Specialty generic pharmaceutical company Teligent proves that Estonia is a great place for the pharmaceutical industry.
“Teligent is a specialty generic pharmaceutical company focusing on dermatology, topical pain, hospital injectable products and ophthalmic products. Teligent has grown its sales 800% in the last 5 years, while expanding the company into Canada and Europe and is looking forward to exciting future,” says Jason Grenfell-Gardner, CEO of Teligent.
Teligent’s global headquarters and manufacturing plant are located in the United States. In 2015 Teligent acquired a pharmaceutical business in Canada, which is why Teligent now finds itself in Estonia. “The main reason why we’re here was initially because of our Canadian operations, and their contract manufacturing partners are located in Europe. Since our operations are based in North America, we decided that it was much easier to manage our supply chain from a location in Europe. The next logical step after setting up our supply chain operation in Estonia was then to incrementally build on to our value chain by adding laboratory operations. In Estonia, our focus is on pharmaceutical product development, as well as on quality operations. Our quality team audits our suppliers and manufacturing partners, whether in Europe, Asia or the US, to ensure they meet regulatory requirements” explains Anneli Simm, General Manager of Teligent in Estonia. “While we don’t manufacture products in Estonia, our R&D work helps to build the company’s pipeline of future medicines,” she adds.
Jason Grenfell-Gardner gives some good reasons why Teligent chose Estonia for its location in Europe. “You can manage the supply chain from other countries in Europe. As a matter of fact, a lot of companies from North America do. But Estonia makes more sense from a tax and e-residence perspective to be able to manage the business costs effectively. It’s simply significantly more efficient to manage our business in Estonia than it would be in any of the other ‘more popular’ destinations in Europe. As we had operations in Estonia, we came to the idea to add a laboratory for analytical chemistry. We have a great number of incredibly qualified analytical chemists that we can recruit in Estonia. We found really good talent and we’re able to transfer some knowledge from our laboratories in United States to the team here,” says Grenfell-Gardner.
“These are the building blocks of a pharmaceutical company. We start piece by piece, one step at a time: start with analytical chemistry and the supply chain, then add quality, regulatory affairs, formulation development and eventually maybe production. At the moment, we are focusing on using our knowledge to do more chemistry to support our company in the US, Canada and potentially Europe,” he points out. “Yes, our dream would be to be able to manufacture in Estonia as well, but we have to build the systems of processes before we make that leap. We opened our laboratory in October 2016, so the enterprise here is really young and we are about to add people,” Grenfell-Gardner adds.
Teligent’s lab in Estonia is in a different position compared to other labs here – as they work for the parent company, they are already busy with their own projects and don’t look for new partners outside. “Our task here is to develop or support the whole organization to grow and to achieve our goals. Our role is to be the strong contributor to the larger organization,” Simm tells.
Grenfell-Gardner is not aware how many FDA-approved laboratories there are in Estonia, but Teligent’s lab, in supporting activities in the US, will be one. It will also be run and managed in a certain way, as the rules are strict. He also gives an example of how the parent company benefits from Estonians’ attitude: “They are always in a hurry, things get done and the approach to the work is very serious. We have big health problems to solve, so that works really well together.”
First submission coming up
According to Grenfell-Gardner, Teligent is working on its first submission in Estonia. “The main focus of this laboratory will be injectable drug development for hospitals. From the North American perspective, this is very important because there have been so many drug shortages, caused by manufacturing and regulatory problems. There are dozens of drugs that aren’t available because of the drug shortage. We have been working on that and as we have our own manufacturing facilities, we can offer a solution – we are working on registration of our first drug in Estonia this year. There are drugs that are used in Estonia, but not available and registered by the State Agency of Medicines. Some of these products are not even approved by the European Union. That’s a challenge. We could use the network and the resources that we have to address this problem,” he says. He won’t agree to reveal what kind of drug this will be, but hopefully we will hear of it soon.
The next challenge that Teligent faces in Estonia is figuring out what to do once they get approval. “I don’t know if we can answer that question yet. If you come to the market with one product, you don’t want to build up your own sales force. But once the number of products grows, it makes sense to get some licenses. At the moment, we are talking about the Baltic market, but it will be a different case when we talk about the Nordic countries or the whole European Union, for example. The next step is to build a regulatory knowledge and capability organization. Once you’ve done that for Estonia, the way is opened for other potential markets in other member states,” Grenfell-Gardner says.
Grenfell-Gardner is excited about the opportunities in Estonia for the pharmaceutical industry: “We have a lot of work to do, but once we get there, there is no reason why we can’t have successful development and manufacturing in Estonia. Not just for Teligent, but more broadly for pharmaceuticals. The fact that we have recognition in Europe and the ability to use the State Agency of Medicines as a reference for other countries has the potential to achieve fast, effective and nimble response to get drugs approved and open markets in Europe. There’s a lot of competition in Europe. But I’m more excited about the other option – that’s being able to use the knowledge base and the manufacturing potential in Estonia to look at markets in North America. Canada has mutual recognition of European standards, so we can get drugs approved in Canada based on European review. We currently manufacture in France, Italy, Germany and Switzerland, but Estonia can be much more competitive,” he says.