Nitec Pharma

Nitec is a speciality pharmaceutical company focused on the development and commercialization of innovative medicines and effective treatment solutions for chronic inflammation and pain-related diseases. The Company 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’s lead product candidate, Lodotra^™, successfully completed a European Phase 3 trial in rheumatoid arthritis (RA) in 2006. A dossier was submitted in 2006 in order to obtain marketing authorization in 15 European countries using the decentralized procedure, and, after successful completion of this decentralized procedure, the marketing authorisation in these countries is expected in the second half of 2008. Lodotra^™ is a proprietary night-time release formulation of prednisone that represents a new class of therapeutic: circadian cytokine modulators (CCMs). In RA, nocturnally elevated pro-inflammatory cytokine levels, such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), are known pro-inflammatory factors leading to morning stiffness. By synchronizing prednisone delivery time with the sufferer’s cytokine rhythm, Lodotra^™ takes effect at a physiologically optimal point to inhibit cytokine production and thus significantly reduce morning stiffness and other RA symptoms. Nitec is also 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.

In addition to RA, Lodotra^™ is being developed for the treatment of severe asthma and polymyalgia rheumatica (PMR), which similarly appear to follow nocturnal circadian cytokine rhythms. Lodotra^™ is in a phase 2 trial for the treatment of severe asthma, and Nitec is designing a label extension trial for the treatment of PMR.

Nitec’s second product candidate is TruNoc (tarenflurbil). Tarenflurbil is a focused inhibitor of certain well-characterized genes (NF-κB and AP-1), whose expression is known to lead to inflammation and pain. The compound is one of two enantiomers (chemically mirror-imaged compounds) that constitute flurbiprofen, an analgesic and anti-inflammatory pharmaceutical, which gained marketing approval in the 1970s. Compared to the opposite enantiomer, tarenflurbil does not exhibit significant COX-I/II inhibition with its associated negative side-effects. Nitec is developing TruNoc for the treatment of chronic inflammation and pain-related diseases. Nitec is conducting pharmacokinetic studies in preparation for phase 2 trials in neuropathic pain and osteoarthritis.

Nitec was founded in 2004 as a spin out from Merck KGaA where Lodotra^™ was originally developed by Nitec’s founders, Jochen Mattis and Achim Schäffler, PhD.

The Company is headquartered in the Basel region of Switzerland, with a wholly-owned subsidiary in Mannheim/Germany.