CE Mark Approval for Cosmetic Dermal Filler Bead
19/03/2009
Biocompatibles is pleased to announce that the Company’s development and marketing partner Merz Pharmaceuticals GmbH has been informed that the Cosmetic Dermal Filler Bead has been granted CE Mark approval. Merz will initiate a progressive launch of the product, which will be called Novabel™, over the course of 2009.
The global market for aesthetic dermal filler products¹ is at least $760m². The current market consists mainly of products manufactured from collagen and hyaluronic acid. Biocompatibles’ subsidiary CellMed manufactures the Cosmetic Dermal Filler Bead from highly purified alginate material, using a proprietary manufacturing process.
Crispin Simon, Chief Executive of Biocompatibles, commented, “We congratulate Merz on the successful conclusion of the EU regulatory process and look forward to the launch of Novabel.”
Merz Pharmaceuticals is part of the Merz Group, a privately owned German pharmaceutical company based in Frankfurt, with turnover of €535m and 2,052 employees. The Group specialises in the fields of CNS-related diseases and aesthetic dermatology. Merz operates internationally with more than 60% of its sales coming from markets outside Germany. The Group has significant operations in the US, UK, France, Italy, Spain, Austria, Switzerland, Russia and Mexico.
The terms of CellMed’s agreement with Merz allow for milestones, royalties and margin on manufactured product. The financial impact in 2009 is incorporated into the financial guidance that has been provided by the Company.
¹ Excludes botulinum toxin products for brow treatment. Dermal filler products are mainly used around the nose and mouth where toxin products are less commonly used.
² Medical Insight Inc. Global market for Dermal Fillers - 2006
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Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division conducts the marketing of Biocompatibles’ approved oncology products, supplied from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead products which are used in more than 35 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd.
Our R&D Facilities are engaged in licensing and in new product development, based on the company’s core drug delivery technologies. The Drug Delivery Division, in Farnham, UK is developing new products for oncology. CellMed, in Alzenau, Germany, is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; and a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca. We also have collaborative agreements with Bayer Healthcare Pharmaceuticals Inc., Medtronic Inc. and Merz Pharmaceuticals GmbH.