Theravance Biopharma Receives FDA Fast Track Designation

Theravance Biopharma, Inc. recently announced that the US Food and Drug Administration (FDA) granted Fast Track Designation to TD-8954 for short-term use with enteral feeding to achieve early nutritional adequacy in critically ill patients at high nutritional risk. TD-8954 is a selective 5-HT4 receptor agonist being evaluated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (EFI). Importantly, there are currently no FDA-approved therapies for EFI, leaving the approximately 1 million Americans who suffer from the disorder without adequate treatment options.

TD-8954 is currently in Phase II clinical development having most recently completed a study in critically ill patients with EFI to evaluate the safety, tolerability, and pharmacodynamics of a single dose of TD-8954 administered intravenously compared to metoclopramide. Theravance Biopharma is preparing for further discussions with FDA regarding potential designs for the next TD-8954 study in EFI patients.

“This Fast Track designation provides key development and regulatory advantages to the TD-8954 program, adding important value to a product that we believe has significant potential to deliver therapeutic benefit to critically ill patients with gastrointestinal motility disorders, including EFI,” said Brett Haumann, Senior Vice President, Clinical Development of Theravance Biopharma. “This regulatory milestone comes at an opportune time for Theravance Biopharma as we continue to assess accelerated development pathways for this program through conversations with the FDA, as well as potential collaboration with prospective partners. We look forward to making additional progress in these discussions and optimally positioning this novel therapeutic for success.”

The FDA’s Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

The mission of Theravance Biopharma is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.

Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the US, Europe, and certain other countries for certain difficult-to-treat infections. TD-4208 is an investigational long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for COPD. Axelopran (TD-1211) is an investigational potential once-daily, oral treatment for opioid-induced constipation (OIC). Our earlier-stage clinical assets represent novel approaches for potentially treating diseases of the lung and gastrointestinal tract and infectious disease. In addition, we have an economic interest in future payments that may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium, and vilanterol (the Closed Triple).

With our successful drug discovery and development track record, commercial infrastructure, experienced management team, and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients. For more information, visit www.theravance.com.