【公告】美時澄清先探週刊2034期及財訊快報報導 2019/04/16中央社 日期：2019年04月16日公司名稱：美時製藥 (1795)主旨：澄清先探週刊2034期及財訊快報報導發言人：沈燁說明：1.事實發生日:108/04/162.公司名稱:美時化學製藥股份有限公司3.與公司關係(請輸入本公司或子公司):本公司4.相互持股比例:不適用5.傳播媒體名稱:先探週刊2034期及財訊快報報導6.報導內容:(1)先探週刊報導「...以終端狀況認列營收...表示未來戒毒癮舌下含片市場就只有美時與Dr Reddy可供貨，不是只有1/3的份額」(2)4/11財訊快報報導「但目前只能確認，由於學名藥就是仿製藥，原廠藥有的疑慮他都有，市場可能大打折扣」...」7.發生緣由:(1)針對媒體報導戒癮藥舌下含片Suboxone film 原廠告訴案後續影響，市佔份額與市場大小改變等皆為媒體推測，本公司重申對此品項之商業價值看法未變，並將持續以sell-through方式認列營收(2)此非本公司之訴訟案，本公司不方便亦不應該評論，因媒體與法人諸多揣測，本公司僅陳述以下事實：A. Buprenorphine/naloxone 舌下含片為美國一線治療鴉片類物質成癮之藥物，FDA所核發藥證用於該適應症，此藥品之核可有「藥品風險評估既管控計畫」(risk evaluation and mitigation strategies, REMS)，依據FDA之核可內容此藥品沒有安全性或有效性問題，此告訴亦非針對品項本身之已核可的安全性與有效性疑慮。B.在其他類似告訴狀況下，如輝瑞因 Neurontin (gabapentin) 品項的市場行為於2000年初開啟的一連串告訴及後續和解中，輝瑞所揭露之數據顯示市場未受影響。8.因應措施:發佈重大訊息予以澄清9.其他應敘明事項:本公司相關營收與營運資訊應以公開資訊觀測站之公告為主。
Pfizer adds another $325M to Neurontin settlement tally. Total? $945M
by Tracy Staton | Jun 2, 2014 4:40pm Off-label marketing strikes again. Pfizer ($PFE) agreed to pay $325 million to wrap up claims that its Parke-Davis unit touted the epilepsy drug Neurontin for uses not approved by the FDA, costing healthcare payers millions in unnecessary spending. It's Pfizer's second round of off-label Neurontin settlements: In 2004, the company shelled out $430 million in a settlement with the U.S. Justice Department. The drugmaker's Warner-Lambert unit pleaded guilty to two violations of the Food, Drug & Cosmetic Act and paid civil and criminal penalties for promoting the drug, known generically as gabapentin, as a treatment for bipolar disorder, ADHD, migraine headaches and other types of pain. And it's the second settlement of Neurontin-related claims in less than 6 weeks. On April 21, Pfizer said it would pay $190 million to settle a federal antitrust lawsuit claiming that the company did some questionable maneuvering to keep cheaper generics off the market. Pfizer did not admit wrongdoing in the latest settlement deal, which must be approved by a federal judge in Boston. The deal wraps up "all third-party payer claims regarding off-label promotion" of Neurontin, a spokesman told Bloomberg. Parke-Davis was a unit of Warner-Lambert, which Pfizer acquired in 2000. The claims about off-label marketing stretch back to 1994. But according to the payers' lawsuit, Pfizer "deliberately expanded the promotion of off-label uses" after the Warner-Lambert buyout. That $325 million may seem like a substantial amount of money, but the payers--which include Louisiana Blue Cross/Blue Shield--had claimed "billions of dollars" in damages from off-label Neurontin use. The company marketed Neurontin "for a variety of uses for which it is not approved or medically efficacious," the lawsuit claimed (as quoted by Bloomberg). The off-label allegations are among many leveled against not only Pfizer, but almost every Big Pharma company. In addition to Pfizer's DoJ settlement involving Neurontin, the company agreed to pay $2.3 billion to resolve Justice Department allegations that it sold a variety of drugs for off-label uses, including the now-withdrawn blockbuster painkiller, Bextra. That settlement included a record-setting $1.3 billion criminal penalty. Other settlements--some even larger--have followed that deal, but Pfizer retains the record. Most recently, Pfizer last year said it would pay $491 million to resolve claims that its Wyeth unit, acquired in a 2009 megamerger, touted the transplant-rejection drug Rapamune for a variety of off-label uses.
(Suboxone原廠恐面對30億美金罰款) 美時 夥伴: 商業價值未變_ Buprenorphine/Naloxone舌下含片(Suboxone學名藥)https://alveice.blogspot.com/2019/04/suboxone30-buprenorphinenaloxonesuboxone.html?m=0
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