Nasdaq GlobeNewswire

Apricus Biosciences Announces FDA Acknowledgement of Vitaros(TM) Class 2 NDA Resubmission

Del

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.

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 GlobeNewswire

Nasdaq GlobeNewswire
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

CP Kelco Appoints Jennifer Aspen Mason as Sr. Vice President, Global Innovation22.2.2018 20:00Pressemelding

ATLANTA, Feb. 22, 2018 (GLOBE NEWSWIRE) -- CP Kelco, a leading global producer of specialty hydrocolloid solutions, announced today that Jennifer Aspen Mason has joined its Executive Leadership Team as Senior Vice President, Global Innovation, reporting directly to CP Kelco President Didier Viala. A global executive with more than 20 years of industry experience, Mason has an extensive background leading science organizations with Fortune 100 companies. Most recently, she spent more than five years with Mars, Incorporated, where she served as Technology and Science Strategy Officer for all Mars segments. In her new role, Mason is responsible for leading CP Kelco's global research and development (R&D) function, including strategic innovation imperatives to drive the company's long-term growth, as well as oversight of technical teams focused on new product innovation, process R&D and research. "We are truly delighted to welcome Jennifer to our team, and will surely benefit from her glob

Leading the industry: Excel Dryer is the first hand dryer manufacturer to publish third-party, verified Environmental Product Declarations (EPDs)22.2.2018 16:00Pressemelding

High-speed, energy-efficient XLERATOR®, XLERATOReco® and ThinAir® Hand Dryers evaluated and proven to be sustainable EAST LONGMEADOW, Mass., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Excel Dryer, Inc., today announced that three of their hand dryers, the original, patented, high-speed, energy-efficient XLERATOR® Hand Dryer, the XLERATOReco® Hand Dryer and the ThinAir® Hand Dryer, were evaluated, and their environmental claims, substantiated with the publication of the hand dryer industry's first Environmental Product Declarations (EPDs) by UL Environment, a business division of Underwriters' Laboratories. An Environmental Product Declaration is a standardized way of quantifying the environmental impact of a product by studying the raw materials and energy consumption during its production, use and disposal. For buyers and specifiers, the EPDs are a disclosure tool that helps purchasers better understand a product's sustainable qualities and environmental repercussions so they can make more inf

Intrinsyc Technologies (TSX: ITC and OTC: ISYRF) debuts system on module and development kit powered by NXP i.MX 8M processor22.2.2018 15:00Pressemelding

Powerful Embedded Computing Solutions Optimized for Multimedia Applications VANCOUVER, British Columbia, Feb. 22, 2018 (GLOBE NEWSWIRE) -- Intrinsyc Technologies Corporation (TSX:ITC) (OTC:ISYRF) ("Intrinsyc" or the "Company"), a leading provider of solutions for the development and production of embedded and Internet of Things ("IoT") products, today announced the availability of the Open-X(TM) 8M System on Module ("SOM") and Development Kit. Intrinsyc's Open-X(TM) 8M SOM incorporates the new 64-bit NXP i.MX 8M processor and is ideal for powering IoT devices ranging from consumer smart home appliances to industrial building automation products. Its ultra-compact (55mm x 35mm) size enables its use in a wide range of form factors. The feature-rich SOM, with its advanced video and audio features, is ideal for streaming video/audio devices, voice control applications, and human-machine interface solutions. It offers high quality video playback with full 4K UHD and HDR along with the highe

Danal Inc. Creates Largest and Best Global Mobile Identity Solution22.2.2018 14:00Pressemelding

On track to cover 3 Billion+ Consumers SAN JOSE, Calif., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Danal, Inc., a global leader in mobile identity and authentication services, today announced that customer demand is driving its expansion into Asia and LATAM. The company is expanding to eight countries in Asia and LATAM this year in addition to its continued expansion in Europe and UK - creating the largest and most comprehensive Mobile Network Operator (MNO) based identity solution in the market. It is on track to cover over 3 Billion consumers worldwide and support numerous Fortune 500 Enterprises in their endeavor to fight fraud, account takeovers, assuring reliable consumer authentication with best in class experiences, and help conform to regulatory compliance including GDPR, TCPA, KYC and AML. Danal is experiencing strong demand by global brands for the US, EU, and Asian markets - especially in the financial sector like banks, insurances, money remitters, payment processors and innovative

Valeritas Announces V-Go® Distribution Agreement in Italy with Movi SpA22.2.2018 13:00Pressemelding

BRIDGEWATER, N.J., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with type 2 diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, today announced it has signed an exclusive distribution agreement with Movi SpA ("Movi") for the commercialization of V-Go Wearable Insulin Delivery device in Italy. Under the terms of the agreement, Valeritas has granted Movi the rights to promote, market, and sell the Company's flagship product V-Go Wearable Insulin Delivery device to diabetes clinics and patients in Italy. "We are thrilled to have Movi as our partner, and our distribution agreement is a significant first step to expand market access for V-Go Wearable Insulin Delivery device outside of the United States," said John Timberlake, CEO and President of Valeritas. "Movi is a truste

SoftServe Appoints Alex Chubay as Chief Technology Officer22.2.2018 13:00Pressemelding

Chubay to Champion the Next Phase of Innovation and Growth at World-Class Digital Consultancy AUSTIN, Texas, Feb. 22, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading global digital authority and consulting company, today announces its appointment of Alex Chubay as Chief Technology Officer, effective immediately. Chubay will lead global IT functions and play a key role in shaping the company's technology capabilities and roadmap. He will be responsible for SoftServe's Centers of Excellence, comprising Experience Design, Solutions, Intelligent Enterprise, Critical Services, Digital Platforms; as well as research and development within the company. He will report to SoftServe's CEO, Chris Baker. "SoftServe has operated at the cutting edge of technology for a quarter century, and to continue that momentum - and most importantly to ensure our customers, partners, and associates are served well in the future - we are delighted to announce Alex Chubay's appointment as CTO," said Baker. "This ne

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

Besøk vårt presserom