Start of Clinical Trial for Cosmetic Dermal Filler Bead
12/10/2007
Biocompatibles International plc (LSE:BII), a leading medical technology company focused on drug device Combination Products principally for use in oncology, is pleased to announce the start of a clinical trial, sponsored by its marketing partner, Merz Pharmaceuticals GmbH, for the evaluation of the Company’s proprietary Dermal Filler Bead as a cosmetic treatment.
The first patient has been treated in a trial that is expected to recruit 145 patients in eight clinics in Germany, France and the UK. Filing and approval for the CE Mark is expected in the first half of 2009. A separate trial is being designed for US approval.
The global market for cosmetic dermal filler products is expected to grow from $760m in 2007 to $1.5b in 2011 . The market is currently populated by products manufactured from collagen and hyaluronic acid. Biocompatibles’ CellMed subsidiary manufactures its Dermal Filler Bead from a highly purified alginate material. The clinical trial programme is expected to demonstrate the benefits of its superior biocompatibility and longevity. Easier handling for the doctor is expected to be a competitive advantage of the new product.
Merz Pharmaceuticals is part of the Merz Group, a privately owned German pharmaceutical company based in Frankfurt, with turnover of €475 m and 1,915 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, Austria, Switzerland, Russia and Mexico.
The terms of CellMed’s agreement with Merz allow for milestones, royalties and margin on manufactured product. Biocompatibles estimates the value of these to be up to $40m over the next six years assuming all the relevant milestones and expected sales are achieved. The impact in each year will be incorporated into the financial guidance that is provided by the Company on a regular basis.
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