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.
- 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