Somerville, Mass. — Genetix Biotherapeutics Inc. and Saudi Pharmaceutical Industries and Medical Appliances Corp., known as SPIMACO, have entered an exclusive agreement to develop, commercialize and manufacture two gene therapies in Saudi Arabia and the broader Middle East.
The agreement covers LYFGENIA and ZYNTEGLO, one-time gene addition cell therapies for sickle cell disease and transfusion-dependent beta-thalassemia, respectively. SPIMACO’s wholly owned subsidiary, SPIMACO Bio, is also part of the collaboration.
Sickle cell disease and beta-thalassemia are estimated to affect more than 500,000 people in Saudi Arabia. The companies said the partnership is intended to expand access to one-time treatments for patients with the rare genetic diseases.
Under the agreement, Genetix will receive ongoing technology-transfer payments and a double-digit royalty on sales. SPIMACO and SPIMACO Bio will be responsible for regulatory approvals, development and commercialization in Saudi Arabia, the Gulf Cooperation Council and the wider Middle East.
SPIMACO also plans to establish local manufacturing capabilities for the therapies in Saudi Arabia.
“This strategic partnership with SPIMACO represents an important milestone in expanding global access to our transformative one-time treatments to the thousands of patients in the Middle East with sickle cell disease and beta-thalassemia,” said David Meek, CEO of Genetix Biotherapeutics. “SPIMACO is the proven leader in Saudi Arabia, bringing established infrastructure and the manufacturing capabilities needed to efficiently scale access to these treatments. This collaboration creates another significant long-term value opportunity for Genetix, as we continue to expand access to our market leading treatments for patients in need.”
“Genetix is a pioneer and U.S. market leader in genetic medicine for the treatment of rare diseases, with demonstrated success commercializing innovative treatments. This collaboration marks an important step in SPIMACO’S strategic expansion into advanced biopharmaceuticals,” said Prof. Ahmed Hamdan Aljedai, Vice Chairman and Managing Director at SPIMACO. “We are focused on gaining access to next-generation therapies while building the capabilities required to support long-term localization and innovation in the Kingdom, in alignment with national healthcare and industrial priorities.”
LYFGENIA, or lovotibeglogene autotemcel, is an ex-vivo lentiviral vector gene addition cell therapy approved for eligible patients with sickle cell disease. The treatment adds a functional beta-globin gene to a patient’s own blood-forming stem and progenitor cells.
The process enables the production of an adult hemoglobin with anti-sickling properties. LYFGENIA has been shown to limit red blood cell sickling and reduce or eliminate vaso-occlusive events.
