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The European Commission has granted orphan drug status to Cytori Therapeutics' broad range of Cytori Cell Therapy formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.
Key benefits of this broad orphan drug designation include: (1) the ability to pursue multiple therapeutic formulations for systemic scleroderma that are not restricted to the processing of the adipose-derived cellular therapeutics at the bedside with the Celution System or other current technology, (2) allows adipose-derived cellular therapeutics that are cryopreserved for later administration and (3) provides a pathway for Cytori to expeditiously seek conditional market approval in the
“This broad orphan designation expands our strategic regulatory position and commercial options in Europe,” said Marc Hedrick, president and CEO of Cytori Therapeutics. “We intend to rely on this orphan designation, as well as long term safety and efficacy data from the SCLERADEC-I trial to seek conditional market authorization from the European Medicines Agency (EMA) on an accelerated timeline.”
“Orphan designation in Europe comes with significant benefits,” said Kenneth K. Kleinhenz, vice president of global regulatory affairs and quality assurance of Cytori Therapeutics. “These benefits include up to 10 years of market exclusivity if the medicine is authorized by the European Medicines Agency (EMA), access to the EMA’s conditional marketing authorization pathway (which is designed for orphan products that have initial clinical data and are actively in the process of completing their pivotal clinical studies), and an additional 10% reduction in regulatory fees beyond the reductions already afforded us because of our SME status. We believe the ECCS-50 therapy for scleroderma may benefit from these accelerated programs in Europe. This broad orphan designation will play a key role in our ability to fully access these programmes.”
