Theravance Pipeline Strong, Dependence on Yupelri a Concern

Theravance Biopharma, Inc. TBPH is a biopharmaceutical company focused on developing treatments targeting various therapeutic areas such as infectious, respiratory, gastrointestinal, cardiovascular, renal, inflammation and immunology diseases.

The company received a huge boost when the FDA approved Yupelri, a long-acting muscarinic antagonist (LAMA), as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD) last November.

Theravance has a collaboration deal with Mylan MYL for the development and commercialization of Yupelri. Both companies formally launched Yupelri in early 2019 and the product is witnessing a strong uptake ever since.

Mylan and Theravance are sharing US profits and losses reported in connection with the commercialization of Yupelri. While Mylan gets 65% of the profits, Theravance is entitled to receive 35%. The product has witnessed strong customer acceptance and brand performance across the key market metrics.

Notably, in November 2018, Theravance completed the sale of its only marketed drug Vibativ to Cumberland Pharmaceuticals.

Meanwhile, Theravance has an economic interest in GlaxoSmithKline's GSK COPD drug Trelegy Ellipta and earns royalties on its sales.

This apart, Theravance has a promising pipeline portfolio, which is progressing well. Last month, the company announced promising outcomes from a phase I study on its inhaled, lung-selective pan-Janus kinase (JAK) inhibitor TD-8236. The candidate is being developed for the treatment of inflammatory lung diseases with minimal systemic exposure.

Theravance also has a collaboration agreement with Johnson & Johnson's JNJ subsidiary Janssen to develop its JAK inhibitor TD-1473 for treating inflammatory intestinal diseases. A phase II study on TD-1473 to treat Crohn's disease and a phase IIb/III study for ulcerative colitis are ongoing. The company plans to report data from both these studies on TD-1473 by late 2020.

Theravance is also evaluating TD-9855 in a phase III study for treating patients with symptomatic neurogenic orthostatic hypotension (nOH).

Successful development and subsequent approval of these candidates will be a huge boost to the company given their potential to offer transformational value to patients and healthcare providers.

However, with the potential sale of Vibativ, Theravance is now solely dependent on profit-sharing revenues from Mylan for Yupelri and collaboration revenues from J&J for funding its pipeline development. Any agreement termination regarding these in the future might be a massive setback for the company.

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