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NANOMI AND INNOCORE ANNOUNCE SUCCESSFUL COMPLETION OF cGMP MICROSPHERE MANUFACTURING FEASIBILITY STUDY

Oldenzaal and Groningen, The Netherlands, November 12^th, 2010

Nanomi BV and InnoCore Technologies BV today announced the successful completion of a feasibility study performed by BioConnection, regarding the cGMP manufacturing of their advanced controlled release microsphere formulations based on the SynBiosys biodegradable polymeric drug delivery system and Monosphere^TM monodisperse microsphere manufacturing technology. This study followed InnoCore's and Nanomi's announcement earlier this year to jointly offer their respective SynBiosys and Monosphere technologies to the market as a powerful platform technology for the creation of microsphere depot formulations for the sustained delivery of biotherapeutics.

Currently parties are negotiating an agreement where BioConnection will take care of clinical manufacturing of controlled release microsphere formulations of biotherapeutic proteins that are under development at Nanomi and InnoCore for a European customer. BioConnection, besides clinical manufacturing, would also provide additional CMC development services, including manufacturing process scale-up to commercial scale.

"BioConnection gives us access to state-of-the-art cGMP manufacturing facilities for parenterals," said Gert Veldhuis, CEO of Nanomi. "Their ability to provide clinical trial material together with a clear perspective towards commercial scale-up would fill up a crucial part of our value proposition to our pharmaceutical clients," added Rob Steendam, CTO of InnoCore."

"We are pleased with the positive outcome of the study", said Alexander Willemse, CEO of BioConnection. "The SynBiosys and Monosphere platforms offer us a beautiful technical challenge where we can apply and enhance our knowledge of biopharmaceutical product development while giving Nanomi and InnoCore access to global manufacturing via our state-of-the-art production facilities." 

About Bioconnection

BioConnection, based in Oss, the Netherlands, offers clinical and commercial scale Fill & Finish - including freeze-drying - of vials, ampoules and syringes to innovative biotech companies around the globe. Their state-of-the art automated filling lines, which are in compliance with the guidelines issued by the EMEA and US FDA can handle batch size from a few hundred up to 250,000 units per batch. Their services include in addition to the cGMP manufacture of injectables a whole range of various CMC development activities (such as formulation development, process and analytical development, lyophilization cycle development, and scale-up) and Clinical Trial Material support (e.g. clinical trial packaging, QP release and distribution to principal investigators). BioConnection is very well positioned and equipped to assist innovative biotech companies in their endeavours to bring their invention from the lab bench to the clinic and/ or to the market. For more information, please refer to www.bioconnection.eu

About Nanomi

Nanomi is an independent, privately owned Dutch life sciences company, providing its customers with novel, high added value, microsphere based (e.g. drug delivery) products enabled by its Monosphere technology. The company was founded in 2004 and is located in the East of the Netherlands. Nanomi is profitable and has successfully entered into business agreements for the development of products for several blue chip multinationals. The heart of the Monosphere technology is the proprietary microsieve^TM emulsification process. Silicon microsieves bring the precision of the semiconductor industry to the life sciences, enabling the production of highly monodisperse droplets and particles in a robust, reproducible and cost effective way. Nanomi targets business-to-business partnerships with companies in drug delivery, molecular imaging, diagnostics, and research and analysis that have a high value product or application that can strongly benefit from its technology. Nanomi does not distribute and market products on its own.

About InnoCore Technologies

InnoCore is a privately owned Dutch biopharmaceutical drug delivery company specialized in the development of novel injectable pharmaceutical drug delivery products and drug eluting medical implants based on its proprietary SynBiosys biodegradable polymeric drug delivery technology. InnoCore focuses on the development of long-acting and minimally invasive controlled release formulations for precise delivery of small lipophilic molecules, therapeutic peptides and proteins. Its technology portfolio comprises various product configurations, including microspheres, long-acting solid implants, in situ forming gels and coatings. Since its inception in 2003, Innocore has successfully established partnerships with biomedical, biotech and pharma companies throughout the world. Various injectable depot formulations including long-acting solid injectable implants for LHRH-agonist and microsphere formulations for several therapeutic proteins are currently under development. Sirolimus-eluting coronary stents comprising SynBiosys coatings are currently evaluated in Orbusneich' REMEDEE trial. To support its customers during clinical product development InnoCore, in collaboration with its strategic partners, is working on the realization of cGMP facilities for small scale clinical production of SynBiosys microspheres and implants.