Swiss pharma giant Roche acquired and Philadelphia-based gene therapy company Spark Therapeutics in an all cash transaction worth $4.8 billion, or $114.50 per share. The merger has been unanimously approved by the boards of Spark Therapeutics and Roche.
Spark Therapeutics, which was founded in 2013 out of gene-therapy research at Children’s Hospital of Philadelphia, is a fully integrated, commercial company committed to discovering, developing and delivering gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders, and neurodegenerative diseases.
In December 2017, Spark received a landmark FDA approval as its inherited retinal disease drug Luxturna (voretigene neparvovec-rzyl), became the first gene therapy ever approved for an inherited disease. Watch the EyewireTV coverage here.
Luxturna is a one-time gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The drug is the first FDA-approved gene therapy for a genetic disease, the first and only pharmacologic treatment for an inherited retinal disease, and the first adeno-associated virus vector gene therapy approved in the United States.
The deal allows Roche to expand its presence treating hemophilia, which is a new and emerging category for the company. Spark’s lead clinical asset is SPK-8011, a novel gene therapy for the treatment of haemophilia A, which is expected to start phase 3 in 2019. Spark also has SPK-8016 in a phase 1/2 trial aimed at addressing the haemophilia A inhibitor population.
Spark Therapeutics’ additional clinical assets include: SPK-9001, an investigational gene therapy for the potential treatment of haemophilia B in phase 3 and SPK-7001 for choroideremia in phase 1/2. The company is also developing SPK-3006 for Pompe disease and SPK-1001 for CLN2 disease (a form of Batten disease) which are expected to be ready for clinical development in 2019, as well as additional preclinical programs for Huntington’s disease and Stargardt disease.
“Spark Therapeutics’ proven expertise in the entire gene therapy value chain may offer important new opportunities for the treatment of serious diseases,” Severin Schwan, CEO of Roche, said in a company news release. “In particular, Spark Therapeutics’ haemophilia A program 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.”
Spark Therapeutics will continue its operations in Philadelphia as an independent company within the Roche Group.
“As the only biotechnology company that has successfully commercialized a gene therapy for a genetic disease in the US, 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 their needs vast,” Jeffrey D. Marrazzo, CEO of Spark Therapeutics, said in the news release. “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.”
Terms of the Agreement
Under the terms of the agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of Spark Therapeutics’ common stock at a price of $114.50 per share in cash. The closing of the tender offer will be subject to a majority of Spark Therapeutics’ outstanding shares being tendered in the tender offer. In addition, the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.
Following completion of the tender offer, Roche will acquire all remaining shares at the same price of $114.50 per share through a second step merger. The closing of the transaction is expected to take place in the second quarter of 2019.