GAITHERSBURG, MD - Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024. 

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact. 

“CYFENDUS™ vaccine is a critical component of Emergent’s anthrax medical countermeasures franchise, and supports the U.S. government's anthrax preparedness strategy,” said Paul Williams, senior vice president, products head at Emergent. “This procurement helps ensure the nation has sufficient anthrax vaccine and aligns with Emergent’s longstanding commitment to strengthen public health preparedness.” 

In 2016, BARDA and Emergent extended their partnership to support clinical development and manufacturing efforts for the AV7909 vaccine, including a Phase 3 trial to demonstrate safety and efficacy, working toward the goal of eventual FDA licensure. A pre-Emergency Use Authorization (EUA) package was submitted in December 2018, and the first pre-EUA doses of AV7909 were delivered to the U.S. government in 2019. In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023. This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts. 

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority under contract HHSO100201600030C.

SAN DIEGO, CA - Asteres Inc., the industry’s leading provider of ScriptCenter® automated lockers and kiosks for prescriptions and personal care products in retail, hospital, and Veteran’s Affairs/Department of Defense (VA/DoD) pharmacies announced today a new group purchasing contract agreement with AllSpire Health GPO to create new savings opportunities for their member hospitals.

ScriptCenter^®, Asteres’ innovative technology, provides a quick and convenient prescription pickup destination for hospital employees, especially those who work when the pharmacy is closed. ScriptCenter® also offers employees the ability to purchase popular retail items such as over-the-counter (OTCs) and personal care products anytime. By offering 24/7 pharmacy services to hospital employees, healthcare systems are able to keep prescriptions ‘in-house’ and substantially reduce pharmacy benefit management (PBM) costs.

"We are committed to working with AllSpire member hospitals in their efforts to improve patient care, reduce PBM costs, and increase pharmacy revenues through employee prescription capture," said David J. Lenny, Asteres President & CEO. “ScriptCenter® has achieved significant savings at multiple AllSpire member locations with impressive paybacks of less than a year and we look forward to helping other AllSpire members recognize similar results while improving patient care."

“We look forward to leveraging ScriptCenter® to improve operational efficiency, reduce costs, and ultimately, deliver enhanced healthcare experiences for our member hospitals,” said Robert Waite, Director of Pharmacy at AllSpire Health GPO.

Texas A&M University’s Irma Lerma Rangel School of Pharmacy is responding to the increasing demand for pharmacy technicians in Texas by adding the Aggie Pharmacy Technician Program (PTP) to its educational offerings.

Pharmacy technicians play a crucial role alongside pharmacists in various health care settings, including hospitals, clinics and pharmacies to prepare and dispense medications, manage inventory, administer vaccines and facilitate communication with patients and health care providers.

“Pharmacy technicians are vital members of the health care team and contribute to delivering effective and timely patient care,” said Andrea Mora, Aggie PTP program director, clinical associate professor and associate department head of pharmacy practice. “A shortage of pharmacy technicians can result in reduced pharmacy business hours, backlogs of unfilled prescriptions, delays in patients receiving their medications and suboptimal health outcomes. Texas is experiencing a shortage and is in dire need of pharmacy technicians,”

The Aggie PTP curriculum, spanning 17 weeks, is shorter than many other programs, and is based on the apprenticeship model where students practice in retail or hospital pharmacies what they learn in the classroom and lab.

“We are working with various pharmacy partners to create paid apprenticeship opportunities for our Aggie PTP trainees. This will mean that during the last five weeks of the curriculum, our trainees will be able to earn while they learn,” said Asim Abu-Baker, clinical professor and associate dean for clinical and professional affairs.

The program also provides American Pharmacists Association Immunization Delivery training for technicians. Upon completion of the program, students will be certified to administer certain immunizations.

The cost of tuition is half as much as the average cost of other technician programs in Texas. The WoodNext Foundation has generously gifted the Rangel School of Pharmacy $1 million to create the Aggie Pharmacy Technician Program and support incoming students in various ways, including scholarships.

The program is seeking American Society of Health System Pharmacists (ASHP) and American Council on Pharmaceutical Education (ACPE) accreditation, ensuring quality and compliance with their standards, as well as the principled Texas A&M standards. Unique to Aggie PTP, courses are taught by Rangel School of Pharmacy Pharm.D. and Ph.D. faculty, and academic support is provided to participants through Pharm.D. peer mentors and other supplemental instructors.

“The Aggie PTP is looking for applicants who are hard-working, motivated, conscientious with high morals, and eager to make a positive impact on patients’ lives,” Mora said.

The program is accepting applicants, with an application deadline set for Jan. 1. The first cohort of students will begin in Spring 2024.

To learn more about eligibility or to apply, visit Aggie PTP.

Kenneth L. Davis, MD, a transformative leader who has been Chief Executive Officer of the Health System and its predecessor since 2003, will become Executive Vice Chairman of the Mount Sinai Boards of Trustees. Both appointments are effective early next year.

“Dr. Carr is a visionary leader and physician who will chart an exciting course for the Health System,” said Richard A. Friedman and James S. Tisch, Co-Chairmen of the Boards of Trustees of the Mount Sinai Health System. “We are certain that he will propel Mount Sinai to further success in our mission to provide compassionate patient care through unrivaled education, research, and outreach in the many diverse communities we serve.”

Mr. Friedman and Mr. Tisch added: “We want to once again thank Dr. Davis for his remarkable and transformative tenure leading Mount Sinai for more than 20 years, and are delighted that we will continue to benefit from his wisdom in his new role. We are extremely fortunate and grateful for Ken’s service and equally excited and honored to have a physician-executive as qualified and accomplished as Dr. Carr as the system’s next leader.”

As Chief Executive Officer, Dr. Carr will report to the Boards of Trustees. In partnership with them, he will chart a strategy for Mount Sinai’s next chapter, and will oversee all critical strategic, operational, and business-building areas of the Health System, including its eight hospitals, the Icahn School of Medicine at Mount Sinai, and more than 400 ambulatory locations and physician practices.

"I am honored and deeply grateful for the opportunity to lead this preeminent institution and dynamic team of people who care deeply about advancing health for the patients and communities we serve,” Dr. Carr said. “Together, we will continue to innovate in order to provide the safe, high-quality, and equitable care that our patients deserve and expect. I would also like to recognize Dr. Davis for his tremendous accomplishments and thank Jim and Rich for their support and partnership.”

Dr. Davis became President and Chief Executive Officer of The Mount Sinai Medical Center in 2003 and of the Mount Sinai Health System upon its formation in 2013. He has led Mount Sinai through an era of unprecedented growth and change, including the creation of the Health System, the transformation of care delivery, the COVID-19 pandemic, and sustained academic and research growth.

“I look forward to working with Brendan in the next few years,” Dr. Davis said. “With Brendan and our existing leadership team, I know the system is in the right hands as we continue to serve New York with the exacting precision and immense passion that are the hallmarks of Mount Sinai.”

Dr. Carr is currently Mount Sinai Professor in Emergency Medicine at Icahn Mount Sinai and Chair of Emergency Medicine for the Mount Sinai Health System. As a renowned emergency physician and health policy researcher, he has focused on building regional systems of emergency care, especially for trauma, stroke, cardiac arrest, and sepsis, and developing innovative delivery system solutions to create a more distributed and accessible acute-care delivery system. He has served in an advisory role to domestic and international organizations and is a member of the National Academy of Medicine.

Dr. Carr previously served on the faculty at the Perelman School of Medicine at the University of Pennsylvania and as an Associate Dean of the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. In addition to his academic accomplishments, Dr. Carr also served the U.S. Department of Health and Human Services in a variety of roles focused on improving trauma and emergency care delivery for the nation. His portfolio focused on aligning the public sector and private sector response during disasters and public health emergencies.

Dr. Carr earned his medical degree from Temple University School of Medicine, and completed both his residency in emergency medicine and his fellowship in trauma and surgical critical care at the University of Pennsylvania. He is an alumnus of the Robert Wood Johnson Foundation’s Clinical Scholars Program and holds master’s degrees in both clinical psychology and health policy research. He is an accomplished researcher, has authored more than 175 manuscripts, and has received funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and multiple foundations.

RAHWAY, NJ & CAMBRIDGE, MA - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Caraway Therapeutics, Inc. announced today that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments. The upfront payment will be expensed by Merck in the fourth quarter of 2023 and included in non-GAAP results.

“Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases,” said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories. “We look forward to applying our expertise to build upon this work with the goal of developing much needed disease-modifying therapies for these conditions.”

Caraway is a preclinical biopharmaceutical company pursuing innovative approaches for the treatment of genetically defined neurodegenerative and rare diseases. The company has built a pipeline of novel, small-molecule therapeutics for the treatment of genetically defined neurodegenerative and rare diseases.

“This important milestone is a testament to the hard work and dedication of the Caraway team and our mission to develop therapeutics with the potential to alter the progression of devasting neurodegenerative diseases and help patients,” said Martin D. Williams, chief executive officer, Caraway Therapeutics. “This acquisition leverages Merck’s industry-leading research and development capabilities to help further advance our discovery and preclinical programs. We thank and appreciate our investors, including SV Health Investors and its Dementia Discovery Fund, AbbVie Ventures, Amgen Ventures, Eisai Innovation and MRL Ventures Fund for their support.”

Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Caraway with earnout milestones associated with the development of certain pipeline candidates. The Board of Directors of Caraway Therapeutics has approved the transaction. Merck, through its MRL Ventures Fund, has been a shareholder of Caraway Therapeutics since 2018.

PRINCETON, NJ & CAMBRIDGE, MA - Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA. The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

The companies anticipate that the committee will review data related to the secondary endpoint of overall survival (OS). The companies look forward to continuing discussions with the FDA and participating in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment. The ODAC meeting has no impact on the currently approved indication for Abecma for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.

The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard regimens, significantly reducing the risk of disease progression or death versus standard regimens in patients with triple-class exposed RRMM. Safety results were consistent with the well-established and generally predictable safety profile of Abecma. Final PFS data and interim OS data from the KarMMa-3 study will be presented on December 11 at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed RRMM based on the KarMMa-3 study results are also currently under review by Japan’s Ministry of Health, Labour and Welfare, European Medicines Agency and Swissmedic.

Researchers at the University of São Paulo (USP) in Brazil, partnering with Foresee Pharmaceuticals, a Taiwan and US-based biopharmaceutical company, have tested a synthetic molecule for the treatment of heart failure. The study, funded by FAPESP, was published in the European Heart Journal. The theme was also highlighted in the magazine's editorial.

Heart failure is a condition in which the heart muscle cannot pump enough blood to meet the body's needs for blood and oxygen. It causes more deaths worldwide than any other disease, in the sense that other cardiovascular disorders tend to lead to heart failure, which affects over 2 million people in Brazil. A number of drugs can slow its progression but currently no treatment exists that can reverse it even partially. A heart transplant is considered if the condition becomes severe.

In the translational study conducted at USP, several experiments were conducted to demonstrate the effect of the molecule, named AD-9308, to restore the activity of the enzyme aldehyde dehydrogenase 2 (ALDH2), which is present in mitochondria (the organelles that generate energy to power cells’ biochemical reactions) and plays a key role in heart failure.

“The study lasted more than ten years and included both laboratory experiments and samples from heart failure patients with the aim of understanding a novel mechanism involved in heart failure progression. In parallel with our experiments, the biopharmaceutical company worked on improving the efficacy of a molecule described back in 2014, which has potential to treat cardiac diseases,” said Julio Cesar Batista Ferreira, corresponding author of the article and a professor at the Institute of Biomedical Sciences (ICB-USP).

The molecule prototype compound first described was named Alda-1. At the time, the researchers found that the drug compound increased heart function by 40% in rats with heart failure and that this effect was due to activation of ALDH2 in cardiac cells (more at: https://agencia.fapesp.br/19463).

Structural modifications were made to the original molecule to boost its pharmacological properties and qualify it as a potential development compound. After many versions iterations and tests, the scientists at Foresee Pharmaceuticals developed the AD-9308. “This new version activates the enzyme ALDH2 three times more than the original molecule,” Ferreira said.

The biopharmaceutical firm has completed clinical trials of another molecule similar to AD-9308, assuring its safety. “The results show that the synthetic molecule is well tolerated by healthy subjects. These are the required steps to apply to the FDA for permission to test the drug in heart failure patients. However, it requires more volunteers and more time, but it’s the only way to find out which kind of heart failure it could treat and at what stage of the disease,” he explained. The FDA is the United States Food and Drug Administration, responsible for protecting public health by assuring the safety and efficacy of human and veterinary drugs, among other duties.

Mitochondrial malfunction

Several studies conducted at ICB-USP in the past ten years have shown that heart failure is associated with mitochondrial malfunction. Like a car engine, mitochondria convert chemical energy into mechanical energy, which the heart needs to pump blood. “When a car engine isn’t running properly, energy conversion is impaired, efficiency drops, and pollution increases,” Ferreira said.

The “pollutant” produced by mitochondria in people with heart failure is 4-hydroxynonenal, a compound belonging to the class of aldehydes. “Every cell has hundreds or sometimes thousands of mitochondria, which produce enough aldehyde to poison the entire cell when they aren’t running properly. We discovered in this latest study that too much of 4-hydroxynonenal switches off a vital event for the cell: processing of microRNAs [small non-coding RNAs that regulate the activity of other genes],” he said.

Using mass spectrometry, the researchers observed that 4-hydroxynonenal [the aldehyde produced by mitochondria] binds irreversibly to Dicer [a protein essential to microRNA formation] and inactivates it. “In addition, we showed that AD-9308 improves mitochondrial filtration enough to eliminate this cellular pollutant,” he said.

Animals genetically engineered to lack Dicer are known to develop heart failure. “In this study, we identified the chemical alterations that inactivate Dicer in rodents and humans owing to the accumulation of aldehyde caused by heart failure. This was a hitherto unknown mechanism. The point is that Dicer is a limiting enzyme for formation and maturation of the microRNAs responsible for overall control of cellular biology,” he said. Interruption of microRNA formation and maturation is associated with several health problems, including cancer, metabolic syndrome, neurodegenerative disorders, and cardiovascular disease.

In experiments involving animals, cell cultures and heart tissue samples from the Heart Institute (Incor) at Hospital das Clínicas, the hospital complex run by the university’s Medical School (FM-USP), the researchers found that aldehyde binding makes Dicer stop working and reduces the amount of microRNAs available to the heart.

In addition to their discovery of this novel mechanism associated with heart failure, the researchers showed in samples of human heart tissue that the disorder can be reversed, and Dicer activity restored using the drug AD-9308.

“In summary, AD-9308 stimulates the removal of aldehyde from sick cells, reducing the likelihood that it will ‘switch off’ Dicer and hence protecting the heart cells. This tends to keep the microRNA profile closer to that of a healthy heart. I consider our partnership with Foresee Pharmaceuticals a success. It's been essential to our multidisciplinary multicenter research and development, producing highly promising results that can now be trialed in patients,” Ferreira said. 

BETHESDA, MD - Today, The Pharmacy Technician Society℠(TPTS), a national membership organization exclusively dedicated to further elevating pharmacy technician roles in patient care and recognizing their significant contributions to healthcare, launched its operations.

Created by ASHP (American Society of Health-System Pharmacists), TPTS is a new organization led by and comprised of pharmacy technicians to provide critical advocacy and advancement opportunities for the pharmacy technician workforce in all patient care settings. The new organization offers a range of services, including comprehensive continuing education, career development, networking, publications and resources, and standards for the professional practice of pharmacy technicians. TPTS will also advocate for federal and state policies and regulations that promote safe and effective medication use and advanced technician roles.

"Pharmacy technicians are critical members of the pharmacy workforce who provide valuable patient care services across the continuum of care and are instrumental in achieving optimal medication outcomes," said ASHP CEO Paul W. Abramowitz, PharmD, ScD (Hon), FASHP. "We believe TPTS will make significant inroads in elevating the role of pharmacy technicians as part of the healthcare team and are proud to lend our extensive experience to create a new organization dedicated to providing education, resources, and needed advocacy to empower current and aspiring pharmacy technicians."

The ASHP Pharmacy Technician Forum, launched in 2018, created the foundation for the formation of TPTS. With the launch of the new organization, ASHP will gradually transition the activities of the Pharmacy Technician Forum to TPTS, with all existing ASHP technician members automatically receiving dual membership to both organizations.

TPTS is offering pharmacy technicians a free trial membership through June 30, 2024, with all members receiving:

• Access to continuing education, webinars, podcasts, and practice resources such as a monthly newsletter, a comprehensive website, and career development services.
• Opportunities to connect with other pharmacy technician professionals across the country through live and virtual networking forums.
• National and state advocacy on behalf of pharmacy technicians.
• Venues to create and advocate for policies and regulations that promote safe medication use and create advanced practice positions for technicians.
• Toolkits, guidelines, publications, and other resources that support the daily work and advancement of pharmacy technicians.

"TPTS will devote substantial attention to addressing the significant workforce opportunities and challenges faced by pharmacy technicians building on ASHP's longstanding commitment to these vital members of the pharmacy workforce," said Hannah K. Vanderpool, PharmD, MA, executive director of TPTS and vice president of ASHP's office of member relations. "We need to ensure technicians across all practice settings have the support they need to thrive and are pleased to provide a new professional home solely dedicated to empowering pharmacy technicians as we support advancements in technicians' careers, expansion of technician knowledge and skills, and advocacy and leadership for the technician workforce."

The U.S. Bureau of Labor and Statistics projects that employment of pharmacy technicians will grow 6% from 2022 to 2032, with more opportunities expected for technicians to expand their roles as increased demand for healthcare services continues. Despite a positive job outlook, recent surveys have highlighted technician workforce challenges. Nearly three-quarters (74%) of hospitals reported shortages of entry-level pharmacy technicians, and 96% experienced shortages of experienced pharmacy technicians, according to the 2022 ASHP National Survey of Pharmacy Practice in Hospital Settings.

TPTS will appoint members to its inaugural Board of Directors in 2024, and technicians will vote for TPTS Board members going forward. Technicians interested in serving in the inaugural TPTS Board of Directors can submit an application by January 31, 2024.

For more information about TPTS, visit pharmtechsociety.org.

LEBANON, TN – Pharmacy Angle, powered by Health Connect Partners, is proud to announce it will be an exhibitor at this year’s ASHP Midyear Clinical Meeting & Exhibition, December 3-7, 2023, inside the Anaheim (CA) Convention Center. Pharmacy professionals attending are encouraged to visit Booth 439 where Pharmacy Angle and Health Connect Partners (HCP) staff will be on hand providing demonstrations of the newest digital resource within the industry and discussing HCP’s annual live & virtual pharmacy conferences.

While exhibiting at ASHP, Pharmacy Angle will be filming new segments for its online Executive Insight videos series (link to examples). The platform is looking for industry leaders willing to volunteer to discuss trending topics, current challenges, and advice for peers who watch the video. If you are interested in scheduling a 15-20-minute recording session at the Pharmacy Angle booth during the exhibit hours, please email the Director of Content, Digital Media at greg.herring@pharmacyangle.com.

Pharmacy Angle, which launched September 7^th of this year, serves as a hub for trending industry news, peer-to-peer educational & professional insights in both written and video form, and an easy-to-use supplier directory. Through a bi-monthly e-newsletter, this valuable content is delivered directly into the inbox of over 10,000 of the most influential hospital pharmacy decision makers in the country. Those currently not receiving the newsletter are encouraged to sign up on the homepage at PharmacyAngle.com.

For those providers unfortunately unable to attend the ASHP Midyear Meeting but have an interest in providing content through a written article or virtual interview, please email Greg Herring at the email address above. Likewise for suppliers who would like to learn more about advertising opportunities and the supplier directory, they can connect via email with Allen Roberson at allen.roberson@pharmacyangle.com. 

PITTSBURGH, PA - Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced positive results from the YUPELRI^® (revefenacin) Phase III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of YUPELRI, a once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of patients with COPD. Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV₁ (forced expiratory volume in one second) versus placebo. The results are comparable to those from studies of the same design used for U.S. registration and provide support for a regulatory filing in China anticipated to occur in mid-2024.

Top Line Results Highlights:

• A total of 258 patients enrolled with 257 included in safety and full analysis sets. Both groups were well balanced for baseline characteristics with 129 treated with YUPELRI and 128 treated with placebo.
• Study population was moderate to very severe COPD patients with mean baseline FEV₁ approximately 50% predicted. Approximately two-thirds of patients remained on long-acting beta-2 agonist/inhaled corticosteroids throughout the study.
• Primary efficacy analysis of change from baseline in trough FEV₁ measured 24 hours after the final dose at week 12 detected a mean (95% confidence intervals) treatment difference of 150.9 (104.1, 197.7) mL compared to placebo.
• Safety and tolerability profile assessed by summary of adverse events consistent with U.S. package insert.

Viatris President Rajiv Malik said, "We are pleased with the positive top-line results of our Phase III clinical results for YUPELRI in China. The strength of the data and the primary endpoint analysis, which is consistent with our U.S. clinical data, firmly supports a comparable efficacy and safety profile of YUPELRI. With this data, we look forward to progressing our regulatory application in China and continue to believe, when approved, a once-daily nebulized revefenacin product will be an important therapeutic option for the millions of patients in the region with COPD."

"Given its novel profile, we and Viatris share a commitment to make YUPELRI available for as many COPD patients as possible, particularly those who stand to benefit from nebulized therapy, and we commend VIATRIS on the execution of this study," said Rick E Winningham, CEO of Theravance Biopharma.  "The consistent lung function improvement demonstrated in this study supports the use of LAMA therapy as foundational in a range of patients and we are encouraged that COPD patients in China may soon have the opportunity to benefit from a new, valuable treatment option."

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 $266 billion in costs annually².

About the Study
The Phase III study was designed to compare the efficacy and safety of revefenacin (175mcg) and double-blind placebo nebulized once-daily in moderate to very severe COPD patients in China over a 12-week treatment period.

About Theravance Biopharma / Viatris Collaboration
Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Theravance Biopharma and Viatris co-promote YUPELRI^® (revefenacin) in the U.S., with their combined sales infrastructure targeting healthcare professionals who treat COPD patients suitable for YUPELRI. In 2019, the companies announced the expansion of their development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories, which include Hong Kong SAR, the Macau SAR and Taiwan.