Sollentuna September 15, 2016 PRESS RELEASE
The pharmaceutical company Sensidose AB announces that the company has passed important milestones:
• Flexilev® for the treatment of Parkinson’s disease is subsidized in Sweden
• Approved national marketing authorisation granted for Flexilev® in further 13 European countries
• A completed share issue was oversubscribed
Sensidose, founded in Uppsala in 1998, ad has developed a unique and patented system for personalized and optimized drug therapy.
The Dental and Pharmaceutical Benefits Agency (TLV) has decided that the company’s product Flexilev® for the treatment of Parkinson’s disease shall be included in the pharmaceutical benefits from the 21st May, 2016.
Sensidose AB applied for a subsidy for a limited group of patients in the late phase of the disease, where the available medication cannot obtain a satisfactory effect, and where treatment involving surgical intervention is considered. TLV-approval is therefore subject to the following condition and restriction: “Reimbursed only for patients with advanced Parkinson’s disease for which conventional tablet treatment with levodopa is no longer enough to control motor fluctuations, and for which only pump delivery of levodopa-carbidopa gel or apomorphine is possible treatment options or where these are inappropriate”.
“We are extremely pleased that we have received the reimbursement of Flexilev® approved by the TLV. Together with the patient association and the doctors, we have noted that there has been a great need for additional treatment options for the group of patients covered by the subsidy. It is very pleasing that we now can offer this treatment option” said Jack Spira, CEO of Sensidose.
“Therapy of Parkinson’s disease in the late phase is complex and often involves not only difficult to adjust treatments, but also side effects that are sometimes unacceptable and leads to discontinuation of treatment. Individualized treatment with Flexilev is a very good and unique options for these patients because the dose may be individually titrated and balanced so that the effect is good, and the side effects are minimal. It is therefore gratifying that Flexilev® now can be a treatment option for the patients “says Sten-Magnus Aquilonius, Professor Emeritus at the Department of Neuroscience, Neurology, at the University of Uppsala.
On June the 30th, Sensidose was granted national marketing authorisation for Flexilev® in 13 further EU countries .
In parallel with the application for subsidy in Sweden, the company has been running a registration process via a so-called Mutual Recognition Procedure (MRP) and now was granted national
marketing authorisation in another 13 European countries. The approval is subject to a commitment to submit additional data in the coming year.
“It is very gratifying to note that we now have marketing authorization for Flexilev® in 13 further EU countries (DK, NO, FI, IS, NL, LU, DE, PL, LV, EE, UK, BE and AT) where we now can start the process of pricing and reimbursement applications and as soon as possible move into sales! Regarding the commitment we were imposed, the company has already completed part of these and the rest will be carried out this autumn and in the spring of 2017” continues Jack Spira.
Rights issue oversubscribed
The Company completed during August a successful rights issue of approximately SEK 10 million, in order to scale up production and meet the need for working capital for the upcoming market introduction of Flexilev in Sweden.
“We are now scaling up production of Flexilev® tablets and dosing device MyFIDTM. At the same time we are looking at various possibilities in order to as quickly as possible to get started with sales both in and outside of Sweden” concludes Jack Spira, CEO of Sensidose.
About Parkinson’s Disease
Parkinson’s disease is a neurological common disease where approximately 20 000 people are affected only in Sweden and more than 3 million worldwide. The symptoms are characterized by stiffness, tremors and limited movements. Symptoms develop gradually over many years and successful treatment requires individualized dosing. Patients are currently treated with several drugs, where levodopa proposed by Professor Arvid Carlsson therapy already in the 1950s and 60s, still constitute the basic gold standard treatment. World-leading research on new strategies to refine and personalize treatment with levodopa has for decades been conducted at Uppsala University and neurology clinic at the University Hospital in Uppsala, from which Sensidose springs.
About Sensidose AB
Sensidose develops new drugs and systems for individual dosage. The company has developed a delivery system based on proprietary microtablets in combination with an electronic dosing device for the calculation and delivery of individual doses. The company’s first micro tablet Flexilev® is a drug for the treatment of Parkinson’s disease. Other indication areas suitable for the system include: treatment of pain, diabetes, and epilepsy. Company website: www.sensidose.se
For further information contact: Jack Spira, CEO of Sensidose AB. Tel: +46722-50 62 72 firstname.lastname@example.org
The Press release is also avalible for download here!