OREANDA-NEWS. Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and Theravance Biopharma, Inc.  (NASDAQ: TBPH) (“Theravance Biopharma”) today announced that the companies have entered into a global license, development and commercialization agreement for TD-8954, a selective 5-HT4 receptor agonist being investigated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (“EFI”). 

TD-8954 is being developed for the short-term use with EFI to achieve early nutritional adequacy in critically ill patients at high nutritional risk, an indication for which the compound received U.S. Food and Drug Administration (FDA) Fast Track Designation.  Theravance Biopharma has most recently completed a study evaluating the safety, tolerability and pharmacodynamics of a single dose of the compound administered intravenously compared to metoclopramide in critically ill patients with EFI. 

“The addition of TD-8954 to our portfolio highlights Takeda’s commitment to the development of treatments to improve the health of patients with gastroenterological disorders,” said Asit Parikh, M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit, Takeda. “As a leader in gastroenterology, Takeda has a history of bringing innovative treatments to patients where there is significant unmet need. We believe that TD-8954 has the potential to deliver therapeutic benefit to patients with gastrointestinal motility disorders, including EFI. Today EFI impacts approximately one million Americans and there are currently no FDA-approved treatment options available.”

“This is an important licensing deal for Theravance Biopharma as it provides a path forward for the development of this much-needed treatment option.  Our single-dose study of TD-8954 in critically ill patients with EFI provided early confidence in the potential for TD-8954 to improve gastric emptying time.  This is important as delayed gastric emptying makes it more difficult to feed patients in the ICU, slowing their recovery time, extending their stay in the ICU and increasing the risk of ICU-related complications,” said Rick E Winningham, Chairman and Chief Executive Officer of Theravance Biopharma. “Takeda is an industry leader in the development of treatments for gastrointestinal disorders, which we believe makes the company an ideal partner to drive the continued advancement of TD-8954.”

Theravance Biopharma will receive an upfront cash payment of $15 million and will be eligible to receive success based development and sales milestone payments as well as double digit royalties on worldwide net sales by Takeda. The first $110 million of potential milestones are associated with the development, regulatory and commercial launch milestones for EFI or other intravenously dosed indications. The transaction is expected to close during the second calendar quarter of 2016, and is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act (“HSR Act”).

About Takeda
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology, central nervous system and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. ENTYVIO® (vedolizumab) demonstrates Takeda’s global capabilities and expansion into the specialty care market in gastroenterology and biologics. Designed and developed specifically to target the gastrointestinal (GI) tract, ENTYVIO was launched in 2014 for the treatment of adults with moderate to severe ulcerative colitis and Crohn’s disease. TAKECAB® (vonoprazan fumarate) is Takeda's potassium-competitive acid blocker and was launched in Japan in 2015. Takeda also markets motility agent AMITIZA® (lubiprostone), which originally launched in 2006 for the treatment of chronic idiopathic constipation, and received subsequent approval to treat irritable bowel syndrome with constipation and opioid-induced constipation. Preceding these notable launches, Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors beginning in the 1990’s with lansoprazole. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Theravance Biopharma 

Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that make a difference in the lives of patients suffering from serious illness.  Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop GI-targeted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases. 

In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain drug development programs, including the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol), currently in development for the treatment of COPD and asthma.