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CEO Letter, December 2022

By |2022-12-27T13:48:26+01:00December 24th, 2022|

Dizlin has during the autumn continued to work on prioritized projects according to the updated project plan. Progress has been made with pharmaceutical development, pump development and the regulatory application process.  

The extensive work with Chemistry Manufacturing and Controls (CMC) – specifically the analyses and documentation required for us to be able to submit a registration application for Infudopa IntraV™ at the end of next year – has gone well and is on schedule.

The development program for the pump which will be used for treatment Infudopa SubC™ in outpatient care is in the final phase. A working prototype has been developed and we will have a number of pumps for use in clinical studies early next year. We are very satisfied with the pump thus far as well as the collaboration with the pump development partner FDE. 

Extensive work to compile data related to the Pre-IND for Infodopa SubC™ has also recently been completed. The Pre-IND is the documentation that the FDA (US Food and Drug Administration) will use to be able to provide us guidance on what is required for an approval in the USA. A response from the FDA is expected at the beginning of March 2023. 

As previously announced, Dizlin has received a broad patent approval for Infudopa in the EU. Some time ago we also received the news that we have been granted patents in Mexico and Japan, which is very positive, as Japan is the world’s second largest market for Parkinson’s disease. We do not yet have a granted patent in the United States, but based on the latest opinion from the patent authority, there is a high likelihood that we will be granted strong patent protection in the United States. We see the progress related to our intellectual property as very positive.

Another welcome piece of news is that the results of the important pharmacokinetic study for both Infudopa SubC™ and Infudopa IntraV™ – study IPO-001 – were published in the respected journal Neurology on 6 September, which also resulted in a positive editorial in the same issue. 

Despite this positive news, there are clouds of concern related to a number of well-known external factors – uncertain macro situation with rising inflation and interest rates, and a falling stock market as a result, make it increasingly difficult to raise capital. We continue to work actively with the planned capital raise and have contact with strategic investors, funds and private investors.

Our ambition is to raise a total of SEK 100 million.

The capital requirement relates to the implementation of the following activities:

  •   Completion of the CMC development and submission of a registration application to the EMA for Infudopa IntraV™
  •   Completion of the pre-clinical work for both Infudopa SubC™
  •   The performance of the pharmacokinetic study on healthy volunteers that is required by the FDA for both Infudopa SubC™ and IntraV™
  •   Submission of a registration application to the FDA for Infudopa IntraV™
  •   The implementation of a small pilot study with the newly developed pump in patients with Parkinson’s disease for Infudopa SubC™

SEK 100 million would take us a long way in our development plan – all the way to the submission of registration applications for Infudopa IntraV™ and up to the initiation of the tolerability study for Infudopa SubC and we continue to work actively to raise this capital. 

Wishing you a Merry Christmas and a Happy New Year 2023

Björn Velin
CEO, Dizlin Pharmaceuticals AB

Dizlin Pharmaceuticals publishes data from pharmacokinetic study (PK) (IPO-001) with Infudopa SubC (DIZ102) and Infudopa IntraV (DIZ101) in Neurology

By |2022-09-07T10:42:34+02:00September 7th, 2022|

Gothenburg, Sweden, September 7, 2022 – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system (CNS), announces that an article has been published in Neurology®, from the American Academy of Neurology®, describing data from the company’s IPO-001 pharmacokinetic cross-over study.   

  • In a pharmacokinetic cross-over study comprising 18 evaluable subjects with advanced Parkinson´s disease, levodopa/carbidopa solutions with a pH of 5.5 were produced by continuous buffering shortly prior to intravenous (DIZ101) or subcutaneous (DIZ102) administration.
  • During the 16h of infusion, both DIZ101 and DIZ102 displayed plasma levels of levodopa comparable to those obtained by means of dose-adjusted intestinal administration of a levodopa/carbidopa gel (Duodopa, LCIG) – predefined bioequivalence aims of the study were hence met.
  • The bioavailability of levodopa was 100% with subcutaneous administration of DIZ102 and 80% with intestinal administration of LCIG.
  • Skin-related side effects were generally absent or mild.

“The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson´s disease”, says principal investigator Filip Bergquist, MD, senior consultant in neurology and professor of pharmacology.

“The data were those that we had hoped for,” says Björn Velin, CEO of Dizlin Pharmaceuticals. “The results suggest that DIZ102 (Infudopa SubC™), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration. The rapid uptake of levodopa from the subcutaneous tissue would enable considerable flexibility in dosing, which we also regard as an important advantage. Unlike intestinal administration of a levodopa/carbidopa gel, Infudopa SubC™ requires no surgery and displays considerable room temperature stability prior to mixing.”

The article in Neurology is accessible for free at:  https://n.neurology.org/content/99/10/e965

This release discusses investigational uses of products in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For more information, please contact:
Björn Velin, CEO, Dizlin Pharmaceuticals AB
Cell phone: + 46 (0)76 879 2325, e-mail: bjorn.velin@dizlin.se

The information was released for public disclosure, through the agency of the contact person above, on September 7, 2022.

About Infudopa IntraV™
Infudopa IntraV™ (DIZ101) is a levodopa-carbidopa solution aimed to be administered intravenously using infusion pumps to inpatients who cannot receive oral administration of levodopa when being the subject of surgery with general anesthesia.

About Infudopa SubC™
Infudopa SubC™ (DIZ102) is a levodopa-carbidopa solution intended for outpatient treatment. Used with a portable twin pump enabling continuous mixing prior to infusion, Infudopa SubC™ is aimed as monotherapy for subjects who experience moderate to severe motor fluctuations when receiving oral administration of levodopa. When reaching the patient, Infudopa SubC™ displays a physiologically acceptable pH which also seems to optimize efficient levodopa uptake. The shelf life is 36 months in refrigerator and at least three months at room temperature, which would represent a significant logistic advantage for patients, e.g., when traveling.

About Parkinson’s disease
Parkinson´s disease (PD) is a serious neurodegenerative disease afflicting more patients than multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy, and myasthenia gravis combined. Characterized by bradykinesia (poverty of motion), tremor, and muscular rigidity, and caused by degeneration of neurons using dopamine as transmitter, PD is a chronic and progressive condition, with a prevalence of 1% over the age of 60 and 3% of those over 75.

About Dizlin Pharmaceuticals
Dizlin Pharmaceuticals AB is a privately held Swedish research-based pharmaceutical development company with focus on diseases of the central nervous system in general and on developing improved treatment for advanced stages of Parkinson’s disease in particular. The company conducts research in collaboration with researchers at the University of Gothenburg and Linköping University in Sweden.

The company has developed a new patented method for treatment of advanced stages of Parkinson’s disease. Dizlin Pharmaceuticals has two products in late phase development stage. The first – Infudopa IntraV™ – is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease. The second – Infudopa SubC™ – is administered as a continuous subcutaneous infusion by means of a portable pump (similar to insulin infusion for diabetes).

PR 20220907 DIZ101 Neurology

CEO Letter, Summer 2022

By |2022-09-02T08:10:44+02:00August 15th, 2022|

During the first half of the year we continued our focus on the further development of Dizlin’s potential treatments for late stage Parkinson’s disease. During the summer we completed an additional financing round from current shareholders which allows us to continue with the current prioritized activities. 

An update on these prioritized activities is as follows: 

The development of the Infudopa SubC™ pump, which has been identified as the single most important activity at the moment, is proceeding according to plan. We expect to have a working prototype at the end of September and a pump which can be used in clinical trials at year end.

A peer-reviewed article containing results from our completed IPO-001 study, which was previously announced, has been accepted to a highly regarded scientific journal. The article is already published in a short version (abstract) and will shortly be published in its entirety.  We look forward to communicating more once the article is published in its entirety. 

The work with Infudopa IntraV™ has intensified and given high priority in order to reach a registration in one or more countries in Europe as soon as possible. In parallel with this, the planning continues for the upcoming study which will form the basis for an approval for Infudopa IntraV™ in the USA (FDA).

We are also proceeding with the Pre-IND (Investigational New Drug) application for Infudopa SubC™ as well as hydrazine testing and a detailed market analysis for Infudopa IntraV™. The market analysis for Infudopa IntraV™ is expected to provide us with feedback from payers and physicians regarding pricing, product profile, product positioning and commercial opportunity.  

August 2022

Björn Velin
CEO, Dizlin Pharmaceuticals AB

CEO Letter, December 2021

By |2021-12-17T10:07:27+01:00December 17th, 2021|

The year was marked by continued positive development of Dizlin’s innovative potential treatments for late stages of Parkinson´s disease and we secured financing for the upcoming steps in development. We can look back with pride over a year marked by advances in our efforts to fulfill our ambition: to improve the quality of life for Parkinson patients with late-stage complications, such as shifts in motor function from immobility to involuntary movements.

It is satisfying to announce that we during the last quarter successfully managed to secure financing that enables us to continue our journey to create value for patients, shareholders, and society at large. Dizlin Pharmaceuticals has two potential products containing levodopa-carbidopa solutions in late development stage. The first, Infudopa SubC™, is a treatment for reducing motor complications of Parkinson’s disease via continuous subcutaneous infusion administered by a portable pump (similar to insulin infusion for diabetes). The second, Infudopa IntraV™, is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease.

Another important milestone was finalizing the partnership for the upcoming commercial production of the portable pump, which is required for the administration of Infudopa SubC™. A clinical study has shown that our product can yield high and even levels of levodopa which is a prerequisite for being able to provide Infudopa SubC™ as a monotherapy. Infudopa SubC™ can be expected to provide at least the same efficacy as the most effective treatment available for advanced Parkinson’s disease, but without the need to implant a tube into the intestine. We have kicked off the collaboration with a manufacturer with extensive experience of producing pumps in line with our expectations and requirements.

In addition, we recently chose a partner for process development activities and for production of clinical trial material. Our efforts and investment in relation to chemistry, manufacturing, and controls (CMC) are critical for the ongoing projects. This is to ensure that we have clinical trial material for pivotal studies and ultimately a commercially viable production process in place.

Regarding our second product, Infudopa IntraV™, our goal is to commence a final minor clinical bioequivalence and tolerability study mid-2022. This product is intended for intravenous treatment to both enable and facilitate surgical procedures for Parkinson patients. During the year, we have initiated follow-up interactions with the health authorities in Europe and the US with the aim to file our applications for market authorization with both the EMA and FDA after completion of the final study.

Strong patents are critical to protect scientific advances. Therefore, an active patent strategy is a precondition for maximizing the commercial value of Dizlin’s scientific advances. In the beginning of the year, we were pleased to obtain a “Decision to Grant” by the European Patent Office regarding Infudopa SubC™.

Two years have passed since I joined the company as CEO, and I am proud of what the team has accomplished so far. We will now continue our important efforts to develop treatments that can improve the quality of life for Parkinson patients and their families. Thank you all for your interest in Dizlin Pharmaceuticals and I wish you all the best for the Holiday Season and the New Year.

Björn Velin
CEO, Dizlin Pharmaceuticals AB

Dizlin Pharmaceuticals AB appoints Daniel Mackey as Chief Financial Officer

By |2021-11-02T13:49:44+01:00November 1st, 2021|

Dizlin Pharmaceuticals announces the appointment of Daniel Mackey as Chief Financial Officer (CFO) effective as of November 1, 2021.

Daniel Mackey brings to Dizlin Pharmaceuticals more than 20 years of finance and controlling experience. Prior to joining the company, Daniel has a background in the finance and life science sector. He has held senior management positions at Nordea in Stockholm, Investors Trust Ireland in Dublin, and most recently the CFO position at Infant Bacterial Therapeutics AB, a pharmaceutical company listed on Nasdaq Stockholm. He holds a BS, Economics from State University of New York College at Plattsburgh, in the US.

“I am pleased to announce that Daniel Mackey has joined our Executive Management Team as CFO. Daniel’s competence, extensive experience in finance and controlling as well as his strategic knowledge will play an important role for Dizlin Pharmaceuticals moving forward. We are excited to have him on board,” says Björn Velin, CEO of Dizlin Pharmaceuticals.

“I look forward to contribute and advance Dizlin Pharmaceuticals’ financial and business objectives that will support and further strengthen the company’s position as a pharmaceutical research company developing new innovative treatments for late stages of Parkinson´s disease,” added Daniel Mackey, Dizlin Pharmaceuticals’ Chief Financial Officer.

Michael Owens, who previously held the position as CFO will continue as Controller, thus ensuring a smooth transition, as well as supporting the company regarding external financial reporting matters.

For more information, please contact:

Björn Velin, CEO of Dizlin Pharmaceuticals AB, + 46 (0)76 879 2325, bjorn.velin@dizlin.se

Dizlin Pharmaceuticals has obtained a “Decision to Grant” by the European Patent Office for Infudopa SubC™, a new potential treatment for Parkinson’s disease

By |2021-11-02T13:48:03+01:00February 4th, 2021|

Dizlin Pharmaceuticals announced today that the European Patent Office (EPO) has issued a Decision to Grant a European patent pursuant to Article 97(1) EPC following examination of European patent application No. 18730319.3. The mention of the Grant was published in the European Patent Bulletin 21/04 on the 27th of January 2021. The Decision to Grant refers to Infudopa SubC™, a new potential treatment for reducing motor complications of Parkinson’s disease via continuous subcutaneous infusion.

A granted patent by EPO will protect the company’s innovative product Infudopa SubC™ for treatment of Parkinson’s disease in all markets in Europe, which have agreed to the Patent Cooperation Treaty (PCT) agreement.

”Strong patents are a prerequisite for successfully commercializing Dizlin Pharmaceutical’s scientific advances. I am therefore pleased to announce that the European Patent Office has decided to issue a Decision to Grant for the company’s innovative product Infudopa SubC™ for the treatment of Parkinson’s disease. This is an important milestone, not only pursuing the company’s patent strategy, but also in our aim to improve the lives of the Parkinson patients,” says Björn Velin, CEO of Dizlin Pharmaceuticals.

For more information, please contact:
Björn Velin, CEO of Dizlin Pharmaceuticals AB, + 46 (0)76 879 2325, bjorn.velin@dizlin.se

Positive final results from pharmacokinetic study (PK) with Infudopa SubC™ and Infudopa IntraV™ (IPO-001)

By |2020-11-25T15:14:50+01:00November 24th, 2020|

In a pharmacokinetic cross-over study, 18 patients with Parkinson´s disease were assessed for 16 hours with respect to blood levels of levodopa when administered levodopa plus carbidopa subcutaneously (Infudopa SubC™), intravenously (Infudopa IntraV™) or intestinally (Duodopa®/Duopa®).

The primary aims of the study, to show bioequivalence of Infudopa SubC™ and Duodopa®/Duopa® with respect to levodopa levels in plasma, and non-inferiority with respect to plasma level fluctuations, were all met. A comparison of levodopa levels following Infudopa SubC™ and Infudopa IntraV™, respectively, shows levodopa bioavailability for Infudopa SubC™ to be close to 100%. Effects on motor symptoms were the same for the three treatment groups. Local side effects of Infudopa SubC™ at the infusion site were mild or moderate.

“We are very much encouraged by these results that show that all the primary aims of the study were met,” says Björn Velin, CEO of Dizlin Pharmaceuticals. “The rapid increase in levodopa levels following subcutaneous administration, and the high concentrations obtained, indicate that Infudopa SubC™ may serve as a flexible monotherapy also for patients requiring high levodopa doses.”

For more information, please contact:
Björn Velin, CEO, Dizlin Pharmaceuticals AB
Mobile: + 46 (0)76 879 23 25
E-mail: bjorn.velin@dizlin.se

Report from the General Meeting of Dizlin Pharmaceuticals AB

By |2020-10-06T11:53:31+02:00May 28th, 2020|

Dizlin Pharmaceuticals held a General Meeting on May 28, 2020.

The ordinary board members Leif Bring, Staffan Schüberg, Elias Eriksson, Anders Stenström and Nil Dizdar were re-elected. Anders Tullgren, Åsa Hansdotter and Johan von Heijne were elected as new board members. Leif Bring was re-elected as Chairman of the Board. All were elected for a term of office extending until the end of the next Annual General Meeting.

Clinical update

By |2020-11-24T17:03:55+01:00March 31st, 2020|

Researchers at Sahlgrenska Academy, in Gothenburg, Sweden, have finalized the clinical pharmacokinetic trial where Infudopa SubC™ and Infudopa IntraV™ have been compared with Duodopa®/Duopa® with respect to serum levodopa levels in 18 patients with late stage Parkinson´s disease. Dizlin Pharmaceuticals expect analyzed data in H2 2020.

Dizlin Pharmaceuticals appoints Chief Commercial Officer

By |2020-07-31T16:17:58+02:00October 20th, 2019|

Henrik Martinsson has been appointed CCO of Dizlin Pharmaceuticals and he joined the company on October 1st.

Henrik Martinsson has worked 20 years in the medical device business, mostly for Abbott in different roles. Most recently, he was the CEO for a Swedish distributor company selling medical device equipment within Ophthalmology to hospitals, private clinics and opticians.

“We are happy to bring Henrik Martinsson onboard our team. He will bring an extensive additional knowledge to Dizlin Pharmaceuticals with respect to business development and in the area of medical devices,” says Björn Velin, CEO of Dizlin Pharmaceuticals AB.

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