Record Number of Bendamustine Abstracts Accepted for Presentation at the Annual Meeting of the American Society of Hematology (ASH)

Cambridge, England (ots/PRNewswire) -

- Total of 43 bendamustine abstracts to be presented at ASH, including five
oral presentations
- New data supports use of bendamustine-rituximab (B-R) regimen in indolent
non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL)

43 abstracts, announcing the results of studies involving
bendamustine in a number of lymphoid malignancies, including chronic
lymphocytic leukemia (CLL), multiple myeloma (MM), indolent NHL and
MCL, will be presented at the 54th Annual Meeting of the American
Society of Hematology (ASH), taking place from 8-11 December 2012 in
Atlanta, Georgia. Five will be oral presentations.

Two oral and three poster presentations focus on indolent NHL
(iNHL) and MCL, comparing treatment with bendamustine-rituximab (B-R)
to the standard first-line treatment, CHOP-R/CVP-R. One study
demonstrated improved complete response rates and progression free
survival (PFS) vs. CHOP-R, whilst another study demonstrated improved
quality of life with B-R compared to the current standards of care
(CHOP-R/CVP-R) for patients with iNHL or MCL.[1],[2],[3]

"We are delighted that such a wealth of bendamustine data has been
included in the ASH scientific program," said Antony Mattessich,
Regional Director, Europe, at Mundipharma. "Mundipharma is commited
to bringing innovative treatments to the cancer community, and we
expect the impact of bendamustine-rituximab on the quality of life
and outcomes of indolent non-Hodgkin lymphoma patients to remain of
central interest in the future."

A summary of the new B-R data being presented at ASH in iNHL and
MCL, is as follows:

Oral presentations

- Differences in Quality of Life Between Bendamustine Plus Rituximab
Compared with Standard First-Line Treatments in Patients with Previously Untreated
Advanced Indolent Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

B-R significantly improved global health status/quality of life
(GHS/QOL) compared to CHOP-R/CVP-R in previously untreated iNHL and
MCL patients.[3]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical
Models: Mantle Cell Lymphoma and Follicular Lymphoma. Sunday,
December 9, 2012: 5:30pm, Sidney Marcus Auditorium, Level 4, Building
A

- An Open-Label, Randomized Study of Bendamustine and Rituximab (BR)
Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in
First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL)
or Mantle Cell Lymphoma (MCL): The Bright Study

B-R produced a non-inferior complete response (CR) rate compared
to CHOP-R/CVP-R in patients with advanced iNHL and MCL (31% B-R vs.
25% CHOP-R/CVP-R, p=0.0225). [1]

Session: 624. Lymphoma - Therapy with Biologic Agents, excluding
Pre-Clinical Models: Optimizing Current Treatment Strategies.
Tuesday, December 11, 2012: 7:45am, B405-B407, Level 4, Building B

Poster Presentations

- Subanalysis of the StiL NHL 1-2003 Study: Achievement of Complete Response
with Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment of Indolent
and Mantle Cell Lymphomas Results in Superior Survival Compared to Partial Response

This subanalysis demonstrated significantly prolonged PFS
(p=0.0037) and overall survival (OS) (p=0.0008) for iNHL and MCL
patients who achieved a CR compared with a partial response (PR),
irrespective of the treatment arm.[2] When comparing the two
treatment arms, first-line treatment with B-R resulted in superior
PFS compared to CHOP-R, regardless of the quality of response.[2]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical
Models: Poster II. Sunday, December 9, 2012, 6:00pm-8:00pm. Hall
B1-B2, Level 1, Building B

- Bendamustine-Rituximab Induction Followed by Observation or Rituximab
Maintenance for Newly Diagnosed Patients with Waldenström's Macroglobulinemia:
Results From a Prospective, Randomized, Multicenter Study (StiL NHL 7-2008 -MAINTAIN-;
ClinicalTrials.gov Identifier: NCT00877214)

B-R was shown to be an efficacious treatment in patients with
Waldenström's Macroglobulinemia, achieving an overall response rate
of 86%, with no uncommon toxicities observed.[4]

Session: 624. Lymphoma - Therapy with Biologic Agents, excluding
Pre-Clinical Models: Poster II. Sunday, December 9, 2012,
6:00pm-8:00pm. Hall B1-B2, Level 1, Building B

- Bendamustine-Rituximab (B-R) Replaces R-CHOP As "Standard of Care" in the
Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres

An analysis of 645 patients receiving systemic first-line
treatment for iNHL in the clinical registry on lymphoid neoplasms
(TLN Registry) found that B-R was the most frequently used systemic
treatment for patients with iNHL in German hematology outpatient
centres, with 66% (n=428) of cases receiving B-R, compared to just
16% receiving CHOP-R as first-line treatment.[5]

Session: 623. Lymphoma - Chemotherapy, excluding Pre-Clinical
Models: Poster III. Monday, December 10, 2012, 6:00pm-8:00pm. Hall
B1-B2, Level 1, Building B

-Notes to Editors-

About Non-Hodgkin Lymphoma

NHL is the tenth most common cancer worldwide and figures from
2008 indicate that there are an estimated 356,000 new cases diagnosed
every year, comprising two out of five haematological cancers.[6]
iNHL represent 40% of all NHL subtypes.[7] The estimated average
incidence of NHL in 2008 in the European Union is 10.8 per
100,000.[6],[8]

About Mundipharma

The Mundipharma network of independent associated companies
consists of privately owned companies and joint ventures covering the
world's pharmaceutical markets. These companies are committed to
bringing to patients the benefits of pioneering treatment options in
the core therapy areas of oncology, pain, respiratory and rheumatoid
arthritis. They are also committed to independent thinking and ground
breaking solutions. Through innovation, design and acquisition, the
Mundipharma network of independent associated companies delivers
cutting-edge treatments to meet the most pressing needs of healthcare
professionals and patients. For further information please visit:
http://www.mundipharma.com

About Bendamustine

Bendamustine was first discovered in Germany 50 years ago in what
was then the German Democratic Republic (East Germany). In 2008 the
US Food and Drug Administration (FDA) approved bendamustine for the
treatment of iNHL and CLL, and it subsequently received European
approval in 2010 for certain types of iNHL, CLL and MM.

Bendamustine has marketing authorisations in Germany, France, UK,
Italy, Spain, Austria, Switzerland, Sweden, Norway, Finland, Denmark,
Poland, Slovakia, Ireland, Cyprus, Iceland, Belgium, The Netherlands,
Greece, Slovenia, Portugal, Czech Republic, Romania and Bulgaria
(Levact(R), Ribomustin(R), Ribovact(R)) where it is marketed by the
Mundipharma network of independent associated companies.

Bendamustine is licensed (Levact(R), Ribomustin(R), Ribovact(R))
from Astellas Deutschland GmbH.

In the United States, bendamustine (TREANDA(R)) is marketed by
Teva Pharmaceutical Industries Ltd. and indicated for the treatment
of patients with CLL, and indolent B-cell NHL that progressed during
or within six months of treatment with rituximab or a
rituximab-containing regimen.

SymBio Pharmaceuticals Ltd holds exclusive rights to develop and
market bendamustine HCL in Japan (sublicensed to Eisai Co Ltd) and
selected Asian countries including Hong Kong and Singapore. In South
America and Australasia the commercial rights are held by
Janssen-Cilag Ltd.

CHOP-R/CVP-R Treatment Regimens

Rituximab plus chemotherapy, most commonly CHOP or CVP, is the
current first-line standard of care for patients with advanced iNHL,
and patients with mantle cell lymphoma who are not fit for high-dose
chemotherapy.[9]

CHOP, a multi-drug chemotherapy regimen, is a combination of three
chemotherapy injections/infusions (cyclophosphamide, doxorubicin and
vincristine) on a single day, with a fourth agent (prednisone) taken
orally for five days. Each cycle is repeated every three weeks for
6-8 cycles.

CVP treatment follows a similar regimen but comprises two
chemotherapy injections/infusions (cyclophosphamide and vincristine),
followed by a five-day course of prednisone tablets.

References

1. Flinn IW, Van der Jagt RH, Kahl BS, et al. An Open-Label,
Randomized Study of Bendamustine and Rituximab (BR) Compared with
Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
(R-CHOP) in First-Line Treatment of Patients with Advanced Indolent
Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The
Bright Study. Abstract presented at ASH 2012. Available at
https://ash.confex.com/ash/2012/webprogram/Paper51442.html.

2. Rummel MJ, Niederle N, Maschmeyer G, et al. Subanalysis of the
StiL NHL 1-2003 Study: Achievement of Complete Response with
Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment
of Indolent and Mantle Cell Lymphomas Results in Superior Survival
Compared to Partial Response. Abstract presented at ASH 2012.
Available at
https://ash.confex.com/ash/2012/webprogram/Paper48063.html.

3. Burke JM, Van der Jagt RH, Kahl BS, et al. Differences in
Quality of Life Between Bendamustine Plus Rituximab Compared with
Standard First-Line Treatments in Patients with Previously Untreated
Advanced Indolent Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma.
Abstract presented at ASH 2012. Available at
https://ash.confex.com/ash/2012/webprogram/Paper49604.html.

4. Rummel MJ, Lerchenmüller C, Greil R, et al.
Bendamustin-Rituximab Induction Followed by Observation or Rituximab
Maintenance for Newly Diagnosed Patients with Waldenström's
Macroglobulinemia: Results From a Prospective, Randomized,
Multicenter Study (StiL NHL 7-2008 -MAINTAIN-; ClinicalTrials.gov
Identifier: NCT00877214). Abstract presented at ASH 2012. Available
at https://ash.confex.com/ash/2012/webprogram/Paper48052.html.

5. Ulrich Knauf W, Abenhardt W, Nusch A, Grugel R, Marschner N.
Bendamustine-Rituximab (BR) Replaces R-CHOP As "Standard of Care" in
the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology
Outpatient Centres. Abstract presented at ASH 2012. Available at
https://ash.confex.com/ash/2012/webprogram/Paper53051.html.

6. Non-Hodgkin lymphoma incidence statistics: In the EU and
worldwide. Cancer Research UK. Available at http://www.cancerresearch
uk.org/cancer-info/cancerstats/types/nhl/incidence/#world [http://www
.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence].
Accessed November 2012. European Age-Standardised rates calculated by
the Cancer Research UK Statistical Information Team, 2011, using data
from GLOBOCAN 2008 v1.2, IARC, version 1.2 [http://globocan.iarc.fr].

7. Gascoyne, Randy D. Hematopathology approaches to diagnosis and
prognosis of indolent B-cell lymphomas. ASH Education Program Book
2005.1 (2005): 299-306.

8. European Age-Standardised rates calculated by the Cancer
Research UK Statistical Information Team, 2011, using data from
GLOBOCAN 2008 v1.2, IARC, version 1.2 [http://globocan.iarc.fr].
Available at Non-Hodgkin lymphoma incidence statistics: In the EU and
worldwide. Cancer Research UK http://www.cancerresearchuk.org/cancer-
info/cancerstats/types/nhl/incidence/#world [http://www.cancerresearc
huk.org/cancer-info/cancerstats/types/nhl/incidence]. Accessed
November 2012.

9. Gribben JG; How I treat indolent lymphoma. Blood
2007;109:4617-4626.

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

Contact:
For further information please contact: Bily Kuo,
bily.kuo@mundipharma.co.uk, +44(0)1223-397-118, Julie Masters,
julie.masters@fleishmaneurope.com, +44(0)2073-957-129.