AstraZeneca Fails to Win U.S. FDA Approval for Plavix Competitor Brilinta
波立维的竞争者——阿斯利康的替卡格雷未通过美国FDA的审批
The Food and Drug Administration asked for additional analysis of a study called Plato comparing Brilinta with Plavix in patients with severe chest pain or earlier heart attacks, the London-based company said yesterday in a statement. The twice- daily pill won a 7-1 recommendation from an FDA advisory panel on July 28.
总部位于伦敦的公司在昨天的发布会上说，美国食品药品监督管理局要求提供更多的Plato试验的分析结果，这一试验是对Brilinta和波立维应用于有严重胸痛或早期心脏病发作的患者进行比较研究的。7月28日，这一每天服用两次的片剂曾获得FDA顾问委员会7：1的推荐。
The FDA’s decision delays a product whose sales may have reached $2.7 billion by 2015, according to the average estimate of three analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.
据Bloomberg 三名分析师的平均预测值,2015年这一产品预期销售额有望达到27亿美元,FDA的决定延迟了这一产品的上市。阿斯利康，作为英国第二大药物制造商，其治疗胃灼热的Nexium（耐信）和精神病治疗药Seroquel在未来四年内专利将到期，去年二者销售额达到了98.3亿美元，因此其急需新药。
Regulators didn’t ask for new clinical trials for the drug, known by its chemical name, ticagrelor, and “our highest priority is to provide the requested Plato analyses to the FDA,” Martin Mackay, AstraZeneca’s president of research and development, said in the company’s statement.
审查者未要求对替卡格雷进行新的临床试验，阿斯利康的研究与开发总裁Martin Mackay在公司声明中称，“我们最先要考虑的事就是提供FDA要求的Plato试验的分析结果”。
“The company remains confident in the submission for ticagrelor and in its ability to respond to the agency’s questions,” AstraZeneca said in its statement.
阿斯利康公司声明称，“公司对提交替卡格雷的申请充满自信，亦有能力及回应委员会的问题”。
AstraZeneca gained 4 pence, or less than 1 percent, to 3,153 pence, in yesterday’s London trading. The drugmaker has gained 8.3 percent this year, compared with a 7.1 percent gain in the 17-member
Bloomberg Europe Pharmaceuticals Index.

Rival Treatments
竞争疗法
Brilinta would compete with Plavix from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA, and Effient, sold by Eli Lilly & Co. All three are pills designed to prevent platelets in the blood from clumping together to form clots, which can cause heart attacks and strokes. Plavix and Effient are taken daily and remain effective for one week after treatment is halted. Brilinta wears off more quickly, so it may pose a lower risk of bleeding for surgery patients.
Brilinta将与Plavix（波立维）以及礼来销售的Effient竞争，波立维是总部位于纽约的百时美施贵宝和总部位于巴黎的赛诺菲安万特的产品。这三种药物均为片剂，用于防止血小板聚集形成血块从而导致心血管事件和中风。Plavix 和Effient每天服用，停药后一周仍保持药效。Brilinta药效的消失要快得多，故此可能会减少外科手术病人发生出血事件的风险。
In Plato, AstraZeneca’s key study of 18,624 people, 9.8 percent of patients on Brilinta for a year had a heart attack, stroke or died from cardiovascular disease, compared with 11.7 percent of those on Plavix. A related study also showed AstraZeneca’s drug was effective regardless of the patients’ genetic makeup, unlike Plavix, which doesn’t work in patients with a certain genetic variation.
Plato试验是阿斯利康开展的涉及18，624人的关键性研究，试验中，服用Brilinta达一年的患者中有9.8%发生心脏病、中风或死于心血管疾病，相对而言，Plavix组此类患者比例为11.7%。一项相关的研究也显示，无论患者为何种基因组成，阿斯利康的这一药物均有效，这一点不同于Plavix，后者对于发生某一类特定遗传变异的患者无效。
Study participants in the U.S. and Canada did worse on Brilinta than people from other parts of the world. In backing the drug, the FDA’s advisers said in July the findings may be the result of chance and could be examined in a new trial after approval. FDA staff rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome.
来自美国和加拿大的实验受试者服用Brilinta的疗效不如世界其他国家的受试者。7月，基于支持此药物的缘由，FDA顾问认为上述结论可能是偶然性的结果，且可在批准以后通过新的临床试验进行考察。阿斯利康认为美国人服用更大量的阿司匹林与这一结果有关，FDA官员未接纳此建议。
European Approval
欧洲批准情况
Brilinta was approved this month in Europe, where it is known as Brilique. AstraZeneca will likely begin marketing the drug in the second half of 2011 once prices are negotiated with member countries, Sarah Lindgreen, a company spokeswoman, said Dec. 6.
Brilinta本月于欧洲获批，商品名Brilique。12月6日，公司女发言人Sarah Lindgreen说，待与各会员国就价格问题议定以后，阿斯利康有望于2011年下半年上市销售
AstraZeneca will market the drug based on the results of the study that showed a benefit over Plavix, Lindgreen said.
Lindgreen说，研究结果显示（服用Brilinta）获益大于Plavix，阿斯利康会依据这一结果进行销售。
Plavix, introduced in 1997, had sales of $9.8 billion last year. Effient, approved in July 2009 with a boxed warning on bleeding risk, made $27 million last year for Indianapolis-based Lilly and its marketing partner, Daiichi Sankyo Co. of Tokyo.
波立维于1997年问世，去年销售额达98亿美元。Effient于2009年7月获准，包装上带有致出血风险的黑框警告，去年销售额达2700万美元，由总部位于Indianapolis的礼来和其销售伙伴，总部位于东京的第一制药三共共同销售。
Lipitor, a cholesterol pill made by New York-based Pfizer Inc., is the world’s best-selling drug with 2009 revenue of $11.4 billion.
降血脂药立普妥由总部位于纽约的辉瑞公司生产，是全球最畅销的药物，2009年销售收入达114亿美元。