NASDAQ OMX

Apricus Biosciences Announces the Initiation of Vitaros Drug-Device Human Factors Study

Dela

Vitaros U.S. NDA Re-Submission on Track for Third Quarter 2017

SAN DIEGO, May 04, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that the Vitaros drug-device combination human factor testing study required by the Food and Drug Administration (FDA) is underway.

"In November of 2016, the FDA designated Vitaros as a drug-device combination and required Apricus to provide additional information regarding the proper use of the applicator in the planned NDA re-submission," stated Richard W. Pascoe, Chief Executive Officer. "We have since confirmed the necessary regulatory requirements for a drug-device combination product and have initiated the required human factors study which we believe is in accordance with the FDA guidance. We expect this study will be completed in the second quarter of this year and the results will be incorporated into our planned Vitaros NDA re-submission, which remains on track for the third quarter of this year."

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 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 completion of the drug-device combination human factor study; the ability of the drug-device combination study to provide results which can be incorporated into Apricus' planned Vitaros NDA resubmission; and the timing of regulatory submission and approval of Vitaros in the United States, if any. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the protocol for the drug-device combination human factor study may not be in compliance with the FDA guidance; the study may produce negative results; Apricus' may not be able to obtain FDA and other requisite governmental approval for Vitaros; Apricus' ability to further develop Vitaros, such as delivery device improvements, may be limited or unsuccessful; Apricus' ability to carry out further clinical studies for Vitaros, if required, as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; and market conditions. 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



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste pressmeddelandena från NASDAQ OMX

Kofax Wins "Most Innovative Solution for Banking Customer Authentication" Award for Third Consecutive Year18.10.2017 08:00Pressmeddelande

Grand Prix Banque & Innovation Honor Recognizes Kofax Mobile ID Customer Onboarding Solution and its Anti-Fraud Capabilities IRVINE, Calif., Oct. 18, 2017 (GLOBE NEWSWIRE) -- Kofax ®, a leading provider of software to simplify and transform the First Mile(TM) of business, today announced that Kofax Mobile ID(TM) has won "Most Innovative Solution for Banking Customer Authentication" in the 2017 Grand Prix Banque & Innovation Awards in Paris, France. Now in its fourth year, the Awards identify excellence and innovation in the banking sector. The program acknowledges technology companies that have launched and implemented the most outstanding banking-related software solutions, initiatives and projects in France over the past twelve months. This award highlights the new facial recognition and ID verificationfeatures of Kofax Mobile ID that determine the authenticity and validity of identification documents and their holders.  

World Conference on Lung Cancer Wednesday Press Conference: PD-1/PD-L1 Advancements and Interventions to Prevent and Treat Lung Cancer18.10.2017 06:25Pressmeddelande

YOKOHAMA, Japan, Oct. 18, 2017 (GLOBE NEWSWIRE) -- The final press conference from the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) highlighted new advancements surrounding the discovery of PD-1 and PD-L1, including a discussion from the researcher credited with discovering PD-1, as well as interventions to prevent lung cancer and improve quality of life for lung cancer patients. Innovations in lung cancer treatment linked to the discovery of PD-1 Prof. Tasuku Honjo of Japan, who was the first to identify PD-1 in 1992, shared an update on how PD-1 blockers have been widely used to treat many types of cancers. After decades of study, research into PD-1 has led to breakthrough immunotherapy treatments that are being hailed as a "penicillin moment" in cancer treatment. "I believe that, just as a number of antibiotics developed in the wake of the discovery of penicillin now p

Barings Supports New Mountain Capital Investment in DRB Systems17.10.2017 16:30Pressmeddelande

CHARLOTTE, N.C., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Barings, one of the world's leading asset management firms, announced today that it served as a Joint Lead Arranger on a Senior Secured Credit Facility to support New Mountain Capital's acquisition of DRB Systems LLC.                                                               Founded in 1984 and based in Akron, Ohio, DRB Systems is the leading provider of turnkey technology solutions used to enhance the operational efficiency of car wash sites across the U.S.  DRB's integrated technology offering includes hardware and software used in point-of-sale and tunnel control systems as well as ancillary modules to support marketing, human resources, and business analytics. "New Mountain Capital is pleased to have completed its investment in DRB Systems," said Jack Qian, Director of New Mountain Capital. Laura Holson, Head of Capital Markets at New Mountain added, "We deeply value Barings' support as a financing pa

Crown Bioscience to Showcase Scientific Expertise in Preclinical Evaluation of Investigational Cancer Compounds17.10.2017 16:12Pressmeddelande

SANTA CLARA, Calif., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:ticker 6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, will showcase their scientific expertise at this year's American Association for Cancer Research's International Conference on Molecular Targets and Cancer Therapeutics (AACR-NCI-EORTC) October 26th through the 30th. CrownBio's scientists will present 13 scientific posters describing their latest research efforts, including generation of novel models for combinatory chemotherapy and immunotherapy studies, creation of 3D screening panels for improved efficacy assessments, demonstration of a checkpoint immunotherapy modulating intestinal microbiota, among other innovative developments in cancer therapeutics and preclinical pharmacology evaluation. On

Oxford Immunotec Schedules Third Quarter 2017 Earnings Release and Conference Call for October 31, 201717.10.2017 15:15Pressmeddelande

OXFORD, United Kingdom and MARLBOROUGH, Mass., Oct. 17, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that it plans to release third quarter 2017 financial results prior to market open on Tuesday, October 31, 2017.  Dr. Peter Wrighton-Smith, Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will host a conference call to review the Company's results at 8:00 a.m. Eastern Time the same day. The call will be concurrently webcast. To listen to the conference call on your telephone, please dial (855) 363-5047 for United States callers and +1 (484) 365-2897 for international callers and reference confirmation code 99539511, approximately ten minutes prior to start time.  To access the live audio webcast or subsequent archived recording, visit the Investor Relations se

World Conference on Lung Cancer Tuesday Press Conference: Evidence to Support Innovative Lung Cancer Interventions17.10.2017 08:16Pressmeddelande

YOKOHAMA, Japan, Oct. 17, 2017 (GLOBE NEWSWIRE) -- Today's press conference at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) featured groundbreaking findings in the study of both small cell and non-small cell lung cancer. The studies presented covered broad research areas, from confirmation of existing classification criteria to ensuring viability of evidence to supporting the use of specific interventions. Biopsy specimen found to be reliable for evaluating DLL3 expression in small cell lung cancer Small cell lung cancer (SCLC) biopsy specimen was found to be reliable material for evaluating DLL3 expression; high levels of DLL3 in SCLC are correlated with poor survival trends. These results may lead to further evaluation of the scoring system for predicting DLL3-targeted therapeutic efficacy and clinical significance of DLL3 expression in high-grade pulmonary neuroendocrine carcinomas.

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum