Theravance, Mylan to Present New Data at 2018 CHEST Annual Meeting

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V.(NASDAQ: MYL) (“Mylan”) today announced that data from studies of YUPELRI^™ (revefenacin) will be presented at the 2018 CHEST annual meeting, being held in San Antonio, Texas on October 6-10, 2018. Multiple presentations will report new results from the previously completed Phase 3 program of YUPELRI in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Researchers will also report data from a new study comparing outcomes for YUPELRI and tiotropium (Spiriva^® HandiHaler^®) in COPD patients with suboptimal peak inspiratory flow rates (PIFR).

YUPELRI is an investigational long-acting muscarinic antagonist (LAMA) currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of COPD. The Prescription Drug User Fee Act (PDUFA) date for YUPELRI is November 13, 2018. If approved, YUPELRI would be the first and only once-daily, long-acting nebulized bronchodilator for the treatment of COPD. YUPELRI is designed to be compatible with any standard jet nebulizer.

Details of the presentations at CHEST 2018 are as follows:

Efficacy of Revefenacin by Nebulization and Tiotropium by Handihaler^® in Subjects with COPD and Suboptimal Peak Inspiratory Flow Rates (PIFR)

• Poster Number: 153
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Efficacy of Revefenacin, a Long-Acting Muscarinic Antagonist for Nebulized Therapy, in Chronic Obstructive Pulmonary Disease Patients with Markers of More Severe Disease

• Poster Number: 147
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Cardiovascular Safety of Revefenacin for Nebulization: a Review of Randomized Controlled Trial Data

• Poster Number: 146
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

About YUPELRI

YUPELRI (revefenacin) inhalation solution is a novel investigational once-daily nebulized LAMA under FDA review 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.¹ LAMAs are a cornerstone of maintenance therapy for COPD and, if approved, YUPELRI would be the first and only once-daily, long-acting single-agent product for COPD patients who require, or prefer, nebulized therapy. YUPELRI’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 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.

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