主页 > 医药生命 >
【技术产业】以彼之道，还施彼身
Dec. 23 (Bloomberg) -- A copy of Teva Pharmaceutical Industries Ltd.’s top-selling multiple sclerosis medicine Copaxone may win U.S. approval as soon as next month, Bank of America Merrill Lynch analysts said.
A 30-month stay of approval on the copy, manufactured by Novartis AG and Momenta Pharmaceuticals Inc., expires on or around Jan. 16, New York-based analyst Gregg Gilbert said in a note today. Approval of the generic is possibly “at least in theory” on that day, though the Food and Drug Administration will likely need more time to review it, Gilbert said.
Teva has said the drug’s molecular structure is so complex that clinical trials should be required to prove that any copied version has the same effect. The drug has about 40 percent of the MS market, Gilbert said. It accounted for 18 percent of Teva’s $13.9 billion in sales last year and contributes “disproportionately” to profit, Teva said.
“While key patents protect the drug into 2014, generic challengers in the U.S. hope to launch sooner,” Gilbert wrote.
Teva has sued to block the copy from Basel-based Novartis and Cambridge, Massachusetts-based Momenta. The partners are free to launch at-risk without warning Teva beforehand if the FDA approves their copy, Gilbert said.
The Petah Tikva, Israel-based drugmaker has asked the FDA for approval of a lower-volume version of Copaxone. A ruling on the new version of the drug may come after Jan. 1, Gilbert said.
http://www.businessweek.com/news/2010-12-23/teva-may-face-copaxone-copy-from-novartis-momenta-next-month.html 仿制药大亨也被仿制了，呵呵！ 自己编译一下！ Teva May Face Copaxone Copy From Novartis, Momenta Next Month
Teva 公司的Copaxone下个月可能会面临着诺华和Momenta的仿制药竞争
Dec. 23 (Bloomberg) -- A copy of Teva Pharmaceutical Industries Ltd.’s top-selling multiple sclerosis medicine Copaxone may win U.S. approval as soon as next month, Bank of America Merrill Lynch analysts said.
美国银行的分析师Merrill Lynch说，Teva公司最畅销的治疗多发性硬化症的产品下个个月可能会面临仿制产品的竞争。
A 30-month stay of approval on the copy, manufactured by Novartis AG and Momenta Pharmaceuticals Inc., expires on or around Jan. 16, New York-based analyst Gregg Gilbert said in a note today. Approval of the generic is possibly “at least in theory” on that day, though the Food and Drug Administration will likely need more time to review it, Gilbert said.
总部在纽约Gregg Glibert说，对于诺华和Momenta公司仿制药的30天的品评估结果会在下个月16号出来。总部设在纽约的分析机构Gregg Gilbert说，至少在理论上可能批准Copaxone的仿制药，但FDA还需更多的时间去评估它。
Teva has said the drug’s molecular structure is so complex that clinical trials should be required to prove that any copied version has the same effect. The drug has about 40 percent of the MS market, Gilbert said. It accounted for 18 percent of Teva’s $13.9 billion in sales last year and contributes “disproportionately” to profit, Teva said.
Teva说Copaxone的药物分子结构比较复杂，临床实验需要证明它的仿制药具有同等疗效。Copaxone大约占到美国多发性硬化症药物市场的40%，大约占到Teva公司去年139亿销售额的18%，至于利润可能还会更多。
“While key patents protect the drug into 2014, generic challengers in the U.S. hope to launch sooner,” Gilbert wrote.
尽管这个药物的关键专利技术要到2014年才到期，但是仿制药挑战者希望能在美国尽快上市。
Teva has sued to block the copy from Basel-based Novartis and Cambridge, Massachusetts-based Momenta. The partners are free to launch at-risk without warning Teva beforehand if the FDA approves their copy, Gilbert said.
Teva公司已经上通过诉来阻止Copaxone的仿制药上市，该仿制药由诺华和总部设在马萨诸塞州剑桥附近的Momenta合作开发。Gilbert说如果FDA批准了他们的仿制药，诺华和Momenta就不会因为没有事先警告Teva公司而承受风险。
The Petah Tikva, Israel-based drugmaker has asked the FDA for approval of a lower-volume version of Copaxone. A ruling on the new version of the drug may come after Jan. 1, Gilbert said.
以色列的Teva公司已经向FDA递交了小体积的Copaxone申请，按规定新规格可能会在1月后批准。 Teva 公司的Copaxone下个月可能会面临着诺华和Momenta的仿制药竞争
美国银行的分析师Merrill Lynch说，Teva公司最畅销的治疗多发性硬化症的产品下个个月可能会面临仿制产品的竞争。
总部在纽约Gregg Glibert说，对于诺华和Momenta公司仿制药的30天的品评估结果会在下个月16号出来。总部设在纽约的分析机构Gregg Gilbert说，至少在理论上可能批准Copaxone的仿制药，但FDA还需更多的时间去评估它。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2010-12-25 12:22
医学,生命科学网