RXi Pharmaceuticals Corporation has announced that they have signed a distribution agreement with Ethicor Ltd., a UK based unlicensed medicinal products (“Specials”) pharmaceutical company.
The agreement provides Ethicor with the distribution rights to RXI-109 in the European Union, with the possibility to extend it to other regions of the world, excluding the United States, Canada and Mexico, prior to and until the registration of the product in the different countries covered by the agreement.
Under the European medicines legislation (Directive 2001/83/EC, Article 5(1)), Ethicor will be able to supply, prior to regulatory approval, RXI-109 as a “Special”.
A “Special” may be requested by an authorized health-care professional to meet the special needs of an individual patient under their direct responsibility. Specials cannot be actively promoted to health-care professionals.
Under the terms of the agreement, the gross profit generated from this “Specials” sale will be shared between RXi Pharmaceuticals and Ethicor.
Once RXI-109 becomes an approved drug in a given country, the marketing rights to the approved product in that country revert back to RXi.
“We are very pleased to be working with Ethicor on this opportunity for RXI-109, because the Ethicor management team has a broad and deep experience in commercializing Specials”, said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals.
He added that: “This collaboration is important for health-care professionals and patients who can get safe controlled early access to a developmental drug that could be transformational for patients’ lives. It is also a significant milestone for RXi Pharmaceuticals because, in addition to some possible early revenue, the increased exposure for RXI-109 may be a key in accelerating the development of our drug, and in making other companies aware of the business development potential of RXi’s unique proprietary self-delivering platform of RNAi oligonucleotides.”