Beloren auf Companisto | Pitch-Video

The German pharmaceutical market consists to 75% of generic medications. These, in turn, make up only 9% of the costs in the health care system. Beloren will become part of this market. Beloren is a medication to treat acne. It is a cream and a gel for external use, it is available on prescription, reimbursed by health insurance companies, and it’s fully developed. We have already concluded a license agreement with a major German pharma company, which will help us simultaneously enter the market of 11 European countries. In most cases where medications are developed, a patent protection is still in place. When the protection expires, however, these products can be copied. These generic medications have the same active ingredients, but the formula is never identical to that of the original product. Beloren is a generic version of Skinoren. Skinoren generates annual revenues of approx. EUR 150 million and is sold in more than 70 countries. Skinoren’s patent protection expires at the end of this year and we are the first to bring a generic version to the European market. Acne is a complex skin condition caused by several pathomechanisms. The active ingredient of the original product is azelaic acid, which has the capability of interfering with these pathomechanisms. This way, it reduces cornification, has anti-bacterial properties, and reduces inflammation. The admission of medicaments is a tedious process. This also applies to generic medicaments. Having identified a molecule, one has to demonstrate that it has no side-effects. The medicament is tested on animals before being tested on humans in three phases that often span a period of more than ten years. One starts with healthy volunteers. If the medicament agrees with them, one can start treating patients. This has to be proven in the extensive studies of phase 3. As a result, less than 5% succeed in being submitted to the admission authorities. Beloren is currently about to enter phase 3, which means we will submit all regulatory documents to the admission authorities. The remarkable thing is that we were allowed to skip the entire second phase of clinical studies. The statement of the authorities was clear; they confirmed to us that, because our product is so close to the original, we do not have to conduct these admission studies and can directly enter the admission process. We can proudly say that we already entered into a lucrative licensing agreement at an early stage. Our sales partner is one of Germany’s last family-owned pharmaceutical companies. Aristo has secured the licensing rights for the 11 most profitable European countries and was willing to make a binding advance payment. This means that 1.2 million tubes are already guaranteed for a contract period of 5 years. As of 2019, Degode’s revenues will increase from EUR 1.9 million to EUR 5.9 million over a period of 5 years. The original product is produced in Segrate, Milan, while we produce exclusively in Germany. Like us, our contract manufacturer specializes in dermatological products, which means they produce only cremes, ointments, and gels. The co-payment for the original product is EUR 5 per package; the co-payment for our product will, of course, be lower thanks to our sales partner Aristo. Physicians are required to prescribe admitted generic products to insured patients if available. This regulates costs for health insurance companies, since a product that is almost identical will have the same effectiveness and the same side-effects. Ours isn’t a business with market estimates – we know it down to the individual tube. Our current agreement with Aristo covers 11 countries. These 11 countries generate combined sales of EUR 10.5 million. Worldwide, sales amount to EUR 150 million across 70 countries. We are currently conducting negotiations with an American pharmaceutical company and we expect the American admission authority to follow suit with the European one. When this occurs, we will have access to a market of EUR 100 million. The development of Beloren is complete and we are about to submit the admission. The last step is demonstrating that we are able to produce along industry standards, which is between 400-1,000 kg. We also have to bridge the decentralized procedure’s regulatory waiting period of 210 days. This is where your investment comes into play. Lastly, a personal note. At Degode, we want to donate 5% of our annual profit for the benefit of minorities in society, for rare, incurable skin diseases, namely for epidermolysis bullosa (EB). The donations go toward research at the university in Munich.

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