Esteve License Deal: New Treatment for Severe Primary Ciliary Dyskinesia

by drbyos

Esteve Bolsters Rare Disease Treatment with Global Rights to Increlex®

Archynetys.com – April 2, 2025 – Barcelona, Spain – Esteve, a global pharmaceutical company headquartered in Barcelona, has significantly expanded it’s portfolio by acquiring the global rights to Increlex® (mecasermin [rDNA origin]) outside of the United States. This strategic move underscores Esteve’s commitment to addressing unmet medical needs, notably in the realm of rare diseases.

Targeting Severe primary Insulin-like Growth Factor-1 Deficiency (SPIGFD)

Increlex®, a biological medicine, is specifically designed for the long-term treatment of growth disorders in children and adolescents aged 2 to 18 who suffer from severe primary insulin-like growth factor-1 deficiency (SPIGFD). SPIGFD is a rare condition characterized by low levels of insulin-like growth factor-1 (IGF-1), a crucial hormone for normal growth and advancement.

the acquisition of Increlex® from Eton Pharmaceuticals marks Esteve’s entry into the biologics market and aligns with its strategic focus on specialized treatments for conditions with significant unmet medical needs. This is particularly relevant given the challenges faced by SPIGFD patients.

Addressing the challenges in diagnosing and treating SPIGFD is paramount. Delayed diagnosis and limited access to appropriate therapies can significantly impact the physical health and overall quality of life for these young patients. Raising awareness and adopting a multidisciplinary approach are essential to improving their outcomes.

Increlex®: A Designated Orphan Drug with Global Approval

Increlex® received orphan drug designation in 2006, highlighting the rarity and severity of SPIGFD. It has secured approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and is currently available in over 40 countries worldwide.

The prevalence of rare diseases, like SPIGFD, is a growing concern globally. According to the National Institutes of Health (NIH), a rare disease is defined as one that affects fewer than 200,000 people in the United States. However, collectively, rare diseases impact millions of individuals and families, emphasizing the importance of pharmaceutical companies like Esteve investing in their treatment.

Esteve’s Commitment to Improving Lives

Founded in 1929, Esteve has a long-standing commitment to improving people’s lives through innovative pharmaceutical solutions. With a strong international presence,including branches in Spain,Portugal,Italy,Germany,France,the United kingdom,and the United States,Esteve is well-positioned to deliver Increlex® to patients in need.

Beyond its innovative pharmaceutical business, Esteve also offers comprehensive contract manufacturing services (CMO), specializing in the production of pharmaceutical active ingredients (APIs) in state-of-the-art facilities across Spain, Mexico, and China.

Esteve’s core values – people, transparency, and duty – remain central to all its activities, driving its commitment to addressing unmet medical needs and improving patient outcomes.

Keywords: esteve, increlex, SPIGFD, rare disease, orphan drug, biologics, pharmaceutical, growth disorder, IGF-1, treatment.

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