Nitec Pharma Reports Positive and Highly Significant Phase III Results From Capra-2...

Nitec Pharma Reports Positive and Highly Significant Phase III Results From
Capra-2 Study of Lodotra(TM) in RA

BASEL and REINACH, Switzerland, September 2 /PRNewswire/ --
- CAPRA-2-Data Will be Used to File for US Marketing Approval
Nitec Pharma AG ("Nitec" or "Nitec Pharma"), a Switzerland-based
specialty pharma company focused on the development and commercialization of
medicines to treat chronic inflammation and pain-related diseases, today
announced positive results from the second pivotal phase III trial for its
lead product, Lodotra(TM).
The CAPRA-2 study (Circadian Administration of Prednisone in Rheumatoid
Arthritis-2) was a 12-week, multicentre, double-blind phase III trial
evaluating the safety and efficacy of Lodotra(TM) for the treatment of
rheumatoid arthritis ("RA"), a chronic, progressive and disabling autoimmune
disorder. In total 350 patients, all inadequate responders to DMARD therapy,
were randomised in one of two arms to receive either Lodotra(TM) (5mg once
daily), or placebo in addition to their existing therapy. The primary
efficacy endpoint was the ACR-20 response rate, which is defined as at least
a 20% improvement in a number of disease-specific criteria. The key secondary
endpoint was the change in the duration of morning stiffness of the joints.
CAPRA-2-data will be used to file for US marketing approval with the FDA
together with the data already available from the CAPRA-1 pivotal phase III
trial which has shown the superiority of Lodotra(TM) over standard prednisone
treatment.
Lodotra(TM)-treated patients showed an ACR-20 response of 49% compared to
29% in the placebo group. The difference was highly significant (p=0.0002;
LOCF). The reduction of morning stiffness was 44% in the Lodotra(TM) group
(21 % in the placebo group). This difference was also highly significant
(p=0.0008). Lodotra(TM) was safe and well tolerated. The number of adverse
events was low and comparable in both groups.
Dr. Anders Harfstrand, CEO of Nitec commented: "We are delighted to
report successful and very positive outcomes of the CAPRA-2 study. These
strongly underline the benefits of Lodotra(TM) in the treatment of RA. The
study confirms clearly that the innovative delivery system of Lodotra(TM) is
able to adapt the timing of glucocorticoid treatment to a patient's circadian
rhythm in order to improve the efficacy and safety of prednisone. CAPRA-2 is
the first pivotal phase III study to demonstrate the ACR-20 response of a
very low dose of prednisone as a primary endpoint. Following the successful
European launches of Lodotra(TM) and the positive feedback that we have
received from RA specialists, we look forward to completing the regulatory
process in the US."
LodotraTM, Nitec's novel single-pulse delayed-release ("SPDR") low-dose
prednisone tablet, was launched in Germany by Merck KGaA, which holds the
exclusive distribution rights for Germany and Austria. In April 2009
Mundipharma acquired the distribution rights to LodotraTM in the rest of
Europe and Nitec retains all commercialization rights for the US and rest of
the world.
About Nitec Pharma AG
Nitec Pharma is a Switzerland-based specialty pharmaceutical company
focused on the development and commercialisation of innovative medicines and
effective treatment solutions for chronic inflammation and pain-related
diseases. Nitec's most advanced product is Lodotra(TM), a circadian cytokine
modulator (CCM) for the treatment of rheumatoid arthritis (RA), which has
received a recommendation for European regulatory approval and is launched in
Germany. Nitec was originally founded in 2004 as a spin-out of Merck KGaA and
is headquartered in Reinach in Switzerland. Nitec is financed by Atlas
Venture, Global Life Science Ventures, NGN Capital, TVM Capital and a
principal investment arm of Deutsche Bank AG, London. For further information
about Nitec Pharma please visit www.nitecpharma.com
About Lodotra(TM)
Lodotra(TM) is a circadian cytokine modulator (CCM), which can be taken
at bedtime. Lodotra(TM)'s unique release mechanism releases the
glucocorticoid prednisone during the night around 2am enabling suppression of
the nocturnal proinflammatory cytokines. This results in an effective relief
of the early morning symptoms of RA, in addition to the well established
treatment effects of glucocorticoids.
Further Information:

Anders Harfstrand, MD PhD
CEO
Nitec Pharma AG
Tel: +41-61-715-20-46
Mobile: +41-79-83493-20
E-mail: anders.harfstrand@nitecpharma.com

SOURCE Nitec Pharma AG

Further Information: Anders Harfstrand, MD PhD, CEO, Nitec Pharma AG, Tel:
+41-61-715-20-46, Mobile: +41-79-83493-20, E-mail:
anders.harfstrand@nitecpharma.com