PHARMENA SA is a dynamically growing, public limited biotechnology company, which is mainly involved in development and commercialization of innovative products based on a patented physiological and natural active ingredient – 1‑MNA. The Company’s strategy is focused on two business areas:
- Clinical trials of an innovative drug with a view to commercializing it;
- Marketing of innovative dietary supplements based on 1‑MNA.
- Development and implementation of an innovative medical device.
When it comes to the innovative drug project, based on the preclinical and early clinical trials, potential therapeutic indications for 1-MNA include pulmonary fibrosis, respiratory tract diseases (such as pneumonia, bronchitis, asthma, Sars-CoV-2 infection) inflammatory diseases, such as non‑alcoholic steatohepatitis (NASH) and pulmonary arterial hypertension (PAH), dyslipidemia, atherosclerosis, cardiac infarction. In pre‑clinical and clinical trials, 1‑MNA demonstrated anti-inflammatory and anti-fibrotic properties, affected cardiovascular risk biomarkers, while, through a unique capacity to stimulate the production of endogenous prostacyclin (PGI2), showed antithrombotic properties and improved the functioning of the endothelium.
With the purpose of further commercialisation of the drug project, the Company plans to present the results to the pharmaceutical industry in terms of pulmonary fibrosis, respiratory tract infections, including COVID-19.
The company also continues works on the commercialisation of 1-MNA in non‑alcoholic steatohepatitis (NASH) and pulmonary arterial hypertension (PAH).
At the same time, when it comes to reducing the risk of cardiovascular events, the Company has achieved positive results of the phase 2 clinical trials, which gives the green light for the further work on the project.
The positive results of 1-MNA trials relating to pulmonary fibrosis, asthma and viral infections, especially infections leading to a respiratory tract inflammation (e.g. Sars-CoV-2 infection, influenza, pneumonia, bronchitis) allow for further commercialisation of 1-MNA as a drug candidate in the above indications. This can bring benefits to the business, financial results and further development prospects of the Issuer and their Corporate Group, especially considering the ongoing spread of Sars-CoV-2 in Poland and the world as well as the increasing number of SARS-CoV-2 cases and people suffering from pulmonary fibrosis.
Potential revenues from the commercialisation of the 1‑MNA drug may have a significant influence on the Company’s financial results. Non‑alcoholic steatohepatitis is a disease for which no drug has been registered yet, while the global market value by 2025 is estimated to reach around USD 35-40 bn. Pulmonary arterial hypertension, on the other hand, is a rare disease for which effective therapies are still being sought, while its global market is around USD 5 bn.
The marketing of innovative dietary supplements (novel food) based on 1‑MNA constitutes a new business area of the Company. The global market of dietary supplements is growing rapidly, which is thanks to the healthy lifestyle trend, higher awareness of the significance of prevention in health care, higher life expectancy, and better financial situation of consumers. It is estimated that the dietary supplement market in Poland will rise in 2023 to the value of PLN 3.67 bn (from PLN 2.89 bn in 2017). In 2017, the potential market value for the projected categories of the dietary supplements based on 1‑MNA amounted to ca. PLN 490 million.
In May 2013, PHARMENA began its efforts aimed at marketing an innovative dietary supplement based on 1‑MNA. The company applied to the Food Standards Agency (FSA) in London for the authorization of 1-MNA as a novel food ingredient pursuant to Article 4 of the Regulation No. 258/97. In August 2018, the European Commission authorized 1‑MNA as a novel food ingredient and additionally granted the Issuer a five‑year protection of the scientific data contained in the 1‑MNA authorization application, which means an exclusive right to market novel food containing 1‑MNA for the period of five years from the date of issuing a marketing authorization for the novel food.
PHARMENA plans to build in Poland a strong brand named ENDOTELIO for dietary supplements based on the innovative 1‑MNA molecule. The Company plans to grow its portfolio further by marketing new innovative products.
In the fourth quarter of 2023, PHARMENA is planning to begin works on the development and implementation of an innovative medical device that will be used to treat wounds that are difficult to heal, including diabetic foot ulcers. Clinical trials of the device are one of the initial steps, followed by certification from the proper notified bodies. The product will be designed for household use.
The global market for products dedicated to hard-to-heal wounds in 2022 amounted to more than USD 20 bn, with products used in domestic settings accounting for nearly 20% of the market. In the next ten years, the market is predicted to expand at a rate of approximately 5,5% per annum.
PHARMENA anticipates that the testing and certification process will last about 3 years. The project will be funded either directly out of our own funds or with additional funding from EU funds.