Chiesi Group and Holostem Terapie Avanzate announce transfer of Holoclar® from the Chiesi Group to Holostem

PRESS RELEASE

Parma and Modena, 16 June 2020 – Chiesi Farmaceutici, international research-focussed group (Chiesi Group), and Holostem Terapie Avanzate, top Italian biotech company entirely dedicated to the development, production, registration and distribution of medicinal products for advanced therapies, announce the signing of a contract for the transfer of the business branch of Holoclar^®, an autologous stem-cell therapy for the treatment of patients with severe ocular surface burns. The mutual agreement reached between the two parties provides for the Holoclar^® Marketing Authorisation, approved yesterday by the European Medicines Agency (EMA), to be transferred from Chiesi Farmaceutici to Holostem Terapie Avanzate.

The agreement aims to allow both companies to focus on their own strategic objectives and in particular to accelerate access procedures for rare disease patients to available therapies and those being developed. The Chiesi Group – whose contribution in the early phases of development has been key to gaining more rapid market and patient access for the Holoclar® advanced therapy – has always looked to the future and to innovation and will continue to focus on the development of its product portfolio and pipeline in the field of rare diseases, requiring a significant commitment in terms of R&D and commercialization, thanks to the Chiesi Global Rare Diseases business unit set up in February 2020.

“Holostem is a university spin-off founded in 2008 by the University of Modena and Reggio Emilia, with the commercial support of Chiesi Group,” says Andrea Chiesi President of Holostem and Shareholder of Chiesi Group. “Today it boasts a solid business structure combined with international scientific know-how in the field of stem-cell biology, which has been successfully applied for decades in cellular and gene therapy protocols within the scope of translational medicine. I am proud of the work that was carried out so far to bring back Holoclar in Holostem, right where it started and where it has always been manufactured”.

As a result of this agreement, Holostem will be able to optimise the application of Holoclar and facilitate patient access to the drug by interacting with the network of European clinics, which will be in direct contact with the production and control of the product.