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 Transfer, approved yesterday by the European Medicines Agency (EMA), 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.
The Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international, research-focussed group (Chiesi Group) with 85 years’ experience in the pharmaceutical sector and present in 29 countries. The Group - research, development and marketing of innovative drugs for respiratory therapies, special care and rare diseases. The Group’s Research and Development is based in Parma (Italy) and works alongside other key Chiesi research and development groups in France, the US, the UK and Sweden, promoting its own preclinical, clinical and registration programmes. The Group employs around 6,000 people. The Chiesi Group is a certified B Corp. For further information go to www.chiesi.com
Holostem Terapie Avanzate, based in Modena, Italy, is a top biotech company entirely dedicated to the development, production, registration and distribution of medicinal products for advanced therapies (ATMPs) based on epithelial stem cell cultures for cellular and gene therapy. The main objective of Holostem Terapie Avanzate is in fact to promote Regenerative Medicine based on the use of epithelial stem cells for patients without therapeutic alternatives. Holostem Terapie Avanzate is located within the "Stefano Ferrari" Regenerative Medicine Centre at the University of Modena and Reggio Emilia. It was founded in 2008 thanks to the successful combination of scientific know-how of internationally renowned researchers such as Graziella Pellegrini and Michele De Luca, the innovative spirit of the University of Modena and Reggio Emilia and the industrial expertise of Chiesi Farmaceutici. For further information go to http://www.holostem.com/
For further information:
Valentina Biagini Stefania Bettinelli
Chiesi Farmaceutici Spa Holostem Terapie Avanzate S.r.l.
Senior Group Communication Manager Communication & External Relations
Tel +39 348 7693 623 Tel +39 345 2601842
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