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Theravance’s (TBPH) COPD Drug Wins FDA Approval


Today, the FDA approved Theravance’s (TBPH) Yupelri (revefenacin) inhalation solution for the treatment of COPD. Thervance and Mylan (MYL) are partnered on the opportunity.

Yupelri (revefenacin, formerly TD-4208) inhalation solution is a novel once-daily nebulized LAMA for the treatment of moderate to very severe COPD. Phase 3 data highlight efficacy advantages for 175 mcg/day of Yupelri in key patient subgroups and demonstrate acceptable cardiovascular safety profile.

This approval has made Yupelri the first and only once-daily, long-acting singleagent product for COPD patients who require, or prefer, nebulized therapy. Mylan and Theravance are making significant progress in finalizing their commercial strategy for a 4Q18 launch.

Theravance CEO Rick E Winningham stated, “Long-acting muscarinic antagonists are recognized by international COPD treatment guidelines as a cornerstone first-line therapy for COPD, regardless of the severity of disease. To date, however, there have been no once-daily nebulized options available to patients or to prescribers. We believe that YUPELRI, discovered and characterized in our laboratories, is well positioned to address this need.  With this approval, COPD patients who require or prefer nebulized therapy can access a once-daily nebulized bronchodilator for the first time [….] This approval, which comes during National COPD Awareness Month, is a testament to the collaborative efforts of the Theravance Biopharma and Mylan teams and their dedication to bringing an important treatment option for adults that suffer from COPD.”

Mylan President Rajiv Malik added, “The approval of YUPELRI represents a key milestone in advancing and expanding our scientific expertise regarding respiratory care. YUPELRI provides COPD patients with access to a nebulized LAMA therapy that offers consistent 24-hour lung function improvement with the convenience of once-daily dosing delivered through any standard jet nebulizer. We are proud to be part of this important approval and pleased to add YUPELRI to Mylan’s expanding portfolio of respiratory therapies […] Mylan and Theravance Biopharma’s shared commitment to address an important need in the COPD treatment paradigm has served as the driving force behind the success of the clinical development program and ultimate commercial approval of YUPELRI.”

Net-net, Wall Street’s confidence backing this biotech player is strong, with TipRanks analytics showcasing TBPH as a Strong Buy. Based on 4 analysts polled by TipRanks in the last 3 months, all 4 rate a Buy on Thervance stock. The 12-month average price target stands at $44.33, marking over 70% upside potential from where the stock is currently trading. (See TBPH’s price targets and analyst ratings on TipRanks)