Levact(R) (bendamustine) Recommended for Approval in Europe for Treating Blood Cancers

By Mundipharma, PRNE
Thursday, March 18, 2010

CAMBRIDGE, England, March 19, 2010 - Mundipharma announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
issued a positive opinion recommending that marketing authorisations can be
granted in Germany and the following Member States of the EU: Austria,
Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway,
Poland, Spain and the United Kingdom (UK) for the use of bendamustine in the
treatment of patients with indolent non-Hodgkin's lymphoma (NHL), chronic
lymphocytic leukaemia (CLL) and multiple myeloma (MM).[1] If adopted by EU
authorities, bendamustine will be another vital treatment in the fight
against blood cancers.

Dr Thomas Mehrling from Mundipharma commented, "We are delighted with
this decision and believe it represents a dramatic step towards improved
treatment for patients with haematological malignancies."

Following a European Commission decision on this positive
opinion and the granting of national licences, the first launches of
bendamustine in the European Union are anticipated in mid-2010 in Austria,
Denmark, Finland and the UK.

Bendamustine is a highly effective chemotherapy agent which
differs from those that are already available due to its unique chemical
structure and activity.[2] The announcement is particularly important for
those patients with common white blood cell malignancies, notably indolent
NHL, CLL and MM, including those patients with indolent NHL that have not
responded to other therapies, or those patients where their cancer has
returned after a period of absence.

Bendamustine is currently licensed in Germany (under the brand
name Ribomustin(R)) for CLL, first-line therapy of advanced indolent NHL in a
combination protocol, and in combination with prednisone for advanced MM
stage II with progress or stage III.[3] Between 2008 and 2009, bendamustine
was used to treat 13,357 patients in Germany.[4] In the United States,
bendamustine is indicated for the treatment of indolent B-cell NHL that has
progressed during or within six months of treatment with rituximab or a
rituximab-containing regimen and also for the treatment of patients with
CLL.[5] Since its launch, 14,000 patients have been treated in the United

"New treatments capable of inducing further remission without
excessive toxicity are urgently needed. Many of the patients who may benefit
from bendamustine currently have no or few treatment options available. This
product provides these patients with renewed hope" commented Professor Marco
, Department of Haematology, Niguarda Ca'Granda Hospital, Milan,



[1] European Medicines Agency website: Accessed March 2010:

[2] Leoni LM et al, Bendamustine (Treanda) Displays a Distinct Pattern of
Cytotoxicity and Unique Mechanistic Features Compared with Other Alkylating
Agents. Clin Cancer Res 2008; 14(1):309-317

[3] Ribomustin SPC

[4] IMS Oncology Analyzer- data on file

[5] Treanda website: Accessed March 2010: www.treanda.com/

[6] Tandem Audit 2010-data on file

For further information please contact: Bily Kuo, Mundipharma International, Tel: +44(0)1223-397118, Mob: +44(0)7760-619251, bily.kuo at mundipharma.co.uk; Rachel Bannister, Tonic Life Communications, Tel: +44(0)207-798 9997, Mob: +44(0)7961-426396, rachel.bannister at toniclc.com

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