"Our OTC portfolio is ready for export, and it includes our patented diclofenac mouthwash and three unique medical devices, indicated respectively for acne, rosacea and for the prevention of foot infections – a world premiere."

Alessandro Casero

CEO, FARMAKA

November 16, 2021

Could you introduce Farmaka?

Farmaka is a privately-owned business founded in 1969 by my father, an expert pharmacist, and my uncle, a polyglot and orientalist. The company initially operated as a licensing link between Japan and Italy, but soon started investing in R&D, gradually transforming its core business from in-licensing of third-party APIs to out-licensing of proprietary technology. Today Farmaka's formulations, which comprise Rx, OTCs, medical devices, dermo-cosmetics and dietary supplements, are distributed in more than 30 countries worldwide. Among these is a patented diclofenac mouthwash indicated for sore throat and gingivitis, which is both our strongest prospect and greatest success story to date. Finally, in 2019 the company started launching its best technologies under proprietary trademarks in Italy, closing the circle from R&D to consumers.

Could you elaborate on your portfolio and current geographic reach?

Our OTC portfolio is ready for export, and it includes our patented diclofenac mouthwash and three unique medical devices, indicated respectively for acne, rosacea and for the prevention of foot infections – a world premiere. These formulations are available in the form of branded products ready for sale, or else for tailor-made private labelling.  

At present, our main markets are Poland, Korea, the UK and Scandinavia, and, of course, Italy, but in 2021 alone we have witnessed new launchings in China, Vietnam, Taiwan and South Africa. In the mid-term, we will focus on strengthening our marketing in Italy and on licensing-out our diclofenac mouthwash in France, Germany and Spain. In parallel, we will start evaluating JVs and eventually the intervention of a VC for a new, ambitious project: upgrading the indications of our mouthwash to include mucositis in oncology, an orphan indication for which this formulation has already showed clinical efficacy.

What is unique about Farmaka’s diclofenac-based mouthwash?

Diclofenac is the single most-prescribed anti-inflammatory agent in the world, and is currently available in virtually every possible form except as a mouthwash, as this API is absolutely insoluble and strongly bitter. These two technical problems are overcome by our patent, which allows both crystal-clear solubilization and perfect palatability; also, solubilization is attained without alcohol.  Hence, our mouthwash is not only the only one with diclofenac, but also the only anti-inflammatory solution without alcohol, two striking USPs that place our technology a cut above competitors. Last but not least, the approved OTC indications are quite ample: sore throat, gingivitis and pain related to dental procedures.

As of today, this product is marketed in 12 countries worldwide, but we plan on doubling this figure within 2028.

Could you give more details into the development and market reception for your Excilor spray?

We have been approached by Vemedia, one of the largest OTC players in the EU, for the R&D of a medical device indicated for the prevention of foot infections, i.e. onychomycosis, athlete’s foot and warts. From a scientific and regulatory point of view, the project was an absolute first, hence we had to invent not only the technology, but also the body of evidence supporting safety and efficacy. To cut a long story short, we have engineered an acrylic polymer that can be conveniently sprayed onto the skin, where it dries in seconds forming a clean and breathable “invisible sock”. Interestingly, the film’s cobweb is impermeable to fungi and, more importantly, to viruses as small as the papilloma virus (HPV).

This innovative technology is currently available for licensing in selected countries inside and outside of the EU.

How do you observe the markets’ behaviour around API supply stock management?

The pandemic taught us the importance of supply chain continuity by exposing, in a dramatic way, the vulnerabilities of long supply chains. I fear that the next 2-3 years will be characterized by big fluctuations between low demand-high stock, and high demand-low stock, with companies allocating more of their investments to create larger stocks.

In our case, we have not suffered disruptions in our trade with Japan, probably because this country was more mildly hit in the beginning, and possibly for its cultural preparedness to sudden catastrophes. Unfortunately, the opposite is true for India and Italy, where hard-line lockdowns have caused delays that will cost us dearly.

Do you have a final message?

In the aftermath of the pandemic, this is the right time to plant a new seed. Farmaka can move fast and hit the target thanks to products that have a strong USP and a successful pedigree. “E quindi uscimmo a riveder le stelle.”    

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