ESTEVE acquires Caprelsa from Sanofi to boost rare cancer drug portfolio and global specialty focus

Barcelona-based pharmaceutical group ESTEVE has formally signed a deal to acquire Caprelsa® (vandetanib) from Sanofi, marking a strategic expansion into the high-stakes medullary thyroid cancer space. Caprelsa is a protein tyrosine kinase inhibitor used to treat aggressive and symptomatic medullary thyroid carcinoma (MTC) in adults and children over five. ESTEVE’s acquisition includes rights in over 50 countries, positioning the company for deeper global reach in the oncology and endocrine therapeutics segment. The financial details of the agreement have not been publicly disclosed, and the completion is contingent upon standard regulatory approvals.

Originally developed and commercialized under AstraZeneca before being acquired by Sanofi, Caprelsa is one of the only approved systemic therapies for progressive MTC, a rare neuroendocrine tumor that originates in the parafollicular cells of the thyroid and is often resistant to traditional treatment approaches like surgery or radioactive iodine.

What makes Caprelsa’s acquisition critical to ESTEVE’s international rare disease treatment strategy?

The deal reflects ESTEVE’s long-term commitment to therapeutic innovation in underserved medical niches, notably within rare cancers and endocrine disorders. Medullary thyroid carcinoma represents just 1–2% of all thyroid cancers but poses significant treatment challenges due to its neuroendocrine origin and variable progression rates. Vandetanib, the active compound in Caprelsa, works by inhibiting multiple tyrosine kinases such as RET, VEGFR, and EGFR, thus reducing tumor vascularization and cellular proliferation.

In recent years, ESTEVE has systematically aligned its growth strategy with rare disease treatment. In April 2024, the company completed the acquisition of a business focused on ultra-rare endocrine and onco-endocrine diseases, significantly enhancing its presence in niche markets like endogenous Cushing’s syndrome and adrenocortical carcinoma. This trajectory continued with the acquisition of a biologic therapy addressing severe primary insulin-like growth factor 1 deficiency and an adjuvant chemotherapy regimen for pediatric osteosarcoma.

By securing Caprelsa, ESTEVE gains not just market share in a rare indication but also strategic positioning in the tyrosine kinase inhibitor space, which has become increasingly relevant with the rise of molecular oncology and personalized therapeutics.

How are institutional investors and analysts interpreting ESTEVE’s pivot toward oncology and endocrinology?

While ESTEVE is a privately held pharmaceutical entity, analysts tracking rare disease investment trends interpret this latest acquisition as part of a broader realignment seen across mid-sized pharma players seeking differentiation in non-generic, high-value therapeutics. By expanding its portfolio with Caprelsa, ESTEVE positions itself in a segment characterized by lower competition and stronger pricing power, especially given the drug’s orphan designation in several markets including Europe and the United States.

Institutional sentiment leans favorable, with experts viewing the Caprelsa acquisition as synergistic with ESTEVE’s existing rare disease portfolio and manufacturing capabilities. Vandetanib’s relatively stable demand curve and limited direct competition offer revenue predictability while serving an unmet clinical need—two factors highly prized in specialty pharma valuations. This sentiment is amplified by the company’s proven track record of integrating rare disease assets and launching treatments globally through its affiliate networks across Spain, Italy, France, Germany, and the UK.

Why does medullary thyroid carcinoma present a challenging therapeutic landscape for drugmakers?

Medullary thyroid cancer arises from the C cells (parafollicular cells) of the thyroid, which secrete the hormone calcitonin. Unlike other thyroid malignancies, MTC is not iodine-avid and therefore does not respond to standard radioactive iodine therapy. Surgical intervention remains the first-line treatment, but recurrence or metastasis is common in aggressive forms, necessitating systemic interventions.

Caprelsa, approved by regulatory agencies including the European Medicines Agency and the FDA, is one of the few targeted therapies addressing RET mutations, which are frequently implicated in hereditary and sporadic MTC. However, its safety profile requires careful monitoring, particularly in pediatric populations, due to risks of QT prolongation and other cardiovascular side effects.

The complex diagnostic pathway, variable symptom presentation, and relatively small patient population make drug development in this space both scientifically and commercially challenging. ESTEVE’s willingness to enter this segment indicates confidence in its scientific infrastructure, regulatory navigation, and specialist sales channels.

What other therapeutic additions are enhancing ESTEVE’s profile in the rare disease market?

Alongside Caprelsa, ESTEVE has made targeted acquisitions and licensing deals that collectively elevate its rare disease footprint. Earlier this year, it licensed a biologic treatment approved in Europe for managing severe primary insulin-like growth factor 1 deficiency in children aged 2–18. Shortly afterward, the company obtained rights to a therapy used as the standard of care for high-grade, resectable, non-metastatic osteosarcoma in pediatric and young adult patients up to 30 years of age.

These moves reinforce ESTEVE’s strategy of pursuing “high unmet need, low competition” therapies with global relevance. The company’s commercial infrastructure and contract manufacturing operations in Spain, Mexico, and China enable it to scale such products efficiently.

From a pipeline integration standpoint, analysts believe ESTEVE is pursuing a modular rare disease platform strategy—acquiring or licensing narrowly focused treatments that can be channeled through shared clinical, regulatory, and distribution frameworks.

How does ESTEVE plan to integrate Caprelsa and expand its impact across new geographies?

ESTEVE has stated that Caprelsa will be added to its portfolio across more than 50 countries, leveraging its pharmaceutical affiliates and commercial partnerships. Although specific launch strategies or regulatory plans were not detailed, the drug’s existing approvals provide a foundation for rapid market expansion, especially in regions underserved by rare cancer treatments.

The company’s leadership, including Chief Scientific & Medical Officer José María Giménez-Arnau and Chief Commercial Officer Jacob Tolstrup, emphasized ESTEVE’s ambition to be a partner of choice for healthcare professionals treating rare and aggressive cancers. Their statements underline a patient-centric focus combined with a global ambition—two themes increasingly defining the mid-tier specialty pharma sector.

Industry observers expect ESTEVE to continue building on this momentum with further acquisitions or collaborative R&D in the orphan oncology and endocrine segments. With regulatory clearance pending, Caprelsa is likely to become a flagship therapy in ESTEVE’s expanding international portfolio.