Biocompatibles International Plc Filing For CE Mark Approval For Dermal Filler Bead

Main Category: Dermatology
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 15 Dec 2008 - 0:00 PDT

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Biocompatibles (LSE:BII) is pleased to announce the filing for CE Mark approval by the Company's development and marketing partner Merz Pharmaceuticals GmbH for the Cosmetic Dermal Filler Bead. The product has been licensed to Merz and will be manufactured by Biocompatibles' German subsidiary, CellMed AG.

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.

Merz and Biocompatibles have also concluded a Finance and Investment Agreement. Merz will provide capital to CellMed for the establishment of sufficient manufacturing capacity to meet Merz' medium and long term market needs following the roll out of the product in the US market. In exchange for capital provided by Merz in 2009, CellMed will grant a discount on future product sales by Merz in the US market, until the contribution and an additional premium have been repaid. All revenues from the Merz collaboration are incorporated into the Company's financial guidance.

Dr. Martin Zügel, CEO of Merz Pharmaceuticals, commented "We are pleased to have achieved a timely filing of the regulatory documents of the novel Cosmetic Dermal Filler. Upon approval we look forward to a successful market launch in Merz' key European territories in 2009. And we are delighted to have concluded the Finance and Investment Agreement with Biocompatibles, which will secure high volume manufacturing capabilities to serve international markets with sufficient quantities according Merz current business projections".

Crispin Simon, Chief Executive of Biocompatibles, commented, "We congratulate Merz on the CE Mark filing and look forward to the launch of the Cosmetic Dermal Filler Bead. This is an important milestone for us, for the Dermal Filler Beads programme and also for our proprietary alginate material - in view of its use in the Stem Cell Stroke Product".

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 Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products, operating through three businesses. The International Division conducts the marketing of Biocompatibles' approved products - Biocompatibles' Drug-Eluting Bead products which are used in the treatment of primary and secondary liver cancers and BrachySciences' radiation-delivering seeds which are used in the treatment of prostate cancer.

The Drug Delivery Division and CellMed are engaged in new product development and licensing. The Drug Delivery Division is developing new products for oncology and other indications, based on the company's core drug delivery technologies. CellMed is developing a Bead product for cosmetic dermatology and a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology.

Our strategic partners include Angiodynamics Inc, Medtronic Inc, Merz Pharmaceuticals GmbH and Terumo Corporation. Further information is available at www.biocompatibles.com

Merz Pharmaceuticals www.merz.de