- Roche extended the tender offer for U.S. based gene therapy company Spark Therapeutics until early May from an original deadline of midnight Wednesday in a surprise holdup to the union.
- Shareholders representing 29.4% of Spark have agreed to sell at $114.50 a share, falling short of the majority necessary to complete the acquisition.
- If completed, Roche's $4.8 billion acquisition would put the pharma in a leading position in gene therapy thanks to Spark's marketed blindness treatment Luxturna and a pipeline of rare-disease projects.
Roche joined big pharma rivals Novartis and Pfizer in gene therapy dealmaking in late February when it offered to buy Philadelphia-based Spark Therapeutics for $4.8 billion. Spark was a prize thanks to its history-making FDA approval of Luxturna (voretigene neparvovec), a gene therapy for a rare type of blindness, in 2017.
Failure to secure a majority of shares by the tender offer's expiration is a hiccup in the acquisition, however. Roche did not specify which shareholders had yet to agree to sell, nor why.
Spark's board of directors, who held 5.9% of the company's shares last year, unanimously supported the deal. Other major shareholders include Fidelity, T. Rowe Price, Wellington Management, BlackRock, and the CHOP Foundation, the charity at the Children's Hospital of Philadelphia where Spark was founded.
In statement emailed to BioPharma Dive, Roche said the extension was made in agreement with Spark and the Federal Trade Commission to allow the agency sufficient time to review the deal for compliance with U.S. antitrust law.
Gene therapy is a ripe area for biopharma investment, with industry analysts anticipating billions of dollars in annual sales in coming years. Manufacturers expect that the one-time treatments for rare, genetically-driven diseases will be able to command premium prices, in excess of $1 million, because they are hoped to avert at least as much in lifetime healthcare costs.
Roche's crosstown rival Novartis bought U.S. company AveXis last year for $8.7 billion for its gene therapy Zolgensma (onasemnogene abeparvovec), which is awaiting FDA approval. Novartis has suggested that the therapy, which treats a fatal infant condition called spinal muscular atrophy, could be cost-effective at a price of $4 million or more, although an independent assessment has put the number closer to $1.5 million or less.
To satisfy payer requests, Spark last year reached agreement with some commercial insurers to receive reimbursement in installments, based on whether patients treated with Luxturna achieved improvements in their vision.
Spark's Luxturna treats a type of blindness driven by a mutation in the RPE65 gene, which encodes for a protein that supports the retina. The company reported that it had shipped 75 vials of Luxturna — each vial treats a single eye — accounting for $27 million in sales.
The company is also developing gene therapies for hemophilia, Huntington's disease and other rare disorders.