FDA grants MUMS status and sponsor fee waiver to Panion's epilepsy project

After a review of the request and documentation submitted by Panion in June 2017, the FDA has decided to grant the MUMS status and a sponsor fee waiver to Panion's development product for treatment of drug-refractory idiopathic temporal- lobe epilepsy in dogs. FDA's decision is based on the so-called Minor Use in a Major Species - MUMS. The MUMS designation is a status similar to the Orphan Drug status for human drugs. The MUMS status gives no guarantee that the product will be approved in the end, but it entitles Panion to a 7-year period of exclusive marketing rights following approval, and it provides eligibility to apply for MUMS grants, which could help to advance the development. The fee waiver means that we do not have to pay the annual sponsor fee of approximately 75.000 US dollars to FDA.

"It is very reassuring that FDA grants the MUMS status, and the connected fee waiver opens the door to the INAD application for Panion's epilepsy product for dogs" says Anja Holm, CEO of Panion.


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 September 18 2017.

For further information, please contact:
Anja E. H. Holm, VD
+ 45-22 94 66 00 

Panion Animal Health AB
Frykholmsgatan 11, 281 31 Hässleholm, Sweden

In June 2015 CombiGene formed a wholly owned subsidiary, then called CombiGene Vet AB, and in April 2016 the decision was taken to distribute the subsidiary to CombiGe- ne's shareholders with the aim of listing the company. The company, which has been renamed Panion Animal Health AB, will use CombiGene's discoveries to develop a treatment for canine epilepsy. Panion aims at inlicensing or acquiring other veterinary medicine projects or products.


Panion Animal Health AB's Director Regulatory Affairs, Niels-Erik Manniche, has decided to leave the company.


Panion Animal Health AB (the "Company") has entered into a financing agreement with New York based Yorkville Advisors Global ("Yorkville") as the investment manager and on behalf of one or more of its investment funds has agreed to purchase up to SEK 9,000,000 of Convertible Notes of Panion Animal Health AB. In addition, Panion has entered into a financing agreement with Dividend Sweden who has agreed to purchase SEK 500,000 of convertible Notes of Panion Animal Health AB.


Panion Animal Health AB ("Panion") has in Q4-17 requested the FDA to open an Investigational New Animal Drug application file to carry out the development of our new product for use in the dog. Panion plans to develop and gain approval for the use of CG-01-canine, a recombinant adeno-associated virus vector expressing neuropeptide Y and receptor peptide Y2 to treat drug refractory idiopathic epilepsy in the dog via intracranial injection.


Panion Animal Health AB has had a very satisfactory cooperation with our CFO Anni Acs, who excellently handled the business transition into the stock market, shares issue, and daily financial controlling. Anni has moved to a new job challenge and we wish her all the best.


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. 



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