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Trevena Reports Second Quarter 2018 Financial Results
Oliceridine NDA remains on track for a November 2, 2018 FDA decision
First license agreements for ex-US development and commercialization of oliceridine add potential revenue streams
Early pipeline continues to advance
CHESTERBROOK, PA, August 2, 2018 Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended June 30, 2018 and provided an update on its pipeline of differentiated new chemical entities, including its lead asset, oliceridine, currently under review by the U.S. Food and Drug Administration (FDA) for potential approval this year.
The second quarter saw important progress towards Trevenas long-term success, said Maxine Gowen, Ph.D., President and Chief Executive Officer. We remain confident that the oliceridine NDA remains on track for an FDA decision by the November 2, 2018 PDUFA date, and we look forward to discussing the oliceridine data at an Advisory Committee meeting, likely in October. In addition, the second quarter saw us secure two important ex-US licensing transactions for oliceridine, strengthen our leadership team with important medical and commercial hires, and continue a smooth transition to Carrie Bourdows assumption of the CEO role.
Second quarter and recent corporate highlights
· Prescription Drug User Fee Act (PDUFA) date for oliceridine: November 2, 2018. Oliceridine is an investigational product under FDA review for the management of moderate to severe acute pain where parenteral opioid analgesia is warranted and was designed to provide the pain relief of IV opioids with fewer associated adverse effects. The FDA has informed the Company that it intends to convene an advisory committee meeting, likely in October, to discuss the oliceridine NDA. If oliceridine is approved by the FDA, and following DEA scheduling, the Company expects the commercial launch of oliceridine in the first half of 2019.
· Licensed oliceridine for development and commercialization in South Korea and China. In April, the Company and privately held Pharmbio Korea Inc. announced that they have entered into an exclusive license agreement for the development and commercialization of oliceridine in South Korea. In May, the Company and Jiangsu Nhwa Pharmaceutical Co. Ltd. (Nhwa) announced that they have entered an exclusive license agreement for the development and commercialization of oliceridine in China. Under these agreements, Trevena has received a total of $5.5 million in upfront payments, and it is eligible for further regulatory and commercial milestones and royalties. Nhwa has since exercised its option to exclusive rights to manufacture oliceridine for potential distribution in China. The Company continues to pursue its strategy to outlicense oliceridine in additional territories.
The following information was filed by Trevena Inc (TRVN) on Thursday, August 2, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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