NITEC PHARMA GRANTS EXCLUSIVE EUROPEAN DISTRIBUTION LICENCE TO MUNDIPHARMA FOR LODOTRATM Basel/Reinach, Switzerland, 31 March 2009 – 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 that it has granted an exclusive licence to Mundipharma International Corporation
Limited (‘Mundipharma’) for the distribution of LodotraTM in Europe.
Under the terms of the agreement, Mundipharma wil acquire the distribution rights to
LodotraTM in Europe, excluding Germany and Austria which are licensed to Merck KGaA, and
Nitec wil receive undisclosed royalty payments. Nitec retains al commercialisation rights for
LodotraTM, Nitec’s novel single-pulse delayed-release (“SPDR”) low-dose prednisone tablet,
was recommended for European regulatory approval for the treatment of rheumatoid arthritis
(“RA”) and associated morning stiffness in January 2009. Germany lead the Decentralised
Procedure and Lodotra™ is now also considered approvable by the regulatory agencies of 14
other countries (the “Euro15”). LodotraTM is expected to be launched in Germany within the
Dr. Anders Härfstrand, CEO of Nitec Pharma: “Our agreement with Mundipharma is a key
milestone for Nitec as we prepare for a European launch. Mundipharma has a proven track
record in successful y launching and commercialising pharmaceutical products in Europe.
Their strength, as a partner, is with their strong expertise with the target prescribers in these
key markets. We are confident that this agreement with Mundipharma’s highly committed and
specialized sales force wil accelerate Lodotra’s market success. Personal y, I strongly believe
that our two companies wil cooperate effectively as we share values and an entrepreneurial
Åke Wikström, Regional Director, Europe, Mundipharma International Limited, said:
“Lodotra™ represents a major advance in the treatment of Rheumatoid Arthritis and
associated morning stiffness. We are delighted to partner with Nitec Pharma in the
commercialisation of this exciting new product in Europe.”
Lodotra™ is a circadian cytokine modulator (CCM), which can be taken at bedtime.
Lodotra™’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 wel
established treatment effects of glucocorticoids.
Further Information:
E-mail: anders.harfstrand@nitecpharma.com
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™, a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis
(RA), which has recently received a recommendation for European regulatory approval. Nitec
was original y 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 Mundipharma
The Mundipharma independent associated companies, including Mundipharma, Purdue and
Napp are privately owned companies and joint ventures covering the world’s pharmaceutical
markets. The companies worldwide are dedicated to bringing to patients with severe and
debilitating diseases the benefit of novel treatment options in fields such as severe pain,
haemato-oncology and respiratory disease. For more information: www.mundipharma.co.uk
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