Liane / DERMAGO


23. September 2024 Press0

Aresus Pharma GmbH, a company of the DERMAGO Group, Germany, announces the signing of a collaboration agreement with ANI Pharmaceuticals, Inc., USA, for the set-up of a new manufacturer for the active pharmaceutical ingredient (API) sinecatechins (synonyms: extract from green tea leaves, Polyphenon® E) to ensure long-term coverage of the increasing global market demand for the API.

 

Sinecatechins is the active pharmaceutical ingredient for the ointment Veregen®, which is currently approved in the indication of external anogenital warts and is undergoing a Phase III clinical trial in the indication Actinic Keratosis.

 

The collaboration is led by Aresus, owner of the global Veregen® assets outside USA, including all proprietary drug master files for sinecatechins.  Aresus is commercializing Veregen® globally through a network of national and international renowned pharmaceutical companies.

 

ANI has commercialized Veregen® in the US since 2021 and is the owner of the US Veregen® assets.  ANI will contribute fifty percent of the transfer fee to the new manufacturer and will exclusively purchase the API from Aresus for the US market.

 

First commercial supply of sinecatechins from the new manufacturer, which has already been selected by both companies, is anticipated for 2027 after acceptance by the competent regulatory authorities in Europe and the USA.

 

ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products. ANI has commercialized Veregen® in the US market since 2021, after purchase of the product from its former owner Sandoz. In 2006, Veregen® was the first botanical pharmaceutical product approved by the US FDA.

 

 

  1. Shaw T Chen, Jinhui Dou, Robert Temple, Rajiv Agarwal, Kuei-Meng Wu & Susan Walker, New therapies from old medicines, NATURE BIOTECHNOLOGY Volume 26, Number 10, October 2008

 

Contact:

DERMAGO GmbH

Kastanienallee 46

15344 Strausberg

Email: info@dermago-group.com

Phone: 03341-589 90 40

www.dermago-group.com



4. September 2024 Press0

Aresus Pharma GmbH, a company of the DERMAGO Group, is pleased to announce the inclusion of the first patient in its Phase III clinical trial with the active ingredient Sinecatechins (synonyms: green tea extract, Polyphenon® E) in the indication actinic keratosis.

The study, entitled ‘Exact-1: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients with Actinic Keratosis of the Scalp and the Face’ (EXACT-1 EU CT: 2022-502811-12-00), will enrol approximately 280 patients in 9 study centres in Germany.

‘The inclusion of the first patient in our EXACT-1 study with the innovative compound sinecatechins is an important step towards developing further therapeutic options for the treatment of actinic keratoses and I would like to thank all study participants for their support,’ says Sven Schimansky-Wabra, CEO of Aresus.

With the inclusion of the first patient in the study, which is co-financed by Aresus’ distribution partners, Aresus will receive a milestone payment of an undisclosed amount.

Actinic keratoses (AK), which are considered a precursor of squamous cell carcinoma or very early squamous cell carcinoma, are among the skin diseases frequently treated by dermatologists. ‘In the last decade, a significant increase in AK has been observed. In addition to aetiological factors such as chronic UV exposure, this is due to demographic change with a higher proportion of older people. It is estimated that 1.7 million people in Germany are currently undergoing dermatological treatment for AK. However, the number of patients actually suffering from AK is much higher and will continue to rise in the coming years in line with the population structure. ‘1

 

1S3 guideline Actinic keratosis and squamous cell carcinoma of the skin long version 1.1 – March 2020, AWMF register number: 032/022OL



16. January 2024 Press0

Around 370 Companists pledged to invest in the manufacturer of prescription dermatologicals

The pharmaceutical startup DERMAGO recently successfully closed its financing round on the private investor network Companisto and secured a total of around EUR 1.6 million in capital. Around 370 Companists and co-investors participated. The startup manufactures and distributes prescription drugs in the field of dermatology.
DERMAGO promotes access to new dermatological drugs and thus provides high social added value. DERMAGO markets its prescription drugs for skin diseases such as acne, neurodermatitis and genital warts worldwide via a distribution network of renowned international pharmaceutical companies.
The DERMAGO Group is the parent company of the three pharmaceutical companies Aresus Pharma, DEGODE Pharma and Skin Care Pharma. All three companies were merged into a group structure in 2021 in order to exploit synergies in sales, development, quality management and administration. The parent company DERMAGO has already completed its second financing round with Companisto.
The team around founder Sven Schimansky-Wabra will receive capital with the successfully completed financing round, which will be used for the expansion of the product portfolio, the further development of the company’s own pharmaceutical laboratory and the expansion of international sales. In addition, the DERMAGO team has received valuable support from the network through the participation of around 370 investors. This will enable the team to benefit from extensive knowledge and diverse experience in the future.

“I am very pleased that, together with Companisto, we have been able to attract additional investors to support us in our growth strategy. Many thanks to our investors for their trust and to Companisto for their professional support during the financing round. We will use the new capital primarily to advance our clinical trial for our drug Veregen ® in the indication actinic keratosis,” says Sven Schimansky-Wabra, CEO of DERMAGO, about the successful investment round and the cooperation with Companisto.

About DERMAGO

DERMAGO GmbH is a service company that specializes in developing unique generic versions and originator products of prescription dermatological drugs that are eligible for reimbursement and independently bringing them through the pharmaceutical approval process.
DERMAGO GmbH’s services also include consulting activities, scientific assessments, the preparation of expert opinions and qualitative and quantitative studies, especially for dermatological pharmaceuticals. The development of analytical methods and procedures as well as services for the approval of pharmaceuticals are also part of the range of services.

About Companisto
Companisto is the market-leading private investor network in the D-A-CH region and has been a leading venture capital provider for startup investments for seven years in a row. To date, Companisto has committed around EUR 223.1 million in over 310 financing rounds. Since 2018, Companisto has expanded its network of currently 149,000 private investors with a digitally organized Business Angel Club. Around 2,100 business angels invest in the equity of companies via Companisto with investments starting at EUR 10,000. The investment process and investment management have been fully digitalized.

Further information can be found at
www.companisto.com, www.companisto.com/de/angel-club, https://www.dermago-group.com/

Contact person
presse@companisto.com
Companisto GmbH | Köpenicker Str. 154 | 10997 Berlin

Keywords for press release:
Companisto, DERMAGO, startup, pharma startup, pharma startup,



10. November 2023 Press0

Strausberg, 8 November 2023

Today, DERMAGO GmbH, headquartered in Strausberg, has announced that Mittelständische Beteiligungsgesellschaft Berlin-Brandenburg GmbH (MBG) is to invest EUR 300,000 in the company group in the form of a silent partnership.

The new capital will be used for the financing of new clinical development projects as well as for further investments in the in-house laboratory.

Sven Schimansky-Wabra, CEO of DERMAGO, states: “I am delighted that MBG has joined DERMAGO as a silent partner! This partnership is an exciting step towards innovation and sustainable growth in our region.

The fact that MBG has joined our company is not only a sign of confidence in our vision, but also a strong commitment to promoting entrepreneurship and economic development in our home region. This cooperation enables us to realize our ambitious plans for the further development of DERMAGO.

From the very beginning, our mission has been to revolutionize the healthcare industry through innovative solutions and with this new partnership, we will further strengthen our efforts.”

Stefanie Richter, DERMAGO’s CFO, adds: “We are proud to have the support of MBG at our side and we are determined to jointly leave a positive impact on healthcare and the economy of our region.”

 

About DERMAGO

DERMAGO GmbH is a service company specializing in the development of unique generic versions and original preparations of prescription-only, reimbursable dermatological pharmaceutical products and bringing them through the pharmaceutical marketing authorization process under its own management.

In addition, the services of DERMAGO GmbH include consulting activities, scientific assessments, the preparation of expert opinions as well as qualitative and quantitative studies, especially for dermatological pharmaceutical products. The development of analytical methods and procedures as well as services for the marketing authorization of pharmaceutical products are also part of DERMAGO’s range of services.



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



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