Biotts launches clinical trials in 2023! The startup has received permission to manufacture medicinal products
Wroclaw-based Biotts is a Polish biopharmaceutical company, creating drug formulations and recipes, as well as proprietary carriers that increase the bioavailability of active substances. The innovative technology of the Wroclaw-based startup makes it possible to administer pharmaceutical preparations through the skin – thus facilitating the fight against many common and serious diseases whose treatment is still burdensome.
Biotts’ next milestones
The General Pharmaceutical Inspectorate (GIF) has issued Biotts with a license to manufacture and import a medicinal product. The company has thus met the stringent requirements and realized the applicable international standard, confirming the quality of the results obtained in Biotts’ laboratories. Working under the GMP standard, i.e. systems defining production and control procedures, guarantees that the medicinal products manufactured by Biotts meet the necessary quality requirements. Thanks to this, the Wroclaw scientists can not only control themselves, but also be part of the chain of production of the final product, which will be used, among other things, in clinical trials.
Clinical trials of the Biotts product will start in the first quarter of 2023, and the company will conduct the studies jointly with the BioResearch Group research center. The company’s CEO adds that animal studies of the product with the Biotts carrier and substance in anticancer indications are also nearing completion.
“We are analyzing the data coming down from the center and preliminary reports indicate spectacular effects as early as 30 days after application. For now, two cancers are being studied – melanoma and breast cancer. After 30 days, we are getting significantly fewer side effects and greater efficacy than the drug traditionally used in this type of therapy. The study should be completed in the coming weeks and we will announce the results then.” – Biernat explains.
In 2023, in addition to the research and development aspects and the start of clinical trials, the company wants to enter a new stage of business development.
“We are working to make Biotts an international technology partner for global pharmaceutical companies. To accelerate this process, in the middle of the year we will transform our Boston technology commercialization office into a branch of Biotts US, a company that will be co-founded by experienced specialists from the US biopharmaceutical industry. The goal of Biotts US, in addition to establishing business partnerships, will be to support research work in Poland and coordinate the process of registering our drugs with the FDA (Food and Drug Administration).”
– Konrad Krajewski, a member of the company’s management board, talks about Biotts’ plans.
New is coming – big pharma appreciates Polish solution
A man from big pharma – Jan Hendriks – with extensive experience in bringing innovative active pharmaceutical ingredients to the market, previously associated with Ashland, among others, has joined the Biotts team. Hendriks has spent the last few years at Noramco, a pharmaceutical company owned by global conglomerate Johnson & Johnson. At Noramco, he was responsible for global commercial strategy and business development in the pharmaceutical industry, and through his efforts the company achieved $200 million in sales revenue.
“Biotts is a very interesting start-up, its technology opens up completely new possibilities for delivering drugs to patients. Oral administration of drugs can lead to significant and undesirable side effects and reduced bioavailability. Injections have the disadvantage that many people are afraid of needles, and often a professional medical staff or a complicated device is required to administer the drug in this way. In such cases, transdermal drug delivery is an ideal solution. The market for transdermal drug delivery continues to grow, and I predict that this trend will continue. The company has been founded, the technology has been created – now we need to build the Biotts brand. This is where I intend to focus my attention in the near future.”
– says Jan Hendriks, Chief Business Officer at Biotts
Transdermal systems the future of therapy
The market in which Biotts operates has been going from strength to strength for more than a dozen years, and thanks to new technologies, it still has the best ahead of it. According to research by Verified Market Research®, the global market for transdermal drug delivery systems was valued at $5.9 billion in 2020 and is expected to reach $8.4 billion by 2028, growing at a CAGR of 4.5% between 2021 and 2028.
“The limitation of transdermal drug delivery has always been the size of the molecule. Traditionally, only small ones (< 500 Da) could be transported through the skin, and even today only about 20 molecules are administered this way. Until now, research efforts to transport larger molecules through the skin have been unsuccessful. Biotts technology has changed that. Thanks to our company’s patented technology, larger molecules (up to 25,000 Da) can also be delivered transdermally. In the future, a patient with diabetes, instead of receiving daily injections, will wear a patch that he or she will stick on his or her own, for example, once a week. This opens up a whole new and huge opportunity for the Biotts solution.” – Hendriks explains.
