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Roche and Sarepta Entered into a $1.15 Billion Licensing Deal for Gene Therapy

Roche Holding AG (Roche), a Switzerland-based multinational healthcare company made a $1.15 billion deal with an American medical research and drug development company, Sarepta Therapeutics, Inc. (Sarepta), on December 23, 2019.

As per the deal, Roche will receive the license to use of Sarepta’s investigational gene therapy for commercial operations outside the US. The therapy is used for Duchenne muscular dystrophy (DMD), which is a rare neuromuscular disorder.

License Agreement for DMD

According to Roche, “DMD is a rare degenerative neuromuscular disorder, affecting about one in 3,500–5,000 male births worldwide and causing severe progressive muscle loss and premature death.” Sarepta, which is known for providing various treatments for rare disorders, has been developing genetic medicine therapy for DMD patients. In early December 2019, Sarepta’s DMD drug called ‘Vyondys 53’ received approval from the US FDA approval.

Under the license agreement, Roche owns the exclusive right to use SRP-9001, Sarepta’s micro-dystrophin gene therapy. On Monday, December 23, 2019, the Swiss healthcare company announced, “Roche will make an upfront payment of $750 million in cash and $400 million worth in equity at closing for Sarepta’s investigational micro-dystrophin gene therapy SRP-9001 that is currently in clinical development.”

The deal, which is likely to be concluded in the first quarter of 2020, will give Sarepta additional benefits worth $1.7 billion from both regulatory as well as sales. As per the agreement, Sarepta will take responsibility for the development and manufacturing of SRP-9001 gene therapy, while the clinical development costs will be shared equally with the Swiss company.

Venture for Medical Treatment

The agreement will strengthen Roche’s global reach and commercial presence, which is likely to accelerate access to gene therapy SRP-9001 outside the US. Additionally, gene therapy is likely to generate numerous benefits for DMD patients across the globe.

In the light of the new agreement, James Sabry, the head of Roche’s Pharma Partnering stated, “We are excited to enter this licensing agreement with Sarepta. By working together to provide SRP-9001 to patients, we hope to fundamentally transform the lives of patients and families living with this devastating disorder for which there are currently only limited treatment options.”

Sarepta’s CEO, Doug Ingram, described the agreement as, “As a mission-driven organization, we are inspired to partner with Roche with the goal of bringing SRP-9001 to patients outside the United States. This collaboration will not only increase the speed with which SRP-9001 could benefit patients outside the United States but will also greatly expand the scope of territories within which we could potentially launch SRP-9001 to improve and save lives.”

Ingram further stated, “In  addition  to  the  validation  that  comes  from joining  forces  with  Roche,  this  licensing  agreement – one  of  the  most  significant  ex-U.S.  licensing transactions  in  bio-pharma – will  provide  Sarepta  with  the  resources  and  focus  to   accelerate  our  gene  therapy  engine  and,  if  successful,  bring SRP-9001 to  patients  as   quickly   as   possible,    potentially transforming the lives of countless DMD patients across the globe.”

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