Panion prepares for USA

Panion Animal Health AB develops a novel treatment for epilepsy in dogs and targets the American market first. In week 43, 2018, Panion is invited to a meeting with the USFDA in Washington DC where the development product will be presented for authority reviewers from both FDA and USDA. From Panion, three persons will participate in person; regulatory FDA-expert Dave Petrick, Director of Business development Carlos N. Velez, and CEO, DVM Anja Holm. In addition, the FDA project manager has accepted to establish a telephone connection to two of Panion's scientific experts, so they can listen in and answer specific questions.

"We are really excited that this important meeting is taking place now. A presubmission meeting with the authorities, who will evaluate the application in the end, is of utmost importance. We have prepared and submitted a long document to the FDA including a list of questions that we expect to get the reviewers feed-back on. This will help us make the development plan as concrete as possible, including getting a firm estimate of the development costs and timelines." says Anja Holm.

Panion is also progressing the next step in the development plan after the recently finalized safety study in dogs; a pilot study in family dogs with true drug-refractory epilepsy. In the same week, meetings will be held at the investigator clinic, which is an optimal choice of clinic because of its large size, full equipment, and the highly skilled staff, including veterinary neurosurgeons and neurologists. The meetings will concern details of the study plan, roles, responsibilities and timelines.

"The expert neurologists at the clinic are very interested in our innovative treatment for this group of dogs that are currently lacking good treatment options, and they seem optimistic with regards to the speed of enrollment in the study, which is very encouraging for us. We aim at good progress in the pilot-study and expect to send out further details when we are back from the tour" says Anja Holm.

Anja E. H. Holm, CEO
+ 45-22 94 66 00 

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.

Nerladdningsbara filer

New CFO in Panion; Katarina Holm

The new CFO for Panion Animal Health AB from the of November 2018 is Katarina Holm, who cooperates with our current CFO, Sofia Josephson, for a smooth transition of the role.

Panion prepares for USA

2018 Q2 report, Period April-June for Panion Animal Health AB

Period April-June

  • Net sales: kSEK 0 (0). 
  • Operating profit: kSEK -1 299 (-1 156). 
  • Earnings per share: SEK -0,08 (-0,21). 
  • Liquidity at the end of the period: kSEK 15 (796).

Period January-June

  • Net sales: kSEK 0 (0). 
  • Operating profit: kSEK -1 996 (-2 423). 
  • Earnings per share: SEK -0,08 (-0,21). 
  • Liquidity at the end of the period: kSEK 15 (796).

Panion in FDA pre-submission conference

Panion Animal Health AB develops a unique new gene therapy treatment for dogs with drug-resistant epilepsy and the primary targeted market is the USA. The company has just been assigned to a pre-submission conference for this product with staff and experts from the FDA's Center for Veterinary Medicine to take place in October in FDA-CVM's office, Maryland, USA. At the meeting, the product will be introduced, the development plan will be discussed, and comments from the experts will be sought for a faster and smoother access to approval and marketing.

Panion's emission is finalised and the dog safety study is progressing well

Panion's shares emission that was running from 16-30 May and raised appr. 5.2 MSEK before emission costs, has now been completed and all payments processed.

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