Paris, France | Posted on March 18th, 2015 NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces it has appointed CordenPharma as its manufacturing partner. The opening of a new manufacturing line and the scaling up of production is an important step in NBTXR3's route to commercialization. Nanobiotix appoints its Manufacturing Partner, CordenPharma : another step towards commercialization: New manufacturing unit increases production capacity 25 fold. The new manufacturing line, located in France, will increase the amount of NBTXR3 product available. With an anticipated award of a CE mark in 2016, the Company is preparing to scale-up production further to meet the needs of future commercialization. Furthermore, Nanobiotix is anticipating future demand from clinical trials in the coming years in Europe and in the United States. CordenPharma is an international full service CMO (contract manufacturing organization) which provides specialized technologies for the development and manufacture of health products. The company is recognized by EMA and FDA thanks to its eight cGMP facilities across Europe and the United States and works with both pharma and biotech companies. Its facilities are regularly inspected by the regulatory authorities (FDA and EMA) and have a good track record. Laurent Lévy, Chief Executive Officer at Nanobiotix, commented: "Finding the right manufacturing partner is essential, since ensuring quality and sufficient levels of supply is fundamental for meeting the market demands and the growth of the Company." Yves Michon, Président Synkem - CordenPharma said: "Nanobiotix's product, NBTXR3 is a fascinating product - not only with respect to its properties, but also in its manufacture. We are working closely with Nanobiotix to ensure a seamless process and manage the scale-up of the product." NBTXR3 is Nanobiotix's lead product in the NanoXray portfolio. The product comprises Hafnium Oxide nanoparticles which can be injected directly into tumor. With the application of radiotherapy, these nanoparticles absorb X-rays have the potential to significantly enhances the radiation dose within the cancer cells without increasing the dose to the surrounding healthy tissues. NBTXR3 has the potential to cause a paradigm shift in cancer therapy with significant clinical benefit for patients. In November 2014, Nanobiotix announced its global clinical development plan. In addition to Soft Tissue Sarcoma and Head and Neck cancer, the plan now includes metastatic liver cancer, hepatocellular carcinomas and prostate cancer. In the second half of 2015, the liver cancers and high risk prostate cancer programs are anticipated to enter the clinical stage.
About Nanobiotix Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of cancers including Soft Tissue Sarcoma, Head and Neck Cancer, Liver Cancers, Prostate Cancer, Breast Cancer, Glioblastoma, etc., via multiple routes of administration. Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical development for Soft Tissue Sarcoma and locally advanced Head and Neck Cancer. The company has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia. Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The company, based in Paris, France, opened an affiliate office in the Boston area of the United States in September 2014.
About CordenPharma: CordenPharma is the pharmaceutical brand of International Chemical Investors Group (ICIG). Formed in 2006, CordenPharma is a full-service partner for the cGMP Contract Development & Manufacturing (CDMO) of Active Pharmaceutical Ingredients, Drug Products and associated Packaging Services.
PEP503是一種結晶狀之奈米鉿氧化物(nanoparticle formulation of hafnium oxide crystals, HfO2）。其主要作用是PEP503在放射線(X-Ray)照射下，將其內部鉿氧化物(HfO2)分子或原子游離或變成激發狀態後，可直接或間接的引起細胞DNA結構的化學變化，進而造成細胞的死亡。其以局部治療(local treatment)為目的，具有提升癌症放射線治療的作用，因此是一種放射線治療提升劑(radioenhancer)。PEP503預期能夠大幅增加使用放射線治療時的劑量區間(therapeutic window)，在不增加放射線治療劑量下提高抑制腫瘤的效果，並減少造成健康組織的損害。所以預期癌症病人在接受治療後，能夠獲得更好抑制腫瘤反應率，並能提高存活率。
Merrimack上周股價大漲，智擎今年營運也樂觀 MoneyDJ新聞 2015-03-09 11:34:09 記者 蕭燕翔 報導 智擎(4162)策略夥伴Merrimack上周股價大漲15%、一度又創新高，帶動市場對於胰臟癌二線用藥MM-398的後續想像。根據其法說釋出訊息，仍維持本季底、下季初送件申請美國藥證的進度，市場估算，再授權的歐洲夥伴Baxter可望於下半年跟進申請歐亞藥證，有助於智擎認列里程碑金，衝高獲利。而在智擎去年預期已轉虧為盈下，不排除今年有首度發放股利可能，充裕的現金亦有助其他產品線進度的推進。今年應該是不少新藥或特殊學名藥公司，開始將過去耕耘多年的產品Pipeline，從研發支出逐步邁向實質獲利的一年。智擎也是其中翹楚， 授權夥伴Merrimack主導的三期臨床結果去年已正式發表，中位數存活期可較對照組延長1.9個月，並已取得FDA快速審查資格，得採Rolling Review(資料隨到隨審)方式，FDA也期許Merrimack能放大量產數據後，一併申請藥證，Merrimack也計畫申請優先審查(Priority Review)，更能明確掌握審查期間。根據掌握，Merrimack先前量產批次已可達1萬針以上，並已進行安定性的數據累積，該公司二月底法說也釋出，送件申請美國藥證的時間將維持前次預期，亦即落在本季底、下季初。法說會也確定，將新增一線胰臟癌、胃癌等適應症，並自中後期臨床接手，擴大MM-398市場價值。而先前Merrimack也將歐亞區(不含台灣)的權利，再授權給大廠Baxter，市場估計，送件的時間點約落在美國一至二季，亦即最慢今年下半年也將跟進。對智擎而言，假設歐亞送件及審證順利、並可全數到手，今年看的到的收入，一為四月的500萬美元，另一則是送件申請與拿到歐亞藥證共計四階段7千萬美元收入，該部分對智擎的每股盈餘挹注超過20元。而因Merrimack再授權Baxter的動作，該公司除去年已認列700萬美元的收入外，未來在某些條件成立下，最高還將認列3,950萬美元的再授權收入。未來MM-398上市銷售後，只要銷售達成雙方協議的階段目標，智擎還有1.3億美元的銷售里程碑金(Sales Milestone)入帳，未來還將依歐亞銷售淨額拆帳，法人估計的權利金比例近10%。法人也評估，因智擎今年認列的收入可期，且去年也可望順利轉虧為盈，不排除今年將有首度的股利配發。且在營運現金流量轉正下，對推進其他產品Pipeline有正面助益，最值得期待的當屬放療輔助治療的PEP-503，後續進度可期。
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