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Nitec's IND Application for Clinical Development With Lodotra Accepted by the FDA

BASEL, Switzerland, September 24 /PRNewswire/ -- Nitec Pharma AG today announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application submitted by Nitec for the initiation of clinical development for Lodotra.

Following the positive results of a European Phase III trial (CAPRA-1; Circadian Administration of Prednisone in Rheumatoid Arthritis), Nitec submitted a dossier for marketing authorization in Europe. The FDA's acceptance of the IND will now allow Nitec to start clinical development of Lodotra in the USA.

A second Phase III study (CAPRA-2), currently planned to be initiated in the second quarter of 2008 will include about 300 patients in the US and EU.

"The new Lodotra trial is highly relevant for rheumatoid arthritis patients. Lodotra reduces IL-6 levels and has great potential to improve the signs and symptoms of RA, such as morning stiffness," commented Professor Kenneth G. Saag of the University of Alabama at Birmingham, member of the scientific steering group in the planned Phase III trial.

Clinical trials of Lodotra have demonstrated that it is a treatment that can make a difference to the lives of patients with RA. Morning stiffness is a debilitating symptom of the disease with a significant negative impact on the lives of patients with RA and Lodotra now offer clinicians an effective potential treatment option.

"It was always our intention to conduct the appropriate trials in the US and to further elucidate the additional benefits which Lodotra can bring to RA patients on top of the exciting results we have seen in our CAPRA-1 study. We are therefore very pleased to have been given the go-ahead from the FDA to initiate the clinical development of Lodotra in the USA," said Anders Harfstrand, CEO of Nitec Pharma.

Lodotra is a modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone in Rheumatoid Arthritis (RA). Lodotra has the additional, clinically important advantage of reducing the morning stiffness characteristic of RA, which is combined with a convenient dosing regimen and a comparable safety profile to standard prednisone.

About Nitec Pharma AG:

Nitec Pharma is a biopharmaceutical company specialized in the development and commercialization of optimized medicines for the treatment of chronic inflammatory diseases and pain. Nitec is headquartered in Reinach, Switzerland, with a subsidiary in Mannheim, Germany. The Company's most advanced product is Lodotra(R), a circadian cytokine modulator for the treatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004 as a spin-out of Merck KGaA. The Company is financed by Atlas Venture, Global Life Science Ventures and NGN Capital. For further information about Nitec Pharma please visit

This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

Notes for Editors:


Lodotra provides all the benefits of standard immediate release (IR) prednisone but has the additional, clinically important advantage of reduced morning stiffness combined with a convenient dosing regimen and a comparable safety profile.

The diurnal rhythm in RA is characterised by elevated night time levels of inflammatory cytokines such as IL6, which leads to extreme stiffness and pain in the hours immediately after awaking. It has been established that these morning symptoms can be addressed with prednisone administered at 2am. However, until now this has been impossible without disturbing sleep. Lodotra is an oral medication that has a unique delivery system that ensures rapid release of the prednisone from the tablet core about 4 hours after ingestion. Administration of Lodotra at night time (10 PM) results in release of prednisone at about 2am for a more effective treatment of the morning symptoms of RA.

Lodotra successfully completed Phase III trials in mid-2006.

SOURCE Nitec Pharma AG
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