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:
-
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。
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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。
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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。
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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。
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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.
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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
報名方式：網路報名
會議聯絡人：林紫嵐 (電話：02-26558133
ext.114)
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議 程 Agenda
- ＊ 主辦單位得視情況保留變更議程之權利 |
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時間 |
活
動
項
目 |
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14:00~14:10 |
報
到 |
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14:10~14:20 |
長官及貴賓致詞 |
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14:20~15:00 |
Dance
Pharmaceuticals產品及投資策略介紹 |
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15:00~16:00 |
Q＆A |
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