PITTSBURGH, Sept. 16, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL), one of the world's leading global pharmaceutical
companies, today announced it is initiating Phase III clinical
trials for its generic version of GlaxoSmithKline's Advair Diskus®
and its insulin analog to Sanofi's Lantus®.
In October 2014, Mylan will
commence a Phase III clinical trial to evaluate the equivalence of
its product to Advair Diskus when administered by inhalation in
adult asthma patients.
Two Phase III clinical trials for Mylan's insulin analog program
already are underway. In August 2014,
the company initiated INSTRIDE 1 and INSTRIDE 2 to compare the
efficacy and safety of Mylan's insulin Glargine with that of
Lantus® in both Type 1 and Type 2 diabetes mellitus patients.
Mylan CEO Heather Bresch said,
"The commencement of Phase III clinical trials for Mylan's generic
Advair Diskus® and insulin Glargine programs are important
milestones in the progress of two of our strategic growth drivers,
demonstrating our strong capabilities in developing complex,
difficult-to-manufacture products. We look forward to providing
patients with access to high quality, more affordable versions of
these medications upon final FDA approval."
Mylan President Rajiv Malik
added, "These noteworthy clinical trial developments, combined with
the significant strides we have made in advancing our production
scale manufacturing, reinforce our continued belief that Mylan will
be the first to bring to market an AB-rated, substitutable generic
form of Advair Diskus and one of the first to bring to market an
interchangeable insulin analog to Lantus. These products, in
addition to the hundreds of others in our pipeline, will continue
to expand and diversify our portfolio and further differentiate
Mylan with its customers."
About Generic Advair Diskus Trial
The clinical trial
is a randomized, double-blind, double dummy, parallel group study
to determine the local equivalence of multiple doses of Mylan's
generic product to Advair Diskus when administered via oral
inhalation in adult asthma patients. The primary endpoint of the
study is the FEV1 area under the effect curve, which is the volume
of air that has been forcibly exhaled in one second, after full
inspiration. The study also will examine adverse events and device
usability. The study is expected to commence in October 2014 and be completed in April 2015. More information about the trial will
be available at clinicaltrials.gov.
About INSTRIDE 1 and INSTRIDE 2 Trials
INSTRIDE 1 and
INSTRIDE 2 are open-label, randomized, multicenter, parallel-group
clinical trials comparing the efficacy and safety of Mylan's
insulin Glargine with that of Lantus® in Type 1 and Type 2 diabetes
mellitus patients, respectively. The purpose of both studies is to
test whether Mylan's insulin Glargine once daily is non-inferior to
Lantus® once daily when administered in combination with other
anti-diabetic drugs. Both studies commenced in August 2014 and are expected to be completed in
June 2016. More information about INSTRIDE 1 and INSTRIDE 2
is available at clinicaltrials.gov.
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
products and the company's strategy, future growth and performance.
These statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Because such
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: the impacts of competition; changes in economic and
financial conditions of the company's business; strategies by
competitors or other third parties to delay or prevent product
introductions; risks inherent in legal and regulatory processes;
uncertainties and matters beyond the control of management; and the
other risks detailed in the company's filings with the Securities
and Exchange Commission. The company undertakes no obligation to
update these statements for revisions or changes after the date of
this release.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. But don't take our word for
it. See for yourself. See inside. mylan.com
Logo - http://photos.prnewswire.com/prnh/20140423/77793
SOURCE Mylan Inc.