TG-2349獲准進行FDA一期臨床試驗
競逐需求強烈的C肝用藥市場
2011/12/08
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太景生物科技獲得奈諾沙星全球獨家權利
2011/12/08
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太景生技與Warner Chilcott簽署奈諾沙星授權協議
2010/10/14
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TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing in Diabetic Foot Infection Met Primary Endpoints
2010/03/12
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TaiGen Biotechnology Reports Phase I and Preclinical Data for TG-0054 at the 2009 American Society of Hematology (ASH) Annual Meeting
2009/12/07
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Excellent Stem Cell Mobilization and Safety Profile for TG-0054
2009/09/28
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TaiGen Biotechnology Secures 37 Million USD in Series C Round Financing
2009/01/20
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TaiGen Announces Presentation of Nemonoxacin at the Joint Meeting of ICAAC/IDSA
2008/10/20
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TaiGen Announces Positive Data From the Phase II Study of Nemonoxacin (TG-873870) in Community-Acquired Pneumonia
2008/04/07
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TaiGen Initiates Phase I Trial of the Stem Cell Mobilizer TG-0054
2008/04/07
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TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
2007/08/10
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TaiGen Biotechnology Announces Election of New Chairman
207/06/04
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TaiGen's CEO Delivers a Keynote Speech at the 6th Annual China Pharmaceutical and Healthcare Industry Summit
2007/04/12
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TaiGen Biotechnology Initiates Phase II Trial Of Nemonoxacin For Treatment Of Adult Community Acquired Pneumonia (CAP)
2007/01/08
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TaiGen Biotechnology Announces Appointment of William Keller as a Member of the Board of Directors
2006/02/10
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TaiGen Receives NT$116.6 Million MOEA grant for Developing new drugs
2005/11/18
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TaiGen Initiates Phase 1B Trial of a Novel Quinolone Antibiotic
2005/06/16
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TaiGen Biotechnology Announces Strategic Agreement with Procter & Gamble
2005/01/06
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TaiGen Biotechnology Announces Appointment of Senior Vice President of Business Development Stephen H. Ip, PhD
2004/07/19
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TaiGen Announces Appointment of Chief Financial Officer John Cheng.
2004/03/18
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TaiGen Raises $38 Million in Its First Closing of Series B Financing.
2004/03/16
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TaiGen Received Funding for Anti-SARS Drug Discovery and Development From The Executive Yuan, Republic of China.
2003/10/22
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TaiGen and TTY Biopharm Jointly Develop and Commercialize a Novel Topoiso-merase I Inhibitor DB67 for Cancer Treatment.
2003/10/20
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TaiGen Biotechnology Forms New Scientific Advisory Board.
2003/05/22
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TG-2349獲准進行FDA一期臨床試驗
競逐需求強烈的C肝用藥市場
【2011年12月08日】太景生物科技宣布，其研發之抗C型肝炎病毒新藥TG-2349 ，獲得美國FDA IND後，已順利啟動一期臨床試驗。TG-2349具有高活性、一天僅需口服一次之競爭優勢。目前全球C肝患者高達一億八千萬人，但仍未有理想藥物，TG-2349將是此一需求強烈市場的有力競爭者。
可望成為同級藥物中最優
太景生物科技指出，TG-2349與已上市及開發中的同型藥物相較下,在不同基因型的C型肝炎病毒都顯示優越的病毒消減力，而且每天僅需口服一次，相較現行核准上市同類藥物，不但用藥較為簡單，且毒性低，具有「Best in Class」的競爭潛力。
太景過去一年已延伸目前抗C肝病毒藥物的成果，研發不需搭配干擾素與Ribavirin使用的藥物，未來可與TG-2349搭配，來取代讓醫生與病人最困擾的干擾素，讓病人免除治療上幾乎無法忍受的副作用。
已在美國進行第一期臨床試驗
TG-2349為抗C型肝炎NS3/4A蛋白脢酵素抑制劑，在今年四月底向美國FDA申請IND（Investigational New Drug）。在送件後30天內，即獲得美國食品藥物管理局（FDA）無異議核准進行Phase I/IIa臨床試驗。目前已經在美國進行健康受試者的體臨床試驗。
為太景第二個獲得FDA IND的小分子創新藥物
這是太景繼幹細胞驅動劑「倍力沙福」(Burixafor)新药後，第二個自行研發獲准進入美國FDA臨床試驗的新藥。「倍力沙福」也正在進行人體臨床二期試驗中。太景產品線中另外一個藥物「奈諾沙星在大中華區的三期口服劑型臨床試驗預計明年底完成。
根據統計，目前全球共有一億八千萬C肝病人，中國就佔其中的近四分之一，市場需求強烈。目前已經有兩個C型肝炎病毒NS3/4A蛋白酶抑製劑，包括 Vertex Pharmaceuticals的Incivek和默克藥廠的Victrelis， 各在2011年5月獲得美國 FDA批准上市，這兩個藥都是需要搭配干擾素、Ribavirin的C型肝炎雞尾酒療法。
既有新藥有很大的改善空間
然而，上述兩種藥物，每個病人必須每8小時吃一次，每天必須服用2.4公克大量的藥物，而且必須和干擾素及Ribavirin同時使用，因此干擾素的副作用，仍然存在，常常讓病人無法完成整個療程。且上述兩種藥物整個療程長達半年，費用高達八萬五千美元。
初步試驗結果令人振奮
與目前已上市以及開發中的同型药物相較，根據在健康受試者的初步臨床數據及藥物濃度推算，TG-2349服用50毫克一天（約為前例兩種新藥五十分之一的劑量），就可以降低90％以上的病毒量，而且無副作用或毒性。依據臨床前GLP動物毒理試驗，TG-2349在人體可安全服用到800毫克。現在看來，TG-2349具有在同類藥品中，脫穎而出的潛力。
在目前Phase I/IIa臨床試驗是以隨機採樣、雙盲、加上安慰劑對照組，以逐漸增高口服劑量方式，在東方人與白種人各半的健康受試者進行評估藥物的安全性、耐受性、血中藥物濃度及藥物動力學特徵; 完成健康受試者試驗後，將在台灣的C型肝炎患者初步評估其藥效。
延伸C肝產品線搶攻市場
太景董事長暨執行長許明珠博士表示：「我們很與奮在太景臨床試驗產品線上加上第二個完全在國內所研發的創新藥物，初步觀察與預期效果一致。除了既有的以TG-2349搭配干擾素與Ribavirin的療法以外，太景更計畫將研發中的C型肝炎複製酶抑制劑，取代干擾素與Ribavrin，與TG-2349合併使用，期望太景對國內、亞洲及世界其他地區的C肝病人帶來福音」。
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太景生物科技獲得奈諾沙星全球獨家權利
【2011年12月08日台北訊】太景生物科技8日宣布，Warner Chilcott藥廠將移轉其持有的新一代抗生素奈諾沙星（Nemonoxacin）權利給予太景生物科技。換句話說，太景將獲得奈諾沙星的全球獨家權利，包括後續的臨床研發、製造、商品化，以及再授權等。
奈諾沙星是一個全新非氟奎諾酮抗生素，太景已經在美國、台灣與南非完成社區型肺炎與糖尿病足美國FDA的二期人體試驗，證實可以消滅具有強大抗藥性的金黃色葡萄球菌（MRSA）等抗藥性細菌。目前太景正在台灣與中國進行第三期人體臨床試驗。
FDA改變CAP臨床試驗的設計準則
美國食品與藥物管制局（FDA）發佈的新版抗生素臨床試驗指導方針草案 ，針對社區型肺炎(CAP)進行的臨床試驗，規定受試者在受試前必須沒有接受其他抗生素治療。然而在實務診斷上，通常醫生會馬上對肺炎給藥。因此，此一新規定增加臨床試驗病人入組的困難度。尤其依美國FDA申請新藥藥證的規定，CAP需要兩個主要大型三期臨床試驗，入組病人可能高達兩千人之譜。
太景無償取得奈諾沙星全球獨家專利
在上述考量下，Warner Chilcott決定不啟動社區性肺炎的三期臨床試驗，並於2011年12月1日通知太景，依合約將奈諾沙星歐美日專利、研發、製造、銷售及再授權的權利無償移轉給太景；太景亦無須自未來收入中支付任何授權金或權利金予Warner Chilcott。因此，太景將取得奈諾沙星的全球獨家權利。
奈諾沙星是太景從寶鹼製藥(P&G Pharmaceuticals) 取得授權，依照授權合約，太景擁有中國、台灣共亞洲十國專屬開發、銷售及製造權，在完成社區型肺炎及糖尿病足二期臨床試驗後，在2010年由併購P&G Pharmaceuticals的Warner Chilcott向太景提出條件取得歐、美及日本權利。
太景將受惠全球獨家的權利
太景董事長及執行長許明珠博士表示：「美國針對社區型肺炎(CAP) 所公佈新的
臨床指導方針草案，使得業界開發此類的抗生素難度加高。然而，我們在世界其他國家並沒有看到類似的限制；相反的，最近歐盟及中國由於抗藥性金黃葡萄球菌(MRSA) 感染率持續升高，公佈了鼓勵發展抗生素政策以加速審查來縮短新藥上巿時程。」
價值可望在大中華區臨床三期完成後更為提昇
許博士進一步指出，「依照目前奈諾沙星在中國及台灣的開發進度，太景預定會在2012年，在台灣與中國完成口服劑型臨床三期人體試驗，並啟動針劑臨床二期試驗。大中華區臨床結果的公佈，將更提昇奈諾沙星全球巿場的價值。太景已開始積極計劃與國際藥廠接觸，洽談授權大中華區以外國家的權利。」
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太景生技與Warner Chilcott簽署奈諾沙星授權協議
【2010年10月14日台北訊】太景生技今（14）日宣布，已經與國際知名藥廠Warner Chilcott簽署抗生素新藥奈諾沙星（Nemonoxacin）開發及銷售授權協議。Warner Chilcott，將在歐美地區進行三期奈諾沙星的人體臨床試驗，並在上述地區取得上市核可後，進行製造與銷售。而亞洲區的授權，太景亦正與其他國際大型藥廠緊鑼密鼓洽談中。
對社區性肺炎及糖尿病足療效佳且有效消減MRSA及其它各種抗藥性細菌
太景生技指出，該公司是於2005年，從寶鹼公司(P＆G)製藥部門取得奈諾沙星的授權，接手後完成臨床一期重複給藥試驗，接著完成美國FDA核准的二個適應症，社區性肺炎與糖尿病病足感染臨床人體二期試驗。
試驗結果證明，奈諾沙星不僅對社區型肺炎與糖尿病足感染（DFI）有極佳療效，且安全性佳，也可用來治療抗藥性強、治療十分棘手的黃金葡萄球菌(MRSA) 。試驗報告出爐後，受到國際知名藥廠青睞，紛紛要求洽談授權。
此一授權協議，可望為太景帶來可觀的短、中、長期收入
根據太景生技與Warner Chilcott簽訂的合約，Warner Chilcott在簽約同時，需支付給太景生技簽約金（upfront fee），並依照人體試驗進度支付太景生技里程碑 (milestones)，待完成取得新藥核可上市後，每年支付銷售權利金（royalty）及達到銷售里程碑款(sales threadhold)。
因雙方簽訂保密協定，無法透露具體的簽約金金額與後續里程碑及權利金。
根據國際知名醫藥市場策略及資料分析公司IMS估計，奈諾沙星的最高年銷售額可達12億美元。
此一授權案證明，太景之研發品質獲得歐美藥廠認可
Warner Chilcott於2009年10月，以31億美元併購了寶鹼的製藥部門，主要產品線為婦女與皮膚用藥，在美國納斯達克掛牌上市（代號:WCRX）。
其新上任之研發總經理 Mahdi Fawzi以及其研發團隊，具有強力的抗生素的研發能力，亦有豐富的產品開發經驗。目前該公司即有兩個抗生素類藥品， 其中屬四環素類的廣譜抗菌藥Doryx，2010年第二季的銷售超過5000萬美元。預料奈諾沙星將可填補其現有藥物專利權到期後的營收缺口，且證明太景之研發能力深獲肯定。
歐美以外地區包括中國、台灣、南韓、香港與亞洲地區國家授權刻正洽談中
太景生技指出，除了與Warner Chilcott達成歐美國家地區的產品開發及銷售權利協議外，奈諾沙星在亞洲地區的銷售權，目前仍在緊鑼密鼓洽談中。基於保密協議，目前不便透露。
奈諾沙星將在2012年底在台灣與中國申請上市許可
由於中國抗藥性問題嚴重，且為全球成長最快的藥品市場，已在2005年在中國設立分公司的太景生技，以高規格中國1.1類新藥作為在中國開發奈諾沙星的策略，將在今（2010）年年末，在台灣與中國兩地進行第三期人體試驗。若實驗結果良好，預計在2012年底在台灣與中國兩地申請新藥上市許可。
若成功上市，奈諾沙星國際授權之授權收入將為原始授權成本百倍以上
太景生物科技執行長許明珠表示：「奈諾沙星授權Warner Chilcott所獲得的簽約金收入，約為太景當初付給P＆G製藥部門權利金的10倍之譜，投資報酬率明顯高於國際同類型授權的7~8倍。若計入未來里程碑款及銷售權利金及亞洲地區的授權收入，將是原始授權成本的百倍以上，這成功印證了太景同時採取自行研發及開發引進授權的商業模式是正確的。」
此一授權案，證明太景以研發為核心產品為導向的策略奏效
許明珠進一步指出：「引進具有世界專利保護的奈諾沙星，除了為太景帶來了近期的獲利，商品化後的後續收入更將帶來長期穩定的收入，讓公司得以持續投入研發，證明太景一路走來堅持以研發為核心，以產品為導向的獲利模式可行。
目前太景生物科技自行研發的新藥，包括正在進行美國FDA核准的二期臨床試驗的幹細胞驅動藥物TG-0054，還有預定在今（2010）年底申請美國IND之後，明年初進入一期臨床試驗的C型肝炎藥TG-2349，預料也將為太景生技增添獲利來源。這不但說明在台灣進行新藥研發是一條可行的道路。更是台灣的優秀的研發人才的努力成果獲得國際認可的明證。」
關於太景生物科技
太景生物科技股份有限公司創立於2001年，是以研究為主、產品導向的醫藥公司，致力於開發與傳染病、癌症及糖尿病的併發症有關的新療法。
太景生技的業務策略充分發揮經營團隊在世界首創新藥的發現、開發、全球法規，以及使研發結果在中國商品化的專長，全心打造出全方位整合的醫藥公司。太景生技經營團隊網羅了全球生技與醫藥界的跨國資深經營者，這項獨特的優勢，讓太景生技團隊能夠結合其豐富內部研究及授權引進並進，針對尚無有效藥物的症病，研發出世界首創或最佳的新藥。
太景生技總公司位於台灣台北，包含89名工作人員，其中包括了70位研發人員，並且於北京分公司進行「1.1類新藥」臨床試驗與註冊。
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TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing in Diabetic Foot Infection Met Primary Endpoints
Promising Anti-MRSA Activity and Excellent Pharmacokinetic Profile Demonstrated in a Phase II Proof of Concept trial
TAIPEI, Taiwan, March 12 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. announced today the Phase II trial of nemonoxacin (TG-873870) in Diabetic Foot Infection (DFI) with once-a-day dosing met the primary endpoints and showed promising clinical efficacy and good tolerability. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Importantly, nemonoxacin possesses activities against Methicillin-Resistant Staphylococcus aureus (MRSA) and vancomycin-resistant pathogens. This single arm, proof-of-concept study was conducted in US, South Africa, Thailand and Taiwan in mild to moderate DFI patients who were treated with nemonoxacin 750mg once daily for one or two weeks. Nemonoxacin showed higher clinical and microbiology success rates compared with previous DFI trials. Among the 40 enrolled patients, there were four MRSA-infected patients, including one patient with quinolone-resistant MRSA, who were clinically successful treated. Nemonoxacin also demonstrated excellent pharmacokinetic profile in tissue penetration and relatively low drug-drug interactions in this group of patients who received multiple medications concomitantly for other disease conditions.
"In addition to the top-line efficacy and safety data from our early phase 2 Community-Acquired Pneumonia (CAP) trial, we are very encouraged by the DFI data. With the clinically proven superior anti-MRSA activity and efficacy in DFI patients - a very difficult-to-treat patient population, we believe nemonoxacin is not only the best in class quinolone drug, but also the first in class anti-MRSA quinolone drug with excellent safety profile. Increasing prevalence of Community-acquired MRSA infection has become a highly unmet medical need with limited alternative treatment options. Nemonoxacin represents a promise to the cure that TaiGen will deliver with great hope," commented Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company has a full capacity in discovery research and clinical development in China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market. Nemonoxacin, a novel broad-spectrum non-fluorinated quinolone with anti-MRSA activity and in- licensed from P&G Pharmaceuticals, achieved non-inferiority in clinical cure rate and safety profile compared with Levofloxacin in its Phase II CAP trial. TaiGen is seeking Nemonoxacin licensees for the US, EU and Japan markets.
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TaiGen Biotechnology Reports Phase I and Preclinical Data for TG-0054 at the 2009 American Society of Hematology (ASH) Annual Meeting
TAIPEI, Taiwan, Dec. 7 /PRNewswire-Asia/ -- TaiGen Biotechnology Co.,
Ltd. announced today the presentation of Phase I and preclinical data for
TG-0054, the Company's chemokine receptor CXCR4 antagonist and a novel,
potent stem cell mobilizer, at the ASH Annual Meeting held in New Orleans,
the US, from December 5 to 8, 2009.
The clinical data of Phase 1 study will be presented. In this
randomized, double-blind, placebo-controlled, sequential ascending single
intravenous dose study, TG-0054 exhibited excellent and favorable safety,
tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profile. A
maximally tolerated dose (MTD) was established. Good tolerability was
observed. PK parameters showed dose proportionality over the dose range
studied. PD results showed potent, dose-dependent mobilization of CD34+
hematopoietic stem cells and CD133+ endothelial progenitor cells into
peripheral blood circulation.
The preclinical data will be reported on in vitro assays and in vivo
studies in mouse models. TG-0054 demonstrated potent and selective
antagonistic activities against CXCR4 in vitro. Significant mobilization of
CD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells was
observed when TG-0054 was used alone or combined with G-CSF in preclinical
models.
The preclinical and Phase I results support further clinical
investigation. The Phase 2 study entitled "A Phase II, Randomized,
Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics,
and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients with
Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease" will begin to
enroll patients in December, 2009.
ASH 2009 Meeting Presentation:
Clinical
Oral presentation: TG-0054, a Novel and Potent Stem Cell Mobilizer,
Displays Excellent PK/PD and Safety Profile in Phase 1
Trial
Tuesday, December 8, 2009: 7:30 AM-9:00 AM
Preclinical
Poster: Rapid Mobilization of Murine Hematopoietic Stem and Progenitor
Cells with TG-0054, a Novel CXCR4 Antagonist (Poster Board
number: III-479)
Monday, December 7, 2009: 6:00 PM-8:00 PM
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com/) is a leading
development stage pharmaceutical company based in Taiwan with a
wholly-owned subsidiary in Beijing, China. The company has a full capacity
in discovery research and clinical development in China/Taiwan/US. Its
current pipeline includes therapeutics for infectious diseases, diabetic
complications and cancer for the worldwide market. In addition to TG-0054,
Nemonoxacin, a novel broad-spectrum non-fluorinated quinolone with
anti-MRSA activity and in-licensed from P&G Pharmaceuticals, achieved
non-inferiority in clinical cure rate and safety profile compared with
Levofloxacin in its Phase II CAP trial. The company has completed a second
phase II study in diabetic foot infection to demonstrate Nemonoxacin's
anti-MRSA activity with once-a-day oral dosing. TaiGen is seeking
Nemonoxacin licensees for the US, EU and Japan markets. TaiGen also has HCV
protease inhibitors in advanced preclinical programs to treat chronic
hepatitis C infection.
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Excellent Stem Cell Mobilization and Safety Profile for TG-0054
TAIPEI, Taiwan, Sept. 28 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. announced today that in a phase 1 study in healthy volunteers TG-0054, a chemokine receptor CXCR4 antagonist, was well tolerated and rapidly mobilized stem cells and endothelial progenitor cells from bone marrow into peripheral blood. The number of CD34+ stem cells in circulation after one dose of TG-0054 was equal or higher than reported cell numbers needed for stem cell transplantation in cancer patients. The observed AEs were all mild and transient. A phase 2 study in stem cell transplantation for multiple myeloma, non-Hodgkin lymphoma and Hodgkin disease patients is currently being initiated.
The trial was a randomized, double-blind, placebo-controlled, single intravenous dose study including 64 healthy volunteers in US, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TG-0054 in 8 cohorts. The mobilized stem and progenitor cells peaked at 4-6 hours following one single intravenous dose.
"We are greatly encouraged by the phase 1 study results which indicates that TG-0054 has the potential to be used alone, not in combination with G- CSF, for allogenic or autologous stem cell transplantation in cancer patients. This should greatly reduce the hospital and other associated cost for such a procedure. Importantly, the activity and safety profile in the phase 1 study will support our future development of TG-0054 in chemosensitization and tissue ischemia, including myocardial infarction, stroke and severe intermittent claudication. Our preclinical animal disease models and the phase 1 study results lend strong support to clinical development for these clinical indications," said Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com/) is a leading
development stage pharmaceutical company based in Taiwan with a
wholly-owned subsidiary in Beijing, China. The company has a full capacity
in discovery research and clinical development in China/Taiwan/US. Its
current pipeline includes therapeutics for infectious diseases, diabetic
complications and cancer for the worldwide market. In addition to TG-0054,
Nemonoxacin, a novel broad-spectrum non-fluorinated quinolone with
anti-MRSA activity and in-licensed from P&G Pharmaceuticals, achieved
non-inferiority in clinical cure rate and safety profile compared with
Levofloxacin in its Phase II CAP trial. The company has completed a second
phase II study in diabetic foot infection to demonstrate Nemonoxacin's
anti-MRSA activity with once-a-day oral dosing. TaiGen is seeking
Nemonoxacin licensees for the US, EU and Japan markets. TaiGen also has HCV
protease inhibitors in advanced preclinical programs to treat chronic
hepatitis C infection.
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TaiGen Biotechnology Secures 37 Million USD in Series C Round Financing
TAIPEI, Taiwan, Jan. 20 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd., a privately-held pharmaceutical company focused on developing drugs to treat infectious diseases, cancer and diabetes-related complications, announced that it has raised 37 million USD through the private placement of preferred C stock from its existing shareholders and new investors, including MPM Capital, National Development Fund, YFY group, Taiwan Sugar Corporation, Yao-Hwa Glass Management Commission and Taiwan Global BioFund. This new round of financing was completed through TaiGen Biopharmaceuticals Holdings Limited (Cayman), the parent company of TaiGen Biotechnology Co., Ltd. The proceeds are to be used primarily for advancing its global clinical development of Nemonoxacin in MRSA infections, its first-in-class stem cell mobilizer, TG-0054, in stem cell transplant, chemosensitization and tissue ischemia, and its hepatitis C protease inhibitor program. Dr. Ming-Chu Hsu, President & CEO said, "We are very pleased to have completed this round of financing. Being able to raise funds in the current challenging financial market is a strong validation of the value of our research programs and the significant progress we made in the past few years in our clinical development programs. The additional capital will allow us to continue building a robust and innovative product pipeline. This round of financing will greatly expedite our growth."
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TaiGen Announces Presentation of Nemonoxacin at the Joint Meeting of ICAAC/IDSA
TAIPEI, Taiwan--(BUSINESS WIRE)--Taipei, Taiwan ¡VOctober 20 2008 ¡V TaiGen Biotechnology Co., Ltd. today announced a total of 11 posters on its investigational drug nemonoxacin will be presented at the joint 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) / 46th Annual Meeting of Infectious Diseases Society of America (IDSA) to be held in Washington, D.C. from October 25-28, 2008.
Nemonoxacin, a non-fluorinated quinolone, has an exceptional activity against MRSA (Methicilin-Resistant Staphylococcus aureus). Particular activity was demonstrated toward community-acquired MRSA, an emerging concern of the public health. The drug has an excellent activity toward vancomycin-intermediate or resistant Staphylococcus aureus. In a comparative in vitro study with other quinolones in clinical use, nemonoxacin is less prone to the development of resistance and is active against quinolone-resistant clinical strains.
The top-rated phase 2 data of a randomized double-blind trial in comparison to levofloxacin will be reported. Nemonoxacin met the primary endpoints of non-inferiority to levofloxacin in both cure rate and safety. Patient enrollment for the second phase 2 trial of diabetic foot infection (DFI) is on-going to demonstrate the anti-MRSA activity with oral administration of nemonoxacin.
Clinical
Saturday, October 25, 12:15 pm - 1:15 pm
Poster Session # 44: The World of Community-Acquired Pneumonia
Presentation # L678: Efficacy and Safety of Nemonoxacin versus Levofloxacin for the Treatment of Community-Acquired Pneumonia
Microbiological
Saturday, October 25, 12:15 pm - 1:15 pm
Poster Session # 12: Staphylococcus aureus: MRSA and More
Presentation # C1-189: Comparative Antistaphylococcal activity of Nemonoxacin, a Novel Broad-spectrum Quinolone
Saturday, October 25, 12:15 pm - 1.:15 pm
Poster Session # 16: Resistance in Streptococcus pneumoniae
Presentation # C2-254: In Vitro Activity of Nemonoxacin (TG-873870), a Novel Non-Fluorinated Quinolone, against Clinical Isolates of Streptococcus pneumoniae in Taiwan
Monday, October 27, 11:15 a.m. - 12:15 p.m
Poster Session # 189. Quinolones
Presentation # C1-1957: Activity of Nemonoxacin, an Investigational C8-methoxy Non-fluorinated Quinolone, Against Gram-Negative Bacilli Obtained From Canadian Hospitals: CANWARD 2007
Monday, Oct 27, 2008, 11:15 a.m. -12:15 p.m.
Poster Session # 190: Respiratory, Skin, and Genital Infections
Presentation # C1-1971: In Vitro Resistance Development to Nemonoxacin for Streptococcus pneumoniae
Monday, October 27, 11:15 a.m. - 12:15 p.m
Poster Session # 195. New Topoisomerase Inhibitors
Presentation # F1-2057: Activity of Nemonoxacin, an Investigational C8-methoxy Non-fluorinated Quinolone Against Gram-Positive Cocci Obtained From Canadian Hospitals: CANWARD 2007
Tuesday, Oct 28, 2008, 11:15 a.m. -12:15 p.m.
Poster Session # 286: Surveys of Susceptibility Testing and Resistance
Presentation # C2-3931: In Vitro Activity of Nemonoxacin against Helicobacter pylori
In vivo Efficacy Model
Saturday, Oct 25, 2008, 12:15 p.m. - 1:15 p.m.
Poster Session # 6: Therapy of Bacterial Infections in Animal Models
Presentation # B-056: In Vivo Efficacy of Nemonoxacin in a Mouse Pulmonary Infection Model
Sunday, Oct 26, 2008, 11:15 a.m. -12:15 p.m.
Poster Session #93: Antistaphylococcal Therapy Testing in Animal Models
Presentation # B-1005: In Vivo Efficacy of Nemonoxacin in a Mouse Protection Model
Safety Assessment
Monday, Oct 27, 2008, 11:15 a.m. -12:15 p.m.
Poster Session # 195: New Topoisomerase Inhibitors
Presentation # F1-2055: Systemic Hypersensitivity Test of Nemonoxacin, a Novel Potent Broad-Spectrum Non-Fluorinated Quinolone, in Guinea Pigs
Monday, Oct 27, 2008, 11:15 a.m. -12:15 p.m.
Poster Session # 195: New Topoisomerase Inhibitors
Presentation # F1-2056: Fertility and Early Embryonic Developmental Toxicity of Nemonoxacin after Oral Administration to Rats
These data and their reception by the conference program committee highlight the potential of nemonoxacin to become a potent novel drug to treat some of the most threatening multi-drug resistant bacteria infection.
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com/) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. The company's in-house R&D has developed first-in-class drug candidates and the first such drug, TG-0054, is currently in phase 1 trial in the US. TaiGen plans to develop TG-0054 for stem cell transplantation, critical limb ischemia and age-related macular degeneration. Nemonoxacin, a broad-spectrum non-fluorinated quinolone achieved the non-inferiority clinical cure rate compared with levofloxacin and two drugs have comparable safety profile in the phase II trial. Patient enrollment for the second phase II trial in nemonoxacin with diabetic foot infection (DFI) will soon initiate to demonstrate anti-MRSA activity with oral administration of nemonoxacin.
TaiGen plans to commercialize the nemonoxacin in greater China and ASEAN countries. The company will out-license nemonoxacin for the US/EU/Japan market with P&G Pharmaceuticals. The "First-class New Drug" trials in China are on-going and product projected to launch in 2011. TaiGen has advanced programs in preclinical development for chronic hepatitis C infection (target at the viral protease) and solid tumors.
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TaiGen Announces Positive Data From the Phase II Study of Nemonoxacin (TG-873870) in Community-Acquired Pneumonia
TAIPEI, Taiwan--(BUSINESS WIRE)--TaiGen Biotechnology Co., Ltd. announced today that the nemonoxacin phase II top-line data in community-acquired pneumonia (CAP) met the primary endpoint of non-inferiority versus levofloxacin, the leading quinolone on the market. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Importantly, nemonoxacin possesses the first-in-class activity against MRSA (both hospital- and community-acquired) and vancomycin-resistant pathogens.
The multinational Phase II clinical trial, with an enrollment of 265 patients in three arms, showed nemonoxacin 750 mg once daily in an oral dose over a period of seven days achieved non-inferiority in clinical cure rate of CAP compared with levofloxacin 500 mg once daily in this double-blinded study.
Overall, 82.6% of the intent-to-treat population and 90% of the evaluable population were cured with nemonoxacin compared with 80.0% and 91% cure rate in the levofloxacin arm.
Nemonoxacin demonstrated safety results that were similar to those seen with levofloxacin and were consistent with the favorable safety profile observed with nemonoxacin in earlier phase 1a and phase 1b trials.
¡§We are very encouraged by this top-line data of the first phase II study of nemonoxacin. With the superior activity against MRSA and vancomycin-resistant pathogens coupled with the cure rate and safety profile seen in CAP patients, this novel antibacterial has the potential to become the first and best in the quinolone class. TaiGen's second phase II trial in diabetes-foot infection is designed to demonstrate nemonoxacin's anti-MRSA activity with oral dosing. A once-a-day IV dosing is scheduled to enter clinical trial 2Q 2008,¡¨ commented Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.
About TaiGen Biotechnology
TaiGen Biotechnology (
http://www.taigenbiotech.com) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. The company's in-house R&D has developed first-in-class drug candidates and the first such drug, TG-0054, is currently in phase 1 trial in the US. TaiGen plans to develop TG-0054 for stem cell transplantation, critical limb ischemia and age-related macular degeneration. TaiGen in-licensed nemonoxacin, a novel broad-spectrum antibacterial with anti-MRSA activity, from P&G Pharmaceuticals. The company also announced today the top-line result of the first phase II study of nemonoxacin in community-acquired pneumonia. Nemonoxacin achieved the non-inferiority clinical cure rate compared with levofloxacin and two drugs have comparable safety profile in the phase II trial. P&G and TaiGen are seeking nemonoxacin licensees or co-development partners for the US, EU and Japan market. TaiGen has advanced programs in preclinical development for chronic hepatitis C infection (target at the viral protease) and solid tumors.
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TaiGen Initiates Phase I Trial of the Stem Cell Mobilizer TG-0054
TAIPEI, Taiwan--(BUSINESS WIRE)--TaiGen Biotechnology Co., Ltd. announced today the enrollment for the TG-0054 phase I trial under an IND from the US FDA. TG-0054 is a potent and selective inhibitor for the binding of the chemokine cell-surface receptor CXCR4 to its ligand SDF-1 and efficiently mobilizes stem cells (CD34+) and endothelial progenitor cells (CD133+) from bone marrow into peripheral circulation in a mouse model. TG-0054 will initially be developed for the indication of stem cell transplantation in cancer patients.
The randomized, double-blinded, placebo-controlled, sequential ascending single intravenous dose study of TG-0054 will evaluate the safety, tolerability, pharmacokinetics and the biomarkers, the CD34+ stem cells and the CD133+ progenitor cells in peripheral circulation, in healthy subjects. Results from this study are expected in 4Q 2008.
¡§We are very pleased to have an exciting addition to our clinical pipeline. In addition to stem cell transplantation, TaiGen is prepared to develop TG-0054 as the first-in-class therapy for age-related macular degeneration and critical limb ischemia,¡¨ stated Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen. ¡§This is the first of a series of in-house derived drug candidates that TaiGen plans to take into clinical development in the next 1-2 years.¡¨
About TaiGen Biotechnology
TaiGen Biotechnology (www.taigenbiotech.com/) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. The company's in-house R&D has developed first-in-class drug candidates and the first such drug, TG-0054, is currently in phase 1 trial in the US. TaiGen plans to develop TG-0054 for stem cell transplantation, critical limb ischemia and age-related macular degeneration. TaiGen in-licensed nemonoxacin, a novel broad-spectrum antibacterial with anti-MRSA activity, from P&G Pharmaceuticals. The company also announced today the top-line result of the first phase II study of nemonoxacin in community-acquired pneumonia. Nemonoxacin achieved the non-inferiority clinical curate compared with levofloxacin and two drugs have comparable safety profile in the phase II trial. P&G and TaiGen are seeking nemonoxacin licensees or co-development partners for the US, EU and Japan market. TaiGen has advanced programs in preclinical development for chronic hepatitis C infection (target at the viral protease) and solid tumors.
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TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
TAIPEI, Taiwan, Aug. 10 /Xinhua-PRNewswire/ -- TaiGen Biotechnology Inc. announces the successful completion of patient recruitment for the global double-blind Phase II clinical trial of Nemonoxacin (TG-873870) for the treatment of adult community-acquired pneumonia (CAP). A total of 265 patients have been admitted to the trial. Completion of the trial data analysis is expected in the last quarter of 2007. In this trial, the effect of Nemonoxacin in comparison with levofloxacin, the leading quinolone on the market, is evaluated with both clinical and bacteriological success rates in treating adult patients with CAP.
"We are pleased with the efficient manner in which the 18 clinical centers have enrolled patients in the phase II study," said Dr. Ming Chu Hsu, Chairman and CEO of TaiGen. "Completing enrollment in this study shall keep us on track of our projected development timeline for this highly promising antibacterial for the treatments of resistant infection."
About TaiGen Biotechnology
TaiGen Biotechnology (
www.taigenbiotech.com) is a leading pharmaceutical company based in Taiwan and has a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. Nemonoxacin, once-a-day oral and IV antibacterial active against MRSA, gram-positive and -negative pathogens, is currently in US phase 2 trials for community-acquired pneumonia and soon diabetes foot infection. The company has first-in-class phase 1-ready drug candidates for treating critical limb ischemia and retinopathy/age-related macular degeneracy, and advanced preclinical candidates for chronic Hepatitis C virus infection and cancer.
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TaiGen Biotechnology Announces Election of New Chairman
TAIPEI, Taiwan, June 4 /Xinhua-PRNewswire/ -- TaiGen Biotechnology today announced that current board member, President and Chief Executive Officer, Dr. Ming Chu Hsu, has been unanimously elected as Chairman of the Company¡¦s Board of Directors.
Dr. Hsu will assume the position of Chairman from Mr. Show Chung Ho, who will continue his role as a member of the Steering Committee and Director of the Board.
"Mr. Ho's vision and support have been vital to TaiGen since its inception. We are all grateful for his past and continuing contributions," said Dr. Hsu. "My role as CEO with TaiGen¡¦s business and scientific teams has been extremely rewarding, and I welcome the Board¡¦s support in its decision to expand my duties to the position of Chairman. It is a very exciting time for the company. I look forward to working with my colleagues and fellow board members as we push forward our development programs and business plan."
Dr. Hsu founded TaiGen Biotechnology in 2001 as President and Chief Executive Officer, and has led TaiGen through a period of extraordinary growth. Dr. Hsu was the founding director of the Division of Biotechnology and Pharmaceutical Research, National Health Research Institutes and Program Leader of the National Science and Technology Program in Biotech / Pharmaceutical Research in Taiwan. Before her return to Taiwan in 1998, Dr. Hsu was Research Director for Oncology and Virology at Hoffmann - La Roche USA.
About TaiGen Biotechnology
TaiGen Biotechnology (www.taigenbiotech.com) is a leading pharmaceutical company based in Taiwan and has a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. Nemonoxacin, once-a-day oral and IV antibacterial active against MRSA, gram-positive and -negative pathogens, is currently in US phase 2 trials for community-acquired pneumonia and soon diabetes foot infection. The company has first-in-class phase 1-ready drug candidates for treating critical limb ischemia and retinopathy/age-related macular degeneracy, and advanced preclinical candidates for chronic Hepatitis C virus infection and cancer.
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TaiGen's CEO Delivers a Keynote Speech at the 6th Annual China Pharmaceutical and Healthcare Industry Summit
TAIPEI, Taiwan, April 12 /Xinhua-PRNewswire/ -- At the 6th Annual China Pharmaceutical and Healthcare Industry Summit at Shanghai in China today, Dr. Ming-Chu Hsu, President & CEO of TaiGen Biotechnology Co., Ltd, delivered a keynote speech on the company's strategic focus, "Building Locally and Expanding Globally". She stressed on the long-term and sustainable R&D core value which TaiGen has built through fully utilizing the particular local resources at a relatively lower cost in China and Taiwan. TaiGen has a deep product pipeline from internal R&D programs and clinical stage products in- licensed from biotech companies in USA. TaiGen's full pipeline, pointed out by Dr. Hsu, has validated such a business model for the emerging biotech industry in Asia.
About TaiGen Biotechnology
TaiGen Biotechnology (www.taigenbiotech.com) is a leading pharmaceutical company based in Taiwan and has a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. Nemonoxacin, once-a-day oral and IV antibacterial active against MRSA, gram-positive and -negative pathogens, is currently in US phase 2 trials for community-acquired pneumonia and soon diabetes foot infection. The company has first-in-class phase 1-ready drug candidates for treating critical limb ischemia and retinopathy/age-related macular degeneracy, and advanced preclinical candidates for chronic Hepatitis C virus infection and cancer.
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TaiGen Biotechnology Initiates Phase II Trial Of Nemonoxacin For Treatment Of Adult Community Acquired Pneumonia (CAP)
TAIPEI, Taiwan, Jan. 8 /Xinhua-PRNewswire/ -- TaiGen Biotechnology Inc. announced today that the company has started enrollment of patients for the Phase II clinical trial of Nemonoxacin (TG-873870) for the treatment of adult community acquired pneumonia (CAP). The randomized, double-blind, comparative, multi-center study is designed to evaluate the effect of Nemonoxacin in comparison with levofloxacin, the leading quinolone on the market. The study will evaluate both clinical and bacteriological success rates in treating adult patients with CAP.
"The initiation of the Phase II study is an important milestone for TaiGen as we continue to build our product portfolio for treating infectious diseases," stated Dr. Ming-Chu Hsu, President & CEO of TaiGen. "In our early non-clinical studies, Nemonoxacin has demonstrated superior activity against various resistant pathogens, including MRSA, in comparison with otherantibiotics. The incident of MRSA infection is rising worldwide. With its extremely broad-spectrum of activity and good safety profile demonstrated in the phase 1 trials, TaiGen plans to develop the oral Nemonoxacin for multiple indications, including a phase 2 trial to treat diabetic foot infection to be initiated soon." An intravenous formulation of Nemonoxacin is scheduled to enter clinical trials in the spring of 2007
About TaiGen Biotechnology
TaiGen Biotechnology (www.taigenbiotech.com) is a leading pharmaceutical company based in Taiwan and has a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, cancer and diabetic complications. TaiGen has established a full capacity to conduct new drug research and clinical development in China, US and other countries. The company is building its product pipeline through internal research and in-licensing of late clinical stage products. In addition to the clinical development of Nemonoxacin, the company has pre-clinical drug candidates for treating hepatitis C virus infection, cancer and diabetic related complications including diabetic critical limb ischemia and retinopathy.
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TaiGen Biotechnology Announces Appointment of William Keller as a Member of the Board of Directors
Taipei, Taiwan Feb 10, 2006 -- TaiGen Biotechnology announced today that Mr. William Keller has been elected to the Board.
"We are honored to have Mr. Keller join the Board of Directors," said Ming-Chu Hsu, Ph.D., the President & CEO of TaiGen Biotechnology. "His deep industry knowledge and 12-year tenure as the head of Roche China and Hon Kong will provide TaiGen with invaluable insights and facilitate TaiGen's development strategy in the fast growing China market."
Mr. Keller spent more than 30 years of his career at Roche. Prior to joining the Board of Directors at TaiGen Biotechnology, he was the General Manager of Roche China, Ltd., where he formulated and developed Roche strategy for China and Hong Kong. Under his leadership, Roche became one of the leading pharmaceutical companies in China. Mr. Keller first joined Roche in 1972. Over the years, he was given increasing responsibilities and rose through the ranks at Roche. He was promoted to the Deputy General Manager of Roche Brazil and later, the General Manager of Roche Columbia before he became the General Manager of Roche China.
About TaiGen Biotechnology
TaiGen Biotechnology is a privately held pharmaceutical development company founded in 2001 and headquartered in Taiwan. The company focuses on developing innovative therapeutic products to treat cancer, infectious diseases and diabetic complications. In addition to its own internal research programs, the company is also pursuing in-licensing late-stage development drug candidates for early commercialization in Asia. TaiGen has operations in Taiwan and China. Please visit http://www.taigenbiotech.com for additional news and information about TaiGen Biotechnology.
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TaiGen Receives NT$116.6 Million MOEA grant for Developing new drugs
Taipei, Taiwan November, 18th, 2005 -- TaiGen Biotechnology Co. Ltd. announced today that MOEA, Executive Yuan of Taiwan, has awarded the company NT$ 98.3 Million ($2,900,000 USD) grant to advance its novel antibiotic drug candidate, TG-873870, into Phase II clinical trial. MOEA has also awarded TaiGen a second NT$18.3 Million ($600,000 USD) grant for the development of TG-5628, a new drug compound for the treatment of diabetic complications.
"The Executive Yuan of Taiwan has again demonstrated its commitment in facilitating the growth of the biotechnology industry in Taiwan," said Dr. Ming-Chu Hsu, President & CEO of TaiGen Biotech. "The support from MOEA is invaluable not only in helping TaiGen to further advance its product pipeline, but it also helps the development of life sciences related satellite industries in Taiwan."
About TG-873870
TG-873870 is a new class of synthetic inhibitor of bacterial topoisomerase, an essential protein for bacteria propagation. In clinical studies, compared with currently marketed synthetic antibacterial drug, TG-873870 has superior antibacterial activity and less susceptible to drug resistance development. TaiGen has completed Phase I study in the US in October 2005 and plans to initiate worldwide Phase II clinical trial in early 2006.
About TG-5628
TG-5628 is a new drug candidate currently under preclinical development for the treatment of ischemia-related diseases such as diabetic complications (critical limb ischemia; diabetic retinopathy), stroke, and cardiac ischemia. In preclinical animal model, TG-5628 significantly enhanced tissue blood flow and increased the recovery of limb function. TG-5628 has demonstrated to satisfy toxicology and safety criteria in preliminary evaluation for entering clinical trial. TaiGen plans to complete preclinical evaluation and initiate Phase I/II clinical trial in 2006.
About TaiGen Biotechnology
TaiGen Biotechnology is a privately held pharmaceutical development company founded in 2001 and headquartered in Taiwan. The company focuses on developing innovative therapeutic products to treat cancer, infectious diseases and diabetic complications. In addition to its own internal research programs, the company is also pursuing in-licensing late-stage development drug candidates for early commercialization in Asia. TaiGen has operations in Taiwan and China. Please visit http://www.taigenbiotech.com for additional news and information about TaiGen Biotechnology.
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TaiGen Initiates Phase 1B Trial of a Novel Quinolone Antibiotic with Broad-Spectrum Activity Toward Drug-Sensitive and Resistant Bacteria
TAIPEI, June 17, 2005 -- TaiGen Biotechnology Co. Ltd. announced today that it has initiated dosing in a Phase 1B trial for TG-873870, a novel quinolone antibiotic with the potential for treating drug-sensitive and drug-resistant bacterial infections. The multiple-dose tolerance and safety study is being conducted at a leading clinical research center in the United States.
In October 2004, Procter & Gamble Pharmaceuticals completed the phase1A single-dose escalating studies. TaiGen Biotechnology licensed the product for worldwide clinical development. Based on favorable safety and pharmacokinetic profiles, the double-blinded, multiple-dose escalating Phase 1B trial in healthy volunteers will guide the selection of the dosage in Phase 2 trials planned for the first half of 2006.
Dr. Ming-Chu Hsu, President and CEO of TaiGen Biotechnology, has given the following statement: "Based on the activity profile of TG-873870, we believe that this antibiotic, which has a unique quinolone structure, could potentially be effective in treating multi-drug resistant infections, including infections of methicillin-resistant Staphylococcus aureus (MRSA). The product is particularly important for Asian countries where the incidence of drug resistant infections is significantly higher than in the rest of the world. Through an alliance with P&G for worldwide development, TaiGen has established a business model for emerging Asian biotechnology companies, with the goal of gaining access to the worldwide market while retaining commercial participation in the region."
About TG-873870
TG-873870 is a bacterial topoisomerase inhibitor. Compared with currently marketed quinolones, TG-873870 represents a novel structural series. Antibacterial activity and resistance development in the pre-clinical studies suggest a unique clinical potential for treating drug-resistant infections. These properties may distinguish TG-873870 from other members of the quinolone class.
About TaiGen Biotechnology
TaiGen Biotechnology is a privately held pharmaceutical company based in Taiwan. The company is developing into an integrated pharmaceutical company and is currently developing a number of innovative new products, both internally and by in-licensing, including drugs to treat immune disorders, cancer and infectious diseases. After three years of operation, in addition to the clinical development of TG-873870, the company has drug candidates in pre-clinical development for tissue ischemia, transplant rejection, rheumatoid arthritis, solid tumors and SARS, and is actively pursuing late-stage development compounds. TaiGen currently has offices in Taiwan, China and the US for R&D, business development, clinical development and marketing operations. Please visit http://www.taigenbiotech.com for the latest news and in-depth information about TaiGen Biotechnology.
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TaiGen Biotechnology Announces Strategic Agreement with Procter & Gamble, Taipei, Taiwan
TaiGen Biotechnology Announces Strategic Agreement with Procter & Gamble, Taipei, Taiwan January 6,2005-TaiGen Biotechnology Co., Ltd. announced today the signing of a strategic alliance relationship with Procter & Gamble Pharmaceuticals (P&GP) to further the development and commercialization of a novel non-flourinated quinolone antibiotic, invented by P&GP. Under the terms of the agreement, TaiGen will be responsible for conducting Phase Ib and Phase II development of the compound to meet worldwide regulatory standards.If Phase II results are positive, Procter & Gamble, in conjunction with TaiGen, may then seek a pharmaceutical partner for the Phase III development and subsequent commercialization of the compound.In addition, TaiGen acquires development and commercialization rights within China, Taiwan, Korea and the ASEAN countries.
Ming-Chu Hsu, President & Chief Executive Officer of TaiGen commented, ¡§In addition to the robust preclinical pipeline built through internal discovery programs in the past three years, this deal realizes two major strategic objectives of TaiGen.The commercialization rights to the compound within Asia is an important step forward in our goal of becoming a fully integrated pharmaceutical company, particularly with our emphasis on realizing value from our activities in China. In addition, we look forward to the opportunity to demonstrate our capabilities in early stage pharmaceutical development and to share that value with our partner P&GP.¡¨
Don Lucas, Worldwide Strategic Alliances for Procter & Gamble Pharmaceuticals noted the strategic flexibility achieved by this agreement.He said, ¡§We believe this is a strong development candidate.However, at this time anti-infectives is not a core strategic focus of our internal development organization, thus a partnership for this compound makes sense.This deal allows the continued advancement of the compound , while retaining for P&GP the rights to re-evaluate this opportunity after Phase II studies are complete.Options at that point could include re-partnering the technology or undertaking Phase III development and commercialization outside of specific Asian territories.¡¨
Burrill & Company was retained by P&GP to assist in the deal.G. Steven Burrill commented, ¡§This is truly a groundbreaking deal.Both sides win, and achieve important strategic objectives with a novel deal structure.We also think it plays well into the rapidly emerging biotechnology capabilities in Asia.We were pleased to be part of developing this deal between two innovative partners.¡¨
TaiGen Biotechnology
TaiGen Biotechnology is a privately held pharmaceutical company based in Taiwan with a vision of becoming a fully integrated pharmaceutical company. The company is developing an innovative pipeline of development candidates through internal discovery and in-licensing, including drugs to treat immune disorders, cancer and infectious diseases. Three years into operation, the company has four compounds in preclinical development for tissue ischemia; transplant rejection, solid tumors and SARS and is actively pursuing late-stage development compounds. To date, TaiGen has raised a total of US$75 million through two rounds of financing with MPM Capital leading the first round and China Steel leading the second round. The company's strategic partners include Arena Pharmaceuticals of the US for the application of constitutively-activated receptor technology (CART) for selected G protein-coupled receptors (GPCRs), Fujisawa Pharmaceuticals of Japan for out-licensing of a drug target and proprietary assays for the discovery of drugs to treat chronic inflammatory diseases, BioXell of Italy for collaboration in discovery of novel drug targets, Chang Gung Memorial Hospital of Taiwan for access to tumor and hepatitis-infected tissues from 7,000 patients and TTY Biopharmof Taiwan for joint development and marketing of a novel drug for cancer treatment. At present, TaiGen has 96 employees, including 75 scientists recruited from the US, Europe, Canada and Taiwan. Its 40,000 square foot state-of-the-art research facility is located in Taipei near major research institutions and hospitals. TaiGen currently has offices in Taiwan, China and the US with R&D, business development, clinical development and marketing operations.
About P&G (NYSE:PG)
Two billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including PampersR, TideR, ArielR, AlwaysR, WhisperR, PanteneR, BountyR, PringlesR, FolgersR, CharminR, DownyR, LenorR, IamsR, CrestR, ActonelR, OlayR and Clairol Nice 'n EasyR, Head & ShouldersR, and Wella.The P&G community consists of almost 110,000 employees working in over 80 countries worldwide.Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.
Burrill & Company
Burrill & Company is a life sciences merchant bank, focused exclusively on companies involved in biotechnology, pharmaceuticals, diagnostics, human healthcare and related medical technologies, wellness and nutraceuticals, agricultural technologies, and industrial biotechnology (biomaterials/bioprocesses). Burrill & Company's website at www.burrillandco.com.
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TaiGen Biotechnology Announces Appointment of Senior Vice President of Business Development Stephen H. Ip, PhD
Taipei, Taiwan July 19, 2004 - TaiGen Biotechnology Co., Ltd. announced today the appointment of Stephen H. Ip as its Senior Vice President of Business Development. Dr. Ip has over 25 years of experience in operation and in starting and managing public and private biotechnology companies in the US. Prior to Joining of TaiGen Biotechnology, Dr Ip held various management positions including, Vice President of Business development, Head of Far East at Matritech, Inc., President, American Biogenetic Sciences, Inc., President & Founder of CytoMed Inc. (Now as Part of UCB Pharma & Millennium Pharmaceutical).He was also Vice President, Technology & Co-Founding scientist of T Cell Sciences (now Avant Immunotherapeutics, Inc.), and held marketing and research manager positions at Ortho (Johnson & Johnson) and was a founding member of Cambridge Research Lab of Johnson & Johnson. Dr. Ip was responsible in developing joint programs with pharmaceutical companies including SmithKline Beecham, Yamanuchi, Mitsubishi, Sysmex, Astra, Chiron, Pfizer, Syntex (now part of Roche), Purdue Pharma and others. Dr. Ip received his Ph.D. in 1976 from University of Virginia Medical School and was a staff fellow at the Hematology and Oncology of the University of Pennsylvania Medical School.Dr. Ip was appointed as adjunct associate professor of Pathology at Columbia University Medical School between 1982-84.
TaiGen Biotechnology (www.taigenbiotech.com) is a privately held pharmaceutical company based in Taiwan with a vision to become a fully integrated pharmaceutical company. The company is developing an innovative pipeline in immune disorders, oncology and infectious disease through internal discovery and in-licensing of promising development candidates. Three and a half years into operation, the company has several compounds in preclinical development and actively pursuing late-stage development compounds. To date, TaiGen has raised a total of US$ 75 million through two rounds of financing with MPM Capital leading the first round and China Steel leading the second round. The company's strategic partners include Arena Pharmaceuticals of USA for the application of constitutively-activated receptor technology (CART) to selected G protein-coupled receptors (GPCRs), Fujisawa Pharmaceuticals of Japan for out-licensing of a drug target and proprietary assay for discovery of drug to treat chronic inflammatory diseases, BioXell of Italy for collaboration in discovery of novel drug targets, Chang Gung Memorial Hospital of Taiwan for access to tumor and hepatitis tissues from 7,000 patients and TTY Biopharm Co., Ltd.of Taiwan for joint development and market of a novel drug for cancer treatment. At present, TaiGen has 96 employees including 75 scientists recruited from US, Europe, Canada and Taiwan. Its 40,000 square feet state-of-the-art research facility is located in Taipei near major research institutions and hospitals. TaiGen currently has operations in Taiwan, China and the US with R&D, clinical development and sales and marketing capabilities.
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TaiGen Biotechnology Announces Appointment of Chief Financial Officer John Cheng
Taipei, Taiwan March 18, 2004 - TaiGen Biotechnology Co., Ltd. announced today the appointment of John Cheng as its Chief Financial Officer. Mr. Cheng brings with him a strong background of financial and management skills, vast experience in fund raising (over US$2 billion) and M&A (over US$100 million) activities, and solid exposure in a broad spectrum of business disciplines. Prior to TaiGen, Mr. Cheng was mainly involved in the semiconductor industry, including Taiwan Semiconductor Manufacturing Corporation (TSMC) -- the world's largest IC foundry-and Vanguard International Semiconductor Corporation (VIS), where he ran the finance operation and marketing/corporate development, respectively. Mr. Cheng was instrumental to TSMC's IPO at the NYSE, which was the first of its kind for any company in Taiwan, and VIS's corporate restructuring efforts, which turned VIS from a money-losing DRAM manufacturer to a profitable specialty IC foundry. Between TSMC and VIS, Mr. Cheng devoted himself to assisting several technology start-ups, both in Taiwan and mainland China, in strategic planning, business development, corporate development, M&A, financial planning, and fund raising. In 2000, Mr. Cheng worked with Goldman Sachs' Asia Private Equity to successfully merge ChinaRen with NASDAQ-listed Sohu to form the then largest Internet portal in the Greater China area. In his earlier career, Mr.Cheng held management position at DuPont, Bank of America, President Securities, and Ogilvy & Mather, where he was responsible for a variety of functions, including sales, marketing, finance, business development, and securities underwriting. Mr. Cheng has a B.S. in civil engineering, an MBA in marketing and an MS in finance.
TaiGen Biotechnology (www.taigenbiotech.com) is a privately held pharmaceutical company based in Taiwan with a vision to become a fully integrated pharmaceutical company. The company is developing an innovative pipeline in oncology, chronic inflammation and viral infection through internal discovery and in-licensing of promising development candidates. Two and half years into operation, the company has several compounds in preclinical development and actively pursuing late-stage development compounds. TaiGen has a strong financial backing with series-A financing of 37 million US dollars closed in July, 2001, led by MPM Capital, the world largest biotech venture firm, along with the Taiwanese government and top-tier institutional investors in Taiwan. On March 16, 2004, TaiGen announced the first closing of Series B of 38 million US dollars led by China Steel and participated by major Series A investors. The company's strategic partners include Arena Pharmaceuticals of USA for the application of constitutively-activated receptor technology (CART) to selected G protein-coupled receptors (GPCRs), Fujisawa Pharmaceuticals of Japan for out-licensing of a drug target and proprietary assay for discovery of drug to treat chronic inflammatory diseases, BioXell of Italy for collaboration in discovery of novel drug targets, and Chang Gung Memorial Hospital of Taiwan for access to tumor and hepatitis tissues from 7,000 patients. At present, TaiGen has 90 employees including 75 scientists recruited from US, Europe, Canada and Taiwan. Its 40,000 square feet state-of-the-art research facility is located in Taipei near major research institutions and hospitals.
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TaiGen Biotechnology Raises $38 Million in Its First Closing of Series B Financing
Taipei, Taiwan March 16, 2004 - TaiGen Biotechnology Co., Ltd. announced today that it has raised $38 million USD through the private placement of preferred stock with existing and new investors. China Steel led the B round. Major Series A investors, MPM Capital, Development Fund, YFY Group, China Development Industrial Bank (CDIB), Shin Kong Life Insurance and Cathay Life Insurance, all participated in the new round. The company is planning for a second closing in 2004.
TaiGen intends to use the funds to continue the internal R&D programs and clinical development of in-licensed drug candidates, focusing on immune disorders, cancer and viral infection. In the two and half years since its inception, TaiGen has advanced three of its discovery programs, stem-cell mobilization, Th1-mediated chronic inflammation and SARS antiviral, to preclinical development. At the same time, TaiGen is co-developing DB67 with TTY Biopharm to treat solid tumors, in particular brain tumor. The compound is currently in GLP toxicology studies and scheduled to enter clinical trials in 1Q 2005. The company has an on-going effort to in-license late-stage clinical candidates to treat Asian prevalent diseases and is planning to build commercial capabilities in selected Asian markets.
Dr. Ming-Chu Hsu, President & CEO said, "We are very pleased to have completed the first closing of our series B financing. The R&D progress we made in the past two years has impressed the existing and new investors to pay a 50% step-up price for this new round. The additional capital will allow us to continue building a robust and innovative product pipeline through internal discovery efforts and in-licensing of promising drug candidates. This round of financing will greatly expedite our growth."
China Steel announced its investment in TaiGen and commented that TaiGen is the leading research-based and product-driven pharmaceutical company in Taiwan. The company has very strong scientific and management teams and clear short-, mid-, and long-term goals. It has attracted the most prominent and experienced investors. China Steel considers its investment into TaiGen a "strategic move" into the biotechnology and pharmaceutical businesses.
TaiGen Biotechnology (http://www.taigenbiotech.com/) is a privately held pharmaceutical company based in Taiwan with a vision to become a fully integrated pharmaceutical company. TaiGen has a strong financial backing with series-A financing of 37 million US dollars closed in July, 2001, led by MPM Capital, the world largest biotech venture firm, along with the Taiwanese government and top-tier institutional investors in Taiwan. The company's strategic partners include Arena Pharmaceuticals of USA for the application of constitutively-activated receptor technology (CART) to selected G protein-coupled receptors (GPCRs), Fujisawa Pharmaceuticals of Japan for out-licensing of a drug target and proprietary assay for discovery of drugs to treat chronic inflammatory diseases, BioXell of Italy for collaboration in discovery of novel drug targets, and Chang Gung Memorial Hospital of Taiwan for access to tumor and hepatitis tissues from 7,000 patients. At present, TaiGen has 90 employees including 75 scientists recruited from US, Europe, Canada and Taiwan. Its 40,000 squire feet state-of-the-art research facility is located in Taipei near major research institutions and hospitals.
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TaiGen Received Funding for Anti-SARS Drug Discovery and Development From The Executive Yuan, Republic of China
Taipei, Taiwan October 22, 2003 - TaiGen Biotechnology Co., Ltd. announced today the signing of an agreement with and receiving the research funding of NT$ 29.5 MM ($890,000 USD) from The Executive Yuan, Republic of China for the discovery and development of drugs against the coronavirus causing SARS. The funding will support 50% of the total cost in the first year. Future year funding of the 6-year research and development proposal will depend on the progress made. In July 2003, TaiGen initiated a structure-base drug discovery program targeting at SARS virus 3CL protease. A multi-disciplined team has been assembled to tackle the deadly disease, including a X-ray crystallography group at Academia Sinica, a medicinal chemistry team from Industrial Technology Research Institutes (ITRI) and the SARS virus laboratory at Cheng Gung Memorial Hospital.
Dr. Ming-Chu Hsu, President & CEO of TaiGen, said, "As a responsible corporate citizen, TaiGen feels obligated to use our expertise and experience in anti-viral research to fight SARS, the deadly disease that paralyzed Asia and other areas in the world this summer. We are very pleased to receive the funding from The Executive Yuan. Since the starting of our discovery effort in July 2003, the project team has made significant progress, including design and synthesis of highly potent 3CL protease inhibitors and obtaining the X-ray structure of the protease. The government has put a tremendous effort to control the spread of the disease during the last outbreak and is continuing its effort in disease control and development of vaccine and therapeutics. TaiGen is proud to be part of the concerted effort." TaiGen Biotechnology is a privately held pharmaceutical company based in Taiwan with a vision to become a fully integrated global pharmaceutical company. The company's areas of therapeutic focus include oncology, chronic inflammation and viral infection. TaiGen has strong financial backing with series-A financing of 37 millions US dollars closed in July, 2001, led by MPM Capital, the world largest biotech venture firm, along with the Taiwanese government and top-tier Taiwanese investors. The company is building an innovative product pipeline through in house discovery programs and in-license of development candidates. TaiGen's strategic partners include Arena Pharmaceuticals of USA for the application of constitutively-activated receptor technology (CART) to selected G protein-coupled receptors (GPCRs), Chang Geng Memorial Hospital of Taiwan for access to tumor and hepatitis tissues from 7,000 patients and discovery of novel drug targets, Fujisawa Pharmaceuticals of Japan for out-licensing of a CART-GPCR target for discovery of drugs to treat inflammatory diseases, and BioXell of Italy for collaboration in discovery of novel drug target and therapeutics to treat chronic inflammation. At present, TaiGen has 84 employees including 76 scientists recruited from the US, Europe, Canada and Taiwan. The company is planning to enter clinical trials of a in-licensed drug candidate DB67 and has several lead compounds in preclinical development to treat rheumatoid arthritis, transplant rejection, multiple sclerosis, cancer and stem cell mobilization.
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TaiGen and TTY Biopharm Jointly Develop and Commercialize a Novel Topoisomerase I Inhibitor DB67 for Cancer Treatment
Taipei, Taiwan October 20, 2003 - TaiGen Biotechnology Co., Ltd. and TTY Biopharm Co., Ltd. announced today the signing of an agreement to jointly develop and market a novel topoisomerase I inhibitor, DB67, for cancer treatment.
DB67, the lead compound of a series of topoisomerase I inhibitors, was discovered and patented by the researchers at the University of Pittsburgh, USA. National Health Research Institutes (NHRI) of Taiwan, through funding from the Ministry of Economic Affairs (MOEA) and with an aim to help accelerate new drug development by the local pharmaceutical industry, has licensed the Asian rights (including Japan) of DB67 and assigned them to TTY for development and commercialization. DB67 has shown potent activities in various preclinical tumor models and, due to its physical property, has a great potential to treat brain malignancy. The current MOEA funding will cover almost all the cost before phase I clinical trials. MOEA could also fund up to 40% for phase I and II trials and up to 25% for phase III trials for selected drug candidates.
Under the terms of the agreement, TaiGen and TTY will be responsible for conducting studies based on each party!|s experience and expertise. TaiGen will be in areas of animal disease models, pharmacokinetics, drug metabolism and toxicology, and TTY in formulation, GMP production of dosage forms and organization of clinical trials. TaiGen and TTY have a plan in place to market the drug jointly in Asia. The financial terms of the agreement were not disclosed.
Dr. Ming-Chu Hsu, President & CEO of TaiGen, said, "We are very pleased to partner with TTY Biopharma, a leading Taiwanese pharmaceutical company, for the development and commercialization of DB67, a promising drug candidate with proven mechanism of action. TaiGen and TTY clearly have complementary strengths that can accelerate drug development. The GLP toxicology studies are underway and filing of IND is planned for 4Q 2004. This agreement endorses the value of our drug discovery and development capabilities and enriches our pipeline that currently consists of several candidates in preclinical development. We look forward to a fruitful collaboration with TTY".
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TaiGen Biotechnology Forms New Scientific Advisory Board
Taipei, Taiwan May 22, 2003 - Taipei, Taiwan, May 22 2003 - TaiGen Biotechnology Co., Ltd. announced today the formation of new scientific advisory board. Dr. Ming-Chu Hsu, President and CEO of TaiGen, said, "TaiGen is moving forward rapidly in both the discovery and development programs. We are excited about the formation of our new Scientific Advisory Board with several world renowned experts who have tremendous expertise and experiences in bring innovative therapeutics to patients. They will certainly further strengthen our programs." The following are the brief bibliographies of the new advisors:
William R. Benjamin Ph.D.
Vice President of Research Technologies, Protein Design Labs, Inc. Prior to his current position, Dr. Benjamin served as Vice President of Research Operations, Vice President of Research Operations and Drug Discovery and Vice President, Drug Discovery of Protein Design Labs. From 1982 to 1997, Dr. Benjamin was with Hoffmann La Roche Inc., and most recently served as Vice President of Inflammation and Autoimmune Diseases. At Roche, Dr. Benjamin was responsible for leading the drug discovery activities of a multidisciplinary research department in the areas of inflammatory and immune-based diseases.
Alice Yu, M.D.
Professor and Chief, Division of Pediatric Hematology/Oncology, UC San Diego Dr. Yu has served as the chair of many US National Clinical Trials on experimental drugs and biological agents for cancer treatment. Over the past 20 years, she has provided leadership in the international cooperative Pediatric Oncology Group and Children's Oncology Group consisting of over 235 medical institutions in the US, Canada, Europe and Australia. Currently, she is a member of the NCI Cancer Research Manpower Review Committee, and has served for several review committees on cancer therapeutics for NIH and NCI.
Leroy F. Liu Ph.D.
Chairman, Department of Pharmacology, UMDNJ-Robert Wood Johnson Medical School Dr. Liu received his Ph. D. in Biophysics from UC Berkeley in 1977 and his postdoctoral training in molecular biology at both Harvard University and UC San Francisco. He joined Johns Hopkins Medical School as Assistant Professor of Biological Chemistry in 1980 and was promoted to full professor in 1988. Dr. Liu is a world-renowned expert on DNA topoisomerases and drugs directed at these important cellular enzymes. He discovered that human DNA topoisomerase I is the molecular target for the antitumor plant alkaloid camptothecin.
Check Y. Quon, Ph.D.
President iNDa Consulting, Inc
Dr. Quon started the drug development strategy consulting firm in 2002. He was employed at DuPont Merck PharmaceuticalsCompany from 1979 to 2001 and most recently served as Executive Director of Drug Metabolism and Pharmacokinetics. Dr. Quon has extensive experiences and accomplishments in preclinical and clinical drug development. He chaired the Pre-Development Committee and supported the submission/approval of 7 NDAs and over 45 IND/ERCs.
TaiGen Biotechnology (www.taigenbiotech.com) is a privately held pharmaceutical company based in Taiwan with a vision to become a fully integrated global pharmaceutical company, focusing on oncology, anti-viral and anti-inflammatory drug discovery and development. The company has strong financial backing, with series-A financing of 37 millions US dollars closed on July, 2001 and led by MPM Capital, the world largest biotech venture firm along with top-tier Taiwanese investors and FITE. At its inception TaiGen Biotechnology formed a strategic partnership with Arena Pharmaceuticals, a shareholder of TaiGen, and is focusing its drug discovery effort on G protein-coupled receptors (GPCRs), employing Arena's "constitutively activated receptor technology" (CART) which enables drug discovery without the need to identify the ligand of an orphan GPCR and therefore bypasses the usual bottleneck. For novel drug target identification and validation, TaiGen has a strong tie with Chang Geng Memorial Hospital, one of the largest research hospitals in Taiwan, which has a tumor and hepatitis tissue bank from over 7,000 patients. In last September, TaiGen signed a collaborative research agreement with BioXell, a leading Italian biotech company focusing on immunological disorders. In February 2003, TaiGen and Fujisawa Pharmaceuticals signed a licensing and collaborative agreement on a GPCR drug target, its proprietary High-Throughput assay system and lead compound development for immune and inflammatory diseases. At present, TaiGen has 75 employees including 64 scientists trained in the US, Canada, Europe and Taiwan. The company currently has several drug leads in active preclinical development.
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