Massachusetts-based Genetix Biotherapeutics has struck an exclusive licensing and commercialization agreement with Saudi-based Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO) and its subsidiary SPIMACO Bio, covering commercialization and localized manufacturing of two FDA-approved gene therapies across Saudi Arabia and the broader Middle East. The deal covers lovotibeglogene autotemcel (Lyfgenia), an ex vivo lentiviral vector gene addition therapy for sickle cell disease, and betibeglogene autotemcel (Zynteglo), a comparable therapy for transfusion-dependent beta-thalassemia. Both conditions are estimated to affect over 500,000 people in Saudi Arabia, according to the announcement.
Under the terms, Genetix will receive ongoing technology transfer fee payments and a double-digit royalty on sales. SPIMACO and SPIMACO Bio will be responsible for obtaining market authorization, development, and commercialization across Saudi Arabia, the GCC, and the broader Middle East, and will establish localized manufacturing capabilities in the Kingdom.
Deal context
Both Lyfgenia and Zynteglo are one-time, ex vivo lentiviral vector gene addition therapies in which functional beta-globin gene copies are added to a patient's own hematopoietic stem and progenitor cells. Lyfgenia, approved by the US FDA for patients 12 years and older with sickle cell disease and a history of vaso-occlusive events, results in production of hemoglobin with anti-sickling properties. Zynteglo, approved for transfusion-dependent beta-thalassemia, enables total hemoglobin to reach normal or near-normal levels, eliminating the need for regular red blood cell transfusions in eligible patients.
Genetix — formerly known as bluebird bio before rebranding following a corporate restructuring — holds the US commercial rights to Lyfgenia, Zynteglo, and a third gene therapy, elivaldogene autotemcel (Skysona), for cerebral adrenoleukodystrophy. The company expanded its manufacturing partnership with Minaris Advanced Therapies in January 2026 to scale commercial supply of Lyfgenia, and in February 2026 selected Orsini as a specialty pharmacy partner for distribution of Lyfgenia, Zynteglo, and Skysona in the US. The SPIMACO agreement represents Genetix's first disclosed international commercialization deal for these assets.