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MSD Statement Regarding CHMP Review of Incretin-Based Therapies for Type 2 Diabetes, Including Sitagliptin



  MSD Statement Regarding CHMP Review of Incretin-Based Therapies for Type 2
  Diabetes, Including Sitagliptin

Business Wire

WHITEHOUSE STATION, N.J. -- July 26, 2013

Merck Sharpe and Dohme (MSD), known as Merck in the United States and Canada,
issued the following statement regarding the conclusion of the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)
review of GLP-1, or incretin-based, therapies, including sitagliptin. The EMA
issued a news release today, “Investigation into GLP-1 based diabetes
therapies concluded: No new concerns for GLP-1 therapies identified on the
basis of available evidence.” The EMA’s full news release is available here.

“Nothing is more important to us than the safety of our medicines and the
people who take them. We appreciate the important role that the EMA and its
CHMP play in monitoring the safety of medicines in Europe,” said Michael
Rosenblatt, M.D., executive vice president and chief medical officer, MSD. “We
are confident in the safety profile of sitagliptin, an important medicine to
help adults with type 2 diabetes lower their blood sugar levels.”

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a Drug
Safety Communication on incretin-based drugs, including sitagliptin. The
statement indicated that the FDA has not reached any new conclusions about
safety risks with incretin mimetic drugs, and recommended that patients
continue to take their medicine as directed until they talk to their health
care professional, and that health care professionals continue to follow the
prescribing recommendations in the drug labels. The FDA said “it will
communicate its final conclusions and recommendations when its review is
complete or when the Agency has additional information to report.”

The American Diabetes Association (ADA), the European Association for the
Study of Diabetes (EASD) and the International Diabetes Federation (IDF) said
that they have reviewed the data available to date and found that there is
insufficient information to modify current treatment recommendations. On June
28, the three organizations issued a joint statement, which is available here.

“The efficacy and safety profile of sitagliptin supports its use in a wide
range of adult patients with type 2 diabetes,” Rosenblatt said. “We will
continue to monitor the safety of sitagliptin in close collaboration with
regulatory agencies and scientific experts.”

About MSD’s review of the data on the safety profile of sitagliptin

In June, MSD presented data regarding the safety profile of sitagliptin at the
National Institutes of Health (NIH) Workshop on
Pancreatitis-Diabetes-Pancreatic Cancer in the United States. In that
presentation, MSD reviewed the available safety data from the company’s
non-clinical studies, data from randomised clinical trials with sitagliptin in
more than 14,000 patients, post-marketing data including reports of pancreatic
cancer, independent observational studies, and a meta-analysis conducted by an
independent academic research group of published clinical trials with DPP-4
inhibitors involving more than 33,000 patients^1.

Safety information from randomised controlled clinical trial data

Randomised, controlled clinical trials continue to be the gold standard for
evaluation of the safety of any medicine. MSD conducted a large pooled
analysis that included data from 25 randomised controlled clinical studies
that enrolled more than 14,000 patients who were followed for up to two years.
In this analysis, which was recently published in Diabetes Therapy^2, there
were no differences in the incidence of pancreatitis or pancreatic cancer
between patients taking sitagliptin and those who did not take sitagliptin.
There were five reports of pancreatitis/acute pancreatitis in the group
treated with sitagliptin and five reports in the group that was not treated
with sitagliptin, and there were three reports of pancreatic cancer in the
group treated with sitagliptin and three reports in the group that was not
treated with sitagliptin. Studies in the pooled analysis were not designed or
powered to identify or adjudicate events of pancreatitis or pancreatic cancer,
and do not allow for inference on the potential for long-term effects.

The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) is the
largest randomised controlled clinical study with sitagliptin, with more than
14,000 patients enrolled. This study, which began in 2008, is being led by an
independent academic research collaboration between the University of Oxford
Diabetes Trials Unit and the Duke University Clinical Research
Institute. TECOS continues to be monitored through an independent Data and
Safety Monitoring Board (DSMB), which has access to unblinded safety reports.
The DSMB most recently reviewed data from TECOS in February 2013 and did not
identify any safety concerns to MSD or recommend any changes to the study^3.

Information from MSD non-clinical safety studies

The safety of sitagliptin is also supported by an extensive non-clinical
safety program and none of these studies has shown an association or
established a causal relationship between sitagliptin and pancreatitis or
pancreatic cancer. The non-clinical program includes FDA-requested studies to
assess for carcinogenicity in rodents. These are conducted over the lifetime
of the animals, and the absence of tumors in rodent carcinogenicity studies is
highly predictive of an absence of human cancer risk. The carcinogenicity
studies were conducted using doses that achieved levels of sitagliptin
approximately 60 to 70 times higher than the levels of sitagliptin achieved in
patients taking the maximum recommended daily adult human dose of sitagliptin
(100 mg/day). In these studies, no adverse effects on the pancreas were
observed and sitagliptin was not associated with an increase in the incidence
of pancreatic malignancies.

About DPP-4 Inhibitors

Both DPP-4 inhibitors and GLP-1 analogues are incretin-based treatments;
however, DPP-4 inhibitors and GLP-1 analogues have different mechanism of
actions. DPP-4 inhibitors enhance the body’s own ability to lower blood sugar
levels by increasing the levels of the body’s own active incretins, called
GLP-1 and glucose-dependent insulinotropic polypeptide, or GIP. GLP-1
analogues are biological products that act as incretin mimetics by directly
stimulating the GLP-1 receptors and have no known effect on GIP.

About JANUVIA® (sitagliptin) and Janumet® (sitagliptin/metformin) ^4,5

For safety Information about sitagliptin and before initiating therapy, please
consult the full prescribing information. Januvia
http://ec.europa.eu/health/documents/community-register/html/h383.htm. Janumet
http://ec.europa.eu/health/documents/community-register/html/h455.htm.

About MSD

Today's MSD is a global healthcare leader working to help the world be well.
MSD is a trade name of Merck & Co., Inc., with headquarters in Whitehouse
Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic
therapies, and consumer care and animal health products, we work with
customers and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For more
information, visit www.msd.com and connect with us on Twitter, Facebook and
YouTube.

MSD forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs and
expectations of MSD’s management and are subject to significant risks and
uncertainties. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially from those set
forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approval; MSD’s ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of MSD’s patents
and other protections for innovative products; and the exposure to litigation,
including patent litigation, and/or regulatory actions.

MSD undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise. Additional
factors that could cause results to differ materially from those described in
the forward-looking statements can be found in MSD’s/Merck’s 2012 Annual
Report on Form 10-K and the company’s other filings with the Securities and
Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Januvia®, Janumet® are registered trademarks of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc.

References:

 1. Monami, M, Dicembrini, I, Martelli, D, Mannucci, E. Safety of dipeptidyl
    peptidase-4 inhibitors: a meta-analysis of randomised clinical trials.
    Current Medical Research and Opinion, 2011. Vol. 27; pp. 57-64
 2. Engel, SS, Round, E, Golm, GT, Kaufman, KD, Goldstein, BJ. Safety and
    tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25
    clinical studies. Diabetes Therapy, 2013. Vol. 1, pp. 119-145.
 3. Merck. Update on cardiovascular outcomes study with JANUVIA. Merck
    Clinical Trials, 2013. Available at
    http://www.merck.com/mrl/clinical_trials/outcomes_study.html (Last
    accessed July 25, 2013)
 4. Januvia
    http://ec.europa.eu/health/documents/community-register/html/h383.htm
 5. Janumet
    http://ec.europa.eu/health/documents/community-register/html/h455.htm

Contact:

MSD
Media:
Pam Eisele, +1-908-423-5042
Michael Close, +1-267-305-1211
Investor:
Carol Ferguson, +1-908-423-4465
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