How can life be made easier for people with epilepsy?
That was the question posed by Christer Sjögren, one of SWIPP’s two founders. Our story begins before 2017. After a successful career in the pharmaceutical industry, holding senior positions in several different companies, Christer decides to look for a new challenge. This turns out to be creating the best possible product for treating convulsive epilepsy seizures. The idea of the buccal film with midazolam is born, and soon thereafter he submits a patent application.
Bengt Westrin, the co-founder of SWIPP, has successfully developed and patented a medical oral film for another company. Christer Sjögren and Bengt Westrin are former colleagues, and decide to collaborate and pool their expertise. Bengt has extensive experience of pharmaceutical development and understands the necessary stages and conditions of a project.
In October 2017, SWIPP is founded. The company’s focus is the buccal midazolam film project, but it won’t be long before new ideas take shape.
The results of market research conducted by Drive Research (US) are released. Forty epilepsy specialists in the USA, the UK, Germany and France were asked about SWIPP’s buccal film (Project 1).
The responses showed unequivocally that they appreciated the product and that they would prescribe it if it were available.
The results of the first study within Project 2 is released: SWIPP-011. These results are also very positive and confirm that the product concept in Project 2 works.
A new website is launched, introducing for the first time SWIPP to a wider audience.
Preparing a pre-IND meeting with the FDA about SWIPP’s Project 2, including the results from SWIPP-011.
New share issue planned for Q4 2022.
Three seed investors who share SWIPP’s vision get on board: Lars Hedbys, Lars Persson, and Johan & Annette Säfholm.
Cooperation begins with the regulatory advisor SOFUS in Stockholm (now ProPharma Group).
Regulatory advice received from the Swedish Medical Products Agency (MPA/Läkemedelsverket) and from the MHRA in the UK.
Conducting 20 in-depth interviews with neurologists, parents and other caretakers in the epilepsy field. The product concept is well received. The pace picks up.
Cooperation begins with Quinta-Analytica in Prague, a one-stop-shop CRO specialized on Phase I studies and bioequivalence studies.
Cooperation begins with the GMP manufacturer AdhexPharma in France. AdhexPharma also decides to invest in SWIPP.
Scientific Advice Meeting with the Swedish MPA.
Advisory meeting with the Swedish Dental and Pharmaceutical Benefits Agency (TLV) regarding future pricing for SWIPP’s product.
Mastan AB, AB Seglarevägen and Margaretha Cronvall are welcomed as new shareholders.
Eight new co-owners are welcomed on board, including a number of successful entrepreneurs from the health care and biotech industries.
An unusually eventful month. A share issue is made, with 15 of the company’s 17 co-owners participating. Intensive preparations continue for SWIPP-012, and of SWIPP-011 which will be the first study within Project 2. Clinical trial applications submitted to the State Institute for Drug Control (SUKL) in the Czech Republic are approved, import and export licences are granted for the trial product, and a new GMP batch is manufactured. All deadlines are met!