NASDAQ OMX

Apricus Biosciences Files NDA Resubmission for Vitaros(TM)

Del

Approval Decision Expected in First Quarter 2018

SAN DIEGO, Aug. 29, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that it recently filed its resubmission of a New Drug Application ("NDA") for Vitaros(TM) (alprostadil, DDAIP.HCl) with the U.S. Food and Drug Administration ("FDA").  Apricus anticipates a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) goal date in the first quarter of 2018, which it expects the FDA to acknowledge within 30 days of the NDA filing date.

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 pleased to announce that we have filed the U.S. Vitaros NDA resubmission with the FDA," stated Richard W. Pascoe, Chief Executive Officer. "We have received electronic confirmation of the FDA's receipt of our filing and we anticipate an approval decision in the first quarter of 2018.  Importantly, we believe we have completely addressed the deficiencies noted in the complete response letter and strengthened the overall Vitaros risk-reward profile with the goal of bringing an innovative erectile dysfunction treatment to patients whose needs are not met by currently approved therapies."

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 PDUFA goal date to be set by the FDA; and whether Apricus completely addressed the clinical and non-clinical data deficiencies and other deficiencies noted in the 2008 Complete Response letter. 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 may not accept the filing of the Vitaros NDA resubmission; the FDA could require additional clinical and pre-clinical data; Apricus' ability to have addressed any conditions for approvability raised by the FDA; 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; 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.

CONTACT:
Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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 OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra NASDAQ OMX

Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra NASDAQ OMX

Nasdaq Welcomes Secoo Holding Limited (Nasdaq: SECO) to The Nasdaq Global Market22.9.2017 21:11Pressemelding

NEW YORK, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Secoo Holding Limited (Nasdaq:SECO), Asia's largest online integrated upscale products and services platform, rang the opening bell at the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Global Market. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/45f7dc57-524d-4463-a839-d201c341a0f1 http://www.globenewswire.com/NewsRoom/AttachmentNg/149603ca-4949-4531-bf94-aeb6ded2e6df http://www.globenewswire.com/NewsRoom/AttachmentNg/e80a55e0-3858-41cb-80d3-9c9296d6143a Secoo is a consumer-focused online retail platform that offers offline experience centers to provide customer support and membership services. Secoo has built a trusted and comprehensive global supply chain for upscale produ

Alipay teams up with Nordic partners to bring "smart tourism" to Chinese visitors22.9.2017 11:42Pressemelding

HANGZHOU, China, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Alipay, the world's largest online and mobile payment platform, operated by Ant Financial Services Group ("Ant Financial", "Ant"), today announced that it has signed separate MoUs with Finpro (Finland), Svensk Handel (Sweden) and the Scandinavian Tourist Board, which will enable merchants across Nordic region to accept payment via Alipay and reach Chinese customers before, during and after their visit via Alipay's in-app marketing platform. This will bring Chinese tourists the same convenient payment and travel experience that they enjoy in China. Douglas Feagin, President of International Business, Ant Financial Services Group, said, "Alipay has been leading the trend of smart living in China. People not only use Alipay for payment, but also for settlement of all types of needs in their daily life. As part of our globalization strategy, we are focused on working with local partners to bring this

OpenAire brings in the sun with retractable structures across Europe22.9.2017 08:00Pressemelding

OAKVILLE, Ontario, Sept. 22, 2017 (GLOBE NEWSWIRE) -- Venues around the world have been thrilled by OpenAire's retractable roof and enclosure designs since 1989. In 28 years, OpenAire's team of experts has completed nearly 1,000 unique retractable roof enclosures and operable skylights for venues of every size and kind internationally, including many groundbreaking designs across Europe. From Russia to warm and sunny Gibraltar, OpenAire has provided many commercial enterprises, resorts and even some private residences with beautiful retractable enclosures that suit their location and climate perfectly. OpenAire works closely with every client from the start, providing them with the flexibility to make their visions a reality. Many clients across Europe have seen increased business and excellent reviews after building an OpenAire solution. Some notable OpenAire designs include: Aqua Sferra's record-breaking 5,667 m2 (60,999 sq. ft.) free-standing aluminum dome housing its indoor

XBiotech to Present at Cantor Fitzgerald's Global Healthcare Conference21.9.2017 14:00Pressemelding

AUSTIN, Texas, Sept.  21, 2017  (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that management will be presenting at Cantor Fitzgerald's Global Healthcare Conference taking place September 25-27 at the InterContinental New York Barclay Hotel in New York City. Mr. Benjamin Guzman, the Company's Senior Vice President of Corporate Strategy & Finance, will provide a corporate overview on Wednesday, September 27th at 2:50pm Eastern Time. About True Human(TM) Therapeutic Antibodies Unlike previous generations of antibody therapies, XBiotech's True Human(TM) antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability. About XBiotech

At the 10th anniversary of the iPhone, Chairman of Pilatus Bank draws a stark comparison of the role technology has played in banking vs telecommunication21.9.2017 08:58Pressemelding

LONDON, Sept. 21, 2017 (GLOBE NEWSWIRE) -- Ali Sadr, Chairman of Pilatus Bank, believes that banks have failed to capture the true essence of technology for improving quality of service, as well as lacking the vision necessary to capture customers' imaginations. Meanwhile, other industries have been revolutionized and continue to thrive by the same technology. America has in the last 10 years been forced to close 10,000 branches. Since 2008, Europe has lost close to 48,000 branches, which is more than 20% of its branch network. There is little doubt that branch banking is on the decline, and online banking is failing to provide a quality service.  As we mark the 10th anniversary of the iPhone, Ali Sadr, Chairman of Pilatus Bank, gives a sobering count of the current state of affairs in the use of technology among well established banks, and elaborates on a vision that has the potential to become the largest revolution the banking industry is yet to experience. Chairman Al

Asure Software to Attend at Quora Consulting's Smartworking Summit21.9.2017 07:00Pressemelding

Asure Join's Industry Leaders to Discuss "Understanding the Productivity Enigma" AUSTIN, Texas, Sept. 21, 2017 (GLOBE NEWSWIRE) -- Asure Software, (NASDAQ:ASUR), a leading provider in human capital management and workspace management software, will be sponsoring Quora Consulting's Smartworking Summit in central London, September 28th 2017. These summits have continued to lead in addressing work space issues, such as occupancy, utilization, and productivity in the workforce. Dominic Jackson, Asure Sales Director of EMEA commented, "It is workplace issues like productivity that have driven thought leadership here at Asure." He continued "Utilization of workspace solutions help you recruit and retain the best talent, improve employee productivity, streamline operations, and realize a significant ROI on your most valuable assets - people, space and technology. We are thrilled to be not only part of the discussion, but part of the solu

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom