2015年4月1日讯 /生物谷BIOON/ --上周，日本制药巨头武田（Takeda）在糖尿病市场投下了一枚重磅炸弹，该公司研发的全球首个每周口服一次的降糖药Zafatek（trelagliptin succinate，曲格列汀琥珀酸盐）获批，给广大2型糖尿病患者群体带来了福音。然而不幸的是，同样在糖尿病市场，武田目前正深陷于另一种糖尿病畅销药艾可拓（Actos）的致癌风波。
本周一彭博社最新报道，据3位知情人士爆料，武田将支付超过22亿美元，用于解决因隐瞒旗下糖尿病药物艾可拓（Actos，通用名：吡格列酮）致癌风险的相关指控。据爆料，武田此次将解决在美国联邦及州立法院超过8000例法律诉讼，每个案子将支付27.5万美元，合计支付金额超过22亿美元，这也将是美国制药历史上最大的罚单之一。
知情人士透露，武田提供的解决方案是，只有那些已经提起诉讼或已经聘请律师即将提交诉讼的服用过Actos的糖尿病患者才有资格参与赔偿，这一限制条件意图帮助该公司避免支付新一波的法律诉讼。该人士透露，目前武田与联邦及州立法院尚未达成最终协议，仍有谈判失败的可能性；武田也可能选择解决其中一些诉讼，并继续在其他诉讼上进行协商。不过，也有一些律师表达了强烈的反对，认为22亿美元的赔偿金不足以支付所有已患膀胱癌的糖尿病患者。
据了解，自2013年以来，武田被指控至少在9个临床试验中隐瞒Actos的致癌风险。去年，美国联邦法院陪审团对武田及合作伙伴礼来分别处于60亿美元和30亿美元（合并90亿美元）的罚款，成为美国制药领域的最大一笔罚单。不过去年10月，这一罚单被戏剧性地降至3680万美元，降低幅度高达99%。而就在业界认为武田和礼来会松一口气，结束这场惊心动魄的诉讼攻守战时，武田和礼来的律师却表示：还要再次上诉！
武田与合作伙伴礼来自1999年开始在美国联合销售糖尿病药物艾可拓（Actos），直至2006年结束合作。之后，礼来保留Actos在亚洲及欧洲一些国家、加拿大、墨西哥的销售权。根据彭博社汇总的数据，艾可拓（Actos）在截止2011年3月的年销售额峰值高达45亿美元，约占武田当时收入的27%。另外，根据法庭文件，艾可拓（Actos）自1999年上市以来，合计销售额已超过160亿美元。目前，该药正面临着来自兰伯西（Ranbaxy）的仿制药的竞争。
英文原文：Takeda Offers $2.2 Billion to Settle Actos Drug Cases
(Bloomberg) -- Takeda Pharmaceutical Co. has offered to pay more than $2.2 billion to resolve claims of hiding its Actos diabetes medicine’s cancer risks in what would be one of the largest U.S. settlements of patient lawsuits targeting drugs or devices, three people familiar with the matter said.
Officials at Asia’s largest drugmaker propose to settle more than 8,000 lawsuits in federal and state courts in the U.S., said the people, who asked not to be identified because they weren’t authorized to speak publicly about the offer.
Such a deal would amount to a payment of about $275,000 for each case. Any settlement would be the first in the three-year litigation over the diabetes drug.
A federal jury in Louisiana last year ordered Takeda and Eli Lilly & Co. to pay a combined $9 billion in damages to a shopkeeper who blamed Actos for causing his bladder cancer. That award, the seventh-largest in U.S. history based on data compiled by Bloomberg, was later reduced by more than 99 percent to $36.8 million by a judge.
“This is a strong signal that Takeda really wants to settle these cases so it can avoid any more huge verdicts,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “But the per-case number indicates they don’t want to have to pay a premium to settle these claims.”
Teagan Knapp, an outside spokeswoman for Osaka, Japan-based Takeda, didn’t immediately respond to phone and e-mail messages after regular business hours Tuesday seeking comment on the settlement offer in the Actos litigation. Kazumi Kobayashi, a Takeda spokesman in Tokyo, wasn’t immediately able to respond to a request for comment.
Proposal Critics
A final deal hasn’t been reached and the talks could still fall apart, the people said. Takeda also could choose to settle some lawyers’ inventories of cases under the $2.2 billion proposal and continue negotiations on others, the people added.
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There’s opposition to Takeda’s settlement offer from some lawyers who have sued the drugmaker over Actos, the people familiar with it said. Some attorneys contend $2.2 billion isn’t enough compensation for all patients who developed bladder cancer after taking the drug, the people said.
Actos sales peaked in the year ended March 2011 at $4.5 billion and accounted for 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Takeda now faces generic competition over the drug from Ranbaxy Laboratories Ltd.
Consolidated Lawsuits
More than 3,500 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial information exchanges, according to court dockets. The company faces another 4,500 cases in state courts in Illinois, West Virginia, California and Pennsylvania, according to court records.
Under Takeda’s offer, only Actos patients who have already sued or who have already hired a lawyer to file a lawsuit would be eligible to participate in the settlement, the people said. That limitation is designed to help the company avoid paying to resolve a new wave of suits, the people added.
“There is no deal and it is highly questionable whether there will be one without further scorched-earth litigation,” Paul Pennock, one of two lawyers overseeing the federal-court litigation for plaintiffs, said in an e-mail “But at least Takeda recognizes that attempting to compensate these cancer victims and their families is the right thing to do.”
Takeda’s Lawyer
Takeda hired Douglas Marvin, a lawyer with Williams & Connolly LLP in Washington, to help negotiate the potential deal with lawyers for former Actos patients, the people said. Marvin helped negotiate a $4.85 billion settlement with Merck to resolve about 30,000 lawsuits over its withdrawn painkiller Vioxx in 2007.
Marvin didn’t return a call seeking comment after regular business hours Tuesday.
Takeda has faced at least nine trials since 2013 over claims it hid Actos’s cancer risks, including the Louisiana trial. The company has won three defense verdicts and other damage awards against the drugmaker have been thrown out or are on appeal.
Still, five juries that have reviewed the evidence of Takeda’s handing of Actos have held the company liable for consumers’ injuries.
Potential Judgments
“If Takeda can settle the multidistrict cases for $2.2 billion, they should sign the papers and leave town,” Erik Gordon a professor at the University of Michigan’s business and law schools who teaches about class-action settlements.
“Given the results of the trials so far and the number of potential judgments against the company, $2.2. billion is a bargain,” Gordon added.
Former Actos users argued Takeda executives ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999 and misled U.S. regulators about the medicine’s risks.
Lilly was Takeda’s U.S. partner in selling and marketing the drug over seven years starting in 1999. That partnership ended in 2006, with Lilly retaining rights to sell Actos in parts of Asia and Europe, as well as in Canada and Mexico.
Lilly officials contend Takeda agreed to cover all legal costs stemming from its U.S. sales of Actos and for all the Louisiana verdict.
Takeda’s settlement offer is more than double what Stryker Corp. agreed to pay last year to resolve claims over its recalled artificial hips and more than triple the $650 million German drugmaker Boehringer Ingelheim GmbH paid to settle lawsuits over its Pradaxa blood-thinning drug.
The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).