BII Biocompatibles

 
TIDMBII 
 
17 December 2010 
 
                       BIOCOMPATIBLES INTERNATIONAL PLC 
 
                      ("Biocompatibles" or the "Company") 
 
Eisai submits marketing authorisation application in Japan for DC Bead (Embolic 
                                  Bead E7040) 
 
Farnham UK, 17 December 2010: Biocompatibles International plc (LSE:BII) is 
pleased to announce that yesterday Eisai Co. Ltd submitted the marketing 
authorisation application in Japan for DC Bead (Embolic Bead E7040) to the 
Japanese Ministry of Health and Welfare. 
 
The total annual number of HCC patients in Japan is estimated at 67,000. With 
about 40,000 new cases being diagnosed each year, this is an incidence 
approximately twice that of the USA. 
 
The full text of the announcement made by Eisai is contained below. 
 
Crispin Simon, Chief Executive of Biocompatibles, commented: "We congratulate 
Eisai on submission of the DC bead Marketing Authorisation. The designation of 
DC Bead for fast track registration in Japan recognises the benefits this 
product brings over conventional therapies, and the size of the Japanese HCC 
patient population." 
 
                                    -Ends- 
 
Contact: 
 
Biocompatibles +44 (0)1252 732706 
 
Crispin Simon, Chief Executive 
 
Ian Ardill, Finance Director 
 
Anna Keeble +44 (0) 7879 818876 
 
FOR IMMEDIATE RELEASE 
December 16, 2010 
 
EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION 
IN JAPAN FOR EMBOLIC BEAD E7040 
 
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") 
announced today that it has submitted a marketing authorization application in 
Japan seeking approval to market the embolic bead E7040 for Transcatheter 
Arterial Embolization (TAE) in patients with hepatocellular carcinoma(HCC). 
 
E7040 is a hydrophilic microspherical particle produced from a polyvinyl 
alcohol polymer. It is an embolic bead that is injected through a catheter to 
physically and selectively embolize targeted blood vessels. Due to it being 
microscopic and uniformly spherical, the bead allows for precise embolization 
of targeted vessels based on vascular diameter and tumor size. The Japanese 
Ministry of Health, Labour and Welfare's "Study Council for the Early 
Introduction of Highly Needed Medical Devices" recommended that the product be 
made available on the Japanese market as early as possible at a meeting 
convened in January 2009. 
 
E7040 was developed by Biocompatibles International plc (Headquarters: Farnham, 
United Kingdom, CEO: Crispin Simon, "Biocompatibles") and is currently marketed 
in more than 40 countries worldwide, mainly in Europe and the United States, as 
an effective embolization material intended for the purpose of embolizing HCC 
and a variety of other malignant hypervascularized tumors (brand name in 
Europe: DC Bead®, brand name in the U.S.: LC Beadtm). Eisai acquired the 
exclusive rights to develop and market the product in Japan in a licensing 
agreement it concluded with Biocompatibles in July 2009. 
 
The total annual number of HCC patients in Japan is estimated at 67,000, with 
about 40,000 new cases being diagnosed each year. TAE, one of the treatment 
options available for HCC, uses an embolization material to selectively 
embolize the artery that supplies the tumor with nutrients, thereby selectively 
inducing tumor necrosis. This kind of therapy is performed on around half of 
all HCC patients, with an estimated 20,000 patients qualifying for the 
procedure each year. 
 
Eisai positions oncology as a therapeutic area of focus. Having already 
demonstrated its commitment to the field with TREAKISYM® Injection 100 mg 
(manufactured and co-marketed by: SymBio Pharmaceuticals Limited), the first 
anticancer agent for the company to launch in Japan, and eribulin mesylate 
(generic name, brand name in the U.S.: Halaventm), an in-house developed novel 
anticancer agent for which regulatory applications were simultaneously 
submitted to the health authorities in Japan, the United States and European 
Union (approved in the U.S., under regulatory review in Japan), Eisai will 
continue to make every effort to ensure the early introduction of E7040 onto 
the Japanese market. Eisai will also continue to enhance its portfolio of 
oncology-related products in Japan, and make further contributions to 
addressing the diversified needs of cancer patients and their families. 
 
  [ Please refer to the following notes for further information on E7040 and 
                     Transcatheter Arterial Embolization ] 
 
Media Inquiries: 
Public Relations Department, 
Eisai Co., Ltd. 
+81-(0)3-3817-5120 
 
< Notes to editors > 
 
1. About E7040 
E7040 is a hydrophilic microspherical particle produced from a polyvinyl 
alcohol polymer. It is an embolic bead that is injected through a catheter to 
physically and selectively embolize targeted blood vessels. Due to it being 
microscopic and uniformly spherical, the bead allows for precise embolization 
of targeted vessels based on vascular diameter and tumor size. 
 
The product was developed by Biocompatibles and is currently marketed in more 
than 40 countries worldwide, mainly in Europe and the United States, as an 
effective embolization material intended for the purpose of embolizing 
hepatocellular carcinoma (HCC) and a variety of other malignant 
hypervascularized tumors. It is marketed in Europe and the United States under 
the brand names of DC Bead® and LC Beadtm, respectively. 
 
2. Transcatheter Arterial Embolization (TAE) 
Transcatheter Arterial Embolization (TAE) is a kind of therapy used to 
selectively induce tumor necrosis in HCC by injecting an embolization material 
into the hepatic artery that supplies the tumor so as to occlude the nutrient 
artery. There are two types of TAE, one that involves embolization without 
chemotherapy, and Transcatheter Arterial Chemoembolization (TACE), which is 
performed in combination with chemotherapeutic agents to induce tumor necrosis 
and adjunctively suppress cancer cell activity. 
 
3. Malignant Hypervascularized Tumor 
A malignant hypervascularized tumor most commonly refers to hepatocellular 
carcinoma, renal cell carcinoma cancer, bone and soft tissue sarcoma, and other 
malignant tumors that receive nourishment via a sophisticated vascular network 
formed in tumor tissue. 
 
                                    - end - 
 
Dealing Disclosure Requirements 
 
Following the announcement made on Monday, 20 September 2010 that the Company 
is in an offer period for the purposes of the Takeover Code, the Company is 
required to restate the following: 
 
Under Rule 8.3(a) of the Code, any person who is interested in 1% or more of 
any class of relevant securities of an offeree company or of any paper offeror 
(being any offeror other than an offeror in respect of which it has been 
announced that its offer is, or is likely to be, solely in cash) must make an 
Opening Position Disclosure following the commencement of the offer period and, 
if later, following the announcement in which any paper offeror is first 
identified. An Opening Position Disclosure must contain details of the person's 
interests and short positions in, and rights to subscribe for, any relevant 
securities of each of (i) the offeree company and (ii) any paper offeror(s). An 
Opening Position Disclosure by a person to whom Rule 8.3(a) applies must be 
made by no later than 3.30 pm (London time) on the 10th business day following 
the commencement of the offer period and, if appropriate, by no later than 3.30 
pm (London time) on the 10th business day following the announcement in which 
any paper offeror is first identified. Relevant persons who deal in the 
relevant securities of the offeree company or of a paper offeror prior to the 
deadline for making an Opening Position Disclosure must instead make a Dealing 
Disclosure. 
 
Under Rule 8.3(b) of the Code, any person who is, or becomes, interested in 1% 
or more of any class of relevant securities of the offeree company or of any 
paper offeror must make a Dealing Disclosure if the person deals in any 
relevant securities of the offeree company or of any paper offeror. A Dealing 
Disclosure must contain details of the dealing concerned and of the person's 
interests and short positions in, and rights to subscribe for, any relevant 
securities of each of (i) the offeree company and (ii) any paper offeror, save 
to the extent that these details have previously been disclosed under Rule 8. A 
Dealing Disclosure by a person to whom Rule 8.3(b) applies must be made by no 
later than 3.30 pm (London time) on the business day following the date of the 
relevant dealing. If two or more persons act together pursuant to an agreement 
or understanding, whether formal or informal, to acquire or control an interest 
in relevant securities of an offeree company or a paper offeror, they will be 
deemed to be a single person for the purpose of Rule 8.3. 
 
Opening Position Disclosures must also be made by the offeree company and by 
any offeror and Dealing Disclosures must also be made by the offeree company, 
by any offeror and by any persons acting in concert with any of them (see Rules 
8.1, 8.2 and 8.4). 
 
Details of the offeree and offeror companies in respect of whose relevant 
securities Opening Position Disclosures and Dealing Disclosures must be made 
can be found in the Disclosure Table on the Takeover Panel's website at 
www.thetakeoverpanel.org.uk, including details of the number of relevant 
securities in issue, when the offer period commenced and when any offeror was 
first identified. If you are in any doubt as to whether you are required to 
make an Opening Position Disclosure or a Dealing Disclosure, you should contact 
the Panel's Market Surveillance Unit on +44 (0)20 7638 0129. 
 
Biocompatibles International plc (www.biocompatibles.com) 
 
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. 
 
 
 
END 
 

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