Sensidose sells and markets a treatment for patients with advanced Parkinson's disease. The company's prescription drugs Flexilife, is designed as microtablets that are dosed using the dosing device MyFIDThis enables individualized and finely tuned medication for Parkinson's patients, who thereby receive an optimized drug dose and good symptom control. Flexilev is produced via a CMO in Germany and MyFID in Sweden.
The number of patients currently undergoing treatment is approximately 270. A recently published follow-up study on Flexilev-treated patients shows that as many as 85 percent of patients in the study report symptom improvement when using Flexilev compared to previous standard treatments.
Sensidose is also developing a completely new dosing device, ORAFID, which targets patients in earlier stages of Parkinson's disease – a significantly larger target group than for the current product.
MDR application submitted
Sensidose holds all the quality systems, licenses and permits needed to sell both a pharmaceutical and a medical device. Sensidose recently submitted an application for certification of MyFID under the MDR, the EU's new Medical Device Regulation. Review and potential approval are expected in 2023.
Preparing for expansion and further development
Sensidose currently sells its products in Sweden, Norway and Denmark. To facilitate logistics, the company has decided to develop a new packaging that is intended to be used throughout the Nordic region. As this requires a regulatory application, this is a process that will take some time to complete as all countries where Flexilev is approved must approve the change, even those not covered by the change.
Sensidose's work on expanding to more markets, in the near future primarily Finland and Poland, is ongoing with both the preparation of application documents, meetings with neurologists in each country and discussions with possible future partners.
Furthermore, to facilitate the use of Flexilev, the company has developed a digital tool that doctors can use to easily obtain dosage instructions, which can then be discussed and given to the patient.
Rising sales despite component shortages
Cumulative sales increased during the first months of the year despite a shortage of semiconductor components for the MyFID dosing device. To solve the problem, the company purchased an alternative component, which they now have in stock. The new component requires some new software, and therefore the dosing device is currently being reprogrammed. Sensidose expects to have new dosing devices for patients waiting to start treatment with Flexilev after the summer.
Sensidose CEO comments
BioStock contacted Sensidose CEO Jack Spira to learn more about the company's development.
Jack, how would you summarize Sensidose's first half of 2022?
– It has been a successful year overall. We have made progress in terms of the existing market, geographical expansion, the search process for new employees and the development of Orafid. So far, everything is going well. Unfortunately, we are not yet fully on track with the component shortage, but we have high hopes that the path we have chosen with an alternative key component will lead to us finally being able to produce and supply our patients with dosing machines. As previously announced, we have many patients waiting in line to start treatment with Flexilev and our highest priority is to help them achieve a better quality of life.
How do you prepare the way for a successful market introduction in countries such as Poland and Finland?
– We are working on information for neurologists in parallel with our applications. From this point of view, the pandemic has been good now that WEB meetings for information and discussion have become everyday life for everyone involved. We have had a successful such meeting in Poland and will organize a similar one in Finland. Then it is important that our partners establish good contact with the doctors and create understanding of how the product should be used and which patient group we are targeting.
The listing on Spotlight is of course one of your biggest achievements so far this year. How has the listing affected your business?
– The expansion in the various projects we are running today would not have been possible without the listing and the new share issue. Thanks to it, we can work forward with greater strength and concentration. We are also of course aware of our new obligations towards the market and owners, with regard to information, for example. It is a job where we hope to be able to do even better when we have warmed up a bit.
»The expansion in the various projects we are running today would not have been possible without the listing and the new share issue.«
Can you also give an outlook for the next six months, what do you hope to achieve?
– We hope that our good start to the year in terms of sales will continue and look forward to having MyFID in production again. In the short term, it is crucial to improve our figures. At the same time, we continue to work to give more patients access to our Parkinson's treatment through further development, market expansion and information. The retrospective study showing that 85 percent of patients using Flexilev report symptom improvements compared to previous therapy is an important tool for increasing awareness among both doctors and patients.
