Lobsor Pharmaceuticals receive approval for Lecigon® in Denmark, Finland and Norway
Uppsala, October 1, 2019. Lobsor Pharmaceuticals AB today announced that Lecigon has been approved, and that the Swedish Medical Products Agency (MPA) has confirmed End of Procedure according to the European Mutual Recognition Procedure (MRP) including Denmark, Finland and Norway.
Ulf Rosén, Co-founder of Lobsor comments: “We are delighted to have now received confirmation of End of Procedure, particularly since it came two months earlier than expected.”
The approval follows the Swedish marketing authorization for Lecigon which was granted in October 2018. Immediately after the MRP Approval, the procedure enters a national phase for approval of labels, package inserts etc. in the local language. The national phase is expected to be finalized end of October 2019 when the national market authorizations can be granted, and subsequent commercialization initiated.
“The positive outcome underscores our commitment to providing widespread patient access to this treatment “, continues Rosén. “We will seek additional European approvals via the MRP procedure over the next 18 months.”
The current worldwide sales of intestinal infusion based on levodopa is approaching USD 450 million in sales during the last 12 months with an annualized growth of >12%.
For further information, please contact:
Ulf Rosén, Co-founder and CEO of Lobsor Pharmaceuticals AB
Telephone: +46 70 686 29 16
Email: ulf.rosen@lobsor.com
Press release in Swedish and To the editor below
PÅ SVENSKA
Lobsor Pharmaceuticals får godkännande för Lecigon® i Danmark, Finland och Norge
Uppsala, 1 oktober 2019. Lobsor Pharmaceuticals AB meddelade idag att Lecigon har godkänts, och att Läkemedelsverket har bekräftat att man avslutat utvärderingen (End of Procedure) enligt proceduren för ömsesidigt godkännande (MRP) för Danmark, Finland och Norge.
Ulf Rosén, medgrundare av Lobsor kommenterar: "Vi är mycket glada över att vi fått bekräftelse att MRP processen är avslutad, särskilt eftersom det sker två månader tidigare än väntat."
Godkännandet följer på svenska marknadsföringstillståndet för Lecigon som beviljades i oktober 2018. Omedelbart efter MRP-godkännandet går förfarandet in i en nationell fas för godkännande av etiketter, katalogtexter etc. på det lokala språket. Den nationella fasen förväntas vara slutförd i slutet av oktober 2019. Sedan kan marknadstillstånd beviljas på den lokala marknaden och kommersialisering påbörjas.
”Framgången understryker vårt åtagande att bereda patienter tillgång till denna behandling på bred front”, fortsätter Rosén. "Vi kommer att söka ytterligare europeiska godkännanden via MRP-förfarandet under de kommande 18 månaderna."
Den nuvarande globala försäljningen av produkt för kontinuerlig infusion i tunntarmen baserat på levodopa närmar sig 450 miljoner USD i försäljning under de senaste 12 månaderna med en årlig tillväxt på> 12%.
För ytterligare information kontakta:
Ulf Rosén, grundare och styrelseordförande i Lobsor Holding AB
Telefon: +46 70 686 29 16
E-post: ulf.rosen@lobsor.com
To the editor
About Parkinson's Disease
Parkinson’s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease. PD is age-related and affects nearly 1% of the population over 60 years and 5% over 85 years, with high health, social, and economic impact. PD is a progressive disorder in which dopaminergic neurons are degenerated. Dopamine deficiency at (striatal) receptor sites presents as both motor and non-motor disability such as bradykinesia (slow movement), tremor, rigidity (stiffness), postural instability, depression, and sleep disturbance. The symptoms vary between patients and the number of symptoms and the severity tend to increase over time, creating a more complex clinical picture.
Parkinson’s disease, particularly in its advanced stage is a devastating disease with symptoms including uncontrollable shaking or tremor, lack of coordination and speaking difficulties. No less than an estimated seven to ten million people worldwide are living with Parkinson's disease and for most patients their disease will eventually reach the advanced stage. In addition, erratic gastric functioning is an important part of making patients refractive to oral treatment and techniques are used to bypass the stomach by introducing a small tube via the abdomen wall for pharmaceutical infusion into the duodenum. With disease progression patients eventually reaches the stage of Advanced Parkinson’s Disease. It is estimated that about 10% of individuals with PD are in advanced stage, of whom only 10 – 30% receive an adequate treatment. The advanced therapies are expected to continue to grow for many years.
About Lobsor
Lobsor Pharmaceuticals is a privately held company based in Uppsala, Sweden founded late 2013. It is a fully owned subsidiary to Lobsor Holding AB. The founders of Lobsor, Ulf Rosén and Roger Bolsöy, have substantial previous experience from the treatment of Parkinson’s disease in advanced stages especially continuous infusion of levodopa into the small intestine via a pump. Based on their own experience, and in close liaison with leading neurologists and patient organizations expressing and formulating areas of therapy improvements, the Lecigon treatment system has been developed with the aim to, in several aspects, improve daily living for individuals affected by progressive Parkinson’s disease and suitable for an invasive treatment.
In 2018 founders established US based company, Intrance Medical Systems Inc. which is responsible to obtain market authorizations the US and Canada. Several interactions have already been made with the US medical agency (FDA). In addition, Lobsor is now exploring various commercial routes forward to ensure that the treatment will be made available for patients in the European market and the rest of the world.
About Lecigon
The new patented treatment is a pharmaceutical gel formulation containing a combination of levodopa/carbidopa and entacapone in a 50 ml pre-filled container for continuous infusion into the small intestine. The treatment system includes a newly developed wearable pump that weighs 134 grams. Lecigon, is marketed in the Nordic countries through a collaboration with NordicInfu Care.
About NordicInfu Care
Lobsor has signed a collaboration agreement with NordicInfu Care for market insights in the development phase, in addition to sales, marketing and distribution of Lecigon in the Nordic market. NordicInfu Care with about 80 employees was founded in Stockholm Sweden 2004 and is currently serving > 50,000 patients in the Nordic countries. The company is a part of Air Liquide Healthcare, a company serving 15,000 clinics and hospitals as well as 1.5 million patients with home care.