Apricus Biosciences Announces Scheduling of Vitaros(TM) End-of-Review Meeting with FDA
Meeting Scheduled for April 12, 2018
SAN DIEGO, March 26, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that its end-of-review meeting with the U.S. Food and Drug Administration ("FDA") to discuss the New Drug Application ("NDA") for Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction, is now scheduled to be held on April 12, 2018.
The FDA previously issued a Complete Response Letter ("CRL") for the Vitaros NDA, indicating that the FDA could not approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
"We are looking forward to our end-of-review meeting with the FDA. We intend to further clarify the deficiencies raised in the CRL and the information that may be needed to resolve such deficiencies and to assess the path forward for further development and a potential approval of Vitaros," stated Richard W. Pascoe, Chief Executive Officer. "Following receipt of the end-of-review meeting minutes, we intend to update the market on our future plans for 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: Vitaros, 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); and RayVa, a product candidate which has completed a Phase 2a clinical trial for the treatment of the circulatory disorder Raynaud's phenomenon, secondary to scleroderma, for which Apricus owns 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 occurrence of the end-of-review meeting with the FDA; the timing of any clinical and non-clinical studies to address the FDA's concerns and whether the results of such studies would be sufficient to overcome the deficiencies raised in the CRL; and the timing and results of Apricus' evaluation on the path forward for Vitaros. 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: Apricus' financial position and need for additional capital to fund its operations, which may be adversely impacted if Apricus is unable to maintain the continued listing of its common stock on the Nasdaq stock market; Apricus' ability to address any conditions for approvability of Vitaros raised by the FDA in the CRL; 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; 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 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
Service Providers Speed Deployment, Reduce Costs with Patton Cloud Edge Orchestration Service20.9.2018 22:16 | Pressemelding
Now, Telecom and UCaaS service providers can easily provision, manage, monitor, secure, alert, troubleshoot, analyze, and optimize services on the customer premise GAITHERSBURG, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Patton Electronics—US-manufacturer of UC, cloud, and IoT-enabling solutions for carrier, enterprise, and industrial networks—has launched the new Patton Cloud service for carriers and service providers that deliver All-IP and hybrid voice-and-data services to business subscribers. Patton Cloud delivers a low-cost, easy-to-use, web-based edge-orchestration service that delivers a superior user experience. It offers remote touchless provisioning, monitoring, and troubleshooting—as well as security and alerting tools that reduce service turn-up costs, trouble tickets, and subscriber attrition. The Patton Cloud service offers quality-control mechanisms including pro-active monitoring and troubleshooting—combined with feature-license distribution pools for managing value-added
Inspirata Promotes Top Executives to Expanded Roles in Digital Pathology20.9.2018 21:12 | Pressemelding
Inspirata Founder and Executive Vice President, Mark Lloyd, is taking on an expanded role overseeing product management, and Inspirata Senior Vice President, Andrew Chomos, has been appointed to General Manager, Digital Pathology, overseeing the Center of Excellence in Pittsburgh along with all North America sales and customer support efforts. Tampa, FL, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Cancer informatics and digital pathology workflow solution provider Inspirata®, Inc. announced today that two of its executives have taken on expanded roles in the company. The two are Inspirata Executive Vice President and Founder, Mark Lloyd, and Senior Vice President and General Manager, Digital Pathology, Andrew Chomos. Dr. Lloyd has accepted the expansion of his role to include product management for Digital Pathology. He is former cancer researcher at both Lombardi Cancer and Moffitt Cancer Center and is Inspirata’s foremost subject matter expert and thought leader on digital pathology and image
Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA™ (eravacycline) for the Treatment of Complicated Intra-Abdominal Infections20.9.2018 19:08 | Pressemelding
– Broad Product Label for Treatment of Complicated Intra-Abdominal Infections – – Phased Commercial Launch Expected in the First Half of 2019 – WATERTOWN, Mass., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for XERAVA (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem. “The European approval of XERAVA, right after our recently announced FDA approval, marks our second significant regulatory approval within one month
UPDATE— Taconic Biosciences Becomes the First Animal Model Provider on General Services Administration Contract Schedule20.9.2018 18:07 | Pressemelding
RENSSELAER, N.Y., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces a new relationship with Government Scientific Source (GSS). GSS is a leading dedicated distributor of laboratory equipment to federal, state, and local governments on contract with the GSA (General Services Administration). By having Taconic’s products available via GSS, they can now be accessed by all federal agencies, including but not limited to the National Institutes of Health and the Department of Defense. Taconic is the only animal model provider affiliated with GSS and the only animal model provider available on GSA Contract. “An important component of providing customers with the best animal model solutions is access to key resources. Through this exciting new relationship with GSS, Taconic can now easily connect with scientists doing some of the most valuable research in the world and provide them with high quality sol
Digital Transformation is Not a One-Off — It’s About the Digital Journey20.9.2018 17:44 | Pressemelding
SoftServe study confirms four digital journey states with 71 percent of enterprises reporting early stages of adoption AUSTIN, Texas, Sept. 20, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, today released the results of its market research study that examines how enterprises are responding to the digital economy. The research found that 71 percent of the respondents in the United States and the European Union are in the early stages—Reveal and Transform—of four unique states across the Enterprise Digital Journey. For an in-depth analysis and the full results, read The Enterprise Digital Journey white paper. With fierce competition in today’s global landscape, leveraging cutting-edge technology and deploying new business models is not a one-off pursuit, but rather a continuous process of iteration and refinement. Companies should stop referring to Digital Transformation and instead plan for a continuous Digital Journey. “The term Digital Transfo
Anomali Announces Major Expansion of Threat Platform Partner Ecosystem20.9.2018 16:00 | Pressemelding
New Developer SDKs enable partners to integrate solutions with Anomali Threat Platform NATIONAL HARBOR, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Anomali today announced at the Detect Conference 2018 the expansion of the partner ecosystem with the launch of a suite of partner developer resources. The new tools enable easier and faster integration with the Anomali Threat Platform and APP Store, allowing clients immediate access to partner content, integrations and analytics. The partner program expansion includes the launch of a suite of software development kits (SDKs). The SDKs address three critical integration areas: Threat Intelligence Feeds SDK: integrate proprietary threat intelligence feeds and make these accessible via the APP Store Integration SDK: integrate threat intelligence from the Anomali Threat Platform into third party products and solutions Enrichment SDK: integrate 3rd party threat analysis and data enrichments into the Anomali Threat Platform “Organizations need a com
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom