Attention Business/Financial Editors:
ZEFFIX REDUCES POST-LIVER TRANSPLANT HEPATITIS B REINFECTION AND CAN DELAY THE NEED FOR LIVER TRANSPLANTATION IN SOME PATIENTS WITH CHRONIC HEPATITIS B
LAVAL, QUEBEC, CANADA, Nov 7 /CNW/ - BioChem Pharma Inc. (NASDAQ: BCHE; ME, TSE: BCH) announces that important new research on its discovery Zeffix (lamivudine), presented today at a major liver specialists' congress, may offer some new options for hepatitis B patients undergoing or awaiting liver transplant.
A liver transplant operation is often the only option left open to
doctors treating patients with life-threatening liver damage induced by hepatitis B. However, because the virus is present in tissues outside the liver and in the blood at the time of the transplant procedure, patients undergoing transplant surgery run the risk of often fatal hepatitis B virus (HBV) reinfection occurring in the grafted organ. In light of this, many liver transplant centers will not offer liver transplantation to end-stage hepatitis B patients unless adequate suppression of HBV infection can be achieved.
The data, presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in Dallas, Texas, show that treatment with Zeffix (lamivudine) can reduce the post-transplant recurrence of HBV infection, delay or potentially remove the need for liver transplantation in some patients, and alleviate the clinical signs of liver failure-endpoints which could all be viewed as positive signals for improved survival.
The North American multicenter study looked at the effects of Zeffix (100 mg daily) treatment on patients who were accepted as candidates for a liver transplant. It then divided into two arms, one looking at the incidence of reinfection post-transplant, the other evaluating the disease outcomes for those patients who did not progress to transplantation.
Within the study, 47 patients who were being treated with Zeffix 100 mg daily received a liver transplant and continued treatment following surgery. Of the patients with available data following one year of treatment post-transplant with Zeffix, there was no evidence of recurrent HBV reinfection post-transplant in 71% (24/34). This figure is higher than historical expectations(1) for post-transplant reinfection.
Dr. Robert Perrillo, Director of Gastroenterology and Hepatology, Ochsner Clinic, New Orleans, and the lead investigator of the study explained: ''We set out to evaluate the extent to which lamivudine prevented reinfection with HBV following transplant surgery. We've seen that lamivudine therapy reduces the proportion of patients with HBV reinfection post-transplant and that most patients were clinically stable one year following liver transplantation.''
Additionally, there were 27 patients with advanced hepatitis B who were accepted as candidates for a liver transplant, but who did not undergo the procedure for a number of reasons. Results from these patients were presented by Dr. Perrillo in a separate report at the Dallas meeting. Data from the evaluable patients in this group demonstrated that 63% (12/19) were HBV DNA negative (a marker of viral replication) at last study visit (weeks 6 to 136). These data demonstrate that Zeffix treatment may result in prolonged periods
of disease improvement or stabilization and extended pre-transplant survival for patients with advanced hepatitis B.
Approximately 350 million people are long-term carriers of the hepatitis B virus(2) and up to 40% of those who become infected will die as a consequence of cirrhosis (severe liver scarring) and liver cancer(3).
Lamivudine for hepatitis B is already available in 17 countries including China, South Korea, the US, Canada, UK, Germany and France. In most markets the trade name Zeffix is used; in the US it is known as Epivir-HBV; in Canada as Heptovir and in China as Heptodin.
Under agreement, BioChem Pharma receives royalties from Glaxo Wellcome on sales of lamivudine for use in treatment of both HIV/AIDS
(3TC/Epivir/Combivir) and HBV (Zeffix/Epivir-HBV/Heptovir/Heptodin). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention and treatment of human diseases with a focus in the anti-infective and anticancer areas.
Zeffix, Epivir-HBV, Heptovir, Heptodin, 3TC, Epivir and Combivir are trademarks of the Glaxo Wellcome group of companies.
BioChem Pharma news releases and other company information can be found on the World Wide Web at www.biochempharma.com.
References:
1. Samuel et al. N Engl J Med 1993; 329:1842-1847.
2. The World Health Report. WHO 1998.
3. Mast EE, Alter MJ. Epidemiology of viral hepatitis: an overview.
For further information: Michèle Roy (media), (450) 978-7938, Christine Lennon (investors), (450) 978-7771, Corporate Communications BioChem Pharma Inc., E-mail: corpcom@biochempharma.com; SOURCE: BioChem Pharma Inc.
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