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Jaguar Health Announces Receipt by Napo Therapeutics of Small and Medium Enterprise (SME) Designation from the European Medicines Agency
SME status is an important designation for Italy-based Napo Therapeutics' rare/orphan disease business modelSAN FRANCISCO, CA and MILAN, ITALY / ACCESSWIRE /
About this update from Jaguar Health, Inc.
[{"type":"text","content":"SME status is an important designation for Italy-based Napo Therapeutics' rare/orphan disease business modelSAN FRANCISCO, CA and MILAN, ITALY / ACCESSWIRE / February 15, 2022 / Jaguar Health (NASDAQ:JAGX) and Napo Therapeutics S.p.A., an Italian corporation established by Jaguar Health in Milan, Italy, today announced that Napo Therapeutics has been granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA).\"We are very pleased to have received SME designation, which allows us to benefit from financial incentives and support from the EMA as we aim to provide access to crofelemer in Europe for significant rare/orphan diseases,\" said Massimo Mineo, General Manager of Napo Therapeutics.The SME designation was established by the EMA to promote innovation and the development of new medicinal products by smaller companies.\"Companies with SME status have displayed a high success rate for marketing authorization applications in the European Union - reaching 89% in 2020 - and receive financial advantages on all associated regulatory fees and activities,\" said Annabella Amatulli, Chief Regulatory Officer of Napo Therapeutics. \"Companies with SME status developed nearly 20% of all human medicines recommended for authorization by the EMA in 2020, and half of these medicines target a rare disease.\"SME status also allows companies to receive special regulatory benefits, such as the ability to engage in an early dialogue with a dedicated, multidisciplinary EMA team to discuss regulatory strategy, receipt of guidance on clinical data publication, and discuss eligibility for the EMA's programs (such as the PRIME program) and other dedicated initiatives.1About Jaguar Health, Inc., Jaguar Animal Health, Napo Pharmaceuticals, Inc. & Napo Therapeutics S.p.A.Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, specifically chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Jaguar Health is the maj...