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news.Napo Pharmaceuticals has formed collaboration with Salix Pharmaceuticals for the license of crofelemer for all indications in North America, Europe, excluding certain smaller countries, and Japan, and certain indications worldwide.
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Crofelemer is Napo’s novel anti-secretory, gastrointestinal agent currently in a final Phase III trial for the treatment of chronic diarrhea in people living with HIV/AIDS (the ADVENT program) under fast-track status and special protocol assessment agreement with the FDA.
The terms of the deal include an up-front license fee for the crofelemer intellectual property of $4.5 million and an equity investment of $500,000 for the purchase of 250,000 shares of Napo common stock; as well as regulatory and sales milestones payments tailored to the significance of the indication and performance of the product; and tiered royalty rates ascending to a $400 million annual sales threshold. The terms provide for full funding by Salix of the on-going ADVENT program, some of which costs will be off-set against future milestone payments to Napo.
Salix will have the commercialization rights to the drug with potential application to a broad range of indications. Crofelemer is currently in clinical development for three additional indications: adult acute infectious diarrhea, including cholera in Phase II; irritable bowel syndrome in Phase II; and pediatric diarrhea in Phase I.
Crofelemer product labeling by Salix (or its affiliates, sub-licensees or distributors as defined in the collaboration agreement) will include a reference to Napo as the licensor and will include Napo’s logo and refer to the sustainable supply of crofelemer, to the extent legally allowed.
Crofelemer is also licensed to Glenmark Pharmaceuticals of Mumbai, India in 140 emerging and developing countries for diarrhea indications; and to AsiaPharm in greater China for diarrhea indications. In conjunction with this license to Salix, Glenmark and Salix have entered into a commercial supply agreement for crofelemer API (active pharmaceutical ingredient).
Lisa Conte, Napo’s founder and CEO, said: Salix is an important force in providing solutions and expertise in the gastro-intestinal field. We are thrilled to have their leadership, skill, and committed resources to bring crofelemer first to the HIV community in the US. Ultimately, this license and Salix’s international network in the gastro-intestinal field can provide global access of crofelemer to all populations for all indications.