MONTREAL, June 26, 2025 /CNW/ - Pendopharm®, a division of Pharmascience Inc., has entered into an exclusive distribution agreement with KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a global biopharmaceutical company focused on the development of novel oral treatments for rare diseases. This agreement grants Pendopharm® the rights to manage regulatory approval and commercialization of sebetralstat, an investigational oral therapy for Hereditary Angioedema (HAE), developed by KalVista® in Canada. Financial details of the agreement remain confidential.

Sebetralstat is poised to become the first oral on-demand treatment for hereditary angioedema in Canada. This treatment addresses a critical need for patients living with HAE - a rare and potentially life-threatening genetic disorder marked by unpredictable episodes of severe swelling. ¹

"HAE can significantly disrupt patients' lives due to sudden, severe and potentially life threatening attacks of swelling" said Dr. Stephen Betschel, Chair of the Canadian Hereditary Angioedema Network. "This potential new therapeutic option would be welcomed, and would represent a significant advancement in the treatment of HAE in Canada".

Jad Isber, Vice President & General Manager of Pendopharm®, emphasized the company's dedication to patient care: "This collaboration reflects our mission to deliver therapies that address unmet medical needs. We look forward to working with healthcare providers across Canada to ensure access to sebetralstat for those who need it."

"We are pleased to partner with Pendopharm®, whose expertise in the Canadian healthcare landscape and established success in pharmaceutical commercialization make them a well-suited collaborator," said Ben Palleiko, CEO of KalVista®. "This agreement advances our mission to make sebetralstat accessible worldwide as the first and only oral on-demand treatment with the potential to change the way HAE is managed."

About Sebetralstat

Sebetralstat is an investigational oral therapy developed for the on-demand treatment of acute HAE attacks. It is currently under regulatory review in several countries as a potential oral therapy for hereditary angioedema (HAE). ¹

About Hereditary Angioedema (HAE)

HAE is severe swelling (angioedema) in various parts of the body, including the hands, feet, genitals, stomach, face and/or throat. Swelling in the airway can restrict breathing and be fatal. The vast majority of people with HAE have a genetic defect that causes a deficiency in the plasma protein called C1-Inhibitor. HAE is also seen in people who have normal levels of C1-Inhibitor, however, genetic defects in other genes cause their angioedema. ²

About Pendopharm

Pendopharm®, a division of Pharmascience Inc., is a Canadian specialty pharmaceutical company that partners with various companies to bring treatments in areas such as rare diseases, gastroenterology, sports medicine, neurology, and cardiology to the Canadian market.

For more information about Pendopharm®, please visit www.pendopharm.com. Please do not further distribute this press release.

© 2025 Pendopharm®, division of Pharmascience Inc. All rights reserved.

Pendopharm® is a registered trademark owned by Finchley Research and Development Inc., used under license by Pharmascience Inc.

Kalvista® is a registered trademark owned by Kalvista Pharmaceuticals Limited.

About Pharmascience Inc.

Headquartered in Montreal, Pharmascience Inc. is one of Canada's largest pharmaceutical manufacturers, supplying high-quality medicines to over 50 countries. Its global reach and agile development model ensure timely responses to patient needs worldwide.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.

For more information about KalVista®, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.

References

1. Riedl, M. A., Wedner, H. J., et al. Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks. N Engl J Med. 2024;390(22):2031-2041.
2. HAE Canada. (2022, August 18). What is HAE? - HAE Canada - AOH Canada. HAE Canada - AOH Canada. https://haecanada.org/what-is-hae/

SOURCE Pendopharm