Apricus Biosciences Announces FDA Acknowledgement of Vitaros(TM) Class 2 NDA Resubmission
PDUFA Goal Date of February 17, 2018
SAN DIEGO, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration ("FDA") has acknowledged receipt of its recently resubmitted New Drug Application ("NDA") for Vitaros(TM) (alprostadil, DDAIP.HCl) and considers it a complete, class 2 response to Apricus' 2008 action letter. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA's review of the Vitaros NDA is set for February 17, 2018, which is the standard six month review period for NDA resubmissions.
Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction ("ED") and a new potential entrant into the U.S. ED treatment market. Vitaros has been approved in Canada, Mexico, and certain countries in Europe, Latin America and the Middle East, and the product is being commercialized by Ferring International Center S.A. and its licensees throughout Europe and in the Middle East.
"We are very pleased to announce that the FDA has acknowledged receipt of our U.S. Vitaros NDA resubmission and our PDUFA goal date is February 17, 2018," stated Richard W. Pascoe, Chief Executive Officer. "The FDA has determined that the resubmission is a complete, class 2 response to our 2008 action letter. Importantly, we believe that Vitaros, if approved, will address a significant unmet need in the erectile dysfunction market."
Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan pursuant to a license agreement entered into between the parties in September 2015. The U.S. Vitaros asset was previously purchased by Warner Chilcott, now a subsidiary of Allergan, from Apricus back in February 2009. Pursuant to the terms of the license agreement, upon FDA approval of the NDA for Vitaros, Allergan may elect to exercise a one-time opt-in right to assume all future marketing and selling activities in the United States. If Allergan exercises its opt-in right, Apricus may receive up to a total of $25 million in upfront and potential launch milestone payments, plus a double-digit royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may commercialize Vitaros and in return will pay Allergan a double-digit royalty on net sales of Vitaros.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud's phenomenon, secondary to scleroderma, for which we own worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros(TM) is Apricus' trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa(TM) is Apricus' trademark, which is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: the timing of the FDA's review of the re-submission of the Vitaros NDA; the potential approval of the NDA by the FDA; and Vitaros addressing a significant unmet need in the ED market. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus' control, including, but not limited to: the FDA could require additional clinical and pre-clinical data; Apricus' ability to have addressed any conditions for approvability raised by the FDA in the 2008 action letter or the FDA identifying other deficiencies in the resubmission; risks related to the possibility of an advisory committee meeting related to Vitaros; the risks of any additional adverse safety or other data arising from the sales and use of Vitaros in certain countries in Europe and elsewhere; Apricus' financial position and need for additional capital to fund its operations through the FDA's review of the NDA, which may be adversely impacted if Apricus is unable to maintain the continued listing of its common stock on the Nasdaq stock market; competition in the ED market; and other risks identified by Apricus in its reports filed with the Securities and Exchange Commission (SEC). These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.
The Trout Group
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Atico Reports Consolidated Financial Results for the Second Quarter of 201814.8.2018 22:30 | Pressemelding
(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the “Company” or “Atico”) (TSX.V:ATY) (OTC:ATCMF) today announced its financial results for the three months ended June 30, 2018, posting a net income of $2.8 million. Fernando E. Ganoza, CEO and Director, commented, "We are pleased to report a strong second quarter and first half of the year. The Company showed improvements in earnings and working capital over the same period last year while remaining on schedule to fully repay the senior debt facility during this fiscal year. Mr. Ganoza continued, "For the second half of this year, we will continue focusing on cost control initiatives to reduce operating costs while also advancing on our regional and underground exploration drill programs." Second Quarter Financial Highlights Net income for the three months ended June 30, 2018 (“Q2-2018”) amounted to $2.8 million, compared with $0.6 m
2018 Online Journalism Awards finalists and James Foley Award recipient announced14.8.2018 19:29 | Pressemelding
WASHINGTON, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Finalists for the 2018 Online Journalism Awards, representing a wide range of local and international media, nonprofit, public, academic and emerging technology organizations, were announced today by the Online News Association. Thirteen of the awards come with $58,500 in prize money, courtesy of John S. and James L. Knight Foundation, the Gannett Foundation , the University of Florida College of Journalism and Communications and Journalism 360. These awards honor data journalism, visual digital storytelling, investigative journalism, immersive storytelling, public service, technical innovation, student journalism and general excellence. This year’s awards introduced a new category for Excellence in Collaboration and Partnerships, honoring newsrooms and companies who formed innovative partnerships or collaborations to cover a topic or story with a digital focus. In addition, the General Excellence category now has a micro size group for new
Pinnacle Studio 22 Ultimate Amps Up Video Editing with New Pro-inspired Features14.8.2018 15:11 | Pressemelding
New Three- and Four-Point Editing, Color Grading, and MultiCam Capture Lite deliver advanced video editing options to bring your videos even closer to pro OTTAWA, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Introducing Pinnacle Studio™ 22 Ultimate, Pinnacle’s flagship video editing software that offers powerful features, precise editing controls, and premium effects to create eye-catching video projects with professional flair. With new Three- and Four-Point Editing, Color Grading, dynamic Split Screen videos, MultiCam Capture Lite, and more, Pinnacle Studio 22 Ultimate gives users a complete collection of pro-inspired features to express their unique vision and achieve stunning results. “Pinnacle Studio Ultimate is the go-to choice for users looking for true creative control and a sophisticated editing experience from a consumer video editor,” said Michel Yavercovski, Senior Director of Product Management for Pinnacle. “With the latest version, we’re pushing this even further with a pro-inspire
Keesal, Young & Logan and Mitratech Announce TAP Workflow Automation Partnership with the Launch of Keesal Propulsion Labs14.8.2018 15:02 | Pressemelding
NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Keesal, Young & Logan (KYL) and Mitratech announced today the TAP Workflow Automation partnership to help a greater number of legal professionals quickly implement standardization and compliance across a wide range of legal processes, starting with KYL’s own clients. But it doesn’t stop there. The partnership has resulted in the launch of Keesal Propulsion Labs (KPL) designed to position KYL as an extension of their clients’ teams — helping them to expand and connect their tech stack to solve complex legal and business process challenges. “The goal of KPL is to break down the walls between solution providers, law firms and clients so they can operate as one unit and transform legal operations into a center of excellence that drives innovation across the entire organization,” said Justin Hectus, CIO/CISO at KYL. “By creating cross-ecosystem collaboration, we are uniting people, processes, and compliance, to help mitigate risk and position the
Meltwater launches data science platform Fairhair.ai to tame real-time market signals found in world’s online data14.8.2018 15:00 | Pressemelding
AI-powered platform democratises analytics of forward-looking indicators based on insights from the outside, known as Outside Insight SAN FRANCISCO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- In the quest to become data-driven, companies are increasingly investing in Business Intelligence software to gain a competitive advantage. Yet the insights generated by those tools are mostly fuelled by data from within a company’s walls, instead of the real-time market signals found externally online – from consumer opinions to corporate filings. This outside data can unlock key indicators about an industry or competitor, but harnessing the volume and variety of global data is a time-intensive task. And although advances in artificial intelligence have made it easier to capture and analyse this data to create powerful insights, most commercial AI tools are one-size-fits-all models with limited capabilities. That’s why Meltwater – a pioneer of media intelligence and curator of the world’s most diverse col
Gratomic Provides Update on Perpetuus Graphene Development Program14.8.2018 14:00 | Pressemelding
TORONTO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. (“GRAT” or the “Company”) (TSX-V: GRAT) (FRANKFURT:CB81, WKN:A2JAP3). Gratomic, is pleased to provide an update on its previously announced Graphene development program primarily targeted towards elastomer and polymer tire markets, launched with its European partner, Perpetuus Carbon Technologies Limited (“Perpetuus”), a wholly owned subsidiary of Perpetuus Advanced Materials. As disclosed by Gratomic on April 22, 2018, Perpetuus and Gratomic executed a letter of collaboration pursuant to which Perpetuus undertook to build three specialized process tooling chambers (“Chambers”) to be used solely for processing Graphite from Gratomic’s Aukam Graphite mine in Namibia. The first of such Chambers has passed the testing phase and is ready to process the Aukam sourced Graphite, the second Chamber is presently under construction with the third to follow immediately thereafter. Photos accompanying this announcement are available at http:
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom