Theravance Biopharma's YUPELRI® Receives Regulatory Green Light
Theravance Biopharma's YUPELRI® Approves by China's NMPA
Theravance Biopharma, Inc. (NASDAQ: TBPH) has announced a major achievement with the approval of YUPELRI® (revefenacin) by China’s National Medical Products Administration (NMPA). This landmark decision positions YUPELRI as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) to be approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in patients. This innovative treatment option is vital as it offers an essential alternative for managing COPD, a condition that significantly impacts patients' quality of life.
Significant Financial Milestones
The approval of YUPELRI marks a critical milestone for Theravance Biopharma, triggering a one-time milestone payment of $7.5 million from Viatris, the partner responsible for launching and commercializing the drug in the region. In addition to this initial milestone, Theravance Biopharma stands to gain up to $37.5 million in further sales-based milestones and tiered royalties ranging from 14% to 20% on net sales in China. This financial injection is expected to be substantial given the potential demand for effective COPD treatments in the growing market.
Commercialization Strategy
Theravance Biopharma bears no commercial costs associated with the launch, as Viatris will handle all aspects of development and commercialization of YUPELRI in China. This partnership allows Theravance to focus on its core operations while capitalizing on the significant market opportunity presented by the approval.
Enhancing Financial Position
This regulatory success aligns with Theravance Biopharma’s ongoing efforts to enhance its financial stability and growth. Recently, the company reported cash reserves of $131 million as of a previous quarter, bolstered by an additional $225 million from the sale of TRELEGY royalties to GSK. Moreover, the company retains a share of 35% of U.S. YUPELRI profits, further solidifying its financial backbone. These developments reflect Theravance Biopharma’s strategy of diversifying its revenue streams, securing financial sustainability, and enhancing shareholder value.
Research and Development Efforts
In addition to YUPELRI, Theravance is advancing its investigational drug ampreloxetine for treating neurogenic orthostatic hypotension in patients with multiple system atrophy (MSA). As the company approaches the completion of participant enrollment in the open label portion of the CYPRESS study—a pivotal clinical trial for ampreloxetine—there is promise for addressing significant unmet needs in this rare neurological disorder.
About YUPELRI®
YUPELRI is designed for patients suffering from COPD, aiming to improve their overall respiratory function and quality of life. The administration of YUPELRI via nebulization provides a user-friendly approach that could enhance treatment adherence and patient outcomes. The design of once-daily dosing potentially simplifies the medication regimen for patients, making it a beneficial option for both patients and healthcare providers.
About Theravance Biopharma
Theravance Biopharma is committed to delivering innovative and effective medicines that make a meaningful difference in patients' lives. The company’s focus on developing therapies that meet crucial health needs illustrates its dedication to improving health outcomes. With a strong portfolio including FDA-approved medicines and promising clinical assets, Theravance Biopharma is well-positioned to make significant contributions to the field of biotechnology.
Frequently Asked Questions
What is YUPELRI® and what is its primary use?
YUPELRI® (revefenacin) is a once-daily nebulized LAMA approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Who is responsible for the commercialization of YUPELRI in China?
Viatris is tasked with the launch and commercialization of YUPELRI in China, relieving Theravance Biopharma of those responsibilities.
What financial benefits will Theravance Biopharma receive from this approval?
Theravance Biopharma will receive a $7.5 million milestone payment, potential additional sales milestones up to $37.5 million, and tiered royalties from net sales in China.
What other drugs are in Theravance's pipeline?
Theravance Biopharma is developing ampreloxetine for symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy (MSA).
How does YUPELRI compare to other COPD treatments?
YUPELRI offers a unique delivery method with a once-daily dosing regimen, making it an appealing alternative for patients managing COPD.
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