Trevena Inc. & Forest Laboratories Announce a Collaborative Agreement for Development of TRV027 for the Treatment of Acute He...
May 09 2013 - 6:00AM
Business Wire
Trevena Inc., (Trevena) a clinical stage pharmaceutical company
and the leader in the discovery and development of G-protein
coupled receptors (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.
TRV-027 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. TRV-027 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.
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024