Expanded
Access Program for MK-0518, an Investigational HIV Integrase
Inhibitor, Established for Patients with Limited Available Treatment Options
Worldwide Access Program Will Be Conducted Along
With Phase III Studies
TORONTO, Aug. 17, 2006 -- A worldwide expanded access program for HIV/AIDS patients
with limited or no treatment options was announced today by Merck & Co., Inc.,
Whitehouse Station, N.J., U.S.A., with respect to its investigational HIV integrase
inhibitor, MK-0518, now in Phase III development. Program enrollment will begin
in the next few months, pending regulatory review and approvals.
"Making MK-0518 available to those who would like access
to this investigational drug but who are unable to participate in the clinical
studies underscores our commitment to patients," said Dr. Peter S. Kim, president,
Merck Research Laboratories (MRL).
MK-0518
belongs to a new class of investigational antiretroviral therapy (ART) agents
called integrase inhibitors that inhibit the insertion
of the HIV viral DNA into human DNA. Integrase is one
of three HIV enzymes - reverse transcriptase, protease and integrase - required by the virus to reproduce. Drugs are
available that inhibit the functions of the protease and reverse transcriptase
enzymes but, to date, there are no approved drugs that target the integration
stage of the HIV-1 lifecycle.
Expanded
access
"The MK-0518 program is another
example of Merck's dedication to people living with HIV/AIDS around the world,"
commented Dr. Randi Leavitt, senior director, Infectious
Diseases - Clinical Research, MRL and lead coordinator of the expanded access
program. "This makes the third expanded access program that Merck has initiated.
In mid and late 1990, the Company implemented expanded access programs for two
other investigational drugs for treatment of HIV," Dr. Leavitt explained.
Expanded access is a mechanism supported by
regulatory agencies for getting investigational treatment to patients who have
a life threatening disease and who cannot be satisfactorily treated with an alternative
therapy or available drug. Expanded access programs are not required by regulatory
agencies. These programs are initiated and supported by drug manufacturers in
recognition of the promise an unapproved drug may hold for patients facing a life-threatening
disease.
MK-0518 expanded access study design
The expanded access program with MK-0518 is a non-comparative,
multi-center, open-label, voluntary treatment use study. Investigators will follow
patients according to standard of care. The study will continue until approximately
three months after MK-0518 has been launched in the local market.
To be eligible to participate, patients must have
documented HIV-1 infection, be at least 16 years old, have limited or no treatment
options available to them due to resistance or intolerance to multiple anti-retroviral
regimens, are not achieving adequate virologic suppression
on current regimen and be at risk of clinical or immunologic progression, and
be clinically stable. Patients are excluded from the study if they have received
MK-0518 in a clinical trial, require any medications prohibited by the protocol,
have acute hepatitis due to any cause or clinically significant chronic liver
disease, have a condition which the investigator deems will interfere with adherence
and safety, or are pregnant.
Patients will
receive open-label MK-0518 400 mg twice daily, in addition to optimized background
therapy (OBT). Investigators will select the OBT based on the patient's prior
treatment history and anti-retroviral resistance testing. OBT will not be provided
by Merck. Safety and tolerability of MK-0518 will be monitored.
The program will be managed by a clinical research organization
(CRO). The CRO will collect all case report information including serious adverse
events and drug-related adverse events that result in Grade 3 or above laboratory
toxicity, leading to treatment interruption or discontinuation. No efficacy data
will be collected.
About Merck's HIV/AIDS
research program
Merck's HIV clinical
research program began in 1985. Merck scientists were among the first to discover
and develop medicines for the treatment of HIV/AIDS. In 1996, Merck introduced
a protease inhibitor, which was followed by the introduction in 1999 of a non-nucleoside
reverse transcriptase inhibitor (NNRTI).
In
addition to MK-0518, Merck is focused on developing new treatments for millions
of individuals who are already infected with HIV, as well as on preventing HIV
transmission through the development of a vaccine. Merck also licensed a compound
to the International Partnership for Microbicides (IPM)
for development as a possible means of preventing HIV infection in women.
Merck's HIV/AIDS access commitment
Since Merck's first HIV products reached the market a decade ago, the Company
has worked to expand access to these medicines - particularly in the world's poorest
countries and those hardest hit by the pandemic. Today, Merck programs and partnerships
round the world are helping to prevent and treat HIV/AIDS, expand health care
capacity, foster greater disease awareness and acceptance and provide support
for people living with HIV/AIDS, their families and communities. Through these
and other pioneering efforts, Merck is making a substantial contribution toward
meeting one of the most critical needs targeted by the United Nations Millennium
Development Goals: halting and beginning to reverse the spread of HIV/AIDS.
About Merck
Merck & Co., Inc.
is a global research-driven pharmaceutical company dedicated to putting patients
first. Established in 1891, Merck currently discovers, develops, manufactures
and markets vaccines and medicines to address unmet medical needs. The Company
devotes extensive efforts to increase access to medicines through far-reaching
programs that not only donate Merck medicines but help deliver them to the people
who need them. Merck also publishes unbiased health information as a not-for-profit
service. For more information, visit www.merck.com.
Forward-looking statement
This press release contains
"forward-looking statements" as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements are based on management's
current expectations and involve risks and uncertainties, which may cause results
to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential
or financial performance. No forward-looking statement can be guaranteed, and
actual results may differ materially from those projected. Merck undertakes no
obligation to publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise. Forward-looking statements in
this press release should be evaluated together with the many uncertainties that
affect Merck's business, particularly those mentioned in the cautionary statements
in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by reference. |
