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Trevena Reports First Quarter 2018 Financial Results
First license agreements for ex-US development and commercialization of oliceridine add potential revenue streams
Oliceridine NDA on track for potential approval in November
CHESTERBROOK, PA, May 3, 2018 Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended March 31, 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.
In 2018, we have made important progress in Trevenas evolution, said Maxine Gowen, Ph.D., president and chief executive officer. We have initiated a smooth and constructive transition in preparation for Carrie Bourdow to assume the CEO position later this year. We also have begun to broaden the potential revenue from oliceridine by completing our first ex-US licensing agreements. We continue to have an ongoing productive dialogue with the FDA as they review our oliceridine NDA, and look forward to an advisory committee meeting later this year and potential approval in November.
First quarter and recent corporate highlights
· New Drug Application (NDA) for oliceridine submitted and accepted. In January 2018, the Company announced that the FDA has accepted the Companys NDA for oliceridine, an investigational product for the management of moderate to severe acute pain. Oliceridine is the first G protein biased ligand of the mu receptor, and was designed to provide IV opioid pain relief with fewer associated adverse effects. The FDA has informed the Company that it intends to convene an advisory committee meeting to discuss the oliceridine NDA ahead of the Prescription Drug User Fee Act (PDUFA) review date of November 2, 2018. If approved, the Company expects commercial launch of oliceridine in the first quarter of 2019, following DEA scheduling.
· Licensed oliceridine for development and commercialization in two ex-US territories. 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. announced that they have entered an exclusive license agreement for the development and commercialization of oliceridine in China. Under these agreements, Trevena will receive a total of $5.5 million in upfront payments, and is eligible for further regulatory and commercial milestones and royalties. The Company remains in active discussions for licensing oliceridine in additional territories.
· Carrie Bourdow selected as next CEO. In April, the Company announced that President and Chief Executive Officer, Maxine Gowen, Ph.D., will retire on October 1, 2018 and will continue to serve on the Trevena Board of Directors. The Board of Directors has selected Carrie L. Bourdow, who
The following information was filed by Trevena Inc (TRVN) on Thursday, May 3, 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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