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[JLS]

MYL breaking higher today.

Now, in one day, trading higher than all significant SMAs up to SMA(200).

Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases

MYL ("Mylan") today announced the presentation of additional efficacy and safety data from the three-month, pivotal Phase 3 studies of revefenacin (TD-4208) at the American Thoracic Society (ATS) International Conference in Washington, D.C. Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD).

COPD is a growing and devastating disease that is the third leading cause of death in the U.S. An estimated 12.7 million American adults are diagnosed with COPD and an almost equal number are believed to be undiagnosed. There were more than 700,000 hospital discharges related to COPD in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly $50 billion in 2010, including $29.5 billion in direct healthcare expenditures, $8 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.

The revefenacin Phase 3 program also includes an ongoing 12-month, open-label, active comparator safety study in more than 1,050 patients, which is expected to be completed in mid-2017. Together, the three studies enrolled approximately 2,300 patients. Should outcomes from the safety study be supportive, Theravance Biopharma expects to file a New Drug Application (NDA) for revefenacin with the U.S. Food and Drug Administration (FDA) by the end of 2017.

Mylan President Rajiv Malik commented, "We continue to be very pleased with the progress of the Phase 3 revefenacin program, and are excited to have the opportunity to showcase this important data set at ATS for the first time. According to the GOLD Guidelines for COPD, LAMAs are a cornerstone of therapy for moderate to severe COPD, yet there are currently no nebulized LAMAs available. We believe this product has the potential to help address an unmet medical need for patients. Further, revefenacin represents a key contributor in Mylan's pipeline of promising respiratory products, and supports the growth of our respiratory franchise. If approved, we believe that we are well-positioned to support the commercial success of this product."

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