Company in brief
Dizlin Pharmaceuticals is a pharmaceutical research company developing new treatments for Parkinson´s disease. The company’s basic research is undertaken in collaboration with the University of Gothenburg and Linköping University in Sweden.
Afflicting 10 million people worldwide, Parkinson’s disease is the world’s second most common neurodegenerative disorder, with a prevalence that is increasing with an ageing population.
Parkinson’s disease is the result of a progressive degeneration of dopamine-containing nerve cells and characterized by impaired motor control. At early stages it may be successfully treated with per oral administration of a precursor to dopamine, levodopa, but after a number of years the patient usually develops rapid shifts from immobility to involuntary movements in response to this treatment, so called on-off symptomatology.
It has since long been known that the on-off complication may be effectively managed by replacing levodopa tablets, that cause marked fluctuation in serum levodopa levels, with a continuous infusion of the same substance. Solubility issues, however, have precluded the development of levodopa solutions that may be used clinically for subcutaneous or intravenous infusions.
Dizlin Pharmaceuticals was founded in 2003 with the goal to develop such solutions, and has now managed to do so. The company’s innovative products Infudopa SubC™ and Infudopa IntraV™ thus have the potential to markedly counter on-off symptoms in patients with Parkinson´s disease.
Our business model comprises development of products for the treatment of Parkinson´s disease and to license these to pharmaceutical companies active in this field and hence with existing resources to efficiently introduce them onto the market.
- Dizlin Pharmaceuticals is founded and starts developing intravenous and subcutanous administration of levodopa for the treatment of Parkinson´s disease.
- Nobel Prize Awardee Arvid Carlsson joins as co-owner and member of the board.
- A new levodopa solution displaying increased stability and optimized levodopa uptake from the subcutaneous tissue is invented and named Infudopa™.
- Academic researchers receive MSEK 11 from the Swedish Research Council to conduct a pharmacokinetic study of Infudopa™.
- A Patent Cooperation Treaty (PCT) application for a modified version of Infudopa™ is submitted.
- Following positive response from the PCT authority, patent applications are submitted in the US, Europe, and other relevant countries including BRIC and Asia.
- The final results of a pivotal pharmacokinetic study, that is completed in April 2020, yield support for a good tolerability and excellent levodopa bioavailability following administration of Infudopa SubC™.
“I have an ethical responsibility to contribute to Infudopa™ becoming available to patients suffering from Parkinson’s disease”
– Arvid Carlsson – Nobel Prize winner
Vision & Mission
Our vision is to be a leading pharmaceutical research company specialized in Parkinson’s disease.
Our mission is to improve the quality of life for patients with Parkinson’s disease by developing innovative treatments.
The clinical implementation will be pursued by selling licenses and/or establishing partnership with companies that have the potential to implement the products on the market with sufficient experience and structure to give patients and health care professionals the best possible support.
The unique features of Infudopa™
The pros and cons of levodopa
The cardinal symptoms of Parkinson´s disease are all secondary to the loss of dopamine – replenishing dopamine levels by peroral administration of a dopamine precursor, levodopa, thus effectively restores normal motor function. To avoid side-effects caused by dopamine formation outside the brain, and to increase the amount of levodopa reaching the brain, levodopa is usually co-administered with carbidopa, a compound blocking peripheral conversion of levodopa to dopamine.
Due to the short half-life of levodopa, the serum levels of the molecule display marked fluctuations when it is administered as tablets. At the early stages of the disorder, this poses no major problem, since there are sufficient dopaminergic neurons still available that are capable of transforming levodopa to dopamine, store the transmitter and release it when appropriate. At later stages of the disease, the remaining dopaminergic neurons are, however, too few to fulfil this task – instead levodopa is taken up by non-dopaminergic neurons and released in a non-physiological manner, with marked fluctuations from hypokinesia to dyskinesias – the on-off complication – as result.
The benefit of levodopa infusions
It has since long been known that avoiding serum fluctuations of levodopa by administering the compound as a continuous intravenous infusion restores normal motor function in patients with on-off symptoms. In line with these early studies, continuous administration of levodopa plus carbidopa into the intestines by means of a pump and an implanted tube – Duodopa®/Duopa®– is now an approved and well-established treatment for late-stage Parkinson´s disease with on-off complications.
While it would be much more convenient to instead administer levodopa subcutaneously, in the same manner as insulin is administered to patients with diabetes, the poor solubility and stability of levodopa, impeding the formulation of highly concentrated levodopa solutions, until now has made this strategy inaccessible.
A levodopa-containing solution aimed for outpatient treatment of Parkinson´s disease should meet several criteria to be optimal for this purpose. It should be sufficiently concentrated to be administered by means of a portable pump. To prevent peripheral side effects and to enhance the amount of levodopa reaching the brain, it should contain not only levodopa but also carbidopa. It should be stable in refrigerator and preferably also in room temperature. And it should display a pH that does not cause adverse skin reactions and promotes rapid uptake from the subcutaneous tissue, i.e. 5-6.
The creation of such a solution is the discovery forming the basis of Dizlin Pharmaceuticals. Infudopa SubC™ thus is a levodopa- and carbidopa-containing solution that is highly stable in room temperature with a pH of approximately 5 when administered to the patient, hence producing a rapid uptake of levodopa from the subcutaneous tissue with a bioavailability close to 100%.
Infudopa™ may serve as monotherapy also in patients requiring high levodopa levels. The rapid uptake enables individualized and flexible dosing.
Infudopa IntraV™ is a similar but different product aimed for intravenous administration to inpatients in situations where levodopa cannot be administrated orally or intestinally, e.g. prior to and after surgery, and/or when peak-dose dyskinesias or end-of-dose wearing off prevent various diagnostic and treatment procedures.
At present, there is no levodopa solution aimed for subcutaneous or intravenous administration on the market.
Business & Strategy
By generating innovative treatments that improve life for patients with disorders in the brain, Dizlin Pharmaceuticals Our research focuses on disorders in the brain that affect large groups of people around the world, where the need for better therapies is significant.
The business model of Dizlin Pharmaceuticals comprises development of products for the treatment of brain disorders and licensing of developed products to pharmaceutical companies active in this field and hence with existing resources to efficiently introduce the products on the market.
Our product portfolio addresses an important and significant medical unmet need
Prompted by the observation that the on-off symptomatology marring per oral levodopa administration in late stages of Parkinson´s disease is markedly improved if serum fluctuations of levodopa can be avoided, Dizlin Pharmaceuticals is currently concentrating its resources on developing levodopa solutions feasible for pump-based continuous administration.
Active patent strategy
Strong patents are a prerequisite for successfully commercializing Dizlin Pharmaceutical’s scientific advances. By pursuing an active patent strategy, patents protecting of the company’s original formulation have been granted both in the US and Europe as well as in other major drug markets.
A new patent application was filed in June 2017. The new application covers important features of a further development of the original formulation. Additional measures have been taken as well, in order to protect the Infudopa™ intellectual property, which altogether with granted patents and recent patent applications constitute a robust protection of the company’s intellectual property.