Theravance Biopharma and Mylan Submit New Drug Application to FDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
"This submission represents a key step in our efforts to bring the first once-daily nebulized LAMA to the COPD patient community. While a significant number of COPD patients require or prefer nebulized therapy, these same patients currently have no access to a nebulized LAMA, broadly considered the cornerstone of COPD maintenance therapy," said
"We are proud of our collaboration with
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
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
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.,
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo and VIBATIV® are registered trademarks of the
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
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 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. 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 the NDA submission for revefenacin to the
Head of Investor Relations
1 "Clinically meaningful" is defined by industry established Minimal Clinically Important Difference (MCID) for lung function (100 ml improvement in FEV1).
4 TBPH market research (N = 160 physicians); Refers to US COPD patients
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