-Sebetralstat has potential to become first oral on-demand treatment for HAE in Canada-
-Pendopharm brings proven track record in commercializing innovative therapies across multiple therapeutic areas with capabilities to launch sebetralstat in Canadian market-
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that its wholly-owned subsidiary, KalVista Pharmaceuticals, Ltd., has granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Sebetralstat is an investigational, oral on-demand treatment for hereditary angioedema (HAE).
"We look forward to collaborating with Pendopharm, whose deep knowledge of the Canadian market and proven track record make them a strong partner as we work to bring sebetralstat to people living with HAE," said Ben Palleiko, CEO of KalVista. "This partnership supports our broader goal of making sebetralstat available globally, as the first and only oral on-demand treatment that has the potential to transform HAE care."
Financial terms of the agreement are not being disclosed.
About Sebetralstat
Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.
About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.
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
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.
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.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will," and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timings or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.
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Contacts:
Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Molly Cameron
Director, Corporate Communications
(857) 356-0164
molly.cameron@kalvista.com
