New scientific paper published on the mechanism of action of Polyphenon® E, a defined extract from green tea leaves, in preliminary stages of skin cancer

Strausberg, 28 July 2022

DERMAGO GmbH today announced the publication of an article by the research group of PD Dr. J. Eberle from Charité-Universitätsmedizin Berlin, Germany.

The article entitled “Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells Is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential” was released in the peer-reviewed journal Antioxidants¹

The complete publication can be found on the internet at the following link

https://www.mdpi.com/2076-3921/11/7/1416

Within the framework of the study, the authors led by PD Dr. Eberle and Prof. Dr. Stockfleth were able to demonstrate that Polyphenon® E induces a concentration-dependent inhibition of cell proliferation as well as a reduction of cell vitality in four different squamous cell carcinoma cell lines (SCL-I, SCL-II, SCC-12 and SCC-13). These modifications correlate with changes in mitochondria as well as with an imbalance of cellular reactive oxygen compounds. The new findings support the previously known comprehensive mechanism of action² of Polyphenon® E. On the basis of the results, the authors conclude a possible efficacy of Polyphenon® E in the indication actinic keratosis (AK).

Preliminary squamous cell carcinomas such as actinic keratosis (AK) have been among the most common skin diseases treated by dermatologists. Furthermore, a significant increase in actinic keratoses has been observed in the last decade. Apart from etiological factors such as chronic UV exposure, this can be attributed to demographic change with a higher proportion of older people in the population. An estimated 1.7 million people in Germany are currently undergoing dermatological treatment for AK. Actually, the number of patients suffering from AK is much higher and is expected to increase in the next years in line with the population structure. ³

The exclusive manufacturing patents for the active ingredient “Polyphenon® E” (synonyms: “defined extract from green tea leaves” and “sinecatechins”) were taken over by Dermago GmbH from Mitsui Norin Co., Ltd., Japan, in December 2021.

References:

¹Zhu, J.; Gillissen, B.; Dang Tran, D.L.; May, S.; Ulrich, C.; Stockfleth, E.; Eberle, J. Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells Is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential. Antioxidants 2022, 11, 1416. https://doi.org/10.3390/antiox11071416

²Apoptotic Gene Expression in Sinecatechins-Treated External Genital and Perianal Warts, Stephen K. Tyring et al, Viral Immunology, Volume 27, Number 10, 2014

Sinecatechins, Effects on HPV-Induced Enzymes Involved in Inflammatory Mediator Generation, Stephen K. Tyring, The Journal of Clinical_Aesthetic Dermatology, January 2012, Volume 5, Number 1

Effect of Sinecatechins on HPV-Activated Cell Growth and Induction of Apoptosis, Stepehn K. Tyring, The Journal of Clinical_Aesthetic Dermatology, February 2012, Volume 5, Number 2

³ S3 guideline actinic keratosis and cutaneous squamous cell carcinoma long version 1.1 – March 2020, AWMF registration number: 032/022OL

Contact data:

DERMAGO Verwaltungs GmbH

Kastanienallee 46

15344 Strausberg, Germany

E-mail: info@dermago-group.com

Phone: 03341-589 90 40

Aresus announces presentation of clincial data for the treatment of female sexual pain with sinecatechins ointment

Strausberg, Germany, 21 July 2022

 Aresus Pharma GmbH, a subsidiary of DERMAGO GmbH, announced today that clinical results on the efficacy of 5-10% Topical Sinecatechins (synonyms: “Polyphenon® E“, ”defined extract from green tea leaves“) Ointment for Postmenopausal Vestibulodynia¹ were presented  at the 2nd Congress on Women’s Health Innovations & Inventions in Tel Aviv on July 11-12^th, 2022. Additionally, the poster had previously been presented at the North American Menopause Annual Meeting in Washington, D.C. in December 2021 and at the International Society for the Study of Women’s Sexual Health Annual Meeting in Dallas, Texas in March 2022.

The research was performed by a clinical team under the lead of Dr. Lila Nachtigall, Professor of Obstetrics and Gynecology at New York University School of Medicine.

In the randomized, double-blind, placebo-controlled trial, 32 postmenopausal sexually active women with significant to severe secondary provoked vestibulodynia were enrolled. The authors concluded that topical 5% sinecatechins ointment applied once daily or 10% sinecatechins ointment applied three times a week significantly reduced provoked secondary vestibulodynia in postmenopausal women without having a proliferating effect on the vaginal epithelium.

The funds for the study were provided by GTO Pharmaceutical, LLC (GTO). GTO Pharmaceutical, LLC and Aresus Pharma GmbH are evaluating the further development and commercialization strategy for the use of sinecatechins ointment in vestibulodynia.

Dr. Wendy (Keller) Epstein, CEO of GTO Pharmaceutical, LLC.  and, Adjunct Assistant Professor of Dermatology at New York University School of Medicine comments:

“A large proportion of  postmenopausal women need access to an effective non-hormonal topical drug that alleviates vestibulodynia, the most common cause of sexual pain. Sinecatechins ointment fulfils this unmet medical need because it can be used by women with or without a history of estrogen sensitive malignancies.

Although requiring further study, researchers reported that several women noted an increase in lubrication, sexual arousal and/or decreased latency to orgasm, a finding consistent with the known neurobiology of female sexual pain and arousal “.

Vestibulodynia is chronic pain and discomfort that occurs in the area around the opening of the vagina, inside the inner lips of the vulva. This area is known as the vestibule. The pain may occur when the area is touched, when a tampon is used, during sexual intercourse, during a pelvic exam, when tight clothes are worn, or even when sitting for a long time. In some cases the area may also be red and inflamed. Vestibulodynia is a specific type or localized form of vulvodynia, chronic pain of the vulva.² It is estimated that at least 16% of women in the United States are affected by vestibulodynia.³

¹ Nachtigall L, et al Efficacy of 5-10% Topical Sinecatechins Ointment for Postmenopausal Vestibulodynia.  Menopause Vol 28  No. 12 2021 pp 1467

² Vestibulodynia – What Is Vestibulodynia? Baylor Medicine (last access: 20.07.2022) https://www.bcm.edu/healthcare/specialties/obstetrics-and-gynecology/ob-gyn-conditions/vestibulodynia

³ The causes and prevalence of vestibulodynia: a vulvar pain disorder,   Feldhaus-Dahir, M. Urol Nur . Jan-Feb 2011;31(1):51-4.

Related Literature:

Shahrahmani H, Kariman N, Jannesari S, et al. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized,double‐blind, placebo‐controlled clinical trial. Phytotherapy
Research. 2018;32:522–530.

Press contact:

DERMAGO GmbH

Kastanienallee 46

15344 Strausberg

Email: info@dermago-group.com

phone: ++49 (0) 3341-589 90 40

Dermago takes over laboratory furniture of Life Science Inkubator GmbH in Bonn to build up their own analytical laboratory

Strausberg, 12 July 2022

The pharmaceutical company DERMAGO GmbH, based in Strausberg, Brandenburg, acquired around 300 m² of laboratory furniture  from Life Science Inkubator GmbH, Bonn, in June 2022. The equipment became available due to the discontinuation of LSI’s incubation activities and is to be reassembled in DERMAGO GmbH’s new laboratory facilities at the Strausberg site. The company expects the construction work to be completed by the 4^th quarter of 2022.

With this investment in the Strausberg site, DERMAGO intends to carry out the pharma analytics in-house for its subsidiaries Aresus Pharma, Skin Care Pharma and Degode Pharma in the future and expects significant cost savings as a result. In addition, Dermago will also offer the analytical services to external companies.

The establishment of the infrastructure as well as further product development will be co-financed through the company’s capital round concluded via Companisto in June 2022.

About DERMAGO

DERMAGO GmbH is a service company that has been specializing in the development of unique generic versions and originator preparations of prescription, reimbursable dermatological pharmaceuticals and in independently advancing these through the pharmaceutical approval process. The services of DERMAGO GmbH also include consulting activities, scientific assessments, the preparation of expert reports as well as qualitative and quantitative studies especially for dermatological pharmaceuticals. The development of analytical methods and procedures as well as services for obtaining marketing authorization for pharmaceutical products are also part of the range of the company’s activities.

About LSI Life Science Inkubator

In a trial phase lasting more than 10 years, the Bonn-based Life Science Inkubator GmbH (LSI) built up a unique incubation concept for people interested in founding a company. Innovative projects in the fields of biotechnology, pharmaceuticals and medical technology were evaluated at an early stage and developed together with the project group until they were ready for financing and market launch. After completion of the instrument testing in June 2022, the Life Science Inkubator discontinued its incubation activities. The spin-offs that have emerged from the incubation in recent years will continue to be managed by the incubator’s investment company, LSI Pre-Seed-Fonds GmbH.

Press contact:

DERMAGO GmbH

Kastanienallee 46

15344 Strausberg

Email:info@dermago-group.com

Phone: 03341-589 90 40

DERMAGO receives 2 million euros by private investor network.

Via Companisto, more than 750 private investors participate in the financing of the pharmaceutical company with international sales and distribution.

Berlin, 28 June 2022

In the financing round on Companisto, the pharmaceutical company DERMAGO GmbH received an investment commitment of just under 2 million euros within only a few weeks. More than 750 private investors participated in the pharmaceutical company, which has already launched 2 out of 3 reimbursable pharmaceuticals for international distribution on the market.

The pharmaceutical company has been developing and marketing generics for prescription medicines in the field of skin diseases. In addition, the company also has a patent-protected originator product in the same field.

By investing in DERMAGO GmbH, the investors had the opportunity to make investments in three pharmaceutical companies at the same time with DERMAGO GmbH acting as the parent company of its subsidiaries Aresus Pharma, DEGODE Pharma and Skin Care Pharma. Both DEGODE Pharma and Aresus Pharma are no strangers to the private investor network.

Already in 2018, DEGODE Pharma completed a successful financing round on Companisto. In 2019, Aresus Pharma followed suit and was also able to successfully complete the round.

In 2021, the parent company was founded to create synergy effects in the areas of distribution, administration, development as well as quality management and was carried out with the support of Companisto. The funds from the current financing round are to be used both for sales expansion and for the clinical study of a new indication.

Owing to the investment round on Companisto, the pharmaceutical company was also able to gain additional active supporters for the further development of the startup.

Along with many other relevant industries, investors from the health care and pharmaceutical industries can be found in the Companisto private investor network, who are supporting DERMAGO in its further growth.

Press release – Companisto – DERMAGO GmbH financing round

COMPANISTO

Sven Schimansky-Wabra, founder and general manager of DERMAGO GmbH, commented on the successfully completed financing round on Companisto: “I am really pleased that we have completed another successful financing round with Companisto and would like to thank our investors for the trust they have vested in us.

We will make good use of the funds to advance the clinical development of our products and provide patients and physicians with new treatment options”.

About DERMAGO

DERMAGO GmbH is a service company that has been specializing in the development of unique generic versions and originator preparations of prescription, reimbursable dermatological pharmaceuticals and in independently advancing these through the pharmaceutical approval process.

The services of DERMAGO GmbH also include consulting activities, scientific assessments, the preparation of expert reports as well as qualitative and quantitative studies especially for dermatological pharmaceuticals.

The development of analytical methods and procedures as well as services for obtaining marketing authorization for pharmaceutical products are also part of the range of the company’s activities.

About Companisto

Companisto is the market-leading private investor network in the D-A-CH region (Germany, Austria and Switzerland) and has been the most active private venture capital provider in Germany for five years in a row.

Over 152 million euros have been committed via Companisto to date in currently 230 financing rounds. Since 2018, Companisto has expanded its network of at present 124,000 private investors with a digitally organized Business Angel Club. Some 1,400 business angels invest in the equity of companies via Companisto with investments starting at 10,000 euros.

The investment process and management of participations have been fully digitalized.

Further information

www.companisto.com, www.companisto.com/de/angel-club, www.dermago-group.com

Contact partner

presse@companisto.com

Companisto GmbH | Köpenicker Str. 154 | 10997 Berlin

Press release – Companisto – DERMAGO GmbH financing round