Based on its superior proprietary nanotechnology platform, leon-nanodrugs has a prime position in the development of nanotechnology-based supergenerics and high-barrier generics. Co-founder and CSO Dr Wolfgang Beier speaks to World Pharmaceutical Frontiers about the company’s product development.

In the past two years, leon has made significant investments in building a global GMP production network at a commercial scale. What is its actual status?

Dr Wolfgang Beier: leon is developing oral as well as parenteral drugs. Given the fact that leon will launch its first in-house-developed drug product – which is an oral product – in 2018, we started the selection of a CMO/CDMO partner. During the next three months, we will have finished the tech transfer of a newly built reactor unit, and we will start CTM production of the first leon product in the fourth quarter of 2016.

leon cooperates with CoreRx, a US-based formulation specialist in Clearwater, Florida. This is a big step forward for leon – on an international scale – especially for building the US business.

CoreRx has a proven track record in the formulation of oral applications and has the ability to produce small-scale GMP batches.

What about the production of parenteral products?

We use our nanotechnology platform for the reformulation of very poor-water-soluble substances. A major issue is the removal and handling of organic solvents during the development and manufacturing process. There are only a limited number of highly qualified CMOs /CDMOs able to provide the necessary GMP equipment to do this job.

leon is currently in the final stage of selecting a global CMO/CDMO that can provide GMP production facilities for parenteral drugs.

leon is launching its first product in 2018; what kind of product is it and will leon sell it using its own sales force?

It will be an oral product in oncology. It is the generic version of a top seller, and we have the chance to enter the market as the patent of the originator is expiring. leon will out-license or sell this product to a pharmaceutical company with presence in major markets – at least in the US and Europe.

leon is a nanotechnology-based drug development company: using our proprietary and superior nanotechnology platform, we develop final drug products and reformulations that show added values; for example, new patients benefit, and there is a lower cost of goods compared with the originator drug. We do this either with a partner or at our own risk, which depends very much on the technical challenge of the API, the indication, the competition in the specific market and the existing market size.

leon is a technology leader in the reformulation arena, based on its superior MicroJetReactor (MJR) technology. What is the company doing to defend this technological position against other companies with competitive solubility technologies?

Together with MJR Pharmjet – shareholder and technology partner of leon – we have been working on a second generation of the MJR reactor unit since 2014. We have patent protection until 2030. We don’t have to reinvent the wheel regarding the hardware, but we will introduce a new reactor version that will allow more in-process control features in real-time measurements.

What are key items on leon’s agenda for 2016 and 2017?

To stay on track for success, leon has to achieve the following goals: select the most attractive substance for reformulation, launch its first product in 2018 and build a GMP environment for parenteral drugs with a highly qualified CMO/CDMO.