• 04.03.2011, 11:05:11
  • /
  • OTE0005

/C O R R E C T I O N -- Bristol-Myers Squibb and AstraZeneca/

Paris and London (ots/PRNewswire) - In the news release,
"ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in
Europe" issued on 4 Mar 2011 08:00 GMT, by Bristol-Myers Squibb and
AstraZeneca NYSE:AZN over PR Newswire, we would like to advise that
the headline was incorrectly transmitted by PR Newswire and should
have read "ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available
for Use in Europe in Type 2 Diabetes Patients With Moderate or
Severe Renal Impairment" rather than "ONGLYZA(R) Becomes the First
DPP-4 Inhibitor Available for Use in Europe".

Complete, corrected release follows:

ONGLYZA(R) Becomes the First DPP-4 Inhibitor Available for Use in
Europe in Type 2 Diabetes Patients With Moderate or Severe Renal
Impairment

Bristol-Myers Squibb Company (http://www.bms.com) and AstraZeneca
(http://www.astrazeneca.com) today announced that the European
Commission has approved a label update for ONGLYZA(R) (saxagliptin)
in the treatment of adults with type 2 diabetes who have moderate or
severe renal impairment. The approved dosage for the patient group is
a new once-daily 2.5 mg dose.

ONGLYZA will be the first dipeptidyl peptidase-4 (DPP-4) inhibitor
in Europe available for type 2 diabetes patients with moderate or
severe renal impairment. ONGLYZA is indicated in adult patients with
type 2 diabetes mellitus to improve glycaemic control in combination
with metformin, sulphonylurea, or thiazolidinedione, when each
treatment alone, with diet and exercise, does not provide adequate
glycaemic control.

This label update was granted on the basis of clinical data
submitted to the European Medicines Agency (EMA) from a 12-week,
multi-centre, randomized, double-blind, placebo-controlled study to
evaluate the treatment effect of ONGLYZA 2.5 mg once-daily compared
with placebo in 170 patients with type 2 diabetes and renal
impairment (creatinine clearance [CrCl] less than or equal to 50
mL/min). In this study, 98.2% of the patients were treated with other
antihyperglycaemic medication. The results of the study, which are
described in the Summary of Product Characteristics (SmPc),
demonstrated that ONGLYZA 2.5 mg was safe and effective, compared
with placebo, in adults with type 2 diabetes who have moderate or
severe renal impairment.

According to routine clinical care, assessment of renal function
is recommended in type 2 diabetes patients and the dose of ONGLYZA
should be adjusted accordingly. No dose adjustment is recommended for
patients with mild renal impairment. For patients with moderate or
severe renal impairment, the dose of ONGLYZA is 2.5 mg once daily.

The use of ONGLYZA in patients with severe renal impairment is
very limited. Therefore, ONGLYZA should be used with caution in this
population. ONGLYZA is not recommended for patients with end-stage
renal disease (ESRD) requiring hemodialysis.

About ONGLYZA

ONGLYZA has been submitted for regulatory review in more than 87
countries and is approved in 56 countries, including the United
States, Canada, Mexico, 30 European countries, Chile, India, Brazil
and Argentina.

ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in
adult patients with type 2 diabetes mellitus to improve glycaemic
control:

- in combination with metformin, when metformin alone, with diet and
      exercise, does not provide adequate glycaemic control;
    - in combination with a sulphonylurea, when sulphonylurea alone, with
      diet and exercise, does not provide adequate glycaemic control in
      patients for whom use of metformin is considered inappropriate; or
    - in combination with a thiazolidinedione, when the thiazolidinedione
      alone, with diet and exercise, does not provide adequate glycaemic
      control in patients for whom use of a thiazolidinedione is considered
      appropriate

ONGLYZA is currently not indicated in combination with insulin
therapy.

Please see the Summary of Product Characteristics for the full
prescribing information.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration
in January 2007 to enable the companies to research, develop and
commercialise select investigational drugs for type 2 diabetes. The
Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated
to global patient care, improving patient outcomes and creating a new
vision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines that
help patients prevail over serious diseases. About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical
business with a primary focus on the discovery, development and
commercialisation of prescription medicines for gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology
and infectious disease. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. For more information please visit:
http://www.astrazeneca.com.

ONGLYZA is a registered trademark of the Bristol-Myers Squibb
Company.

Contacts:

Media: Carmel Hogan, Bristol-Myers Squibb, +33-158-836-555,
[email protected]

Jim Minnick, AstraZeneca, +1-302-885-5135,
[email protected]

Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611,
[email protected]

Karl Hard, AstraZeneca, +44-20-7604-8123,
[email protected]

Rückfragehinweis:
Contacts: Media: Carmel Hogan, Bristol-Myers Squibb,+33-158-836-555,
[email protected]; Jim Minnick, AstraZeneca,+1-302-885-5135,
[email protected]; Investors: John Elicker,Bristol-Myers
Squibb, +1-609-252-4611,[email protected]; Karl Hard, AstraZeneca,
+44-20-7604-8123,[email protected]

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | PRN

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