NEOVACS SIGNS STRATEGIC SOURCING AGREEMENT TO SUPPLY INTERFERON ALPHA FOR PHASE IIB LUPUS TRIAL
Paris, May 5, 2014 - NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced it entered into a strategic agreement with Pharmedartis to supply the interferon alpha (IFNalpha) needed for the manufacturing of IFNalpha-Kinoid for Neovacs' upcoming phase IIb clinical trial in lupus.
Under the agreement, Pharmedartis will begin delivering IFNalpha to the Company in the third quarter of 2014. Based on the planned delivery and manufacturing timeline, Neovacs expects to begin its phase IIb trial of IFNalpha-Kinoid for the treatment of lupus in mid-2015.
"This strategic supply agreement is an important first step toward the launch of our next clinical trial for IFNalpha-Kinoid immunotherapy. Through Pharmedartis, Neovacs will benefit from the Fraunhofer Institute for Molecular Biology and Applied Ecology's leading capabilities and expertise. Fraunhofer IME will notably prepare the GMP[1] campaign for the production of interferon. With Pharmedartis as our supply partner, we believe that we are well equipped for the next development phase of IFNalpha-Kinoid," said Miguel Sieler, CEO of Neovacs.
About the IFNalpha-Kinoid phase IIb clinical trial in lupus
Neovacs plans to initiate a phase IIb clinical trial of IFNalpha-Kinoid for the treatment of lupus in mid-2015. This multi-center international study will have a primary endpoint of clinical efficacy. Lupus is a chronic and systemic auto-immune disease with significant medical need. It affects more than 3 million people in the 7 major pharmaceutical markets[2], with 1.5 million cases in the US[3] and 1.2 million cases in China alone[4].
About Pharmedartis
Pharmedartis GmbH is a biotechnology company founded by experienced scientists of the German Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Aachen. Pharmedartis strives to improve the quality of life by providing better proteins for biopharmaceuticals at lower costs in a shorter timeframe.
[1] GMP : Good manufacturing Practices required in order to conform to guidelines recommended by agencies which control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.
[2] Source : Datamonitor 2011 // La Merie 2012
[3] Lupus Foundation of America http://www.lupus.org/about/statistics-on-lupus
[4] Source : Datamonitor 2011 // La Merie 2012
