Multicare, KalVista to expand oral HAE treatment in Latin America

Multicare Pharmaceuticals and KalVista Pharmaceuticals have signed a partnership to introduce an oral, on-demand treatment for hereditary angioedema in key Latin American markets, expanding access to a therapy already approved in the United States and the European Union.

The agreement reflects a broader effort to reduce gaps in rare disease care in the region, where delayed diagnosis and limited treatment options remain common. “Time — currently the main enemy of the patient with a rare disease — must become their greatest ally,” writes David López, Former Managing Director For Mexico and the Central America and Caribbean Region , BioMarin Pharmaceuticals Mexico.

Under the terms of the agreement announced Jan. 14, Multicare will manage regulatory registration, importation, and distribution of KalVista’s oral therapy for hereditary angioedema (HAE) in Brazil, Argentina, Colombia, and Mexico. Financial terms were not disclosed. The product is the first and only oral, on-demand treatment approved for acute HAE attacks and is marketed in the United States and the European Union.

HAE is a rare genetic disorder caused by a deficiency or dysfunction of the C1 esterase inhibitor, which leads to uncontrolled activation of the kallikrein-kinin system. Patients experience recurrent episodes of swelling that can be painful and, in some cases, life-threatening. Until now, approved on-demand treatments have required intravenous or subcutaneous administration, creating logistical and clinical burdens for patients and caregivers.

KalVista’s therapy is a plasma kallikrein inhibitor approved for patients 12 years and older in multiple markets, including the United States, the European Union, the United Kingdom, Switzerland, Singapore, Australia, and Japan. Clinical trials are ongoing to evaluate its use in children ages two to 11, and additional regulatory reviews are underway globally.

Multicare, which has operated in Latin America for more than 40 years, specializes in the licensing, registration, and commercialization of therapies for rare and complex diseases. The company says its regional infrastructure and experience navigating regulatory processes were key factors in the partnership. KalVista, a global biopharmaceutical company focused on rare diseases, developed the therapy as part of a strategy to address unmet medical needs through less invasive treatment options.

The agreement comes as rare disease care in Latin America faces persistent structural challenges. López, drawing on two decades of experience in Mexico’s biopharmaceutical sector, explains that early diagnosis remains the exception rather than the rule. In cases where multiple family members are affected or where a physician has specific expertise in rare diseases, diagnosis may occur early enough to allow timely intervention. More often, however, patients and families face what is known internationally as a “diagnostic odyssey,” a process that can last for years.

Data cited by industry experts show that in the European Union the average time from first symptoms to correct diagnosis for a rare disease is nearly five years, with longer delays reported in Spain and Latin America. In Mexico, estimates from the Mexican Rare Diseases Registry suggest delays of seven to eight years, with patients often consulting six to eight specialists before receiving a definitive diagnosis. During this period, symptoms such as muscle weakness, recurrent infections, respiratory difficulties, or joint problems may be attributed to more common conditions, delaying clinical suspicion of a rare disorder.

The consequences of delayed diagnosis are both clinical and economic. By the time a diagnosis is made, many patients already have irreversible organ damage or functional impairment. Studies cited by López indicate that diagnostic delays in pediatric patients increase the risk of neurological and developmental complications, while in adults they may limit the effectiveness of available therapies. For health systems, prolonged diagnostic journeys lead to higher costs from repeated tests, hospitalizations, and treatments that address symptoms rather than underlying causes.

Within this context, an oral, on-demand treatment for HAE can signal a broader shift toward improving quality of life for patients with rare diseases. Oral administration can reduce reliance on hospital-based care and trained personnel, allowing patients to manage acute attacks more promptly. While the therapy does not address diagnostic delays directly, access to effective and easier-to-administer treatments can mitigate some of the long-term impacts of late diagnosis.

Experts argue that improving rare disease outcomes in Latin America will also require systemic changes, including expanded medical training, faster referral pathways, greater access to genetic testing, and the consolidation of specialized centers. Digital tools and data-sharing initiatives, such as national rare disease registries, are increasingly cited as mechanisms to shorten diagnostic timelines.

For Multicare and KalVista, the partnership positions both companies within this evolving landscape. KalVista gains a regional partner with established regulatory and distribution capabilities, while Multicare adds a first-in-class therapy to its portfolio. For patients in Brazil, Argentina, Colombia, and Mexico, the agreement could translate into earlier access to a treatment option already in use in other major markets.

As López says in his assessment of rare disease care, late diagnosis is not merely an administrative issue but a determinant of health outcomes. The expansion of therapies such as KalVista’s oral HAE treatment highlights how industry partnerships can play a role in addressing unmet needs, even as broader efforts continue to reduce the time between symptom onset and diagnosis across Latin America.