LONDON, August 8, 2016 /PRNewswire/ --
Norgine B.V. today announced that it has entered into a licensing agreement with Valeant Pharmaceuticals International, Inc. ("Valeant" or the "Company") under which Valeant has obtained the rights to develop and commercialise NER1006 Powder for Oral Solution in the US 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.
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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 randomised parallel group studies: NOCT, MORA, and DAYB. The NOCT and MORA studies support efficacy, whereas the DAYB study contributes to the safety evaluation.
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(R). Valeant has an established presence in gastroenterology in the US 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 commercialisation of products in Europe. Valeant is therefore an excellent choice as our partner for the launch of NER1006 in the US and Canada."
"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."
Norgine will manufacture and supply NER1006 for Valeant. Financial terms of the agreement have not been disclosed.
You can view the full press release on http://www.norgine.com
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