Press / DERMAGO

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26. April 2023 Press0


Today Skin Care Pharma GmbH announces the successful submission of the Marketing Authorisation application of its product Skinatan® cream, the first generic version of the originator product Advantan® (active substance: Methlyprednisolone aceponate) to the South African competent local authority SAHPRA (“South African Health Products Regulatory Authority“). Submission was made successfully under the responsibility of Abex Pharmaceutica (Pty) Ltd., the commercial partner of Skin Care Pharma in South Africa and Australia.

Skin Care Pharma and Abex Pharmaceutica entered into a mutually exclusive partnership Agreement for the registration and commercialization of Skinatan® formulations in South Africa and Australia in 2020.

After the submission of the Skinatan® Cream Marketing Authorisation Applications in certain European countries, South Africa is the first country outside of Europe, where the cream formulation has been presented to the regulatory authorities for assessment of approvability.  

Ed Hallam, Chief Executive Officer of Abex comments: “Once Abex has been granted approval for the Skinatan® product range, it will create an opportunity for us to bring a new high quality cost effective generic option into the hands of health care practitioners, this will increase access and improve the quality of lives of South African patients living with eczema. South Africa represents a growing market where the prevalence of atopic dermatitis ranges from between 4.7% of the adult population to approximately 23% in children who suffer from this skin condition. This opportunity is fully in line with our objectives to strengthen key therapeutic areas, and we are looking forward to expanding our partnership with Skin Care Pharma with exciting new projects.”

Sven Schimansky-Wabra, Chief Executive Officer of Skin Care Pharma adds: “Congratulations to the whole Abex team for achievement of this important milestone in South Africa. The ongoing submission process in South Africa starts a series of registrations for Skinatan® in further countries in the coming months.“

About Abex:

Abex Pharmaceutica (Pty) Ltd is a South African-based international healthcare company involved in the development, manufacturing, registration, and commercialisation of prescription and over-the-counter pharmaceuticals which have been clinically proven to meet international standards. The company is recognised globally for its networks and excellence in service, reliability, high quality, effective and innovative healthcare solutions. Abex is a privately owned, family business, with headquarters and operational focus in South Africa; as well as international B2B operations in the United Kingdom, Australia, New Zealand, China and selected countries across MENA and LATAM geographies.  

About Skin Care Pharma, part of the DERMAGO Group:

Skin Care Pharma GmbH is part of the DERMAGO Group, with headquarters in Strausberg, Germany.

DERMAGO 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 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.


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20. April 2023 Press0

Since April, Stefanie Richter has joined the company’s management team. Together with Sven Schimansky-Wabra, they will set sail for the future.

Strausberg, April 19th, 2023.

DERMAGO GmbH announced today the strengthening of its management team and the addition of experienced financial expert Stefanie Richter.
Additional services through the laboratory, sharpened strategic alignment: DERMAGO GmbH is on a growth trajectory and has brought additional expertise on board. With Stefanie Richter and Sven Schimansky-Wabra, two managing directors now jointly lead the fortunes of the DERMAGO Group.
Sven Schimansky-Wabra says: “The entire DERMAGO team warmly welcomes Stefanie Richter. After planning our new laboratory in Strausberg and applying for approval from the state authority, we want to continue growing with new projects. Stefanie will lead us with her many years of expertise in the financial sector in aligning and financing our growth strategy.”

In the future, Sven Schimansky-Wabra will be responsible for strategy, operational planning, product development, and laboratory services. His new partner, Stefanie Richter, will take over finance, controlling, personnel, and administration.

Stefanie Richter has gained her high level of professional experience in many positions and brings more than 15 years of experience in finance & controlling as well as personnel management. Most recently, she was responsible for the commercial management of a medium-sized company in Brandenburg.

Stefanie Richter explains the change: “DERMAGO has steadily grown and developed very well in recent years. Now, the next steps in development are ahead. I am excited to be part of this future.”

The DERMAGO Group includes:
Skin Care Pharma GmbH with Skinatan® as the first generic approval for Advantan®, a prescription drug for the indications of atopic dermatitis and psoriasis in individual countries.
DEGODE Pharma GmbH with Beloren® as the first generic development for the prescription originator product Skinoren/Finacea, approved for acne/rosacea indications.
As well as:
Aresus Pharma GmbH with Veregen®, a patented, prescription-only original product approved for the indication of condylomata acuminata caused by HPV viruses.



1. August 2022 Press0

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



21. July 2022 Press0

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 11-12th, 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



14. July 2022 Press0

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 4th 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



29. June 2022 Press0

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



17. December 2021 Press0

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



24. September 2021 Press0

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).

 



20. July 2021 Press0

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 31st 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 31st 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



3. December 2020 Press

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.”