Company Performance Metrics
Nitec is a specialty pharmaceutical company focused on the commercialization and development of medicines to treat chronic inflammation and pain-related diseases. It seeks to address areas of high unmet medical need within these markets by developing proprietary products based on well-characterized pharmaceuticals and disease targets. The Company
is a spin-out of Merck KGaA and is headquartered in the Basel region of Switzerland. Since its formation in 2004, Nitec has developed and commercialized its lead product, Lodotra™.
Nitecâ€:tm:s most advanced product candidate is Lodotra™, a circadian cytokine modulator, which successfully completed a European phase 3 trial in rheumatoid arthritis (RA) in 2006. In January 2009, Lodotra™ was recommended for European regulatory approval for the treatment of rheumatoid arthritis (“RA“), particularly the associated and debilitating morning stiffness, following the successful completion of a phase III trial (CAPRA-1) in 2006. Germany was the Reference Member State and Lodotra™ is now also expected approvable by the regulatory agencies of 14 other countries under the Decentralized Procedure. In March Nitec announced a European partnership for Lodotraâ€:tm:s commercialization with MundiPharma. Merck KGaA, which holds the distribution rights to Lodotra™ in Germany and Austria, have recently launched the product in Germany.
Nitec is conducting a second pivotal phase 3 trial in preparation for the filing of an NDA with the FDA seeking US approval of Lodotra™ for the treatment of the signs and symptoms of RA including morning stiffness. Lodotra™ is also being developed for the treatment of severe asthma and polymyalgia rheumatica (PMR).
Nitecâ€:tm:s second product candidate is TruNoc™ (tarenflurbil), which is being developed as a treatment of neuropathic pain and other chronic inflammation and pain-related diseases. Nitec is conducting pharmacokinetic studies in preparation for phase 2 trials in neuropathic pain.
