Trevena Granted Key Composition of Matter Patent for TRV027 in U.S.
Patent coverage granted until 2031 for Trevena's lead Phase 2 compound in acute heart failure
KING OF PRUSSIA, Pa., July 17, 2013 /PRNewswire/ -- Trevena, Inc., (Trevena) a clinical stage pharmaceutical company and the leader in the discovery and development of G-protein coupled receptor (GPCR) biased ligands, announced today that the United States Patent and Trademark Office has granted Trevena a composition of matter patent covering its development product TRV027. United States Patent No. 8,486,885 entitled "Beta-Arrestin Effectors and Composition and Methods of Use Thereof," is expected to provide coverage for TRV027 until at least July 2031.
TRV027 is an experimental intravenous drug for the treatment of acute decompensated heart failure (ADHF), currently in mid-stage clinical trials. It is a novel beta-arrestin biased ligand of the angiotensin II type 1 receptor that combines the proven benefits of angiotensin blockade with new beta-arrestin-mediated biology to preserve cardiac and renal function. Trevena recently entered into a collaborative licensing option agreement for the development of TRV027 with Forest Laboratories Inc. (NYSE:FRX). The company expects to commence a 500-patient multi-center Phase 2b clinical trial for TRV027 in ADHF patients by year end.
"This core patent provides the foundation for broad and enforceable intellectual property protection for TRV027, and is followed by a series of patent applications made by Trevena to protect our growing pipeline of GPCR biased ligands in key markets around the world," said Maxine Gowen, Trevena's President and Chief Executive Officer. David Solomon, Forest's SVP of Corporate Development & Strategic Planning, and a Board member at Trevena, added, "This issued patent enhances the value potential of TRV027, and provides an essential platform from which to drive its commercialization."
Trevena recently presented the results of a Phase 2a study on the hemodynamic effects of TRV027 in patients with advanced heart failure with reduced ejection fraction (NCT01187836), as a poster at the American College of Cardiology meeting in March 2013. The Phase 2a trial was an ascending dose titration study in patients with stable NYHA Class 3 or 4 heart failure.
The American Heart Association estimates that ADHF hospitalization costs the U.S. healthcare system more than $20 billion each year in direct spending. ADHF is already the leading reason for hospitalization of individuals over 65 years old in the United States, with more than 1 million hospital admissions per year. ADHF is also the most costly diagnosis for Medicare in the nation. Despite the significance of this problem, current therapies are not producing meaningful improvements in patient outcomes. ADHF incidence is increasing globally, and both heart failure mortality and hospital re-admission following an ADHF event remain extremely high.
Trevena, Inc. is a clinical stage pharmaceutical company focused on discovering and developing the next generation of GPCR targeted medicines. GPCRs are the targets for at least one-third of modern medicinal products, and remain the predominant class of targets under clinical evaluation. Trevena's expertise lies in engineering "biased ligands" that activate only the beneficial signaling pathways downstream of a GPCR to unlock new biology and avoid drug adverse effects. In addition to TRV027, Trevena's pipeline currently includes a clinical stage mu-opioid biased ligand for post-operative pain, and earlier-stage programs for chronic pain, and Parkinson's disease. For more details, visit www.Trevenainc.com.
About Forest Laboratories
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest's pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
For more information, please contact:
Rosamond Deegan, Vice President, Business Development 610-354-8840 x225 (Corporate Inquiries)
Kimberly Minarovich, Christensen, 917-533-3268 (Media Inquiries)
SOURCE Trevena, Inc.
Released July 17, 2013