實務座談(3)台灣生技新藥產業發展策略

生技新藥條例之後 : 台灣生技島的領航策略與優勢分析吳榮燦教授兼主任

新藥研究中心暨生物藥學研究所 國立陽明大學

ROBERT F. SERVICESurviving the Blockbuster Syndrome. Science 303:1796, 2004 New technologies have sent drug company R&D costs soaring, but with no corresponding rise as yet in the number of new drugs. Executives are talking about mergers, reorganization, and other ways to kick-start their production engines

Merck Announces Voluntary Worldwide Withdrawal of VIOXXR

WHITEHOUSE STATION, N.J., Sept. 30, 2004—Merck & Co., Inc. today announced a voluntary worldwide withdrawal of VIOXXR (rofecoxib), its arthritis and acute pain medication. The company’s decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo. The results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on VIOXX, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for VIOXX. VIOXX was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.

Simon FrantzPharma companies becoming more aggressive towards generics firms:Merck’s tactics with statin shows how brand companies are upping the ante to retain market shareNature Reviews Drug Discovery 5:619,2006.

The battle between brand and genericdrug companies is becoming morefevered, reflecting just how muchrevenue is at stake. Over the nextfew years, more than US$50 billiondollars-worth of drugs will facegeneric competition in the US alone.

Merck, the latest company toface patent expiration on one of itstop-selling drugs, has taken the mostaggressive action so far by targetingthe heart of the strategy that genericcompanies depend on for much oftheir profits.

Figure 3. Deal distributions. Optimal deal timing for a. pharma and b. biotech.

從生技新藥產業發展條例看國內推動 生技產業發展策略1.立法宗旨 : 爲發展我國生技新藥產業 , 成為帶動經濟 轉型的主力產業 .

2.生技新藥定義 : 人類用藥、高風險醫療器材、植物用 藥、動物用藥 .

3.核心架構 : 研發型知識經濟產業 .

4.發展主軸：產學合作與研究人員創業 . (?)

國際生技新藥產業的特性：多元化、多階段產品需求 .

國內過去經濟發展的特性 : 中小企業的多元化與機動性 .

國內過去高科技產業的發展 : 財富集中的 M 型社會 .

植物性產品發展的特性：多元化、多階段、邊際效益普及化 . 　植物性產品發展的階段：食品　　保健食品　　健康食品 　植物性新藥　　化學新藥　農民 農民　　　　研究人員　　研究人員　　　研究人員

南投縣埔里鎮農會輔導的有容金線蓮產銷班昨（ 13 ）日舉行台灣金線蓮保健功效原料純化萃取技術授權簽約儀式暨生技園區啟用典禮，見證農業轉型生技的發展與茁壯

有容生技公司 : 國家型農業生技研發應用計畫

國家型農業生技研發應用計畫

Title A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

Phase Phase II

Objective

The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis. The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.

FDAInvestigational New Drug (IND)

PH3 RESEARCH NUMBER : PH-CP011SPONSOR : PhytoHealth Corporation ( 懷特新藥公司 )RELEASE DATE : 09/07/2007 Approved: 14/10/2007

陽明大學產學合作計畫 : 屏東農業生技園區育種及企作

艾奎諾巡視菲律賓第一座椰子生化柴油廠 (2005/08/12 Asia Pulse Newscenter)

菲律賓總統艾奎諾視察這座耗資 11.7 百萬美元興建的椰子生化柴油廠，這項發展主要是因應高油價時代，並且希望藉這個機會運用當地資源製造替代性燃料，降低對進口油料的依賴，雖然目前椰子生化柴油的價格比傳統汽油稍高，但因為每公升的柴油可跑的公里數比汽油多，因此實際計算後其實比較划算。此次的興建計畫將分三期，預計到 2008年生產量可增加到每年 1 億 8 千萬噸，充滿商機。

醫藥級殘渣 : Bioethanol or 藥酒 ?廢耕農地 : 種電 ( 太陽能 ) ? 種油 (Biofuel)? 種酒 ( 藥酒 )?1000 家小型生質能源場不是夢 !!! (10 萬美金 ) X 1000 = ?

Our pharmaceuticals business started its operation in 1946 with the production of penicillin, and has contributed to the realization of today's long-lived society by providing various types of anti-infectious drugs. Over the last few years, we have expanded our product line with medicines for the central nervous system, winning Meiji Seika a respected presence in the neurology and infectious disease sectors. In these ways and more, Meiji Seika is steadily growing as a specialty pharmaceutical company.

The Pharmaceutical Division's R&D activities are focused on kidney diseases, cancer (including hematopoietic diseases), and immune-system/allergy-related diseases. In the field of kidney diseases, the division is committed to the development of KRN321, which is positioned as the second generation of the previously commercialized "ESPO" product. Using data supplied by Amgen, a U.S. company, the division aims to develop KRN321 as quickly as possible. Development is also underway of KRN1493, a drug for the treatment of secondary hyperparathyroidism. In the field of cancer, the division is committed to the development of TPO, an agent that increases the number of platelets and that has been successfully cloned by our company. In addition, development is underway of drugs such as KRN7000, which is expected to activate the immune system. In the field of immune-system/allergy-related diseases, the division's efforts include a joint study with the LIAI (La Jolla Institute for Allergy and Immunology) located in California, U.S.A. Recently, the division has focused on studies of human antibodies and cell-based therapeutic vaccine. Relying on its proprietary technology, the division successfully developed a mouse (the TC mouse) that carries human antibody genes.

我國生技製藥產業的瓶頸• 大學研究方向與產業界需求有相當落差。• 政府對企業的研發產業政策手段與國際有嚴重落差 ---

• 大學發展方向政府部會之間缺乏協調。 ( 教育部五年五百億與經濟部學界科專 ?)

• 具有國際生技產業經驗的科技和經理人才嚴重缺乏。• 生技製藥公司欠缺嚴謹投資評估機制。• 無法擺脫代工生產、短期獲利的心態。 • 生技製藥公司未能充分了解研發產業、知識經濟的本質。•電子及資訊等賺錢異業的投入十分欠缺。

中草藥傳統使用經驗的利基與優勢(1) 多標的多療效的特性，遠勝西藥老藥新用的機會(2) 臨床使用經驗長期累積，資訊可以比對分析(3) 使用經驗可以避開西方新藥開發面臨毒理副作用的瓶頸(4) 目標導向的開發，可以節省免除西方大量篩選的巨額成本(5) 中草藥的開發可以成為西方的未來藥，彌補西方藥物對於 慢性疾病治療的死角(6) 中草藥可作為單一成份新藥開發的寶貴資源 .

(7) 多元化多階段的開發，可以帶動綠色產業解決基層農民生計 .

立法院生技新藥發展條例之後 , 政府何去何從 ?1.走美國的路 ? MIT 自 1980 年以後 , 大學輔導教授成立四千家公司 , 這些公 司目前市值四千億美金 ( 徐小波 ).

2.走瑞士的路 ? Norvatis、 Roche 兩大跨國藥廠 .

3.走自己的路 --- 結合農業生技發展植物性產品 , 擴大邊際效益 .

國際化有容 --農家 --農場 --生技公司 -- 五百家 ( 三千萬 ) ( 一億餘 ) (五億 ) (營業額二千五百億 ) 懷特新藥公司 五十家 ( 二億二千萬 )(增資至九億六千萬 , 市值六十億 ) (市值三千億 )

政府配合生技新藥產業發展條例推動生技產業發展建議 :

1.以植物性產品為利基發展生技新藥產業 , 結合醫藥與農業生技 , 擴大邊際效益 , 來達成本條例的立法宗旨 , 發展我國生技新藥產業 , 成為帶動經濟轉型的主 力產業 , 同時也可以提供其他農業縣市農民的就業機會 , 達到均衡經濟發展 的國家目標 . ( 國家型藥用植物及綠色產業深耕計劃的推動 )

2.科技基本法回饋條例的修正及智慧財產財稅優惠相關法令的修正 . ( 跨部會專案辦公室委外推動 )

3.建構大學產學合作環境，落實大學領航發展知識經濟產業的使命 . a.五年五百億一流大學計劃應逐年將建構產學合作經費比例提升至百分之五十 ，徹底將大學教師由 SCI 的魔咒中解放 . b.落實國外大學育成中心的建構 , 鼓勵學者新創公司輔導措施 - MIT 為例 .

4.政府各部會輔導產業發展計劃的績效提升 . a.由審查制度轉型為輔導制度 - 大學評鑑中心為例 . b.跨領域專家委員的導入 . c.統一評審事權 ( 應以技審會為依歸 , 學界、法人、業界科專、主導性新產品 ?) d.大學及法人在生技新藥產業發展的定位、區隔 、合作關係的檢討 .