首页 > 资讯 > 日本制药公司回应美国FDA对Ranbaxy公司的禁令

出自识林

2014-02-04 WSJ

日本制药公司回应美国FDA对Ranbaxy公司的禁令：
— 第一三共株式会社发誓采取大幅措施以提高Ranbaxy质量

日本制药企业第一三共株式会社强调到现在为止，该公司未曾考虑降低在Ranbaxy制药公司的持股比例，相反，这家公司承诺将继续对旗下这家存在问题的印度制药公司采取重大的新措施以改进其质量控制。

第一三共的一位高管做出这一回应。早些时候，FDA禁止美国市场使用Ranbaxy位于印度西北部旁遮普省Toansa工厂所生产的原料药。

由于Toansa工厂供应多种Ranbaxy公司仿制药使用的关键原料药，这一最新的禁令，紧随对其它Ranbaxy设施的类似限制，是对第一三共的沉重打击。财务总监酒井学表示，在问题得以解决之前，该印度部门（Ranbaxy）将不得不从第三方获取原料药或成品。

“第一三共已投入相当多的精力支持Ranbaxy，但目前看还不够”，酒井补充道，“我们希望采取严厉的新措施。”

但是这家销售收入位列日本第三的制药公司并未提供所构想措施的更多细节。该公司已聘用了顾问派出第一三共的雇员以帮助Ranbaxy工厂加强质量控制。

FDA的这一行动紧随着这家机构在去年9月禁止来自于Ranbaxy印度北部的Mohali 工厂进口的决定。就在第一三共以46亿美元并购这家印度仿制药生产商仅仅几个月之后，其它两家Ranbaxy场地在2008年收到了类似的禁令。

酒井承认，Ranbaxy工厂所面临的问题比企业最初认为的更复杂，特别令人不安的是FDA发现Ranbaxy质量控制实验室问题，而不像之前认定的问题来自于生产工厂。

第一三共现已持有Ranbaxy超过六成的股份，已派出雇员培训工厂经理，但是他表示，培训还未延伸至实验室。

根据FDA检查员在其报告中所指出的，Ranbaxy公司Toansa工厂员工在原辅料与原料药未能所需标准时，一再捏造检验数据，使之看上去达标。

总部位于印度Gurgaon的Ranbaxy公司，拒绝发表评论。

在之前举行的一个单独的电话会议上，多位分析师质问酒井，公司为何忽视诸如FDA报告中指证的删除检验结果不合格证据的涉嫌违规的行为。

“我们需要掌握类似事件如何发生，违规行为的广泛程度，以及是否是由某个特定人员的过失所致。”酒井回应大家。

“我们需要做的看起来越来越多，” 酒井表示，并补充道，公司就Ranbaxy工厂还在接受一些美国以外的机构的问询。

周五，第一三共公布其预期全年净利润可达650亿日元（6.34亿美元），尽管今年头9个月至12月已经超过该数字。虽然公司仍在估算FDA禁令对Ranbaxy公司收益所造成的影响，但酒井表示，对Ranbaxy的担忧，并未改变第一三共的的盈利预期。在9个月的时间内，Ranbaxy的销售额占第一三共总销售额约20%。

“我们不考虑立刻降低我们所持股份，”他表示，“但是这对Ranbaxy的收益将有负面影响，我们需要全盘考虑我们应该如何去做。”他简要地补充道。

校译：识林-Kapok 2014-02-03

Daiichi Sankyo Vows Drastic Steps to Improve Ranbaxy Quality
Japanese Drug Maker Responds to U.S. Ban
By Kana Inagaki
Jan. 31, 2014 3:11 a.m. ET

TOKYO—Japanese pharmaceutical maker Daiichi Sankyo Co. 4568.TO +2.74% insisted it is not considering lowering its stake in Ranbaxy Laboratories Ltd. 500359.BY +0.81% for now, promising instead to take significant new measures to revamp quality control at its problematic Indian drug unit. The comments from a senior Daiichi Sankyo executive come after the Food and Drug Administration earlier in January banned U.S. market use of drug ingredients produced at Ranbaxy's Toansa factory in the northwestern Indian state of Punjab, citing quality issues.

The latest ban, following similar restrictions on other Ranbaxy facilities, is a serious blow for Daiichi Sankyo since Toansa supplies many of the critical ingredients used in the Ranbaxy's generic drugs. Until the problem is resolved, the Indian unit will need to obtain active pharmaceutical ingredients or finished products from third parties, Chief Finance Officer Manabu Sakai told reporters.

"Daiichi Sankyo has put considerable effort into supporting Ranbaxy, but those efforts have been insufficient," Mr. Sakai said. "We hope to prepare drastic new measures," he added.

But Japan's third-largest drug maker by revenue provided few details of what kind of measures it envisages. It has already hired consultants and sent over Daiichi Sankyo employees to help enhance quality control at Ranbaxy plants.

The FDA move follows a decision in September to block imports from Ranbaxy's Mohali plant in north India. Two other Ranbaxy facilities were similarly blocked in 2008, just a few months after Daiichi Sankyo acquired the Indian generic drugs maker for $4.6 billion.

Mr. Sakai conceded that the problems at Ranbaxy factories were deeper than the company had initially thought, saying it was particularly disturbing that the FDA found problems at Ranbaxy's quality-control labs instead of at the manufacturing sites as was the case in previous findings.

Daiichi Sankyo, which now holds more than a 60% stake in Ranbaxy, had sent its employees to train plant managers, but its training had not extended to labs, he said.

According to a report by FDA inspectors, workers at Ranbaxy's Toansa plant repeatedly fudged test results to make it appear that raw materials and active pharmaceutical ingredients met required standards when they didn't.

Ranbaxy, contacted in Gurgaon, India, declined to comment.

In a separate conference call on Friday, analysts grilled Mr. Sakai about how the company could possibly overlook alleged violations such as the deletion of evidence of failed tests cited in the FDA's report.

"We need to grasp how something like this could occur, how extensive the transgressions were and whether they were the fault of a particular person," Mr. Sakai told them.

"What we need to do seems to be growing and growing," Mr. Sakai said, adding that the company is also receiving inquiries about Ranbaxy plants from authorities outside the U.S.

On Friday, Daiichi Sankyo kept its full-year net profit forecast at ¥65 billion ($634 million) despite already topping that figure in the first nine months through December. While the company is still gauging the impact of the FDA ban on Ranbaxy earnings, Mr. Sakai said concern about Ranbaxy was one factor for not changing its outlook. For the nine-month period, Ranbaxy sales accounted for about 20% of Daiichi Sankyo's overall revenue.

"We aren't thinking of immediately lowering our stake," he said. "But there will be a negative impact on Ranbaxy's earnings so we need to consider comprehensively what we are going to do," he added without elaborating.

—Sean McLain contributed to this article.

原文请见 Daiichi Sankyo Vows Drastic Steps to Improve Ranbaxy Quality
相关链接 Ranbaxy production sites in India