Apricus Biosciences, Inc. (APRI-NASDAQ)

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March 9, 2012 Issue

The Most Powerful Name In Corporate News and Information


Apricus Biosciences, Inc. has Metamorphosed From a Clinical Development Company To a Commercial Stage, Specialty Pharma with Large Pharma Pushing their Vitaros® Product and a Sales Force as they Prepare for Their Own Product Launch in 2012

Dr. Bassam Damaj Ph.D.
President, CEO, and Chairman

Dr. Damaj was appointed to serve as President and Chief Executive Officer and as a member of the Board in December 2009 and was elected as Chairman of the Board in October 2010. Dr. Damaj is the co-founder and former Chief Scientific Officer of Bio-Quant, and served in that capacity since its inception in 1999. Dr. Damaj brings to the Company numerous years of biotechnology and pharmaceutical experience in drug discovery and development.


Prior to Bio-Quant, Dr. Damaj served as President & Chief Executive Officer of BioSignature Diagnostics, Inc. He also served as the Group Leader for the Office of New Target Intelligence and a Group Leader for immunological and inflammatory disease programs at Tanabe Research Laboratories, U.S.A., Inc. Previous appointments included Pharmacopeia Inc., a New Jersey based company where Dr. Damaj served as a senior scientist and a member of the senior staff board of the drug discovery department. He was also a visiting scientist at Genentech, Inc., Pfizer Inc. and the NIH (NIAID). Dr. Damaj is the founder of Celltek Biotechnology, Mina Holdings, BioSignature Diagnostics and R&D Healthcare Inc.


He holds numerous patents in this field and authored numerous peer reviewed scientific publications, and is the author of the Immunological Reagents and Solutions reference book. Dr. Damaj served on several scientific advisory boards of biopharmaceuticals including Celltek, Virocell and Microislet, Inc. He is the holder of the U.S. Congress Award for the development of the first Anthrax Diagnostic Blood Test for the United States in 2003. He also represented the State of California on the Congressional Scientific Liaison Committee in 2002. Dr. Damaj holds a Ph.D. in Immunology/Microbiology, a postdoctoral fellowship in Molecular Oncology and an MBA in Healthcare. He has been involved with over seven drug candidates currently in clinical trials for a variety of diseases.

Company Profile:

Apricus Bio is a San Diego-based revenue-generating specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology.

Apricus Bio currently markets Totect® in the U.S. (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation and will market in 2012 in the U.S. or certain other countries (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral™, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva and (c) NitroMist® (nitroglycerin sublingual spray), an FDA-approved nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris (chest pain) due to coronary artery disease (narrowing of the blood vessels that supply blood to the heart).

Apricus Bio's current NexACT® pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.

The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.

For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio.

Specialty Drug Company

Apricus Biosciences, Inc.
11975 El Camino Real, Suite 300

San Diego, CA 92130

Phone: 858-222-8041


Interview conducted by: Bud Wayne, Editorial Executive, CEOCFO Magazine, Published – March 9, 2012

Dr. Damaj, what is the growth strategy of the company?


Dr. Damaj: Since the acquisition of Topotarget USA, the company has been transformed from a clinical development company into a hybrid biopharmaceutical company, a specialty pharma. The growth and strategy now is really becoming a revenue driven pharma through both the partnership and commercialization of the high-value products we have based on NexACT® through our partners, such as Abbott and Novartis. Then through the second arm of the business, which is the Oncology Supportive Care, we have our own sales force for the current three products that we have in the United States. That will compliment revenues from our partners.  Having said that, our plan is to bring in more partners for our pipeline and acquire more drugs for the sales arm to drive revenues for the company.


CEOCFO: What is new as far as products, services, and technology?

Dr. Damaj: We have signed Abbott as our commercialization partner for Vitaros® in Canada and then we signed the Novartis AG’s subsidiary Sandoz for the commercialization of Vitaros® in Germany. Therefore, we have brought in two large pharma as partners in a very short period of time. In addition to that, we acquired Topotarget USA and we are in the process of acquiring PediatRx, which will give us three drugs on the market in the US. Those include Totect®
for the treatment of anthracycline extravasation, Granisol® as an anti-emetic and Aquoral™ for xerostomia. So, there has been a lot of new products coming in and new technology. In addition, we acquired the rights for a product that is on the market, NitroMist®, an FDA-approved vasodilator for the treatment of an attack of angina pectoris (chest pain) due to coronary artery disease, from NovaDel Pharma Inc. We are moving forward with the registration and filings worldwide for these products.


CEOCFO: What makes Apricus unique?


Dr. Damaj: The company now is unique in multiple ways. First of all, it is unique because it has a proprietary platform NexACT® that allows us to deliver drugs through the skin and other areas very fast, and deliver enough of the drug to have it succeed in a safe manner. Also, we have the high-value products that we partner through our large pharma to put on the market. At the same time, we have a specialty arm of the business, where we have our own sales force and we have three drugs on the market right now. Therefore, we can book our own revenues from them. This combination actually makes Apricus a very unique and flexible company. We now have the potential to grow very fast and bring in large revenues for the company.


CEOCFO: How do you maintain a competitive edge?


Dr. Damaj: This is a very good question. As you know, there are a lot of companies out there that have delivery technologies, but we are one of the few companies that have a clinically validated drug delivery technology where there are drugs approved, with partners such as Abbott in Canada. That is one competitive advantage we have. The other competitive advantage we have is that we may be able to bring in additional large pharmaceutical companies as partners. The large pharma have looked at the technology, they have validated it, they are comfortable with it and there is a drug approved. This brings a lot of validation to the company itself, not just on the technology, but also the commercial strategy and the outcome of the technologies. In addition, what makes us unique is that we have our own sales force on the Oncology Supportive Care, so we can sell our own products and we have control over them. As far as products that require a large sales force, we go through our partners. This has been a very competitive edge for us and especially that we have a lot of cash in the bank now. So, many companies are now coming to us to offer products to go to market or to sell for them in the US. Since other companies see that three large pharmas have partnered with us, many large pharma out there are contacting us now. Therefore, we are having a lot of leverage from both ends of the business.


CEOCFO: How are you planning to grow the company, will it be through mergers or acquisitions, and do you have the capital or credit to accomplish this?


Dr. Damaj: This is a very important question for us, because we have been out on the road clearly presenting the company and telling the market our growth strategy. First, we have our own pipeline, which we are developing internally organically and then we have to keep on pushing that product towards approval and partnering, as we have done with Vitaros® and continue doing. This is the first part of our strategy, which is based on bringing in new partners, upfront money through milestones. Then the relaunch of the products we acquired in the US, which will bring revenue to the company and we are looking at continuously acquiring new products for our sales force to sell. The other important growth strategy with us is we are looking into growing into some European markets now where we will have our own sales force there and push our own drugs there also. We are very well capitalized right now. We have almost $25 million in the bank, excluding what we have signed and the upfront from Abbott and from Sandoz Novartis, which will put us in a better position and allow us to acquire more companies and drugs. We will grow through the partnerships, through our own pipeline, and through acquisitions from companies that have drugs on the market.


CEOCFO: How is the company positioned in the market place?


Dr. Damaj: The position of the company right now as we are going out is a hybrid specialty pharmaceutical company. We feel that it is a hybrid because we have our own platform NexACT®, where we have develop our own drug delivery platform, and also a specialty pharmaceutical company, because we have approved drugs and our own sales force for the Oncology Supportive Care. In addition, the company has been historically a retail based stock, where as we are now moving to an institutional base. Now we have more institutions looking at us and we hope that the analysts will come in. We also have the cash, as well as we are repositioning the company from that of a drug development clinical development company into a company that has its own products, revenues and sales force in the United States.


CEOCFO: Why did you decide to acquire NitroMist™?

Dr. Damaj: NitroMist™ is a very good product. We look at NitroMist as being complimentary in two ways. First, NitroMist™ has a very important differentiator against other nitroglycerin forms out there. In fact, it is the only product that has a 36-month shelf life. The main problem with the nitroglycerines out there for the patients take them is that within three months the tablets start losing their potency and the patients cannot go and exchange them. So, if they have a heart attack, it is less efficacious and they do not respond to it. Whereas, NitroMist™ is the only product out there that has a 36-month shelf life and it is efficacious throughout the 36-months. Again, as part of our strategy to expand outside the US, this was a very good opportunity for us to acquire the rights outside of the US, and to partner it out. Since it is sold here, it will also be easy for us to move it forward.


CEOCFO: Would you tell us more about the importance of the German collaboration for Vitaros® with Sandoz?

Dr. Damaj: We signed with a subsidiary of Novartis, which is called Sandoz. It is a very good deal, over $27 million for the German market with upfronts, milestones and a royalty from the product. The importance of this deal, it is not just because Novartis is the largest company there, so obviously they control the market, but also we used to have Novartis as a partner for MycoVa™. They dropped out five years ago and Novartis coming back to being a partner on another NexACT® based product is actually a testimony to their belief that the technology is a strong and vital technology. It is also a testimony that Vitaros® is a strong and good product and will compete with the products that are currently available on the market.


CEOCFO: Where you with Vitaros® in the US?


Dr. Damaj: As I’m sure you’ve seen we recently had an 8-K with the Vitaros® clinical supply agreement with Warner Chillcott and while we can’t speak for Warner Chillcott we do feel they are moving forward with the product hopefully in the near term.


CEOCFO: Where are you in getting Femprox® through the clinical trials and MycoVa™?


Dr. Damaj: Besides Vitaros®, the most advanced clinical NexACT® product that we have right now is Femprox®, which is for female sexual arousal disorder. The active ingredient is alprostadil. We actually have completed a Phase III clinical trial with 400 women and we are preparing the briefing documents that we need for the US, Canada and Europe, to get guidance as to the next step, such as if we need a second Phase III trial or not or if we can file with the current one.


For MycoVa™, we have completed the Phase III trials and again, we are preparing the briefing documents that you need for the Health Agency in Canada and the FDA in the US. Our plan is to meet with them and request guidance for the regulatory strategy to file the NDA for market authorization.


In addition, we are contemplating additional market filings for a number of our current marketed products. Therefore, we have a very strong pipeline, with a lot of filings for market authorizations going on this year.


CEOCFO: Why should potential investors consider Apricus Biosciences at this point in time?


Dr. Damaj: Apricus Biosciences has really changed, and has metamorphosed from a clinical development company to a commercial stage, specialty pharma, where now we have the large pharma pushing our products like Vitaros® and others and we have our own sales force and our own products we are launching this year. So, the company has changed quite a bit from just developing drugs to having four drugs approved already. We are pushing for the approval of four, we are planning more and we will have our own revenue then. Therefore, we do feel that the company is undervalued right now. There are some analysts that have given us “buy” rating, and we are looking for more research analysts. So, a company like ours that has a strong pipeline and platform technology would be at multiples of our market cap. We are really looking forward to the market appreciating the company, the stock appreciating and the market cap of the company appreciating. With the more we deliver, we expect that to happen.


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Apricus Biosciences has really changed, and has metamorphosed from a clinical development company to a commercial stage, specialty pharma, where now we have the large pharma pushing our products like Vitaros® and others and we have our own sales force and our own products we are launching this year. - Dr. Bassam Damaj Ph.D.



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