Roche to strengthen gene therapy portfolio with Spark Therapeutics acquisition

Swiss pharmaceutical giant Roche has reached a major agreement to acquire the U.S.-based gene therapy company Spark Therapeutics in an all-cash deal valued at $4.3 billion. Under the terms of the deal, Roche will purchase 100% of Spark Therapeutics for $114.50 per share. This acquisition is a strategic move to expand Roche’s capabilities in the rapidly advancing gene therapy space, which addresses a variety of serious genetic diseases.

Founded in 2013, Spark Therapeutics has made significant strides in the development of gene therapies, with a focus on conditions such as blindness, neurodegenerative diseases, haemophilia, and lysosomal storage disorders. Spark’s flagship product, Luxturna (voretigene neparvovec), gained U.S. Food and Drug Administration (FDA) approval in December 2017 as the first gene therapy for a genetic disease. Specifically, Luxturna treats biallelic RPE65 mutation-associated retinal dystrophy, a rare form of inherited vision loss. This approval marked a milestone, making Luxturna the first-ever FDA-approved gene therapy for a genetic disorder.

Less than a year after its approval in the U.S., Luxturna also gained approval from the European Commission, further cementing its global significance as a treatment for inherited retinal diseases. Spark’s gene therapy has shown significant potential for improving the quality of life for patients suffering from genetic vision disorders.

Beyond Luxturna, Spark Therapeutics has an extensive pipeline of gene therapies in various stages of clinical development. One of the most promising candidates is SPK-8011, a gene therapy aimed at treating haemophilia A. This treatment is expected to enter phase 3 clinical trials, advancing its potential as a groundbreaking option for haemophilia patients. In addition, Spark is developing SPK-8016, another gene therapy targeting haemophilia A in inhibitor patients, as well as SPK-9001, which is in phase 3 development for haemophilia B. Other gene therapies in the pipeline include treatments for conditions such as choroideremia, Pompe disease, and CLN2 disease, a form of Batten disease.

Spark’s CEO, Jeffrey D. Marrazzo, expressed confidence in the partnership with Roche, stating that the Swiss pharma giant’s global resources and reach will enable Spark to accelerate its mission of developing more gene therapies for patients suffering from genetic diseases. He highlighted that Roche’s support would significantly bolster their ability to bring innovative treatments to the market more quickly, potentially improving the lives of patients worldwide.

Severin Schwan, CEO of Roche, shared his excitement over the acquisition, particularly the opportunity to advance treatments for haemophilia A, which could provide a new therapeutic option for individuals living with the disease. He also praised Spark’s commitment to maintaining Philadelphia as a centre of excellence for gene therapy development.

The acquisition is expected to close in the second quarter of 2019, pending customary regulatory approvals. Post-merger, Spark Therapeutics will continue to operate as an independent entity within the Roche Group, with its headquarters remaining in Philadelphia.

This acquisition marks a significant step for Roche as it strengthens its gene therapy capabilities, an area that holds vast potential in treating currently untreatable genetic conditions. By integrating Spark’s expertise and innovative therapies, Roche aims to expand its position in the fast-evolving biotech sector.