May 9, 2013 – King of Prussia, PA and New York, NY – Trevena, Inc., (Trevena) a clinical stage pharmaceutical company and the leader in the discovery and development of G protein coupled receptor (GPCR) biased ligands, and Forest Laboratories Holding Limited (Forest), a subsidiary of Forest Laboratories Inc. (NYSE:FRX), an international pharmaceutical company, announced today that they have entered into a collaborative licensing option agreement for the development of TRV027, an AT1R biased-ligand that recently completed Phase 2a clinical trials. Trevena expects to commence a 500-patient multi-center Phase 2b clinical trial in acute decompensated heart failure (ADHF) by year end.
Specific terms of the transaction were not disclosed but the agreement includes a $30 million equity investment by Forest in Trevena and the grant by Trevena to Forest of an option to exclusively license TRV027 on a worldwide basis following completion of the planned Phase 2b clinical trial which will be funded by Trevena. The parties will establish a joint development committee to oversee the development of TRV027 with Trevena retaining operational authority during the option period. Following the exercise of the option, Forest will make payments of up to $430 million, depending upon the achievement of future development and commercial milestones, plus royalties, and will have responsibility for the development and commercialization of the product.
"We are excited to enter into this collaboration with Trevena, a leader in the ground breaking science of GPCR biased ligands. TRV027 represents an important opportunity for Forest to build on our presence in the cardiovascular market and the hospital segment. ADHF is the fourth leading cause of hospitalizations in the United States and there has been no material change in the standard of care for patients with ADHF for decades. TRV027 has the potential to be a significant new advance in the treatment of ADHF because it addresses the underlying pathophysiology of the disease which has been demonstrated in pre-clinical and early clinical work by Trevena." said David Solomon, Forest’s SVP of Corporate Development & Strategic Planning.
"Forest Labs brings a wealth of drug development and commercialization experience to the TRV027 program," said Maxine Gowen, Trevena’s President and Chief Executive Officer. "This collaboration provides us with an opportunity to maximize the potential of this promising compound, and further validates our biased ligand approach to GPCR drug discovery."
Under the terms of the deal, Forest Labs will lead Trevena's $60 million Series C financing round with a $30 million investment. An executive of Forest Laboratories will also join Trevena’s Board of Directors. Existing investors also participating in the round are Alta Partners, Healthcare Ventures, NEA, Polaris and Yasuda Enterprise Development Company.
About TRV027 and ADHF
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 (AT1R) that combines the proven benefits of angiotensin blockade with new beta-arrestin-mediated biology to preserve cardiac and renal function. 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, as a poster at the American College of Cardiology meeting in March 2013. Trevena successfully completed the Phase 2a study in October 2012, in which TRV027 was generally well-tolerated and produced a beneficial set of hemodynamic effects. The Phase 2a study was a randomized, double-blind, placebo-controlled, adaptive, ascending dose-titration study to evaluate the safety, tolerability, pharmacokinetics, and invasive hemodynamics of TRV027 in patients with stable NYHA Class 3 and 4 heart failure (NCT01187836).
The American Heart Association estimated 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 over 1.3 million hospital admissions per year. ADHF is also the most costly diagnosis for Medicare. 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 G-protein coupled receptor (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 discovery-stage programs for chronic pain, and Parkinson’s disease.
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)
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