KING OF PRUSSIA, Pa. and
NEW YORK, May 9, 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, 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.
About Trevena
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)
SOURCE Trevena, Inc.