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Apricus Biosciences Announces Corporate Goals For 2013

Stocks in this article: APRI

SAN DIEGO, Jan. 3, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) ( www.apricusbio.com) today announced its corporate goals for 2013, which includes focusing its corporate strategy on its high value assets such as Vitaros ® for erectile dysfunction ("ED") and Femprox ® for female sexual arousal disorder ("FSAD") and plans to seek a buyer for its oncology supportive care products, which consists of two approved products now sold in the United States. The planned divestiture will allow Apricus Bio to better align its resources with its main corporate objectives.

Rusty Ray, Chairman of the Board of Apricus Bio, commented, "The Board of Directors believes that the greatest potential for shareholder value creation is in the further development and commercialization, through strategic partnerships, of the Company's primary commercial and pipeline assets, particularly Vitaros ® (alprostadil 0.3% topical cream) and Femprox ® (alprostadil 0.4% topical cream) for male and female sexual health. Both products utilize Apricus Bio's proprietary NexACT ® transdermal delivery platform. The Company's resources therefore, will be directed toward these key assets, a decision that will concentrate the Company's strategic focus and better allow us to deliver value through 2013 and beyond."

Apricus Bio's oncology supportive care business includes the rights to Totect ® (dexrazoxane for injection) for the treatment for extravasation from intravenous anthracycline chemotherapy in the U.S. and the Americas, and the U.S. co-promotion rights to Granisol ® (granisetron HCl oral solution) for the prevention of nausea and vomiting associated with certain emetogenic cancer therapy and radiation in the US. Each of these products is now commercially available and marketed in the U.S.

"We achieved important progress with respect to Apricus Bio's pipeline development and commercialization goals in 2012, including, manufacturing, preparation and assistance in Abbott Laboratories' up-coming launch of Vitaros ® in Canada and the steps of responding and advancing Vitaros ® through what is hopefully European approval in 2013," said Steve Martin, Interim Chief Executive Officer and Chief Financial Officer of Apricus Bio. "These steps will position us to build significant value for our shareholders as we execute our strategy over the coming year."

Vitaros ®

Vitaros ®, Apricus Bio's lead product candidate for the treatment of ED, is a topically-applied cream formulation of alprostadil, a vasodilator, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE5 inhibitors for difficult to treat patients, and Vitaros ® is relatively safe and effective, and offers greater market opportunity due to its patient-friendly form versus both other alprostadil dosage forms and also relative to oral ED products. With a market affecting nearly 150 million men worldwide and representing approximately $2.6 billion in revenue – excluding the U.S. – Vitaros ® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population. Vitaros ®-related goals for 2013 include:

  • Commercial launch in Canada through Abbott Laboratories. Apricus Bio is actively supporting Abbott with their pre-launch efforts, and continues to expect that a full launch will occur in the first half of 2013.
  • European approval via the Decentralized Procedure ("DCP"). A decision regarding the approval of Vitaros ® in Europe via the DCP with Netherlands as the Reference Member State is expected to occur in the first half of 2013, followed by national phase approvals in each of the major markets of Europe. Marketing of Vitaros ® can then be initiated in each country either by Apricus Bio partners or by the Company directly as applicable. In Europe, existing ED products currently generate over $1 billion dollar in sales and Apricus Bio believes a significant portion of the market remains untreated or undertreated.
  • Secure additional partnerships.Vitaros ® is now partnered in key markets around the world, including the U.S., Canada, Germany, the United Kingdom, Italy, the Gulf countries, certain other countries in the Middle East and Israel. In France, a very significant ED market, Apricus Bio is preparing to commercialize the product directly through its European sales subsidiary. The Company is looking to secure partnerships in the remaining international territories, particularly in the emerging markets.

Femprox ®

Femprox ® is a topical alprostadil cream for the treatment of FSAD. In recent months, Apricus Bio completed pre-filing meetings with Health Canada and the U.S. FDA regarding the suitability of its existing clinical, preclinical, and chemistry data for Femprox ® to support filings in each country. Femprox ®-related goals for 2013 include:

  • Obtain feedback from regulatory agencies and initiate next clinical steps. In 2013, Apricus Bio expects to announce feedback from its meeting with Health Canada and the U.S. FDA, as well as its plan for Femprox ® clinical development going forward.

Oncology Supportive Care

The Company intends to seek a buyer for its U.S. oncology supportive care business, which is being conducted through Apricus Pharmaceuticals USA, Inc., its wholly-owned subsidiary ("Apricus Pharma").  Apricus Pharma has been focused on commercializing its oncology supportive care products, including Totect ® and Granisol ® in the U.S. In connection with the proposed sale and divestiture of this subsidiary and/or its products, the Company expects to terminate certain employees and all of the members if its U.S. contract sales force that are associated with Apricus Pharma.

As a result of this strategic action, the Company expects to incur one-time costs of approximately $0.3 million in connection with the workforce reduction. Asset balances related to the Apricus Pharma segment as of December 31, 2012, total approximately $5.5 million, which consist of intangible assets and goodwill of $4.7 million and inventory and other assets of $0.8 million. Any possible impairment charge associated with the potential sale of the business cannot yet be determined. The restructuring and divestiture will have the effect of reducing the use of cash for this business segment in 2013 and proceeds from any potential sale of the assets in the future would supplement our cash resources. As of December 31, 2012, Apricus Bio has cash and cash equivalents of approximately $15.0 million.

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