智擎拿下Nanobiotix S.A.公司NBTXR3 (EU class III medical device) 亞太權利!!

智擎生技：智擎公司與法國Nanobiotix S.A.公司共同簽署 NBTXR3亞太地區獨家授權與合作契約 鉅亨網新聞中心2012-08-06 16:05:50第三十四條第8款1.事實發生日:101/08/062.契約或承諾相對人:法國Nanobiotix公司3.與公司關係:無4.契約或承諾起迄日期(或解除日期):101/08/065.主要內容(解除者不適用):智擎公司與法國Nanobiotix S.A.公司共同簽署NBTXR3之亞太地區獨家授權與合作契約，NBTXR3目前正進行第一期人體臨床試驗中。Nanobiotix S.A公司專精於開發具前瞻性的放射線治療(radiotherapy)技術，NBTXR3為該公司開發提升放射線治療技術系列中之第一個產品，該技術除了可以讓放射線治療更容易殺死腫瘤細胞外，還可以使腫瘤周圍的健康組織受到較少的影響或傷害。NBTXR3在現有的癌症放射線標準治療中，可以扮演一重要的角色，來彌補現今放射線治療的不足。目前全世界大約有50%的癌症病人接受放射線治療，因此NBTXR3能在已經成熟且龐大的放射線治療癌症市場，創造利基性的需求。依據雙方所簽署的授權與合作契約內容，智擎公司取得NBTXR3在台灣、中國大陸、日本、韓國、印度、澳洲及其他亞太地區國家之開發與商品化之獨家授權。智擎公司將給付Nanobiotix S.A.公司美金一百萬元之簽約金(upfront payment)、及共計可達美金五千六百萬元之未來開發成功上市及銷售階段性授權金(milestone payment)；並在NBTXR3上市後，智擎公司將依照其在授權區域內之淨銷售額分級，支付Nanobiotix S.A.公司最高可達兩位數百分比的權利金(royalties)。此外，智擎公司將依據雙方同意的開發計畫及時程，負責NBTXR3在三種不同適應症上的臨床試驗開發。6.限制條款(解除者不適用):無7.對公司財務、業務之影響(解除者不適用):對智擎公司之未來發展應有正面之影響8.具體目的(解除者不適用):引進新專案授權與合作契約9.其他應敘明事項:無

PharmaEngine, Inc. and Nanobiotix S.A. Enter into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a Radioenhancer, accelerating the development of NBTXR3 in conjunction with radiotherapy Aug. 6, 2012, 5:17 a.m. EDT  TAIPEI, Taiwan, Aug 06, 2012 (BUSINESS WIRE) -- PharmaEngine, Inc. (two:4162) announced today the execution of an exclusive license and collaboration agreement with France-based Nanobiotix S.A. for the development and commercialization of NBTXR3, currently being investigated in a phase I study with soft tissue sarcoma patients. Nanobiotix is a leading nanomedicine company that intends to revolutionize radiotherapy, making it more deadly to tumors while preserving healthy tissues. NBTXR3 will play a seminal role in addressing a major unmet medical need to allow the creation of a huge and well-structured market within the existing standard of care. Approximately 50% of cancer patients receive radiotherapy. Under the terms of the agreement, PharmaEngine will receive the exclusive rights to develop and commercialize NBTXR3 in Australia, China, India, Japan, Korea, Taiwan and other countries in the Asia-Pacific region. Nanobiotix will receive an upfront payment of US$1 million, and is eligible to receive up to a total of US$56 million upon achievement of certain development, regulatory and sales milestones, as well as tiered, up to double-digit royalties on net product sales of NBTXR3 in the licensed territory. PharmaEngine will further fund the clinical development of NBTXR3 in three different indications according to an agreed upon time schedule and development plan."We are attracted by the innovative approach of NBTXR3 to overcome the current limitations of radiotherapy, and the possibility of developing it as a medical device which follows a faster development and regulatory pathway than a drug," said C. Grace Yeh, Ph.D., President and Chief Executive Officer of PharmaEngine. "We believe that by joining forces with Nanobiotix, PharmaEngine can expand the clinical applications of this project based on our successful experience with a nanoparticle formulation of irinotecan (PEP02)."

About NBTXR3 NBTXR3, the lead compound of the NanoXray pipeline, is a nanoparticle formulation of hafnium oxide crystals for the local treatment of tumors to enhance the efficacy of radiotherapy. NBTXR3 has been classified in the EU as class III medical device and is currently being tested in a European phase I trial to establish feasibility and safety of NBTXR3 in patients with soft tissue sarcoma. PharmaEngine will designate NBTXR3 as PEP503 in its development pipeline.

SOURCE: PharmaEngine, Inc.