News

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.

SEPTEMBER 18 2017

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 

Panion Animal Health AB
Frykholmsgatan 11, 281 31 Hässleholm, Sweden
info@panion-animalhealth.com

linkedin.com/company/panion-animalhealth
twitter.com/panionanihealth
panion-animalhealth.com/newsletter

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.

2017-08-21

Period April-June

  • Net sales: kSEK 0 (0)
  • Operating profit: kSEK -1 269 (0)
  • Earnings per share: SEK -0,10 (-).
  • Liquidity at the end of the period: kSEK 796 (582).

Period January-June

  • Net sales: kSEK 0 (0). 
  • Operating profit: kSEK -2 536 (-). 
  • Earnings per share: SEK -0,21 (-). 
  • Liquidity at the end of the period: kSEK 796 (582).
2017-08-14

Panion has made an agreement with Copenhagen University about transfer and use of technical data from a study in dogs. 

2017-07-14

After raising new capital, veterinary medicine company Panion Animal Health AB is now ready to ramp
up development of its treatment method for canine epilepsy. At the same time, discussions are under
way for a licensing deal that could give Panion access to a new major market.

2017-07-03

Panion Animal Health AB (publ) ("Panion") has received approval for admission to trading of its shares on AktieTorget. The listing of Panion on AktieTorget facilitates distribution of CombiGene's shares in Panion to CombiGene's shareholders. The first day of trading in Panion's share on AktieTorget is Thursday, 6 July 2017.

1
2
3
4
5

Subscribe

Press releases and reports via E-mail.