Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros(TM)
Company Evaluating Deficiencies and Potential Path Forward
SAN DIEGO, Feb. 16, 2018 (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 issued a complete response letter ("CRL") for the New Drug Application ("NDA") of Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
"We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early March of this year," stated Richard W. Pascoe, Chief Executive Officer.
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 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; the timing of any interaction with Allergan; and the timing and results of Apricus' evaluation on the path forward for the company. 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 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
ISSI HyperFlash™ memory has successfully been designed into the NXP i.MX RT106A MCU-based solution for AVS (Alexa Voice Service)19.3.2019 21:30:00 CET | Pressemelding
MILPITAS, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Integrated Silicon Solution, Inc. a leader in advanced memory solutions, today announced the adoption of HyperFlash™ memory IS26KL256S-DABLI00 (256Mb 3.3V BGA package) with NXP’s i.MX RT106A MCU based solution for AVS (Alexa Voice Service). The Alexa Voice Service (AVS) is a virtual assistant developed by Amazon that provides cloud-based automatic speech recognition (ASR) and natural language understanding (NLU) to provide information, media playback, communication and smart device control capabilities to consumers. HyperFlash™ memory based on the HyperBus™ technology dramatically improves memory performance while reducing pin count and board space, essential for NXP’s implementation to save BOM cost without compromising performance to do XIP (execute-in-place) operations. “NXP is an important partner for us. We are very glad that NXP adopted our HyperFlash™ solution. HyperFlash™ fits nicely in the application to meet the increasingl
NLS Pharmaceutics Announces the Completion of the Merger between NLS Pharma Ltd., NLS-1 Pharma Ltd. and NLS-0 Pharma, Unifying the Global Operations and Development of Nolazol®19.3.2019 21:05:00 CET | Pressemelding
The combined company was named NLS Pharmaceutics Ltd (NLS) STANS, Switzerland, March 19, 2019 (GLOBE NEWSWIRE) -- NLS Pharmaceutics Ltd (NLS), a Swiss biotech firm focusing on the development of novel treatments for Attention-Deficit/Hyperactivity Disorder (ADHD) and other cognitive disorders and impairments, today announced the closing of the merger of NLS Pharma Ltd., NLS-1 Pharma Ltd. and NLS-0 Pharma, effective immediately. The combined company was named “NLS Pharmaceutics Ltd.” The sideways merger brings together the global operations and assets of the three companies in order to streamline the development of Nolazol®, a controlled release formulation of mazindol that is currently being developed as a non-amphetamine DEA schedule C-4 treatment option for ADHD and narcolepsy, as well as a promising pipeline of early to late-stage compounds focusing on ADHD, sleep disorder and other rare diseases. Leading the combined company as Chief Executive Officer is Alex Zwyer, who served as c
INVNT Recognised for Xero and TEDxSydney Work at The Event Marketing Awards 201919.3.2019 14:30:00 CET | Pressemelding
HONG KONG, March 19, 2019 (GLOBE NEWSWIRE) -- INVNT, the global live brand storytelling agency™, in partnership with Xero has received the Best Corporate Event Gold Award at the prestigious Event Marketing Awards 2019 organised by Campaign Asia-Pacific and CEI, for its production, management and design of Xerocon Brisbane 2018 – Australasia’s largest technology conference for the accounting industry. During the ceremony, which was held at the Eaton Club in Hong Kong on Tuesday evening local time, INVNT was also recognised with the Best Sustainability Bronze Award alongside client TEDxSydney, for the production of the not-for-profit organisation’s flagship event in 2018, which was themed around the concept of HumanKind and saw the agency devise and implement a series of environmentally friendly initiatives. Now in their fourth year, the Event Marketing Awards organised by Campaign Asia-Pacific and CEI recognise best practice in the creation, planning, production and management of innova
Crocus Technology Unveils its 2nd Generation TMR Linear Sensor with Unparalleled Temperature Stability19.3.2019 13:00:00 CET | Pressemelding
The CT100 is a unique TMR magnetic sensor with industry-leading performance SANTA CLARA, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Crocus Technology Inc., a leading supplier of disruptive Tunnel Magneto-Resistance (TMR) sensors, today announces the CT100 device, an advanced, high-performance linear (1D) magnetic sensor based on Crocus’ patented and unique TMR-based technology. The CT100 has best-in-class performance across a wide temperature range coupled with an extremely low linearity error, low hysteresis, and low noise which enables it to address many consumer, industrial and automotive applications and markets. The CT100 outperforms competitors’ xMR or Hall-based linear magnetic sensor technology available today in terms of performance, deviation over temperature, current consumption, and overall robustness. The CT100 does not require any expensive flux guides or concentrators, chopping circuits or set/reset pulses and operates over a wide magnetic field range. Crocus’s revolutio
Despite Brexit Uncertainty, Business Schools in UK Continue to See Strong International Demand19.3.2019 09:00:00 CET | Pressemelding
Majority of Candidates Say Brexit has No Impact on Decision to Study in the United Kingdom RESTON, Va., March 19, 2019 (GLOBE NEWSWIRE) -- In response to the initial Brexit vote in June 2016, the Graduate Management Admission Council™ (GMAC™) has been tracking Graduate Management Admission Test™ (GMAT™) examinee interest in studying in the UK. This has included periodic surveys of non-U.K. citizens who sent a GMAT score report to a UK business school program, as an indication of where they are interested in studying. In the immediate aftermath of the vote, it was unclear what the impact would be on the international flow of students to UK programs, which are heavily reliant on enrollees from other countries. Brexit, it’s been feared, could restrict or complicate the student visa process and dampen international candidates’ postgraduation job prospects in the UK, both because of possible changes to work visa policies and jobs leaving the UK. However, the most recent survey findings, fro
General Electric Company: Doc re. GE files DEFA14A19.3.2019 08:00:00 CET | Pressemelding
FAIRFIELD, Conn., March 19, 2019 (GLOBE NEWSWIRE) -- Company ISIN Symbol Headline General Electric Company US3696041033 London: GEC | Paris: GNE Doc re: GE files DEFA14A March 18, 2019 On March 18, 2019, General Electric Company (the "Company") filed a DEFA14A (Definitive Additional Materials) with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to the U.K. National Storage Mechanism and will be available shortly for inspection at http://www.morningstar.co.uk/uk/NSM. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. CONTACT: GE Jennifer Erickson +001 646 682 5620 firstname.lastname@example.org This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this informatio