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

Cambridge, England, March 19, 2010 (ots/PRNewswire) - 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 States.[6]

"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 Montillo, Department of Haematology,
Niguarda Ca'Granda Hospital, Milan, Italy.

References

---------------------------------

[1] European Medicines Agency website: Accessed March 2010:
http://www.ema.europa.eu/

[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: http://www.treanda.com/

[6] Tandem Audit 2010-data on file

ots Originaltext: Mundipharma International
Im Internet recherchierbar: http://www.presseportal.de

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