Shares of Apricus Biosciences Inc. (APRI: Quote) have gained more than 27 percent in the past one month and trade around $3. Given the fact that the company has a number of key events up its sleeve, it might be worth keeping an eye on this stock.
For readers who are new to Apricus Bio, here's a brief overview of its business and the upcoming milestones...
San Diego-based Apricus Bio has commercial products and a broad pipeline across numerous therapeutic classes. The company's proprietary drug delivery technology is called NexACT, which enhances absorption of drugs through the skin and other barriers including the nail plate and nail bed.
Under the NexACT drug delivery platform, the company has one approved drug namely, Vitaros, which is approved in Canada for the treatment of erectile dysfunction, and late stage product candidates namely, Femprox for female sexual arousal disorder; MycoVa for onychomycosis (nail fungal infection); RayVa for Raynaud's Syndrome and PrevOnco for liver cancer.
Though Vitaros was granted approval in Canada in late 2010 itself, it was only as recently as January of 2012 did Apricus Bio enter into an agreement with Abbott Laboratories Ltd. (ABT), granting Abbott the exclusive rights to commercialize Vitaros for erectile dysfunction in Canada. Abbott is expected to launch Vitaros in Canada in the second half of 2012.
Under the licensing agreement with Abbott, Apricus Bio is entitled to receive up to $16 million in up-front license fees and aggregate milestone payments, in addition to tiered royalty payments. The upfront license fee will be recognized by Apricus this quarter. (2Q, 2012).
Last week, Apricus Bio filed its response to questions received from Swissmedic, the Agency for Therapeutic Products in Switzerland, for its Vitaros marketing application. The company is expected to finalize some partnerships to commercialize Vitaros in Europe in the coming quarters.
Vitaros is not approved in the U.S. yet. However, the active ingredient Alprostadil in Vitaros is already approved by the FDA, and is available under the brand names Edex, Caverject and MUSE. Warner Chilcott owns the U.S. rights to Vitaros, and should Vitaros receive FDA approval, Apricus Bio is eligible to receive $2.5 million from Warner Chilcott.
Femprox, a topical cream for the treatment of female sexual arousal disorder, has successfully completed a phase III clinical study. A pre-New Drug Submission meeting with Health Canada, which would help Apricus Bio obtain regulatory guidance for Femprox, is scheduled for July 17, 2012. A similar meeting to obtain regulatory guidance from the FDA for Femprox is expected to take place late next month.
MycoVa, the company's topical treatment for onychomycosis, or nail fungus, developed under the NexACT drug delivery platform, is yet another product, which has successfully completed phase III studies. Apricus Bio has a guidance meeting with Health Canada regarding MycoVa on July 18, and with the FDA in late July.
Under an agreement signed late last year, Stellar Pharmaceuticals Inc has the exclusive rights to market MycoVa in Canada, upon approval.
Apricus Bio also intends to request guidance meetings for MycoVa with various European health agencies.
Also in the company's pipeline is a preclinical product , Nupen for post-chemotherapy recovery of neutrophil.
Apricus Bio's sales roster includes FDA-approved products namely, Totect for extravasation from intravenous anthracycline chemotherapy, the accidental leakage of chemotherapy drugs into surrounding tissue; Granisol oral solution for the prevention of nausea and vomiting associated with cancer therapy; Aquoral spray for the treatment of dry mouth due to a lack of saliva (Xerostomia) and NitroMist, a mouth spray to relieve episodes of chest pain (angina).
Totect came into Apricus Bio's fold following the acquisition of Topotarget USA Inc. last December. The rights to Granisol and Aquoral were acquired by Apricus Bio from PediatRx Inc. in January of this year. The following month - in February 2012, Apricus Bio acquired from NovaDel Pharma Inc, the right to develop and commercialize NitroMist in all countries worldwide except the United States, Canada and Mexico.
Though Totect, Granisol and Aquoral have been available in the U.S. even before they came into its portfolio, Apricus Bio is working towards a formal re-launch the three oncology supportive care commercial products this year, and expects to recognize revenue in 2012.
A quick look at the company's balance sheet...
Incorporated in Nevada in 1987, Apricus Bio has incurred losses each year since inception, and had an accumulated deficit of $224.1 million as of March 31, 2012.
In the first quarter of 2012, the company incurred a net loss of $4.71 million or $0.20 per share on revenue of $781 thousand. That compares with a loss of $3.41 million or $0.18 per share on revenue of $1.59 million in the first quarter of 2011.
The company ended the first quarter of 2012 with $21.53 million in cash, sufficient to sustain its operations into the middle of 2014.
Apricus Bio shares have thus far hit a 52-week low of $2.25 and a 52-week high of $5.94. The stock closed Monday's trading at $3.14.
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by RTT Staff Writer
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