(BW)(MA-BIOGEN-IDEC)(BIIB) Biogen Idec公司启动复方口服药BG-12第三期临床项目，治疗多发性硬化症

美国商业资讯2007年1月9日麻省剑桥消息——

Biogen Idec公司（纳斯达克股票代码：BIIB）今天宣布，启动BG-12第三期临床试验项目。BG-12是正在开发的一种口服药，成分为延胡索酸盐（fumarate），用于治疗复发好转型多发性硬化症（MS）。

北美、欧洲和世界其它地区共计2000多名患者将参加DEFINE研究（确定口服延胡索酸盐药治疗复发好转型多发性硬化症的安全性和药效）和CONFIRM研究（参比药品与口服延胡索酸盐药治疗复发好转型多发性硬化症的对比研究）。研究项目已在全球范围展开，Biogen Idec公司计划年内在美国启动上述研究项目。DEFINE和CONFIRM研究为期两年，采取多中心随机双盲的形式开展临床试验，以安慰剂来控制，进行剂量比较，决定BG-12治疗受试者所患复发好转型多发性硬化症的安全性和药效。CONFIRM研究还将设立使用glatiramer acetate（一种人工新合成的肽类制剂，Copaxone(R)）的参比药物参照组。

两项研究的最终目的有，评价BG-12对于临床复发测定、残疾状况的恶化和各类磁共振成像（MRI）测定所起的作用。

DEFINE首席研究员、医学博士、德国波鸿-鲁尔大学圣若瑟医院（St. Josef-Hospital）神经科主任Ralf Gold教授说，“早先完成的BG-12研究显示，BG-12有可能成为治疗多发性硬化症的口服药。BG-12第三期临床试验项目将开展全面研究，让人们对BG-12治疗多发性硬化症的疗效有更深入的了解。对于治疗多发性硬化症，目前仍缺乏安全有效的口服疗法。”

Biogen Idec公司神经学研究开发部资深副总裁、医学博士Alfred Sandrock说，“开发BG-12药物，让Biogen Idec公司朝着承诺目标迈进了一步，推动了多发性硬化症的治疗研究。我们的治疗候选方案种类丰富，公司致力于开展创新研究，为这类重症患者提供多种治疗方案。”

BG-12二期临床研究结果

2006年，在欧洲的两次神经病医学会议上，公布了用于评价BG-12的药效和安全性的二期临床研究数据。二期试验采取多中心双盲的形式，以安慰剂来控制，对剂量进行比较；257名患者在欧洲10个国家的不同试验地点参加了这项临床研究。试验时，患者随机打乱分组，每天分别口服安慰剂或120毫克、360毫克、720毫克剂量的BG-12药物，连续服用六个月。从研究进行到第12周的时候开始，每月测定一次，直到第24周试验结束。结果显示，对照服用安慰剂的试验组，日服720毫克BG-12的患者组服药后出现钆增强病变的平均发病数降低了69％（p<0.001）。与基线相比，六个月内，720毫克剂量试验组出现新的或新扩大的T2-高信号病变的发病率也下降了48％（p<0.001）。虽然就这一目的来说，此次研究重点并不在于取得突出的统计结果，不过，与安慰剂对比试验组相比，720毫克剂量试验组的复发率也降低了32％（p=0.272）。按照试验目的来对比，120毫克以及360毫克剂量试验组的试验结果与安慰剂对照组在统计数字方面差别不大。

最常见的副作用是潮红、胃肠功能紊乱、头痛、鼻咽炎。将安慰剂控制的研究阶段任意时刻的正常上限值做为基准，三组主动治疗试验组中，肝脏酶分泌增加量大于等于三倍上限值的发生频率在2％到8％之间，与之相比，安慰剂试验组的发生率为5％。停止服用BG-12后，肝脏酶分泌水平提高了。综合考虑服用BG-12的试验组和服用安慰剂的试验组，总体感染率相同，且没有发生机会性感染。

关于BG-12

数据显示，口服型延胡索酸盐衍生药品BG-12是一种免疫调节剂，结合细胞保护和抗炎症的特性，形成新型作用机制。根据有关BG-12和延胡索酸盐的现有临床资料及科学资料，开发BG-12药物来治疗众多T细胞调节的自身免疫性疾病和/或炎症，有充分的技术保障。

关于Biogen Idec公司

Biogen Idec公司为肿瘤学、神经病学和免疫学创立了新的护理标准。作为创新疗法开发、生产及商业推广的全球一流企业，Biogen Idec公司利用科学发现推动人类健康保健领域的发展。如需了解产品商标、新闻稿以及Biogen Idec公司的详细信息，请访问网站： http://www.biogenidec.com 。

免责声明/前瞻性表述

本新闻稿包含有关开发BG-12药物治疗多发性硬化症的前瞻性表述。这些表述是以我们目前的观点和预期为基础而发表的。受药品开发内在风险的影响，其中包括：更大范围的临床试验中，产品的效果可能无法达到预期水平的风险；临床试验期间可能出现安全问题、其它问题或延迟的风险；未曾预料的技术困难或生产困难；知识产权争端。无法确保产品的风险/效益符合公司的要求，或达到监管机构对特定的适应症的要求。药物开发涉及高风险。只有一小部分研发项目能实现产品商业化。前期临床试验的成功并不能确保后期或更大规模的临床试验也取得成功。对于影响这些前瞻性表述的相关风险和不确定因素，如需了解详细情况，可参见Biogen Idec公司定期向美国证券交易委员会呈报的文件和其它报表文件，从中亦可了解Biogen Idec公司的其它经营活动。Biogen Idec公司不承担公开更新任何前瞻性表述的责任。

联系方式：Biogen Idec公司 新闻媒体请联系： Amy Brockelman，617-914-6524 或者 投资者请联系： Eric Hoffman，617-679-2812

(BW)(MA-BIOGEN-IDEC)(BIIB) Biogen Idec Initiates Phase III Clinical Program of Oral Compound BG-12 for Multiple Sclerosis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 9, 2007--

Biogen Idec (NASDAQ: BIIB) announced today that it has initiated the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS).

The DEFINE (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and CONFIRM (comparator and an oral fumarate in relapsing-remitting MS) studies will include more than 2,000 total patients in North America, Europe and rest of world. These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year. DEFINE and CONFIRM are two-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting MS. CONFIRM will also include a glatiramer acetate (Copaxone(R)) reference comparator arm.

Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.

"Earlier studies of BG-12 support its potential as an oral therapy for multiple sclerosis. The extensive Phase III clinical program of BG-12 will provide greater understanding of its promise in MS," said DEFINE lead investigator Ralf Gold, MD, Professor and Chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum. "MS is a disease that continues to have an unmet need for safe and effective oral therapeutic options."

"The development of BG-12 furthers Biogen Idec's commitment to advancing the treatment of MS. We have a diverse portfolio of therapeutic candidates and are dedicated to the pursuit of innovative research that will yield multiple options for people living with this devastating disease,"said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec.

BG-12 Phase II Study Results

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two European neurological medical meetings in 2006. The Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day orally for six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction (p<0.001) in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction (p<0.001) in new or newly enlarging T2-hyperintense lesions at six months compared to baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32% reduction (p=0.272) in relapse rate compared to placebo at the 720 mg dose. The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo on any endpoints.

The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. The incidence of liver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the placebo controlled phase of the study was between 2% and 8% in the three active treatment groups, compared with 5% in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. The overall rate of infection was the same in the total BG-12-and placebo-treated groups, and no opportunistic infections occurred.

About BG-12

Data suggest that BG-12, an oral fumarate derivative, is an immunomodulator with a novel mechanism of action with a combination of cytoprotective and anti-inflammatory properties. Based on available clinical and scientific information with BG-12 and fumarates, there is strong technical rationale for development of BG-12 in a number of T-cell mediated autoimmune and/or inflammatory diseases.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com .

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding the development of BG-12 for multiple sclerosis. These statements are based on our current beliefs and expectations. They are subject to the risks inherent in drug development, including the risks that the effects of the product in larger clinical trials may not be as expected or that there may be safety issues or other problems or delays that arise during clinical trials, unexpected technical or manufacturing hurdles, or intellectual property disputes. There is no certainty that the risk/benefit profile of the product will be acceptable to the Company or to regulatory authorities for a particular indication. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. For more detailed information on the risks and uncertainties associated with these forward looking statements and Biogen Idec's other activities, see the periodic and other reports that Biogen Idec has filed with the SEC. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.

CONTACT: Biogen Idec MEDIA CONTACTS: Amy Brockelman, 617-914-6524 or INVESTOR CONTACTS: Eric Hoffman, 617-679-2812