Theravance Biopharma and Mylan Expand YUPELRI® (revefenacin) Development and Commercialization Agreement to Include China and Adjacent Territories
It is estimated that COPD affects nearly 100 million individuals in China1 with approximately 43 percent of those patients suffering from moderate to very severe forms of the disease2. COPD is one of the top three causes of mortality in China, accounting for approximately 910,000 deaths annually3. COPD presents a significant financial burden to the healthcare system in China, contributing up to
"We are pleased to expand our ongoing revefenacin development and commercialization collaboration with Mylan to include China, as we believe that this novel compound has the therapeutic profile to provide key benefits to the country's large and underserved COPD patient population. Our companies share the belief that revefenacin can play a critical role in COPD treatment, particularly for those patients who require or prefer nebulized therapy," said Rick E Winningham, chairman and chief executive officer of
Revefenacin inhalation solution, marketed as YUPELRI in the US, is a novel once-daily nebulized LAMA that is approved for the maintenance treatment of COPD in the US. LAMAs are a cornerstone of maintenance therapy for COPD and revefenacin is positioned as a first-in-class once-daily single-agent bronchodilator product for COPD patients who require, or prefer, nebulized therapy. Revefenacin'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.
In two replicate pivotal Phase 3 efficacy studies conducted in the US, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing.4 Revefenacin had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), 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 cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Additionally, a 12-month Phase 3 open-label safety study versus tiotropium did not identify any new safety issues. Rates of AEs and SAEs in the study were low and comparable to those seen in the tiotropium treatment arm.
YUPELRI is a registered trademark of
In pursuit of our purpose, we apply insights and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. These efforts leverage years of experience in developing lung-selective medicines to treat respiratory disease, including
We have an economic interest in potential future payments from
For more information, please visit www.theravance.com.
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.
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 offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally 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 approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to the outcome of clinical trials. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in
1 C. Wang, J. Xu, L. Yang et al., "Prevalence and risk factors of chronic obstructive pulmonary disease in China (the
2 Fang L, Gao P, Bao H, et al., "Chronic obstructive pulmonary disease in China: a nationwide prevalence study," Lancet Respir Med 2018; 6: 421–430.
3 Yin P, Wang H, Vos T, et al., "A subnational analysis of mortality and prevalence of COPD in
4 "Clinically meaningful" is defined by industry established Minimal Clinically Important Difference (MCID) for lung function (100 mL improvement in FEV1).
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