice of Compliance with Conditions or NOC/c) from Health Canada, pending the results of trials to verify its clinical benefit. Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.  Further, Health Canada approval follows an accelerated priority review of the Ocaliva New Drug Submission, recognizing the unmet need for new therapies in PBC. "We are excited to be introducing the first new treatment option for PBC in over 20 years for Canadian patients so closely following regulatory approval in the U.S. and Europe,” said Mark Pruzanski, M.D., President and CEO of Intercept. “Health Canada’s approval is encouraging news for patients and represents another important step in Intercept's mission to improve the lives of people with progressive non-viral liver diseases." Intercept is actively pursuing reimbursement of Ocaliva with private insurance carriers and public drug plans across Canada. Intercept is committed to ensuring patients with PBC can access Ocaliva as quickly and easily as possible and has launched the Navigate™ Patient Support Program to provide comprehensive and personalized support for eligible patients prescribed Ocaliva for PBC. “We are very excited that Canadians living with PBC will now have an important new treatment option,” said Gail Wright, President of the Canadian PBC Society. “It is such a promising time for PBC patients, and the community has been energized by new advances in research, growing disease awareness among the public and clinicians and now the introduction of a much-needed new therapy to help patients better manage their disease.” About Primary Biliary Cholangitis Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population. About Ocaliva™ (obeticholic acid) Ocaliva (obeticholic acid) is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. Ocaliva is indicated in Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva has been issued a marketing authorization with conditions from Health Canada, pending the results of trials to verify its clinical benefit. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC. In December 2016, Ocaliva received conditional marketing authorization in Europe from the European Medicines Authority. Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Ocaliva is contraindicated in patients with complete biliary obstruction. In two 3-month, placebo-controlled clinical trials, a dose-response relationship was observed for the occurrence of liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare with dosages of Ocaliva of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with Ocaliva. Monitor patients during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse reactions. Weigh the potential risks against the benefits of continuing treatment with Ocaliva in patients who have experienced clinically significant liver-related adverse reactions. Discontinue Ocaliva in patients who develop complete biliary obstruction. Pruritus was mostly mild to moderate in severity and generally started within the first month following the initiation of treatment with Ocaliva and decreased in severity over time with continued dosing. Severe pruritus was reported in 23% of patients in the Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm, and 7% of patients in the placebo arm, respectively. Management strategies include the addition of bile acid resins or antihistamines, Ocaliva dosage reduction, and/or temporary interruption of Ocaliva dosing. The most common adverse drug reactions reported in double-blind clinical trials (frequency≥5%) were pruritus, fatigue, constipation, oropharyngeal pain and arthralgia. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets please see the Product Monograph. About Intercept Pharma Canada Inc. Intercept Pharma Canada Inc. is the Canadian subsidiary of Intercept Pharmaceuticals, Inc., founded in 2015 and based in Mississauga, Ontario. Intercept is a proud member of Ontario’s biopharmaceutical community, and is committed to helping support the needs of Canada’s liver health community. About Intercept Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. Intercept’s International headquarters are located in London. For more information about Intercept, please visit www.interceptpharma.com. Safe Harbor Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance and utility of ALP, bilirubin and the surrogate endpoint used in the Phase 3 POISE trial to predict clinical outcomes, the acceptance of OcalivaTM (obeticholic acid) as a treatment for PBC by healthcare providers, patients and payors, the commercial availability of OCA for the treatment of PBC and timelines related thereto, the anticipated prevalence of and other epidemiological estimates and market data related to PBC, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Intercept's ability to successfully commercialize Ocaliva in PBC, and Intercept's ability to maintain its regulatory approval in jurisdictions in which Ocaliva is approved for use in PBC; the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA in PBC in countries outside the ones in which it is approved and in indications other than PBC and any other product candidates it may develop such as INT-767; conditions that may be imposed by regulatory authorities on Intercept's marketing approvals for its products and product candidates such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), and any related restrictions, limitations, and/or warnings in the label of any approved products and product candidates; Intercept's plans to research, develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its products and product candidates; Intercept's ability to successfully commercialize its products and product candidates; the size and growth of the markets for Intercept's products and product candidates and its ability to serve those markets; the rate and degree of market acceptance of any of Intercept's products, which may be affected by the reimbursement received from payors; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, revenues and capital requirements and the accuracy thereof; Intercept's use of cash and short-term investments; Intercept's ability to attract and retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in our annual report on Form 10-K for the year ended December 31, 2016 filed on March 1, 2017 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.


NEW YORK, May 25, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.  PBC is a rare, progressive, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications, affecting an estimated 11,000 Canadians. PBC impacts people in the prime of their lives and is the leading cause of liver transplantation among women in Canada. Ocaliva is a farnesoid X receptor (FXR) agonist that will fill an important unmet need for patients who have an inadequate response to, or are unable to tolerate, the standard of care, UDCA, and therefore remain at significantly increased risk of liver failure, need for liver transplantation, or death. “A substantial number of PBC patients are not achieving treatment goals with UDCA alone and a few cannot tolerate this standard of care. Until now we have only had experimental adjunctive therapies to help these non-responders with progressive disease,” said Andrew Mason, MBS, FRCPI, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “The introduction of Ocaliva will help to address this critical need and provide an opportunity for physicians to revisit treatment goals with their patients.” Ocaliva has been issued a marketing authorization with conditions (also known as a Notice of Compliance with Conditions or NOC/c) from Health Canada, pending the results of trials to verify its clinical benefit. Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.  Further, Health Canada approval follows an accelerated priority review of the Ocaliva New Drug Submission, recognizing the unmet need for new therapies in PBC. "We are excited to be introducing the first new treatment option for PBC in over 20 years for Canadian patients so closely following regulatory approval in the U.S. and Europe,” said Mark Pruzanski, M.D., President and CEO of Intercept. “Health Canada’s approval is encouraging news for patients and represents another important step in Intercept's mission to improve the lives of people with progressive non-viral liver diseases." Intercept is actively pursuing reimbursement of Ocaliva with private insurance carriers and public drug plans across Canada. Intercept is committed to ensuring patients with PBC can access Ocaliva as quickly and easily as possible and has launched the Navigate™ Patient Support Program to provide comprehensive and personalized support for eligible patients prescribed Ocaliva for PBC. “We are very excited that Canadians living with PBC will now have an important new treatment option,” said Gail Wright, President of the Canadian PBC Society. “It is such a promising time for PBC patients, and the community has been energized by new advances in research, growing disease awareness among the public and clinicians and now the introduction of a much-needed new therapy to help patients better manage their disease.” About Primary Biliary Cholangitis Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population. About Ocaliva™ (obeticholic acid) Ocaliva (obeticholic acid) is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. Ocaliva is indicated in Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva has been issued a marketing authorization with conditions from Health Canada, pending the results of trials to verify its clinical benefit. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC. In December 2016, Ocaliva received conditional marketing authorization in Europe from the European Medicines Authority. Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Ocaliva is contraindicated in patients with complete biliary obstruction. In two 3-month, placebo-controlled clinical trials, a dose-response relationship was observed for the occurrence of liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare with dosages of Ocaliva of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with Ocaliva. Monitor patients during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse reactions. Weigh the potential risks against the benefits of continuing treatment with Ocaliva in patients who have experienced clinically significant liver-related adverse reactions. Discontinue Ocaliva in patients who develop complete biliary obstruction. Pruritus was mostly mild to moderate in severity and generally started within the first month following the initiation of treatment with Ocaliva and decreased in severity over time with continued dosing. Severe pruritus was reported in 23% of patients in the Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm, and 7% of patients in the placebo arm, respectively. Management strategies include the addition of bile acid resins or antihistamines, Ocaliva dosage reduction, and/or temporary interruption of Ocaliva dosing. The most common adverse drug reactions reported in double-blind clinical trials (frequency≥5%) were pruritus, fatigue, constipation, oropharyngeal pain and arthralgia. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets please see the Product Monograph. About Intercept Pharma Canada Inc. Intercept Pharma Canada Inc. is the Canadian subsidiary of Intercept Pharmaceuticals, Inc., founded in 2015 and based in Mississauga, Ontario. Intercept is a proud member of Ontario’s biopharmaceutical community, and is committed to helping support the needs of Canada’s liver health community. About Intercept Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. Intercept’s International headquarters are located in London. For more information about Intercept, please visit www.interceptpharma.com. Safe Harbor Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance and utility of ALP, bilirubin and the surrogate endpoint used in the Phase 3 POISE trial to predict clinical outcomes, the acceptance of OcalivaTM (obeticholic acid) as a treatment for PBC by healthcare providers, patients and payors, the commercial availability of OCA for the treatment of PBC and timelines related thereto, the anticipated prevalence of and other epidemiological estimates and market data related to PBC, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Intercept's ability to successfully commercialize Ocaliva in PBC, and Intercept's ability to maintain its regulatory approval in jurisdictions in which Ocaliva is approved for use in PBC; the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA in PBC in countries outside the ones in which it is approved and in indications other than PBC and any other product candidates it may develop such as INT-767; conditions that may be imposed by regulatory authorities on Intercept's marketing approvals for its products and product candidates such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), and any related restrictions, limitations, and/or warnings in the label of any approved products and product candidates; Intercept's plans to research, develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its products and product candidates; Intercept's ability to successfully commercialize its products and product candidates; the size and growth of the markets for Intercept's products and product candidates and its ability to serve those markets; the rate and degree of market acceptance of any of Intercept's products, which may be affected by the reimbursement received from payors; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, revenues and capital requirements and the accuracy thereof; Intercept's use of cash and short-term investments; Intercept's ability to attract and retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in our annual report on Form 10-K for the year ended December 31, 2016 filed on March 1, 2017 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.


News Article | May 25, 2017
Site: www.prweb.com

INT is pleased to announce the launch of IVAAP™­, the first and only digital framework designed to accelerate the development of web-based data visualization and analysis solutions for upstream E&P. Designed to respond to the evolving needs of geoscience analysts, IVAAP helps companies develop and deploy real-time monitoring and analysis applications quickly, reducing costs and delivering higher value in a shorter time frame. “We strive to develop our products ahead of the curve, at the forefront of technology, ensuring that we can position our clients for the utmost success in the industry,” said Dr. Olivier Lhemann, President of INT, Inc. “Our HTML5 products—now including IVAAP—are consistently the most advanced in the field.” Cloud-enabled and highly scalable, IVAAP includes a powerful HTML5 client dashboard, a microservices-based back end server, and robust user management and reporting tools. — A modern back end based on modular microservices that aggregates multiple data sources and offers built-in support for standard data streams, including WITSML. — A powerful SDK that helps integrate your proprietary processing workflows and analytics for a complete, custom digital application that can be easily deployed on a private server or in the cloud. — A flexible browser-based HTML5 client that incorporates a range of mobile-responsive widgets to create custom dashboards. Built upon INT’s extensive domain expertise in E&P data visualization, IVAAP is the ideal platform to help companies transform and optimize their exploration and production business processes. For product owners, architects, and IT professionals, IVAAP simplifies the development and deployment of highly integrated and scalable applications, lowering the cost of ownership and allowing them to focus on their specific IP, science, and workflows. Visit us online at http://www.int.com/ivaap or at our booth at EAGE in Paris June 12–15 for a preview of IVAAP or for a demo of INT’s other data visualization products. For more information, please visit http://www.int.com or email us.


NEW YORK, May 25, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.  PBC is a rare, progressive, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications, affecting an estimated 11,000 Canadians. PBC impacts people in the prime of their lives and is the leading cause of liver transplantation among women in Canada. Ocaliva is a farnesoid X receptor (FXR) agonist that will fill an important unmet need for patients who have an inadequate response to, or are unable to tolerate, the standard of care, UDCA, and therefore remain at significantly increased risk of liver failure, need for liver transplantation, or death. “A substantial number of PBC patients are not achieving treatment goals with UDCA alone and a few cannot tolerate this standard of care. Until now we have only had experimental adjunctive therapies to help these non-responders with progressive disease,” said Andrew Mason, MBS, FRCPI, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “The introduction of Ocaliva will help to address this critical need and provide an opportunity for physicians to revisit treatment goals with their patients.” Ocaliva has been issued a marketing authorization with conditions (also known as a Notice of Compliance with Conditions or NOC/c) from Health Canada, pending the results of trials to verify its clinical benefit. Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.  Further, Health Canada approval follows an accelerated priority review of the Ocaliva New Drug Submission, recognizing the unmet need for new therapies in PBC. "We are excited to be introducing the first new treatment option for PBC in over 20 years for Canadian patients so closely following regulatory approval in the U.S. and Europe,” said Mark Pruzanski, M.D., President and CEO of Intercept. “Health Canada’s approval is encouraging news for patients and represents another important step in Intercept's mission to improve the lives of people with progressive non-viral liver diseases." Intercept is actively pursuing reimbursement of Ocaliva with private insurance carriers and public drug plans across Canada. Intercept is committed to ensuring patients with PBC can access Ocaliva as quickly and easily as possible and has launched the Navigate™ Patient Support Program to provide comprehensive and personalized support for eligible patients prescribed Ocaliva for PBC. “We are very excited that Canadians living with PBC will now have an important new treatment option,” said Gail Wright, President of the Canadian PBC Society. “It is such a promising time for PBC patients, and the community has been energized by new advances in research, growing disease awareness among the public and clinicians and now the introduction of a much-needed new therapy to help patients better manage their disease.” About Primary Biliary Cholangitis Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population. About Ocaliva™ (obeticholic acid) Ocaliva (obeticholic acid) is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. Ocaliva is indicated in Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Ocaliva has been issued a marketing authorization with conditions from Health Canada, pending the results of trials to verify its clinical benefit. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC. In December 2016, Ocaliva received conditional marketing authorization in Europe from the European Medicines Authority. Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Ocaliva is contraindicated in patients with complete biliary obstruction. In two 3-month, placebo-controlled clinical trials, a dose-response relationship was observed for the occurrence of liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare with dosages of Ocaliva of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with Ocaliva. Monitor patients during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse reactions. Weigh the potential risks against the benefits of continuing treatment with Ocaliva in patients who have experienced clinically significant liver-related adverse reactions. Discontinue Ocaliva in patients who develop complete biliary obstruction. Pruritus was mostly mild to moderate in severity and generally started within the first month following the initiation of treatment with Ocaliva and decreased in severity over time with continued dosing. Severe pruritus was reported in 23% of patients in the Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm, and 7% of patients in the placebo arm, respectively. Management strategies include the addition of bile acid resins or antihistamines, Ocaliva dosage reduction, and/or temporary interruption of Ocaliva dosing. The most common adverse drug reactions reported in double-blind clinical trials (frequency≥5%) were pruritus, fatigue, constipation, oropharyngeal pain and arthralgia. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets please see the Product Monograph. About Intercept Pharma Canada Inc. Intercept Pharma Canada Inc. is the Canadian subsidiary of Intercept Pharmaceuticals, Inc., founded in 2015 and based in Mississauga, Ontario. Intercept is a proud member of Ontario’s biopharmaceutical community, and is committed to helping support the needs of Canada’s liver health community. About Intercept Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. Founded in 2002 in New York, Intercept now has operations in the United States, Europe and Canada. Intercept’s International headquarters are located in London. For more information about Intercept, please visit www.interceptpharma.com. Safe Harbor Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance and utility of ALP, bilirubin and the surrogate endpoint used in the Phase 3 POISE trial to predict clinical outcomes, the acceptance of OcalivaTM (obeticholic acid) as a treatment for PBC by healthcare providers, patients and payors, the commercial availability of OCA for the treatment of PBC and timelines related thereto, the anticipated prevalence of and other epidemiological estimates and market data related to PBC, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Intercept's ability to successfully commercialize Ocaliva in PBC, and Intercept's ability to maintain its regulatory approval in jurisdictions in which Ocaliva is approved for use in PBC; the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA in PBC in countries outside the ones in which it is approved and in indications other than PBC and any other product candidates it may develop such as INT-767; conditions that may be imposed by regulatory authorities on Intercept's marketing approvals for its products and product candidates such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), and any related restrictions, limitations, and/or warnings in the label of any approved products and product candidates; Intercept's plans to research, develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its products and product candidates; Intercept's ability to successfully commercialize its products and product candidates; the size and growth of the markets for Intercept's products and product candidates and its ability to serve those markets; the rate and degree of market acceptance of any of Intercept's products, which may be affected by the reimbursement received from payors; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, revenues and capital requirements and the accuracy thereof; Intercept's use of cash and short-term investments; Intercept's ability to attract and retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in our annual report on Form 10-K for the year ended December 31, 2016 filed on March 1, 2017 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.


PARIS, May 11, 2017 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat ageing diseases, has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos. Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “We are delighted to announce the recruitment of the first patient in the SARA-OBS clinical study in the United States. The US clinical centers of Boston and Gainesville are now open and recruiting patients. These centers are specialized in sarcopenia patients care, led by internationally renowned clinicians, and ideally complete our European clinical network. It marks an important step of our development strategy in the US, our primary market, which was announced one year ago. We are now focusing on the preparation of the interventional phase, SARA-INT, which will follow on this observational study.” BIOPHYTIS has obtained the authorization of the regulatory authorities to start the SARA-OBS clinical study in sarcopenia. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor. The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy) and the United States has now begun. Sarcopenia patients will be monitored for 6 months before being possibly included in the interventional phase 2b SARA-INT study, after obtaining their consent. The opening of centers in the United States is a critical marker of the development strategy initiated a year ago. It consists in a doubling of the size of the clinical study by recruiting patients in the US (the most important market for BIOPHYTIS in terms of number of patients), opening of a subsidiary in Boston, recruitment of reputable clinicians, in particular Roger A Fielding who joined BIOPHYTIS’ Scientific Advisory Board, and is the head researcher of the SARA-OBS/SARA-INT study. To know more about the SARA clinical program and Sarcopenia, you may also watch the introductory video by following this link: http://www.biophytis.com/en/actualites/SARA-ICFSR-2017/ About SARA-OBS: SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients recruited in 8 clinical centers in Europe and the United States. Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, mobility (SPPB test), muscle strength (grip test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of the target population for the Sarconeos treatment. Patients in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the end of 6 months, once consent is given. ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people.  This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide. About BIOPHYTIS: BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute. BIOPHYTIS is listed on the Alternext market of Euronext Paris (ALBPS; ISIN: FR0012816825). BIOPHYTIS is eligible for the SMEs scheme Disclaimer This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Alternext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on BIOPHYTIS’ website (www.biophytis.com). This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in 5 both French and English. In the event of any differences between the two texts, the French language version shall supersede.

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