Chiesi Group acquires Santhera’s idebenone assets

Under the 2019 agreement, Chiesi Group in-licensed Raxone for the treatment ofLeber's hereditary optic neuropathy (LHON) and obtained rights to all other ophthalmological indications worldwide, except France and North America, where Santhera Pharmaceuticals retained rights. Chiesi Group also had the option to fully acquire said business outside North America.

At the end of July this year, Chiesi Group concluded an agreement with Santhera to acquire all assets and certain liabilities related to idebenone in all indications worldwide, including Raxone in LHON. The agreement simplifies the Raxone business significantly for both companies with Chiesi becoming the global brand owner while enabling Santhera to focus on the launch of vamorolone in Europe, subject to approval.

Under the terms of the agreement, Chiesi Group will assume the responsibility for the settlement agreed between Santhera and the French reimbursement authorities relating to Raxone in LHON amounting to EUR 25.3 million, significantly reducing near-term financial obligations and strengthening Santhera’s balance sheet. Furthermore, the cessation of Raxone-related activities allows Santhera to streamline business processes, thereby reducing operating costs and freeing up resources to be deployed for the European vamorolone launch and strategic projects.

In addition, Santhera is eligible to participate in a potential marketing approval of Raxone in LHON in the U.S. through single-digit variable payments on net sales or milestone payments of up to USD 10 million. In the event that Chiesi chooses to pursue idebenone in non-ophthalmological indications, Santhera would be eligible for additional milestone payments in a similar order of magnitude and high single-digit variable payments on net sales.

“Securing this agreement is an important step for the business, as we sharpen our focus on the commercialization of vamorolone in Europe, subject to approval. We look forward to seeing Chiesi’s progress over the coming months and years for the benefit of patients worldwide”, said Dario Eklund, CEO of Santhera.  

Giacomo Chiesi, Head of Chiesi Global Rare Diseases, said: “We are very pleased to have reached this agreement with Santhera, securing the North American and other rights to an exciting therapy for LHON. This agreement allows Chiesi to accelerate the regulatory and clinical development of Raxone at a global level. We look forward to working with the patient and medical communities, the FDA and other agencies around the world to continue the development of this experimental opportunity for the benefit of the patients.”

(Press release/RAN)