BioStock: Sunday interview with Annette Agerskov


Enorama Pharmas Vice President on the Market Application Agreement

Enorama Pharma develops drug delivery products in the form of medical chewing gums that will be sold over-the-counter directly to consumers under retailers’ own brands. The company’s first product is a nicotine gum for smoking cessation. Recently, a bioequivalence study was re-done with new positive results communicated this week. Thus, Enorama Pharma has passed all obstacles on the way to a market introduction. In today’s Sunday interview, the vice President Annette Agerskov comments on the event as well as the general timetable for marketing applications and the upcoming product launch.

Annette Agerskov, you have recently published the results of your bioequivalence study for your nicotine gum with fruit flavors. In your press release it appears that you see the established bioequivalence as an accomplishment of great importance for your product development. Can you tell us more about what the results mean for your future plans?

“It’s very big for us. The study results mean that we now have all the necessary data needed to compile a marketing authorization application to send to the authorities.

One should be aware that developing medical chewing gums is complex. Partly because both the content of the active substance and its release must be checked. You have the product in your mouth for 20-30 minutes on average, after which you spit it out. Thus it is crucial that you can document that the active substance is released from the chewing gum and absorbed by the body. In addition, most people do not want to have a product in their mouth for so long if it does not taste good and because most of the medicine-active substances have a bitter bitterness, flavoring is a very important discipline to master when developing medical chewing gums.”

– Annette Agerskov, Vice President Enorama Pharma.

Read the full interview in Swedish