• Proposed indication is treatment for accelerated healing of partial thickness wounds
• Oleogel-S10 ointment aims to become first-in-class prescription pharmaceutical with proven efficacy in accelerating wound healing
• Day 120 scheduled on February 26th, 2015
Niefern-Öschelbronn, Germany, November 3, 2014 / B3C newswire / - Birken AG, a biopharmaceutical and dermo-cosmetic company, announces that the European Medicines Agency (EMA) has accepted its Oleogel-S10 Marketing Authorization Application (MAA) for review. Birken’s MAA seeks approval of Oleogel-S10 ointment for accelerated healing of partial thickness wounds.
Dr. Armin Scheffler, board member at Birken AG and inventor of Oleogel-S10, stated: “We are very happy about EMA’s acceptance of our MAA submission for review. This is an important milestone in the development of Oleogel-S10 and the history of Birken AG. Partial thickness wounds are painful and at risk for infections and wound healing complications, therefore an acceleration of the healing process would be very beneficial. Oleogel-S10 addresses an unmet medical need, as no other pharmaceutical is currently approved by the EMA for accelerated healing of partial thickness wounds. Birken is dedicated to bring this new therapeutic option to hospitals and patients.”
The submission includes results from the three Phase III trials that have demonstrated a significantly faster wound healing with Oleogel-S10 compared to current standard of care consisting mainly of applying wound dressing materials. The EMA will review the application under the centralized marketing authorization procedure. If approved by the EMA, Oleogel-S10 would receive marketing authorization in all 28 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Birken anticipates a decision until end of 2015.
About Oleogel-S10
Oleogel-S10 is an innovative, sterile ointment which consists only of the active pharmaceutical ingredient ‘dry extract from birch bark’ and sunflower oil. In this unique and internationally patent protected formulation the active pharmaceutical ingredient also functions as sole galenic substance. This formulation of only two ingredients minimizes the risk of wound healing irritations caused by additives.
Several pre-clinical and clinical studies have shown that dry extract from birch bark accelerates wound healing and skin regeneration processes. Dry extract from birch bark transiently upregulates pro-inflammatory cytokines (e.g., IL-6) and cyclooxygenase-2 (COX-2) on gene and protein level. Dry extract from birch bark promotes keratinocyte migration, putatively by increasing the formation of actin filopodia, lamellipodia and stress fibers (Ebeling et al., PLoS One, 2014), and promotes keratinocyte terminal differentiation in a TRPC6 calcium channel dependent manner (Woelfle et al., J Invest Dermatol, 2010).
Oleogel-S10 aims to become the new standard in the treatment of partial thickness wounds at a new level of medical evidence in this indication.
About Birken
Birken AG is a biopharmaceutical and dermo-cosmetic company. The company was founded in the year 2000. Birken’s core business is the extraction of active ingredients from birch bark and the development and sales of medical skin care products as well as pharmaceuticals for acceleration of wound healing.
Disclaimer
The development, approval and manufacturing of Oleogel-S10 is subject to extensive oversight by various regulatory agencies. Submissions may be subject to lengthy review and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could increase operating costs or delay product launches.
Contact
Dr. Mike Bastian
Business Development Manager
Birken AG
Streiflingsweg 11
75223 Niefern-Öschelbronn
Germany
Phone: +49 7233 9749-115
presse@birken.eu
www.birken.eu
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