Gnosis is a fully vertically integrated biotech company specialized in the manufacturing and sales of fermentation raw materials and natural finished products used in the pharmaceutical, nutraceutical, cosmetic, veterinary, and agricultural industries. The business development director shares the company’s future plans to strengthen its international footprint.

Given your experience, what do you feel the “made in Italy” brand means to your clients?

One of the most recent trends we have seen is companies coming back from Asia to manufacture in Europe and the US, especially for certain complex products where special capabilities are required. We rely on a long tradition in Europe, and also in Italy, of merging tradition with innovation. When you introduce yourself as a European, and more specifically as an Italian manufacturer, you usually find people interested, especially once they get to know you are a direct manufacturer.

If we look specifically at the nutraceutical segment, where Gnosis is a clear leader, what role do you feel the Italian industry is playing in the advancement of the global nutraceutical field? What role does the company play?

Italy has a long tradition of food and the Mediterranean diet is one of the healthiest in the world. We mainly focus on two areas: Bioactives, which are directly derived from food, and One-Carbon Metabolism, which is how nutrients are used in your body. One of Gnosis’s products was discovered by an Italian scientist, Dr. Cantoni, in 1952, so we mix tradition, science, and research for what we call Advanced Nutrition. We also have a further area of research: Probiotics. The mechanism of probiotics is very well known, but we focus only on few of them, for which we can get an API. That’s something our customers are looking for, especially in the nutraceutical segment.

More generally, Gnosis is an Italian company present in five different locations around the world focused on the development of innovative products in different areas. We are an API manufacturer with strong capabilities in biotech, and are becoming increasingly vertically integrated as we can develop formulations for our customers, participate in clinical trials, and even provide support in developing marketing materials and commercial strategies. However, while we may increase our downstream activities, we do not have plans for Gnosis itself to enter the market with its own finished product line

Last year saw a nutraceutical product included in treatment guidelines for managing a major therapeutic area for the first time ever. How do you expect the role of nutraceuticals in medicine to evolve in the coming years?

Some of our products are already been sold as medical food, for instance in the US. We are talking about formulations which are still pharmaceutical formulations; in fact the delivery form can be a capsule or a pill but the content should be part of a food, in our case we are purifying the active ingredient, and it is used to support certain pathologies but with a different approach, because we are trying to find the cause connected to your metabolism rather than curing the effect.

This is the new frontier: a product we developed, Quatrefolic®, won an award in the category of medical food at Vitafoods in Geneva. In this case we not only developed the active ingredient but also the finished formula by using a proprietary natural coating that has been patented. Another of our products, which is a derivate of yeast called Superesse®, was granted a health claim by Japan’s Ministry of Health. You can see that in a country with a lot of regulatory measures we are able to get noticed.

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What international markets have you been focusing on?

Our main market is the US, but developing countries are increasingly gaining market share in our turnover. We started in China three years ago, with a one-man office to study the market, find the right business partner and file the dossiers for our product portfolio. This process has been quite complicated, but recently one of our products, Quatrefolic ® again, has been approved by the Chinese Ministry of Health, so by the end of the year we should be distributing it in China.

A further example is India, where we are serving most of the generic companies with antibiotics. We are one of the few companies able to produce Teicoplanin and the first to have the same complex fingerprint API of the originator. As a result, India has become one of our biggest markets for this kind of products, ranging from broad-spectrum to injectable antibiotics. A further example is Brazil where we are selling APIs and nutraceuticals. One of our latest launches in this market was our vitamin K2 in March this year. Regulation regarding APIs in developing countries has become very similar to more mature markets; hence we can easily file our products.

Although we are mainly devoted to export, we also work with Italian customers, who receive finished products manufactured outside of Italy with our API. Nonetheless it still is a small market, which represents less than five percent of our total turnover.

The Gnosis portfolio has been expanded significantly in recent years. What are some of the synergies and opportunities Gnosis hopes to unlock through the new partnership with Lesaffre that was started last year? What are the big items in the horizon?

We are still working on the development of the two areas. In biopharma we are increasing our number of API including the ones made in our plant in Pisticci, in Italy, and have been investing in separating and creating new lines of production. The target is very well defined: complex APIs where we can use bacteria as the starting point with purification and semi-synthesis, an area where we combine different technologies in one pot. One specific area is glycopeptides, which are sold as antibiotics in the same category; we are not performing clinical trials yet, so are approaching the process in a more traditional way but trying to be innovative in the way we manufacture them

The next stage will be to further develop foreign markets: some of the products of our portfolio are not sold in many countries, so we are interested in commercial development. But the growth of the company has been fostered because we sell the APIs also developing the process to manufacture them. We are looking for a new production plant in the US: we haven’t found the right one, so most probably we will build it from scratch.

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One of our key pillars is also try to find an alternative source for natural ingredients, for nutraceutical and pharmaceutical application. One example is the chondroitin sulfate, which is sold as a drug in Europe and as a dietary supplement in the US. We are the first company being able to produce it by bacterial fermentation. We usually try to develop and manufacture the product in different ways, different business areas and also in geographically different markets. Our three-year plan is to move from last year’s EUR 82 million turnover to EUR 115 million in 2018.

What makes Gnosis the global partner of choice for your clients?

We like challenges and we have demonstrated being able to develop processes to bring innovative products to the market. We are a fully integrated company, encompassing the developing process, manufacturing and offering commercial support. We are able to take care of the details, bringing something different to the market.

Where do you see yourself in 2020?

To be honest when we make plans we try to do them as a company, thinking what is best for the company, including the people we hire to bring Gnosis to another level. It doesn’t matter where will I be, but where will the company be going. For sure we are looking to enlarge the network of our production sites and we are looking for bright people in order to move forward.