For Subscribers

Get the complete article now!

TWST: Can we start with an introduction to Girindus(Frankfurt:588040.F) and your core markets?

Mr. Link: Our strength is developing processes and producing drug actives for the researching pharmaceutical industry, starting at the pre-clinical stage needed for toxicity studies, through to Phase III. In late Phase III you have to file your NDA (New Drug Application). In Phase III you are starting with the launching qualities and quantities which we can also make, however preferably for orphan drugs, not for block busters. Our strength is the pre-NDA business, from tox to launch. It takes an average of about 12 years to develop a drug and until FDA approval is reached. There are certain products that go much faster and there are others that take longer. It costs over EUR 500 million per drug. Consider patent life and market exclusivity, you have only a few years to recover your investment.

TWST: How do you position yourself on the competitive landscape?

Mr. Link: When you look at the beginning of drug development, you have the screening, you screen 10,000 substances and a few come through. And then you go to medicinal chemistry and you try in the milligram scale a thousand substances and maybe a few more come through. These early areas we do not cover. There are other companies specializing on it. On the other extreme, after the drug has found FDA approval, you have a number of large companies, which are the Lonza’s, the Bayer’s, the DSM’s etc. Since many generics have gone to the Far East, the large companies are concentrating more on the patent protected products and also play a little bit in our backyard. Typically, their core business is not to cover the quantities needed for the clinical trial phases. That’s our niche. That’s where we feel really strong, covering practically all organic chemistry and also fermentation.

TWST: Is that broad expertise your comparative advantage?

Mr. Link: Yes, and our flexibility. We’re very strong in chemical process development and scale-up. By developing a robust and cost-effective manufacturing process from early on that can be scaled up for bulk production we offer significant cost savings for our customers. The whole Girindus group employs about 150 people with 80 in our KB plant in Germany, in the production scale-up area. And we have been inspected successfully by the FDA several times. I would consider ourselves to be a front player, an international front player.

TWST: What’s the game plan going forward? Can you outline the strategic direction you see the company taking over the next 12 or 24 months?

Mr. Link: We believe that the future drugs will become more target specific; in other words, you don’t have a blockbuster that everybody’s got to take. We think these drug actives are going to be more effective, more specific to the individual. Individualized medicines will probably take more room in the future and our facilities are tailored for that scale, also on commercial scale. There is always, of course, room for further improvement. So, we are getting into the area of purification, clean room and things like that. We are filling our pipeline with products that are getting close to FDA approval and then, if they are block busters, we will invite partners to cooperate with us. There are a number of companies now knocking at our door because they realize that our niche is extremely interesting. Nowadays, you’ve got to start early in the game, as we do.

TWST: As a summary, what are the three or four points you would like to leave potential investors with?

Mr. Link: Girindus was founded in 1975 and served many chemical industries over the years with the emphasis on pharmaceuticals in both, the USA and in Europe. Based on this experience, the company went public in May 2000 and is since then a drug actives production company concentrating on the niche, bench to market. In 30 months, the company created about 30 million of new business and became a forerunner in their business segment in the Western Hemisphere. Imagine when the world economics will come out of the current recession and the pharmaceutical business will pick-up again. I would want to be a shareholder of Girindus.