– Company now plans to submit its New Drug Application for OLINVOTM (oliceridine injection) in September or October 2017 –
– Topline results from ATHENA safety study further support potential value of OLINVO in patients at risk of opioid-related adverse events –
– Pipeline progress includes continuing Phase 1 study of TRV250 for acute migraine and newly disclosed preclinical S1P modulator program –
KING OF PRUSSIA, Pa., July 20, 2017 (GLOBE NEWSWIRE) -- 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:
OLINVO program updates to be discussed
Pipeline updates to be discussed
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.