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scam ...not true
one day -- dreaming
http://ih.advfn.com/p.php?pid=nmona&article=63088432
gap up
!!??!!
07/24 - BOIG with Name/Symbol change
http://www.otcbb.com/asp/dailylist_detail.asp?d=07/23/2014&mkt_ctg=ALL
Information Statement - All Other (definitive) (def 14c)
Date : 06/24/2014 @ 11:06AM
http://ih.advfn.com/p.php?pid=nmona&article=62681246
??/?? - NHYT with Name/Symbol change
Information Statement - All Other (definitive) (def 14c)
Date : 06/25/2014 @ 5:12PM
http://ih.advfn.com/p.php?pid=nmona&article=62701876
yes...
L2 anyone?
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Apricus Biosciences Announces New Data Published in the International Journal of Pharmaceutics Confirming Efficiency of NexACT(R) Drug Delivery Technology
Date : 10/13/2011 @ 11:15AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=49530455&symbol=APRI
Apricus Biosciences Announces New Data Published in the International Journal of Pharmaceutics Confirming Efficiency of NexACT(R) Drug Delivery Technology
Date : 10/13/2011 @ 11:15AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=49530455&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today the publication of an article in the peer-reviewed International Journal of Pharmaceutics, entitled, "Transdermal and Transbuccal Drug Delivery Systems: Enhancement Using Iontophoretic and Chemical Approaches," which confirms the Company's NexACT® technology (DDAIP.HCL) to be the most effective chemical enhancer among three used in a study for the transbuccal delivery of lidocaine HCL ("LHCL"), Nicotine hydrogen tartrate ("NHT"), as well as for the transdermal delivery of diltiazem HCl ("DHCI").
The article appears in the International Journal of Pharmaceutics' on-line version of its November 2011 issue. The new data discussed is based on research conducted by, and at, the Ernest Mario School of Pharmacy, Rutgers-The State University of New Jersey, in Piscataway, NJ. The abstract is available and can be accessed at the following site: http://www.sciencedirect.com/science/article/pii/S037851731100874X
In the article, the effects of iontophoresis, the use of a local electric current to introduce the ions of a drug into the tissues, and a number of chemical enhancers such as the Company's NexACT® (DDAIP.HCI) technology on the transbuccal and transdermal delivery of three drugs LHCI, NHT and DHCI was evaluated on porcine skin and buccal tissues in vitro. Specifically, the article highlights the ability of the NexACT® technology to act as an effective enhancer for the transbuccal delivery of two drugs, LHCI and NHT, and the transdermal delivery of DHCI. The combination of iontophoresis and the NexACT® technology provided the best overall results for all three drugs and, as a result, this combined technology may provide new and more effective treatment approaches upon future research into this area.
Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio, noted, "We are very pleased with the success of our NexACT® technology when utilized by independent research labs, and, in particular, by this additional, promising data showing the effectiveness of our NexACT® technology primarily for the transbuccal delivery of the drugs studied. The data lends more support to previous work done by both Apricus Bio, as well as other independent research labs, related to the ability of our proprietary NexACT® drug delivery technology to effectively deliver drugs via the buccal route, and continues to illustrate a higher penetration rate than that achieved by currently used chemical enhancers."
About the NexACT® Technology
NexACT® utilizes biodegradable excipients, that when incorporated into drug formulations, has demonstrated the ability to help overcome the body's natural barrier properties and thereby enable rapid penetration of higher concentrations of active drug directly through the skin and major biological membranes, resulting in more effective delivery of therapies. Varying the concentration of the enhancer allows for local or systemic delivery of active drug, as desired. NexACT® has shown in studies to efficiently enable the delivery of drugs across different classes and over a wide range of indications via transdermal, oral, subcutaneous, rectal and buccal routes of administration.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing Rx Division product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
The Company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the Company's NexACT® technology to comply with the FDA's over-the-counter ("OTC") requirements, be cleared as 510(k) topical creams that are considered to be medical devices or approved as Abbreviated New Drug Applications ("ANDAs") as generic drugs. The Company will also seek to market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. Information may also be found at http://twitter.com/apricusbio, and http://facebook.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 conduct or part with other companies to conduct research that demonstrates the effectiveness of its NexACT® drug delivery technology to enhance the delivery of drugs through various routes of administration such as transdermal, transbuccal among others, its ability to receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its Rx Division products and product candidates approved by relevant regulatory authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products along with its Consumer Healthcare Division products and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Chart ( daily / weekly ) >>> LINK back
(12/03/2009) - 22 month later...
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APRI - Apricus Biosciences Announces Presentation of Efficacy and Clinical Safety Data for Vitaros(R) at Upcoming Industry Conference
http://ih.advfn.com/p.php?pid=nmona&article=49481882
...The poster presentation will discuss additional subgroup analyses on a combined dataset from two pivotal Phase 3 clinical trials in 1,732 patients suffering from erectile dysfunction ("ED"). The data further demonstrates the efficacy and safety of Vitaros® as an easy-to-administer, topical first-line treatment option for all ED patients, independent of age, body mass index ("BMI") and risk factors, such as cardiovascular disease and diabetes.
Apricus Biosciences Announces Presentation of Efficacy and Clinical Safety Data for Vitaros(R) at Upcoming Industry Conference
Date : 10/10/2011 @ 10:31AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=49481882
...The poster presentation will discuss additional subgroup analyses on a combined dataset from two pivotal Phase 3 clinical trials in 1,732 patients suffering from erectile dysfunction ("ED"). The data further demonstrates the efficacy and safety of Vitaros® as an easy-to-administer, topical first-line treatment option for all ED patients, independent of age, body mass index ("BMI") and risk factors, such as cardiovascular disease and diabetes.
CXM - Cardium Announces FDA 510(k) Clearance for U.S. Marketing and Sale of Excellagen
http://ih.advfn.com/p.php?pid=nmona&article=49480240
Cardium Announces FDA 510(k) Clearance for U.S. Marketing and Sale of Excellagen Formulated Collagen Topical Gel for Diabetic Foot Ulcers, Pressure Ulcers and Other Dermal Wounds
Date : 10/10/2011 @ 9:00AM
Source : PR Newswire
Stock : Cardium Therapeutics Common Stock (CXM)
http://ih.advfn.com/p.php?pid=nmona&article=49480240&symbol=CXM
Apricus Biosciences Quietly Rising To Top Of Biotech World
August 31, 2011
http://seekingalpha.com/article/290871-apricus-biosciences-quietly-rising-to-top-of-biotech-world?source=feed
With a growing pipeline and increasing revenue, Apricus Biosciences (APRI) is quietly solidifying its and its shareholders' futures with little fanfare. The company has been quietly garnering support and partnerships with larger pharmaceuticals with a solid and growing pipeline that will soon be the envy of the biotech world.
Vitaros
Apricus received approval to market its first drug, Vitaros, in Canada in November of 2010. Vitaros is a topical cream for the treatment of erectile dysfunction. Its active ingredient is alprostadil, and the cream utilizes Apricus’ proprietary NexACT permeation enhancer (DDAIP.HCL). It is Vitaros’ approval that gives NexACT legitimacy and puts it at the forefront of the Apricus pipeline on a dangling hook to attract potential licensees for its drugs and gives Apricus a platform by which to administer other drugs for multiple indications. In a move to survive and create immediate revenue, Apricus sold the rights to Vitaros in the United States to Irish company Warner Chilcott (WCRX) for a $2.5 million upfront payment and an additional $2.5 million milestone payment to be paid upon FDA approval. The drug was initially rejected by the FDA in 2008 because of some minor concerns in a rodent study, so the sale to Warner staves off the financial requirements of another study in the United States and allows it to save money for marketing and commercialization in other countries. It's currently seeking approval for Vitaros in Europe, Asia, South America (Brazil most recently), Switzerland and the Middle East.
Femprox
For the female population, Apricus has completed one phase III trial on Femprox and is seeking guidance of health agencies in Canada and Europe for approval. Femprox also uses alprostadil and the NexACT system, but for the treatment of Female Sexual Arousal Disorder. For this indication, Apricus would have no competition as there is no approved drug to treat this disorder. Apricus intends to meet with the FDA in order to come to an agreement on a second phase III trial before attempting to file for marketing in the United States.
Other Late-Stage Drugs
Apricus' other late-stage drugs include PrevOnco for HCC, or primary liver cancer. The company is currently in discussions with the FDA for a SPA phase III trial design before beginning trials for this indication. It will also be filing an IND for a SPA phase III trial for RayVa (also using the NexACT system) to treat Raynaud’s Syndrome (secondary to Schleroderma) in the near future. To wrap up its late stage drugs, MycoVa has been tested in three phase III trials (in the U.S., EU and Canada) for the treatment of onychomycosis, a fungal nail infection that can often cause permanent damage to the nails, can cause skin infections and can often be recurrent on different locations on the body. According to APRI's pipeline, Apricus has a pre-NDS meeting scheduled with Canada’s health agency and pre-filing meetings scheduled with Europe and MENA for MycoVa’s regulatory process.
OTC Drugs
During the month of August, Apricus received two FDA approvals for OTC (over the counter) indications. The first, issued on August 18, was approval for its wholly-owned subsidiary, NexMed, for Tolnaftate-D as a topical antifungal; the second on August 23, also from NexMed for Hydrocortisone-D as a topical anti-itch. Both drugs utilize Apricus’ NexACT technology. As a hint of things to come, the PR for the latter drug contained the statement:
Since January we have been working on building out our OTC portfolio. With Tolnaftate-D having been cleared last week and Hydrocortisone-D coming in this week, we are creating a new division that can contribute to both near-term revenues and long-term growth," stated Dr. Damaj (president and CEO).
August 29 Update
On August 29, senior vice president and CFO Steve Martin presented a company overview at the 2011 Southern California Investor Conference. Here are some excerpts of interest to investors:
Present Cash Position was $9.1 million, which according to the presentation should be enough to get through 2H 2012. Market capitalization at the time was $83 million, and at market close on Aug. 30 was $87.4 million. Specialty biopharmaceuticals company with one approved product, two OTC cleared products and a proprietary platform technology (NexACT) to rapidly advance drug candidates through clinical development. Mid-to-late stage pipeline with multiple, significant near-term value drivers. Multiple partnerships in place with additional significant partnerships expected near term. NexACT's Patented: New Chemical Entity patents based on proprietary permeation enhancers that are biodegradable, biocompatible, non-toxic ingredients that mimic the composition of human skin and tissues. Over 130 patents have been granted; over 120 patents are pending.
In the latter part of the presentation there is a section entitled “Upcoming Milestones” which to traders and investors could be aptly named “Upcoming Catalysts." These all represent value drivers (for buyout/partnerships), stock price drivers and represent immediate and future revenue. Significant ones are:
* Announce additional commercial partnerships for Vitaros: Canada, Europe and Latin America.
* Commence sales of Vitaros in Canada.
* Announce first NexACT technology licensing deal.
* Announce continued expansion of the OTC portfolio.
* File for marketing approval depending on regulatory guidance for MycoVa and Femprox.
* Out-license other late stage products (Femprox, MyCova, PrevOnco).
Apricus Biosciences Receives FDA Clearance for Its Third OTC Drug Containing NexACT(R) Technology
Date : 08/31/2011 @ 9:47AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=49012726
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that its wholly-owned subsidiary, NexMed USA, Inc., has received clearance from the U.S. Food and Drug Administration ("FDA") for its third, over-the-counter ("OTC") drug, Diphenhydramine-D™, containing the Company's NexACT® technology.
"This latest clearance from the FDA of our third OTC drug containing our proprietary NexACT® drug delivery technology, illustrates the progress we have achieved in a relatively short period of time toward building out our OTC Consumer Healthcare Division, and puts us one step closer to being able to provide a full-line of OTC products in the topical area," said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. "As such, we will continue to seek clearance for a number of additional OTC drugs in order to further expand this division and maximize the flexibility of our proprietary technology platform. In addition, we will be seeking partners with established distribution channels to partner with and commercialize these products," he added.
The active ingredients in this OTC drug are diphenhydramine hydrochloride (2%) and zinc acetate (0.1%). Diphenhydramine hydrochloride is a topical analgesic and zinc acetate is a skin protectorant, both of which are in the OTC monograph and can be sold as creams. They are currently used in combination to treat itching associated with insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes due to poison ivy, poison oak and poison sumac. They are also used to dry the oozing and weeping caused by poison ivy, poison oak and poison sumac and are sold under several third party brand names, most notably Demarest (Fougera & Co.), Benadryl Extra Strength Itch Stopping Gel (McNeill PPC, Inc.) and Derma-Pax (Recsei Laboratories, Inc.).
Apricus Bio's new Diphenhydramine-D™ product combines diphenhydramine hydrochloride and zinc acetate with DDAIP, the main ingredient in NexACT®, the Company's proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells allowing for improved permeation of a drug through the cells to the target area.
According to the FDA, OTC products can be marketed under the authority of an approved product-specific new drug application ("NDA") or an abbreviated NDA ("ANDA"), or under an OTC drug monograph. Unlike NDAs, monographs specify the active ingredients that can be contained in OTC drug products. In addition to specifying the active ingredients, the OTC monographs contain information regarding the permitted concentrations of active ingredients, dosage limits, indications, and other requirements for legal marketing under monograph status.
To view the current U.S. monographs for OTC products, please go to http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf (to view by Active Ingredient), or http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf (to view by Monograph Category). To view the current approval listing, please go to http://dailymed.nlm.nih.gov and type diphenhydramine hydrochloride and zinc acetate in the search index.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others. The Company is also developing its over-the counter ("OTC") Consumer Healthcare Division by seeking clearance for a number of drugs that contain active ingredients listed in the OTC drug monograph combined with Apricus Bio's NexACT® technology.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary, please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros® approved by relevant regulatory authorities, to successfully commercialize such products including Diphenhydramine-D™ and other over-the-counter products ("OTC") and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences to Present Corporate Overview at the 2011 Southern California Investor Conference
Date : 08/25/2011 @ 9:00AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48952780
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Steve Martin, Senior Vice President and Chief Financial Officer, will present a company overview at the 2011 Southern California Investor Conference on Monday, August 29, 2011 at 2:30pm PT at The Island Hotel in Newport Beach, CA.
Mr. Martin's presentation will be webcast live, accessible to the public online at http://events.powerstream.net/002/00271/20110829_SCIC_T2/ or via Apricus Bio's web site at http://www.apricusbio.com.
The corporate presentation will include a discussion of the Company's recent announcements regarding receipt of FDA approval to market its first two anti-fungal, over-the-counter ("OTC") drugs, Tolnaftate-D™ and Hydrocortisone-D™, each containing the NexACT® technology. Tolnaftate, an already approved anti-fungal agent, which can be sold as a cream, powder, spray or liquid aerosol, is currently used to treat jock itch, athlete's foot and ringworm and is sold under several third party brand names, most notably Tinactin® (Merck) and Lamisil AF® (Novartis), among others. Hydrocortisone is also an already approved anti-itch agent, which can be sold as a cream. It is currently used to treat itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak and psoriasis, among others. It is sold under several third party brand names, most notably Corizone® (Chattern/Sanofi Avewntis) and Cortaid® (Johnson & Johnson).
With the approval of Tolnaftate-D™ and Hydrocortisone-D™, DDAIP, the mainstay of Apricus Bio's NexACT® technology, is now listed as an excipient in an approved drug and is part of the U.S. monograph (the underlying FDA regulatory document). As such, DDAIP can be combined with active ingredients listed in the monograph to develop a greater number of OTC products, which can be sold in the U.S.
Mr. Martin will also provide a review of Apricus Bio's partnership plans for Canada and Europe for Vitaros®, which has been approved for marketing in Canada as a topical treatment for erectile dysfunction. The Company is currently in active negotiations for both individual and bundled partnership agreements relating to Canada and Europe, and is proceeding with manufacturing, scale-up and commercial batches of the drug for Canada, where it is expected to be available later this year.
Additionally, an overview of the status of Apricus Bio's later stage pipeline will also be provided, including: Femprox® for female sexual arousal disorder, MycoVa™ for onychomycosis (toe nail fungus, excluding Tinea Pedis), PrevOnco® for human hepatocellular carcinoma (liver cancer) and RayVa™ for Raynaud's Syndrome.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others. The Company is also developing its over-the counter ("OTC") products division by seeking clearance for a number of drugs that contain active ingredients listed in the OTC drug monograph, combined with Apricus Bio's NexACT® technology.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros® approved by relevant regulatory authorities, to successfully commercialize such products including over-the-counter products ("OTC") and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences Announces FDA Clearance for Its Second OTC Anti-Itch Drug (Hydrocortisone-D(TM)) Containing NexACT(R) Technology
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=66447622
Apricus Biosciences Announces FDA Clearance for Its First Anti-Fungal OTC Drug (Tolnaftate-D(TM)) Containing NexACT(R) Technology
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=66447959
Apricus Biosciences Announces FDA Clearance for Its First Anti-Fungal OTC Drug (Tolnaftate-D(TM)) Containing NexACT(R) Technology
DDAIP Now Listed on U.S. Monograph for OTC Products
http://www.finanznachrichten.de/nachrichten-2011-08/21111807-apricus-biosciences-inc-photo-release-apricus-biosciences-announces-fda-clearance-for-its-first-anti-fungal-otc-drug-tolnaftate-d-tm-containi-252.htm
SAN DIEGO, 2011-08-18 15:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that its wholly owned subsidiary, NexMed USA, has received clearance from the U.S. Food and Drug Administration ("FDA") to market its first anti-fungal, over-the-counter ("OTC") drug, Tolnaftate-D', containing the Company's NexACT® technology.
A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10161
"This is the first approval by the FDA of a drug containing Apricus Bio's NexACT® drug delivery technology, and as such, is a very important milestone for us," explained Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. "In particular, we believe this is a crucial validation of our technology. Our expectation is that this may represent just the first of many such OTC drugs containing our proprietary technology."
The active ingredient in the cleared OTC drug, tolnaftate, is an already approved anti-fungal agent, which can be sold as a cream, powder, spray or liquid aerosol, and is currently used to treat jock itch, athlete's foot and ringworm. It is sold under several third party brand names, most notably Tinactin® (Merck) and Lamisil AF® (Novartis), among others.
Apricus Bio's Tolnaftate-D' incorporates NexACT®, the Company's proprietary drug delivery technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.
With the approval of this drug, DDAIP, the mainstay of the Company's NexACT® technology, is now listed as an excipient in an approved drug and is part of the U.S. monograph (the underlying FDA regulatory document). As such, DDAIP can be combined with active ingredients listed in the monograph to develop a greater number of OTC products, which can be sold in the U.S.
"We have been working on obtaining such status for over eight months and we believe that the cleared anti-fungal drug containing DDAIP and tolnaftate may be the first of many such OTC drugs that we and our partners will market and sell," stated Dr. Damaj. "In addition, being added to the monograph permits us to work with other companies in developing combinations of our NexACT® technology with the potentially hundreds of active ingredients listed in the monograph and to develop their proprietary drugs using NexACT® at the concentration used in our approved Tolnaftate-D' OTC drug."
According to the FDA, OTC products can be marketed under the authority of an approved product-specific new drug application ("NDA"), abbreviated NDA ("ANDA") or under and OTC drug monograph. Unlike NDAs, which are based on drug products, monographs specify the active ingredients that can be contained within OTC drug products. In addition to specifying the active ingredients, the OTC monographs contain information regarding the permitted concentrations of active ingredients, dosage limits, indications, and other requirements for legal marketing under monograph status. To view the current U.S. monographs for OTC products, please go to http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf (to view by Active Ingredient), or http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf (to view by Monograph Category). To view the current approval listing, please go to http://dailymed.nlm.nih.gov and type Tolnaftate in the search index.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros® approved by relevant regulatory authorities, to successfully commercialize such products including over-the-counter products ("OTC") and product candidates and to achieve its other 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.
The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.
CONTACT: Apricus Biosciences, Inc. Edward Cox, V.P. Corporate Development & Investor Relations, Apricus Bio, Inc. (858) 848-4249 ecox@apricusbio.com
Apricus Bio Investor Relations Paula Schwartz Rx Communications Group, LLC (917) 322-2216 pschwartz@rxir.com
© 2011 GlobeNewswire
Apricus Biosciences Announces FDA Clearance for Its Second OTC Anti-Itch Drug (Hydrocortisone-D(TM)) Containing NexACT(R) Technology
Date : 08/23/2011 @ 10:18AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48924600
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that its wholly owned subsidiary, NexMed USA, has received clearance from the U.S. Food and Drug Administration ("FDA") to market its second, over-the-counter ("OTC") anti-itch drug, Hydrocortisone-D™, containing the Company's NexACT® technology.
"This is the second clearance by the FDA of a drug containing Apricus Bio's NexACT® drug delivery technology, and as such, enhances our strategy of building out our OTC products division and creating a new revenue-generating portfolio for the Company," explained Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio."
The active ingredient in the cleared OTC drug, hydrocortisone, is an already approved anti-itch agent, which can be sold as a cream. It is currently used to treat itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, and psoriasis (among others). It is sold under several third party brand names, most notably Cortizone® (Chattem/Sanofi Aventis) and Cortaid® (Johnson & Johnson).
Apricus Bio's new Hydrocortisone-D™ product combines hydrocortisone with DDAIP, the main ingredient in NexACT®, the Company's proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells to allow more permeation.
"Since January we have been working on building out our OTC portfolio. With Tolnaftate-D™ having been cleared last week and Hydrocortisone-D™ coming in this week, we are creating a new division that can contribute to both near-term revenues and long-term growth," stated Dr. Damaj.
According to the FDA, OTC products can be marketed under the authority of an approved product-specific new drug application ("NDA") or an abbreviated NDA ("ANDA"), or under an OTC drug monograph. Unlike NDAs, which are based on drug products, monographs specify the active ingredients that can be contained in OTC drug products. In addition to specifying the active ingredients, the OTC monographs contain information regarding the permitted concentrations of active ingredients, dosage limits, indications, and other requirements for legal marketing under monograph status. To view the current U.S. monographs for OTC products, please go to http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf (to view by Active Ingredient), or http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf (to view by Monograph Category). To view the current approval listing, please go to http://dailymed.nlm.nih.gov and type Hydrocortisone in the search index.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its products and product candidates such as Vitaros® approved by relevant regulatory authorities, to successfully commercialize such products including over-the-counter products ("OTC") and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences CEO Interviewed on CEOLIVE.TV
Date : 08/11/2011 @ 11:33AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48797110
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Chairman, President and Chief Executive Officer, Dr. Bassam Damaj, was interviewed recently by the CEOLIVE financial network (http://ceolive.tv/). The interview is available at the following link: http://www.youtube.com/user/Apricusbio#p/u/19/xD0UCcm2swo.
During the interview, Dr. Damaj reported on plans for the Company's pipeline, including the proposed commercialization in Canada and Europe of Vitaros®, a topical treatment for erectile dysfunction.
Dr. Damaj stated that, while Apricus Bio is negotiating both individual and bundled partnership agreements relating to Canada and Europe, the Company is also proceeding with manufacturing, scale-up and commercial batches of the drug for Canada, where the drug has already been approved. As previously stated, the Company expects Vitaros® to be available to patients in Canada later this year. Commenting on the option of bundling Canada and Europe into a single partnership deal, Dr. Damaj noted that the market sizes for erectile dysfunction are currently estimated to be approximately $180 million in Canada, and more than $1 billion in Europe. The potential to sign a deal that would cover both Europe and Canada has attracted a greater amount of competition for the product and may allow a European partnership to be finalized earlier than originally expected.
As with other drugs in Apricus Bio's pipeline, Vitaros®, which incorporates the active ingredient, alprostadil, utilizes the Company's patented NexACT® drug delivery technology to enhance the systemic absorption of a drug through the skin barrier.
During the CEOLIVE interview, Dr. Damaj also reviewed the Company's progress with respect to Femprox® (containing a combination of alprostadil and DDAIP ), for the treatment of female sexual arousal disorder ("FSAD"). Specifically, Dr. Damaj noted that Apricus Bio is currently seeking guidance from regulatory authorities in Europe, Canada and the U.S., with the goal of potentially filing for approval in those countries and regions. To date, Apricus Bio has completed one Phase III study in close to 400 women in China, which achieved a statistically significant response rate for all primary and secondary endpoints.
To the Company's knowledge, there are currently no products approved for FSAD in the U.S., and by some projections, the annual market there may be as large as $4 billion, annually.
Dr. Damaj also provided an update on MycoVa™, for which the Company owns global rights. MycoVa™ combines terbinafine, an existing, approved drug for onychomycosis (nail fungus), with the Company's NexACT® technology, in order to enhance the absorption of the drug through the nail bed. Apricus Bio has previously stated that, based on a reanalysis of prior data, it plans to seek regulatory approval guidance in order to potentially market the product as a treatment for nail fungus, excluding patients with Tinea Pedis (athlete's foot), in Europe and North America. In particular, Apricus Bio has produced a statistically significant reanalysis of its U.S. Phase III data which indicated that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in patients with mild to moderate dermatophyte onychomycosis (excluding patients with Tinea Pedis) at the same level of effectiveness as the current European standard of care and at similar levels to U.S. topical treatments.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary, please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 products and product candidates such as Vitaros®, to have its products and product candidates such as Vitaros® approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences to File for Market Authorization to Sell Vitaros(R) for Erectile Dysfunction in Latin America
Date : 08/08/2011 @ 10:03AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48741485
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it will file for market authorization to sell its erectile dysfunction drug, Vitaros®, in Latin America. The Company also stated that it has engaged the services of Quintiles Global Regulatory Affairs, a leading international regulatory consultancy, to prepare its regulatory filings for Vitaros® for marketing approval in the following Latin American countries: Mexico, Brazil, Argentina, Colombia, Chile and Peru. "By preparing to file in Latin America, we are moving forward with our plan to make Vitaros® available worldwide," noted Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio.
According to IMS Health Data (2010), the potential market size for Vitaros® for ED in Brazil, alone, is approximately $347 million.
Apricus Bio has already prepared the necessary regulatory document -- known as the Electronic Common Technical Document ("ECTD") -- to file for approval of Vitaros® for ED throughout Latin America. Quintiles, a fully integrated biopharmaceutical company offering commercial, consulting and capital solutions worldwide, including a network of 22,000 professionals in 60 countries, will provide additional guidance and regulatory advice in order to facilitate the filings in each country. Specifically, Apricus Bio will utilize the services of Quintiles Global Regulatory Affairs, comprised of an experienced and dedicated team of approximately 45 regulatory experts, with decades of experience working with international regulatory agencies--especially those in Latin America.
Apricus Bio currently expects that its first regulatory filing in Latin America will be made within eight to 10 weeks. A number of other filings will be submitted on or abut the same time. Approval requirements and timelines differ across the six countries.
"We believe that the opportunities to sell our product in this region are great, and the potential market sizes are substantial," Damaj said. "The Company is now in the process of negotiating with a number of international and regional pharmaceutical companies with sales and marketing teams in such countries for commercialization partnerships throughout Latin America."
Apricus Bio received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2011 for sales of the product in that country. In April 2011, the Company filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. In July 2011, Apricus Bio filed for regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros® in that country.
About Vitaros® and the ED Market
The current leading drugs for erectile dysfunction are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the Company believes is much faster than the results from the currently marketed oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® is combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®. The side effects reported were localized and transient. "We believe that Vitaros® will be an attractive alternative to the oral PDE5 inhibitors for many patients with erectile dysfunction," stated Damaj.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 development products and product candidates such as Vitaros®, to have its products and product candidates such as Vitaros® approved by relevant regulatory including those in the following Latin American countries: Mexico, Brazil, Columbia, Argentina, Peru and Chile, to successfully commercialize such products and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences Provides Corporate Mid-Year Update
Date : 08/04/2011 @ 1:19PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48703148
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today a corporate mid-year update covering Company activities, expected near-term events and comments on recent market conditions, as follows:
Vitaros®
The key focus of the Company's management team has been, and continues to be, partnering Vitaros®, for the treatment of erectile dysfunction (ED), in Canada, Europe, and internationally; ramping up the manufacturing process for Vitaros® for erectile dysfunction (ED), and; ensuring that Vitaros® launches in the Canadian market by the end of this year.
Dr. Bassam Damaj, the Chairman, President and Chief Executive Officer of Apricus Bio, noted, "Our partnership negotiations for Vitaros® are proceeding on a timely basis and we are confident that we will complete and announce our partnership for Canada, and potentially for Europe, in the near future. As we have stated previously, we are in multiple, late-stage partnership negotiations with various pharmaceutical companies for a range of territories and combinations. Our goal is to negotiate the most advantageous deal in each territory, both in upfront financial terms and to ensure that each partner has the capability to launch the product and achieve the sales and market penetration that we believe is warranted. We believe that our shareholders will be pleased, both in terms of the economics of our partnerships and the caliber of our partners for these territories, once announced."
He continued, "We are also pushing, full-steam ahead with the scale up of Vitaros® manufacturing. We have already completed our engineering batches, and commercial batches are expected to be completed before the end of the year. In parallel, the Company continues with its development of the room-temperature formulation of Vitaros® for ED, as previously announced, and we have requested guidance from Health Canada on the regulatory path required for approval.
"As stated earlier, we currently anticipate that Vitaros® will be introduced in Canada by the end of this year, though we may make it available online prior to the launch, pending discussions with our partner. We believe that the market will be pleased, both in terms of the economics of our partnerships and the caliber of our partners for these territories, once announced."
Femprox® and MycoVa™
With regard to Femprox®, for the treatment of female sexual arousal disorder ("FASD"), and MycoVa™, a topically-applied treatment for onychomycosis, or nail fungus, Dr. Damaj noted that the Company is continuing to work with its Clinical Advisory Boards and health regulatory agencies with regard to guidance on if, and when, the Company can file for marketing approvals in various territories.
Specifically, the Company is currently moving forward with guidance from health agencies in Europe and Canada in order to file for market authorization for Femprox® in those markets. In the U.S., Apricus Bio intends to request a meeting with the U.S. Food & Drug Administration (FDA) in order to come to agreement on the second Phase III trial required before potential market authorization.
"As for MycoVa™," Dr. Damaj stated, "despite the fact that the drug did not show efficacy in a previously conducted Phase III trials in the general onychomycosis patients population, the successful and statistically significant reanalysis of our U.S. Phase III data has indicated that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in 20% of patients with mild to moderate dermatophyte onychomycosis (excluding patients with Tinea Pedis, or athlete's foot) and is as effective as for the treatment of nail fungus as the current European standard of care, Loceryl® (an ointment made by Galderma) and Penlac® (an ointment made by Sanofi-aventis). As such, we plan to seek regulatory approval guidance in order to potentially market the product as a treatment for nail fungus in Europe and North America. If successful, this strategy may eliminate the time and costs to run an additional Phase III trial. Moreover, if approved, MycoVa™ has the potential to represent the first FDA-approved drug for which Apricus Bio would own the global rights."
Finally, commenting on the macro environment, Dr. Damaj stated, "The overall market, and in particular, the small cap biotech sector, have been down significantly. Despite this, we are proud of the progress that Apricus Bio has made so far this year."
Second Quarter 2011 Conference Call Information
The Company also announced today that it will be holding its second quarter 2011 teleconference call to discuss financial and operating results for the three months ended June 30, 2011, at 4:00 pm ET on Monday, August 15, 2011 and will provide further information closer to that date regarding dial-in information.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary, please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 Vitaros®, Femprox® and MycoVa™ and other products and product candidates, to have its products and product candidates approved by relevant European, U.S. and other regulatory authorities, to successfully commercialize such products and product candidates in Europe, the U.S. and other markets and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Apricus Biosciences Files Marketing Application for Vitaros(R) as a Treatment for Erectile Dysfunction in Switzerland
Date : 07/19/2011 @ 9:57AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48492091&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today its filing of a marketing application for Vitaros® as a treatment for patients with erectile dysfunction ("ED") in Switzerland, with Swissmedic, the Swiss Agency for Therapeutic Products. "We are excited about making our third major filing for our flagship product, Vitaros® for the treatment of ED," said Dr. Bassam Damaj, Chairman, Chief Executive Officer and President of Apricus Bio.
According to IMS Health data, the annual ED market in Switzerland in 2010 was estimated at €27 million. The potential market for a drug approved in Switzerland, however, is much larger than just the Swiss market. Swissmedic approval is relied upon by the regulatory authorities in numerous European countries that are not members of the European Union, as well as by many other countries worldwide. The approval time for Swissmedic is currently approximately 15 months from the time of submission.
The Company received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010, for sales of the product in that country. In April 2011, Apricus Bio filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States.
Switzerland, however, is not part of the European Medicines Agency ("EMA"). Marketing drugs in Switzerland requires an independent application and approval from Swissmedic. "Swissmedic is considered one of the most well-respected drug regulatory authorities that is relied on by many countries throughout the world," said Damaj. "As we have stated previously, we look forward to applying for approval for this product and for the ED indication in other important international markets in the future."
About Vitaros® and the ED Market
The current leading drugs for erectile dysfunction are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of being a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the Company believes is much faster than the results from the oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® is combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®. The side effects reported were localized and transient. "We believe that Vitaros® will be an attractive alternative to the oral PDE5 inhibitors for many patients with erectile dysfunction," stated Damaj.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 development products and product candidates such as Vitaros®, to have its products and product candidates such as Vitaros® approved by relevant regulatory authorities including Swissmedic, to successfully commercialize such products and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
FDA Says Keryx (KERX) Promoted Investigational and Unapproved Drug on Co. Website
http://www.streetinsider.com/Corporate+News/FDA+Says+Keryx+%28KERX%29+Promoted+Investigational+and+Unapproved+Drug+on+Co.+Website/6643086.html
July 18, 2011 1:57 PM EDT
FDA says on June 30th it sent a letter to Keryx Biopharma (Nasdaq: KERX) alleging the company promoted its unapproved and investigational drug on the company's website.
Apricus Biosciences Sells Bio-Quant CRO Subsidiary to BioTox Sciences
Date : 07/06/2011 @ 9:00AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48339114&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it has sold its wholly-owned subsidiary, Bio-Quant, Inc. ("Bio-Quant"), a specialty biotechnology Contract Research Organization ("CRO"), to BioTox Sciences ("BioTox"), a San Diego-based CRO. Under terms of the agreement, Apricus Bio will receive a minimum of $5 million in up-front and future earn-out payments, with the potential for as much as $20 million over the next ten years, based on BioTox's currently projected revenues. Additionally, Apricus Bio has retained all NexMed-related research conducted by Bio-Quant as well as the profitable Bio-Quant diagnostic kit business.
"While our Bio-Quant subsidiary has been driving revenues over the past year, this divesture represents a key strategic decision for Apricus Bio, as licensing revenues from Vitaros® have increased during the first half of 2011, and are currently projected to constitute the majority of our revenue stream for the remainder of 2011," stated Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of the Company. "The sale enables us to focus our efforts where we believe we will generate the greatest return on investment -- speeding our specialty biopharmaceutical drugs to market. While Bio-Quant has been instrumental in advancing the uses of our NexACT® technology and preclinical pipeline, we have now entered the commercialization stage with our first product and intend to focus our efforts on the generation of revenues from our drug pipeline," continued Dr. Damaj.
Apricus Bio's top priority is to commercialize Vitaros®, for the treatment of erectile dysfunction. Vitaros® was approved for marketing and sales in Canada in 2010, and the Company recently filed for approval in Europe. Management is in advanced partnering negotiations for Vitaros® in Canada and/or Europe and expects to announce a partnership in the second half of 2011. In addition, Apricus Bio is focused on developing and commercializing the other 12 products and product candidates in its pipeline, including Femprox®, MycoVa™ and PrevOnco™.
Bio-Quant, founded in 2001, is one of San Diego's most experienced CROs for non-GLP (good laboratory practices) contract drug discovery and pre-clinical development services, specializing in oncology, inflammation, immunology and metabolic diseases. Bio-Quant has clients world-wide. Revenues are generated from pre-clinical contract services and housing services.
During 2010, the Bio-Quant CRO business helped advance Apricus Bio's proprietary NexACT® technology and increase its product and product candidate portfolio from four products to 13. With the divestiture of Bio-Quant, Apricus Bio has decided to outsource its primary preclinical CRO work for its NexMed subsidiary and narrow its focus on commercializing its late stage products -- Vitaros® for erectile dysfunction, Femprox® for female sexual arousal disorder, MycoVa™ for nail fungus, PrevOnco™ for liver cancer and RayVa™ for Reynaud's Syndrome -- in addition to continuing to develop the eight other, earlier stage product candidates in its pipeline.
BioTox is a San Diego CRO founded in 2007 that focuses primarily on GLP studies and has been interested in expanding its operations in San Diego on the non-GLP side.
"We look forward to seeing BioTox achieve even greater success, which will result in greater earn-out payments for Apricus Bio," said Dr. Damaj.
"We were actively looking for opportunities to expand our footprint in the Discovery CRO area and add more In-Vitro and In-Vivo disease models to increase the range of services we currently offer to our clients," stated BioTox's President, Sami Abunadi, in a company statement. "Bio-Quant offers a long and successful history in non-GLP preclinical research in areas such as oncology, inflammation, immunology, metabolic diseases and high throughput screening capabilities. We believe that this transaction will not only be revenue and earnings enhancing and highly valuable to our shareholders, but will also provide both a superior and quicker entry point than the other build or buy options we considered," said Mr. Abunadi.
In addition to adding key services and becoming a major participant in Southern California, BioTox can now scale its operation and reach to become a true national and global presence. BioTox intends to build on its present IND and NDA enabling In-Vivo GLP toxicology offerings, and as such, expects to be able to offer both Bio-Quant's and BioTox's clients a more attractive strategic outsourcing alliance with proven economic and scientific depth.
"We can now take our clients' compounds through the preclinical drug development process and utilize state-of-the-art capabilities by integrating Bio-Quant's study execution software platform Intranet with BioTox's Sponsor friendly and GLP compliant study Data Acquisition Software, called iAdavantage, and thus accelerate the development process economically and effectively" Mr. Abunadi added.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating specialty biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiaries please visit http://www.nexmedusa.com or http://www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
About BioTox Sciences
BioTox Sciences, based in San Diego, is a Contract Research Organization (CRO) offering comprehensive services for nonclinical and preclinical studies (GLP and Non-GLP) utilizing state of the art vivarium(s). Its services encompass toxicology, pharmacology, metabolism testing and various disease models in support of nonclinical drug development. URL: http://www.biotoxsciences.com
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 receive the earnout payments from the sale of its Bio-Quant CRO business to BioTox Sciences, further development products and product candidates, have such products and product candidates approved by relevant regulatory authorities, to successfully commercialize its Vitaros®, Femprox®, MycoVa™, PrevOnco™ and RayVa™ products and other products and product candidates and to achieve its other development, commercialization and financial goals such as its revenue projections from the sale of its products. 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations,
Apricus Biosciences, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
BioTox Sciences
Sami Abunadi, President
info@biotoxsciences.com
Apricus Biosciences' Marketing Application for Vitaros(R), for the Treatment of Erectile Dysfunction, is Accepted for Review in Europe
Date : 06/28/2011 @ 10:47AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48233307&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that its marketing application for Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED"), has been accepted for review through the European Decentralized Procedure ("DCP").
In connection with the DCP, on April 28, 2011, the Company filed its application for marketing approval in multiple European countries, with the Netherlands serving as its Reference Member State ("RMS"). The RMS evaluated the application and has found it acceptable for review by the Company's chosen European Union countries for their individual consideration and approval. The DCP process takes approximately 240 days from the time of acceptance for review to final approval, and if approved, would give Apricus Bio the right to sell Vitaros® as a treatment for ED in multiple chosen countries within the European Union.
"We are very pleased that our marketing application for Vitaros® for ED has been accepted for review, as it speaks to the quality of the trials and clinical responses and is consistent with the guidance we received prior to filing," said Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus. "We look forward to working with the European regulatory authorities in order to make Vitaros® available in Europe. In tandem, we are in the process of preparing a submission for Vitaros® for ED in Switzerland, in the near future. In addition, we are actively working with our current partner in Italy and with other potential European partners on the commercialization of the product in this region."
Vitaros® is approved in Canada for the treatment of ED. The Company's current plan is for commercial launch of the product in that country during the second half of 2011.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 development products and product candidates, to have its products and product candidates approved by relevant European and other regulatory authorities, to successfully commercialize such products and product candidates in Europe and other markets and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
******************************************************************************************
http://www.finanznachrichten.de/nachrichten-2011-06/20645380-apricus-biosciences-marketing-application-for-vitaros-r-for-the-treatment-of-erectile-dysfunction-is-accepted-for-review-in-europe-016.htm
Apricus Biosciences Reports Reanalysis of Its U.S. Phase III Trials for MycoVa Showing Drug is Effective in Mycological Cure Resulting in Eradication of Nail Fungus
Date : 06/27/2011 @ 10:17AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48216865
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that, based on a successful and statistically significant reanalysis of its U.S. Phase III trials for its MycoVa™ product, originally intended for treating onychomycosis (nail fungus), it is revisiting its regulatory strategy for the drug. Specifically, a combined post-hoc analysis of two randomized, double-blind, vehicle controlled, multicenter, parallel group Phase III studies to assess the efficacy, safety and tolerability of MycoVa™, demonstrated statistically significant results in mycological cure, resulting in the eradication of nail fungus in favor of active treatment in patients who did not present with comorbid tinea pedis (athlete's foot), as these patients are considered at higher risk of reinfection.
Dr. Aditya Gupta, Medical Investigator at Mediprobe Research, who also acted as the Principal Investigator of one of the Phase III trials, was consulted to review the data with a view to the feasibility of reanalysis. The analysis investigated mycological cure as most relevant in terms of effectiveness, as this identifies if the drug is actually capable of treating the infectious process.
The reanalysis indicates that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in 20% of patients with mild to moderate dermatophyte onychomycosis. Mycological cure is significantly greater in patients without comorbid tinea pedis who are treated with MycoVa™ over a period of 48 weeks compared to those receiving placebo extending through to a week 52 follow-up. MycoVa™ combines terbinafine -- an existing, approved drug for nail fungus -- with Apricus Bio's NexACT® technology, which enhances the absorption of the drug through the skin. In January 2011, Apricus Bio reported results of an additional analysis showing that MycoVa™ is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl® (an ointment made by Galderma). Those results convinced the Company to seek regulatory guidance meetings from certain health agencies in Europe.
"The previously reported non-inferiority analyses and the new data with stratification by comorbid athlete's foot will enable us to move forward with our plans to seek regulatory approval guidance for MycoVa™, and to potentially market the product as an antifungal nail treatment in Europe and North America," said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio.
The Company currently holds 16 patents related to the treatment of nail fungus, with 13 patent applications pending, and has patent protection for its underlying NexACT® technology used in the nail fungus treatment in Europe, and well as in a number of other countries.
The advantage of Apricus Bio's MycoVa™ is that it is easy to apply, thus improving patient compliance. MycoVa™ is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 are outside the control of the Company, including, but not limited to, its ability to further development MycoVa™ and other products and product candidates, have such products and product candidates approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its other 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations,
Apricus Biosciences, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
**************************************************************************************
http://www.benzinga.com/news/11/06/1203036/apricus-biosciences-reports-reanalysis-of-its-u-s-phase-iii-trials-for-mycova-sho
FIFA Women’s World Cup Germany 2011
http://www.fifa.com/index.html?language=en
Corporate Presentation June 2011
http://www.apricusbio.com/pdf/ApricusBio_June12011_JefferiesCorporatePresentation.pdf
Apricus Bio CEO Bassam Damaj to Present at the 2011 Biotechnology Industry Organization (BIO) International Convention
Date : 06/24/2011 @ 10:33AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48198664&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) Chairman, President and Chief Executive Officer, Dr. Bassam Damaj, will present at the BIO International Conference in Washington, D.C. Dr. Damaj will deliver his presentation on Tuesday, June 28, 2011 at 10:15 a.m. at the Walter E. Washington Convention Center in Washington, D.C. In addition to a corporate presentation, Dr. Damaj will discuss the room temperature version of Vitaros® for erectile dysfunction, which is expected to have a shelf life of two years; Dr. Damaj will also present the latest positive analysis done by the key opinion leader, Dr. A. Gupta, at Mediprobe Research, of the US Phase III trials of the Company's anti-fungal drug candidate MycoVa™.
The BIO International Convention is the largest global event for the biotechnology industry.
Vitaros® and MycoVa™ utilize Apricus Bio's proprietary NexACT® drug delivery technology, which enables the rapid absorption of various active pharmaceutical ingredients through the skin, with the goal of improving patient outcomes and reducing side effects.
Dr. Damaj's presentation at the BIO International Conference will be accessible to the public on the Apricus Bio web site at www.apricusbio.com .
Vitaros® is approved for sale in Canada and is expected to be on the market in that country during the second half of 2011. Apricus Bio has filed a marketing application filing for Vitaros® in Europe, and the Company expects to file a marketing application in Switzerland.
The Company is seeking guidance from the regulatory agencies to file for market authorization of MycoVa™ in Europe, Canada and the US. It is also seeking guidance from regulatory agencies for Femprox®, its product for the treatment of female sexual arousal disorder in Europe and Canada.
For additional background on the Company's NexACT® drug delivery technology, Apricus Bio has produced and posted on its website a series of videos at http://www.apricusbio.com/video_faq.html
Other later stage drugs in Apricus Bio's pipeline include: PrevOnco™, a treatment for hepatocellular liver carcinoma and RayVa™, for Raynaud's Syndrome.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating specialty biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiaries please visit http://www.nexmedusa.com or http://www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 develop the room temperature version of Vitaros® for erectile dysfunction and the development of MycoVa™ for nail fungus, further development of its other products and product candidates, have such products and product candidates approved by relevant regulatory authorities in a timely fashion, to successfully commercialize and launch the room temperature version of Vitaros®, MycoVa™ and Femprox® and such other products and product candidates and to achieve its other development, commercialization and financial goals such as its revenue projections from the sale of its products. 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 Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Apricus Bio, Inc. Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
...hopefully
Higher Revenue if Pfizer Viagra(R) Litigation is Successful
Apricus Biosciences' CEO Sees Higher Revenue if Pfizer Viagra(R) Litigation is Successful
Date : 06/17/2011 @ 2:25PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=48115393
Dr. Bassam Damaj, the Chairman, President and Chief Executive Officer of Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) noted today his belief that the specialty biopharmaceutical company could see higher revenues should Pfizer, Inc. ("Pfizer") be successful in its patent litigation battle against the introduction of generic versions of its Viagra® product for the treatment of erectile dysfunction ("ED").
"If the recent global litigation effort by Pfizer is successful in extending the life of its Viagra® patents in certain markets, then Apricus Bio and its partners could expect to see the projected per unit price of its Vitaros® product for ED increase an average of $1.00 to $2.00 over the next several years in those geographic areas," said Dr. Damaj. "This could result in higher projected revenues for our product in the future in those markets where Pfizer is successful."
To the Company's knowledge, Pfizer introduced patent litigation in 2010 and recently in May and June 2011, filed additional suits against generic manufacturers of its Viagra® product for ED such as Teva Pharmaceuticals, Inc. ("Teva") and Watson Pharmaceuticals, Inc. ("Watson"). The Pfizer patent litigation mainly seeks to extend the patent life of its Viagra® product in the United States, Canada and in certain other countries and to keep generic versions of Viagra® made by companies, such as Teva and Watson, from being introduced.
Apricus Bio, a specialty biopharmaceutical company that develops and commercializes products using its proprietary NexACT® drug delivery technology, previously announced that its first product, Vitaros®, was approved by Health Canada in November 2010 for the treatment of patients with ED in that country. The Company has commercialization relationships with partners in the U.S. (Warner Chilcott Company, Inc.), Italy (Bracco SpA), the Gulf Region, and parts of the Middle East (Elis Pharmaceuticals, Inc.) and Israel (Neopharm Scientific, Ltd) for the future introduction of its product in those countries and regions, and is attempting to develop additional partnerships internationally.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating specialty biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiaries please visit http://www.nexmedusa.com or http://www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 development products and product candidates, have such products and product candidates approved by relevant regulatory authorities, to price its Vitaros® product for ED competitively as compared to the market leaders such as Viagra® among others, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and financial goals such as its revenue projections from the sale of its products. 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 Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations
Apricus Biosciences, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com