阿的福韦-Adefovir Dipivoxil 提交FDA新药申请

　　美国肝联　 提供 2002-3-22

　　GILEAD公司今天已经正式向FDA提出新药申请上市：阿的福韦-Adefovir Dipivoxil 10mg。研究显示：阿的福韦-Adefovir Dipivoxil 对于ｅ抗原＋性，ｅ抗原－性，拉米夫定抗药的乙肝患者几乎统统有效。公司总裁执行官讲，“治疗慢性ＨＢＶ已经成为世界医疗界当务之急，阿的福韦-Adefovir Dipivoxil 的通过将是治疗乙肝的又一个里程碑！”

　　今天去医院和新的移植小组认识、聊天时，医生和药剂师估计ＦＤＡ将很快通过！

　　此外其它的药也有很看好的。

　　另据星光医学网的报道：

　　Adefovir Dipivoxil 10mg 的新药申请

　　(2002-3-26 10:33:49 　10)

　　Dow Jones online news ----Gilead Sciences Inc(GILD)公司向FDA递交了其治疗慢性乙肝的药物adefovir dipivoxil 10mg的新药申请。 　　

　　每日一次的adefovir能够有效安全地对抗病毒的变异， 可以成为市场上销售的其他同类药如，先灵葆雅的α干扰素,商品名为Intro A,以及葛兰素史克的3TC,商品名为Epivir的替代产品。

　　然而， 一些支持adefovir 上市的人士却但心这种药物可能产生的肾脏毒性作用。 1999年， FDA专家顾问团拒绝同意高剂量的adefovir用于治疗HIV，因为它可能会产生很大的肾脏损伤， 为此，公司也停止了对adefovir治疗HIV的临床试验。 作为治疗慢性乙肝的药物， 低剂量的adefovir 好象不会对肾脏造成损伤， 但这种担忧仍然存在。

　　新闻发布会上， Gilead 称， 新药申请中包括了adefovir治疗乙肝E抗原阳性病人， 乙肝E抗原阴性病人以及携带对拉米夫定有耐药性的乙肝病毒的慢性乙肝病人的肯定性的三期临床试验数据。

　　Gilead公司原打算上半年在美国和欧洲完成adefovir的上市申请。但现在看来，估计FDA 的审查时限就需要6个月， 而欧洲的审查标准时限则为12个月。

　　公司在上周二称， 会马上向欧盟提交 adefovir10mg的上市申请。

　　（星光医药网　雪梅编译）

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　　BW2564 MAR 21,2002 13:17 PACIFIC 16:17 EASTERN

　　( BW)(CA-GILEAD-SCIENCES)(GILD) Gilead Submits New Drug Application to U.S. FDA for Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B

　　Business Editors/Health p; Medical Writers

　　FOSTER CITY, Calif.--(BUSINESS WIRE)--March 21, 2002--Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of adefovir dipivoxil 10 mg. Gilead is seeking an indication for the treatment of patients with chronic hepatitis B, including treatment-naive and treatment-experienced patients. The application is supported by data from Phase III studies in hepatitis B "e" antigen-positive patients, hepatitis B "e" antigen-negative patients and chronic hepatitis B patients with lamivudine-resistant HBV. Based on the unmet medical needs of patients with chronic hepatitis B, Gilead has submitted a request for a priority, or six-month, review of the adefovir dipivoxil NDA. The company will submit an application for marketing approval of adefovir dipivoxil 10 mg in Europe shortly.

　　"Current therapeutic options are limited, and the need for safe, effective and durable treatments for patients with chronic hepatitis B is an urgent one," said John C. Martin, PhD, President and CEO, Gilead Sciences. "The achievement of this milestone marks an important advancement toward our goal of providing a potential new treatment to the many patients suffering from chronic hepatitis B. It also marks the second NDA submission for a novel Gilead antiviral in less than one year, underscoring our expertise and our leadership role in anti-infective therapies."

　　About Adefovir Dipivoxil

　　Adefovir dipivoxil belongs to a class of drugs called nucleotide analogues which are designed to work by blocking hepatitis B virus (HBV) DNA polymerase, an enzyme involved in the replication of the virus in the body.

　　Data from two pivotal studies and a number of supportive studies of adefovir dipivoxil in a variety of chronic hepatitis B patient populations will be presented in April at the 37th Annual Meeting of the European Association for the Study of the Liver (EASL). Presentations include data from studies of hepatitis B "e" antigen-positive patients, precore mutant (hepatitis B "e" antigen-negative) patients, those with lamivudine-resistant HBV, patients post-liver transplantation and patients co-infected with HIV. Since 1999, Gilead has provided access to adefovir dipivoxil through Study 435 to approximately 400 chronic hepatitis B patients with lamivudine-resistant HBV who are wait listed for or have received a liver transplant. Adefovir dipivoxil is an investigational compound and has not yet been determined safe or efficacious in humans.

　　Chronic Hepatitis B

　　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 one of the 10 most common causes of death. 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 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.

　　Early Access Program Initiated

　　In March 2002, Gilead announced the initiation of an early access program in the United States to provide adefovir dipivoxil to chronic hepatitis B patients with lamivudine-resistant HBV. A similar program opened in France in July 2001 and has enrolled 289 patients to date. Additional programs in Canada, Australia and in other countries in Europe will open in the coming months as appropriate regulatory approvals are obtained.

　　For more information regarding the adefovir dipivoxil early access program, or to request program registration materials, physicians may call 1-800-GILEAD-5 or 1-650-574-3000.

　　Gilead Sciences

　　Gilead Sciences 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, Calif., Gilead has operations in the United States, Europe and Australia.

　　This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. Such risks and uncertainties include the risk that the FDA may not agree that the safety and efficacy data from pivotal studies are sufficient for marketing approval, the risk that the FDA may require additional studies and data prior to approval, the risk that the FDA may not review the application in 2002 and the risk that further data from ongoing and future clinical trials may not be as favorable as current data. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2000 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.

　　For more information on Gilead Sciences, please visit the company's web site atwww.gilead.com or call the Gilead Corporate Communications Department at 1-800-GILEAD-5 or 1-650-574-3000.

　　-- --30--kwp/sf*

　　-- CONTACT: Gilead Sciences, Inc.

　　-- Susan Hubbard, 650/522-5715 (Investors)

　　-- Amy Flood, 650/522-5643 (Media)

　　-- KEYWORD: CALIFORNIA

　　-- INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL MEDICAL

　　-- SOURCE: Gilead Sciences, Inc.