Roche, Sarepta Sign $2.85-Bn Licensing Deal for Gene TherapyBy
Roche has signed a licensing agreement, worth up to $2.85 billion ($1.15 billion upfront), with Sarepta Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company, to provide Roche with exclusive commercial rights outside the US to SRP-9001, Sarepta’s investigational gene therapy for treating Duchenne muscular dystrophy (DMD), a rare degenerative neuromuscular disorder.
Under the terms of the agreement, Sarepta will receive $1.15 billion in an upfront payment and an equity investment ($750 million in cash and $400 million in equity). In addition, Sarepta is eligible to receive up to $1.7 billion in regulatory and sales milestones; and royalties on net sales, anticipated to be in the mid-teens. In addition, Roche and Sarepta will equally share global development expenses. Sarepta retains all rights to SRP-9001 in the United States.
DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. SRP-9001, currently in clinical development for DMD, is designed to deliver the microdystrophin-encoding gene directly to the muscle tissue for the targeted production of the microdystrophin protein.
As part of the agreement, Sarepta will continue to be responsible for the global development plan and manufacturing build-out for SRP-9001. Sarepta will remain responsible for manufacturing of clinical and commercial supplies. Sarepta has also granted Roche an option to acquire ex-US rights to certain future DMD-specific programs, in exchange for separate milestone and royalty considerations, and cost sharing.
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. The parties anticipate that the agreement will close in the first quarter of 2020.