Farnham UK, 30 June 2010: Biocompatibles International plc (LSE:BII), the medical technology company, is announcing the decision of its licencee and marketing partner, Merz Pharmaceuticals GmbH, to write a letter to its customers and temporarily suspend shipments of Novabel.
The letter states:
“It has been just over 5 months since Merz Aesthetics launched the unique, aesthetics injectable filler Novabel in 7 EU Countries. Novabel has been successfully used in multiple areas of the face generating high levels of physician and patient satisfaction.
As part of our commitment to open communication we wish to advise you of recently reported adverse reactions in a few patients treated with Novabel, most commonly in the infra-orbital area. Given the unique nature of Novabel, an effective treatment has not yet been identified to quickly resolve these events. As patient and physician satisfaction is a critical component of continued Novabel success, Merz will temporarily suspend all sales, product shipping and promotional efforts of Novabel pending the availability of effective treatment protocols appropriate for highly sensitive areas.”
The two companies are therefore now developing these treatment protocols with materials and techniques that are in routine medical practice. The procedures will be similar to those currently available for conventional fillers and, subject to validation of these techniques, the two companies intend that shipments to physicians would resume in the near future.
Crispin Simon, Chief Executive of Biocompatibles, commented:
“I am confident that our CellMed team will have a safe and effective technique for sensitive areas ready for evaluation in the next few weeks.”
Steve Basta, Chief Executive of Merz Aesthetics, commented :
“We remain very positive and excited about the many, unique benefits Novabel offers doctors and patients.”
Biocompatibles confirms that there is no change to the 2010 financial guidance that was last updated on 16th June and will provide an update on progress of the technique project with the publication of the Interim Results on August 26th.
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1 Novabel is a registered trademark of Merz Pharmaceuticals GmbH, Biocompatibles’ licencee and marketing partner.
Contact:
Biocompatibles
Crispin Simon, Chief Executive
Ian Ardill, Finance Director |
+44 (0) 1252 732706 |
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| Anna Keeble |
+44 (0) 7879 818876 |
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead Products which are used in more than 40 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. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
This news release contains forward-looking statements that reflect Biocompatibles’ current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of Biocompatibles’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.