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Theravance/Mylan Advance COPD Candidate into Phase III

Theravance Biopharma, Inc.TBPH and Mylan MYL announced the initiation of a phase III program for revefenacin (TD-4208). Revefenacin is a once-daily nebulized long-acting muscarinic antagonist, being developed for the treatment of chronic obstructive pulmonary disease (COPD).

Under the phase III program, the company is conducting two replicate, randomized, double-blind, placebo-controlled, parallel-group, 12-week efficacy studies, data from which should mature in 2016. The company is also conducting a single, open-label, active comparator 12-month safety study. Data from this study should be out in 2017.

We note that earlier this year Mylan entered into an agreement with Theravance to collaborate for the development and commercialization of revefenacin for COPD and other respiratory diseases.

If revefenacin is successfully developed and eventually approved, it will be complementary to Mylan's existing portfolio of respiratory products, which already includes a nebulized COPD product, Perforomist Inhalation Solution. The approval of revefenacin should further reinforce Mylan's leadership position in the field of nebulized respiratory therapy.

According to the American Lung Association, COPD is the third-leading cause of death in the U.S. Given American Thoracic Society's estimate that 12.7 million people in the U.S. are diagnosed with the disease and almost an equal number of patients remain undiagnosed, we believe there is need for new treatments in this indication.

Mylan carries a Zacks Rank #3 (Hold), while Theravance carries a Zacks Rank #4 (Sell). A couple of favorably ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Infinity Pharmaceuticals, Inc. INFI . While Valeant carries a Zacks Rank #1 (Strong Buy), Infinity Pharma holds a Zacks Rank #2 (Buy).

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VALEANT PHARMA (VRX): Free Stock Analysis Report

MYLAN NV (MYL): Free Stock Analysis Report

INFINITY PHARMA (INFI): Free Stock Analysis Report

THERAVANCE BIO (TBPH): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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