第二代吸入式胰島素-美國Dance Pharmaceutical投資說明會

 

Dance Pharma 成立於2009,宗旨為研發生產第二代吸入式胰島素,以提供給糖尿病患者一個非侵入性,簡易使用,無痛且與針劑式胰島素相同或更容易控制血糖的療法。Dance Pharma執行長John Patton 博士在2006 年主導Nektar 公司第一代吸入式胰島素之研發,並在Pfizer 支持下獲FDA 通過在美國上市,也得到華爾街日報2006 年度醫療創新獎; 後來由於製造成本及價格關係而停止生產。

現在,藉由Patton 博士的經驗及其堅強的團隊,Dance Pharma 以先進的技術研發出能夠更加便宜生產,對於患者更便利的第二代吸入式胰島素, 由於可利用過去已核准的數據,Dance Pharma 的臨床實驗費用會大幅降低並縮短進入市場時程。根據Global Diabetes ( Lancet Goodarz 2011), 全球糖尿病人口在2030年會從現今的347百萬人增加至439百萬人, 因此這樣的市場潛力是相當可觀的。

Dance Pharma吸入式胰島素的競爭優勢如下:

  1. 所需第二期臨床實驗的時間短花費少: 因可使用Nektar當初所製造的Exubera而已公開實驗數據, 第二期臨床所需病例數少, 且只需做 dose calibration study。

  2. 胰島素用量少且穩定性高: 新的製程大幅降低所需胰島素用量, 並能夠在室溫下保存7-14天。

  3. 安全性高: 長達八年共118個人體試驗(總病例數超過1萬八千人) 結果顯示對肺部安全無虞。

  4. 生產費用低: 與吸入器研發公司Aerogen有合作協議而不需支付龐大的權利金, 加上與Sanofi已簽訂胰島素製造供應合約, 大幅降低製造成本, 因此未來每天病人使用Dance Pharma 吸入式胰島素的費用只需3~3.5美元, 這樣的費用與針劑胰島素相差無幾。

  5. 專利保護: 擁有多項美國及國際專利。

這次Dance Pharma來台募集第二期臨床試驗所需費用並尋找策略合作夥伴, 共同開發亞洲及全球市場, 以期早日提供給糖尿病患更先進更便利的治療方式。

Company Overview

Dance Pharma was founded by Dr. John Patton, founder of a biotechnology company called Inhale Therapeutics (later named Nektar), which developed Exubera®, the first (and only) approved inhaled insulin product that was marketed by Pfizer in 2006-2007. Expectations were that inhaled insulin would be a blockbuster product, reaching into the billions of US dollars in revenues. The product received the Wall Street Journal’s Medical Innovation of the year in 2006 and was front page news all over the world. Patient preference for inhaled insulin versus injected insulin was very high and validated in multiple clinical studies using independent measures of patient satisfaction. However, commercial issues, primarily high cost of goods, and the large size of the inhalation device, led Pfizer to shut down the program after less than 1 year of commercialization and take a large write-off on their investment.

Dance Pharmaceuticals has leveraged the experience of Dr. John Patton and many of the key developers of the first-generation products to resolve the issues that made the earlier product commercially infeasible. We are also leveraging the large 20-year safety and efficacy data base on inhaled insulin to quickly bring our first product to market through an abbreviated regulatory pathway. The company is combining the best established proprietary technologies to produce lower cost and more patient-friendly second-generation products. Dance’s first product, Dance01, will be the subject of a relatively short clinical development program, bridging to published data to achieve marketing approval.

Dance01 is designed specifically to overcome the commercial hurdles that limited the use of Exubera, without introducing new technical hurdles, and is expected to tap into the multi billion dollar market potential for inhaled insulin by delivering a cost effective product that is easy for patients to use and carry.

Dance Pharmaceuticals aims to initially develop Dance01 independent of a partnership with a large multinational pharmaceutical company in order to retain the value and direction of the product within Dance Pharmaceuticals and its shareholders. Capital will be raised via individual investors and regional partnerships to support development of the product. As the first product progresses towards an FDA/EMA filing, liquidity and additional capital will be achieved through either a major pharma alliance, venture debt, or through listing on NASDQ.


指導單位:經濟部工業局
主辦單位:經濟部生技醫藥產業發展推動小組 / 美國Dance Pharmaceuticals

日 期:101年5月10日(週四)14:00~16:00
地 點:台北市南港區園區街3號 (南港軟體工業園區F棟) 17樓A室
經濟部生技醫藥產業發展推動小組 會議室
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會議聯絡人:林紫嵐 (電話:02-26558133 ext.114)

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