spark therapeutics

Roche and Spark Therapeutics have announced they are to enter a definitive merger agreement for Roche to fully acquire Spark for $4.3bn – the first company to gain approval for a gene therapy in the U.S.

The deal, at $114.50 per share, will allow Roche access to approved therapy Luxturna (voretigene neparvovec) for a rare rental disease, in addition to four drugs in clinical trials, including SPK-8011, a therapy for haemophilia A expected to begin phase III testing before the end of the year.

Luxturna is an $850,000 per year treatment and is the only gene therapy approved in the US and Europe, making $27m in sales in the last quarter of 2018.

Alongside SPK-8011, Spark also possesses SPK-8016, another treatment for haemophilia A in phase I/II trials as well as SPK-9001 – a drug for haemophilia B.

Competition in the haemophilia department  is strong as BioMarin’s valoctocogene roxaparovovec is also in phase III trials and expected to be the first treatment coming to market. Additionally UniQure and Pfizer are also aiming to bring their own haemophilia B therapies to market which are currently undergoing trials.

Spark also has treatments for choroideremia and Pompe disease in clinical programmes as well as preclinical trials in Huntington’s disease and Stargardt.

Jeffrey D. Marrazzo, CEO at Spark Therapeutics, said: “As the only biotechnology company that has successfully commercialized a gene therapy for a genetic disease in the U.S., we have built unmatched competencies in the discovery, development and delivery of genetic medicines. But the needs of patients and families living with genetic diseases are immediate and vast.

“With its worldwide reach and extensive resources, Roche will help us accelerate the development of more gene therapies for more patients for more diseases and further expedite our vision of a world where no life is limited by genetic disease.”

Severin Schwan, CEO at Roche also commented: “Spark Therapeutics’ proven expertise in the entire gene therapy value chain may offer important new opportunities for the treatment of serious diseases.

“In particular, Spark Therapeutics’ haemophilia A programme could become a new therapeutic option for people living with this disease. We are also excited to continue the investments in Spark Therapeutics’ broad product portfolio and commitment to Philadelphia as a center of excellence.”