Our competitive edge
Due to a sophisticated formulation which is very close to the original, DEGODE was able to convince the EU authorities to dispense with the usually long-term and cost-intensive efficacy studies.
This means a significant competitive advantage for DEGODE. As a result of this unique regulatory study situation, DEGODE will be the first supplier within the EU.
Due to an experienced distribution partner, large market shares are obtained early on.
A large, established development and approval network
12 months before an original medicine becomes patent-free, generic companies may start work on the development of the reproduction (generic drug). After the development process, clinical trials are normally required for the approval of generics, which are cost-intensive. When the formulation had been submitted to the responsible authorities, DEGODE was pleased to receive the confirmation that the formulation is so close to the original that studies are not necessary as a result. This considerable cost saving is a great competitive advantage for DEGODE as it – as initial supplier – can act faster and secure a significant head start over its future competitors.
Customers are–in a broader sense – our license partners as they exclusively acquire the products & product rights.
Our license agreements with the distribution partners are formulated in such a way that we only work together with companies that are experienced in the field of dermatology. The distribution partners must have a dedicated sales force in the countries and, of course, plan their sales reliably for the contract term (how many tubes per cream/gel per country).
The generic “Beloren” is a product which does not have to be newly established since the original product Skinoren was already launched worldwide on the dermatology market by Schering/Bayer in recent years. Our target group includes dermatologists, paediatricians and, to a lesser extent, general practitioners who are already the prescribing doctors of the original product Skinoren.
DEGODE also wishes to be socially committed; therefore, we donate 5 % of our profit to the research of the incurable epidermolysis bullosa, a dermatological disease which is associated with high suffering pressure for the affected people. For this purpose, we have entered into a co-operation with Prof. Dr. med. Kathrin Giehl,Center for Rare and Genetic Skin Diseases, Department of Dermatology and Allergology of the Ludwig-Maximilians-University (LMU) Munich.
- The pharmaceutical company DEGODE launches the first generic drug against acne und rosacea on the market through crowd-investing. The product is a reimbursable and prescription drug.
- DEGODE is the first manufacturer that offers the medicine as a generic (copy of a drug containing the same active ingredient) of the original which was patent-protected in the EU up to the end of 2018.
- The original product Skinoren generates a worldwide annual turnover of approx. €150 m in over 70 countries. The global market for acne drugs is forecast to grow by 75 % (currently: 3.1 billion dollars worldwide). Source: Global Data
- Normally, the approval process for generics is very time-consuming, as the development takes several years and costs tens of millions of euros
- In addition, the chance of approval by the Federal Institute for Drugs and Medical Devices BfArM at the first attempt is less than 10%.
- DEGODE has succeeded in developing a formulation so close to the original product that the EU authorities will dispense with the usual long-term studies at a cost of 14 million euros.
- DEGODE was founded by Sven Schimansky-Wabra who, with more than 8 years of experience in the pharmaceutical industry under his belt, already successfully accompanied the process of bringing a generic drug with 5 formulations to market authorization at Skin Care.