Confluence Pharmaceuticals and AOP Orphan Pharmaceuticals AG have announced that they have signed a definitive agreement to co-develop and market Confluence’s lead asset, a product for the treatment of Fragile X Syndrome in Europe and the Middle East.
Confluence is a biopharmaceutical company focused on developing therapeutic treatments for Fragile X Syndrome and Autism Spectrum Disorders. AOP is an Austrian based company specializing in the development and marketing of medicines for rare and complex diseases.
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.
“The relationship we have established with AOP is an exciting opportunity for Confluence to leverage AOP’s knowledge and expertise in Europe and the Middle East to accelerate this breakthrough treatment for the benefit of Fragile X patients,” said Confluence President and Founder Steven Johns. Today, Fragile X patients have no approved treatment for the core social and communication impairments.
Commenting on today's announcement, Dr. Rudi Widmann, Chief Executive Officer of AOP, said, "The cooperation between AOP and Confluence will allow AOP to further its mission for finding and developing therapies for rare diseases. AOP has a unique record of developing and distributing products for rare and complex diseases, and Confluence will benefit from AOP's access to treatment centers and its long term expertise in commercializing drugs for rare and complex diseases."