Tuesday, February 12, 2019

(FP-001 ,leuprorelin depot) 排除 美/中/日/台/以/土/中東市場: 逸達8600萬美元授權 Accord Healthcare (UK-based subsidiary of Indian biopharma company Intas Pharmaceuticals)


逸達新藥授權金逾25 2019-02-11 23:26經濟日報 記者黃文奇/台北報導 逸達生技(6576)昨(11)日宣布,與國際生物製藥公司 Accord Healthcare Ltd簽訂逸達研發之FP-001柳菩林前列腺癌新劑型新藥獨家授權經銷合約,總授權金額最高達8,600萬美元(約新台幣25.8億元)。逸達表示,此次授權合約,授權市場除美國、中國大陸、日本、台灣,以及稍早已簽訂經銷授權合約的以色列、土耳其及中東市場外,Accord將負責FP-001於其餘全球市場之產品銷售。依據本授權合約,逸達將獲得簽約金、產品開發里程金、銷售里程金等,總額最高達8,600萬美元之權利金收入,另在授權市場擁有可觀比例之產品銷售分潤,Accord將負責經銷市場所有商業化成本。逸達董事長簡銘達表示,Accord過去成功推動多項複雜的癌症及特殊用藥的審理與上市,在藥物經銷方面更擁有完整資源配置及堅強團隊。得力於 Accord 的商業平台,FP-001未來在這些市場的成功深具信心。Accord歐洲區執行副總裁James Burt說,Accord致力提供癌症患者高複雜度且具附加價值的產品,以此提升醫療照護品質進而改善病患生活。此次與逸達的合作,將為Accord豐富的癌症治療產品線更添一項關鍵療法。

逸達 發言日期 108/02/11 發言時間 17:33:37 發言人 鍾定安 發言人職稱 投資人關係資深專員 發言人電話 (02)77500188 主旨 逸達生技授權 Accord Healthcare Ltd. 經銷前列腺癌緩釋 針劑藥物 FP-001 符合條款  10 事實發生日 108/02/11 說明 1.事實發生日:108/02/11 2.契約或承諾相對人:Accord Healthcare Ltd. 3.與公司關係: 4.契約或承諾起迄日期(或解除日期):108/02/11 5.主要內容(解除者不適用):本公司與國際生物製藥公司Accord Healthcare Ltd. 簽訂 FP-001柳普林前列腺癌新劑型新藥獨家授權經銷合約,Accord Healthcare Ltd. 將獲得 FP-001除美國、中國大陸、日本、台灣市場及稍早已簽訂經銷授權合約之以色列、土耳 其及中東市場外其餘全球市場之產品開發銷售權利,並支付本公司簽約金、產品開發里 程金、銷售里程金,以及產品銷售分潤。 6.限制條款(解除者不適用):依合約規定。7.對公司財務、業務之影響(解除者不適用): (1)逸達將獲得簽約金、產品開發里程金、銷售里程金等最高達美金 8,600 萬元之權利 金收入,以及授權市場之產品銷售分潤。(2) 在符合本公司核心研發銷售領域及合理授權條件下,將新藥之特定市場行銷權授權予國外公司,可將資源有效運用並增進公司可使用資金以提升公司整體價值。8.具體目的(解除者不適用):協助本公司開發全球前列腺癌醫療市場並持續提升逸達在藥物研發行銷之國際影響力及能見度。9.其他應敘明事項新藥開發時程長、投入經費高且申請藥證之時程有其不確定性,此等可能使投資面臨風險,投資人應審慎判斷謹慎投資。

Foresee Pharma out-licenses FP-001 program 11-02-2019 Accord Healthcare, a UK-based subsidiary of Indian biopharma company Intas Pharmaceuticals, has been granted the rights to a novel FP-001 program (leuprorelin depot), leuprolide mesylate injectables (LMIS) ready-to-use subcutaneous depot formulations by Foresee Pharmaceutical (6576. TWO). Under the terms of this partnership, Foresee, a Taiwan and USA based biopharmaceutical company, will receive a combination of upfront, regulatory milestones and sales milestones payments totalling up to$ 86 million in addition to a significant share of the product revenue in the territory. Accord Healthcare will cover all costs of commercialisation in the territory. Despite the news, Foresee's shares fell 4.47% to 66.30 won by close of trading today. The license agreement will cover the global market with the exception of the USA, mainland China, Japan, Taiwan and previously partnered territories,Israel, Turkey and certain Middle East countries. Rights to the program for Turkey and the Middle East markets were granted to TRPharm in 2017. Dr Ben Chien, founder and executive chairman of Foresee, commented: "We are very pleased to have established this collaboration with Accord, whose established track record of successful registrations and launches of complex oncology and specialty products makes us confident that they will make our FP-001 portfolio a major success in their market. Accord has a remarkable commercial team and infrastructure in place and we are highly confident in their ability to successfully leverage their commercial platform." James Burt, executive vice president, Europe, said: "Accord is very committed to bringing complex, added value medicines to market, improving the standard of care and ultimately the lives of patients. This agreement will contribute another key therapy to our already extensive oncology franchise and our comprehensive footprint will ensure that patients and healthcare providers can access this differentiated cancer therapy. We look forward to a mutually beneficial, successful collaboration with Foresee."

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