Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus® and Insulin Analo...
`
`Page 1 of 2
`
`News
`Select
`
`
`Mylan Commences Phase III Clinical Trials for its
`Generic Version of Advair Diskus® and Insulin Analog
`to Lantus®
`
`Print
`
`Clinical Trials Mark Important Milestone in Development of Two Highly Complex Products
`
`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
`
`http://newsroom.mylan.com/press-releases?item=123251
`
`12/27/2018
`
`Sanofi Exhibit 2002.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus® and Insulin Analo...
`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.
`
`Page 2 of 2
`
`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.
`
`For further information: Nina Devlin (Media) 724.514.1968 or Kris King (Investors) 724.514.1813
`
`http://newsroom.mylan.com/press-releases?item=123251
`
`12/27/2018
`
`Sanofi Exhibit 2002.002
`Mylan v. Sanofi
`IPR2018-01676
`
`