Valeant Pharmaceuticals International, Inc announced that it has entered into a licensing agreement with Norgine B.V. ("Norgine"); under which Valeant has obtained the rights to develop and commercialize NER1006 Powder for Oral Solution in the U.S. and Canada. NER1006 is a novel, low-volume (1L) polyethylene glycol-based bowel preparation for cleansing of the colon in preparation of colonoscopy, whose U.S. regulatory filing is anticipated in 2016.
Norgine is a European specialist pharmaceutical company focused on developing, manufacturing, and marketing its products in various therapeutic areas, including: gastroenterology, hepatology, and critical and supportive care.
NER1006 has been developed to provide overall bowel cleansing, with an additional focus on the ascending colon in adults. The NER1006 Phase III clinical trial program is now completed and includes three multicenter randomized parallel group studies: NOCT, MORA, and DAYB. The NOCT and MORA studies support efficacy, whereas the DAYB study contributes to the safety evaluation.
"We are excited to partner with Norgine to bring an innovative treatment to the patients that need it most," said Joseph C. Papa, chairman and chief executive officer of Valeant. "To date, NER1006's clinical results have been positive and it is an excellent strategic fit with the Salix portfolio that will enhance our gastrointestinal business. This agreement reflects our commitment to bolstering R&D and our commercial offerings as we continue to shape Valeant for the future."
Peter Stein, CEO at Norgine said, "We are extremely pleased to enter into this agreement with Valeant and build upon our successful partnership for MOVIPREP®. Valeant has an established presence in gastroenterology in the U.S. and Canada and a strong portfolio of products in this therapy area. As a European specialist pharma company, Norgine is entirely focused upon the development and commercialization of products in Europe. Valeant is therefore an excellent choice as our partner for the launch of NER1006 in the U.S. and Canada."
Norgine will manufacture and supply NER1006 for Valeant. Financial terms of the agreement have not been disclosed.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. Norgine provides expertise and 'know how' in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine's approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth. Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales, and one in Dreux, France. For more information, please visit www.norgine.com
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