SAN FRANCISCO--(BUSINESS WIRE)--Salix Pharmaceuticals, Inc. (“Salix”) and Napo Pharmaceuticals, Inc. (“Napo”) today announced the settlement (the “Settlement”) of Napo’s litigation with Salix.
As part of the Settlement, the Collaboration Agreement between Salix and Napo dated December 9, 2008 has been terminated. Accordingly, Napo has regained the rights for Fulyzaq® (crofelemer) which has been approved by the FDA for the systematic relief of non-infectious diarrhea in adults with HIV/AIDs on antiretroviral therapy as well as the rights for the development and commercialization of:
- Crofelemer for diarrhea predominant irritable bowel syndrome (CRO-IBS), Phase 2, worldwide;
- Crofelemer for acute infectious diarrhea, including cholera (CRO-ID), Phase 2, Western Territories including the US, most EU and Japan;
- Crofelemer for pediatric diarrhea (CRO-PED), Phase 1, Western Territories including the US, most EU and Japan;
Napo will assume all commercial and regulatory responsibility for Fulyzaq® within thirty-(30) days and is developing plans for the further development of crofelemer for other potential indications. As part of the Settlement, Napo will receive all finished product inventory and inventory used in the production of crofelemer API.
Lisa A. Conte, Napo’s Interim CEO commented, “I am happy that we were able to achieve this Settlement Agreement with Salix. We are developing plans to provide for expanded commercial access and awareness of Fulyzaq to people living with HIV/AIDS, and development of crofelemer for indication expansion.”
Napo's proprietary patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent isolated and purified from Croton lechleri, a medicinal plant sustainably harvested under fair-trade working conditions in several South American countries. Crofelemer (trade name Fulyzaq®) was approved in 2012 and is indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer is in various stages of clinical development for the following indications:
- Crofelemer for diarrhea predominant irritable bowel syndrome (CRO-IBS), Phase 2
- Crofelemer for acute infectious diarrhea, including cholera (CRO-ID), and
- Crofelemer for pediatric diarrhea (CRO-PED), Phase 1.
The FDA has granted fast track status to crofelemer development for the IBS indication.
About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Jaguar Animal Health, Inc. (Nasdaq: JAGX) and Napo are engaged in preliminary exploratory discussions to review a potential merger and/or other ways to cooperate with their respective business endeavors. Napo owns 26.3% of the outstanding shares of Jaguar Animal Health, Inc. Napo is based in San Francisco.
Please note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the cost and unpredictability of the duration and results of clinical trials and FDA approval; the possible impairment of, or inability to obtain, intellectual property rights, and the costs of obtaining such rights from third parties; market acceptance for approved products; ability to secure the product; and generic and other competition, and the need to acquire new products.