New manufacturing unit increases production capacity 25 fold
Paris, France, 18 March, 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.
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: www.nanobiotix.com
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.
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.
This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix registered by the French Financial Markets Authority (Autorité des marchés financiers) on November 25, 2014 under number R.14-071 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.
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Melanie Toyne-SewellManaging Partner