Conference Call/Webcast to be Held Friday, August 10, 2012 at 10:30 a.m. ET
SAN DIEGO, Aug. 8, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today that it will hold a conference call to discuss its second quarter 2012 financial results and ongoing corporate activities on Friday, August 10, 2012 at 10:30 a.m. ET. The Company expects to file its Form 10-Q for the quarter ended June 30, 2012 by the close of business on Thursday, August 9, 2012.
"The second quarter of 2012 was marked by significant progress with our mid- and long-term commercial and corporate growth strategies," said Dr. Bassam Damaj, President and Chief Executive Officer. "In addition to progress on the regulatory and intellectual property fronts with a number of our products, we signed the Finesco-Scomedica transaction, a transformative agreement that launches Apricus' commercial operations in Europe. We expect the transaction, which closed in late July, to build a strong revenue base in several key markets, beginning in France, and create significant value for our shareholders over the long-term. In addition, we completed two guidance meetings for Femprox® and MycoVa™ in Canada. We look forward to announcing additional partnerships later in the year and to moving forward in 2013 with marketing authorization filings for some of our product candidates that have completed late-stage clinical trials."
Second Quarter 2012 and Recent Highlights
- Announced submission of regulatory response to Swissmedic for Vitaros®. In June 2012, Apricus Bio filed its response to regulatory questions received from Swissmedic, the Agency for Therapeutic Products in Switzerland, relating to its marketing application previously filed for Vitaros®, the Company's lead product candidate for the treatment of erectile dysfunction. Switzerland is not part of the European Union and is therefore not regulated by the European Medicines Agency ("EMA"). Marketing drugs in Switzerland requires an independent application and approval from Swissmedic. In addition, Swissmedic is considered one of the most well-respected health agencies in the world, and its decisions often influence the regulatory decisions of other countries.
- Announced acquisition of Scomedica, a leading French drug sales and marketing company. In July 2012, Apricus Bio announced it acquired Finesco SAS, the parent and holding company of Scomedica SAS, a revenue-generating healthcare contract sales and marketing organization. This transaction will give the Company the ability to in-license and co-promote additional products in the French market and build a product pipeline in that country. It may also enable Apricus Bio to directly launch Vitaros® in France, Europe's second largest drug market, when and if approved by the EMA. In addition, the Company intends to use its French sales force as a base for commercial operations in Europe. As a reminder Scomedica is comprised of a large pharmaceutical sales force that can deliver over 100,000 details a year and currently successfully details multiple products on the French market for companies such as Novartis and had annual revenues of approximately €8 million ($10.1 million) in 2011.
- Strengthened patent estate with issuance of 3 new patents. In the second quarter of 2012, Apricus Bio strengthened its patent portfolio with the grant and allowance of 3 new patents. The first was a new U.S. patent claiming certain compositions and methods for inhibiting tumor growth related to PrevOnco™, its Phase III-ready investigational drug for patients with advanced, unresectable liver cancer. This is the first PrevOnco™ patent granted in the U.S. The Company was also granted a patent in New Zealand for certain pharmaceutical compositions of Vitaros®, including a room temperature formulation and a Canadian patent on certain methods of manufacture for the Company's platform NexACT® drug delivery technology.
Key Upcoming Milestones
- Commercialization of Vitaros® in Canada. The Company's Canadian partner, Abbott Laboratories Limited ("Abbott") has indicated their intention to launch Vitaros® for the treatment of erectile dysfunction in the second half of 2012. Apricus Bio has completed the transfer of the Canadian New Drug Submission to Abbott in preparation for the launch later this year.
- Partnerships for multiple pipeline products in Europe. Apricus Bio continues to engage in partnership discussions for Vitaros®, as well as its other pipeline products, throughout the remaining territories in Europe and looks forward to announcing signed partnerships with upfront cash, milestones, and royalties. The Company is in commercial contract negotiations for several territories in Europe, some of which it currently expects to finalize in the third or fourth quarters of this year.
- Additional Vitaros® filings in Europe and Latin America. Apricus Bio currently intends to file its answers to its DCP in Europe and expects to file a response in September 2012. On the Latin American front, the Company expects Mexico to be the first Latin American country in which it will file for Vitaros® and it expects that filing to take place in the near future.
- Regulatory guidance for Femprox® development program. The Company met with Health Canada regarding Femprox® in July 2012 and is planning to meet with regulatory agencies in the U.S. and Europe in the third and fourth quarters of 2012. It hopes to obtain guidance regarding the suitability of the existing clinical, preclinical, and chemistry data to support approval filings in each territory.
- Regulatory guidance for MycoVa™ development program. The Company met with Health Canada regarding MycoVa™ in July 2012 and is planning to meet with regulatory agencies in the U.S. and Europe in the third and fourth quarters of 2012. It hopes to obtain guidance regarding the suitability of their existing clinical, preclinical and chemistry data to support approval filings in each territory.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus Bio Conference Call. The teleconference replay will be available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay passcodes 286 and 398232 are both required for playback. The conference call will also be webcast live at http://www.investorcalendar.com/IC/CEPage.asp?ID=168504. The webcast replay will be available for three months.
About Apricus Biosciences, Inc.
Apricus Bio (Nasdaq:APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The Company has four approved products and has developed a strong pipeline of multiple late-stage product candidates. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenues and growth from sales of its commercial products and by out-licensing, in certain territories, its pipeline products and NexACT® technology.
Apricus Bio's growth strategy is to acquire, develop, and commercialize new products through strategic partnerships. The Company currently has commercial partnerships with multiple large pharmaceutical companies including Novartis, Abbott Laboratories, Sandoz, Warner Chilcott, Wockhardt, and Bracco, and co-promotes multiple products in France.
Apricus Bio is headquartered in San Diego, CA and is publicly traded on the NASDAQ Capital Market under the ticker symbol APRI.
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 products and product candidates, to have its products and product candidates such as Vitaros®, Femprox® and MycoVa™ receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Totect®, Granisol® , Aquoral™ and NitroMist™ and NexACT® product candidates and drug delivery technology and to achieve its development, commercialization and financial goals, including any and all of the goals set forth above under the caption Key Upcoming Milestones. Readers are cautioned that there can be no assurance that the Company will successfully achieve any of these milestones in a timely fashion, or at all. Readers are further 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: