Catalent and Siren Biotechnology have partnered in a gene therapy manufacturing deal announced this week.
As part of the partnership, Catalent will handle process development and cGMP manufacturing of Siren Biotechnology's adeno-associated viral (AAV) vector-based therapies aimed at new options for cancer treatment. The work will be carried out at Catalent’s process and clinical development center in Baltimore, Maryland, where the company will also focus on process optimization.
Siren Biotechnology calls its approach ‘universal AAV immuno-gene therapy.’ The biotech says it's merging two therapies, AAV gene therapy and cytokine immunotherapy, into one treatment that disrupts the current method of attacking tumor cells and enhancing anti-tumor immunity.
Earlier this year, Catalent made headlines when Novo Holdings, parent company to Novo Nordisk, announced a merger agreement to acquire the contract manufacturing giant in an all-cash transaction valued at $16.5 billion. A few days after the acquisition was announced, Reuters reported that the FDA revealed troubling quality control deficiencies at Catalent's Bloomington, Indiana plant, with close to approximately 194 deviations recorded between October 31, 2021, and October 31, 2022.
Like many other pharma deals, the transaction has been scrutinized by the Federal Trade Commission. Recently, the FTC issued a 'second request' for more details on Novo and Catalent's proposed merger, potentially affecting the deal’s closing timeline. This request extends the FTC's review period by an additional 30 days after the companies submit the required information, as stated in a May 3 SEC filing by Catalent.
This marks Novo’s second submission, following a withdrawal and reapplication after initial discussions with the FTC, according to an April 3 Catalent SEC filing. As part of the agreement first announced in February, Novo Holdings will sell three Catalent fill-finish sites to its subsidiary, Novo Nordisk, for $11 billion. These sites in Italy, the USA, and Belgium are intended to boost Novo Nordisk's capacity for its weight loss and diabetes treatments.