Hansa Biopharma: Partner news from Sarepta

Partner news from Sarepta on pipeline project in Gene Therapy!!!

Shares in Hansa Biopharma and Sarepta are up more than 5 and 30 percent respectively - yesterday, following a surprise decision by an FDA advisor panel on Friday to recommend FDA to grant accelerated approval of gene therapy product SRP-9001 from Hansa Biopharma’s partner Sarepta Therapeutics at an upcoming FDA meeting late May. Hansa Biopharma’s enzyme cleaving technology imlifidase may potentially be used as a pre-treatment to SRP-9001 in up to 14% of the DMD patient population and if successful in both DMD and LGMD Hansa Biopharma will be eligible to receive up to USD 400 million in milestones from Sarepta Therapeutics plus up to midteens in royalty payments and sales of imlifidase . According to Fierce Biotech, expectations in DMD are high with SRP-9001 potentially be one of the biggest biotech product launches in 2023 with annual sales of more than USD 2 billion in less than five years. 

The decision to recommend SRP-9001 for accelerated approval came after FDA last week released documents send to the advisors that raised concerns regarding efficacy, safety etc. of SRP-900, but among other things the advisory panel instead put weight on the high need for treatment options becoming available to patients as well as convincing testimonials from clinicians that SRP-9001has shown good results for individual patients. That said, the vote in favor to recommend approval was very narrow and the smallest possible with 8 members voting in favor and 6 against. Also, FDA does not have to follow a positive recommendation from the advisory panel, but until the FDA decision meeting in late May, the pendulum has swung back in favor Sarepta Theraputics and Hansa Biopharma.

Disclaimer: HC Andersen Capital receives payment from Hansa Biopharma for a Digital IR/Corporate Visibility subscription agreement. /ANALYST Claus Thestrup 10:25 AM 05-16-2023.