SAN DIEGO, Feb. 16, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today a corporate update to address Company activities and expected near-term events.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio, stated, "We believe that 2012 will be the most important in Apricus Bio's history so far." Dr. Damaj informed shareholders, "The Company is now shifting from a development stage company with little institutional ownership to a commercial revenue-generating global operation with hopefully long-term institutional investment support. The Company also expects to book approximately $4 million from Vitaros® collaborations signed so far this year. We believe that signing two major collaborations in the first quarter of this year is a good indication that the Company plans to have major revenues from Vitaros® collaborations and the beginning of product sales this year."
The addition of a commercial oncology sales force with three marketed drugs to sell in the U.S. is a major step for the Company in its efforts to start generating its own direct sales. "It's an important shift for the Company to begin selling our drug products ourselves in some territories as it can drive more revenue growth and places many of our commercialization timelines under our own control," Dr. Damaj stated. "Oncology supportive care is our first step in the U.S. with a sales force. Our goal is to expand into other focused disease areas moving forward."
"Apricus Bio's recently announced, institutionally-focused financing, now provides our specialty pharmaceutical company with the institutional investment support necessary to grow to the next level," Dr. Damaj continued. "Apricus Bio looks forward to much broader investment coverage by an expanded range of financial analysts in 2012."
Apricus Bio is expanding the ownership of its stock from a predominantly retail base to becoming more institutionally held. "Such financing has provided our Company with the important funding resources to directly grow Apricus Bio's value by filing for commercialization authorization for up to five drug products in 2012 and 2013; to launch newly acquired products; and to continue to acquire additional, revenue-producing drug products," he explained.
NexACT® Platform Products:
Vitaros® (alprostadil), Apricus Bio's treatment for erectile dysfunction, is now partnered in the U.S., Canada, Germany, certain countries in the Middle East, the Gulf countries, Israel and Italy. Most recently, the Company entered into (1) an exclusive licensing agreement with Abbott Laboratories Limited ("Abbott") to market Vitaros® in Canada, who plan to launch the product in Canada in 2012 and (2) Sandoz, a division of Novartis, for Germany. The Company's recent deal with Sandoz-Novartis is an important partnership to Apricus not just for its large size but also for us being able to bring back Novartis as a partner which brings back the confidence in our NexACT® technology and the drugs based on it.
Apricus Bio's near term focus for Vitaros® is to commence sales in Canada this year though its commercial partner Abbott, continue to generate revenue from partnerships for the product with major pharma, including some which the Company intends to enter into and announce in the near term.
The Company may also market the drug itself in certain territories in Europe as the company expands its sales force and presence.
Femprox®, a topical cream for the treatment of female sexual arousal disorder ("FSAD"), has been the subject of nine clinical studies completed to date, including the only successfully completed Phase III and most advanced product in development for the indication.
The Company expects to have guidance from the health agencies in the U.S., Europe and Canada by the end of Q2 2012.
Despite several setbacks in a similar space by third parties on other drugs in this space recently, we are still the most advanced and the only Company that ran a successful 400 patient Phase III clinical trial in FSAD and achieved statistical significance on the primary and secondary endpoints. The Company believes Femprox® is unique not only because of its direct and local mechanism of action and safety profile, but also because of its relatively high response rate in its successful Phase III clinical trial.
Apricus Bio also feels that this is a potential blockbuster product, which some have estimated to be a $4 billion dollar space with no approved products on the market yet.
MycoVa™, a topical treatment for onychomycosis (nail fungal infection) is the Company's second partnered pipeline product utilizing Apricus Bio's proprietary NexACT® technology. In December 2011 and January 2012, the Company completed two licensing agreements granting exclusive marketing rights for MycoVa™ with Stellar Pharmaceuticals, Inc. in Canada and Elis Pharmaceuticals in certain countries in the Middle East and the Gulf Countries (excluding Israel).
The Company's regulatory strategy in the U.S. is to use its human blood and nail bioequivalency study against Lamisil® cream in conjunctions with the secondary endpoints from our 3 Phase III trials and file for approval using the 505b2 path. In Europe, the company intends to file for approval using the non-inferiority analysis achieved against Loceryl® in our European phase III trial. Lamisil® is a registered trademark of Novartis and Loceryl® is a registered trademark of Galderma.
The Company expects to have guidance from the health agencies in the U.S., Europe and Canada by the end of Q2 2012.
Apricus Bio's Commercial Sales Force: Oncology Supportive Care Marketed Products.
The Company launched its commercialization arm beginning in oncology supportive care in December 2011 with the acquisition of Topotarget USA, Inc. (since renamed Apricus Pharmaceuticals USA, Inc.) , gaining a pre-existing sales infrastructure, sales team, and a revenue-generating product with what the Company believes to be a strong future growth potential and additional second use label. The oncology supportive care product platform was expanded through an agreement with PediatRx, Inc. in January, with co-promotion rights to two additional products in this space, Granisol™ and Aquoral™.
Totect® (dexrazoxane HCl) is for the treatment of anthracycline extravasation, the leakage of chemotherapies from the vein into the surrounding healthy tissue. Totect® is the only proven protection against the potentially devastating effects of anthracycline extravasation. The Company also intends to grow the market potential for this product by filing a supplemental NDA this year for a second use of cardiac protection for Doxorubicin use based on the trials the Company has already run. The Company intends to further monetize Totect® by partnering the product throughout Canada and Latin America. There are presently 3,500 cancer centers in the U.S., all of which should eventually carry Totect. There are approximately 550,000 anthracycline infusions each year in the U.S. with estimates of extravasations calculated as high, occurring 1% of the time, and potential uses for the second label if granted by the FDA.
Granisol™ (granisetron) is the only FDA-approved, oral, ready-to-use liquid solution of granisetron oral solution for prevention of nausea and vomiting associated with emetogenic cancer therapy and radiation. In addition to U.S. co-promotion rights, Apricus Bio purchased non-U.S rights to Granisol™. The present oral solution market for the anti-emetics is approximately $70 million in the U.S. with the overall oral market for anti-emetics above $3 billion.
Aquoral is an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva). Xerostomia is caused by oncology, central nervous system drugs. The Company intends to detail the drug for the oncology use through its sales force and partner the CNS use.
The advantage of an oncology support sales force is that the same salesperson can help sell multiple products to the same end user which in our case is the oncology supportive care nurse and the hospital pharmacist who stocks the product. Chemotherapy and radiation therapy may result in side effects and often the same patients can experience extravasation (therefore requiring Totect®), nausea (therefore requiring Granisol™) and Xerostomia (therefore requiring Aquoral™) in addition to pain, mucositis, dermatitis in addition to other potential side effects.
The Company additionally has announced in January of this year that it is in negotiations to acquire PediatRx and it currently expects to have approximately 25 supportive care sales force in addition to an additional 100 on-call nurses and a pharmacist call-center.
The Company is also currently in negotiations to acquire additional products for this sales force
Other Specialty Pharmaceutical Transactions.
Apricus Bio further expanded its commercial arm worldwide with the acquisition of ex-U.S. rights to NitroMist™, an FDA-approved and marketed nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris (chest pain) due to coronary artery disease (narrowing of the blood vessels that supply blood to the heart). In February 2012, NovaDel Pharma Inc. sold Apricus Bio the rights to sell and license NitroMist™ in territories outside of the United States, Canada and Mexico. NovaDel has estimated the worldwide market for NitroMist™ to be more than $200 million. The Company intends to file for marketing authorization in Europe and certain other countries in the acquired territory in 2012 and has already initiated commercial partnering discussions.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.
Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology. Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. Apricus Bio's current pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.
The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop its and their products and product candidates, to have its products such as Vitaros®, Femprox® and MycoVa™ and product candidates approved by relevant regulatory authorities, to successfully commercialize such NexACT® products and product candidates, to achieve its development, commercialization and financial goals such as the booking of $4 million for Vitaros® partnerships to date and the further commercialization of Totect®, Granisol™ and Aquoral™ and to achieve its other regulatory, commercial and financial goals in the U.S. and in other countries. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's 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 or without charge from the Company.
CONTACT: Apricus Bio Investor Relations: David Pitts Argot Partners 212-600-1902 email@example.com