Chiesi Group Acquires Raxone®/Idebenone Business from Santhera

Santhera Pharmaceuticals (SIX: SANN) has finalized the sale of its Raxone®/Idebenone business worldwide and for all indications to Chiesi Group, an international healthcare group specializing in research. The transaction supersedes the previous license agreement between the two companies, which was established in 2019.

As per the terms of the agreement, Chiesi Group has acquired all assets and certain liabilities related to idebenone in all indications worldwide, including Raxone in LHON (Leber's hereditary optic neuropathy), except for North America and France, where Santhera will retain the rights. This deal simplifies the Raxone business for both companies, with Chiesi becoming the global brand owner, while Santhera can now focus on launching vamorolone in Europe, pending approval. The transaction was completed on July 28, 2023.

Chiesi Group will also take responsibility for the settlement agreed upon between Santhera and the French reimbursement authorities concerning Raxone in LHON, amounting to 25.3 million euros. This move significantly reduces Santhera's short-term financial obligations and strengthens their balance sheet. Moreover, by discontinuing Raxone-related activities, Santhera aims to streamline business processes, reduce operating costs, and allocate resources to the European launch of vamorolone and strategic projects.

Under the agreement, Santhera retains the right to participate in potential marketing approval of Raxone in the US for LHON, through single-digit variable payments on net sales or milestone payments up to US$10 million. If Chiesi decides to pursue idebenone for non-ophthalmic indications, Santhera could be eligible for other milestone payments of similar value and high single-digit variable payments on net sales.

Dario Eklund, CEO of Santhera, expressed the significance of the agreement in focusing on vamorolone's commercialization in Europe, while Giacomo Chiesi, Chief of Chiesi Global Rare Diseases, conveyed excitement about the opportunity to accelerate the regulatory and clinical development of Raxone on a global scale for the benefit of patients worldwide.

Notably, under the previous 2019 agreement, Chiesi Group held the license for Raxone in LHON and all other ophthalmological indications worldwide, except for France and North America. The recent transaction provides Chiesi Group with rights to the business outside of North America.

About Santhera:

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company dedicated to developing and commercializing innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical needs. Their portfolio includes vamorolone, a dissociative steroid with a novel mode of action investigated in a pivotal study for patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. Santhera has submitted a new drug application (NDA) for vamorolone's treatment of DMD to the US FDA, a marketing authorization application (MAA) to the European Medicines Agency (EMA), and an MAA to Medicines in the United Kingdom and the Healthcare Products Regulatory Agency (MHRA). The company has licensed the rights to vamorolone for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. Additionally, their clinical stage lead includes lonodelestat for treating cystic fibrosis (CF) and other neutrophilic lung diseases.

About Chiesi Group:

Chiesi is an international, research-focused biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to enhance the quality of people's lives while acting responsibly towards the community and the environment. Chiesi has become a Benefit Corporation in Italy, the US, and France, legally binding the commitment to creating shared value for society in its decision-making process. The company is also a certified B Corp since 2019, aligning with a global community of businesses with high standards of social and environmental impact. Moreover, Chiesi aims to achieve Net-Zero greenhouse gas (GHG) emissions by 2035 and operates in 31 countries with over 6,500 employees.

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