News Article | May 25, 2017
Norwich-based Broadland Housing Group is delighted to announce four new appointments to its board. -- Siobhan Trice and Samantha England join as tenant board members, while Chris Ewbank and Dr Simon Hibberd join as independents. All four have been co-opted onto the Board and will face formal election by shareholders at the AGM in September.Chris Ewbank will, subject to election by shareholders, succeed Jenny Manser as Chair in the autumn. Jenny has been interim Chair since last summer, when Alison Inman, who was elected Chair in 2015, had to resign from the Board due to ill health. Jenny is planning to retire from the Board at the 2017 AGM after 9 years of service to the Group.is the Chief Financial Officer/Senior Bursar of St John's College, Cambridge, responsible for the college's £525 million endowment, human resources, strategic planning, governance, regulatory compliance and fundraising. Before joining St John's in 2005, Chris was Chief Operating Officer of Rothschild's Asian Investment banking in Hong Kong, having joined Rothschild in 2000. Previously, he was an investment banker for Schroders in London, Singapore and New York. Chris qualified as a solicitor in 1988 and holds an MBA from INSEAD.worked as GP in Norfolk for almost 30 years, retiring earlier this year. As Senior Partner of his practice, Simon championed collaborative working across local health and social services; established the innovative social enterprise Breckland Care at Home, which provides almost 700 hours of personal care each week; and worked closely with the South Norfolk Clinical Commissioning Group.is a Health and Social Care Assessor for NVQs at Babington Business College, Derby. She has spent most of her career in the field of health and social care, including roles as Service Manager for Leaf Care Services and Training Adviser for the YMCA. She is a member of her local Patient and Participant Group (PPG) and the Independent Advisory Group (IAG) for Norfolk Constabularyis the Business Officer for a local ecological consultancy, responsible for the organisation's general office management and financial reporting. She was previously Business Development Manager for Loddon Equestrian and Adnams plc. She has also worked as a Distillery Tour Guide and Contact Centre Coordinator for Adnams.Michael Newey, Group Chief Executive, commented: "We are delighted to welcome four new members to the Board. They bring with them diverse skills and experience that will further strengthen our governance and strategic planning. Siobhan and Sam will help us maintain our emphasis on ensuring that our services are fit for purpose for our residents; Simon will strengthen our focus on joining up housing with health and social care; while Chris not only brings his considerable chairing skills, but also his understanding and experience of funding markets at a time when we know we have to raise more debt to meet our ambition to grow our housing stock by 3% per annum. The Board and executive are looking forward to working with all four new members over the years ahead."
News Article | May 4, 2017
NORTHBROOK, Ill.--(BUSINESS WIRE)--Global home furnishings retailer Crate and Barrel today announced the appointment of Neela Montgomery as Chief Executive Officer. The former Executive Board Member for Multi-Channel Retail of Crate and Barrel’s shareholder, Hamburg-based Otto Group, will assume the role effective August 1, 2017. The 42-year-old Briton joined the Otto Group in November 2014 and has very successfully led the Otto Group’s Multi-Channel Retail strategy. Serving simultaneously on multiple boards for Otto Group companies, the Chairwoman has guided the outstanding development of the companies she has served; including most notably Crate and Barrel. “Crate and Barrel is a strong brand, a great company and a team of wonderful people,” says Neela Montgomery. "I am looking forward to developing the company further by taking over not only strategic, but now also operational responsibility.” Before joining the Otto Group, Montgomery spent twelve years at Tesco Plc, the world's third-largest retailer, where she held a variety of leadership roles internationally including Chief Merchant for Tesco Malaysia, U.K. E-Commerce Director and U.K. General Merchandise Director on the U.K. Board of Tesco. Montgomery started her career in strategy and marketing consulting both in the U.S. and U.K. She holds a Bachelor's degree from Oxford University and an M.B.A. from INSEAD having studied in France and Singapore. “I respect Neela Montgomery’s decision to lead a company under her responsibility,” shared Dr. Michael Otto, Chairman of the Otto Group Supervisory Board. “Though we will miss her strategic and creative force on the Group Executive Board, Crate and Barrel gains a passionate global leader.” Crate and Barrel is an industry-leading home furnishings retailer known for exclusive designs, excellent value and superb customer service. Working directly with European ateliers and factories, Crate and Barrel was among the first to introduce affordable household goods and contemporary home décor to American consumers. Founded in 1962 and headquartered in Illinois, the brand's essence has translated perfectly to the omnichannel era more than 50 years after opening its first store. The company operates stores throughout the U.S. and Canada as well as international franchise locations across the globe. For more information, visit www.crateandbarrel.com.
News Article | April 28, 2017
Hotheaded, impulsive men who shoot first and ask questions later are a staple of Westerns and 1970s cop films, but new research shows there might be truth to the trope. A study conducted by researchers from Caltech, the Wharton School, Western University, and ZRT Laboratory tested the hypothesis that higher levels of testosterone increase the tendency in men to rely on their intuitive judgments and reduce cognitive reflection--a decision-making process by which a person stops to consider whether their gut reaction to something makes sense. The researchers found that men given doses of testosterone performed more poorly on a test designed to measure cognitive reflection than a group given a placebo. The research will appear in an upcoming issue of the journal Psychological Science. "What we found was the testosterone group was quicker to make snap judgments on brain teasers where your initial guess is usually wrong," says Caltech's Colin Camerer, the Robert Kirby Professor of Behavioral Economics and T&C Chen Center for Social and Decision Neuroscience Leadership Chair. "The testosterone is either inhibiting the process of mentally checking your work or increasing the intuitive feeling that 'I'm definitely right.'" The study, which is one of the largest of its type ever conducted, included 243 males who were randomly selected to receive a dose of testosterone gel or placebo gel before taking a cognitive reflection test. A math task was also given to control for participant engagement, motivation level, and basic math skills. The questions included on the cognitive reflection test are exemplified by the following: A bat and a ball cost $1.10 in total. The bat costs $1 more than the ball. How much does the ball cost? For many people, the first answer that comes to mind is that the ball costs 10 cents, but that's incorrect because then the bat costs only 90 cents more than the ball. The correct answer is that the ball costs 5 cents and the bat costs $1.05. An individual prone to relying on their gut instincts would be more likely to accept their first answer of 10 cents. However, another person might realize their initial error through cognitive reflection and come up with the correct answer. Participants were not limited on time while taking the test and were offered $1 for each correct answer and an additional $2 if they answered all the questions correctly. The results show that the group that received testosterone scored significantly lower than the group that received the placebo, on average answering 20 percent fewer questions correctly. The testosterone group also "gave incorrect answers more quickly, and correct answers more slowly than the placebo group," the authors write. The same effect was not seen in the results of the basic math tests administered to both groups. The results "demonstrate a clear and robust causal effect of [testosterone] on human cognition and decision-making," they conclude. The researchers believe that the phenomenon they've observed can be linked to testosterone's effect of increasing confidence in humans. Testosterone is thought to generally enhance the male drive for social status, and recent studies have shown that confidence enhances status. "We think it works through confidence enhancement. If you're more confident, you'll feel like you're right and will not have enough self-doubt to correct mistakes," Camerer says. Camerer says the results of the study raise questions about potential negative effects of the growing testosterone-replacement therapy industry, which is primarily aimed at reversing the decline in sex drive many middle-aged men experience. "If men want more testosterone to increase sex drive, are there other effects? Do these men become too mentally bold and thinking they know things they don't?" The paper is titled "Single dose testosterone administration impairs cognitive reflection in men." Co-authors are Camerer's former graduate student Gideon Nave (PhD '16), now at the Wharton School of the University of Pennsylvania; Amos Nadler of Western University in Canada; and David Zava of ZRT Laboratory. Funding for the study came from the MacArthur Foundation, Ivey Business School, International Foundation for Research in Experimental Economics, Russell Sage Foundation, USC, INSEAD, and the Stockholm School of Economics.
News Article | April 26, 2017
All six of the most popular employers of elite MBA graduates will be holding sessions for incoming MBA students at the second annual Pre-MBA Networking Festival sponsored by Poets&Quants on May 11-12 in New York City. Google, McKinsey & Co., The Boston Consulting Group, Bain & Co., Deloitte, and Amazon—the top half dozen companies most MBA want to work in—will all hold sessions in their New York offices. They will be among more than 20 world-class sponsors, presenters and world-class MBA employers, including Anheuser-Busch, Accenture Strategy, American Express, A.T. Kearney, CommonBond, Deutsche Bank, General Electric, Goldman Sachs, J.P. Morgan, L’Oréal, Morgan Stanley, and PwC. “This is an extraordinary event, a once-in-a-lifetime opportunity for newly admitted MBA candidates to gain a deep and early understanding of their future career options,” says John A. Byrne, editor-in-chief of PoetsandQuants.com. “The employer sessions give incoming students a headstart in helping to decide what industry and job they would most want to have as an internship and ultimately a full-time position.” The first festival, held last year, was a rousing success, with 100% of the attendees saying in a survey that they would highly recommend the event to others. “Students came away with great contacts that immediately led to summer internships at great companies, including Amazon, JP Morgan Chase and McKinsey,” adds Byrne. “And they were able to get a handle on each of these companies without the pressures or distractions of balancing their school work and social obligations.” Registered attendees as of April 15th include successful MBA applicants to Harvard Business School, the University of Pennsylvania’s Wharton School of Business, the University of Chicago’s Booth School of Business, Northwestern Kellogg School of Management, Columbia Business School, Yale’s School of Management, NYU’s Stern School of Business, INSEAD, London Business School, Dartmouth College’s Tuck School of Business, Cornell’s Graduate Johnson School of Management, Duke University’s Fuqua School of Business, among many other of the world’s leading business schools. Some 10% of the registered attendees will be coming to the event from overseas. The festival opens on the evening of May 11 at New York University’s Stern School of Business, with a panel discussion on MBA careers that will feature Colleen Baum, principal at McKinsey, Marco Caggiano, managing director at JP Morgan’s merger & acquisitions group, Michael Grimstad, regional leader for Amazon Prime Now, Brian Perkins, global vice-president at AbInBev’s Budweiser, and Priyanka “Piya” Nair Newkirk, Vice President of Makeup Marketing at Lancôme, L’Oréal. NYU Stern Dean Peter Henry will welcome attendees to the opening, where students also will hear from a career coach and a comedian. On May 12th, attendees are able to attend five separate company sessions where executives and partners explain what it’s like to work in their companies, what kinds of jobs newly hired MBAs perform, and offer candid advice on how to pursue an opportunity in their companies. The festival ends with a lavish evening reception sponsored by JPMorgan Chase. Attendees can begin to create their custom agenda for the festival on April 27th. Registration for the event closes on April 30. There is still a limited number of seats still available. To register for the event, go to: http://poetsandquants.com/event/2017-poetsquants-premba-networking-festival/ To see a video highlighting last year’s festival, go to: https://youtu.be/2l-qocugQ6c
News Article | May 1, 2017
Men who took high doses of testosterone performed worse on a test designed to measure cognitive reflection—the process in which we stop to consider if our gut reactions are right. “What we found was the testosterone group was quicker to make snap judgments on brain teasers where your initial guess is usually wrong,” says Colin Camerer, professor of behavioral economics and leadership chair of the T&C Chen Center for Social and Decision Neuroscience at the Caltech. “The testosterone is either inhibiting the process of mentally checking your work or increasing the intuitive feeling that ‘I’m definitely right.'” The study, which is one of the largest of its type ever conducted, included 243 men who were randomly selected to receive a dose of testosterone gel or placebo gel before taking a cognitive reflection test. A math task was also given to control for participant engagement, motivation level, and basic math skills. The following question exemplifies those on the cognitive reflection test: “A bat and a ball cost $1.10 in total. The bat costs $1 more than the ball. How much does the ball cost?” For many people, the first answer that comes to mind is that the ball costs 10 cents, but that’s incorrect because then the bat costs only 90 cents more than the ball. The correct answer is that the ball costs 5 cents and the bat costs $1.05. An individual prone to relying on their gut instincts would be more likely to accept their first answer of 10 cents. However, another person might realize their initial error through cognitive reflection and come up with the correct answer. Participants were not limited on time while taking the test and were offered $1 for each correct answer and an additional $2 if they answered all the questions correctly. The results show that the group that received testosterone scored significantly lower than the group that received the placebo, on average answering 20 percent fewer questions correctly. The testosterone group also “gave incorrect answers more quickly, and correct answers more slowly than the placebo group,” the authors write. The same effect was not seen in the results of the basic math tests administered to both groups. The results “demonstrate a clear and robust causal effect of [testosterone] on human cognition and decision-making,” they conclude. The researchers believe that the phenomenon they’ve observed can be linked to testosterone’s effect of increasing confidence in humans. Testosterone is thought to generally enhance the male drive for social status, and recent studies have shown that confidence enhances status. “We think it works through confidence enhancement. If you’re more confident, you’ll feel like you’re right and will not have enough self-doubt to correct mistakes,” Camerer says. Camerer says the results of the study raise questions about potential negative effects of the growing testosterone-replacement therapy industry, which is primarily aimed at reversing the decline in sex drive many middle-aged men experience. “If men want more testosterone to increase sex drive, are there other effects? Do these men become too mentally bold and thinking they know things they don’t?” The research will appear in an upcoming issue of the journal Psychological Science. Coauthors are from the Wharton School of the University of Pennsylvania; Western University in Canada; and ZRT Laboratory. Funding for the study came from the MacArthur Foundation, Ivey Business School, International Foundation for Research in Experimental Economics, Russell Sage Foundation, USC, INSEAD, and the Stockholm School of Economics.
News Article | May 4, 2017
Conference call scheduled for 8:30 a.m. ET today NEW YORK, May 04, 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 ended March 31, 2017 and provided other general business updates. “I’m very pleased with our commercial and development progress thus far in 2017, and look forward to building on the positive momentum as a leader in progressive non-viral liver disease,” said Mark Pruzanski, M.D., President and CEO of Intercept. “In the U.S., we have seen strong execution on our launch plans for Ocaliva, as evidenced by steady quarter over quarter growth. In Europe, we remain focused on market access and are enthusiastic about the rapid reimbursement decision for Ocaliva from the highly regarded UK regulatory body NICE.” “In our NASH program, we achieved a major milestone with the completion of enrollment of our interim analysis cohort in REGENERATE, the first and largest Phase 3 trial in NASH,” added Dr. Pruzanski. “As we look to the middle of the year, we expect to announce top-line data from two additional Phase 2 trials of OCA: CONTROL, assessing combination statin therapy in NASH patients, and AESOP in primary sclerosing cholangitis." Intercept recorded $20.6 million of global net Ocaliva sales in the first quarter of 2017. Net U.S. Ocaliva sales were $19.8 million for the first quarter of 2017. Ocaliva was approved by the U.S. Food and Drug Administration (FDA) in May 2016 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. 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. Net ex-U.S. Ocaliva sales were $0.8 million for the first quarter of 2017. 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 David Ford will be appointed as Chief Human Resources Officer effective May 8, 2017. Mr. Ford brings over 25 years of experience in a variety of Human Resources roles across the United States, Europe, Latin America and New Zealand. Prior to joining Intercept, Mr. Ford spent nearly 15 years at Sanofi where most recently he served as Vice President Human Resources for the Sanofi Genzyme global business unit and, prior to that, Vice President Human Resources for the Sanofi North American businesses. Mr. Ford joined the pharmaceutical industry in 2002 as the HR Director – United Kingdom and Republic of Ireland for Sanofi-Synthelabo. Mr. Ford holds a master’s degree in business administration from INSEAD, Fontainebleau (France). Financial Results for the Three Months Ended March 31, 2017 For the three months ended March 31, 2017, Intercept reported a net loss of $89.9 million. GAAP operating expense for the three months ended March 31, 2017 was $105.0 million. Non-GAAP adjusted operating expense1 for the three months ended March 31, 2017 was $90.1 million, which excludes non-cash stock-based compensation expense of $14.1 million and depreciation expense of $0.8 million. Intercept recognized $20.6 million of net sales of Ocaliva for the first quarter 2017. 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 $0.4 million and $0.4 million of license revenue related to the amortization of the up-front and milestone payments under the collaboration agreement with Sumitomo Dainippon for the three months ended March 31, 2017 and 2016, respectively. Costs of goods sold (COGS) was negligible for the first quarter of 2017. 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 decreased to $61.1 million for the quarter ended March 31, 2017, down from $95.9 million for the quarter ended March 31, 2016. The decrease from the prior period was primarily driven by the one-time net expense of $45.0 million attributable to the settlement of a purported securities class action lawsuit in the quarter ended March 31, 2016, offset by expenses due to an increase in Ocaliva commercialization activities and additional personnel-related costs. Research and development expenses increased to $43.8 million for the quarter ended March 31, 2017, up from $32.0 million for the quarter ended March 31, 2016. 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 quarter ended March 31, 2017 was $7.2 million. The interest expense is related to the 3.25% convertible senior notes due 2023 issued in July 2016. 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. 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." As of March 31, 2017, Intercept had cash, cash equivalents and investment securities available for sale of approximately $608.0 million, compared to $689.4 million as of December 31, 2016. Intercept continues to project 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 May 4th at 8:30 a.m. ET Intercept will hold its first quarter 2017 financial results conference call and webcast on Thursday, May 4th 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 quarter ended March 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, 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 | April 19, 2017
GRAND BAIE, MAURITIUS--(Marketwired - April 19, 2017) - Alphamin Resources Corp. (TSX VENTURE:AFM) ("Alphamin" or the "Company") is pleased to announce that the Alphamin Bisie Mining Project ("the Project") has commenced the construction of the mine box cut and upgrade of the access road following the mobilisation of two earthworks contractors to site, and the appointment of the mining contractor. Alphamin is also pleased to announce the appointment of two experienced directors, Bernard Swanepoel and Paul Baloyi, to the Company's Board. The appointments are subject to regulatory approval. The recent completion of the Front-End Engineering Design (FEED) program and associated Control Budget Estimate (CBE) by DRA Projects (DRA), the engineering, procurement and construction contractor for the project, confirmed the robust economic metrics and potential of the Project, and its development into North Kivu's first commercial mine, and a new premier global tin producing mine. A comprehensive process for estimating capital costs was followed and the CBE results illustrated that the Project has the potential to remain strongly profitable at lower tin prices, as well as at increased prices for key consumables. The completed FEED and CBE increase proven and probable reserves to 4.67 Mt at 3.58% Sn containing 167.3 Kt of tin, while also increasing the life of mine (LoM) to 150 months or 12.5 years. The optimised process flow sheet resulted in 6% higher annual average plant throughput rates, and an increase in tin recoveries to 73%. The borehole drilling to prove the current reserves and provide mine planning has been carried out to a depth of 550 meters below surface and 720 meters down plunge. This results in a current planned life of mine of 12.5 years producing an average of 373,800 tonnes of Rom per annum. The Logistical challenge of locating a deep drilling rig on site restricted the evaluation of the resource to a proven reserve below this Level. The confidence of the drilling to date and the geological model indicates that the resource continues at depth. If this deep drilling is successful, management believes that it should allow for the current life of mine estimate for the Project to be increased. A cash margin of some US$ 11,040 per tonne of tin sold is foreseen, yielding a LoM annual average EBITDA of approximately US$ 110 million (constant 2017 terms), and robust economic performance indicators of a Net Present Value (8%) of US$ 402.2 million, a real, after tax, Project IRR of 49.1%, and a projected payback period of 17 months from first tin production. CONTRACTORS MOBILIZED, EXCAVATION OF BOX CUT AND UPGRADE OF ACCESS ROAD COMMENCED Alphamin has appointed Kongo River SA and VRSC SARL (VRSC) as the Project's earthworks contractors, and Reliant Congo SARL ("Reliant") as the Project's Phase I mining contractor. The appointment of these contractors followed a stringent due diligence process and evaluation of each potential contractor's safety records, submitted schedules, DRC experience, technical capacity and price. VRSC has worked on the construction of both Banro Corporation's mines in South Kivu & Kibali in the North-Eastern corner of the DRC. Reliant operates in the Democratic Republic of Congo and Zambia, and have a strong track record of safety and production. Reliant have worked for Glencore plc (Glencore) in the DRC & and continue to mine for Glencore in Zambia, and Vedanta Resources plc in India. Reliant are in the process of mobilising their equipment to begin developing the decline in early July 2017 in accordance with the project implementation schedule. "It is very encouraging that work has commenced, and subject to finalisation of the full funding solution, the Project is expected to be completed on time, and within budget by the end of Q1 of 2019." says Boris Kamstra, CEO of Alphamin Resources Corp. "Alphamin has appointed three contractors following an extensive tender process and the early works have commenced at the Alphamin Bisie Mining Tin project," explains Kamstra. "A total of 22 heavy earthmoving machines, their operators, management, and support have been deployed for work at the Mpama North site and on the access road. The work on the box cut and the continued upgrading of the 34km access road has already commenced, following the completion of the initial 9km of the access road upgrade to enable the carrying of normal traffic. The access road is expected to be completed by December 2017," states Kamstra. In addition, the return airway has advanced to 97m, and the orebody is expected to be intersected at 120m. The camps and associated infrastructure to house the project implementation team, has been completed. The development of the Project will be a catalyst for regional economic growth. "Alphamin is committed to contributing to the stability and economic activity in North Kivu, bringing significant benefit to the community and other stakeholders alike," says Kamstra. "We are cognisant of the importance of managing and delivering on community expectations. We have been careful in positioning ourselves as a catalyst for change, not as the source or sole reason for change," he says. "We are particularly confident that the recent establishment of the government committee, CAIMB, will help Alphamin in both the development of the project and addressing the communities' concerns". Community development activities are implemented via the Lowa Alliance (a not-for-profit foundation funded by the Company's DRC subsidiary, Alphamin Bisie Mining SA. (ABM) in collaboration with the Walikale local community) and include the recent inauguration of the flagship Luuka Primary School at Logu in February by the North Kivu Minister of Mines and the Deputy Ambassador of South Africa, and the commencement of a further 10 development projects for 2017 out of the 115 envisioned for the first five years of the Bisie Tin Project. Alphamin is also pleased to announce that significant progress has been made towards finalising the funding package for the Project. Funding will include a combination of debt, equity and an equity standby facility. It is anticipated that the total funding package will be finalised within the next four weeks, and further announcements will follow in this regard as appropriate. Bernard Swanepoel and Paul Baloyi, seasoned business executives with significant experience and expertise, have accepted invitations to join the Board of Directors of Alphamin, subject to regulatory approval. Charles Needham, Chairman of Alphamin Resources Corp. expressed his delight at the Board appointments, stating: "We welcome the new board members and look forward to their contribution. The calibre and top level experience of the two gentlemen will stand Alphamin in very good stead. Not only do they enjoy international business clout and respect, but their expertise will add value to the Board as it guides the Alphamin business into a prosperous future." Bernard Swanepoel holds a BscEng (Mining) and BCom (Hons) (FinManagement), and currently serves on the boards of Impala, Zimplats, AREP (a clean energy company), eXtract Limited and African Rainbow Minerals Limited. He is a partner in THINKspiration (a leadership and strategy consultancy), founder of To-The-Point Growth Specialists (active in the junior mining space), Chairman and managing partner of MMC, a privately-owned manganese value added producer, and recently created a R1bn resources investment fund in partnership with eXtract and other investors. He is also the Chairman and co-owner of the annual Joburg Indaba (SA's premier Mining conference), as well as President of the AHi (SA's SME Business Chamber). Bernard has over 30 years experience in local and international mining, and mining project development. He started his career at Gengold, moving to Rand Mines in the mid-nineties, where he remained as CEO of Harmony Gold Mining Company Limited until 2007. Paul Baloyi, the Industrial Development Corporation's representative on the Company's Board, holds an MBA (University of Bangor Manchester), MDP, AMP (INSEAD) and SEP (Harvard), and currently serves on the Boards of Old Mutual South Africa, Basil Read Limited (Chairman), Bidcorp Limited, ENX Group Limited amongst others. Paul has over 35 years of experience in the international finance sector, having served as Chief Executive Officer of the Development Bank of Southern Africa (including the DBSA Development Fund), Managing Director of Nedbank Africa, and holding senior positions within Standard Bank. He is a past member of the Institute of Bankers and the Institute of Directors. Paul Baloyi commented on his appointment to the Alphamin Board "I am very very pleased and excited for the opportunity to join the best team assembled on what is increasingly proving the be great project . I am looking forward to adding value on the development of the mine." Alphamin is a tin exploration and development company with the vision to be respected in the international tin sector by unleashing the full profit and potential of its world-class tin asset in North Kivu, DRC currently under development. Alphamin has the vision to become a premier tin producer by: Information in this news release that is not a statement of historical fact constitutes forward-looking information. Forward-looking statements contained herein include, without limitation, statements relating to costs of production, success of mining operations, the ranking of the project in terms of cash cost and production, economic return estimates, social, community and environmental impacts, and continued positive discussions and relationships with local communities and stakeholders. Forward-looking statements are based on assumptions management believes to be reasonable at the time such statements are made. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Although Alphamin has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Factors that may cause actual results to differ materially from expected results described in forward-looking statements include, but are not limited to: Alphamin's ability to secure sufficient financing to advance and complete the Bisie Tin Project, uncertainties associated with Alphamin's resource and reserve estimates, uncertainties regarding global supply and demand for tin and market and sales prices, uncertainties associated with securing off-take agreements and customer contracts, uncertainties with respect to social, community and environmental impacts, adverse political events, uncertainties with respect to optimization opportunities for the Bisie Tin Project, as well as those risk factors set out in the Company's Management Discussion and Analysis and other disclosure documents available under the Company's profile at www.sedar.com. Forward-looking statements contained herein are made as of the date of this news release and Alphamin disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise, except as required by applicable securities laws."