東洋說明與to-BBB共同開發腦瘤標靶型藥物
2009/08/26 14:24
公開資訊觀測站重大訊息公告
(4105)台灣東洋-工商時報於98/08/26報導本公司與to-BBB共同合作開發腦瘤標靶新藥
1.傳播媒體名稱:工商時報B5版
2.報導日期:98/08/26
3.報導內容:標靶治療癌症已成趨勢下,東洋(4105)25日宣布,將與荷蘭to-BBB製藥公司共同開發腦瘤標靶型liposomal doxorubicin藥物,搶進全球腦腫瘤治療用藥市場20億美元商機。
4.投資人提供訊息概要:無
5.公司對該等報導或提供訊息之說明:
(1)本公司與荷蘭to-BBB製藥公司日前達成協議，共同合作開發生產治療腦瘤標靶型liposomal doxorubicin藥物。
(2)依據日前達成的協議，這一項共同合作開發生產案，臺灣東洋將保有藥品未來上市後的獨家生產銷售權，未來臺灣東洋亦將負責製造此新藥，以供應to-BBB在歐美、日本及其他國家的銷售需求。在此合作生產案中，初期to-BBB將付給臺灣東洋國際標準委託合作的生產費用，未來上市後將再根據銷售數量付給臺灣東洋生產費用。
(3)腦腫瘤在美國及歐洲各有約200,000的病人，目前對於這個疾病的治療藥物，效果極為有限，而且癒後不佳；主要的原因是血腦障璧限制了許多抗癌藥物的傳輸，目前全世界幾乎沒有有效的藥物可以治療這一類的疾病。2008年全球腦腫瘤治療用藥市場規模約為20億美元。
(4)這個腦瘤標靶型liposomal doxorubicin藥物是to-BBB技術移轉自工研院的「血腦障壁(Blood Brain Barrier, BBB)藥物傳輸技術」發展而成。這個Glutathione-PEG doxorubicin liposomes藥物在概念性的試驗當中驗證它可以有效的抑制腦瘤的成長，即將進入動物與人體的臨床試驗。
(5)to-BBB是一家專門研究大腦藥物傳輸技術的國際公司，總部設於荷蘭萊登生命科學園區，是荷蘭歷史最悠久的萊登大學（Leiden University）的衍生公司，to-BBB期望能利用這項血腦障壁藥物傳輸機轉當作開發藥物的技術平台來發展藥物，治療目前無法治療的嚴重大腦疾病。
6.因應措施:無
7.其他應敘明事項:
本項資訊係與荷方同時發佈;檢附荷方to-BBB公司同步發佈之新聞稿,請參考:
PRESS RELEASE
Acceleration of the development of to-BBB’s brain cancer treatment
Manufacturing collaboration with TTY Biopharm
Leiden, The Netherlands, and Taipei, Taiwan, August 20th 2009
TTY Biopharm, the Taiwanese biotech manufacturer of Lipo-Dox, will
become a co-development partner of to-BBB, the Dutch brain drug
delivery company, for the manufacturing of brain-targeted doxorubicin
liposomes. These liposomes are essential for the clinical development
of to-BBB’s lead product for the treatment of brain cancer.
Werner Gladdines, Head of Clinical Operations at to-BBB, is very
pleased withthis agreement: “TTY Biopharm is highly specialized in the
preparation of doxorubicin PEG-liposomes and will thus be able to
efficiently manufacture brain-targeted doxorubicin liposomes with the
same precision within a shorttimeframe. Working with TTY Biopharm,
therefore, greatly accelerates our clinical development of our lead
product for brain cancer”.
Brain cancer affects up to 200,000 patients annually in the United
States andsimilar numbers in Europe. Treatment options for this
devastating disease are limited and overall prognoses are poor. The
neuroprotective blood-brain barrier (BBB) is limiting the delivery
of many anti-cancer drugs to tumors in the brain, especially to
micrometastases and invasivelygrowing tumor sprouts. to-BBBs
proprietary G-Technology is a safe technology for enhanced drug
delivery to the brain.Based on its proprietary G-Technology,
discovered by the Industrial Technology Research Institute (ITRI) in
Taiwan, to-BBB is developing its lead compound, brain-targeted
doxorubicin liposomes. These liposomes are coated with the tripeptide
glutathione at the tips of polyethylene glycol(PEG) to safely enhance
the delivery of free drug to the brain. Doxorubicin glutathione-PEG
liposomes have shown a reduced brain tumor growth in proof-of-concept
studies, which provides a strong basis for clinical development. For
this development,to-BBB requires clinical scale batches of the
brain-targeted doxorubicin liposomes, produced according to cGMP
standards. TTY Biopharm will provide these liposomes in a timely
manner.
The TTY Biopharm Formulation Team is focused on the development and
commercialization of oral and injectable controlled-release and liposomal
pharmaceuticals. TTY Biopharm currently sells Lipo-Dox, an internally
developed pegylated liposomal doxorubicin, similar to Doxil/Caelyx, for
multiple systemic cancer types for the Taiwanese and Asian market. With a
similar technology in their development process, TTY Biopharm will be able
to manufacture the brain-targeted version of these doxorubicin liposomes
in the shortest possible timeframe. With the EMEA approved facility in
ChangLi, Taiwan,TTY Biopharm currently collaborates with several European
pharmaceutical companies to launch generic oncology drugs for the European
market. Through thecollaboration with to-BBB, TTY Biopharm will
demonstrate their capabilities to develop new drug formulations for the
worldwide market.
About to-BBB
to-BBB is a Dutch biotechnology company in the field of enhanced drug
delivery to the brain. To successfully develop new treatments, to-BBB
provides the safest proprietary brain delivery platform in synergy with
established and marketed drugs. The company’s vision is that the
treatment of currently unserved, devastating brain diseases will be
best achieved by targeting to endogenous blood-to-brain uptake systems
for the delivery of drugs.
to-BBB is headquartered in The Netherlands at the Leiden Bio Science Park
and established a fully owned subsidiary, to-BBB Taiwan Ltd., in Taipei,
Taiwan.
About TTY Biopharm
Since the establishment in 1960, TTY Biopharm has transformed from a
generic drug manufacturer and seller to an international enterprise
focusing on the development of new formulas with the marketing
orientation. TTY Biopharm is specialized in the research and
development of drugs for cancer, anti-infection, cardiovascular disease,
and central nerves. The TTY formulation R&D center has the technology
to develop oral and injectable controlled-release, liposomal and
micro-emulsion formulations. With strict assessment procedures for new
products and patent analysis, an outstanding development capability of
our formulation R&D center, and the long-term established scientific
data on clinical trials, TTY will be the leading drug development
company in Taiwan and enter the global market with high-barrier to
competition and effective drugs of innovative formulations to become
the best partner of the companies that are competitive in drug promotion
in the target market.
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