The pharmaceutical industry is going through a rapid period of change and evolution, and one of the pioneers at the forefront of that evolution is Laxxon Medical.
Recently, we were fortunate enough to be able to sit down with chief executive officer Helmut Kerschbaumer and talk with him about the future of Laxxon Medical and where he saw the pharmaceutical industry heading over the next decade.
What is the single greatest opportunity Laxxon Medical is offering the pharmaceutical industry?
Laxxon’s solution is in our technology, which allows pharmaceutical companies to generate highly complex geometric forms within tablets on a micrometre basis. With our technology, pharmaceutical companies can ‘design’ the release profile of active drug substances and optimize pharmacokinetics.
Additionally, Laxxon has a very strong IP (intellectual property) situation. Laxxon has more than 150 patents and more than 3500 patent claims globally. The combination of our technology and our IP allows us to achieve completely new, disruptive solutions for the pharmaceutical industry.
Laxxon was granted the global patent for the heterogeneous distribution of controlled active substances within a tablet. What does this mean for the pharmaceutical industry, and what does this mean for Laxxon?
We are able to control the heterogeneous distribution of the active substance within a tablet. This patent applies not only to products manufactured with our 3D screen printing method but through all 3D printers.
Why is this important? Because the pharmaceutical industry is talking about the individualizing of medicine. To create individualized medicine, you need to optimize patient release profiles. This will be achieved through multi-drug pills and individual controlled release concepts. Laxxon’s patents correlate to these concepts. This is a game-changer for Laxxon.
How does Laxxon compare to other pharmaceutical manufacturing solutions in the industry, as there are no other “3D screen printed pharmaceutical solutions” on the market right now?
Laxxon is a unique hybrid. We are drug development experts. We deliver strategic solutions, patent extensions, advanced patented generics, and new drug applications. We can manufacture, we can play contract manufacturer. So, we are really a unique program, let’s call it this way, packed up or ended with a fantastic IP situation. So, this is a good thing where we have been getting really phenomenal feedback over the last month from the pharmaceutical industry.
What is the goal of the company for the next year?
We are focusing on bringing value to the company: establishing partnerships, focusing on our in-house product pipeline.
In terms of business development and partnerships, could you speak a little bit about Laxxon’s strategic partnership with Evonik?
Evonik is a very important strategic partner and investment partner for Laxxon. Evonik has allowed us to establish our GMP printer in their FDA-certified facility in Birmingham, Alabama. They also support Laxxon quality management, quality control and all required GMP criteria. We are also running individual development programs together with an Evonik development team in Germany. Additionally, Evonik is a top player in supplying chemical pharmaceuticals to the industry, so Evonik’s Network may also be advantageous for Laxxon.
Can you give one example of how Laxxon is changing the pharmaceutical world?
Levadopa is the golden standard in Parkinson treatment. It’s very common and used globally. Sales [for Levadopa] are currently about $4.5 billion per year. But Levodopa itself as a treatment still has opportunities for improvement. One severe effect of Parkinson is the ‘freezing of gait’ effect where patients are not able to move in the morning until they have their standard Levodopa dose. If patients are not able to move, they need a nurse or relative to administer the intake of Levodopa.
Laxxon has been developing a ‘new product generation’ of Levodopa with a delayed release program of 8-9 hours. This means the patient can, for example, take our Levodopa tablet in the evening and it will be released automatically after 8 to 9 hours to prevent the freezing of gait effect. This will be a dramatic improvement for the Parkinson’s patients suffering from freezing of gait.
What are Advanced Patented Generics?
Although Levodopa is already a generic drug, our new Levodopa generation classifies as an ‘Advanced Patented Generic Drugs’ because it is manufactured with our patented 3D screen printing technology. The drug is still generic, but due to the fact that it’s developed and manufactured with a patented technology, automatically, the product is patented as well.
Why and how can Laxxon offer ‘patent extension’ through technology transfer?
Patent extension through technology transfer was not invented by Laxxon. In the industry, it’s called ‘Product Lifecycle Management’ and it is quite simple: when a product is coming off patent, companies try to overcome the hurdle by manufacturing or developing a new product or application with the same effect as the original product.
At Laxxon, we are developing and manufacturing pharmaceutical products. So, pharmaceutical companies can create a new product generation of their products with our technology and be protected by our patents.
How has Laxxon’s decided which products to develop in their in-house and external pipelines?
For our in-house drugs, our choice was quite simple. Our experts have studied the market and tracked drug disadvantages, side effects, patient compliance, food effectiveness and then how we may address these issues through our technology. We next explored commercial opportunities, sourcing drug candidates which would offer strong revenue streams and would be conducive with our technology and a 505b2 registration program.
What is 505b2 Registration and how does it apply to Laxxon?
505B2 is a special registration program from US FDA which allows a fast-track registration for either 10 or 12 months.
When will Laxxon begin a clinical trial phase?
We are establishing our GMP (Good Manufacturing Practice) development printer (EX432M) in two locations in the Fall of 2022. These printers will be used for the controlling and manufacturing of clinical trials. Our estimate is that by the beginning of 2023, we will be administering clinical samples and phase three clinical trials with our industry partners.
A Future with Laxxon Medical
Thanks so much to Helmut Kerschbaumer for taking the time to sit down and talk about the future of Laxxon Medical and some of the exciting programs that are under development.
The pharmaceutical industry is constantly looking to identify different ways that it cannot only improve the drugs it produces but also the way that those drugs interact with patients to provide a better solution to medical conditions.
Creating personalized medication that is customized to individual patient requirements is the logical next step in the pharmaceutical industry, and thanks to pioneers such as Laxxon Medical, it might be a lot closer than you think!
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.