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November 9, 2013 12:00 pm ET

Data to be Presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced data for its investigational Timothy grass sublingual
allergy immunotherapy tablet (MK-7243) from a study involving 1,501
North American adult and pediatric patients. Results showed that MK-7243
demonstrated significant improvement in Total Combined Score (TCS)
averaged over the entire grass pollen season (the primary endpoint),
which was the sum of the rhinoconjunctivitis daily symptom score (DSS)
and the daily medication score (DMS), compared to placebo. Researchers
will present findings at the American College of Allergy, Asthma &
Immunology Annual Scientific Meeting, Nov. 7-11, in Baltimore.

“Patients in this study who took the investigational Timothy grass
sublingual allergy immunotherapy tablet showed a significant improvement
in common allergy symptoms during the entire grass season,” said Dr.
David Bernstein, professor of Medicine and Environmental Health,
Division of Immunology, Allergy and Rheumatology, University of
Cincinnati College of Medicine, who was one of the study investigators.

“Few large studies have evaluated sublingual immunotherapy for allergic
rhinitis in both adults and children, and we are proud that Merck is
exploring this potential new option for Timothy grass pollen-induced
allergic rhinitis treatment in North America,” said Dr. Sean Curtis,
vice president, Respiratory and Immunology, Merck Research Laboratories.

Study design

This multicenter, double-blind, randomized, placebo-controlled,
parallel-group study evaluated the efficacy and safety of the
investigational MK-7243 sublingual tablet (2800 BAU) in 1,501 pediatric
and adult patients (ages 5-65) with a clinical history of Timothy grass
pollen-induced allergic rhinitis with or without conjunctivitis, with or
without asthma (FEV₁ ≥70 percent of predicted value). As
baseline characteristics, 25 percent of patients in the study had
asthma; patients with a history of severe asthma were excluded.
Additionally, 85 percent of patients in the study were sensitized to
multiple allergens. Patients received either MK-7243 or placebo once
daily for at least 12 weeks prior to and during the grass pollen season.

The primary efficacy assessment of the study was total combined score
(TCS), which was the sum of the rhinoconjunctivitis daily symptom score
(DSS) and the daily medication score (DMS) averaged over the entire
grass pollen season. The DSS consisted of daily ratings of four nasal
symptoms (runny nose, blocked nose, sneezing and itchy nose) and two eye
symptoms (gritty eyes and watery eyes) on a scale from zero (no
symptoms) to three (severe symptoms). The DMS was based on the type and
amount of allergy rescue medication (oral antihistamines, ocular
antihistamines, intranasal corticosteroids or oral corticosteroids) used
each day during the grass pollen season, which patients in both arms of
the study were permitted to use.

Four key secondary endpoints included the average rhinoconjunctivitis
DSS over the entire grass pollen season, the average rhinoconjunctivitis
DMS over the entire grass pollen season, the average rhinoconjunctivitis
TCS over the peak grass season, and the average overall score for the
Rhinoconjunctivitis Quality of Life Questionnaire with Standardized
Activities for Subjects ≥12 Years of Age (RQLQ(S)12+) over the peak
grass pollen season. Safety endpoints included reported adverse events.

Study results

In this study, patients treated with MK-7243 (n=629) showed a 23 percent
improvement in TCS relative to placebo (n=672) over the entire grass
pollen season (median difference: -0.98, P < .001). Additionally,
patients treated with MK-7243 demonstrated a 20 percent improvement in
DSS over the entire grass pollen season (median difference: -0.64, P
=.001), and a 35 percent improvement in DMS over the entire grass pollen
season (mean difference: -0.48, P<.001). During the peak grass pollen
season, patients treated with MK-7243 demonstrated a 29 percent
improvement in TCS (median difference: 1.33, P<.001), and a 12 percent
improvement in RQLQ (median difference: -0.13, P=.027).

The most frequently reported adverse events in the study for MK-7243
(n=753) versus placebo (n=745) were local site reactions: throat
irritation 23 percent vs. 4 percent, oral pruritus 19 percent vs. 3
percent, oral paraesthesia 12 percent vs. 3 percent, mouth edema 13
percent vs. 1 percent and ear pruritus 12 percent vs. 1 percent,
respectively. No serious treatment-related adverse events were reported.
Three patients (2 MK-7243, 1 placebo) had moderate systemic allergic
reactions. Symptoms resolved without treatment for the two patients who
received MK-7243, and both of these patients discontinued treatment.
Four different patients (3 MK-7243, 1 placebo) were administered
epinephrine. Two of the four epinephrine administrations (1 MK-7243, 1
placebo) were reported as unrelated to the study medication. Of the
remaining two administrations for patients who received MK-7243, one was
deemed possibly related to the study medication and the other was deemed
probably related.

These results reflect data from the full analysis set, which included
randomized patients who took at least one dose of study medication and
had at least one efficacy measurement in the corresponding evaluation
period (entire grass pollen season or peak grass pollen season).

These results will be presented in a poster titled “Efficacy and Safety
of MK-7243: A Grass Sublingual Immunotherapy Tablet Treatment in a Large
Randomized Controlled Trial in North American Children and Adults” on
Saturday, Nov. 9 from 12:30 – 1:30 p.m. ET and Sunday, Nov. 10 from
12:30 – 1:30 p.m. ET.

In addition, a pre-specified sub-group analysis of the data from this
clinical trial will be presented in a poster titled “Treatment with
MK-7243, a Grass Sublingual Immunotherapy Tablet, is Associated with
Similar Efficacy and Safety in Children and Adults: Findings from a
Subgroup Analysis of Data from a Large North American Trial” on
Saturday, Nov. 9 from 12:30 – 1:30 p.m. ET and Sunday, Nov. 10 from
12:30 – 1:30 p.m. ET.

Merck’s investigational sublingual allergy immunotherapy tablet
program

Merck’s Timothy grass sublingual allergy immunotherapy tablet is an
investigational once-daily tablet that dissolves under the tongue and is
designed to help treat the underlying cause of allergic rhinitis by
generating an immune response to help protect patients against Timothy
grass pollen.

Earlier this year, Merck announced that the U.S. Food and Drug
Administration (FDA) had accepted for review Biologics License
Applications for its investigational Timothy grass sublingual allergy
immunotherapy tablet and its ragweed sublingual allergy immunotherapy
tablet. Merck expects the FDA’s review for both to be completed in the
first half of 2014. Merck has partnered with ALK-Abello to develop its
sublingual allergy immunotherapy tablets for Timothy grass pollen,
ragweed pollen and house dust mite induced allergic rhinitis in North
America.

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
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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 Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. 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; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 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).

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