New products by Aflofarm

The year 2020 was another period of dynamic development for Aflofarm Farmacja Polska. The company launched more than thirty new products, including medicines registered in the OTC and Rp categories, as well as medical devices, food supplements, and cosmetics. New investments were also made in the area of development and warehousing.

For us, product development and quality always constitute the top-tier priority. We constantly strive to ensure that our products meet patients' expectations. All processes related to launching new products on the market are conducted in accordance with the highest quality standards - comments Jacek Furman, Presidents of the Board at Aflofarm Farmacja Polska.

Currently Aflofarm's portfolio includes about 133 OTC drugs and 60 prescription drugs.

New OTC products in the portfolio

Neosine - one of Aflofarm's key brands, has been expanded with a new, innovative product, available without a prescription - Neosine plus in tablet form. This innovative product with an original composition is indicated for supportive use in immunocompromised persons, in case of recurrent upper respiratory tract infections, as well as in the treatment of herpes of the lips and face caused by the Herpes simplex virus. The drug is used in states of increased demand for zinc, occurring in the above-mentioned indications.

The product contains a combination of two active substances: 500 mg of inosine pranobex (Inosinum pranobexum) and 3.125 mg of zinc ions in the form of zinc gluconate (Zinci gluconas). Inosine pranobex exhibits antiviral and immunostimulant properties, while zinc exhibits antiviral activity and conditions the normal functioning of the immune system. Zinc gluconate therapy may contribute to faster resolution of cold symptoms, reduce the severity of the disease and psychomotor deficits induced by cold and, importantly, reduce the frequency of infections. More on Neosine plus: click.

The medicine's effectiveness is based on a combination of two active substances - asserts Hanna Wahl, Development Director, Board Member at Aflofarm Farmacja Polska - This combination, previously used in the drug Neosine Duo, available upon prescription, was appreciated by doctors and patients alike. Currently the combination of substances described above has been used in Neosine plus, a product registered in the OTC category, which allows pharmacists to issue the product to patients without a doctor's prescription - she adds.

Another novelty among OTC medicines is Bravera Control - the first drug for premature ejaculation available without prescription in Poland^1. The product contains an active ingredient - lidocaine (Lidocainum). The local anesthetic effect of the drug is responsible for reducing penile sensitivity to touch and thus results in delayed ejaculation. Premature ejaculation is a common health problem that affects approximately 20-30% of men between the age of 18 and 70².

At Aflofarm, we create modern therapeutic solutions that improve the quality of life and give patients an additional benefit. Bravera Control is available in an aerosol form, ensuring comfortable application on the skin, which in turn provides a convenient, discreet, and above all accurate way of applying the drug - explains Hanna Wahl. Efficient package of the drug is sufficient for up to 30 applications³. More about Bravera Control: click.

Another portfolio novelty is inVirum - a drug in tablet form used in the treatment of recurrent herpes of lips and face and recurrent herpes of external genitalia caused by the Herpes simplex virus.
1 tablet contains 200 mg of acyclovir (Aciclovirum). For more about inVirum: click.

In response to a public needs related to the SARS-CoV-2 virus pandemic, Aflofarm has introduced Disteryl, a skin solution with disinfectant and antiseptic properties. The product contains the active substance ethanol at a concentration of 96% and is indicated for hygienic and surgical hand skin disinfection. The ethanol contained in the product has bactericidal, fungicidal and virucidal properties, affecting beta coronaviruses such as SARS-CoV, MERS-CoV and SARS-CoV-2. Out of concern for the safety of medical personnel, the entire first batch of the medicinal product has been donated to 13 (out of 16 existing) coordination hospitals across Poland, to the Institute of Mother and Child Health in Łódź, and to the Pabianice Medical Centre. In total, the company donated more than 30,000 packages of the drug Disteryl.

Changes have also taken place in Desmoxan - one of Aflofarm's flagship brands. Until now the drug was available in pharmacies in the form of hard capsules. Since August, the product can also be purchased in the form of easy to swallow tablets. Desmoxan is a drug indicated for smoking cessation and reduction of nicotine craving in people who want to stop smoking. The goal of using Desmoxan is to permanently stop using nicotine-containing products.

Desmoxan tablets, like capsules, contain the active substance cytisine (Cytisinum). One pack of the product (100 tablets) suffices for a full 25 days of treatment. Each tablet contains 1.5 mg of cytisine. More about Desmoxan: click.

The DX2 line has so far only operated in the cosmetics area. In 2020, the company introduced the drug DX2LEK, indicated for the treatment of male pattern baldness in men and in women aged 18 to 65 years. Androgen-induced hair loss is the most common cause of alopecia and affects approximately 70% of men at different periods of life. The condition occurs with varying severity, mostly in men over 40 years of age⁴. DX2LEK is a medicinal product containing the active substance minoxidil 20 mg/1 ml. Minoxidil applied topically inhibits hair loss and stimulates new hair growth. DX2LEK is indicated for men and women over 18 years of age and older. More about DX2LEK: click.

New products in the Rp segment

Among the novelties in the Rp segment is Profitadal, containing the active substance Tadalafilum, which is used to treat erectile dysfunction. This substance is a PDE5 inhibitor (2nd generation), which allows to treat erectile dysfunction in adult men. Profitadal is available in 3 dosages: 5 mg, 10 mg and 20 mg. The first of these is also indicated for the treatment of symptoms of benign prostatic hyperplasia⁵. Tadalafilum is less likely to cause adverse reactions than Sildenafilum, and the 10 mg dose can be used by people with liver failure^5,6,7,8. It is worth noting that erectile problems are very common, with approximately 3 million men suffering from such disfunction in Poland⁹.

The therapeutic indication of the second drug, Toradiur, containing the loop diuretic Torasemideum, is the prevention and treatment of edema and transudates in the course of heart failure. The drug is available in doses of 5 and 10 mg, the tablets are divided into two equal doses. Thanks to its properties, the drug reduces edema, and in the case of treatment of heart failure – leads to the resolution of symptoms and improvement of myocardial function by reducing the load¹⁰. It is worth noting that loop diuretics are among the most potent drugs in this group. Toradiur has additional hypotensive mechanisms, favorable pharmacokinetics, high tolerability, and clinically proven efficacy in both acute and chronic heart failure and hypertension. Toradiur is one of the cheapest drugs with torasemide. The favorable price has a positive impact on the availability of the drug to patients.¹¹

Innovative blood glucose meter

The biggest novelty in the field of medical devices introduced by Aflofarm in 2020 is Examedin - a modern system for monitoring blood glucose levels. The glucometer is dedicated to diabetics with type I and type II diabetes. Examedin, as the first such product on the market, additionally allows to determine: the ambient temperature during the measurement, the use of drugs that may interfere with the result and exercise, which has a significant impact on the measurement.

The determination of additional factors is very important for both the diabetologist and the patient. Thanks to these determinations we can avoid interference with various substances, but most of all eliminate the possibility of false results - explains Tomasz Wilanowski, head of diabetology department at Aflofarm. - Additional functions ensure precise measurement and reliable results, which in turn allows the specialist to choose the optimal therapy for the patient. This is a huge technological advantage over the devices previously available in Poland - he adds. More about Examedin: click.

New investments

In 2020, Aflofarm completed an impressive investment in the warehouse area - a high-storage warehouse was developed in Pabianice, which also constitutes the highest building in the city. The warehouse is fully automated, picking and collection of goods is done by means of high storage stacker cranes. The warehouse is equipped with an innovative fire protection system, still rare in Poland. Inertization, as it is referred to, reduces the amount of oxygen in the atmosphere, thus reducing the risk of fire. The fire protection system has been accredited by VdS (the world's leading expert and certifying body). Specialized ventilation and air conditioning ensure complete safety of the products and materials stored within. The investment also included expansion of the part responsible for collecting and releasing the goods, together with the appropriate ramps.

Aflofarm Farmacja Polska is one of the Polish innovators under the Łódzkie Voivodeship Regional Operational Programme 2014-2020. Under Measure 1.2 - Investments of enterprises in research and innovation, the company obtained funding for the Project entitled "Expansion of research and development facilities at Aflofarm in order to increase R&D activity in the area of developing new medicinal products, medical devices and cosmetics". The research infrastructure purchased thanks to the Project, which increases the research and development potential of Aflofarm's
existing laboratories, enables the company to conduct a range of research work aimed at developing and implementing innovative pharmaceutical products on the market. Value of the project: PLN 9 973 254, including the grant amount of PLN 2 838 430.

Bibliography
1. with reference to URPL data on the basis of the search engine http://pub.rejestrymedyczne.csioz.gov.pl/stan as of 28.04.2020.
2 Lew-Starowicz M.: Disorders of ejaculation and orgasm [In:] Lew-Starowicz Z., Violetta Skrzypulec V. (eds.): Fundamentals of sexology. Wydawnictwo Lekarskie PZWL, Warsaw 2015.
3 How effective the drug is depends on the number of doses the patient uses, within a single application before intercourse. According to the ChPL of Bravera Control, the recommended single dose is 3-7 pump presses.
4. http://pozwolenia.urpl.gov.pl/files/Streszczenie_RMP_Part_VI_2_Finasteridum%20Bluefish.pdf; https://wylecz.to/choroby-skory/lysienie-androgenowe-u-mezczyzn/
5 Profitadal Summary of Product Characteristics: 2.5 mg; 5 mg; 10 mg; 20 mg.
6. Chen L., Staubli S.E., Schneider M.P., et al. Phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction: a trade-off network meta-analysis. Eur Urol. 2015; 68(4):674-680.
(7) There are limited clinical data on the safety of this medicinal product in patients with severe hepatic impairment.
8. refer to the Summary of Product Characteristics of Profitadal before use.
9. ERECY DISORDERS IN POLAND Report by VEDI CLINIC Men's Clinic, based on data obtained in a group of 351 patients aged 18 to 80 years undergoing comprehensive diagnostics at VEDI CLINIC Men's Clinic from 2011 to 2015 and Q1 2016.https://klinikadlamezczyzn.pl/raport-vedi-clinic-zaburzenia-erekcji-w-polsce/
10 Characteristics of the medicinal product Toradiur 5 mg; 10 mg.
11. developed on the basis of sales price data from PEX PharmaSequence database 11.2020 prices of packs of 30 tablets for doses of 5 mg and 10 mg.