European Medicines Agency Grants Jaguar Health Orphan Drug Designation for Crofelemer to Treat Short Bowel Syndrome

Jaguar Health (NASDAQ:JAGX) and its majority owned Italian subsidiary, Napo EU S.p.A. (soon to be renamed Napo Therapeutics), today announced that the European Commission has adopted the decision to grant Orphan Drug Designation (ODD) for crofelemer for the indication of short bowel syndrome (SBS) in the European Union following review of the ODD application Napo EU submitted to the European Medicines Agency (EMA) this past September.

SBS affects approximately 10,000 to 20,000 people in the U.S.¹, according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size.² Despite limited treatment options, the global SBS market exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports.

“Following this very welcome decision from the EMA, Napo EU is initiating efforts to plan and commence a pivotal clinical trial of crofelemer in both adult and pediatric SBS patients in support of our key focus on pursuing the EMA’s accelerated conditional marketing authorization pathway in Europe for this debilitating rare disease,” said Massimo Mineo, General Manager of Napo EU.

“SBS is a devastating disease. The mortality rate of SBS patients on home parenteral nutrition is about 30% after 5 years³, and it is estimated that approximately 70% of SBS patients in Europe are pediatric,” stated Lisa Conte, Jaguar’s president and CEO and Napo EU board member. “The accelerated approval regulatory pathway in Europe is key to our strategy underlying the exclusive license Jaguar Health has provided to Napo EU for crofelemer and to our efforts to make crofelemer’s novel mechanism of action available to patients suffering from rare diseases like SBS in the most rapid manner. Additionally, Jaguar Health has the right to utilize any clinical or regulatory data generated by Napo EU for SBS on a global basis, which provides us with another potential and important ‘shot on goal’ for crofelemer.”

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