TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and China
2013/05/15
More»
TaiGen Biotechnology Out-Licensed China Rights of Novel Antibiotic, Nemonoxacin, to Zhejiang Medicine
2012/06/25
More»
TaiGen Biotechnology obtains the worldwide rights for Nemonoxacin
2011/12/06
More»
TaiGen Amends Global License Agreement with Warner Chilcott plc for Development and Commercialization of Nemonoxacin -- a New Generation Quinolone Antibiotic
2010/10/14
More»
TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing in Diabetic Foot Infection Met Primary Endpoints
2010/03/12
More»
TaiGen Biotechnology Reports Phase I and Preclinical Data for TG-0054 at the 2009 American Society of Hematology (ASH) Annual Meeting
2009/12/07
More»
Excellent Stem Cell Mobilization and Safety Profile for TG-0054
2009/09/28
More»
TaiGen Biotechnology Secures 37 Million USD in Series C Round Financing
2009/01/20
More»
TaiGen Announces Presentation of Nemonoxacin at the Joint Meeting of ICAAC/IDSA
2008/10/20
More»
TaiGen Announces Positive Data From the Phase II Study of Nemonoxacin (TG-873870) in Community-Acquired Pneumonia
2008/04/07
More»
TaiGen Initiates Phase I Trial of the Stem Cell Mobilizer TG-0054
2008/04/07
More»
TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
2007/08/10
More»
TaiGen Biotechnology Announces Election of New Chairman
207/06/04
More»
TaiGen's CEO Delivers a Keynote Speech at the 6th Annual China Pharmaceutical and Healthcare Industry Summit
2007/04/12
More»
TaiGen Biotechnology Initiates Phase II Trial Of Nemonoxacin For Treatment Of Adult Community Acquired Pneumonia (CAP)
2007/01/08
More»
TaiGen Biotechnology Announces Appointment of William Keller as a Member of the Board of Directors
2006/02/10
More»
TaiGen Receives NT$116.6 Million MOEA grant for Developing new drugs
2005/11/18
More»
TaiGen Initiates Phase 1B Trial of a Novel Quinolone Antibiotic
2005/06/16
More»
TaiGen Biotechnology Announces Strategic Agreement with Procter & Gamble
2005/01/06
More»
TaiGen Biotechnology Announces Appointment of Senior Vice President of Business Development Stephen H. Ip, PhD
2004/07/19
More»
TaiGen Announces Appointment of Chief Financial Officer John Cheng.
2004/03/18
More»
TaiGen Raises $38 Million in Its First Closing of Series B Financing.
2004/03/16
More»
TaiGen Received Funding for Anti-SARS Drug Discovery and Development From The Executive Yuan, Republic of China.
2003/10/22
More»
TaiGen and TTY Biopharm Jointly Develop and Commercialize a Novel Topoiso-merase I Inhibitor DB67 for Cancer Treatment.
2003/10/20
More»
TaiGen Biotechnology Forms New Scientific Advisory Board.
2003/05/22
More»
TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and China
TAIPEI, Taiwan, May 16, 2013 – TaiGen Biotechnology Company, Limited ("TaiGen")
today announced that they have submitted New Drug Application (NDA) for the oral
formulation of nemonoxacin to the Taiwan Food and Drug Administration (TFDA) and
China Food and Drug Administration (CFDA). Approval is expected in the first
half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the
Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the
Economic Cooperation Framework Agreement (ECFA) between Taiwan and China. It is
also the first new drug from Taiwan to meet the requirements of CFDA’s Category
1.1 New Drug. Drugs under this classification have to be new chemical entities
(NCEs) that have not been marketed in any country in the world. Nemonoxacin,
thus, represents a landmark in the continued development of cross-strait
relationship between the pharmaceutical industry and regulatory agencies.
Nemonoxacin is a NCE, broad spectrum antibiotic with excellent efficacy and
safety profile. The NDA submission for nemonoxacin is supported by a pivotal
Phase 3 trial with 532 patients in community-acquired pneumonia (CAP). The trial
was conducted in both Taiwan and China (441 patients from mainland China and 91
patients from Taiwan) that met all primary and secondary endpoints including
non-inferiority to the comparator, levofloxacin. TaiGen is currently conducting
Phase 2 trial for the intravenous formulation of nemonoxacin in moderate to
severe CAP patients. In addition to CAP, nemonoxacin has also shown efficacy in
diabetic foot infections in a Phase 2 trial conducted in the US, Taiwan, and
South Africa. In the clinical trials conducted to this point, nemonoxacin have
demonstrated excellent activity against drug-resistant bacteria such as
methicillin-¬resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA
as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the
worldwide patent portfolio of nemonoxacin that protects composition, use, and
processes until 2029.
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, “Since
the founding of TaiGen, we have been focusing on the development of
First-in-class and Best-in-class novel drugs. The submission of the NDA for
nemonoxacin is the culmination of efforts by our experienced management team and
all the staff at TaiGen. I am very pleased with the groundbreaking achievement
of using one NDA dossier for submissions to TFDA and CFDA. Not only nemonoxacin
is our first product to the market, it is also an indication that a world class
medicine can be discovered and developed in Taiwan. TaiGen is well positioned to
advance in the world’s fastest pharmaceutical market, China.”
In June 2012, TaiGen signed an agreement with Zhejiang Medicine Company, Limited
(“ZMC”) to out-license the exclusive marketing and manufacturing rights of
nemonoxacin in China. ZMC is a leading manufacturer and marketer of antibiotics
in China and is a publicly listed company in the Shanghai Stock Exchange. This
partnership combines TaiGen’s R&D expertise and ZMC’s antibiotic marketing
knowhow to compete in China’s US$ 11 billion antibiotic market.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven
biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing,
China. In addition to nemonoxacin, TaiGen has two other in-house discovered NCEs
in clinical development under IND with US FDA: TG-0054, a chemokine receptor
antagonist for stem cell transplantation and chemosensitization, in Phase 2 and
TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection,
in Phase 2. Both TG-0054 and TG-2349 are currently in clinical trials in
patients in the US.
Disclaimer
Certain statements in this press release are forward-looking. These statements
may be identified by the use of forward-looking words such as "anticipate,"
"believe," "forecast," "estimated" and "intend," among others. These
forward-looking statements are based on TaiGen's current expectations and actual
results could differ materially. There are a number of factors that could cause
actual events to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, substantial
competition; our need for additional financing; uncertainties of patent
protection and litigation; uncertainties of government or third party payer
reimbursement; limited sales and marketing efforts and dependence upon third
parties; and risks related to failure to obtain regulatory authority clearances
or approvals and noncompliance with regulatory regulations. As with any drugs
under development, there are significant risks in the development, regulatory
approval and commercialization of new products. There are no guarantees that
future clinical trials discussed in this press release will be completed or
successful or that any product will receive regulatory approval for any
indication or prove to be commercially successful. TaiGen does not undertake an
obligation to update or revise any forward-looking statement.
Top
TaiGen Biotechnology Out-Licensed China Rights of Novel Antibiotic, Nemonoxacin, to Zhejiang Medicine
TAIPEI, Taiwan, June 25, 2012 /PRNewswire-Asia/ -- TaiGen Biotechnology Company,
Limited ("TaiGen") and Zhejiang Medicine Company, Limited ("ZMC") today
announced that they have signed an exclusive agreement to manufacture and
commercialize nemonoxacin, a novel broad-spectrum antibiotic, in China
(excluding Hong Kong, and Macau). Nemonoxacin is a novel broad-spectrum
non-fluorinated quinolone antibiotic under development for respiratory
infections. TaiGen will be responsible for completing the Phase 3 clinical trial
for community acquired pneumonia ("CAP") in China. ZMC will be responsible for
manufacturing, sales and marketing of nemonoxacin in China through its
wholly-owned subsidiary, XinChang Pharmaceuticals. TaiGen will retain full
development and commercialization rights outside the licensed territory
including Taiwan, the United States, European Union, and Japan. Under the terms
of the agreement, TaiGen will receive an upfront payment of US$ 8 million from
ZMC and will receive additional milestones as well as royalties on product
sales. The term of the agreement is 20 years.
Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot
infection in multinational and multi-center clinical trials conducted by TaiGen.
In particular, nemonoxacin has excellent activity against drug-resistant
bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and
quinolone-resistant MRSA. Nemonoxacin is taken once-a-day and available in both
oral and intravenous formulations. Currently, TaiGen is completing a Phase 3 CAP
trial with more than 500 patients from Taiwan and mainland China and expects to
file new drug applications in Taiwan and mainland China simultaneously in early
2013.
China is one of the major antibiotic markets in the world. According to IMS, the
sales of antibiotics in 2011 were approximately US$ 11 billion (RMB 68 billion)
and account for almost 20% of the total pharmaceuticals sales. Rate of
antibiotic resistant infections in China is among the highest in the world.
Mr. Li Chun Bo, Chairman of the ZMC, commented, "We are impressed with
nemonoxacin's broad spectrum activity towards drug-resistant bacteria, in
particular, MRSA, and excellent safety profile. We are excited to establish this
partnership with TaiGen because of its reputation as a premier research-based
biotech company in Asia. This partnership will break new ground for cross-strait
collaboration in the pharmaceutical industry. Nemonoxacin will be a major
addition to ZMC's antibiotic product line and significant profit driver".
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "China
is the world's fastest growing pharmaceutical market. It is poised to overtake
Japan as the second largest pharmaceutical market. We are extremely please to
establish our nemonoxacin partnership with ZMC, a first-class pharmaceutical
company and major player in the Chinese antibiotics market. With nemonoxacin,
TaiGen and ZMC together will bring new medicine to treat unmet medical needs in
China. This partnership will not only set a new record for pharmaceutical
licensing involving a Taiwanese and a mainland Chinese company but hopefully
will also become a model of the future collaborations," Dr. Hsu also added,
"With the conclusion of the partnership in China, we will actively pursue
nemonoxacin licensing discussions in other territories such as European Union."
About Zhejiang Medicine
Zhejiang Medicine Company, Limited is a leading pharmaceutical company in China
specializing in sales and distribution of pharmaceuticals and manufacturing of
active pharmaceutical ingredients (vitamins and antibiotics). Its sales revenue
in 2011 is US $740 million (RMB 4.8 billion). ZMC is a leader in the Chinese
antibiotic market with levofloxacin, vancomycin, and teicoplanin in the product
line. ZMC's Lai Li Xin, a branded levofloxacin, is one of the top selling
antibiotics in China with 2011 sales exceeding US $110 million (RMB 735
million). In addition to pharmaceuticals sales, ZMC is also known for its
manufacturing quality. Its vancomycin active pharmaceutical ingredient has
obtained GMP qualification from US Food and Drug Administration (FDA) and
exported to western countries. ZMC is publicly listed in the Shanghai Stock
Exchange (600216) and has a market capitalization of RMB 11 billion.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven
biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing,
mainland China. TaiGen has full discovery research capacity in Taiwan and
clinical development in mainland China/Taiwan/US. In addition to nemonoxacin,
TaiGen has two other in-house discovered new chemical entities in clinical
development under IND with US FDA: TG-0054, a chemokine receptor antagonist for
stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV
protease inhibitor for treatment of chronic hepatitis infection, in Phase 1.
Both TG-0054 and TG-2349 are currently in clinical development in the US.
Disclaimer
Certain statements in this press release are forward-looking. These statements
may be identified by the use of forward-looking words such as "anticipate,"
"believe," "forecast," "estimated" and "intend," among others. These
forward-looking statements are based on TaiGen's current expectations and actual
results could differ materially. There are a number of factors that could cause
actual events to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, substantial
competition; our need for additional financing; uncertainties of patent
protection and litigation; uncertainties of government or third party payer
reimbursement; limited sales and marketing efforts and dependence upon third
parties; and risks related to failure to obtain regulatory authority clearances
or approvals and noncompliance with regulatory regulations. As with any drugs
under development, there are significant risks in the development, regulatory
approval and commercialization of new products. There are no guarantees that
future clinical trials discussed in this press release will be completed or
successful or that any product will receive regulatory approval for any
indication or prove to be commercially successful. TaiGen does not undertake an
obligation to update or revise any forward-looking statement.
Top
TaiGen Biotechnology obtains the worldwide rights for Nemonoxacin
TAIPEI, Taiwan, Dec 6, 2011/PRNewswire-Asia/ -- TaiGen Biotechnology ("TaiGen") announced today that Warner Chilcott will transfer the worldwide rights for nemonoxacin, a novel non-fluorinated quinolone antibiotic under development for treatment of antibiotic-resistant infection to TaiGen. With the transfer of the compound, a complete regulatory package and related intellectual property rights, TaiGen will hold the worldwide exclusive rights for development, manufacture, commercialization and sub-licensing of nemonoxacin.
TaiGen originally licensed nemonoxacin product rights in ten Asian countries and worldwide development rights through Phase II from Procter & Gamble Pharmaceuticals, which was acquired by Warner Chilcott in October 2009. In August 2010, Warner Chilcott regained all rights outside the TaiGen territories after TaiGen obtained positive data, including effective eradication of MRSA and quinolone-resistant MRSA in two Phase II trials for community acquired pneumonia (“CAP”) and diabetic foot infection under an US IND.
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen said, "The draft FDA regulatory guidelines for CAP trials that exclude patients who have prior antibiotic use pose potential hurdles for conducting clinical trials in the US. We are not aware of such restriction in countries other than US. On the contrary, in recent announcements EU and China have encouraged the development and offered accelerate approval of new antibiotics due to rising infection rate of MRSA in these regions. This will be an opportunity for TaiGen to capture the full value of nemonoxacin in the worldwide territory."
Dr. Hsu further commented, "More importantly, TaiGen is targeting to complete Phase III oral trial for nemonoxacin in China and Taiwan in 2012. The initiation of the Phase II/III clinical trial for intravenous formulation is also planned in 2012. With the progress of the development in the past year, we have further created value for nemonoxacin. This will greatly enhance the attractiveness to any potential partner." TaiGen will be actively seeking partners for nemonoxacin outside Greater China, particularly in countries where the antibiotic resistant rate is high.
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 mainland China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market.
Top
TaiGen Amends Global License Agreement with Warner Chilcott plc for Development and Commercialization of Nemonoxacin -- a New Generation Quinolone Antibiotic
TAIPEI, Taiwan, Oct 14 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. today announced that TaiGen has entered into an amendment to its license agreement with Warner Chilcott plc regarding the development and commercialization of nemonoxacin -- a new generation quinolone antibiotic.
Under the terms of the original license agreement, entered into in December 2004, TaiGen licensed exclusive development, manufacture and commercialization rights to nemonoxacin from The Procter & Gamble Company in mainland China, Hong Kong, Taiwan, South Korea and certain other Asian countries, and assumed responsibility, at its sole cost and expense, for the conduct of a Phase Ib study and two Phase II trials in community-acquired bacterial pneumonia (CABP) and diabetic foot infection (DFI) patients, respectively, in which nemonoxacin demonstrated an excellent efficacy and safety profile. Upon Warner Chilcott's purchase of the global branded pharmaceuticals business of Procter & Gamble in October 2009, Warner Chilcott assumed Procter & Gamble's interest in the license agreement.
Under the terms of the amended agreement, entered into following the conclusion of Phase II trials, TaiGen keeps its exclusive development, manufacture and commercialization rights to nemonoxacin in the countries under the original license agreement, while Warner Chilcott retains development and commercialization rights in all other markets, including the United States and Europe. TaiGen and Warner Chilcott have agreed to cross-license their respective patent rights relating to nemonoxacin and TaiGen will transfer to Warner Chilcott its Investigational New Drug Application filed with the FDA. Upon the execution of the amended agreement, TaiGen received an upfront payment from Warner Chilcott and is eligible for certain regulatory milestone payments, as well as a royalty based on Warner Chilcott's net sales of the product.
Warner Chilcott plc is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets.
"We are very encouraged by the signing of the amended agreement with Warner Chilcott," said Dr. Ming-Chu, Hsu, Chairman and CEO of TaiGen. "The deal proved TaiGen's capabilities in conducting clinical and regulatory development with high quality and at standards set by the United States Food and Drug Administration (US FDA). It also validated TaiGen's business model of building R&D portfolio through both internal R&D and external collaboration and licensing."
With China being a fast growing pharmaceutical market, TaiGen, which set up its Beijing affiliate in 2005, has been developing nemonoxacin under the China SFDA (China State Food and Drug Administration) regulation. It is expected that nemonoxacin will enter Phase III development in China very soon.
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 mainland China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market.
Top
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.
Top
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.
Top
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.
Top
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."
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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.
Top
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".
Top
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.
Top
Top
