[Q3 INTERIM REPORT JANUARY – SEPTEMBER 2016, NICOCCINO HOLDING AB]
As the Company is focused on developing a licensed drug, Nicoccino has sought new collaborations to secure an optimal production partner that fulfils all regulatory requirements but also has the flexibility and capacity suitable for the Company’s new business model.
In October, Nicoccino signed an agreement with an American manufacturer that has long and extensive experience of the industry.
In order to manage the drug registration in best possible way, Nicoccino has hired consultant companies that are experts in this area and are responsible for both study and communication with the MPA.
As part of the Company’s new strategy, a clinical study will be conducted with the intention of obtaining a drugs classification.
The first step is to produce test and validation batches. Thereafter clinical production and a clinical study will be conducted. When these elements are completed, the dossier is compiled and application submitted to the Medical Products Agency [MPA] in Sweden.
The Company has high hopes to achieve fast results in regards to previous production experience as well as the underlying bioequivalence study that was conducted in 2012.
In 2012 a bioequivalence study took place at St Göran's Hospital in Stockholm with the main purpose to establish the amount of nicotine released into the blood stream when the subjects used the Company’s nicotine film. The equivalent data was collected when the same subjects used a medicinal non-prescription mouth spray. The outcome showed a bioequivalence, meaning that the maximum concentration of nicotine in the blood was the same for both products and that the amount of nicotine absorbed into the bloodstream was the same. The subjects were also asked a series of questions about the use of the nicotine film and its effects with the following outcomes: