Article in Animal Pharm nov 23
Redistributed with permission from Animal Pharm
Panion targets gene therapy pilot study in North America
Panion Animal Health will soon enter a pilot study for its canine epilepsy drug candidate. The Swedish company is developing a gene therapy and recently gained positive safety results following the clinical phase of its treatment study
In a statement regarding the firm’s third-quarter and nine-month results, Anja Holm – chief executive of Panion – said: “The next step in the product development will be the pilot study in privately-owned dogs with drug refractory epilepsy, which we intend to conduct in a specialized clinic in North America.
“We have established good co-operation with a specialist veterinary clinic with full equipment and highly skilled staff, including veterinary neurosurgeons and neurologists.
“The company is targeting a debut commercial launch on the US market. Panion met with the US FDA Center for Veterinary Medicine (CVM) last month in Washington DC.
The pre-submission conference allowed the firm to explain the technology, its development status and future plans. Panion also answered many questions from the authorities.
Dr Holm said: “The dialog was open, interested and curious, and the central reviewers from FDA CVM came across very well prepared and helpful. We had prepared well for this meeting, using both documents and pre-meetings with excellent assistance from our US expert Dave Petrick.
“It is my impression the FDA is very willing to guide us along the way. They expressed several times the opportunity for intermediate exchanges and comments, and for protocol concurrence prior to starting pivotal studies, to ensure acceptability of the data from such studies when we submit the data package.”
More candidates, financial update
Dr Holm also said Panion intends to extend its innovation pipeline. The company is investigating several options for in-licensing deals.
The company has reduced its loss during the third quarter of the year, as well as the first nine months of 2018.
In Q3, net loss was SEK536,000 ($59,000) – compared to SEK923,000 this time last year. At the ninemonth stage, loss was SEK2.53 million versus SEK3.35 million during the same period of 2017.
Dr Holm told Animal Pharm the reduced expenses were largely due to increased cost awareness and streamlining of internal processes. Panion also saw a slight delay in its previous safety study postpone R&D expenses.
By Joseph Harvey | @JHJournalist | joseph.harvey@informa.com
Anja E. H. Holm, CEO
+ 45-22 94 66 00
anja.holm@panion-animalhealth.com
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.