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October 13, 2012 11:15 am ET

Odanacatib Significantly Increased BMD Following Prior Alendronate Treatment

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced results from a Phase II trial for odanacatib, an
investigational cathepsin K (cat-K) inhibitor in development for the
treatment of osteoporosis in post-menopausal women. The results were
presented today at the 34^th Annual Meeting of the American
Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo)
significantly increased Bone Mineral Density (BMD) over a two-year
period in post-menopausal osteoporotic women who previously had three or
more years of treatment with alendronate. Patients were allowed to have
been off alendronate therapy for up to three months immediately prior to
enrollment in the study.

“Odanacatib works differently than other treatments for osteoporosis by
targeting cat-K, a specific enzyme within bone cells,” said Albert
Leung, M.D., Ph.D., executive director, clinical research, Merck
Research Laboratories. “We’re excited about these results because
understanding the effects of odanacatib in a population of
post-menopausal women previously treated for osteoporosis is important
to clinicians.”

Study evaluated efficacy and safety of odanacatib following treatment
with alendronate

This study was a randomized, double-blind, placebo-controlled,
multi-center, 24-month trial of odanacatib in 243 women with
post-menopausal osteoporosis who had been previously treated with
alendronate (dosed daily or weekly) for ≥3 years. Participants were at
least 60 years of age with low BMD T-scores (≤–2.5 and >-3.5) at any hip
site (femoral neck, trochanter, or total hip) without a history of
fragility fracture, or had BMD T-scores ≤-1.5 and > -3.5 at any hip
site, with a history of fragility fracture (except hip fracture). The
patients were randomized in a 1:1 ratio to receive odanacatib 50 mg once
weekly or placebo for 24 months. All patients received vitamin D3 (5600
IU/week) and also calcium supplementation, if needed.

The study evaluated the effects of odanacatib 50 mg once weekly on the
following:

• Femoral neck BMD change from baseline compared to placebo over 24
  months (primary endpoint)
• Femoral neck BMD compared to baseline over 24 months (key secondary
  endpoint)
• BMD at hip trochanter, total hip, lumbar spine and distal forearm
• Biochemical markers of bone resorption and formation at months 12 and
  24
• Clinical and laboratory assessment of safety and tolerability

BMD was assessed by DXA at baseline, 6, 12 and 24 months. This study was
not designed to evaluate the effect of odanacatib on fractures.

Results showed odanacatib significantly increased BMD compared to
placebo

In the odanacatib group, BMD changes from baseline at 24 months were
significantly different versus placebo at all three hip sites (+1.73%,
+1.83%, +0.83% for the femoral neck, hip trochanter, and total hip,
respectively, vs. -0.94%, -1.35%, -1.87% with placebo), and the lumbar
spine (+2.28% vs. -0.30% change with placebo). At the distal forearm,
BMD changes from baseline at 24 months were -0.92% and -1.14%. The
difference versus placebo at the distal forearm (+0.22%) was not
statistically significant.

The overall incidence of adverse events, including those that were
considered drug-related or serious, were similar between treatment
groups. Treatment discontinuations due to adverse events were 9.0
percent for patients receiving odanacatib and 3.3 percent for patients
receiving placebo. The most common clinical adverse events in patients
receiving odanacatib and placebo, respectively, were urinary tract
infection (11.5%, 16.5%), back pain (11.5%, 9.9%), arthralgia (9.0%,
9.9%), fractures (4.9%, 13.2%), bronchitis (5.7%, 4.1%), nasal
pharyngitis (3.3%, 5.8%), and upper respiratory infection (4.1%, 0.8%).

About Odanacatib

In osteoporosis, bone loss occurs because of an imbalance in bone
remodeling (the rate of bone resorption exceeds that of bone formation).
Osteoclasts, cells that resorb bone, secrete signaling factors to
stimulate osteoblasts, cells that form bone. Odanacatib selectively
inhibits cat-K, the primary enzyme in the osteoclasts that digests
proteins during bone resorption. Progressive increases in bone mineral
density have been demonstrated with odanacatib.

In July 2012, Merck announced it planned to begin closing the Phase III
trial assessing fracture risk reduction with odanacatib, at the
recommendation of the study’s Data Monitoring Committee (DMC), after its
first planned interim analysis showed robust efficacy and a favorable
benefit-risk profile. The DMC noted that safety issues remain in certain
selected areas and made a recommendation with respect to following up on
them. Merck’s previously announced plan to conduct a blinded extension
trial will allow further monitoring of the issues. The extension trial
will also continue to measure efficacy.

Final results of the study will be submitted for presentation and
publication in 2013 once the data analysis is complete. Merck
anticipates submitting regulatory applications for odanacatib in the
United States and European Union (EU) in the first half of 2013, and in
Japan in the second half of 2013.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
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.merck.com
and connect with us on Twitter, Facebook and YouTube.

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. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company’s plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck’s ability to accurately predict future market
conditions; dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.

Merck 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 Merck’s 2011 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).

Merck
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Kelley Dougherty, 908-423-4291
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