News of Note—Roche's blockbuster licensing deal; FibroGen's roxadustat application and more

Roche's gene therapy licensing deal with Sarepta headlines today's news of note. (Pixabay)

> In a blockbuster licensing deal, Roche is paying Sarapta more than $1 billion up front for ex-U.S. rights to a Duchenne muscular dystrophy gene therapy candidate. Under the agreement, Sarepta is eligible for up to $1.7 billion in milestones and royalties. The deal comes right after Roche built up its gene therapy presence through its Spark Therapeutics buyout. FierceBiotech story 

> FibroGen has submitted its AstraZeneca-partnered anemia med roxadustat to the FDA. The med scored an approval in China back in August. Release 

> Pfizer inked a licensing deal with Theravance Biopharma, paying $10 million up front for global rights to the company's preclinical JAK inhibitor candidates. Under the agreement, Theravance is eligible for up to $240 million in milestones, plus potential royalties. Release


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

> BioMarin submitted its hemophilia A gene therapy candidate valoctocogene roxaparvovec to the FDA. Meanwhile, the biotech said the European Medicines Agency accepted its application, and the drug's review at that agency will start in January. Release | Release

> Leo Pharma has sold a group of anti-hemorrhoid and dermatology drugs to Karo Pharma for €90 million ($100 million). Leo intends to focus more on innovative meds, and CFO Anders Kronborg said in a statement the “well-established portfolio will be better served by Karo Pharma and its team.” Release 

> AstraZeneca scored approval for its triple-combination therapy for COPD in China, where there are nearly 100 million patients. Regulators in the U.S. and Europe are reviewing the med, which won approval as Breztri Aerosphere in Japan back in June. Release 

> Johnson & Johnson inked a buyout of Taris Biomedical, getting access to the private biotech’s drug delivery technology for bladder diseases. Financial terms weren’t disclosed. Release