GlaxoSmithKline Information

Glaxosmithkline and Gilead Announce International Licensing Agreement to commercialise Adefovir Dipivoxil for the treatment of Chronic Hepatitis B GSK Receives Exclusive Rights in Asia, Latin America and Other Territories GlaxoSmithKline (NYSE: GSK) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the signing of a licensing agreement to commercialise adefovir dipivoxil, an antiviral treatment for chronic hepatitis B currently in phase 3 development. Under the terms of the agreement, GSK will receive exclusive rights to develop and commercialise adefovir dipivoxil for the treatment of hepatitis B in markets across Asia, Latin America and other territories, the most significant of which include China, Korea, Japan and Taiwan. In these markets, GSK plans to develop adefovir dipivoxil as a treatment for patients with chronic hepatitis B, including patients who are naïve to therapy as well as those who have developed lamivudine-resistant HBV. GSK will be responsible for clinical development of adefovir dipivoxil in the covered territories. Gilead will retain rights to adefovir dipivoxil in the United States, Canada, Eastern and Western Europe, Australia and New Zealand. GSK has agreed to pay Gilead an up-front licensing fee of $10 million, and Gilead will receive additional cash payments of up to $30 million upon achievement of certain milestones. In addition, GSK will pay to Gilead a royalty on net sales of adefovir dipivoxil and have full responsibility for development in its territory 'Adefovir dipivoxil will be a valuable addition to our portfolio' said Howard Pien, President, Pharmaceuticals International, GlaxoSmithKline. 'Our experience of working with hepatologists over many years, first with vaccines and more recently with lamivudine confirms that this is a complex disease. We hope adefovir dipivoxil will offer a valuable new treatment option to physicians and will help improve the quality and duration of life of millions of hepatitis B patients across Asia, Latin America and other international areas." "GSK will be a strong sales and marketing partner for Gilead, and we are very pleased to have completed this agreement," said John C. Martin, PhD, President and Chief Executive Officer of Gilead. "The international GSK team has made significant headway in building a HBV market and establishing customer relationships, especially in Asia where chronic hepatitis B is more prevalent than in any other region of the world. Together, Gilead and GSK can help meet the urgent unmet medical needs of patients with chronic hepatitis B by rapidly advancing the development of adefovir dipivoxil in this market." Worldwide, there are approximately 350 million chronic carriers of hepatitis B, of which approximately one million die each year from complications of the disease, making chronic hepatitis B the 10th most common cause of death globally. Complications of chronic hepatitis B include cirrhosis (scarring of the liver), liver failure and primary liver cancer (hepatocellular carcinoma). Between one-quarter and one- third of people with chronic hepatitis B are expected to develop progressive liver disease. Patients infected with the precore mutant strain (hepatitis B "e" antigen-negative) of hepatitis B may be predisposed to more severe and progressive liver injury. Precore mutant hepatitis B infects up to approximately 50 percent of the 350 million chronic hepatitis B carriers worldwide and is most prevalent in countries of the Mediterranean and Southeast Asia, where between 30-80 percent of chronic hepatitis B patients are estimated to be infected with this strain. Adefovir dipivoxil is in Phase III development by Gilead for the treatment of chronic hepatitis B. and was recently submitted for approval in the USA and Europe. Dosed as one oral 10 mg tablet, once daily, adefovir dipivoxil belongs to a class of drugs called nucleotide analogues, which are designed to work by blocking HBV DNA polymerase, an enzyme involved in the replication of HBV in the body. GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has five marketed products and focuses its research and clinical programs on anti-infectives, including antivirals, antifungals and antibacterials. Headquartered in Foster City, CA, Gilead has operations in the United States, Europe and Australia. Statements contained herein that are not historical fact may be forward- looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Gilead or GlaxoSmithKline and that could affect whether and when Gilead would receive any milestone payments or royalties under the agreement. These factors include, but are not limited to: (i) the ability of GlaxoSmithKline to successfully complete clinical development where required in its licensed territories, including China and Japan, (ii) the ability of GlaxoSmithKline to obtain required governmental approvals, and (iii) the ability of GlaxoSmithKline to successfully commercialize adefovir dipivoxil in its licensed territories. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in each company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" for GlaxoSmithKline on Annual Report on Form 10-K/A for the year ended December 31, 2001. Zeffix, Energix-B and Twinrix are registered trademarks of GlaxoSmithKline. For additional information, visit either of the companies' web sites at www.gilead.com or www.gsk.com Enquiries: UK Media enquiries: Martin Sutton (020) 8047 5502 Alan Chandler (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2319 European Analyst/Investor Duncan Learmouth (020) 8047 5540 enquiries: Anita Kidgell (020) 8047 5542 Philip Thomson (020) 8047 5543 US Analyst/ Investor Frank Murdolo (215) 751 7002 enquiries: Tom Curry (215) 751 5419 Gilead Media enquiries Amy Flood (650) 522-5643 Gilead Investor enquiries Susan Hubbard (650) 522-5715 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/04/29/20020429BIT01370/wkr0001.doc http://www.waymaker.net/bitonline/2002/04/29/20020429BIT01370/wkr0002.pdf