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【drug-news】惠氏药厂受挫与仿制药之争
By STEPHANIE SAUL
纽约时报网络版
The popular heartburn drug Protonix could face early generic competition, after a federal judge cleared the way for a copycat version of the medicine.
Federal Appeals Court Blocks Teva from Selling Its Version of Famvir (September 8, 2007) The ruling was the latest in a string of recent setbacks for the drug’s maker, Wyeth. Shares of the company fell 3.8 percent, or $1.82, to $45.72 yesterday.
Wyeth and its generic competitor, Teva Pharmaceutical Industries, announced late Thursday that Judge Jose L. Linares of the Federal District Court in New Jersey rejected Wyeth’s request that he block Teva’s marketing of the generic version. Although the Protonix patent is not set to expire until July 2010, Teva has filed a suit challenging its validity.
Protonix, a so-called proton pump inhibitor that reduces stomach acid production, generated about $1.8 billion in revenue in 2006 and is Wyeth’s third-largest product. The drug, known generically as pantoprazole, is used to treat severe inflammation of the esophagus caused by gastric reflux.
Despite speculation that Teva, a large drug maker based in Israel, might immediately begin marketing its product, several executives in the drug distribution industry said yesterday that there was no indication Teva had begun trying to sell the drug.
It is not unusual for Teva to begin marketing its generics after favorable court rulings. But in a news release Thursday night, the company struck a cautious tone, saying it would complete a “thorough analysis” of the judge’s ruling before deciding what to do. The company declined to comment further yesterday.
Because the ruling by Judge Linares is under seal, Ken Cacciatore, an investment analyst for Cowen & Company, said it was not clear how strongly the judge had worded the ruling in Teva’s favor. “Teva would obviously be much more willing to launch if the ruling was predicated on a high likelihood of success on the merits,” Mr. Cacciatore said in a note to clients.
Wyeth, in a news release Thursday night, said that Judge Linares had emphasized that the findings were preliminary. The company said it believed that the Protonix patent was valid and that it would continue to fight the case.
Continuing Protonix’s patent exclusivity is particularly important for Wyeth, after the company’s two setbacks this summer at the Food and Drug Administration. The agency said it needed more data before it could approve two of the company’s experimental drugs: Pristiq for menopausal symptoms and bifeprunox for schizophrenia.
Mr. Cacciatore said that Teva could wait until a final ruling in the case, negotiate a settlement with Wyeth, or proceed with what is known as an at-risk launch. If Teva did begin selling its version of Protonix, the company would be liable for financial damages should the court ultimately rule in favor of Wyeth, which is based in Madison, N.J. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Wyeth Loses Bout in Fight on a Generic
惠氏药厂与仿制药之争受挫
By STEPHANIE SAUL
纽约时报网络版
The popular heartburn drug Protonix could face early generic competition, after a federal judge cleared the way for a copycat version of the medicine.
在一份联邦判决扫清了仿制版的道路后，Protonix，这个受欢迎的烧心药物可能面对早期仿制药的竞争。
The ruling was the latest in a string of recent setbacks for the drug’s maker, Wyeth. Shares of the company fell 3.8 percent, or $1.82, to $45.72 yesterday.
这份裁决是该药制造商惠氏公司近期一系列受挫事件的最新事件。该公司股票昨天下降了3.8%，1.82美元，跌至45.72美元。
Wyeth and its generic competitor, Teva Pharmaceutical Industries, announced late Thursday that Judge Jose L. Linares of the Federal District Court in New Jersey rejected Wyeth’s request that he block Teva’s marketing of the generic version. Although the Protonix patent is not set to expire until July 2010, Teva has filed a suit challenging its validity.
惠氏和其仿制药竞争对手Teva公司星期四晚些时候就新泽西洲联邦地方法院法官Jose L. Linares驳回惠氏要求阻止Tena的仿制产品上市的请求发表声明。Protonix的专利到期日是2010年7月，但是，Teva公司已经就其有效性提起诉讼。
Protonix, a so-called proton pump inhibitor that reduces stomach acid production, generated about $1.8 billion in revenue in 2006 and is Wyeth’s third-largest product. The drug, known generically as pantoprazole, is used to treat severe inflammation of the esophagus caused by gastric reflux.
Protonix，一种可以减少胃酸分泌称为质子泵抑制剂的药物，2006年为惠氏公司带来了18亿美元的收入，在惠氏产品中位列第3。该药品通用名为袢托拉唑，用于治疗胃酸返流引起的严重食管炎。
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作者:admin@医学,生命科学 2011-06-29 18:20
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