BIOCOMPATIBLES INTERNATIONAL PLC
("Biocompatibles" or the "Company")
Positive Data from Combination Therapy Trial in Primary Liver Cancer
Farnham UK: 3rd November 2009. Biocompatibles is pleased to announce the first
presentation of data from the Company's clinical collaboration agreement with
Bayer HealthCare Pharmaceuticals Inc, first announced on 25th September 2008.
At the 60th meeting of the American Association for the Study of Liver Diseases
(AASLD) Professor Jean-Francois Geschwind MD, Professor of Radiology, Surgery
and Oncology at the Johns Hopkins University School of Medicine in Baltimore,
has presented interim data from 11 patients with liver cancer (HCC) treated
with Biocompatibles' Doxorubicin-Eluting Bead (DEB-DOX) in combination with
Bayer's systemic agent, NexavarA' (sorafenib) tablets. Nexavar is co-developed
by Bayer and Onyx Pharmaceuticals Inc. Dr Geschwind observed a 45% Tumour
Response rate(1) and 100% Disease Control(2). The trial is planned to recruit 50
patients in a single arm Phase II study design.
Dr Geschwind concluded, "Preliminary analysis reveals that the combination
appears to be safe as it did not result in any greater toxicities than with
either therapy alone. Additionally, the preliminary efficacy analysis is
The principal focus of Biocompatibles' Clinical Collaboration with Bayer is a
randomised Phase IIb trial, sponsored by Bayer. Three hundred patients are
being randomised either to DEB-DOX plus placebo, or to DEB-DOX plus Nexavar.
The primary end-point of the trial is time to progression, with secondary
end-points that include safety and survival. The trial is recruiting patients
from approximately 90 hospitals in Europe, Asia and the United States.
Biocompatibles expects that a positive trial result would establish the
combined therapy as the standard of care in the developed world for HCC
patients in the target indication. The trial is not designed as a registration
study for either product.
"We are encouraged by the preliminary results of this clinical trial and look
forward to further evaluating the safety and efficacy of Nexavar in combination
with Biocompatibles' DEB-DOX," said Dimitris Voliotis, Vice President, Nexavar
Clinical Development, Bayer HealthCare Pharmaceuticals.
Crispin Simon, Chief Executive of Biocompatibles, commented:
"Cancer is a systemic and a local disease. So it makes sense to combine the
systemic treatments developed by drug companies with our local Drug-Eluting
Our vision is to be in the mainstream of Oncology and the data from combination
therapy trials will demonstrate the progress that we are making in the months
and years ahead. Today's results with Nexavar are a great start."
(1)EASL (European Association for the Study of Liver Diseases) basis
(2)Includes Tumour Response and Stable Disease
Biocompatibles +44 (0)1252 732732
Crispin Simon, Chief Executive
Ian Ardill, Finance Director
Anna Keeble +44 (0)7879 818876
Julian Walker +44 (0)20 7357 9477
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 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. 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
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of
Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading,
innovative companies in the healthcare and medical products industry, Bayer
HealthCare combines the global activities of the Animal Health, Consumer Care,
Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's Healthcare,
Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and
Oncology. The company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and treating diseases.
Notes to Editors
Nexavar is currently approved in more than 80 countries for the treatment of
patients with liver cancer and in more than 90 countries for the treatment of
patients with advanced kidney cancer. Nexavar is being evaluated by Bayer and
Onyx, international study groups, government agencies and individual
investigators as a single agent or combination treatment in a wide range of
other cancers, including non-small cell lung cancer, breast cancer, ovarian
cancer and as an adjuvant therapy for kidney cancer and liver cancer.
Name of the medicinal product : NexavarA' 200 mg film-coated tablets.
Qualitative and quantitative composition: 200 mg sorafenib (as tosylate)
Indication: 1. Treatment of hepatocellular carcinoma. 2. Treatment of patients
with advanced renal cell carcinoma who have failed prior interferon-alpha or
interleukin-2 based therapy or are considered unsuitable for such therapy.
Contraindications: Hypersensitivity to sorafenib or to any of the excipients.
Warnings and Precautions:Hand-foot skin reaction and rash, usually CTC grade 1
and 2. Increased incidence of arterial hypertension (usually mild to moderate,
early in the course of treatment). Blood pressure should be monitored regularly
and treated as appropriate. Increased risk of bleeding. Increased incidence of
cardiac ischaemia/infarction. Gastrointestinal perforation in less than 1%;
sorafenib to be discontinued. Levels of sorafenib may be increased in patients
with severe hepatic impairment. Infrequent bleeding events or elevations in INR
have been reported in some patients taking warfarin concomitantly. Patients on
such therapy should be monitored. Temporary treatment interruption and/or dose
modification or discontinuation may be considered, depending on the severity of
the observed adverse reactions. No formal studies on wound healing have been
conducted. Temporary interruption of sorafenib therapy is recommended in
patients undergoing major surgical procedures. Experience of use in the elderly
is limited and cases of renal failure have been reported. High risk patients
according to MSKCC prognostic group were not included in the phase III study in
renal cell carcinoma and benefit-risk has not been evaluated in these patients.
Caution is recommended when administeringsorafenib with compounds that are
metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9
pathways. Caution is recommended when sorafenib is co-administered with
docetaxel. The risk of reduced plasma concentrations of sorafenib should be
considered before starting a treatment course with antibiotics. Undesirable
effects: Very common: lymphopenia, hypophosphataemia, haemorrhage (incl.
gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea,
nausea, vomiting, rash, alopecia, hand-foot syndrome (palmar plantar
erythrodysaesthesia syndrome), erythema, pruritus, fatigue, pain (mouth,
abdominal, bone, tumour, headache), increased amylase and lipase. Common:
leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression,
peripheral sensory neuropathy, tinnitus, hoarseness, constipation, stomatitis
(including dry mouth and glossodynia), dyspepsia, dysphagia, dry skin,
dermatitis exfoliative, acne, skin desquamation, arthralgia, myalgia, renal
failure, erectile dysfunction, asthenia, fever, influenza like illness, weight
decrease, transient increase in transaminases. Uncommon: folliculitis,
infection, hypersensitivity reactions (including skin reactions and urticaria),
hypothyroidism, hyperthyroidism, hyponatraemia, dehydration, reversible
posterior leukoencephalopathy, myocardial ischaemia and infarction, congestive
heart failure, hypertensive crisis, rhinorrhea, gastro oesophageal reflux
disease, pancreatitis, gastritis, gastrointestinal perforations, increase in
bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme,
keratoacanthoma / squamous cell cancer of the skin, Stevens-Johnson syndrome,
gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin
level abnormality. On prescription only.
Date of Revision of the Text: July 2009. Please note! For current prescribing
information refer to the package insert and /or contact your local Bayer
Schering Pharma Organisation. Bayer Schering Pharma AG, 13342 Berlin, Germany.
EASL (European Association for the Study of Liver Diseases) basis
Includes Tumour Response and Stable Disease