BOEHRINGER INGELHEIM LAUNCHES FIRST INHALED THERAPY FOR HORSES WITH SEVERE EQUINE ASTHMA IN UNITED STATES

Duluth, Georgia – September 15, 2020 – Boehringer Ingelheim today announced the U.S. launch of the Aservo® EquiHaler® (ciclesonide inhalation spray), the first FDA-approved inhalant therapy for horses with severe equine asthma.

Developed after a decade of collaboration between Boehringer Ingelheim’s human pharmaceutical and animal health businesses, the ASERVO EQUIHALER offers the promise of relief to thousands of horses that suffer from severe equine asthma, which affects 11 to 17 percent of horses.^2,3,4

Horses with severe equine asthma typically have clinical signs that include difficulty breathing, coughing and nasal discharge, which can have a significant impact on a horse’s performance and quality of life.¹ Over time, severely asthmatic horses may develop changes in the lung, which makes it difficult to breathe, even at rest.¹

“We understand the unique and inextricable link between animals and people. By delivering value through innovation, we strive to enhance the wellbeing of both and help shape the future direction of the industry,” said Caroline Belmont, Head of US Global Innovation and US Regulatory Affairs at Boehringer Ingelheim Animal Health. “We are focused on developing breakthrough therapeutics, like the ASERVO EQUIHALER, for animal disease areas with unmet needs to make a true impact in the lives of horses and their owners.”

The ASERVO EQUIHALER marks an industry first in equine medicine, as until now, there has been no FDA-approved inhalant therapy for use in horses with severe equine asthma. Severe equine asthma is an inflammatory disease of the lower airways caused by breathing in high concentrations of organic dust particles small enough to pass with air to the lower airways. Such particles are commonly found in hay and bedding.

Boehringer Ingelheim Animal Health used the Respimat™ inhaler, developed by the company’s human pharmaceutical business, as a basis to develop the unique Soft Mist™ Technology of the ASERVO EQUIHALER,⁵ which is designed specifically for use in horses. The ASERVO EQUIHALER includes an ergonomic handle and dosing lever for ease of user handling, and a nostril adaptor that fits inside the nostril of the horse, allowing them to easily inhale the medicated mist into their lungs.⁶

The active ingredient in the ASERVO EQUIHALER (ciclesonide inhalation spray) is ciclesonide, a glucocorticoid (steroid) that becomes activated in the lungs, which allows for the targeted delivery and activation of the medication. Studies in horses with severe asthma have demonstrated that administration of ciclesonide reversed airway obstruction associated with severe asthma, and to date, ciclesonide is the only glucocorticoid not associated with suppression of serum cortisol, a desired treatment outcome.⁶

To learn more about ASERVO EQUIHALER, visit the ASERVO EQUIHALER WEBSITE.

IMPORTANT SAFETY INFORMATION:
ASERVO EQUIHALER has not been evaluated in pregnant or lactating mares. In a large clinical field study, the most common adverse reactions reported were coughing, nasal discharge, sneezing, and nasal irritation/bleeding. Administration of corticosteroids may worsen existing bacterial, fungal, or viral infection and may induce the first stage of parturition. Do not use in horses with known hypersensitivity to ciclesonide or corticosteroids. Not for use in humans. Keep this and all medications out of the reach of children.

About Boehringer Ingelheim Animal Health USA Inc.

The lives of animals and humans are interconnected in deep and complex ways. We know that when animals are healthy, humans are healthier too.

Across the globe, our 10,000 employees are dedicated to delivering value through innovation, thus enhancing the well-being of both. Respect for animals, humans and the environment is at the heart of what we do.

We develop solutions and provide services to protect animals from disease and pain. We support our customers in taking care of the health of their animals and protect our communities against life- and society- threatening diseases.

Boehringer Ingelheim Animal Health is the second largest animal health business in the world, with net sales of $4.5 billion (4 billion euros) in 2019 and presence in more than 150 countries.

Boehringer Ingelheim Animal Health has a significant presence in the United States, with more than 3,100 employees in places that include Georgia, Missouri, Iowa, Minnesota, New Jersey and Puerto Rico. To learn more, visit www.boehringeringelheim.us, www.facebook.com/BoehringerAHUS or www.twitter.com/Boehringer_AH.

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives.

Since its founding in 1885, Boehringer Ingelheim has been independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

ASERVO® and EQUIHALER® are registered trademarks of Boehringer Ingelheim Vetmedica GmbH, used under license. SPIRIVA® and RESPIMAT® are registered trademarks of Boehringer Ingelheim International GmbH. All other marks are property of their respective owners. ©2020 Boehringer Ingelheim Animal Health USA Inc., Duluth, GA. All rights reserved. US-EQU-0260-2020

References

1. Couëtil, L.L., Cardwell, J.M., Gerber, V., Lavoie, J.P., Léguillette, R. and Richard, E.A., 2016. Inflammatory airway disease of horses—revised consensus statement. J Vet Intern Med, 30(2), pp.503-515.

2. Ivester, K.M., Couëtil, L.L. and Moore, G.E., 2018. An observational study of environmental exposures, airway cytology, and performance in racing thoroughbreds. J Vet Intern Med, 32(5), pp.1754-1762

3. Couëtil, L.L., Ward MP. Analysis of risk factors for recurrent airway obstruction in North American horses: 1,444 cases (1990-1999). J Am Vet Med Assoc 2003;223:1645–50.

4. Wasko, A.J., Barkema, H.W., Nicol, J., Fernandez, N., Logie, N. and Léguillette, R., 2011. Evaluation of a risk‐screening questionnaire to detect equine lung inflammation: results of a large field study. Equine Vet J, 43(2), pp.145-152.

5. Lavoie JP, Leclere M, Rodrigues N, et al. Efficacy of inhaled budesonide for the treatment of severe equine asthma. Equine Vet J. 2018;51(3):401-407.

6. Lavoie JP, Bullone M, Rodrigues N, Germim P, Albrecht B, Salis‐Soglio MV. Effect of different doses of inhaled ciclesonide on lung function, clinical signs related to airflow limitation and serum cortisol levels in horses with experimentally induced mild to severe airway obstruction. Equine Vet J. 2019;51(6):779-786.

7. Mukker JK, Singh RSP, Derendorf H. Ciclesonide: A Pro-Soft Drug Approach for Mitigation of Side Effects of Inhaled Corticosteroids. J Pharm Sci. 2016;105(9):2509-2514.