Date: 2015-03-23
Type of information: Development agreement
Compound: acamprosate
Company: AOP Orphan Pharmaceuticals (Austria) Confluence Pharmaceuticals
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: development
Action mechanism:
Disease: fragile X syndrome
Details: * On March 23, 2015, Confluence Pharmaceuticals and AOP Orphan Pharmaceuticals announced they have signed a definitive agreement to co-develop and market Confluence’s lead asset (acamprosate), a product for the treatment of Fragile X Syndrome in Europe and the Middle East. Confluence has received Orphan Designation in both Europe and the United States for its lead product. With Orphan Designation and pre-IND guidance, the two companies anticipate an accelerated regulatory path to approval for fragile X syndrome. In addition, the companies may qualify for several important benefits such as administrative and procedural assistance, smaller clinical trial sizes, fee reductions and exemptions from administrative expenses, prolonged market exclusivity upon approval and facilitated market access based on Health Technology Assessments of Orphan Drugs.
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