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03/01-2018 16:44:08: (PANION.ST) Panion's epilepsy product candidate for gene therapy in the dog: FDA has established an Investigational New Animal Drug (INAD) file.

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'S EPILEPSY PRODUCT CANDIDATE FOR GENE THERAPY IN THE DOG: FDA HAS ESTABLISHED AN INVESTIGATIONAL NEW ANIMAL DRUG (INAD) FILE.

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.

A summary of the scientific rationale for the therapy and the preliminary work completed to date was submitted and the FDA accepted this with a response letter, which was received from our US consultant on January 02, 2018. Because a MUMS status for Panion development product has been granted, in which the Sponsor User Fee was waived, the application is free of charge for Panion.

The opening of the INAD means that Panion may request a meeting with the FDA and propose a detailed plan of development for discussion with the authorities. In addition, the INAD is prerequisite for shipping of the investigational drug product to the clinical trial investigators in US.

"It is great to see that we are making progress in these regulatory areas, because this is the pathway to authorization of a product" says Anja Holm, CEO of Panion.

JANUARY 03 2018

Anja E. H. Holm, CEO
+ 45-22 94 66 00
anja.holm@panion-animalhealth.com

The following documents can be retrieved from beQuoted
Panion Pressrelease 2018-01-03.pdf

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.

Ekstern link: http://www.bequoted.com/beQPress/P_PressreleasesRecord.asp?Id=13782

Nyheten er levert av beQuoted.

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tirsdag 23/01-2018 04:49:33