Press / DERMAGO

DERMAGO Group (“DERMAGO”), announced today that it has acquired with immediate effect all patents regarding the manufacture of the pharmaceutical ingredient  Polyphenon® E,  a defined extract from green tea leaves, from the Japanese patent holder Mitsui Norin. Synonyms for “Polyphenon® E” are “defined extract from green tea leaves” and “Sinecatechins”.

The patent family comprises patents on the composition as well as the unique, complex manufacturing and extraction procedure of Polyphenon® E from green tea leaves.

With the patent acquisition, DERMAGO is strengthening its position in the market of innovative phytopharmaceutical products.

Polyphenon® E is the active agent of an ointment approved for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients over 18 years of age.

DERMAGO also sees promising potential for the agent’s development for other dermal or specific systemic indications, such as in the area of immunotherapy with the simultaneous development of the respective dosage forms. ¹

DERMAGO is the holding company of Aresus Pharma GmbH, Skin Care Pharma GmbH and DEGODE Pharma GmbH which are all specialized in the area of dermatology.

¹: Dryden GW et. al, Inflamm Bowel Dis. 2013 Aug;19(9):1904-12. doi: 10.1097 /  Jason Yap et al.,  Authorea. March 23, 2020 / Shanafelt TD et al. Cancer. 2013 Jan 15;119(2):363-70. doi: 10.1002/cncr.27719. Epub 2012 Jul 3.

Contact information:

DERMAGO Verwaltungs GmbH

Kastanienallee 46

15344 Strausberg

Email: info@dermago-group.com

Phone: 03341-589 90 40

Skin Care Pharma GmbH, a company of Dermago Verwaltungs GmbH, announces that yet another milestone has been reached in the development and approval of Skinatan^® 1 mg/g Emulsion for cutaneous application with the active ingredient methylprednisolone aceponate (MPA). Upon receipt of the “End of Procedure” notification, the decentralized procedure (DCP) for Skinatan^® 1 mg/g Emulsion has been successfully completed for six European member states. Within the next few weeks, Skin Care Pharma GmbH and its license partners are to be granted marketing approval for Skinatan^® 1 mg/g Emulsion by the respective national authorities.

 Skinatan^® 1 mg/g Emulsion is a dermatological milk for cutaneous use with the active ingredient methylprednisolone aceponate (MPA). MPA belongs to the latest generation of topical glucocorticoids, characterized by a favourable therapeutic index i.e. a positive ratio of effect and side effect.

Skinatan^® is a generic version of Advantan^®. Advantan^® is approved and available in more than 60 countries world-wide with an annual turnover in excess of $100m.

Advantan^® Milk 0.1% Emulsion for cutaneous use is approved among others for acute treatment of mild to moderate skin rashes (eczemas), such as allergic reactions, nummular eczema, dyshidrotic eczema, nonspecific skin rash, and atopic dermatitis or neurodermatitis or scaly and reddened skin rash (seborrheic eczema).

Skin Care Pharma GmbH

Skin Care Pharma GmbH was founded by Sven Schimansky-Wabra in 2012. Skin Care Pharma GmbH specializes in the development of semi-solid pharmaceuticals as generic versions. In 2016, the German regulatory authority BfArM officially confirmed the formulation of the generic Skinatan^® pharmaceuticals in four different topical dosage forms (solution, emulsion, cream and ointment).

As early as 2020, Skinatan^® 1 mg/ml Solution for cutaneous application was successfully developed and approved. In Germany, the latter is marketed by the partner GALENpharma GmbH under MetiGalen^®. This is followed suit by the approval of Skinatan^® 1 mg/g Emulsion for cutaneous application. For the further development of Skinatan^® Cream and Ointment, Skin Care Pharma GmbH was able to successfully complete two pivotal clinical studies and has already applied for marketing approval of both formulations in seven European countries by means of a decentralized procedure (DCP).

Aresus Pharma GmbH, a company of DERMAGO Holding GmbH, announced today that the abstract “Inhibition of cell-proliferation and cell viability by Polyphenon E ® (Veregen®) in cutaneous SCC cell lines” has been accepted as an e-poster short presentation at the 31^st German Skin Cancer Congress.

In the study, the authors around PD Dr. Eberle and Prof. Dr. Stockfleth were able to demonstrate that   Polyphenon® E induces a concentration-dependent inhibition of cell proliferation and cell vitality in four different squamous cell carcinoma cell lines (SCL-I, SCL-II, SCC-12 and SCC-13). These new results support the previously known broad mode of action of Polyphenon® E¹, a defined extract from green tea leaves. From the above findings, the authors conclude a potential effectiveness of Polyphenon® E in the indication actinic keratosis (AK).  PD Dr. Eberle will be presenting the results at the 31^st German Skin Cancer Congress on 10 September 2021 from 8.00 (CET).

Aresus Pharma GmbH has entered into a research agreement on Polyphenon® E (Veregen®) with the European Skin Cancer Foundation and Charité Berlin to characterise the anti-proliferative and pro-apoptotic effects of Polyphenon ® E in cutaneous squamous cell carcinoma cells.

The abstract, discussing the detailed results of the study, will be published after the event.

„Polyphenon® E“, „defined extract from green tea leaves“ and „Sinecatechins“ are synonyms for the active pharmaceutical ingredient of Veregen®.

Veregen® (Polyphenon ® E) is currently approved for the topical treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients older than 18 years of age.  Worldwide sales partnerships have been established for more than 20 countries.

Pre-stages of malignant skin cancer such as  actinic keratosis (AK) are one of the most common skin conditions treated by dermatologists. The past decade has seen a marked rise in actinic keratoses.  In addition to etiological factors such as chronic UV exposure, the reason for this is the demographic change with a higher proportion of elderly population. It is assumed that 1.7m people are currently under dermatological treatment for AK in Germany.  However, the number of patients who actually suffer from AK is much higher and will continue to rise in the years to come in line with the demographic structure. ²

Current market assessments for topical pharmaceuticals used in the treatment of actinic keratoses are at more than double the sales value compared to genital warts.³

¹ Rosen 2012, Tyring 2012, 2014, ² S3 Guidline actinic keratosis and squamous cell carcinoma of the skin³ Own calculations, IQVIA

Strausberg – Aresus Pharma GmbH, a subsidiary of DERMAGO Verwaltungs GmbH, has announced today that Dr. Francisco Harrison left his position as Managing Director for personal reasons. Dr. Harrison was in charge of Aresus‘ medical-scientific division. Co-Managing Director, Mr. Sven Schimansky-Wabra, will be in charge of Aresus‘ business operations as sole Managing Director with immediate effect.

As Managing Director of an affiliate of Aresus, Dr. Harrison will remain associated with the company and will also continue to advise Aresus until its operational activities are handed over to a suitable successor.

Sven Schimansky-Wabra sincerely thanks Dr. Francisco Harrison for his service to Aresus: “Dr. Harrison has supported Aresus with his many years of entrepreneurial and medical experience during the decisive phase of the company’s founding and acquisition of the Veregen® assets, for which I would like to express my sincerest thanks – also in the name of our employees and stakeholders. I wish Dr. Harrison every success and all the best for his future endeavours both professionally and personally.”