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.
Panion is attracting interest from the agribusiness intelligence and animal health media Animal Pharm, where journalist Sian Lazell yesterday, 31.st of January 2019, noted the news on financing of the development program from Panion: https://bit.ly/2t1tgeK "Panion secures extra funding to back R&D. The financing round was carried out through the issuance of notes with warrants attached to Yorkville Advisors Global, that have a principal amount of SEK 100,000 each.
Panion Animal Health AB ("Panion") kallar på en andra tranche från den investeringsfond som förvaltas av Yorkville Advisors Global ("Yorkville").
Panion Animal Health AB ("Panion") draws down a second tranche from the investment fund managed by Yorkville Advisors Global ("Yorkville").
The rights issue in Panion Animal Health AB has been registered by the Swedish Companies Registration Office
The rights issue which was decided by the Board of Panion Animal Health AB, with the authorization of the Annual General Meeting of 29 May 2018, has now been registered by the Swedish Companies Registration Office. Shares and share capital after the registration by the Swedish Companies Registration Office amount to SEK 1,137,110.723254 divided into 24,399,487 shares.
Panion Animal Health AB
Marknadsplats: Spotlight Stock Market
Interim Report Q3 2018
2019-02-22 Delårsrapport Q4 2018