Chiesi Group Completes Acquisition of KalVista Pharmaceuticals
Positioned to Expand Patient Access and Accelerate Impact in Rare Diseases
With the completion of the transaction, Chiesi assumed ownership of EKTERLY® (sebetralstat), the first and only oral, on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is already approved in
Completion of the Tender Offer and Transaction Details
On
As a result of the merger,
Advisors
Lazard served as exclusive financial advisor to Chiesi and
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About EKTERLY® (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in
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. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.
About
Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.
By changing its legal status to a
With 90 years of experience, Chiesi is headquartered in
For more information, visit www.chiesi.com or the website of your local Chiesi affiliate.
About Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a business unit of the
For more information, visit www.chiesirarediseases.com.
About KalVista Pharmaceuticals, Inc.
KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed sebetralstat—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world.
For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
EKTERLY® (sebetralstat) is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
IMPORTANT SAFETY INFORMATION
Adverse reactions: The most commonly reported adverse reaction was headache.
Drug interactions: EKTERLY is a substrate of CYP3A4. Concomitant use of EKTERLY with a strong CYP3A4 inhibitor increases sebetralstat exposure, which may increase the risk of sebetralstat adverse reactions. Avoid use of EKTERLY with strong CYP3A4 inhibitors and reduce the dose of EKTERLY to one dose of 300 mg (one tablet) with moderate CYP3A4 inhibitors. Concomitant use of EKTERLY with a strong or moderate CYP3A4 inducer decreases sebetralstat exposure, which may decrease efficacy. The use of EKTERLY with strong or moderate CYP3A4 inducers is not recommended.
Use in specific populations: Avoid use of EKTERLY in patients with severe hepatic impairment (Child-Pugh Class C). The recommended dosage of EKTERLY is one dose of 300 mg (one tablet) in patients with moderate hepatic impairment (Child-Pugh Class B).
There are no available data on EKTERLY in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no data on the presence of sebetralstat or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
The safety and effectiveness of EKTERLY in pediatric patients aged under 12 years of age have not been established.
To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
FORWARD-LOOKING STATEMENT
This communication contains forward-looking statements related to Chiesi and KalVista. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “target,” “seek,” “believe,” “project,” “estimate,” “expect,” “position,” “strategy,” “future,” “likely,” “may,” “should,” “will” or the negative of these terms or similar references to future periods, although not all forward-looking statements contain these words. In this communication, forward-looking statements include statements about the post-closing operations and the outlook for the parties’ businesses, including, without limitation, the ability to commercialize current and future product candidates (including further commercialization of EKTERLY). Forward-looking statements are subject to certain risks, uncertainties or other factors that are difficult to predict, and could cause actual events or results to differ materially from those currently indicated in any such statements due to a number of risks and uncertainties. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of U.S. Food and Drug Administration approvals or actions, if any; the impact of competitive products and pricing; the risk that the businesses will not be integrated successfully and that Chiesi may not realize the potential benefits of the transactions; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; actual or contingent liabilities; the success of the parties’ efforts to commercialize EKTERLY, including revenues from sales of EKTERLY; the ability to successfully obtain additional foreign regulatory approvals for sebetralstat; expectations about the safety and efficacy of sebetralstat; and expectations regarding market adoption and utilization trends.
You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to Chiesi and KalVista, and Chiesi and KalVista disclaim any obligation to update the information contained in this communication as new information becomes available.
PP-RA-02172 V1.0
View source version on businesswire.com: https://www.businesswire.com/news/home/20260610759093/en/
Press Info:
Chiesi Group:
Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com
Chiara Travagin, Head of Global Communications, Rare: mobile +39 348.8818985, e-mail: c.travagin@chiesi.com
Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com
Source: KalVista Pharmaceuticals, Inc.