For Subscribers

Get the complete article now!

TWST: Can we start with an introduction to Mologen (Frankfurt:663720.F)?

Dr. Wittig: Mologen developed a technology platform, a gene transfer vector, called MIDGE which is today the smallest and safest available. It doesn’t require viral genes or proteins to function and contains no bacterial DNA So it is just that natural form of DNA as present in human beings or animals. Despite that simplicity and homology to the human genetic material it can still be modified chemically to target different organs, and enhance specificity, without compromising safety and efficacy. The acronym MIDGE summarizes its key features. It stands for Minimalistic Immunogenically Defined Gene Expression. The principle developments of MIDGE were finished in 1998 and the company went public in the middle of right that year.

TWST: Can you tell us how your technology is applied?

Dr. Wittig: We follow two lines of development to apply and market MIDGE technology. One is to optimize the MIDGE technology for areas of applications, like DNA vaccines or gene therapy, to offer a stable, clinically applicable, i.e., safe and efficacious gene transfer system, that can be produced in sufficient quantities in GMP quality. The other being MIDGE-based medical products. Here, we are active in late pre-clinical and clinical studies in the areas of preventive DNA vaccines for companion animals, therapeutic DNA vaccines for human cancers, and DNA therapeutics for several human diseases. We develop MIDGE-based products as far as possible in-house and then license to pharma partners with upfront payments, milestone payments and licensing fees -- the widely accepted business model for a biotech company.

TWST: Can you give us a sense of the market size and opportunities that are within your reach?

Dr. Wittig: For Mologen this is question of balance between time to market for the MIDGE-based product most likely to be successful and abroad base of products in our development pipeline, to counteract likelihood of failure in clinical trials. In dealing with fields like DNA vaccines and gene therapy market sizes are huge in general. However, stringent calculations of market sizes for any single MIDGE-based project and MIDGE-based product certainly require much more specific calculations and assumptions. For example, the statistical probability of success in development, or the likelihood of striking early deals versus late deals were quantified in intense discussions and using scientific- as well as business-related calculation tools. I will pass you on to Guido Sandler to continue.

Dr. Sandler: For us, developing a product as far as possible means we will probably take it to clinical phase I or II at the most and then we want to license it to big pharma in order to do clinical trial III and launch the product in the market. So, we are fairly early stage, and that also determines our revenue model. We plan on obtaining upfront and milestone payments and then eventually royalties on the product when it is marketed. However, bringing product candidates early to big pharma means, that there is some inherent risk in and the process before bringing a product to market, so the absolute terms of our royalties reflect those risks. On the veterinary area, right now we have various product candidates in the pipeline which are being evaluated by global pharma partners, and we’re discussing licensing agreements. These products could bring upfront and milestone payments in the next two to three years and should kick in with revenues out of royalties within three years. On the therapeutic area for humans, this is a longer development process and we are not yet in the position of licensing, although we expect to start negotiations with big pharma by the end of this year, early next year.