Filing for CE Mark Approval for Dermal Filler Bead
12/12/2008
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
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Merz Pharmaceuticals, ein Tochterunternehmen von Merz Pharma, ist ein innovatives und internationales Healthcare-Unternehmen, das sich auf die Forschung und Entwicklung von Medikamenten für neurologische und psychiatrische Erkrankungen konzentriert. Merz Pharmaceuticals ist führend im Bereich der Alzheimer-Forschung und hat den weltweit ersten Wirkstoff (Memantine) zur Behandlung von moderater bis schwerer Alzheimer-Demenz entwickelt. Weitere Indikationsgebiete, in denen Merz Pharmaceuticals aktiv ist, sind die Dermatologie sowie Stoffwechselkrankheiten.