With a growing pipeline and increasing revenue, Apricus Biosciences (NASDAQ: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.
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 (NASDAQ: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.
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.
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).
Disclosure: I am long APRI.