DEGODE

Welcome at DEGODE

DEGODE Pharma GmbH has developed a patent-protected prescription drug for the treatment of acne and melasma in form of a cream and for the indication rosacea as a gel (generic). DEGODE is launching these formulations on the market in the EU with an established pharmaceutical company.

Development of the cream has been completed and the approval phase is now pending. Due to a specific formulation, close to the original, DEGODE has succeeded in persuading the EU authorities to dispense with the usual lengthy and cost-intensive 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.

DEGODE Pharma GmbH
Kastanienallee 46
15344 Strausberg

Phone: +49 3341 589 9040
E-Mail: info@degode.eu

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.

Comparability with original product for quality parameters shown:

Customers arein 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.

Social commitment

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 and melasma (cream) as well as rosacea (gel) 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.

 

 

Products

Beloren enthält den seit 20 Jahren bei Akne bewährten Wirkstoff Azelainsäure. In mehr als 70 Ländern ist dieser Wirkstoff in diesem Indikationsfeld zugelassen.
Akne ist eine komplexe Erkrankung, bei der eine ganze Reihe von Pathomechanismen eine Rolle spielt, wie zum Beispiel erhöhte Talgdrüsenaktivität und überbordende Verhornung oder Hyperkeratose mikrobielle Hyperkolonisation, die eine Entzündungsreaktion zur Folge haben.
Azeleinsäure (eine Dicarbonsäure, wie sie auch in der Natur vorkommt) ist für seine keratolytischen Eigenschaften bekannt, sie wirkt antimikrobiell und antientzündlich. Somit greift der Wirkstoff zwei zentrale Prozesse der Aknepathologie an. Gleichzeitig hat sie ein geringes Toxizitätspotenzial, wie das Bundesinstitut für Risikobewertung sie bewertet.

Beloren contains the active ingredient azelaic acid which has been proving its worth for 20 years in the treatment of acne. This substance has been approved in this indication area in over 70 countries.
Acne is a complex disease, often associated with a whole set of pathomechanisms such as an increased activity of the sebaceous gland and exuberant cornification or hyperkeratosis and microbial hypercolonisation, resulting in an inflammatory response.
Azelaic acid (a dicarboxylic acid which also occurs in nature) is known for its keratolytic properties and displays anti-microbial and anti-inflammatory effects. Thus, the active substance interferes in two central processes of the acne pathology. Its toxicity potential is – at the same time – very low according to the German Federal Institute for Risk Assessment.