FEV
United States
FEV
United States

Time filter

Source Type

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) presented data from the Phase 3 GOLDEN trials, showing that treatment with SUN-101/eFlow® significantly improved lung function, health related quality of life and respiratory symptoms among people with moderate-to-very severe chronic obstructive pulmonary disease (COPD), at the American Thoracic Society 2017 International Conference (ATS 2017) held May 19-24, 2017, in Washington D.C. Sunovion also presented data from the long-term safety trial showing a high rate of patient reported satisfaction and confidence with the use of the investigational eFlow® closed system nebulizer. “There are no approved nebulized, long-acting muscarinic antagonists (LAMAs) currently available for use in COPD,” said Thomas H. Goodin, Ph.D., Senior Director, Clinical Development at Sunovion. “These data suggest that for moderate-to-very severe patients, SUN-101/eFlow® could potentially be an effective and well-tolerated maintenance therapy.” If approved, SUN-101/eFlow® will be the first nebulized LAMA approved for the treatment of COPD in the U.S. The investigational eFlow® closed system nebulizer, developed by PARI Pharma GmbH, is portable, virtually silent, designed to deliver the medication in two to three minutes and, unlike handheld inhalers, allows patients to breathe normally while using the device. “COPD symptoms can severely impact patients’ daily activities and health related quality of life, and it is important for any treatment to be not only well-tolerated and effective, but also easy to administer,” said Gary Ferguson, M.D., Pulmonary Research Institute of Southeast Michigan and Principal Investigator for the GOLDEN-5 clinical trial. “With its efficacy and tolerability profile as well as the portability and short administration time, SUN-101/eFlow® could be a valuable treatment option for patients with COPD.” Results from three Phase 3 studies (GOLDEN-3, GOLDEN-4, GOLDEN-5) demonstrate the efficacy and safety of SUN-101/eFlow® in a population of patients with real-world characteristics representing its potential as an important maintenance therapy in patients with moderate-to-very severe COPD. Key data presented included: The expected action date by the U.S. Food and Drug Administration (FDA) under the Prescription Drug User Fee Act (PDUFA) for SUN-101/eFlow® is May 29, 2017. SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow® closed system nebulizer. SUN-101/eFlow® is currently in development as a nebulized treatment for patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The investigational combined product, consisting of SUN-101 and the investigational eFlow® closed system nebulizer, which has been optimized for SUN-101 delivery, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD. A long-acting muscarinic antagonist (LAMA) is a type of long-acting bronchodilator, along with long-acting beta agonists (LABAs). According to the GOLD report, these are currently the first-line standard of care maintenance therapy for symptomatic patients with COPD, and helps the muscles around the airways in lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath.1 LAMAs and LABAs are widely used and important therapeutic approaches for people with COPD. GOLDEN-3 and GOLDEN-4 were pivotal Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing SUN-101/eFlow® with placebo in adults with moderate-to-very severe COPD. The GOLDEN-3 trial enrolled 653 people who were at least 40 years old at 45 sites in the United States. The GOLDEN-4 trial enrolled 641 people who were at least 40 years old at 49 sites in the United States. SUN-101/eFlow® 25 mcg, SUN-101/eFlow® 50 mcg or placebo was administered twice daily in these studies. The primary endpoint was the change from baseline in trough FEV at Week 12. Secondary endpoints included standardized change from baseline at Week 12 in FEV area under the curve (AUC), change from baseline in trough forced vital capacity (FVC) at Week 12, change from baseline in health status measured by St. George’s Respiratory Questionnaire and change in rescue medication use. Safety was assessed by the number of treatment-emergent adverse events (TEAE), serious adverse events (SAE) or major adverse cardiac events (MACE) and the number and percentage of study participants who discontinued the study due to TEAE. Both GOLDEN-3 and GOLDEN-4 studies included not only patients who were taking effective background long acting bronchodilator therapy but also patients with very severe disease and co-existing cardiovascular illness. Approximately 10 percent of the population were elderly (>75 years), 65 percent were classified as being high-risk cardiovascular patients and approximately 30 percent were taking long acting bronchodilator therapy [NCT02347761 and NCT02347774]. GOLDEN-5 was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long term safety and tolerability of SUN-101/eFlow® in adults with moderate-to-very severe COPD. The study enrolled 1,087 patients at 111 investigational sites in the United States and Europe. The study evaluated 50 mcg of SUN-101/eFlow® delivered twice-daily and active comparator 18 mcg of Spiriva® (tiotropium bromide) delivered once-daily by the HandiHaler® device. The primary safety endpoints were: the number and percentage of study participants with treatment-emergent adverse events (TEAE), the number and percentage of study participants with treatment-emergent serious adverse events (SAE), the number and percentage of study participants who discontinued the study due to TEAEs and the number and incidence of subjects with MACE. The secondary endpoint was the mean change from baseline over 48 weeks in trough FEV for all subjects. The study included not only patients who were taking effective background long acting bronchodilator therapy but also patients with very severe disease and co-existing significant cardiovascular illness. Approximately 10 percent of the population were elderly (>75 years), 65 percent were classified as being high-risk cardiovascular patients and more than 40 percent were taking long acting bronchodilator therapy [NCT02276222]. Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.1 Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.2 It is estimated that several million more adults have undiagnosed COPD.3 COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.2 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.2 Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.4 The symptoms of COPD can be most severe during the night and early morning.5 Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation.6 Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality.7 Sunovion is committed to expanding its heritage of advancing new treatments for serious respiratory medical conditions, including the 15.7 million people in the U.S. who are living with chronic obstructive pulmonary disease (COPD).2 The company offers the broadest COPD portfolio in the U.S., providing treatment options for people at various stages of COPD, as well as the flexibility to choose handheld or nebulized delivery based on individual needs. Sunovion goes beyond treatment offerings to support awareness and understanding with the entire COPD community – health care providers, patients and caregivers – and to advancing disease state education through its partnerships with various organizations. Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Brovana® (arformoterol tartrate) inhalation solution, Latuda® (lurasidone HCI) and Aptiom® (eslicarbazepine acetate). Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com. LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc. APTIOM is used under license from Bial. ARCAPTA and NEOHALER are registered trademarks of Novartis AG, used under license. SEEBRI and UTIBRON are trademarks of Novartis AG, used under license. eFlow® is a registered trademark of PARI Pharma GmbH. Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GMBH & Co KG. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. For a copy of this release, visit Sunovion’s web site at www.sunovion.com 1 GOLD Guidelines 2017. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed: March 16, 2017. 2 MMWR: Morbidity and Mortality Weekly Report. Employment and Activity Limitations Among Adults with Chronic Obstructive Pulmonary Disease — United States, 2013. March 27, 2015; 64(11). Available at http://www.cdc.gov/mmwr/ 3 National Heart, Lung, and Blood Institute. “What is COPD?” Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm. Accessed: March 2, 2016 4 National Heart, Lung and Blood Institute. (2013). What Are the Signs and Symptoms of COPD? Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/copd/signs. 5 Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25:2043–8. 6 Roche N, Small M, Broomfield S, Higgins V, Pollard R. Real world COPD: association of morning symptoms with clinical and patient reported outcomes. COPD. 2013;10:679–86. 7 Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183–94.


WASHINGTON & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Pulmonx®, Inc. today announced the results of two multi-center, randomized clinical trials showing clinically meaningful improvements in lung function after treatment with the Zephyr® Endobronchial Valve (EBV) in emphysema patients without collateral ventilation. Six-month data from both the TRANSFORM and IMPACT trials, presented this week at the American Thoracic Society international conference, demonstrate that Zephyr valves provide positive benefits in these patients with either homogeneous or heterogeneous distribution of emphysema. Zephyr Endobronchial Valves are tiny, minimally-invasive, one-way valves placed via a flexible bronchoscope in airways of the lungs to occlude diseased regions and reduce lung hyperinflation. As a result, the remaining healthier regions can function more efficiently, enabling better breathing and an improved quality of life for patients. In the clinical trials, patients were selected based on the absence of collateral ventilation (airflow between regions of the lung that bypasses normal airways), which was assessed in the trials using the Chartis Pulmonary Assessment System from Pulmonx. The effectiveness of endobronchial valves is dependent on selection of an area of the lung without collateral ventilation for treatment. The TRANSFORM study, a multi-center, prospective, randomized, controlled trial, evaluated 97 patients with heterogeneous (more focally-distributed) emphysema at 17 centers in six countries. Patients were randomized 2:1 to Zephyr valve treatment versus standard of care. The authors concluded that Zephyr valve treatment in heterogeneous emphysema patients without collateral ventilation confers clinically and statistically significant sustained benefits, with improvements in lung function, exercise capacity and quality of life. At six months, 56.3 percent of patients treated with Zephyr valves achieved a 12 percent or greater improvement in lung function (FEV ) from baseline, when compared to 3.2 percent of patients in the control group. The lung function (FEV ) in the Zephyr valve-treated group was on average 29.3 percent higher than the control group. Improvements of a similar magnitude were observed between groups in exercise capacity (measured by Six-Minute Walk Distance, or 6MWD), with Zephyr valve-treated patients improving upon the control group by 78.7 meters. Finally, the quality of life of Zephyr valve treated patients improved by 6.5 points over control in the St. Georges Respiratory Questionnaire (SGRQ) score. “The magnitude of benefits to patients in this pan-European trial are dramatic and reinforce results published from prior single center studies,” said Samuel Kemp, MD, principal investigator and respiratory physician at the Royal Brompton Hospital, London, UK. “Using Chartis for patient selection enabled us to accurately identify patients without collateral ventilation, which is a key predictor for good outcomes with this device.” The IMPACT study enrolled 93 patients with severe homogeneous (more diffusely-distributed) emphysema who were randomized 1:1 to Zephyr valve treatment versus medical management. Consistent with the previously published three-month data, the improvements remained statistically and clinically significant at six months with Zephyr valve treated patients experiencing improvements over control for FEV of 16.3 percent (p<0.001), an increase in 6MWD of 28.3 meters (p=0.016), and an improvement in the quality of life based on a decrease in the SGRQ score of –7.5 points (p<0.001). The most common side effect of the Zephyr valves in both studies was pneumothorax (20 to 26 percent in the treated group) and chronic obstructive pulmonary disease exacerbations (11 to 28 percent versus 6 to 18 percent in the control group) in the immediate post-procedure period. Both were addressed with standard medical management. Two prior randomized controlled trials of the Zephyr valve in patients without collateral ventilation (the STELVIO and BeLieVeR-HIFi trials) also support the ability of Zephyr valves to significantly improve lung function, exercise tolerance and quality of life.1,2 Additional published clinical data demonstrate sustained patient benefits out to five years3 and suggest potential survival benefits at five and 10 years post-treatment,4,5 indicating a possible slowing in disease progression. “For patients with severe emphysema, there were previously few therapeutic options,” said Pulmonx Chief Executive Officer Glen French. “Now, we have consistent data from four randomized studies showing that, regardless of disease heterogeneity, when patients are selected for the absence of collateral ventilation, they can gain substantial benefits in quality of life, exercise capacity and lung function with Zephyr valves.” Over the past 10 years, approximately 50,000 Zephyr EBVs have been implanted globally in more than 12,000 patients. To view a video of the Zephyr EBV procedure, click here. Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is an interventional pulmonology company focused on developing life-changing, cost-effective technologies that improve the lives of patients suffering from lung disease worldwide. For more information, visit www.pulmonx.com. The Zephyr Endobronchial Valve is an investigational device in the United States. Limited by U.S. law to investigational use only.


Researchers presented new data from the completed three-month Phase 3 studies, which included more than 1,250 patients with moderate to very severe COPD, in two separate presentations at the 2017 ATS meeting. The first presentation, which focused on efficacy outcomes, demonstrated statistically significant and clinically meaningful improvements over placebo in trough forced expiratory volume in one second (FEV ) and in overall treatment effect on trough FEV (OTE FEV ) after 12 weeks of dosing in each study and for each of the revefenacin doses studied (88 mcg once daily and 175 mcg once daily). The improvements in trough FEV , the primary efficacy endpoint, versus placebo for the intent-to-treat populations across both studies were 118 mL and 145 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001). Additionally, the improvements in OTE FEV , a key secondary endpoint, versus placebo for the intent-to-treat population across both studies were 112 mL and 139 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001). The second presentation featured safety and tolerability data from the two completed three-month Phase 3 studies. Both doses of revefenacin had comparable rates of adverse events to placebo, low rates of serious adverse events, and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, were exacerbations, cough, dyspnea and headache. There were no reports of blurred vision, narrow-angle glaucoma or worsening of urinary retention. Reports of dry mouth were <0.5% in the revefenacin treatment arms. "These presentations build upon the topline results that we announced last October and further confirm that revefenacin may offer meaningful benefits to patients with moderate to very severe COPD," said Brett Haumann, MD, Chief Medical Officer at Theravance Biopharma. "We believe that these results position revefenacin favorably as a potentially key therapeutic option for COPD patients if approved, particularly as revefenacin would represent the first once-daily nebulized bronchodilator for COPD. We anticipate completing the ongoing Phase 3 safety trial of revefenacin in mid-2017 with the goal of filing an NDA by the end of 2017." Mylan President Rajiv Malik commented, "We continue to be very pleased with the progress of the Phase 3 revefenacin program, and are excited to have the opportunity to showcase this important data set at ATS for the first time. According to the GOLD Guidelines for COPD, LAMAs are a cornerstone of therapy for moderate to severe COPD, yet there are currently no nebulized LAMAs available. We believe this product has the potential to help address an unmet medical need for patients. Further, revefenacin represents a key contributor in Mylan's pipeline of promising respiratory products, and supports the growth of our respiratory franchise. If approved, we believe that we are well-positioned to support the commercial success of this product." Revefenacin is being developed as a once-daily, nebulized bronchodilator for the treatment of patients with COPD and will be compatible with a range of jet nebulizers. The three-month Phase 3 pivotal studies were replicate, randomized, double-blind, placebo-controlled, parallel-group trials designed to provide pivotal efficacy and safety data for once-daily revefenacin over a dosing period of 12 weeks. The replicate studies enrolled a combined total of over 1,250 patients in the U.S. across a range of disease severity from moderate to very severe COPD and allowed for the concomitant use of long-acting beta agonist (LABA) and/or long-acting beta agonist/inhaled corticosteroid (LABA/ICS) products in a significant proportion (38%) of the studied population. Study investigators tested two doses (88 mcg and 175 mcg) of revefenacin inhalation solution or matched placebo administered once daily via a standard jet nebulizer in moderate to very severe COPD patients. The revefenacin Phase 3 program also includes an ongoing 12-month, open-label, active comparator safety study in more than 1,050 patients, which is expected to be completed in mid-2017. Together, the three studies enrolled approximately 2,300 patients. Should outcomes from the safety study be supportive, Theravance Biopharma expects to file a New Drug Application (NDA) for revefenacin with the U.S. Food and Drug Administration (FDA) by the end of 2017. Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases. In a separate presentation at 2017 ATS, researchers reported baseline data on the prevalence of COPD patients with low peak inspiratory flow rate (PIFR) who are enrolled in the ongoing 12-month, open-label, active comparator safety study of revefenacin. Of the total population of 1,080 patients who were enrolled in the study, 448 patients had their PIFR measured using a commercially available, easy-to-use instrument (InCheck®) at the time of study randomization. Researchers categorized PIFRs of less than 40 L/min against the resistance of the Handihaler® as "low" for the means of this analysis based upon published research and reference data. Presented results showed that 24% of subjects had a low PIFR rate at the time of randomization. Analysis of patient characteristics showed that patients with a low PIFR tended to be female and exhibited evidence of more severe COPD, although a proportion of patients with less severe COPD were also found to have low PIFR. "Patients with low PIFR may not be able to breathe in with enough force to benefit from the use of handheld COPD devices. There is growing evidence that these patients may have better short-term and long-term benefits from nebulized therapy. This is supported by a recent scientific study that reported that patients with low PIFR, regardless of disease severity, showed statistically significant lower COPD hospital readmission rates within both 30 and 90 days when using nebulized therapy as compared to a handheld product following COPD exacerbation1," said Dr. Haumann. "We believe that revefenacin could provide a unique benefit to patients with low PIFR and are currently evaluating this in a dedicated clinical study." Researchers also presented results from a study highlighting the pharmacological properties of revefenacin in isolated tissue airways, from both rats and humans, to enable preclinical to clinical translation of the in vivo findings in rats. Study data demonstrated that revefenacin produced potent and persistent anti-muscarinic activity in the airway tissues of both rats and humans. These translational findings are consistent with clinical data from the replicate three-month Phase 3 studies of revefenacin demonstrating 24-hour bronchodilatory effects in COPD patients. Theravance Biopharma and Mylan N.V. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Under the terms of the agreement, Theravance Biopharma is leading the U.S. development program for the revefenacin inhalation solution product, with all costs reimbursed by Mylan up until the approval of the first new drug application, after which costs will be shared. Mylan is responsible for ex-U.S. development and commercialization. Theravance Biopharma is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on U.S. sales and double-digit royalties on ex-U.S. sales. Additionally, Theravance Biopharma retains worldwide rights to revefenacin delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI), and the rights to nebulized revefenacin in China. COPD is a growing and devastating disease that is the third leading cause of death in the U.S.2 An estimated 12.7 million American adults are diagnosed with COPD and an almost equal number are believed to be undiagnosed.3There were more than 700,000 hospital discharges related to COPD in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly $50 billion in 2010, including $29.5 billion in direct healthcare expenditures, $8 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.3 Revefenacin (TD-4208) is a novel investigational once-daily nebulized LAMA in Phase 3 development for the treatment of moderate to very severe COPD. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the U.S. use nebulizers for ongoing maintenance therapy.4 LAMAs are a cornerstone of maintenance therapy for COPD and, if approved, revefenacin would provide a once-daily option for COPD patients who require, or prefer, nebulized therapy. The product's stability in both metered dose inhaler and dry powder device formulations suggest that this LAMA could also serve as a foundation for novel handheld combination products. Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness. Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases, such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop intestinally restricted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases. In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain drug development programs, including the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol), currently in development for the treatment of COPD and asthma. For more information, please visit www.theravance.com. THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the Theravance Biopharma group of companies. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners. This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the company's strategies, plans and objectives, the company's regulatory strategies and timing of clinical studies, the potential benefits and mechanisms of action of the company's product and product candidates, the company's expectations for product candidates through development, potential regulatory approval and commercialization (including their potential as components of combination therapies) and the company's expectations for product sales. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the company's product candidates are unsafe or ineffective (including when our product candidates are studied in combination with other compounds),the feasibility of undertaking future clinical trials for our product candidates based on FDA policies and feedback, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop and commercialize product and product candidates, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. Other risks affecting Theravance Biopharma are described under the heading "Risk Factors" contained in Theravance Biopharma's Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 9, 2017 and Theravance Biopharma's other filings with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We market a growing portfolio of approximately 7,500 products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com. This press release includes statements that constitute "forward-looking statements," including with regard to revefenacin having the potential to offer meaningful benefits to patients with moderate to very severe COPD; revefenacin being positioned favorably as a potentially key therapeutic option for COPD patients if approved, particularly as revefenacin would represent the first once-daily nebulized bronchodilator for COPD; anticipated completion of the ongoing Phase 3 safety trial of revefenacin in mid-2017 with the goal of filing an NDA by the end of 2017; revefenacin having the potential to help address an unmet medical need for patients; revefenacin representing a key contributor in Mylan's pipeline of promising respiratory products, and supporting the growth of Mylan's respiratory franchise; Mylan's belief that it is well-positioned to support the commercial success of the product; the ongoing 12-month, open-label, active comparator safety study in more than 1,050 patients, which is expected to be completed in mid-2017; Theravance Biopharma expecting to file a New Drug Application (NDA) for revefenacin with the U.S. Food and Drug Administration (FDA) by the end of 2017; the possibility that revefenacin could provide a unique benefit to patients with low PIFR; and the possibility that this LAMA could also serve as a foundation for novel handheld combination products. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: success of clinical trials and our and our partners' ability to execute on new product opportunities; any regulatory, legal or other impediments to our ability to bring our and our partners' products to market; other risks inherent in product development; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or our partners' business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions; the effect of any changes in our customer and supplier relationships and customer purchasing patterns; any other changes in third-party relationships; changes in the economic and financial conditions of  the businesses of Mylan; uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release. 1 Loh CH, Lovings T, Ohar J. Long acting nebulized agents decrease readmissions in patients with suboptimal peak inspiratory flow. Chest 2016;150:925A–925A. 2American Lung Association. "Chronic Obstructive Pulmonary Disease (COPD)" http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd. 3 American Lung Association. "Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality" http://www.lung.org/assets/documents/research/copd-trend-report.pdf. 4 TBPH market research (N = 160 physicians); Refers to US COPD patients To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/theravance-biopharma-and-mylan-report-additional-phase-3-data-for-revefenacin-td-4208-in-several-presentations-at-2017-ats-300461835.html


News Article | April 21, 2017
Site: www.prnewswire.com

More than 10 million Honeywell turbochargers have been sold in China since the beginning of TS operations in China more than 20 years ago. Key launches in the past year include: the Buick Encore, Chevrolet Trax, Baojun 560/ 730, and the Chery TIGGO7. According to Honeywell's most recent Turbo Forecast, China will remain the highest growth market for turbocharged light vehicles. After a very strong fourth quarter in 2016, Honeywell has updated its forecast for China calling for a 20-point increase in turbo penetration of total sales. This means the annual sales of turbocharged light vehicles in China will increase from 10.6 million in 2016 to more than 16 million in 2021. On display in Shanghai will be Honeywell's Gasoline VNT Turbocharger, which features a variable geometry turbine stage rather than a typical wastegate valve to help achieve better fuel economy. Designed to work in tandem with a combustion phasing technology known as the Miller cycle, this turbo takes on more work and allows greater thermal efficiency in the engine. This results in improved fuel economy and reduced CO2 emissions at nearly all engine speeds. Honeywell has applied the performance-enhancing VNT technology to nearly 70 million turbos used with diesel engines during the past three decades. It is an industry first to apply VNT technology for the higher-temperature gasoline engine environment – suitable for high-production volume passenger vehicles – without resorting to expensive exotic materials. Honeywell Transportation Systems developed its latest VNT turbocharger for the Volkswagen Group's 1.5L gasoline engine to be used in various VW and Audi models. In its most recent benchmarking study, industry analyst FEV Group GmbH determined that the carbon dioxide emissions (108g/km) for a 1,250 kg vehicle with Honeywell's technology represents best-in-class performance for the industry in 2017. Honeywell is bringing a look into the future to its display, with three examples of electric boosting products that can help provide additional benefits for automakers to use in improving performance and meeting regulatory targets. These include: Honeywell expects these solutions will continue to grow in demand as electric and hybrid vehicles are expected to grow globally from a total of 3 million vehicles sold in 2016 to a total of 16 million sold annually by 2021. Within the electrified category, mild hybrids are expected to account for 46 percent of the mix, full hybrids will account for 40 percent; and pure electric vehicles will be most of the remaining 14 percent. Honeywell estimates 70 percent of all mild hybrid vehicles will have a turbo or multiple turbo systems (mechanical and electric). Honeywell will also offer a demo of three software initiatives aimed at diagnostics and prognostics of vehicle condition, automotive cyber security and calibration of vehicle powertrains. In addition to Honeywell's powertrain related technologies, Honeywell will showcase a new automotive refrigerant that achieves a 99.9 percent greenhouse gas emission reduction compared with previous generation refrigerants with the same or better cooling performance. Honeywell will also present a series of Reddot Award winning products including an indoor air purifier and indoor air quality meter. Honeywell is working with automakers on extending these air quality and environmentally friendly technologies to future vehicle cabin designs. "We pay great attention to the Chinese market and have formulated a long-term strategic plan in China," said Honeywell China President Stephen Shang. "Honeywell's goal is to be the best operating global company in China with best products, best quality, best value and fastest speed for our customers. Our turbocharging business is one of the best examples of how Honeywell is applying global innovations and experience to create a tailored local technology solution with fully local end-to-end capacity." "Our unique Honeywell automotive, aerospace and automation expertise allows us to innovate, bringing differentiated turbo technologies for conventional powertrains as well as electric boosting and Automotive Software solutions," said Charles Jin, Honeywell Transportation Systems Vice President and General Manager of High Growth Regions, China and India. "Moreover, we'll bring to the automotive world, innovative technologies that help make vehicles safer, more connected, more energy efficient and environmentally friendly." Honeywell Transportation Systems will be displaying its automotive solutions and conducting demos, tours and contests at Hall 4.2 booth #4B H001 during Auto Shanghai. Honeywell (www.honeywell.com) is a Fortune 100 software-industrial company that delivers industry specific solutions that include aerospace and automotive products and services; control technologies for buildings, homes, and industry; and performance materials globally. Our technologies help everything from aircraft, cars, homes and buildings, manufacturing plants, supply chains, and workers become more connected to make our world smarter, safer, and more sustainable. For more news and information on Honeywell, please visit www.honeywell.com/newsroom. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/honeywell-boosting-chinas-auto-industry-now-and-in-the-future-300443622.html


News Article | May 5, 2017
Site: globenewswire.com

Dublin, May 05, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Range Extenders for Electric Vehicles Land, Water & Air 2017-2027" report to their offering. Over nine million hybrid cars will be made in 2027, each with a range extender, the additional power source that distinguishes them from pure electric cars. Add to that significant money spent on the same devices in buses, military vehicles, boats and so on and a major new market emerges. This unique report is about range extenders for all these purposes - their evolving technology and market size. Whereas today's range extenders usually consist of little more than off the shelf internal combustion engines, these are rapidly being replaced by second generation range extenders consisting of piston engines designed from scratch for fairly constant load in series hybrids. There are some wild cards like Wankel engines and rotary combustion engines or free piston engines both with integral electricity generation. However, a more radical departure is the third generation micro turbines and fuel cells that work at constant load. The report compares all these. It forecasts the lower power needed over the years given assistance from fast charging and energy harvesting innovations ahead. Every aspect of the new range extenders is covered. This report profiles key developers, manufactures and integrators of range extenders for land, water and airborne electric vehicles. It gives ten year forecasts of the different types of electric vehicle and of range extenders by number, unit value and market value. Market drivers and the changing requirements for power output are analysed. Will shaftless range extenders with no separate electricity generator take over and when will that be? What fuels will be used and when? What are the pros and cons of each option and who are the leaders? It is all here. Key Topics Covered: 1. EXECUTIVE SUMMARY AND CONCLUSIONS 1.1. Range extender market in 2027 1.2. EV market 2017 and 2027 identifying hybrids 1.3. Hybrid and pure electric vehicles compared 1.4. Hybrid market drivers 1.5. What will be required of a range extender 2017-2027 1.6. Three generations of range extender 1.7. Why range extenders need lower power over the years 1.8. Energy harvesting - mostly ally not alternative 1.9. Key trends for range extended vehicles 1.10. Combining heating and range-extension for electric vehicles 1.11. Emergency range extenders 1.12. Latest timelines 1.13. BMW 1.14. Effect of 2015 oil price collapse on electric vehicles 1.15. Range extender synergy with energy harvesting 1.16. Interviews 1.17. Lessons from CENEX LCV event UK 2. INTRODUCTION 2.1. Types of electric vehicle 2.2. Many fuels 2.3. Born electric 2.4. Pure electric vehicles are improving 2.5. Series vs parallel hybrid 2.6. Modes of operation of hybrids 2.7. Microhybrid is a misnomer 2.8. Deep hybridisation 2.9. Battery cost and performance are key 2.10. Hybrid price premium 2.11. What is a range extender? 2.12. PEM fuel cells 2.13. Market position of fuel cell range extenders 2.14. Energy harvesting and regenerative acceleration 3. MARKETS AND TECHNOLOGIES FOR REEVS 3.1. Range extenders for land craft 3.2. Range Extenders for electric aircraft 3.3. Comparisons 3.4. Fuel cells in aviation 3.5. Civil aircraft 3.6. Range extenders for marine craft 4. RANGE EXTENDER DEVELOPERS AND MANUFACTURERS 4.1. Advanced Magnet Laboratory USA 4.2. AeroVironment / Protonex Technology USA 4.3. Austro Engine Austria 4.4. Bladon Jets UK 4.5. BMW Germany 4.6. Brayton Energy USA 4.7. Capstone Turbine Corporation USA 4.8. Compound Rotary Engines UK 4.9. Daimler AG inc Mercedes Benz Germany 4.10. DLR German Aerospace Center Germany 4.10.1. Free piston range extenders 4.11. Duke Engine axial piston 4.12. EcoMotors 4.13. Ener1 USA 4.14. ETV Motors Israel 4.15. FEV USA 4.16. Flight Design Germany 4.17. Getrag Germany 4.18. GSE USA 4.19. Hüttlin Germany 4.20. Hyperdrive UK 4.21. Libralato UK 4.22. Intelligent Energy UK 4.23. KSPG Germany 4.24. LiquidPiston USA 4.25. Lotus Engineering UK 4.26. MAHLE Powertrain UK 4.27. Mazda Japan 4.28. Nissan Japan 4.29. Peec-Power BV The Netherlands 4.30. Polaris Industries Switzerland 4.31. Powertrain Technologies UK 4.32. Proton Power Systems plc UK/Germany 4.33. Ricardo UK 4.34. Suzuki Japan 4.35. Techrules China 4.36. Toyota Japan 4.37. Urbee Canada 4.38. Volkswagen Germany 4.39. Volvo Sweden/China 4.39.1. Long term major work 4.39.2. Volvo V8 performance with four cylinders 4.40. Warsaw University of Technology, Poland 5. RANGE EXTENDER INTEGRATORS 5.1. ACAL Energy UK 5.2. Airbus (formerly EADS) Germany 5.3. Altria Controls USA 5.4. Ashok Leyland India 5.5. Audi Germany 5.6. AVL Austria 5.7. Azure Dynamics USA 5.8. BAE Systems UK 5.9. BMW Germany 5.10. Boeing Dreamworks USA 5.11. Chrysler USA 5.12. ENFICA-FC Italy 5.13. Ford USA 5.14. Frazer-Nash UK 5.15. General Motors including Opel 5.16. Honda Japan 5.17. Hyundai Korea 5.18. Jaguar Land Rover UK 5.19. Langford Performance Engineering Ltd UK 5.20. Marion HSPD USA 5.21. Pipistrel Slovenia 5.22. SAIC China 5.23. Skyspark Italy 5.24. Suzuki Japan 5.25. Tata Motors India 5.26. Toyota Japan 5.27. Université de Sherbrooke Canada 5.28. University of Stuttgart Germany 5.29. Volvo Sweden/ China 5.30. Walkera China 5.31. Wrightspeed USA 5.32. Yo-Avto Russia 6. RECENT ADVANCES 6.1. Latest update on Taiwan Automotive International Forum and Exhibition October 2014 6.2. Electric vehicles set for 2014 MPG Marathon 6.3. Hydrogen fuel cell range extenders double the range of EV trucks For more information about this report visit http://www.researchandmarkets.com/research/f68dgx/range_extenders


News Article | May 5, 2017
Site: globenewswire.com

Dublin, May 05, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Range Extenders for Electric Vehicles Land, Water & Air 2017-2027" report to their offering. Over nine million hybrid cars will be made in 2027, each with a range extender, the additional power source that distinguishes them from pure electric cars. Add to that significant money spent on the same devices in buses, military vehicles, boats and so on and a major new market emerges. This unique report is about range extenders for all these purposes - their evolving technology and market size. Whereas today's range extenders usually consist of little more than off the shelf internal combustion engines, these are rapidly being replaced by second generation range extenders consisting of piston engines designed from scratch for fairly constant load in series hybrids. There are some wild cards like Wankel engines and rotary combustion engines or free piston engines both with integral electricity generation. However, a more radical departure is the third generation micro turbines and fuel cells that work at constant load. The report compares all these. It forecasts the lower power needed over the years given assistance from fast charging and energy harvesting innovations ahead. Every aspect of the new range extenders is covered. This report profiles key developers, manufactures and integrators of range extenders for land, water and airborne electric vehicles. It gives ten year forecasts of the different types of electric vehicle and of range extenders by number, unit value and market value. Market drivers and the changing requirements for power output are analysed. Will shaftless range extenders with no separate electricity generator take over and when will that be? What fuels will be used and when? What are the pros and cons of each option and who are the leaders? It is all here. Key Topics Covered: 1. EXECUTIVE SUMMARY AND CONCLUSIONS 1.1. Range extender market in 2027 1.2. EV market 2017 and 2027 identifying hybrids 1.3. Hybrid and pure electric vehicles compared 1.4. Hybrid market drivers 1.5. What will be required of a range extender 2017-2027 1.6. Three generations of range extender 1.7. Why range extenders need lower power over the years 1.8. Energy harvesting - mostly ally not alternative 1.9. Key trends for range extended vehicles 1.10. Combining heating and range-extension for electric vehicles 1.11. Emergency range extenders 1.12. Latest timelines 1.13. BMW 1.14. Effect of 2015 oil price collapse on electric vehicles 1.15. Range extender synergy with energy harvesting 1.16. Interviews 1.17. Lessons from CENEX LCV event UK 2. INTRODUCTION 2.1. Types of electric vehicle 2.2. Many fuels 2.3. Born electric 2.4. Pure electric vehicles are improving 2.5. Series vs parallel hybrid 2.6. Modes of operation of hybrids 2.7. Microhybrid is a misnomer 2.8. Deep hybridisation 2.9. Battery cost and performance are key 2.10. Hybrid price premium 2.11. What is a range extender? 2.12. PEM fuel cells 2.13. Market position of fuel cell range extenders 2.14. Energy harvesting and regenerative acceleration 3. MARKETS AND TECHNOLOGIES FOR REEVS 3.1. Range extenders for land craft 3.2. Range Extenders for electric aircraft 3.3. Comparisons 3.4. Fuel cells in aviation 3.5. Civil aircraft 3.6. Range extenders for marine craft 4. RANGE EXTENDER DEVELOPERS AND MANUFACTURERS 4.1. Advanced Magnet Laboratory USA 4.2. AeroVironment / Protonex Technology USA 4.3. Austro Engine Austria 4.4. Bladon Jets UK 4.5. BMW Germany 4.6. Brayton Energy USA 4.7. Capstone Turbine Corporation USA 4.8. Compound Rotary Engines UK 4.9. Daimler AG inc Mercedes Benz Germany 4.10. DLR German Aerospace Center Germany 4.10.1. Free piston range extenders 4.11. Duke Engine axial piston 4.12. EcoMotors 4.13. Ener1 USA 4.14. ETV Motors Israel 4.15. FEV USA 4.16. Flight Design Germany 4.17. Getrag Germany 4.18. GSE USA 4.19. Hüttlin Germany 4.20. Hyperdrive UK 4.21. Libralato UK 4.22. Intelligent Energy UK 4.23. KSPG Germany 4.24. LiquidPiston USA 4.25. Lotus Engineering UK 4.26. MAHLE Powertrain UK 4.27. Mazda Japan 4.28. Nissan Japan 4.29. Peec-Power BV The Netherlands 4.30. Polaris Industries Switzerland 4.31. Powertrain Technologies UK 4.32. Proton Power Systems plc UK/Germany 4.33. Ricardo UK 4.34. Suzuki Japan 4.35. Techrules China 4.36. Toyota Japan 4.37. Urbee Canada 4.38. Volkswagen Germany 4.39. Volvo Sweden/China 4.39.1. Long term major work 4.39.2. Volvo V8 performance with four cylinders 4.40. Warsaw University of Technology, Poland 5. RANGE EXTENDER INTEGRATORS 5.1. ACAL Energy UK 5.2. Airbus (formerly EADS) Germany 5.3. Altria Controls USA 5.4. Ashok Leyland India 5.5. Audi Germany 5.6. AVL Austria 5.7. Azure Dynamics USA 5.8. BAE Systems UK 5.9. BMW Germany 5.10. Boeing Dreamworks USA 5.11. Chrysler USA 5.12. ENFICA-FC Italy 5.13. Ford USA 5.14. Frazer-Nash UK 5.15. General Motors including Opel 5.16. Honda Japan 5.17. Hyundai Korea 5.18. Jaguar Land Rover UK 5.19. Langford Performance Engineering Ltd UK 5.20. Marion HSPD USA 5.21. Pipistrel Slovenia 5.22. SAIC China 5.23. Skyspark Italy 5.24. Suzuki Japan 5.25. Tata Motors India 5.26. Toyota Japan 5.27. Université de Sherbrooke Canada 5.28. University of Stuttgart Germany 5.29. Volvo Sweden/ China 5.30. Walkera China 5.31. Wrightspeed USA 5.32. Yo-Avto Russia 6. RECENT ADVANCES 6.1. Latest update on Taiwan Automotive International Forum and Exhibition October 2014 6.2. Electric vehicles set for 2014 MPG Marathon 6.3. Hydrogen fuel cell range extenders double the range of EV trucks For more information about this report visit http://www.researchandmarkets.com/research/f68dgx/range_extenders

Loading FEV collaborators
Loading FEV collaborators