| Website | nitecpharma.com/i... |
| Phone | +41 61 715 20 40 |
| Employees | |
| Founded | 2004 |
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, Lodotraâ„¢.
Nitec’s most advanced product candidate is Lodotraâ„¢, a circadian cytokine modulator, which successfully completed a European phase 3 trial in rheumatoid arthritis (RA) in 2006. In January 2009, Lodotraâ„¢ was recommended for European regulatory approval for the treatment of rheumatoid arthritis (“RAâ€), 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 Lodotraâ„¢ 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 Lodotra’s commercialization with MundiPharma. Merck KGaA, which holds the distribution rights to Lodotraâ„¢ 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 Lodotraâ„¢ for the treatment of the signs and symptoms of RA including morning stiffness. Lodotraâ„¢ is also being developed for the treatment of severe asthma and polymyalgia rheumatica (PMR).
Nitec’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.
