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Theravance, Mylan Expand YUPELRI® Development and Commercialization Agreement

June 20, 2019 By americanpharmaceuticalreview

Theravance Biopharma Ireland Limited and Mylan announced the expansion of the companies' current development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories. Revefenacin, marketed as YUPELRI® in the U.S., is a long-acting muscarinic antagonist (LAMA), which is the first and only once-daily, nebulized bronchodilator approved for the treatment of chronic obstructive pulmonary disease (COPD) in the U.S.

It is estimated that COPD affects nearly 100 million individuals in China with approximately 43 percent of those patients suffering from moderate to very severe forms of the disease. COPD is one of the top three causes of mortality in China, accounting for approximately 910,000 deaths annually. COPD presents a significant financial burden to the healthcare system in China, contributing up to $266 billion in costs annually.

In 2015, Theravance Biopharma and Mylan, and their affiliates, established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases in all global markets with the exception of China and adjacent territories. Under terms of the new agreement, Theravance Biopharma has granted Mylan exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories, which include Hong Kong SAR, the Macau SAR and Taiwan. In exchange, Theravance Biopharma will receive an upfront payment of $18.5 million and will be eligible to receive additional potential development and sales milestones totaling $54 million together with tiered royalties on net sales of nebulized revefenacin, if approved. Mylan will be responsible for all aspects of development and commercialization in the partnered regions, including pre- and post-launch activities and product registration and all associated costs.

"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 Theravance Biopharma, Inc. "Mylan is a global leader in nebulized respiratory therapies and has been a valued and trusted partner since we entered our original collaboration in 2015. Based on its deep experience with nebulized revefenacin, Mylan is well positioned to efficiently guide the compound through the development and regulatory approval process in China, as well as maximize its commercial potential in the partnered regions."

"Mylan has had a long-term, strategic focus on its growing presence in China, one of the world's largest pharmaceutical markets,” Mylan President Rajiv Malik said. “Our expanded partnership on revefenacin represents a natural next step, and together with Theravance Biopharma we look forward to making a meaningful difference for the millions of patients living with COPD in China. Through our continued investment in a comprehensive portfolio of products across the value chain, our deep understanding of the evolving Chinese healthcare landscape, our scientific excellence and innovation, and our industry-leading pipeline, we look forward to continue meeting unmet needs for patients in China and the world over."

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. Theravance Biopharma is eligible to receive up to $259 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on US sales and double-digit royalties on ex-US 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).

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 Mylan N.V.

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