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News Article | May 9, 2017
Site: www.businesswire.com

EVANSVILLE, Ind.--(BUSINESS WIRE)--OneMain Holdings, Inc. (NYSE: OMF) (“OMH”) announced today that its indirect, wholly owned subsidiary Springleaf Finance Corporation (“SFC”) is proposing to offer up to $400 million aggregate principal amount of senior notes due 2022 (the “notes”), subject to market and other conditions. The notes will be guaranteed on an unsecured basis by OMH (the “guarantee”). There can be no assurance that the offering of the notes will be consummated. SFC intends to use the net proceeds from the offering for general corporate purposes, which may include debt repurchases and repayments. The offering is being made only by means of a prospectus supplement and accompanying base prospectus. OMH and SFC have filed a registration statement (including a base prospectus) and a preliminary prospectus supplement with the U.S. Securities and Exchange Commission (“SEC”) for the offering to which this communication relates and will file a final prospectus supplement relating to the offering. Prospective investors should read the prospectus supplement and base prospectus in that registration statement and other documents OMH and SFC have filed or will file with the SEC for more complete information about OMH and SFC and this offering. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying base prospectus for the offering may be obtained by contacting Barclays Capital Inc. at Barclays Capital Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (toll-free) at (888) 603-5847 or by e-mail at barclaysprospectus@broadridge.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities being offered have not been approved or disapproved by any regulatory authority, nor has any such authority passed upon the accuracy or adequacy of the prospectus supplement or the shelf registration statement or prospectus. OneMain Holdings, Inc. is a leading consumer finance company providing loan products to customers through its nationwide branch network and the internet. The company has a 100-year track record of high quality origination, underwriting and servicing of personal loans, primarily to non-prime consumers. Certain statements in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, OMH’s and SFC’s intention to consummate this offering and issue the notes and the guarantee, OMH’s and SFC’s expectation regarding the aggregate principal amount of notes to be sold and SFC’s intended use of proceeds of the offering. The consummation of the offering is subject to market conditions and other factors that are beyond our control. Accordingly, no assurance can be given that the offering will be completed on the contemplated terms or at all and you should not place undue reliance on any forward-looking statements contained in this press release. For a discussion of some of the risks and important factors that could affect such forward-looking statements, see the sections entitled “Risk Factors” in the prospectus supplement related to the offering, in OMH’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, in OMH’s subsequent Quarterly Report on Form 10-Q, in SFC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, in SFC’s subsequent Quarterly Report on Form 10-Q, and in OMH’s and SFC’s other filings with the SEC. Neither OMH nor SFC undertakes any obligation to release publicly any revisions to forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.


Basel, May 23, 2017 - Further analyses of Novartis' head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro® Breezhaler® consistently provided superior or similar benefits over Seretide®* in COPD patients regardless of the eosinophil count[1]. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts[2]-[5]. The data was published in the centenary issue of the American Thoracic Society's 'Blue Journal'**[1] and solidifies the need for individualized risk-benefit assessments when considering ICS treatments. The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA***/ICS combination over dual bronchodilation (LABA/LAMA****) in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report[6]. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA. The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%[1]. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler[1]. "These new FLAME study analyses provide evidence that an effective dual bronchodilator such as Ultibro Breezhaler can provide similar or better benefits in patients with high eosinophil counts who may have been considered for an inhaled steroid-containing treatment," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "The data highlight the opportunity to allow more patients to avoid unnecessary exposure steroid-containing regimens and the significant potential associated risks." With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here: https://goo.gl/FlSVck About FLAME FLAME is a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries[7]. Results published in the New England Journal of Medicine[7] confirmed that Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg on the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment in COPD patients with a history of at least one exacerbation in the previous year. Against further secondary endpoints, Ultibro Breezhaler was also superior compared to SFC in reducing or improving the following[7]: The pre-specified analyses of data from the FLAME study compared treatment efficacy according to blood eosinophil percentage (<2% and >=2%, <3% and >=3%, and <5% and >=5%) and absolute blood eosinophil count (<=150 cells/ Mu l, 150 to <300 cells/ Mu l, and >=300cells/ Mu l)[1]. FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD About the Novartis COPD portfolio Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura. Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation[8]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[8],[9]. About COPD Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide[10] and is the third leading cause of death[11]. It is progressive (usually gets worse over time) and can be a life-threatening disease[10],[12]. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life[10],[12]. Exacerbations are a sudden worsening of COPD symptoms that can be frightening for patients, causing distress, anxiety and quality of life deterioration[13]. COPD exacerbations are also associated with significant healthcare resource burden and costs[14], particularly due to the frequent need for hospitalization. Consequently, the prevention of exacerbations is an important goal in COPD management to improve long-term health status and conserve healthcare resources[15]. Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "potential," "suggest," "launching," "suggesting," "can," "may," "addressing," "launch," "launched," "aims," "committed," "continues," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Ultibro Breezhaler or the other products in the Novartis COPD Portfolio, or regarding potential future revenues from Ultibro Breezhaler and the other products in the Novartis COPD Portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be commercially successful in the future. In particular, management's expectations regarding Ultibro Breezhaler and the other products in the Novartis COPD Portfolio could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Notes * Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder. Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies ** American Journal of Respiratory and Critical Care Medicine *** Long-acting beta2-adrenergic agonist **** Long-acting muscarinic antagonist About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis For Novartis multimedia content, please visit www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com References [1] Roche N, Chapman K, Vogelmeier C, et al. Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Am J Respir Crit Care Med. 2017;195:9:1125-1127. [2] Pascoe S, et al. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015;3:435-442. [3] Hinds DR, et al. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open 2016;6:e010099. [4] Siddiqui SH, et al. Blood Eosinophils: A Biomarker of Response to Extrafine Beclomethasone/Formoterol in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015; 192:523-525. [5] Pavord ID, et al. Blood eosinophils and inhaled corticosteroid/long-acting ß-2 agonist efficacy in COPD. Thorax 2016; 71:118-125. [6] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 15 May 2017]. [7] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2017]. [8] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26;11:2527-2533. [9] Ultibro Breezhaler EU Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/medicine/29533 [Accessed 16 May 2017]. [10] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 16 May 2017]. [11] World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 16 May 2017]. [12] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 16 May 2017]. [13] Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary disease-a patients' perspective. Prim Care Respir J. 2006;15:2:102-109. [14] Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010;7:214-28. [15] Anzueto A. Impact of exacerbations on COPD. European Respiratory Review. 2010;19:116:113-118.


News Article | May 19, 2017
Site: www.prnewswire.com

The oversubscribed Fund experienced significant demand with support from a diverse range of institutional investors. Eaton Partners, a Stifel Company, served as advisor and exclusive fund placement agent. "We are very pleased to have closed our fourth institutional private equity fund with commitments from new and returning partners," said Mr. Muñoz, Founding Partner of MCH Private Equity. "Spain is the growth engine of Europe and, with over 5,000 middle market companies, there is significant opportunity for experienced private equity investors to add value and take companies to the next level." "The successful raise of MCH Private Equity's fourth fund amid a challenging marketplace in Europe speaks volumes about the experience and strong track record of the firm and the opportunities investors see in Spanish middle-market companies," said Gianluca D'Angelo, Managing Director and Head of Europe at Eaton Partners. Eaton Partners is widely recognized as one of the largest and most experienced global placement agents. Since 1983, the firm has participated in raising over $75 billion of institutional capital across more than 100 highly differentiated alternative investment funds and offerings, including limited partnership interests, general partner interests, co-investments and direct investment opportunities. With over 60 professionals across offices in North America, Europe, and Asia, the firm raises institutional capital for investment managers across a full range of alternative strategies: private equity, private credit, real assets, real estate, and hedge funds/public market strategies.  Partnering with a select number of the highest-quality fund managers, Eaton Partners has represented some of the most innovative funds of the last three decades In January 2016, Eaton Partners became a wholly owned subsidiary and affiliate of Stifel Financial Corp., a leading middle-market investment bank, to further ensure Eaton's success at the highest level of the global placement business. Eaton Partners, LLC, is a registered broker-dealer and a member of FINRA.   It is registered as an Introducing Broker with the Commodity Futures Trading Commission and is a member of the National Futures Association (NFA).  Eaton Partners (UK) LLP is authorized and regulated by the Financial Conduct Authority (FCA).  Eaton Partners Advisors (HK) Limited is approved as a Type 1 License company under the Securities and Futures Commission (SFC) in Hong Kong.  Eaton Partners and the Eaton partners logo are trademarks of Eaton Partners, LLC, a limited liability company ® Eaton Partners, LLC, 2017.  Eaton Partners, LLC is a wholly owned subsidiary and affiliate of Stifel Financial Corp. Stifel Financial Corp. (NYSE: SF) is a financial services holding company headquartered in St. Louis, Missouri, that conducts its banking, securities, and financial services business through several wholly owned subsidiaries. Stifel's broker-dealer clients are served in the United States through Stifel, Nicolaus & Company, Incorporated; Keefe Bruyette & Woods, Inc.; Miller Buckfire & Co., LLC; Century Securities Associates, Inc.; and Eaton Partners, LLC, and in the United Kingdom and Europe through Stifel Nicolaus Europe Limited. The Company's broker-dealer affiliates provide securities brokerage, investment banking, trading, investment advisory, and related financial services to individual investors, professional money managers, businesses, and municipalities. Stifel Bank & Trust offers a full range of consumer and commercial lending solutions. Stifel Trust Company, N.A. and Stifel Trust Company Delaware, N.A. offer trust and related services. To learn more about Stifel, please visit the Company's web site at http://www.stifel.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eaton-partners-serves-as-placement-agent-for-mch-iberian-capital-fund-iv-lp-300460690.html


Basel, May 23, 2017 - Further analyses of Novartis' head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro® Breezhaler® consistently provided superior or similar benefits over Seretide®* in COPD patients regardless of the eosinophil count[1]. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts[2]-[5]. The data was published in the centenary issue of the American Thoracic Society's 'Blue Journal'**[1] and solidifies the need for individualized risk-benefit assessments when considering ICS treatments. The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA***/ICS combination over dual bronchodilation (LABA/LAMA****) in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report[6]. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA. The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%[1]. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler[1]. "These new FLAME study analyses provide evidence that an effective dual bronchodilator such as Ultibro Breezhaler can provide similar or better benefits in patients with high eosinophil counts who may have been considered for an inhaled steroid-containing treatment," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "The data highlight the opportunity to allow more patients to avoid unnecessary exposure steroid-containing regimens and the significant potential associated risks." With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here: https://goo.gl/FlSVck About FLAME FLAME is a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries[7]. Results published in the New England Journal of Medicine[7] confirmed that Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg on the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment in COPD patients with a history of at least one exacerbation in the previous year. Against further secondary endpoints, Ultibro Breezhaler was also superior compared to SFC in reducing or improving the following[7]: The pre-specified analyses of data from the FLAME study compared treatment efficacy according to blood eosinophil percentage (<2% and >=2%, <3% and >=3%, and <5% and >=5%) and absolute blood eosinophil count (<=150 cells/ Mu l, 150 to <300 cells/ Mu l, and >=300cells/ Mu l)[1]. FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD About the Novartis COPD portfolio Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura. Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation[8]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[8],[9]. About COPD Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide[10] and is the third leading cause of death[11]. It is progressive (usually gets worse over time) and can be a life-threatening disease[10],[12]. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life[10],[12]. Exacerbations are a sudden worsening of COPD symptoms that can be frightening for patients, causing distress, anxiety and quality of life deterioration[13]. COPD exacerbations are also associated with significant healthcare resource burden and costs[14], particularly due to the frequent need for hospitalization. Consequently, the prevention of exacerbations is an important goal in COPD management to improve long-term health status and conserve healthcare resources[15]. Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "potential," "suggest," "launching," "suggesting," "can," "may," "addressing," "launch," "launched," "aims," "committed," "continues," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Ultibro Breezhaler or the other products in the Novartis COPD Portfolio, or regarding potential future revenues from Ultibro Breezhaler and the other products in the Novartis COPD Portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be commercially successful in the future. In particular, management's expectations regarding Ultibro Breezhaler and the other products in the Novartis COPD Portfolio could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Notes * Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder. Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies ** American Journal of Respiratory and Critical Care Medicine *** Long-acting beta2-adrenergic agonist **** Long-acting muscarinic antagonist About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis For Novartis multimedia content, please visit www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com References [1] Roche N, Chapman K, Vogelmeier C, et al. Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Am J Respir Crit Care Med. 2017;195:9:1125-1127. [2] Pascoe S, et al. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015;3:435-442. [3] Hinds DR, et al. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open 2016;6:e010099. [4] Siddiqui SH, et al. Blood Eosinophils: A Biomarker of Response to Extrafine Beclomethasone/Formoterol in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015; 192:523-525. [5] Pavord ID, et al. Blood eosinophils and inhaled corticosteroid/long-acting ß-2 agonist efficacy in COPD. Thorax 2016; 71:118-125. [6] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 15 May 2017]. [7] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2017]. [8] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26;11:2527-2533. [9] Ultibro Breezhaler EU Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/medicine/29533 [Accessed 16 May 2017]. [10] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 16 May 2017]. [11] World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 16 May 2017]. [12] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 16 May 2017]. [13] Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary disease-a patients' perspective. Prim Care Respir J. 2006;15:2:102-109. [14] Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010;7:214-28. [15] Anzueto A. Impact of exacerbations on COPD. European Respiratory Review. 2010;19:116:113-118.


Basel, May 23, 2017 - Further analyses of Novartis' head-to-head FLAME study suggest that inhaled corticosteroids (ICS) may not be needed in some chronic obstructive pulmonary disease (COPD) patients with high blood eosinophil (a type of white blood cell) counts. The new data showed that Ultibro® Breezhaler® consistently provided superior or similar benefits over Seretide®* in COPD patients regardless of the eosinophil count[1]. These results contrast with data suggesting better clinical outcomes with ICS therapies for patients with high eosinophil counts[2]-[5]. The data was published in the centenary issue of the American Thoracic Society's 'Blue Journal'**[1] and solidifies the need for individualized risk-benefit assessments when considering ICS treatments. The potential for high blood eosinophil counts to be considered as a biomarker to direct the use of a LABA***/ICS combination over dual bronchodilation (LABA/LAMA****) in some patients, has been referenced in the 2017 GOLD (Global Initiative for Chronic Obstructive Lung Disease) report[6]. FLAME was the first trial to prospectively study the influence of blood eosinophils on the efficacy of ICS-containing therapies versus a LABA/LAMA. The new analyses showed that once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg was superior to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing exacerbations (flare-ups), independent of a blood eosinophil count above or below 2%[1]. In addition, at no cut-off was Seretide more effective than Ultibro Breezhaler[1]. "These new FLAME study analyses provide evidence that an effective dual bronchodilator such as Ultibro Breezhaler can provide similar or better benefits in patients with high eosinophil counts who may have been considered for an inhaled steroid-containing treatment," said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. "The data highlight the opportunity to allow more patients to avoid unnecessary exposure steroid-containing regimens and the significant potential associated risks." With funding support from Novartis, the International Primary Care Respiratory Group (IPCRG) is addressing the appropriate use and safe withdrawal of ICS in COPD patients with the launch of a primary care physician guide. The guide was launched at the recent IPCRG conference in Slovenia and aims to ensure the latest evidence based treatment guidance from the 2017 GOLD report is translated into daily clinical practice. The guide is accessible on the IPCRG website here: https://goo.gl/FlSVck About FLAME FLAME is a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries[7]. Results published in the New England Journal of Medicine[7] confirmed that Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg on the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment in COPD patients with a history of at least one exacerbation in the previous year. Against further secondary endpoints, Ultibro Breezhaler was also superior compared to SFC in reducing or improving the following[7]: The pre-specified analyses of data from the FLAME study compared treatment efficacy according to blood eosinophil percentage (<2% and >=2%, <3% and >=3%, and <5% and >=5%) and absolute blood eosinophil count (<=150 cells/ Mu l, 150 to <300 cells/ Mu l, and >=300cells/ Mu l)[1]. FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro Breezhaler for the treatment of COPD About the Novartis COPD portfolio Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide), Seebri® Breezhaler® (glycopyrronium bromide) and Onbrez® Breezhaler® (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura. Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation[8]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[8],[9]. About COPD Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide[10] and is the third leading cause of death[11]. It is progressive (usually gets worse over time) and can be a life-threatening disease[10],[12]. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life[10],[12]. Exacerbations are a sudden worsening of COPD symptoms that can be frightening for patients, causing distress, anxiety and quality of life deterioration[13]. COPD exacerbations are also associated with significant healthcare resource burden and costs[14], particularly due to the frequent need for hospitalization. Consequently, the prevention of exacerbations is an important goal in COPD management to improve long-term health status and conserve healthcare resources[15]. Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "potential," "suggest," "launching," "suggesting," "can," "may," "addressing," "launch," "launched," "aims," "committed," "continues," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Ultibro Breezhaler or the other products in the Novartis COPD Portfolio, or regarding potential future revenues from Ultibro Breezhaler and the other products in the Novartis COPD Portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Ultibro Breezhaler or any of the other products in the Novartis COPD Portfolio will be commercially successful in the future. In particular, management's expectations regarding Ultibro Breezhaler and the other products in the Novartis COPD Portfolio could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing and reimbursement pressures; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Notes * Seretide® Accuhaler® (salmeterol/fluticasone) 50 microgram /500 microgram /dose inhalation powder. Seretide and Accuhaler are registered trademarks of the GlaxoSmithKline group of companies ** American Journal of Respiratory and Critical Care Medicine *** Long-acting beta2-adrenergic agonist **** Long-acting muscarinic antagonist About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis For Novartis multimedia content, please visit www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com References [1] Roche N, Chapman K, Vogelmeier C, et al. Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Am J Respir Crit Care Med. 2017;195:9:1125-1127. [2] Pascoe S, et al. Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. Lancet Respir Med. 2015;3:435-442. [3] Hinds DR, et al. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open 2016;6:e010099. [4] Siddiqui SH, et al. Blood Eosinophils: A Biomarker of Response to Extrafine Beclomethasone/Formoterol in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015; 192:523-525. [5] Pavord ID, et al. Blood eosinophils and inhaled corticosteroid/long-acting ß-2 agonist efficacy in COPD. Thorax 2016; 71:118-125. [6] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 15 May 2017]. [7] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016. Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2017]. [8] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO. 2010;26;11:2527-2533. [9] Ultibro Breezhaler EU Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/medicine/29533 [Accessed 16 May 2017]. [10] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD_Manual/en/ [Accessed 16 May 2017]. [11] World Health Organization: The top 10 causes of death fact sheet No 310. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 16 May 2017]. [12] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed 16 May 2017]. [13] Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary disease-a patients' perspective. Prim Care Respir J. 2006;15:2:102-109. [14] Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic obstructive pulmonary disease and exacerbation definition: a review. COPD. 2010;7:214-28. [15] Anzueto A. Impact of exacerbations on COPD. European Respiratory Review. 2010;19:116:113-118.


Patent
SFC Inc | Date: 2016-11-15

A proofed frozen dough includes a dough mixture of flour, water, and optionally additives; gas bubbles dispersed throughout the dough matrix; a spent yeast component; and a preserved yeast component. According to some aspects, the preserved yeast component includes encapsulated yeast, fat-coated yeast, non-hydrated active dry yeast, non-hydrated instant yeast, non-hydrated semi-dry yeast, non-hydrated frozen yeast, or a combination thereof. A frozen dough product can be prepared by mixing dough ingredients to produce a dough composition, where the dough ingredients include water, flour, a first yeast, and a second yeast; proofing the dough, where during proofing the first yeast is spent and the second yeast is preserved; and freezing the dough after proofing.

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