NASDAQ OMX

Apricus Biosciences Confirms Clinical Strategy for Its Novel Treatment for Symptomatic Secondary Hypogonadism Fispemifene

Del

SAN DIEGO, 2015-12-01 18:49 CET (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reaffirmed its regulatory and clinical strategy for the development of fispemifene in response to the Complete Response Letter issued to Repros Therapeutics Inc. (RPRX) by the Food and Drug Administration (FDA). Apricus is developing fispemifene, a SERM (selective estrogen receptor modulator) for the treatment of sexual dysfunction in men with symptomatic secondary hypogonadism.

"Apricus has worked with the FDA to develop our clinical strategy for fispemifene," commented Barbara Troupin, M.D., Chief Medical Officer of Apricus. "For our ongoing Phase 2b study, we developed a protocol that addresses the FDA's suggestions for clearly defining the target patient population, designating clinical benefits which are both important and relevant to the target population, and using symptom-based endpoints aimed at assessing those specific benefits in this population. As a result, we believe we are well-positioned to bring a first-in-class SERM product to the U.S. market."

Apricus expects to report results from the Phase 2b fispemifene trial in the first quarter of 2016 and, if successful, will continue to work closely with the FDA to plan registration studies of fispemifene in 2016.

Phase 2b Trial Design

The Phase 2b proof-of-concept clinical trial is a randomized, double-blind, placebo-controlled, parallel arm, multi-center study in up to 160 hypogonadal men aged 18 to 64 who present with sexual dysfunction related to secondary hypogonadism, or low levels of testosterone. The study will evaluate the safety and tolerability of oral fispemifene, and will assess the effects of treatment on the sexual symptoms using patient reported outcome (PRO) endpoints. The study will also assess relevant pharmacodynamic and pharmacokinetic parameters to evaluate the ability of fispemifene to endogenously increase the serum testosterone level.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus recently completed enrollment in its Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus has completed a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. Apricus' lead commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals) and Mylan NV. Apricus' second-generation room temperature Vitaros is currently under development.

For further information on Apricus, visit http://www.apricusbio.com.

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: Apricus' development activities for fispemifene, including the Phase 2b protocol addressing the FDA's suggestions for such trial, a development pathway and Apricus' ability to move fispemifene into later stage clinical development, and the effects of Repros Therapeutics's complete response letter on such clinical development; the timing and results of the Phase 2b clinical trial to evaluate fispemifene for the treatment of symptomatic male secondary hypogonadism; the potential timing of a competitor's SERM product being approved by the FDA; and the potential timing of any new drug application, or NDA, submission by Apricus. 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 timing and results of the ongoing Phase 2b clinical trial of fispemifene, Apricus' ability to receive feedback from the FDA on the development of fispemifene and, based on such feedback, further develop fispemifene for the treatment of symptomatic male secondary hypogonadism or other urological conditions, as well as the timing of such events; Apricus' ability to carry out further clinical studies for fispemifene, as well as the timing and success of the results of such studies; issues raised by the FDA in Repros Therapeutics;s complete response letter affecting the development of and regulatory approval for fispemifene; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; and Apricus' ability to obtain the requisite governmental approval for fispemifene. 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: Institutional / Retail Investors: Matthew Beck
         mbeck@troutgroup.com
         The Trout Group LLC
         (646) 378-2933

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra NASDAQ OMX

Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra NASDAQ OMX

Nasdaq Welcomes RISE Education Cayman Ltd. (Nasdaq: REDU) to The Nasdaq Stock Market20.10.2017 18:37Pressemelding

NEW YORK, Oct. 20, 2017 (GLOBE NEWSWIRE) -- RISE Education Cayman Ltd. (Nasdaq:REDU), a leader in China's junior English Language Training (ELT) market, rang the opening bell at the Nasdaq MarketSite in Times Square today in celebration of its initial public offering (IPO) on The Nasdaq Stock Market. Photos accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f59490cf-9a81-4114-92a1-05edcb3f5694 http://www.globenewswire.com/NewsRoom/AttachmentNg/5692f99d-9ed0-4be2-928d-9c94f4b152e8 RISE pioneered the "subject-based learning" teaching philosophy in China, whereby various subject matters, such as language arts, math, natural science and social science are used to teach English. RISE's course offerings use interactive courseware to create an immersive English learning environment that helps students learn to speak and think like a native speaker. In addition, their curricula are des

Concurrent Achieves Sales Milestone for Zephyr Transcode19.10.2017 15:35Pressemelding

Concurrent Customers Now Transcoding on Three Continents ATLANTA, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Concurrent (NASDAQ:CCUR), a global leader in storage, protection, transformation, and delivery of visual media assets, announced today that Zephyr Transcode, which Concurrent launched last year as an integral part of its content delivery network (CDN) solutions, is now deployed with customers in Asia, Europe and North America. The deployments already support thousands of on-demand assets being transcoded to multiple formats and bit-rates to support any place, any device content availability. Zephyr Transcode supports multiple formats and quality levels including H.264 (MPEG-4) and H.265 (HEVC), strengthening Concurrent customers' capability to provide high-quality standards-based streams to any device their end-users desire. Zephyr Transcode is software-based and capable of running in traditional Central Processing Units (CPU) as well as Gra

German Armed Forces Renews Contract for Hexagon Geospatial Products19.10.2017 15:11Pressemelding

Defense agency will work closely with Hexagon Geospatial Premium Partner for next two years NORCROSS, Ga., Oct. 19, 2017 (GLOBE NEWSWIRE) -- At the HxGN LOCAL Defense Summit, a conference dedicated to defense and security in Western Europe, Hexagon Geospatial announced that the Bundeswehr Geoinformation Centre (BGIC) recently renewed a large software maintenance contract for Hexagon Geospatial products. The two-year renewal is for more than 100 licenses, mainly within the GeoMedia and ImageStation product families. The contract also includes consulting for workflow optimization. The contract was issued to Geosystems, a Hexagon Geospatial Premium Partner, which will work closely with the local subsidiary of Hexagon Safety & Infrastructure in Bonn and Munich to support BGIC. "The strong Hexagon Geospatial partner network allows our defense customers to benefit from a unique pool of expertise and tradecraft in the areas of remote sensing, GIS, and photog

Novel Preclinical Research Tools Provide Humanized Immune Response to Advance Immunotherapeutic Development, Live Webinar Hosted by Crown Bioscience19.10.2017 14:00Pressemelding

SANTA CLARA, Calif., Oct. 19, 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, announces a live webinar to be presented by Dr. Michelle Mack, Director of Global Scientific Engagement, entitled "Beyond Syngeneics - Novel Tools for Addressing Human Specificity in Immuno-Oncology." Checkpoint inhibitors like anti-PD-1, anti-PD-L1, and anti-CTLA-4 have revolutionized cancer treatment and have recently gained approval in several cancer types. Despite their potential, immunotherapies face significant development challenges due to the specificity and complexity of the human immune system upon which they act. Crown Bioscience has generated innovative research models to address these obstacles early during preclinical drug development.

Perfectus Aluminum Inc. Responds to Trade Group19.10.2017 13:00Pressemelding

ONTARIO, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) -- Perfectus Aluminum Inc. has issued the following: On October 12, 2017 the Aluminum Extruders Council (AEC), an industry group representing largely American aluminum extruders, posted to its blog a false narrative regarding a suit to which Perfectus Aluminum Inc. is a related party. The government is not "seeking unpaid duties from Perfectus for goods brought into the country." Rather, the government is attempting to use a 2017 Department of Commerce determination to assess retroactive antidumping duties on goods imported as early as 2011. It is discouraging that AEC would tout such an obviously egregious government overstep as a "victory" to their members and the industry: were it one of AEC's own members facing such an obvious violation of fair play and due process, it would rightfully argue that government overreach is a threat to manufacturers everywhere. In addition to the hypocrisy of the AEC's promotion of this case, its s

Payvision's annual report reveals cross-border ecommerce trends in 201719.10.2017 09:00Pressemelding

With online marketplaces and consumer technology leading the way for growth AMSTERDAM, The Netherlands, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Payvision, global acquirer and data-driven omnichannel solutions provider, has published the findings of its fifth annual cross-border ecommerce research report, in collaboration with Juniper Research. The paper includes the results of a global survey of various industry players regarding the game-changers, the biggest challenges, the best practices for going cross-border, and much more. When compared to last year's findings, the report reveals a new and exciting context for global cross-border trade. The compound annual growth rate predicted for the next three years for cross-border ecommerce is now 17%, whereas it stands at just 12% for ecommerce overall. Also, over the past 12 months, merchants' attitudes towards cross-border ecommerce have become more positive, with 50% of respondents agreeing and 31% strongly

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

Besøk vårt presserom