泰合 Ondansetron(化療止吐口溶)拚2017日本上市 VS US Zuplenz(R) ondansetron, Galena Biopharma

泰合藥化療止吐片 攻日 2015年08月28日 04:10 記者杜蕙蓉／台北報導 泰合生技（6467）宣布該公司開發癌症化療止吐藥品「TAH4411口溶膜」已向日本醫藥品醫療機器綜合機構（PMDA）遞送藥證申請，力拚2017年取證上市。若經核准，「TAH4411」將成日本第一個化療止吐口溶膜藥品，攻日本逾1.2億美元化療止吐片商機。泰合董事長李世仁表示，「TAH4411」與現行產品相比較，具有：1.快速溶解，迅速發揮療效。2.精緻薄膜，體積小。3.遮蔽藥物不良味覺。4.不需飲水，無嗆喉危險等優勢，在高齡化時代來臨中，極具競爭力，目前積極洽談授權中。據統計，2014年日本化療止吐市場即達1.2億美元，預計全球2018年化療止吐市場將達46億美金。泰合目前自主開發進度較快的三項藥品，適應症分別為化療止吐口溶膜、阿茲海默症及過動症貼片。除了TAH4411已申請日本藥證外，阿茲海默症貼片「TAH8801」已進入第一期臨床試驗中，該藥物全球市場2014年即達70億美金 。另外，過動症貼片「TAH9901」也已進入第一期臨床試驗中，預估過動症全球藥物市場2020年將達99億美金。(工商時報)

泰合生技：本公司研發癌症化療止吐口溶膜「TAH4411」產品，以Ondansetron OD Film製劑「TP」為名稱，向日本獨立行政法人醫藥品醫療機器總合機構(PMDA)遞送藥證申請。 鉅亨網新聞中心 2015-08-27 17:42:03第三十四條　第42款1.事實發生日:104/08/27 2.公司名稱:泰合生技藥品股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:本公司研發癌症化療止吐口溶膜「TAH4411」產品，以Ondansetron OD Film製劑「TP」為名稱，向日本獨立行政法人醫藥品醫療機器總合機構(PMDA)遞送藥證申請。6.因應措施:無。7.其他應敘明事項:(1).研發新藥名稱或代號:化療止吐口溶膜(TAH4411)。(2).用途:係以泰合自有透黏膜傳輸技術平台(Transmucosal),開發TAH4411口溶膜（Orally Dissolving Film, ODF)，是可快速分解溶於口腔中之新劑型，用於降低癌症化療噁心嘔吐的副作用，提升病患治療的生活品質。(3).預計進行之所有研發階段：(3.1).日本當地市場遞送藥證申請。(3.2).其他國家藥證將依當地法規規範進行後續研發及臨床試驗。(4).目前進行中之研發階段：(4.1).提出申請/通過核准/不通過核准：提出申請。(4.2).未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：若未通過，並不影響本公司其他藥品開發進度及佈局，本公司將依照未通過原因，補正資料。(4.3).已通過目的事業主管機關許可者，未來經營方向：目前尚在申請階段。(4.4).已投入之研發費用：不適用。(5).將再進行之下一階段研發：(5.1).預計完成時間：不適用。(5.2).預計應負擔之義務：不適用。(6).新藥開發時程長、投入經費高且未保證一定能成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。

Galena Biopharma, Inc. (NASDAQ: GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care.  Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial.  The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects.

Zuplenz® (ondansetron) Indications The only 5HT3 receptor antagonist indicated for the prevention of highly and moderately emetogenic cancer chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting.

Important Safety Information The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. ZUPLENZ® (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron. Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Avoid ZUPLENZ in patients with congenital long QT syndrome. Monitor ECG in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation. Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. The most common adverse drug events (≥5%) in chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting were: headache, malaise/fatigue, constipation, and diarrhea. The most common adverse event (≥5%) in postoperative nausea and vomiting was headache.

Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987, received a use patent June 1988, and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996. Finally, owing to GlaxoSmithKline's research on pediatric use, ondansetron's patent protection was extended until December 2006. By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US). The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.

Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987, received a use patent June 1988, and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996. Finally, owing to GlaxoSmithKline's research on pediatric use, ondansetron's patent protection was extended until December 2006.[17] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US). The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.

                          Ondansetron