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
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-601 in Advanced Solid Tumors16.1.2019 07:00 | Pressemelding
Pyrrolobenzodiazepine-based antibody drug conjugate targets AXL, a receptor tyrosine kinase highly expressed in solid tumors LAUSANNE, Switzerland, Jan. 16, 2019 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic. ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect™ site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated
GSA Europe’s Managing Director Elected Co-lead of CEN’s TC456 Committee15.1.2019 21:12 | Pressemelding
SAN GWANN, Malta, Jan. 15, 2019 (GLOBE NEWSWIRE) -- GSA Europe’s Managing Director Mark Pace has been elected by the Comité Européen de Normalisation (CEN) to lead the creation of a European Union online gaming reporting standard. CEN has established Technical Committee 456 to create this standard in support of online gambling supervision. GSA Europe joined Technical Committee 456 as a Liaison Organization in 2017. The Technical Committee’s mandate from the European Commission is directly aligned with work that GSA Europe has already started, namely, to create a single standard set of data elements and single standard way in which data is provided by online gambling providers to EU Member State regulatory authorities. In addition to joining and now leading the Technical Committee’s work, GSA Europe also donated their draft Regulatory Data Set and Regulatory Reporting Interface to CEN seeking to help jump-start the Committee’s work. “Joining CEN’s TC456 as a Liaison Organization, and no
Orion Biotechnology Reports Positive Results for Colorectal Cancer in Preclinical Study15.1.2019 15:00 | Pressemelding
OTTAWA, Jan. 15, 2019 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd., a developer of novel medical treatments, today announced preclinical data produced in collaboration with Charles River Laboratories, evaluating the efficacy of OB-002O (5P12-RANTES) in colorectal cancer. BALB/c mice were inoculated subcutaneously with the CT-26 colorectal cancer cell line. Three days after inoculation intraperitoneal treatment was started with OB-002O, a murine anti-PD-1 antibody, OB-002 + anti-PD-1, or saline placebo. Treatment was given daily or every third day. Treatment with OB-0020 alone led to statistically significant delayed tumor growth at multiple time-points. An even more profound effect on the decrease in mean tumor volume was observed in combination cohort where animals received both, OB-0020 and the anti-PD-1 antibody (p>0.05). “There is growing awareness of the role of CCR5 antagonism as an important component of cancer immunotherapy. OB-002O is an extremely potent CCR5 antagonist
Credit Suisse Partners with CGAP on Digital Finance to Catalyze Delivery of Energy, Water and other Services to Low Income People15.1.2019 14:08 | Pressemelding
Washington/Zurich, Jan. 15, 2019 (GLOBE NEWSWIRE) -- Credit Suisse, one of the world's leading financial services providers, is partnering with the Consultative Group to Assist the Poor (CGAP) to support its work in building inclusive and responsible financial systems that help people move out of poverty, protect their economic gains and advance the broader global development agenda. CGAP is a global partnership of more than 30 leading development agencies, private foundations and national governments committed to financial inclusion as a means toward expanding opportunities for poor people. Through their engagement, CGAP and Credit Suisse will capitalize upon and leverage each other’s knowledge to further financial inclusion and its contribution toward achieving the United Nations’ Sustainable Development Goals (SDGs). Among the projects that align well with Credit Suisse’s expertise are CGAP’s work on sustainable business models that use digital finance technologies to lower the cost
TrueCommerce Recognized as a Leader in IDC MarketScape for Worldwide Multi-Enterprise Supply Chain Commerce Network15.1.2019 14:00 | Pressemelding
-- “The vendor offers a true partnership for their customers and has become an extension of their internal staff and resources to manage their supply chains,” says the report -- PITTSBURGH, Jan. 15, 2019 (GLOBE NEWSWIRE) -- TrueCommerce, a global provider of trading partner connectivity, integration and unified commerce solutions , has announced today it was positioned in the Leaders category of the IDC MarketScape for Worldwide Multi-Enterprise Supply Chain Commerce Network report. The research states that TrueCommerce offers a broad set of supply chain applications that extend far beyond traditional data transportation. “Our investments into the cutting-edge unified commerce technology and customer care allowed the company to make this qualitative leap, and we are proud to be recognized by such a reputable global research firm as IDC,” said TrueCommerce president Ross Elliott. “The report advises companies to engage with a network vendor that is at least thinking about what tomorrow
UnionBank Launches First Fully Digital Branch in the Philippines15.1.2019 13:30 | Pressemelding
Appian Cloud Platform Enables Low-Code Rapid Application Development for Powerful Process Automation RESTON, Va. and SYDNEY, Australia , Jan. 15, 2019 (GLOBE NEWSWIRE) -- Appian (NASDAQ: APPN) announces that UnionBank of the Philippines used the Appian Platform to launch its first fully digital branch. The branch, called The Ark, completely transforms the customer experience, making that experience entirely digital, including internet-connected self-service kiosks and virtual reality boxes. Unlike traditional bank branches, The Ark has done away with rows of tellers and long queues, and gone completely paperless. Customers now go to one of the self-service iPad stands stationed around the bank, where they can type in their request, significantly reducing time previously spent waiting in queues for service. “The Ark is an award-winning digital branch that provides a modern experience for our clients within a traditional brick and mortar store,” said Anna Maria Aboitiz Delgado, Head for