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2017-09-18

Panion: 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"

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

anja.holm@panion-animalhealth.com

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.

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http://news.cision.com/se/panion/r/fda-grants-mums-status-and-sponsor-fe...
http://mb.cision.com/Main/15959/2348792/724069.pdf

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