Completion of Patient Recruitment for pivotal aesthetic Dermal Filler Trial
15/02/2008
Rapid Recruitment confirms attractive Market Opportunity
Farnham UK: 15 February 2008 (LSE:BII) Biocompatibles is pleased to announce that patient recruitment is now complete in a clinical trial, managed by Biocompatibles’ partner, Merz Pharmaceuticals, to evaluate the Company’s proprietary Dermal Filler Bead as an aesthetic treatment. Eight centres in Europe, with the principal investigator at the Charité Hospital in Berlin, have effectively recruited the target population – patients with facial wrinkles.
Filing and approval for the CE Mark is expected in the first half of 2009. A separate trial is being designed for US approval.
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, Austria, Switzerland, Russia and Mexico.
The global market for aesthetic dermal filler products1 is expected to grow from $760m in 2007 to $1.5b in 20112 . 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. Feedback from the trial investigators confirmed that the product is easier to handle than the first generation dermal filler products.
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.
Notes:
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Excludes botox and other toxin products for brow treatment. Dermal filler products are mainly used around the nose and mouth where toxin products are less commonly used.
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Medical Insight Inc. Global market for Dermal Fillers - 2006.
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