Panion’s epilepsy product classified as MUMS in EU for dogs and cats
Panion Animal Health AB has received the European Medicines Agency’s acceptance of the classification as MUMS (Minor Use Minor Species) for our epilepsy product for both dogs and cats. The request for classification was submitted to the Committee for Medicinal Products for Veterinary Use (CVMP) in the European Medicines Agency (EMA) earlier in 2017 and has now been successfully evaluated.
The MUMS status is granted to assist applicants that intends to develop and submit applications for products for limited markets in order to stimulate development of new medicines. The measures made available by EMA for MUMS-products range from administrative assistance, reduced data requirements, and if the product is for a food-producing species, also fee reductions. Panion’s product is for non-food-producing species, but we already have other financial incentives from EMA based on our status as SME organization (Small and Medium-sized Enterprise). The MUMS classification covers all aspects of applications from early scientific advice to marketing authorisation. Unlike the MUMS-status that was granted to our product by US FDA earlier in 2017, there is no market exclusivity for MUMS-products in EU.
For Panion, the most important asset of the classification is that we may now refer to the guidelines on reduced data requirements for veterinary medicinal products classified as MUMS. This has the potential to save time and costs, although the application of these reduced data requirements depends on the individual product and the degree of novelty.
The classification was announced on the 8.th of December at 17.50; it is valid for five years and may be renewed.
This press release contains information which Panion Animal Health AB is obliged to publish according to the EU market abuse regulation (MAR). This information was submitted by Panion's CEO, Anja E. H. Holm, for publication on December 11, 2017, 8:55 CET.
Anja E. H. Holm, CEO
+ 45-22 94 66 00
anja.holm@panion-animalhealth.com
Bolaget ska utveckla och kommersialisera genterapi för behandling av epilepsiliknande tillstånd hos hundar och andra djur, samt utveckla och kommersialisera andra veterinärmedicinska produkter och nya behandlingsformer som kan ge sjuka djur bättre livskvalitet.
Panion will develop and commercialize a gene therapy treatment for dogs with drug refractory epilepsy, and other new animal health products and treatments that improve the quality of life for animals suffering from chronic diseases.