Eisai Exercise Option to License in Japan
28/07/2009
Biocompatibles receives £3m initial milestone as Eisai exercises its option to license Drug-Eluting Bead Products in Japan
Farnham UK, 28 July, 2009:Biocompatibles International plc (LSE:BII) is pleased to announce that Eisai Co Ltd (TSE4523.JP) has exercised its option to license Biocompatibles’ DC Bead™ and PRECISION Bead™ products in Japan. The option agreement was previously announced on 16 May, 2008.
Biocompatibles will receive an initial fee of £3m followed by further substantial, additional consideration based on Eisai’s achievement of various commercial and regulatory targets. Following regulatory approval, Biocompatibles will supply Eisai with manufactured products at cost and will receive a double-digit royalty on net sales. The agreement provides Eisai with the first right of refusal to license related products in development at Biocompatibles for further consideration.
Due to revenue recognition rules, the initial milestone will have limited impact on 2009 sales and profit. The Company will provide an update on its 2009 revenue and cash guidance in its statement of Interim Results which will be released on 27 August, 2009.
The option exercise follows 18 months of due diligence, during which Eisai, in consultation with the Japanese authorities, has established the regulatory and clinical requirements to register Biocompatibles’ DC Bead™ product.
The large amount of existing data on DC Bead™ and a recommendation for early introduction by a MoHLW1 expert panel has resulted in the need for Eisai to conduct only a limited safety study in Japanese patients.
Eisai will market the Drug-Eluting Bead products through its direct sales force. Oncology is designated as one of Eisai’s most important areas of therapeutic focus.
There are approximately 40,0002 new cases of HCC in Japan each year, compared to around 15,0002 in the USA. HCC is the fifth most common cancer amongst Japanese patients but the third highest cause of cancer deaths.
Crispin Simon, Chief Executive of Biocompatibles said, “I am delighted that Eisai have exercised their option to license DC Bead™ and PRECISION Bead™. Eisai is an excellent partner for us and the commitment of a large pharmaceutical company is a valuable endorsement of our technology - especially in a region where we expect that our product will bring great benefit to patients”.
1 Ministry of Health Labour and Welfare.
2 Source: Globocan 2002
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Contact:
Biocompatibles +44 (0)1252 732732
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division conducts the marketing of Biocompatibles’ approved oncology products, supplied from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead products which are used in more than 35 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.
Our R&D Facilities are engaged in licensing and in new product development, based on the company’s core drug delivery technologies. The Drug Delivery Division, in Farnham, UK is developing new products for oncology. CellMed, in Alzenau, Germany, is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; and a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca. We also have collaborative agreements with Bayer Healthcare Pharmaceuticals Inc., Medtronic Inc. and Merz Pharmaceuticals GmbH.
Further information is available at www.biocompatibles.com
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.