Apricus Biosciences Submits Response to Swissmedic for Its Vitaros(R) Market Application for Erectile Dysfunction
SAN DIEGO, June 14, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or "the Company") (Nasdaq:APRI) ( www.apricusbio.com ) today announced that the Company has filed its response to 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 ("ED") in Switzerland.
The filing of the Apricus Bio response triggers a 90-day review process, after which if found acceptable, may then trigger a pre-decision by Swissmedic for the approval of Vitaros® for ED in that country. Following a subsequent approval decision and any required Company responses, Apricus Bio would then be required to supply Swissmedic with the final labeling and pricing information of Vitaros®, which could take an additional 90 days for review and acceptance before that product can be marketed in Switzerland.
"An approval in Switzerland would mark our second worldwide approval and our first European approval for Vitaros® for ED and would be an important step for us in our goal of marketing and selling this product on a worldwide basis," said Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio. "Swissmedic is considered one of the most well-respected health regulatory agencies in the world, and their decisions influence the regulatory decisions in many other countries."
Apricus is currently in discussions with multiple potential commercial partners for Vitaros® for ED in Switzerland.
According to IMS Health (RX), the annual ED market in Switzerland was estimated to be ¬27 million in 2010. Switzerland is not part of the European Union and is therefore not regulated by the European Medicines Agency. Marketing drugs in Switzerland requires an independent application and approval from Swissmedic. Marketing applications for Vitaros® have also been filed in the European Union and in the MENA territories.
Apricus Bio has received approval for Vitaros® as a first-line treatment for ED in Canada, where the Company's partner, Abbott Laboratories Limited, plans to launch the product in that country in the second half of 2012. In addition to Canada, partnership and licensing agreements for Vitaros® have been executed by Apricus Bio in the U.S., Germany, Italy, certain Middle East and North African ("MENA"), the Gulf countries and Israel.
Vitaros® is a topically delivered formulation of alprostadil delivered using Dodecyl 2-N, N-(dimethylamino)-propionate hydrochloride (DDAIP HCl), the Company's proprietary NexACT® drug delivery technology, for the treatment of erectile dysfunction (ED). When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection.
Vitaros® differs from oral medications in two ways. First, it is applied locally, directly to the penis as a cream, instead of administered orally and thus is not absorbed systemically. This topical application helps to reduce side effects and provides men who cannot take the existing oral medications a patient-friendly alternative. Second, clinical studies have shown that Vitaros® works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating 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's current NexACT® 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.
Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the U.S. for the treatment of anthracycline extravasation. The Company also plans to market in the U.S. or certain other countries the following products: (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral", an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva) and (c) NitroMist® (nitroglycerin sublingual spray), an FDA-approved 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).
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 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 such as Swissmedic for Switzerland, 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. 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 firstname.lastname@example.org
Source: Apricus Biosciences, Inc. 2012 GlobeNewswire, Inc.