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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 | February 15, 2017
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ClimeCo Corporation (ClimeCo) is pleased to announce that on February 1st, 2017, the first exchange trade occurred for the Ontario Cap and Trade futures contract (Contract: OCA). ClimeCo is proud to have been part of the transaction for December delivery of Vintage 2017 Ontario allowances. The futures contract is a newly-listed product on the Intercontinental Exchange (http://www.theice.com). The contract traded first at CAD$18.05/allowance. Ontario’s Cap and Trade program kicked off on January 1, 2017, with the first auction of allowances scheduled for March 22, 2017. The program reduces Greenhouse Gas (GHG) emissions by placing a cap on the total amount of GHGs emitted each year. Over time, the cap declines. Emitters in Ontario can respond to the declining cap by reducing their own emissions, or by purchasing allowances from other firms or from projects which are able to reduce emissions more economically. The result is the desired reductions in GHG emissions at the lowest possible cost to Ontario consumers. Futures markets are a critical tool in a successful Cap and Trade program, offering price transparency, providing liquidity, and facilitating investment in emission reduction projects and technologies. This first transaction marks an important milestone in the progression of the Ontario Cap and Trade market. Recently, ClimeCo announced its expansion into Canada and the opening of its ClimeCo Canada, ULC subsidiary. Engagement in the futures market for Ontario allowances is a continuation of ClimeCo’s commitment to Canada and to providing its clients unsurpassable market access, leadership, and experience. “This first trade of Ontario futures is an important milestone in the implementation of the Ontario program”, commented ClimeCo Corporation Senior Vice President Derek Six. “ClimeCo is excited to have been a part of it. At ClimeCo, we seize on every opportunity to take a pioneering role in new environmental markets and programs. This leadership is our obligation to our clients- we believe our clients benefit from our experience.” ClimeCo Corporation is a respected project developer, advisor and trader of environmental commodity market products. Specialized expertise in regional criteria pollutant trading programs, WCI cap-and-trade, voluntary markets, and project development and financing of internal CO2 abatement systems, complement ClimeCo’s diverse commodity portfolio. Within the Climate Action Reserve, ClimeCo is the largest developer of U.S. GHG-offset projects and producer of U.S. voluntary carbon offsets, managing projects that reduce more than four million tonnes of CO2e per year. For information, contact 484-415-0501 or mfinneran(at)climeco(dot)com.


Conference call scheduled for 8:30 a.m. ET today NEW YORK, Feb. 23, 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 reported financial results for the three months and full year ended December 31, 2016 and provided other general business updates. “2016 was a truly momentous year for Intercept, marked by the U.S. and European approvals of Ocaliva for the treatment of primary biliary cholangitis (PBC),” said Mark Pruzanski, M.D., President and CEO of Intercept. “We successfully transitioned to a commercial organization with our U.S. launch for PBC in June 2016 that generated net sales of $18.2 million for the year, while making solid progress in our clinical development programs.” “We believe 2017 has the potential to be another transformative year for Intercept," added Dr. Pruzanski. "We are dedicated to bringing Ocaliva to more PBC patients in need, not only in the U.S, but now also internationally. We intend to complete enrollment of the interim analysis cohort in our Phase 3 REGENERATE trial in nonalcoholic steatohepatitis (NASH) patients with fibrosis by mid-2017, an important milestone given our intention to seek regulatory approval based on its results. In addition, we plan to report data for two placebo-controlled Phase 2 trials of OCA, one designed to advance our understanding of OCA’s lipid effects in NASH patients taking statins and the second to evaluate OCA in patients with primary sclerosing cholangitis, a devastating cholestatic liver disease with no approved treatment options. Finally, we will be initiating a Phase 2 trial of our second product candidate, INT-767, in NASH patients with fibrosis.” Net U.S. Ocaliva sales were $18.2 million for the full year 2016, and $13.4 million for the fourth quarter. Ocaliva was approved by the U.S. Food and Drug Administration (FDA) in May 2016 for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Intercept commercially launched Ocaliva in the United States in June 2016 and in conjunction launched Interconnect®, a comprehensive, personalized program that connects patients with dedicated care coordinators who help them understand their disease and provides treatment support and, for eligible patients, financial assistance options. Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. We commenced our European commercial launch in January 2017. Intercept announced today that Jerry Durso has been appointed as Chief Operating Officer. “We are very excited to welcome Jerry as our new COO,” said Dr. Pruzanski. “This is a role that will augment our capabilities in managing the increasing complexity of our business as we continue to grow in size and geography, and broaden our commercial horizons beyond PBC with a view to NASH and other indications.” Mr. Durso brings nearly 25 years of experience in building and leading commercial and business operations at life sciences companies both in the United States and abroad.  Mr. Durso has spent the majority of his career at Sanofi, a global pharmaceutical company, where he most recently served as senior vice president, chief commercial officer of the global diabetes division from 2011 through 2015. From 2010 to 2011, Mr. Durso was senior vice president, chief commercial officer of Sanofi’s U.S. pharmaceuticals business. Prior to that, he served in a number of commercial leadership roles of increasing responsibility in business unit and brand management, marketing and sales since he first joined Sanofi in 1993.  Mr. Durso currently serves as an advisory board member of the Robert Wood Johnson University Hospital Somerset in Somerville, New Jersey. For the full year ended December 31, 2016, Intercept reported a net loss of $412.8 million. GAAP operating expense for the year ended December 31, 2016 was $427.5 million. Non-GAAP adjusted operating expense1 for the full year ended December 31, 2016 was $332.5 million, which excludes a one-time net expense of $45 million for the settlement of a purported class action lawsuit, non-cash stock-based compensation expense of $46.2 million and depreciation expense of $3.8 million. Intercept recognized $18.2 million of net sales of Ocaliva for the full year 2016. Intercept currently recognizes revenue using the sell-through method (i.e., when its specialty pharmacies dispense Ocaliva to patients, not when products are sold to the specialty pharmacies). Revenue recognition will transition from the sell-through method to the sell-in method once a sufficient period of commercial experience has occurred to enable Intercept to estimate product returns. Intercept recognized $6.8 million and $2.8 million of license revenue related to the amortization of the up-front and milestone payments under the collaboration agreement with Sumitomo Dainippon for the year ended December 31, 2016 and 2015, respectively. Costs of goods sold (COGS) was negligible for 2016. Prior to the FDA approval of Ocaliva, Intercept had expensed costs related to the manufacturing and buildup of commercial launch supplies of OCA. Therefore, COGS was only reflective of packaging and labeling costs incurred during the period. Intercept expects COGS to remain negligible until previously expensed supplies of OCA are sold. Selling, general and administrative expenses increased to $273.6 million for the full year ended December 31, 2016, up from $119.2 million for the full year ended December 31, 2015. The increase over the prior period was driven by the U.S. commercial launch of Ocaliva in PBC, along with increased international infrastructure and pre-commercial activities to support the anticipated launch of Ocaliva in PBC outside the United States. Research and development expenses increased to $153.9 million for the full year ended December 31, 2016, up from $112.7 million for the full year ended December 31, 2015. The increase over the prior period was primarily driven by increases in clinical development programs for OCA and infrastructure to support such programs. Interest expense for the full year ended December 31, 2016 was $14.2 million, due to the issuance of the 3.25% convertible senior notes due 2023 (convertible notes) in July 2016. Intercept recognized $13.4 million of net sales of Ocaliva for the three months ended December 31, 2016. Intercept reported a net loss of $120.0 million for the three months ended December 31, 2016, compared to a net loss of $88.3 million for the three months ended December 31, 2015. The net loss included $19.2 million and $12.2 million of non-cash stock-based compensation expenses for the three months ended December 31, 2016 and 2015, respectively. As of December 31, 2016, Intercept had cash, cash equivalents and investment securities available for sale of approximately $689.4 million, compared to $628.1 million as of December 31, 2015. In July 2016, Intercept completed an underwritten public offering of convertible notes. After deducting the underwriting discount and offering expenses, net proceeds from the convertible notes offering were approximately $447.7 million. Approximately $38.4 million of the net proceeds from the offering were used to fund the payment of the cost of capped call transactions entered into in connection with the issuance of the convertible notes. Intercept projects non-GAAP adjusted operating expenses of $380 million to $420 million for the fiscal year ending December 31, 2017. This guidance excludes non-cash items such as stock-based compensation and depreciation. These expenses are planned to support the continued commercialization of Ocaliva in PBC in the United States and other markets, continued clinical development for OCA in PBC and NASH and the continued development of INT-767 and other pipeline programs. Intercept anticipates that stock-based compensation expense will represent the most significant non- cash item that will be excluded in adjusted operating expenses as compared to operating expenses under GAAP. Adjusted operating expense is a financial measure not calculated in accordance with GAAP. A reconciliation of projected operating expense calculated in accordance with GAAP to non- GAAP adjusted operating expense is not available on a forward-looking basis without unreasonable effort due to an inability to make accurate projections and estimates related to certain information needed to calculate, for example, future stock-based compensation expense. Conference Call on February 23rd at 8:30 a.m. ET Intercept will hold its 2016 full year financial results conference call and webcast on Thursday, February 23rd at 8:30 a.m. ET. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) five minutes prior to the start time (no passcode is required). A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks. Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive 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. This press release presents adjusted operating expense, which is a non-GAAP measure, both on a historical and projected basis. Adjusted operating expense should be considered in addition to, but not as a substitute for, operating expense that Intercept prepares and announces in accordance with GAAP. Intercept excludes certain items from adjusted operating expense, such as stock-based compensation and depreciation, that management does not believe affect Intercept's basic operations and that do not meet the GAAP definition of unusual or nonrecurring items. For the year ended December 31, 2016, adjusted operating expense also excludes the one-time $45 million net expense for the settlement of the purported class action lawsuit. A table reconciling historical GAAP operating expense to non-GAAP adjusted operating expense is included below under the heading "Reconciliation of GAAP to Non-GAAP Operating Expense." A reconciliation of projected operating expense calculated in accordance with GAAP to non-GAAP adjusted operating expense is not available on a forward-looking basis without unreasonable effort due to an inability to make accurate projections and estimates related to certain information needed to calculate, for example, future stock-based compensation expense. Management also uses adjusted operating expense to establish budgets and operational goals and to manage Intercept's business. Other companies may define this measure in different ways. Intercept believes this presentation provides investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. Ocaliva is indicated in the United States 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. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP), as a surrogate endpoint which is reasonably likely to predict clinical benefit, including an improvement in liver transplant free-survival. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Intercept is currently enrolling COBALT, a Phase 4 clinical outcomes trial of Ocaliva in patients with PBC with the goal of confirming clinical benefit on a post-marketing basis. In December 2016, Ocaliva received conditional marketing authorization in Europe for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, conditional to the company providing further data post-approval to confirm benefit. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics that can be found on www.ema.europa.eu. 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, 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. In a pooled analysis of three placebo-controlled trials in patients with PBC, the exposure-adjusted incidence rates for all serious and otherwise clinically significant liver-related adverse reactions, and isolated elevations in liver biochemical tests, per 100 patient exposure years (PEY) were: 5.2 in the Ocaliva 10 mg group (highest recommended dosage), 19.8 in the Ocaliva 25 mg group (2.5 times the highest recommended dosage) and 54.5 in the Ocaliva 50 mg group (5 times the highest recommended dosage) compared to 2.4 in the placebo group. 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. The maximum recommended dosage of Ocaliva is 10 mg once daily. Adjust the dosage for patients with moderate or severe hepatic impairment. 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 in the POISE trial, a 12-month double- blind randomized controlled trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. In the subgroup of patients in the Ocaliva titration arm who increased their dosage from 5 mg once daily to 10 mg once daily after 6 months of treatment (n=33), the incidence of severe pruritus was 0% from months 0 to 6 and 15% from months 6 to 12. The median time to onset of severe pruritus was 11, 158 and 75 days for patients in the Ocaliva 10 mg, Ocaliva titration and placebo arms, respectively. Management strategies include the addition of bile acid resins or antihistamines, Ocaliva dosage reduction and/or temporary interruption of Ocaliva dosing. Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high density lipoprotein-cholesterol (HDLC). In the POISE trial, dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in Ocaliva-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. At month 12, the reduction from baseline in mean HDL-C level was 19% in the Ocaliva 10 mg arm, 12% in the Ocaliva titration arm and 2% in the placebo arm. Nine patients in the Ocaliva 10 mg arm and six patients in the Ocaliva titration arm, versus three patients in the placebo arm had reductions in HDL-C to less than 40 mg/dL. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to Ocaliva after one year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. The most common adverse reactions from subjects taking Ocaliva (≥5%) were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema. Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol or colesevelam absorb and reduce bile acid absorption and may reduce the absorption, systemic exposure and efficacy of Ocaliva. If taking bile acid binding resins, take Ocaliva at least 4 hours before or 4 hours after (or at as great an interval as possible) taking a bile acid binding resin. Please see the U.S. Full Prescribing Information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets. 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 Intercept’s financial position, including expected adjusted operating expenses; the activities anticipated to be undertaken by Intercept, including the anticipated progression of the U.S. and EU launches of Ocaliva® in PBC; the potential approval of OCA in PBC by regulatory bodies outside of the United States and the European Union and the timelines related thereto; the timelines for access to OCA for the treatment of PBC in Europe and other jurisdictions outside the United States and timelines related thereto; the initiation, enrollment, conduct and completion of clinical trials and the timelines related thereto, including the full enrollment of the interim analysis cohort for the Phase 3 REGENERATE trial of OCA in NASH patients with liver fibrosis; the anticipated regulatory process and timetable with respect to Intercept’s product candidates; the continued development of OCA and Intercept's other product candidates; and Intercept's 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, including Intercept's development program in NASH; 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 OCA in indications other than PBC and its other 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 that it may receive for its products from payors; the success of competing drugs that are or become available; 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; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; Intercept's use of cash, short-term investments and the proceeds from the offering; 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, 2015 filed on February 29, 2016 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. 1 Adjusted operating expense, as presented above and elsewhere in this press release, is a non-GAAP financial measure. Adjusted operating expense excludes stock-based compensation and other non-cash items from GAAP operating expenses. For the year ended December 31, 2016, adjusted operating expense also excludes the one-time $45 million net expense for the settlement of the purported class action lawsuit. A table reconciling historical adjusted operating expense to GAAP operating expense is included below under the heading "Reconciliation of GAAP to Non-GAAP Operating Expense."


First new medication for primary biliary cholangitis in nearly 20 years Rapid NICE approval only two months after marketing authorization in the EU; one of the fastest approvals to date for an orphan medicine NEW YORK, March 02, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that the National Institute for Health and Care Excellence (NICE) has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland. Ocaliva has been conditionally approved in the European Union 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. The NHS is expected to make Ocaliva available to patients with PBC within 90 days of NICE’s final appraisal publication and Intercept will work with local reimbursement authorities to help ensure eligible patients obtain access. Although it is a rare disease, PBC is a leading cause of liver transplantation in adult women in the UK. Ocaliva is a new treatment option for patients with PBC who do not fully respond to, or are intolerant to, current treatment and remain at risk of their disease progressing toward cirrhosis, liver transplantation or death. “I am excited to see that the substantial group of PBC patients who are not achieving treatment goals with UDCA alone or who cannot tolerate UDCA will soon be able to access the first new therapeutic option in nearly 20 years. This truly is good news for our PBC patients,” said David Jones, M.D., Ph.D., Professor of Liver Immunology at Newcastle University and Consultant Hepatologist at Newcastle upon Tyne Hospitals Trust, which hosts one of Europe's leading clinical services in the disease. “The development of new treatments for PBC is a powerful example of the medical innovation that can occur when government, industry, academia, community clinicians and, most importantly, patients come together to address an unmet need.” Ocaliva is a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at high levels in the liver and intestine and thought to be a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. In December 2016, Ocaliva received conditional marketing authorization in Europe based on efficacy and safety data derived from three randomized double-blind, placebo-controlled clinical trials evaluating the effect of Ocaliva on alkaline phosphatase (ALP) and bilirubin in patients with PBC. The marketing authorization was also supported by two clinical databases that include more than 10,000 patients from the Global PBC Study Group and UK-PBC Group, both independently confirming that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival. The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). Adverse reactions leading to discontinuation were 1% in the Ocaliva titration arm and 11% in the Ocaliva 10 mg arm. The most common adverse reaction leading to discontinuation was pruritus. The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing. “This very rapid decision by NICE, one of the fastest approvals to date for an orphan medication, is an important affirmation of the scientific innovation, clinical value and cost-effectiveness of Ocaliva by one of the most respected health technology assessment bodies,” said Lisa Bright, Intercept’s President, International. “We welcome NICE’s decision to provide broad access to Ocaliva and we owe a tremendous debt to people living with PBC and the clinical groups who helped us to achieve this milestone for the PBC community.” “It is exciting news for PBC patients that this new treatment option will now be routinely available in England, Wales and Northern Ireland,” said Collette Thain MBE, CEO of The PBC Foundation. “When I was diagnosed with PBC, UDCA was the only approved treatment option and PBC wasn’t a major priority for many researchers. Thankfully, so much has changed for people living with PBC since then. After decades of advocacy from the PBC community, we have a new treatment option, a growing awareness of the disease among the general public, greater expertise amongst clinicians and an acceleration of PBC research in the UK and around the globe.” 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. The estimated prevalence of PBC in the UK is approximately 3.9 per 10,000 population, equating to approximately 19,175 people in England. Patients and medical leaders in the UK have played a critical role in accelerating PBC research, innovation and awareness globally. The patient community in the UK has guided Intercept’s efforts to improve PBC education and understand the unmet needs of patients and their families. The UK-PBC Study Group, a research consortium funded by the UK government through the Medical Research Council and National Institute for Health Research, played a critical role in the development of Ocaliva and was one of two clinical databases to independently confirm that achieving lower ALP and/or bilirubin levels is significantly correlated with increased transplant-free survival. Ocaliva (obeticholic acid) is a potent and highly selective 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. In December 2016, Ocaliva received conditional marketing authorization in Europe for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, conditional to the company providing further data post-approval to confirm benefit. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC. For full prescribing information in the U.S., visit Ocaliva.com. Hypersensitivity to the active substance or to any of the excipients and complete biliary obstruction. Elevations in alanine amino transferase (ALT) and aspartate aminotransferase (AST) have been observed in patients taking obeticholic acid. Clinical signs and symptoms of hepatic decompensation have also been observed. These events have occurred as early as within the first month of treatment. Liver-related adverse events have primarily been observed at doses higher than the maximum recommended dose of 10 mg once daily. Patients should be monitored during treatment with Ocaliva for elevations in liver biochemical tests and for the development of liver-related adverse events. Dosage adjustments are needed for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. Severe pruritus was reported in 23% of patients treated with Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm and 7% of patients in the placebo arms. The median time to onset of severe pruritus was 11, 158 and 75 days for patients in the Ocaliva 10 mg, Ocaliva titration and placebo arms, respectively. Management strategies include the addition of bile acid binding resins or antihistamines, dose reduction, reduced dosing frequency and/or temporary dose interruption. The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%). Other common adverse reactions observed in clinical trials (> 5%) were abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema. Bile acid binding resins such as cholestyramine, colestipol or colesevelam adsorb and reduce bile acid absorption and may reduce efficacy of obeticholic acid. When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible. For detailed safety information for Ocaliva (obeticholic acid) 5 mg and 10 mg tablets including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics. 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. 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 Ocaliva® (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, the continued development of OCA and Intercept's other product candidates, 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, including Intercept's development program in NASH; 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 OCA in indications other than PBC and its other 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 that it may receive for its products from payors; the success of competing drugs that are or become available; 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; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; Intercept's use of cash, short-term investments and the proceeds from the offering; 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 | February 27, 2017
Site: www.businesswire.com

DAVENPORT, Iowa--(BUSINESS WIRE)--Following a 10-month review, the Iowa Utilities Board (IUB) today issued an order adjusting rates for Iowa American Water. Iowa American Water’s investment of approximately $38 million in water system improvements is the primary driver behind the rate change request. In its final rate order, the IUB approved an overall increase in additional annual revenue of $3.9 million or 10.37 percent. This final order amount includes the previous temporary rate increase of $2.1 million that was implemented by Iowa American Water on May 9, 2016 as allowed by Iowa Code § 476.6(9). Company officials say those additional revenues will help Iowa American Water continue to invest proactively in its water infrastructure throughout the state. Iowa American Water last received a rate change order from the IUB in 2014. “ Reliable water service is essential to everyday life and a community’s strong economy, and proactive water system upgrades today save money in the long run,” said Randy Moore, president of Iowa American Water. “ All these investments in local water infrastructure systems enhance water quality, service reliability and fire protection for customers while keeping the cost of water service for most local households at about a penny per gallon.” The need to upgrade water systems is a national challenge. In 2013, the American Society of Civil Engineers said that an estimated $1 trillion in capital spending would be needed across the nation over 25 years to replace thousands of miles of pipe, upgrade treatment plants and comply with stricter water quality standards. Iowa American Water is addressing this challenge. Iowa American Water’s rates are based on the costs of providing water service as reviewed and approved by the IUB. Moore added that Iowa American Water has worked to control costs, reducing operating expenses by about 10 percent or $1.7 million since the last rate order. The next step in the process will be for Iowa American Water to prepare and file a rate design for approval by the IUB that breaks down the allowed increase between the company’s various customer classifications. An effective date for the new rates will be established once the IUB approves the company’s rate design. On April 29, 2016, Iowa American Water filed a proposal with the IUB requesting to increase its annual revenue by $5.15 million. Effective May 9, 2016, Iowa American Water implemented an interim rate increase as part of its rate increase application as allowed under state regulations. The interim increase allowed Iowa American to begin collecting a portion of its rate increase while the IUB and Office of Consumer Advocate (“OCA”) reviewed the full filing. The interim rates generated about $2.1 million in additional annual revenue and represent a $2.33 per month increase for the average residential customer. “ As a utility whose services are critical to ensuring public health, we take our responsibility to provide quality drinking water seriously, and as such, are committed to keeping our systems and facilities well maintained,” added Moore. Customers needing assistance paying their water bills can contact Community Action of Eastern Iowa to apply for help from Iowa American Water’s Project H2O “Help to Others” program. Community Action of Eastern Iowa administers this program, and customers needing assistance are urged to contact their local office in either Clinton or Davenport. Customers can contact American Water's Call Service Center toll free at 1-866-641-2108 with additional questions. Additional information can also be found on the Iowa Utilities Board’s website at www.state.ia.us/iub/. Iowa American Water, a subsidiary of American Water (NYSE: AWK), is the largest investor-owned water utility in the state, providing high-quality and reliable water services to approximately 212,000 people. With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly-traded water and wastewater utility company. The company employs more than 6,700 dedicated professionals who provide regulated and market-based drinking water, wastewater and other related services to an estimated 15 million people in 47 states and Ontario, Canada. More information can be found by visiting www.amwater.com.


News Article | February 20, 2017
Site: co.newswire.com

The Owners’ Counsel of America (OCA), a nationwide network of leading eminent domain attorneys, is pleased to announce the recent election of two accomplished condemnation lawyers to serve on its Board of Directors.  Randall A. Smith, founder and managing partner of Smith & Fawer, LLC in New Orleans, Louisiana and Michael F. Faherty, founder and managing partner of Faherty Law Firm in Hershey, Pennsylvania will each serve a three-year term . A veteran trial attorney, Randall A. Smith has successfully litigated a variety of civil, commercial and criminal matters, since graduating from Yale Law School in 1982.  His practice focuses primarily on business and property litigation, including takings and eminent domain litigation representing hundreds of private property owners throughout Louisiana.  Having obtained numerous multi-million dollar judgments, as well as successfully defended against many multi-million dollar claims, Randy has earned a reputation as an assertive, creative, and focused trial counsel.  In addition to his practice, Mr. Smith has served as an Adjunct Professor of Law at Loyola University’s School of Law.  He is also invited to lecture at legal and business seminars locally and nationally, often speaking on the law of eminent domain. Committed to his hometown of New Orleans, Mr. Smith has worked tirelessly for the betterment and improvement of the City, particularly in the area of the arts. Among many Boards he has served on, Mr. Smith was President of the Canal Street Development Corporation (“CSDC”), a public benefit corporation dedicated to the revitalization of Canal Street, for over a decade. His leadership with the CSDC was instrumental in reopening the Saenger Theater following Hurricane Katrina. A Pennsylvania native, Michael F. Faherty, advocates for private property rights providing condemnation counsel exclusively to Pennsylvania property owners. Throughout his more than 25 years of practice, Mike has amassed a wealth of experience in eminent domain law litigating cases across Pennsylvania. He represents landowners threatened by government and private agencies using eminent domain power to acquire private property for projects such as pipelines, roads, power lines, airports and other public uses. In the last several years, Mike has defended the rights of numerous Pennsylvania property owners in condemnation proceedings for the Sunoco Logistics Mariner East 1 and East 2 Pipelines.  He has also represented private landowners, businesses and special purpose property owners against the Pennsylvania Department of Transportation and the Pennsylvania Turnpike Commission. A frequent author and lecturer, Mike has spoken on issues relating to Marcellus shale property rights and pipeline easements before the Pennsylvania Farm Bureau, the Pennsylvania State Association of Township Supervisors and various civic and business groups. He is the recent author of the Eminent Domain Litigation chapter of the Pennsylvania Real Estate Litigation Guide.  He is a contributing author to the Landowner’s Guide to Pipelines, a publication of the Pipeline Safety Trust, and serves on the Eminent Domain Committee of the Real Property, Probate & Trust Section of the Pennsylvania Bar Association.  Mike is also a former employee of the Boy Scouts of America and provides pro bono services to the Scouts. “OCA’s Board of Directors includes highly skilled and effective attorneys from across the country and represents truly extraordinary talent, experience and passion,” remarked Andrew Brigham, OCA President and Board Member.   “I look forward to working with Randy, Mike and the entire Board to advance OCA’s goals and provide assistance to landowners threatened by eminent domain litigation and the loss of property rights nationwide.” The Owners’ Counsel of America (OCA) is a nationwide network of eminent domain attorneys dedicated to protecting the rights of private property owners large and small, locally and nationally, and to advancing the cause of property rights.  The lawyers affiliated with OCA are in private practice in nearly every state and represent individual owners against federal, state, and local governments, utilities, redevelopment authorities and other entities armed with eminent domain power.  For more information or to locate an eminent domain lawyer in your state, please visit www.ownerscounsel.com.


Prologue rappelle qu'est tenu à jour sur son site internet un tableau récapitulatif des OCA, des BSA et du nombre d'actions en circulation. Les termes et conditions des OCA et des BSA tels que modifiés par l'avenant conclu ce jour sont également disponibles sur le site internet de Prologue. A propos de Prologue Prologue est un groupe international spécialisé dans les logiciels, les services IT et la formation professionnelle. Le groupe a développé des offres à forte valeur ajoutée dans les domaines des télécommunications (téléphonie VoIP, SMS, fax, courriel, image, vidéo, etc.), du multimédia (plateforme collaborative Adiict), de la dématérialisation de transactions et des échanges d'information (EDI, facture fiscale, opérations bancaires, administration, santé, taxes, etc.), et du Cloud Computing. Le groupe est présent en France, en Espagne, en Pologne, aux Etats-Unis et en Amérique Latine. Les technologies du groupe sont utilisées par des entreprises prestigieuses en France et à l'étranger comme : Generali, Société Générale, Orange, SFR, LVMH, Vilmorin, Immobilière 3F, MASSA Autopneu, J.C. Decaux, Facom, Telefonica, REALE Assurances, Toyota, Adecco, TINSA, Inter-parfums, NEXITY, Jones Lang Lasalle, AENA, ATOS, EMC, Blédina, Siemens, Liebherr Aerospace, Eurocopter, Kone, Uponor, Cadyssa / Bodybel.


News Article | February 28, 2017
Site: www.prweb.com

Moving Analytics, a company focused on digital solutions for patient rehab programs, announced Monday the close of an investment from OCA Ventures, a leading venture capital firm based in Chicago. Moving Analytics helps hospitals increase enrollment and completion rates in their cardiac rehab programs through a technology-enabled, home-based programs. The San Francisco-based company will use the capital to further expand its sales and marketing efforts and expand into its existing customer locations. "We are excited to partner with OCA Ventures to add further value to our customers," said Moving Analytics CEO and Founder Harsh Vathsangam. "Having them on our team will help us focus on our mission to make cardiac rehab, and more generally - post-acute care, universally accessible." Moving Analytics’ product is based on MULTIFIT, an evidence-based cardiac rehab program developed by world-renowned researchers at Stanford University. The program has been validated on over 70,000 patients and is widely considered the best-in-class program for post-acute heart care. “We are delighted to participate in this round of financing for Moving Analytics.” said Bob Saunders, General Partner of OCA Ventures. “What excites us about this investment is the deep expertise behind the team and strong evidence base behind their solution. At the same time, their technology platform provides a highly scalable pathway of delivering rehab.” Using Moving Analytics’ solution, a care manager can generate an individualized care plan for the patient and send this plan to his or her smartphone. At home, the app guides the patient through a series of supervised exercises, delivers educational content and provides an easy to use interface to track vital signs and chat with his or her provider. The app also analyzes patient behaviors and alerts the care manager if any issues should arise. The care manager coaches the patients in weekly phone-based sessions and modifies their treatment plan based on new symptoms and progress. OCA Ventures joins a team of existing investors in Moving Analytics, including Launchpad Digital Health, a digital health investment firm and accelerator based in San Francisco, CA, and HealthX ventures, a seed-stage venture capital fund based in Madison, WI. Moving Analytics is currently being used in several hospitals across the country including NYU Langone Medical Center, New York, Our Lady of Lourdes, New Jersey and the Atlanta Veterans Affairs Medical Center, Georgia. About Moving Analytics Moving Analytics is a digital health company based in San Francisco, CA. Moving Analytics’ first product, Movn, helps hospitals implement virtual cardiac rehab programs. Movn provides a turnkey program that includes evidence-based clinical protocols, online case management system, mobile application for patients and implementation support. They are working with 10 leading hospitals across the United States including Our Lady of Lourdes Medical Center, NYU Langone Medical Center and Keck School of Medicine. About OCA Ventures OCA Ventures is an early stage (Seed, Series A, and Series B) venture capital firm focused on equity investments in companies with dramatic growth potential, primarily in technology and highly-scalable services businesses. OCA invests in many industries, with a preference for technology, financial services, education and healthcare technology. Founded in 1999, the firm is investing out of its fourth fund in companies spread throughout the United States.


L'exercice 2017 devrait correspondre à une étape décisive dans la stratégie de développement du Groupe. Après seulement deux mois, Delta Drone a finalisé deux opérations de croissance externe très structurantes (Rocketmine en Afrique du Sud puis Techni Drone en France) qui contribueront cette année de manière significative au chiffre d'affaires consolidé. En termes de croissance organique, le développement de l'activité inspections d'antennes avec Orange, la poursuite du projet d'inventaire en entrepôts développé avec Géodis, le démarrage de la campagne Farmstar en partenariat avec Airbus DS et Arvalis, et le référencement gagné chez Eurovia sont autant de sources d'accroissement sensible du chiffre d'affaires. C'est dans ce contexte que Delta Drone annonce l'exercice le 24 février 2017 par la société YA II CD Ltd de cinq cents (500) bons d'émission (« BEOCABSA ») d'obligations convertibles en actions (« OCA ») assorties de bons de souscription d'actions (« BSA ») (les OCA et BSA ensemble, les « OCABSA »), entrainant la souscription le 24 février 2017 par la société YA II CD Ltd de cinq cents (500) OCABSA de ce contrat, correspondant à l'émission de 500 OCA d'une valeur nominale de 10 000 euros chacune représentant un emprunt obligataire de 5.000.000 euros assorties de 4.284.490 BSA ayant un prix d'exercice de 1,167 euro. Cette opération s'inscrit dans le cadre du contrat d'émission d'OCABSA signé entre DELTA DRONE et YA II CD Ltd en octobre 2016[i] et entérinée par l'Assemblée générale extraordinaire du 22 décembre 2016[ii]. Le même jour, le Conseil d'administration avait décidé de l'émission de 2.500 BEOCABSA.


Receive press releases from IQ4I Research & Consultancy Pvt. Ltd.: By Email This pipeline analysis gives comprehensive insights on drugs being developed for the treatment of NASH & their various stages of development in 144 slide decks. This pipeline focuses on novel pharmacologic drugs & regenerative medicines covering small molecules, antibodies, stem cell therapies, recombinant proteins and RNA-based therapeutics. Boston, MA, February 24, 2017 --( This report enables Pharmaceutical/Biotech companies, Academic institutes, Individual researchers, Investors, Medical technology companies, Service providers and other associated stake holders to identify and analyze the available licensing/collaborative commercial opportunities in the Non-alcoholic steatohepataitis (NASH) drugs market. The report also provides strategic insights on some of the molecules that are yet to be launched in the next few years. Some of the key sections covered in the report are given below: *Epidemiology -In this section, epidemiology of NASH is reviewed to understand potential significance and impact of the disease. -Global & US prevalence rates. *Hot Targets, Mechanisms & Therapies -In this section, various NASH associated targets, mechanism and upcoming therapies are discussed. Also, covers novel targets in early research for NASH along with disease progression biomarkers associated with NASH (Inflammatory, apoptosis, fibrosis). *Market analysis -In market analysis section, global NASH drugs market is indicated along with the estimated Peak sales ($) of leading clinical stage drugs forecasted from 2019-2025. -Forecasting model for NASH market. -NASH market dynamics -NASH Market and estimated Peak sales of 8 clinical candidates (OCA-Intercept, Aramchol-Galmed, -GR-MD-02-Gilead, Cenicriviroc-Tobira, Simtuzumab-Gilead, Remo Biphasic-Avolynt, IVA 337- Inventiva Pharma, GFT505-Genfit) -NASH related deals analysis with financials (upfront, milestones and royalties) -Funding scenario in NASH market *Pipeline Analysis -Pipeline analysis was carried to get deeper insights on various treatment modalities in discovery, preclinical & development section, pipelines from major companies were identified and Potential targets were reported along with Mechanism of action, Current development status & nature of molecule. Pipeline analysis by developmental stage (Discovery to Clinical development) -Pipeline analysis by modalities --Monoclonal Antibodies pipeline analysis --RNA-therapeutics pipeline analysis --Recombinant protein pipeline analysis -Pipeline analysis by leading players & Target analysis -Drug analysis based on mechanism (Anti-Inflammatory, Anti-fibrotic & Metabolic) *Key Players Analysis -The key player’s analysis section provides an in-depth understanding of various companies working on Nonalcoholic steatohepatitis (NASH) and their Pipelines with development phase as well as understanding partnering strategies such as deals entered by the company. -Global key players overview -Global key players Pipeline data (Discovery, Pre-clinical & Clinical development) -Global key players deals (Collaborations, Licensing, Service agreements, grants, funds) Boston, MA, February 24, 2017 --( PR.com )-- “Non-alcoholic steatohepataitis (NASH) Pipeline Analysis” gives comprehensive insights on the various drugs being developed for the treatment of NASH. The report covers all the drugs that are in various phases of development (Discovery, Preclinical & Clinical). The pipeline focuses on novel pharmacologic drugs & regenerative medicines covering small molecules, antibodies, stem cell therapies, recombinant proteins and RNA-based therapeutics, but excludes symptom relief drugs, generic combinations and supplemental drugs. The report also covers some of the hot targets in research for NASH treatments and NASH related biomarkers.This report enables Pharmaceutical/Biotech companies, Academic institutes, Individual researchers, Investors, Medical technology companies, Service providers and other associated stake holders to identify and analyze the available licensing/collaborative commercial opportunities in the Non-alcoholic steatohepataitis (NASH) drugs market. The report also provides strategic insights on some of the molecules that are yet to be launched in the next few years.Some of the key sections covered in the report are given below:*Epidemiology-In this section, epidemiology of NASH is reviewed to understand potential significance and impact of the disease.-Global & US prevalence rates.*Hot Targets, Mechanisms & Therapies-In this section, various NASH associated targets, mechanism and upcoming therapies are discussed. Also, covers novel targets in early research for NASH along with disease progression biomarkers associated with NASH (Inflammatory, apoptosis, fibrosis).*Market analysis-In market analysis section, global NASH drugs market is indicated along with the estimated Peak sales ($) of leading clinical stage drugs forecasted from 2019-2025.-Forecasting model for NASH market.-NASH market dynamics-NASH Market and estimated Peak sales of 8 clinical candidates (OCA-Intercept, Aramchol-Galmed,-GR-MD-02-Gilead, Cenicriviroc-Tobira, Simtuzumab-Gilead, Remo Biphasic-Avolynt, IVA 337- Inventiva Pharma, GFT505-Genfit)-NASH related deals analysis with financials (upfront, milestones and royalties)-Funding scenario in NASH market*Pipeline Analysis-Pipeline analysis was carried to get deeper insights on various treatment modalities in discovery, preclinical & development section, pipelines from major companies were identified and Potential targets were reported along with Mechanism of action, Current development status & nature of molecule. Pipeline analysis by developmental stage (Discovery to Clinical development)-Pipeline analysis by modalities--Monoclonal Antibodies pipeline analysis--RNA-therapeutics pipeline analysis--Recombinant protein pipeline analysis-Pipeline analysis by leading players & Target analysis-Drug analysis based on mechanism (Anti-Inflammatory, Anti-fibrotic & Metabolic)*Key Players Analysis-The key player’s analysis section provides an in-depth understanding of various companies working on Nonalcoholic steatohepatitis (NASH) and their Pipelines with development phase as well as understanding partnering strategies such as deals entered by the company.-Global key players overview-Global key players Pipeline data (Discovery, Pre-clinical & Clinical development)-Global key players deals (Collaborations, Licensing, Service agreements, grants, funds) Click here to view the list of recent Press Releases from IQ4I Research & Consultancy Pvt. Ltd.

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