Apricus Biosciences ( APRI // WKN: A1C4WU )
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Halbmarathon2011 : Apricus Biosciences ( APRI // WKN: A1C4WU )
Apricus Biosciences Announces Removal of Auditor's 'Going Concern' Opinion From Its 2010 Form 10-K and Increased Cash Reserves
SAN DIEGO, 2011-03-08 15:57 CET (GLOBE NEWSWIRE) --Apricus Biosciences, Inc. ('Apricus Bio') (Nasdaq:APRI) announced today that the going concern paragraph has been removed from its audit opinion contained in its upcoming filing of Form 10-K for the year ended December 31, 2010 and the Company has increased cash reserves in 2010 compared to the previous year. Apricus Bio will file its Form 10-K for the year ended December 31, 2010 by the close of business on Thursday, March 10, 2011.
The going concern assumption in the Generally Accepted Auditing Standards (SAS 59, The Auditor's Consideration of an Entity's Ability to Continue as a Going Concern) requires an auditor to evaluate conditions or events that raise questions about an entity's ability to continue as a going concern. Typically, if an auditor has concerns about a firm's ability to continue as a going concern, the audit opinion will contain a paragraph outlining issues with this assumption. In its to-be-filed 10-K report for the year ended December 31, 2010, the Company's auditors did not include any such going concern paragraph in their audit opinion.
'Having the going concern issue removed from our audit opinion for the first time in nine years is a significant accomplishment for our relatively new management team, further affirming our continued success in the execution of the Company's goals,' noted Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. 'Having the going concern opinion removed not only validates our business strategy but also instills further trust in our management team by our shareholders, as well as, with the numerous pharmaceutical companies, which we are in active partnership discussions with at this present time.'
Dr. Damaj continued, 'At December 31, 2010, the Company had approximately $9.1 million in cash reserves and our current cash reserves of approximately $11 million should provide us with sufficient cash to fund our operations into the second half of 2012. In addition, we will receive upfront payments and we may receive milestone payments and royalties in 2011 from existing and future licensing deals. We would expect such payments to extend our cash runway even further.'
For the year ended December 31, 2010, the Company reported a net loss per share of $2.49, which includes a non-cash impairment charge of approximately $10 million for the write down of goodwill and intangible assets and non-cash interest charges of approximately $8.7 million, as compared to a net loss per share of $5.43 in 2009 which also included non-cash interest charges of approximately $28.3 million.
'Having laid a solid financial foundation in 2010 we remain focused on continuing to execute our long term strategy to continue to move the company towards eventual profitability,' noted Dr. Damaj.
LINK >>> www.finanznachrichten.de/nachrichten-2011-03/...cash-reserves-016.htm
Halbmarathon2011 : Present at the Bio-Europe Spring 2011 Conference
The presentation will include a discussion of the Company's current worldwide licensing and commercialization efforts for Vitaros(r), its first approved product for erectile dysfunction, as well as a description of the further development of the Company's four later stage products, MycoVa? for onychomycosis, PrevOnco? for liver cancer, Femprox(r) for female sexual arousal disorder and RayVa? for Raynaud's Syndrome. In addition, Ms. Smibert will provide information on the Company's other eight product candidates it is developing that utilize its proprietary NexACT(r) technology.
The Company's Vitaros(r) product for erectile dysfunction has been approved by Health Canada and the Company is working towards identifying a licensing and commercialization partner in that country. The Company is also currently planning to make initial regulatory filings for the product for that indication in Europe and the MENA (Middle Eastern and North African) countries in the second quarter of 2011. In addition, Apricus Bio announced late in the fourth quarter of 2010 and in the first quarter of 2011, licensing and commercialization agreements for Vitaros(r) for erectile dysfunction in the following countries and regions: in Italy with Bracco SpA, in the Gulf Countries and certain countries in the Middle East with Elis Pharmaceuticals, and in Israel and the Palestinian Territories with the Neopharm Group.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, commented on the upcoming presentation, 'We are looking forward to presenting the progress of the Company's first approved Vitaros(r) product for erectile dysfunction and its later stage product candidates. We are very pleased with our Vitaros(r) licensing and commercialization efforts with our current partners and we look forward to entering into additional agreements that will increase the number of worldwide countries that approve the product for marketing and sales therein. Ms. Smibert will also present an update on the progress we are making with our later stage products that we believe will be of interest to potential pharmaceutical company partners. Lastly, we are excited about the pace of the development of many of our earlier stage product candidates that utilize our NexACT(r) technology in the areas of oncology, dermatology, anti-inflammatory, pain, anti-infectives, diabetes and cosmeceuticals, among others, and we look forward to speaking with companies on how we can utilize our proprietary technology to help them improve the effectiveness of their own products, product candidates and compounds.'
LINK >>> http://www.finanznachrichten.de/...ope-spring-2011-conference-016.htm
Halbmarathon2011 : Formation of Clinical Advisory Board
SAN DIEGO, 2011-03-15 15:08 CET (GLOBE NEWSWIRE) --Apricus Biosciences, Inc., ('Apricus Bio') (Nasdaq:APRI) today announced the formation of a Male and Female Sexual Dysfunction Clinical Advisory Board ('Sexual Dysfunction Clinical Advisory Board') as a first step to further the development of its product Femprox(r), for female sexual arousal disorder ('FSAD'). The Sexual Dysfunction Clinical Advisory Board consists of key opinion leaders, Irwin Goldstein, M.D., Jed Kaminetsky, M.D. and Ajay Nehra, M.D.
The Sexual Dysfunction Clinical Advisory Board is the second clinical advisory board maintained by the Company. Apricus Bio also has an Oncology Clinical Advisory Board focused on its current product PrevOnco?, for advanced unrestricted hepatocellular cancer ('HCC'), or liver cancer, as well as a Scientific Advisory Board.
Apricus Bio owns the worldwide rights to Femprox(r), a combination of alprostadil and DDAIP. To date, the Company has completed one Phase II trial in the United States and one Phase III study in close to 400 women in China, which achieved a 44% positive response rate as compared to a placebo. Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted that, 'The Company's plans include a focus on meeting with the U.S. Food&Drug Administration in order to agree on the planned Phase III clinical program required for marketing approval in the U.S. We are also planning to meet with Canadian agency officials to seek guidance as to whether the current Phase III trial will be sufficient for filing a New Drug Submission ('NDS') in Canada.'
To the Company's knowledge, there is currently no approved product in any major market to treat female sexual arousal disorder, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. It is estimated that there are approximately 50 million potential sufferers in the U.S. alone (Fitzheny and Sandberg 2005), and that the market value in the U.S. could exceed $4 billion, with only 15% of patients captured on therapy.
Clinical trials have shown that Femprox(r) exerts a relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. This leads to pelvic engorgement and enhanced secretion activity of the vulvar epithelium. The resultant increase in lubrication and sensory feedback due to pelvic engorgement is believed to produce a clinically significant increase in sexual arousal in women with FSAD. Apricus Bio's Femprox(r) enables a rapid permeation of blood deep into the target tissues, thus potentially enabling a new pharmacotherapy for the treatment of FSAD.
Dr. Damaj stated, 'We are pleased that Drs. Goldstein, Kaminetsky and Nehra have agreed to serve on our new Sexual Dysfunction Clinical Advisory Board. Their expertise will be key to helping us move forward with our Femprox(r) program as well as in the development of other products in the male and female sexual dysfunction field.'
LINK & weitere Informationen >>> http://www.finanznachrichten.de/...l-development-of-femprox-r-016.htm