[转帖]港大研究乙肝新药疗效强

谷子地

http://www.hbver.com 　2004年10月25日22:58 来源:大公网 　 作者: 阅读182次

【大公网讯】香港大学医学院内科学系正进行新一代更有效抑制乙肝病毒药物的临床研究，三种新药可将人体内病毒数量减少至十万分之一至一百万分之一不等，较现有药物减少病毒数量最多达一千倍。

据香港中通社十月二十五日电，港大内科学系讲座教授黎青龙表示，要阻止乙肝病毒在体内繁殖，目前普遍采用的药物拉米夫丁，病人服后九个月产生抗药性，四年后出现抗药性机会高达六成七；另一种药物亚德福伟较少产生抗药性，但服用三年后病人有百分之二点四机会肾脏出现副作用；单独或混合使用上述两种药物，一年后只可将病毒数量减至一千或一万分之一。

黎青龙说，该系正研究三种抑制病毒繁殖新药，港人最快可受惠的是Entecavir，第二期临床试验显示，服用一年后病毒数量减至十万分之一，无副作用及抗药性，预期本年底至明年初可在美国注册。另一种药物Telbivudine，较Entecavir药力更强，估计服用一年后病人体内病毒数量可减少至一百万分之一。

黎青龙又指，港大是全球首个地方为新药LB80380进行临床研究，已完成第一期研究，药力与Telbivudine相若，对服用拉米夫丁出现抗药性的病人疗效更高，对肾脏产生副作用机会较亚德福伟低。未来用药趋势是将药性强及副作用少药物混合使用。

注:【大公网讯】或【大公专讯】为本网即时新闻，非引自《大公报》，敬请留意。

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Tackling Lamivudine Resistant HBV 搞定拉米变异的HBV

Hepatitis B (HBV) is a growing health problem, causing both acute and chronic viral infections. It is found that patients, who receive lamivudine treatment, develop drug resistant HBV. It was observed that lamivudine resistant HBV strains are detected in 14-32% of all patients receiving lamivudine treatment, and the proportion increases with the duration of treatment up to 66% after a 4-year treatment course.

To tackle this problem, LG Life Sciences Ltd (KOSPI: 68870) and Anadys Pharmaceuticals, Inc (Nasdaq: ANDS) have joint efforts in developing LB80380 (ANA380), an active viral compound showing potential activity against HBV, including lamivudine resistant HBV strains.

"Direct antiviral therapies have dramatically enhanced the treatment of HBV due to their improved side effect profile and more convenient oral administration," said Dr Kleanthis Xanthopoulos, ANA President and CEO. "Future improvements in therapy will depend on increased antiviral potencies at well-tolerated doses, and on a resistance profile that suppresses the emergence of new strains while providing treatment for lamivudine-resistant virus. Our goal is to develop a direct antiviral that combines the potency, tolerability and activity against resistant virus to confer these benefits to patients."

Oral LB80380 (ANA380), now entering Phase II clinical trial, has been demonstrated in the Phase I/IIa clinical trials to be effective in reducing viral load by 99.9% in chronic carriers. The 12-week Phase II clinical trial is an open label, multi-center, sequential group dose escalation study which has recently completed enrolment of three cohorts. It aims to assess the safety and antiviral activity of LB80380 (ANA380) in chronic HBV patients who are clinically and genetically resistant to lamivudine.

"We expect that LB80380 (ANA380) will be a best-in-class drug in HBV treatment with high effectiveness against lamivudine resistant strains. I believe we can accomplish this goal through our collaboration with Anadys," said Dr Heung-Joon Yang, LG President and CEO.

Current annual HBV therapy market stands at US$300 million and is expected to hit >US$1 billion by 2009. To date, 350 million chronic sufferers have become HBV carriers, 15-40% will develop serious consequences of infection during their lifetime (e.g. liver cancer, cirrhosis). The mortality rate (HBV or related conditions) stands at 1 million per year (WHO statistics).

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Anadys Pharmaceuticals and LG Life Sciences Enter into Joint Development and License Agreement for LB80380 (ANA380), a Phase II Hepatitis B Compound

Alliance Further Enhances Anadys' Commitment to Chronic Viral Hepatitis

SAN DIEGO & SEOUL, South Korea--(BUSINESS WIRE)--April 19, 2004-- Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) and LG Life Sciences (KOSPI:68870) of Seoul, Korea announced today that they have entered into an agreement to develop for potential commercialization LB80380 (ANA380), a Phase II nucleotide analog for the treatment of chronic hepatitis B virus infection. Based on pre-clinical and clinical study results to date, LG Life Sciences and Anadys are pursuing the development of LB80380 (ANA380) as a potential front-line therapy for the treatment of chronic HBV infection.

Under the terms of the agreement, Anadys has acquired an exclusive license from LG Life Sciences for the clinical development and commercialization of LB80380 (ANA380) for the treatment of chronic HBV infection in North America, Europe, Japan and the rest of the world other than China, Korea, India and countries in Southeast Asia. The agreement further provides that the parties will work jointly and will share costs for the clinical development of LB80380 (ANA380) on a global basis. Specific financial terms were not disclosed.

"LB80380 (ANA380) significantly enhances Anadys' franchise in anti-infective medicines, and we are pleased to have the opportunity to work with LG Life Sciences on the development of this compound," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and CEO.

"LG Life Sciences is very pleased to work closely with Anadys to pursue a global joint development plan. The Anadys management team has a significant track record developing and commercializing anti-infectives. We look forward to a long and productive relationship with Anadys," said Heung-Joon Yang, Ph.D., President and CEO of LG Life Sciences.

About LB80380 (ANA380)

LB80380 (ANA380) is a nucleotide analog currently in Phase II clinical trials for the treatment of chronic HBV infection. The compound has exhibited activity in vitro against both HBV typically found in untreated patients and also HBV variants that demonstrate resistance to treatment with the nucleotide analog lamivudine, which is a currently commercialized therapy for HBV. Preclinical studies have demonstrated significant activity against HBV, low potential for drug interactions and good tolerability in a range of preclinical toxicology studies. Based on clinical trials to date, LB80380 (ANA380) appears to offer the potential for once daily dosing. Data from a 28 day, once daily clinical trial, which enrolled 28 patients, demonstrated that oral administration of LB80380 (ANA380) reduced HBV viral load by up to four log10 units, or 99.99%.

About hepatitis B

Hepatitis B virus, or HBV, infection is a growing global health problem that can cause both acute and chronic viral infections. Approximately 350 million people are chronically infected and have become carriers of HBV. About 15% to 40% of these patients will develop serious consequences of infection during their lifetime, including loss of liver function, cirrhosis, and liver cancer. According to the World Health Organization, approximately 1 million people die each year from chronic HBV or related conditions.

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel and powerful small molecule, anti-infective medicines for the treatment of hepatitis C virus, hepatitis B virus and bacterial infections.

LG Life Sciences, Ltd. (LGLS), an LG affiliate, is a R&D based biopharmaceutical company based in Seoul, Korea that discovers, develops and commercializes new medicines in anti-infectives, cancer, diabetes and other chronic diseases. LGLS had approximately $150 million in sales last year.

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to references to Anadys' business relationship with LGLS, activities expected to occur in connection with that relationship, the nature of LB80380 (ANA380) in HBV infected patients and expectations regarding further clinical trials of and commercial opportunities for LB80380 (ANA380). Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of LGLS and/or Anadys Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include risks related to the implementation of the business relationship between Anadys and LGLS, the uncertainty of results to be obtained in future clinical trials, the use of unproven technologies and delays in the completion of clinical testing. These and other factors that may cause actual results to differ are more fully discussed in the "Risk Factors" section of Anadys' Registration Statement on Form S-1 on file with the SEC. Anadys and LGLS are providing this information as of this date and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

CONTACT: Anadys Pharmaceuticals, Inc. Michael Kamdar, 858-530-3600 [email protected] or LG Life Sciences In-Chull Kim, Ph.D., +82-2-3773-7009 [email protected] or LG Life Sciences, Ltd. Jay J.H. Kwon, +82-2-3773-3358 [email protected] or Atkins + Associates for Anadys Pharmaceuticals Trista Morrison, 858-527-3490 [email protected] SOURCE: Anadys Pharmaceuticals, Inc.

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韩国和美国人合搞的II期核苷类药物，能降低病毒10的4次方。

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Anadys Pharmaceuticals and LG Life Sciences Announce Phase II Clinical Trial of ANA380 (LB80380)Tuesday September 14, 2004
LG Life Sciences, Ltd.

Anadys Pharmaceuticals, Inc. and LG Life Sciences, Ltd. (KOSPI: 68870) today announced that the first two cohorts have completed enrollment in a Phase II clinical trial of ANA380 (LB80380) in patients with lamivudine- resistant hepatitis B virus (HBV) infection. ANA380 is an antiviral compound that has exhibited potent activity against HBV, including in vitro activity against HBV strains resistant to lamivudine, the current standard of treatment for patients infected with HBV. Previously reported results from a completed Phase I/IIa clinical trial demonstrated that oral administration of ANA380 over four weeks was both well tolerated and reduced HBV viral load by 99.9 percent in the chronic HBV infected patients treated in the study.

The current Phase II trial aims to assess the safety and antiviral activity of ANA380 in chronically infected HBV patients who are clinically and genetically resistant to lamivudine. Genetically altered strains of HBV that are resistant to lamivudine can be detected in 14 to 32 percent of all patients after one year of lamivudine treatment. This proportion rises with the duration of treatment, increasing to 66 percent after four years. The current study design calls for enrollment of three cohorts totaling 36 patients in an open label, multi-center, sequential group dose escalation study, evaluating ANA380 for a period of twelve weeks. Eligible patients have been treated with lamivudine therapy and documented to have genetically encoded lamivudine resistance.

"Direct antiviral therapies have dramatically enhanced the treatment of HBV due to their improved side effect profile and more convenient oral administration," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Anadys. "Future improvements in therapy will depend on increased antiviral potencies at well-tolerated doses, and on a resistance profile that suppresses the emergence of new strains while providing treatment for lamivudine-resistant virus. Our goal is to develop a direct antiviral that combines the potency, tolerability and activity against resistant virus to confer these benefits to patients."

"We expect that LB80380 (ANA380) will be a best-in-class drug in HBV treatment with high effectiveness against lamivudine resistant strains. I believe we can accomplish this goal through our collaboration with Anadys," said Heung-Joon Yang, Ph.D., President and Chief Executive Officer of LG Life Sciences.

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Table of Contents

If we are unable to or determine not to exercise our rights under our exclusive option agreement with LGLS, we will not obtain any license or other rights to LB80380 and will not realize the potential benefits of the development of LB80380 or generate any revenues from the commercialization of LB80380. In February 2004, we obtained an exclusive option from LGLS to enter into a license and joint development agreement for the development and commercialization of LB80380 as a therapy for chronic HBV. Although the option agreement sets forth the key business terms of the exclusive license and joint development agreement we would enter into with LGLS, it does not include all of the various terms and conditions necessarily included in agreements of this nature, including provisions governing the ownership of inventions arising out of the parties’ relationship, the manufacture and supply of bulk substance and finished products, the mechanisms for tracking and calculating royalty payments and certain commercialization matters, including specialty license sales and potential royalty reductions. Prior to exercising our option rights, we will be required to negotiate with LGLS and agree upon the final terms and conditions of the exclusive license and joint development agreement. If we are unable to reach an agreement with LGLS on the final terms and conditions of the exclusive license and joint development agreement by April 17, 2004, our option rights will terminate. We cannot guarantee that we and LGLS will be able to agree on the final form of license and development agreement on a timely basis, if at all. Also, because of the relatively short duration of the option agreement, the final terms and conditions of the exclusive license and joint development agreement may not be acceptable to us, or as favorable to us as they may have been if we were provided an opportunity to negotiate the agreement over a longer time period. In addition, LGLS has the right to terminate the option agreement if, as of April 17, 2004, we do not satisfy certain net current assets and net assets criteria. Initially, these required us to have at least $60 million in net current assets and at least $64 million in net assets. However, in view of the anticipated net proceeds from this offering, we and LGLS recently amended these criteria such that LGLS would have the right to terminate the option agreement if, as of April 17, 2004, we do not have at least $48 million in net current assets and at least $52 million in net assets. In connection with this reduction, we agreed to shift the timing of specific milestone payments by increasing the initial milestone amount payable to LGLS following the exercise of this option from $2 million to $4 million, and reducing a later-stage milestone payment by $2 million. We cannot guarantee that the net proceeds of this offering will be sufficient to enable us to satisfy these revised asset requirements. Further, while we are encouraged by our diligence efforts to date, we have not yet completed our full due diligence review of LB80380. As a result of any one or more of these factors, we ultimately may not be willing or able to exercise our rights under the exclusive option agreement with LGLS. If we do not exercise these rights, we will not receive a refund of any portion of the $500,000 option fee we paid to LGLS, nor will we obtain any license or other rights to LB80380 or be entitled to pursue the development and potential commercialization of LB80380. If we do not pursue the development of LB80380, our HBV commercialization efforts could be significantly impaired. Even if we successfully exercise our rights under our exclusive option agreement with LGLS, we may not realize the anticipated benefits of the development and potential commercialization of LB80380. If we exercise our exclusive option with LGLS, we will have an exclusive license to commercialize LB80380 as a therapy for chronic HBV in North America, Europe, Japan and all other countries in the world other than China, Korea, India and countries in Southeast Asia. Under the terms described in the option agreement, we and LGLS would equally conduct and fund the global clinical development of LB80380. As a result, the future success of our HBV programs would depend in part on our ability to maintain our relationship with LGLS with respect to LB80380. We cannot guarantee that LGLS will not reduce or curtail its efforts to develop LB80380 with us because of changes in its research and development budget or other factors affecting its business or operations. If we are not able to maintain a positive relationship with LGLS with respect to LB80380, we may not be able to effectively develop or commercialize products based on LB80380, in which case our HBV development and potential commercialization efforts could be significantly impaired and our ability to generate anticipated product revenues may suffer. 15

hbv_cn

希望早点上市..

lynetchong

只能降病毒吗？对hbsag有效吗？

lj

能降病毒就不错了,至于HBSAG靠你的身体状况了啊

niche

我等》》

没名啊？？？