Twi(安成藥) Takeda(武田)和解 共享Dexilant (胃食道逆流藥) 10億美元市場

安成藥 將獲武田和解金 2015-04-28 04:44:24 經濟日報 記者黃文奇／台北報導安成國際藥業（4180）昨（27）日宣布，旗下所開發Dexilant學名藥與原廠武田（Takeda）達成和解協議，內部透露，此次和解金額度將超越「抗過動症藥」的600萬美元（約新台幣1.85億元），有機會改寫安成藥史上新高紀錄，將是一筆不小的貢獻，並於本季認列，今年轉盈在望。執行長暨總經理陳貞如表示，此項和解，除了讓安成的Dexilant學名藥能在武田的相關專利到期之前許多年，就得以在美國上市，帶來盈利。更重要的是，安成藥在一段時間之內將是Takeda的授權學名藥廠商並供應美國市場Dexilant兩種劑量學名藥，有利未來Dexilant學名藥的上市銷售。安成藥表示，此次與武田和解同步獲得獲得「授權學名藥廠商」（Authorized Generic, AG）資格，未來可共享逾10億美元美國市場，該產品並有機會提前上市。安成藥昨日股價收179元，上漲2.5元。法人估，安成藥本季將可認列與武田的和解協議及授權與供應契約，近期經美國公平交易委員會及司法部審核通過後，因和解金額的貢獻，將使本季單季轉盈無虞，和解金額有機會上看千萬美元。展望全年，若下半年順利認列Megace ES學名藥的原廠Par擔保金1,600萬美元，將有機會提前轉盈。安成藥表示，依據公司與武田的和解協議，武田將撤銷所有對安成Dexilant學名藥相關的專利訴訟；另外，安成開發的Dexilant學名藥緩釋口服劑型分別有30mg及60mg兩種劑量，目前已經完成藥證申請，正在美國食品藥物管理局（FDA）進行審核中。市場方面，據悉，Dexilant為治療胃食道逆流用藥，根據IMS Health資料顯示，該藥品去年在美國全國市場的銷售金額約10.4億美元（約新台幣320億美元）。安成藥表示，在和解協議中，雙方同時簽訂授權與供應契約，使安成藥及其所屬企業有權以武田授權學名藥廠商資格，進行產品銷售。此外，該和解協議亦允許安成藥自行生產之Dexilant學名藥，在第一家以第四類學名藥法規（paragraph IV, P4）申請上市的藥廠，在該產品銷售180天後，得以上市銷售其Dexilant學名藥。Dexilant為治療胃食道逆流用藥，據IMS Health資料顯示，該藥品去(2014)年在全美市場的銷售金額約10億美元。

TWi signs Settlement Agreement with Takeda on patent litigation related to generic Dexilant  Published on April 27, 2015 at 7:24 AM  TWi Pharmaceuticals, Inc. ("TWi") today announced that it has entered into a Settlement Agreement with Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals America, Inc. (individually and collectively, "Takeda") to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. An Abbreviated New Drug Application for TWi's generic product is currently under review at the U.S. Food and Drug Administration. If approved, TWi's product would be a generic version of Takeda's Dexilant®. The Settlement Agreement allows TWi to launch its generic Dexilant® one-hundred eighty (180) days after the first applicant to file its ANDA (commonly known as "first-to-file" or "FTF") launches its generic Dexilant® product, or on an earlier date under certain circumstances. As part of the settlement, the parties also entered into a License and Supply Agreement allowing TWi and its affiliates to sell Dexilant® in both dosage strengths as the Authorized Generic. "We are pleased to resolve the patent litigation with Takeda related to our pending ANDA for dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. This settlement allows TWi to bring a generic Dexilant® to the U.S. market many years prior to the last patent expiration date of Takeda's patent(s) while eliminating the uncertainties and inherent risk of patent litigation and avoiding the substantial cost of continued litigation. Furthermore, the license and supply of the Authorized Generic from Takeda allows TWi to be the supplier of both strengths of a generic Dexilant® in the U.S. market for a period of time, which provides significant sales and marketing advantage as well as furthering TWi's goal bringing affordable healthcare to patients," said Tina Guilder, President & CEO of TWi. The agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Dexilant® is indicated for healing of all grades of erosive esophagitis, maintaining healing of erosive esophagitis and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease. For the 12 months ended December 31, 2014, the product had total U.S. sales of approximately $1.0 Billion, according to IMS health data.