Trevena To Host 2017 Analyst Day and Announce Results of ATHENA Open Label Safety Study of OLINVO
July 20 2017 - 9:00AM
– Company now plans to submit its New Drug
Application for OLINVOTM (oliceridine injection) in September or
October 2017 –
Trevena, Inc. (NASDAQ:TRVN) today announced that it will host an
Analyst Day in New York City beginning at 12:00 pm today with
leading clinicians and Company management discussing the Company’s
portfolio of innovative investigational drugs, including new data
and commercial strategy for its lead program, OLINVO™ (oliceridine
injection), for moderate to severe acute pain. To join the live
audio webcast of the presentation, please visit the Investor
section of the Company’s website. Following the conclusion of the
presentation, the webcast will be available until August 20,
2017.
“We’re pleased to share a number of important updates for OLINVO
and our R&D pipeline,” said Maxine Gowen, Ph.D., chief
executive officer of Trevena. “Observations from the ATHENA open
label study and new analysis of the burden of opioid-related
adverse effects in hospitalized patients now complement the
randomized controlled APOLLO studies to position OLINVO as a
potentially valuable new option for patients who require IV opioids
but are at risk of opioid related adverse effects. Our commercial
strategy will target select procedures and specialties to focus on
bringing OLINVO to these patients.”
At the event, four leading external clinicians and researchers
will discuss care practices, unmet needs, and OLINVO data:
- Eugene R. Viscusi, M.D., Professor of Anesthesiology at the
Sidney Kimmel Medical College at Thomas Jefferson University, will
discuss the landscape for acute pain management and present an
overview of the randomized controlled trial data for OLINVO.
- Peter Whang, M.D., FACS, Associate Professor of Orthopaedics
& Rehabilitation at Yale University School of Medicine, will
discuss unmet needs in orthopedic surgery, including new analysis
of a hospital administrative billing database detailing the
prevalence and costs of opioid-related adverse events in
hospitalized orthopedic patients.
- Michael H. Bourne, M.D., Chairman of Orthopaedic Surgery at St.
Mark’s Hospital and an investigator in the ATHENA study, will
discuss how IV opioids are used in his practice, present topline
results of the ATHENA study, and report observations of OLINVO
performance in the patients treated at his site.
- Hadi Najafian, D.O., FACS, FASCRS, Chief of Colorectal Surgery
at St. Joseph’s Westgate Medical Center, will discuss the use of IV
opioids in pain management following colorectal surgery and the
potential impact of OLINVO on patient outcomes.
OLINVO program updates to be discussed
- New data from an analysis of an administrative billing database
(the Premier Perspective® Hospital Database) quantify the
substantial burden of illness associated with opioid-related
adverse events (ORAEs) in 80 procedures across 8 medical
specialties that will be basis for the Company’s initial
commercialization efforts. This analysis shows that patients having
these procedures require substantial doses of IV opioids despite
multimodal analgesia, and that the prevalence and costs associated
with ORAEs are significant. Specifically:• Postoperative nausea and
vomiting in patients receiving parenteral opioids occurs in 44-72%
of patients and costs $1,600-$8,900 per event across specialties.•
Postoperative respiratory compromise occurs in 3-17% of patients
and costs $4,600-$20,000 per event across specialties.
- The Company has completed enrollment of patients in the ATHENA
study to support its planned NDA submission. In the study, 772
patients were administered OLINVO to manage pain associated with a
wide range of procedures and diagnoses. The most frequent
procedures were orthopedic, gynecologic, colorectal, general, and
plastic surgeries. Patients at risk of opioid-related adverse
events were common, including patients over 65 years old and obese
patients. OLINVO was administered by titration in
post-anesthesia recovery rooms, as-needed by bolus injection, and
by patient-controlled analgesia. Discontinuation rates were less
than 5% for lack of efficacy or for adverse effects.
- Investigator-reported observations from the ATHENA study
included a retrospective chart review in which colorectal surgery
patients administered OLINVO at one site in the ATHENA study had
return of bowel function 28 hours faster than similar patients at
the same site treated with conventional opioids prior to the ATHENA
study (p=0.0001 vs. historical control).
- The Company has successfully completed its chemical,
manufacturing, and controls (CMC), nonclinical, and clinical Type-B
pre-NDA meetings with the U.S. Food and Drug Administration (FDA),
and now plans to submit the OLINVO NDA to the FDA in September or
October of 2017.
- The Company is planning an open label investigation of OLINVO
in key procedures that may yield additional investigator
observations to inform potential prescribers and identify potential
future studies.
- The Company will outline its commercial strategy for OLINVO and
discuss its initial focus on patients who are at greater risk of
ORAEs. Specifically, the Company expects to target medical
education and post-approval promotion to eight physician
specialties with 80 select procedures and diagnoses where pain is
most severe and/or prolonged, and procedure, comorbidity, or
demographic factors place patients at elevated risk of
opioid-related adverse effects. These patients comprise
approximately 7 to 9 million annual hospital inpatients in the
U.S.
Pipeline updates to be discussed
- TRV250, Trevena’s selective delta receptor modulator for
treatment of acute migraine, is currently under investigation in a
single ascending dose trial in healthy volunteers. This study is
evaluating the safety, tolerability, and pharmacokinetics of
subcutaneous and oral TRV250, with results expected in the second
half of 2017.
- The Company disclosed a new preclinical lead optimization
program targeting S1P receptors with a novel mechanism that has
demonstrated activity in preclinical models of chemotherapy-induced
peripheral neuropathy, neuropathic pain, and inflammatory pain.
Trevena’s compounds are expected to be non-addictive and to avoid
the immune suppression associated with approved and investigational
S1P receptor targeted drugs.
Corporate update
Separately, the Company today announced that its chief medical
officer, David Soergel, M.D., is planning to depart from the
Company in late August to pursue a new opportunity. “While I am sad
to see David leave, I am extremely grateful for the extraordinary
dedication and thoughtfulness he has brought to Trevena for the
last seven years,” said Dr. Gowen. “I wish him the best of luck and
am confident he will continue to excel in the future as he has at
Trevena.”
A search for a new chief medical officer is ongoing.
Conference call and webcast
Date: Thursday, July 20, 2017
Time: 12:00 p.m. EDT Telephone
Access: (855) 465-0180 International:
(484) 756-4313 Conference ID: 53894172
To join the live audio webcast of the presentation, please visit
the Investor section of the Company’s website. Following the
conclusion of the presentation, the webcast will be available until
August 20, 2017.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing
innovative therapies based on breakthrough science to benefit
patients and healthcare providers confronting serious medical
conditions. The Company’s lead program is OLINVO™ (oliceridine
injection), which has completed two successful Phase 3 trials for
the management of moderate-to-severe acute pain. Trevena has
discovered four novel and differentiated drug candidates, including
OLINVO. Trevena also has discovered TRV250, in early clinical
development for the treatment of acute migraine. The Company
maintains an early stage portfolio of drug discovery programs.
Cautionary note on forward looking
statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, clinical development of its
therapeutic candidates, plans for potential future product
candidates and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “suggest,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
status, timing, costs, results and interpretation of the Company’s
clinical trials or any future trials, including the interpretation
of the topline results from the APOLLO and ATHENA trials, whether
the Company will undertake any additional open-label investigations
of OLINVO, whether the existing clinical data is sufficient to
support the Company’s NDA to FDA, and whether OLINVO has the
potential to positively impact patient outcomes; the uncertainties
inherent in conducting clinical trials; interpretations of
regulatory interactions and expectations for regulatory submissions
and approvals, including whether the pre-NDA meetings with FDA were
successful and whether the Company will submit the OLINVO NDA in
September or October of 2017; availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements; uncertainties related to the
Company’s intellectual property, including with respect to
compounds for which the Company does not yet have patent
protection; other matters that could affect the availability or
commercial potential of the Company’s therapeutic candidates,
including whether physicians, patients, and payers will conclude
that OLINVO represents a potentially valuable new option for
patients who require IV opioids but are at risk for ORAEs; and
other factors discussed in the Risk Factors set forth in the
Company’s Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings the Company makes with the SEC from time to time. In
addition, the forward-looking statements included in this press
release represent the Company’s views only as of the date hereof.
The Company anticipates that subsequent events and developments may
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to do so,
except as may be required by law.
Contacts
Trevena, Inc.
Investors:
Jonathan Violin, Ph.D.
Vice President, Corporate Strategy & Investor Relations
610-354-8840 x231
jviolin@trevena.com
or
Media:
Public Relations
PR@trevena.com
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