SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today provided a recap of its product pipeline development efforts, as presented by Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, at this afternoon’s PrecisionIR Informed Investors Forum Biotech, Healthcare and Pharma Virtual Conference. Details of the Company’s ongoing development efforts for NexACT and its pre-clinical and clinical product candidates include the following as of the date of this release:
Developing NexACT as a Multi-Route Drug Delivery Technology
Apricus Bio continues to add value to NexACT by expanding its potential applications from transdermal to subcutaneous, oral, buccal, rectal, nasal and ophthalmic. The Company recently announced confirmatory results qualifying NexACT as an anti-microbial preservative against a wide range of bacteria, fungus and mold. This could potentially unlock additional applications for the development of new pharmaceutical and cosmeceutical products.
Apricus is developing PrevOnco™, based on a marketed anti-ulcer compound, lansoprazole, for the treatment of solid tumors, and has filed an Investigational New Drug Application (“IND”) with the U.S. Food & Drug Administration (“FDA”) to begin testing in humans. Based on input from the FDA, Apricus Bio is now finalizing the Special Protocol Assessment Phase 3 registration protocol for a comparator study against doxorubicin in Nexavar® failure, which would be expected to support the filing of an NDA for marketing approval in the U.S. and Europe, subject to positive data. Management expects to submit the Phase 3 protocol to the FDA before year-end 2010.
Another four compounds targeted at cancer are under pre-clinical development. They include:
- A NexACT-based formulation of paclitaxel (Taxol®), which is being finalized for a proof-of-concept human clinical trial. Paclitaxel, a first line chemotherapy drug used to treat breast, lung and ovarian cancers, is currently administered through an intravenous infusion that can take up to 24 hours to complete.
- A new topical, NexACT-based formulation of filgastrim --the active drug in Neupogen®, marketed by Amgen Inc. Filgastrim, delivered via injection, is widely prescribed to speed neutrophil (a type of white blood cell) recovery in patients following a variety of chemotherapy regimens and bone marrow transplantation.
- A new topical 5-fluorouracil (5-fu) formulation to treat pre-cancerous conditions, such as actinic keratosis and genital warts. Pre-clinical data shows that incorporating NexACT in the 5-fu topical formulation resulted in a 33-fold increase in the levels of the drug across human skin, as compared to the current approved formulation. The ability to deliver higher amounts of drug may enable a decrease in the amount of 5-fu needed, and thereby allow for a reduction in toxic side effects.
- A sub-cutaneous NexACT-based formulation of rituximab, the first FDA-approved therapeutic antibody for the treatment of cancer. Pre-clinical data shows that animals receiving subcutaneous injections of rituximab, incorporated with NexACT, demonstrated a 46% enhancement in bioavailability over rituximab alone. Rituximab is a medication that interferes with the development of cancer cells, slowing their growth and spread in the body. Delivered via intravenous infusion, rituximab is the active drug in Rituxan®, currently marketed by Genentech and Biogen IDEC, and prescribed to treat Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia and Rheumatoid Arthritis.
Pipeline: Sexual Dysfunction
Health Canada is currently in the final stages of its review of the Company’s New Drug Submission for Vitaros®, a topically applied treatment for erectile dysfunction and is expected to decide on the approvability of the product before the end of November 2010. In Europe, Apricus Bio is preparing to file a Marketing Authorization Application during the first half of 2011. Management is also preparing to file for marketing approval in the Middle East and North Africa. In the U.S., where the Company has sold the rights to Vitaros to Warner Chilcott, the Company is still awaiting a response from the FDA regarding the Vitaros carcinogenicity assessment (“CAC”) package. In the interim, management is actively engaged in late stage discussions for commercial partnerships for Vitaros in Canada, Europe and other international markets.
Separately, Apricus Bio is actively pursuing development partners in the U.S. and Europe, for Femprox®, its alprostadil-based cream for the treatment of female sexual arousal disorder. To date, nine clinical studies have been completed, including one 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept study in China, where the cost for conducting clinical studies is significantly lower than in the U.S.
Apricus Bio expects to finalize the design of a clinical development program for RayVaTM, its topical alprostadil-based treatment for Raynaud’s syndrome, during the fourth quarter of 2010, having met with the FDA in July 2010 to review the proposed regulatory path for the product candidate. Raynaud’s is a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress.
In anticipation of commencement of human proof-of-concept clinical trials, Apricus Bio has conducted extensive pre-clinical and long-term stability studies on PsoriaVaTM, a NexACT-based formulation of calcipotriene and betamethasone dipropionate for the treatment of psoriasis. Incorporating a highly efficient skin permeation enhancer such as NexACT may greatly reduce the amount of drug delivered, and thereby reduce the potential for toxic side effects. A combination treatment of calcipotriene and betamethasone dipropionate is currently approved under the brand name, Taclonex®, a trademark of Leo Pharma.
Apricus Bio is also developing a fast-acting lidocaine, local anesthesia gel. In various pre-clinical studies, the NexACT-based prototype product increased onset of lidocaine delivery to as little as 15 minutes, compared to 60 minutes achieved by EMLA cream, a product currently commercialized. Additionally, the total amount of lidocaine delivered across human skin was eight times higher compared to that delivered by EMLA cream. Apricus Bio believes that a fast-acting lidocaine product could have significant commercial appeal, and is identifying potential partners to further develop the product.
Anti-Infectives & Cosmeceuticals
Apricus Bio is actively evaluating the feasibility of filing a Marketing Authorization Application for MycoVa™ in Europe. Results from the Company’s 900 patient comparator study of MycoVa versus Loceryl®, a topical nail lacquer currently marketed in Europe, showed comparable safety and efficacy profiles for the two products in patients with mild to moderate toenail fungus.
Management is actively pursuing discussions with potential partners to introduce NexACT to new applications, including the development of cosmeceuticals. Recently reported results from a United States Pharmacopeia Preservative Efficacy Test (USP PET), qualifying NexACT as an anti-microbial preservative, showed that NexACT was effective in killing more than 23 strains of bacteria, fungus and mold. With that data, Apricus Bio is seeking to position NexACT to compete with commonly used preservatives, such as parabens, which are incorporated into more than 90% of all marketed cosmetic products and can cause allergic reactions, such as contact dermatitis and delayed hypersensitivity reaction in about 10% of the population.
Pipeline: Metabolic Diseases
In pre-clinical studies, Apricus Bio successfully demonstrated the ability of the NexACT technology to deliver insulin and other large molecule drugs in a depot-like fashion (or slow release) over a 24-hour period from a single injection. Specifically, the Company’s pre-clinical data has shown bio-equivalency to Lantus® in controlling glucose levels in the blood. Lantus, a product of Sanofi Aventis, is a commonly prescribed insulin injection for treating diabetes. Management is actively pursuing discussions with potential partners concerning the out-licensing of NexACT for development programs for large molecule drugs.
The access Apricus Bio’s Informed Investors Forum audio webcast with slide presentation, go to http://www.vcall.com/customevent/conferences/biotech/20101013/index.html
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: 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 replicate pre-clinical study results in subsequent human clinical studies, enter into partnership agreements and successfully execute business plans. 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 and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC’s website or without charge from the Company.
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INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical