67 WALL STREET, New York - May 1, 2012 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Biotech Stocks Outperformance and Rally - FDA Drug Approval Process - M&A Activity Acceleration in 2012 - U.S. Health Care Regulation
Companies include: BioLife Solutions (BLFS); Abbott (ABT); Achillion (ACHN); Affymax (AFFY); Alexion (ALXN); Amgen (AMGN); and many more.
In the following brief excerpt from the Biotechnology and Pharmaceuticals Report, expert analysts discuss the outlook for the sector and for investors.
Dr. Bassam 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. He is the Co-Founder and former Chief Scientific Officer of Bio-Quant, and served in that capacity since its inception in 1999. Before Bio-Quant, Dr. Damaj served as President and CEO 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. Dr. Damaj holds a Ph.D. in immunology/microbiology, a postdoctoral fellowship in molecular oncology and an MBA in health care.
TWST: Would we start with an overview and history of Apricus Biosciences?
Dr. Damaj: Apricus Biosciences (APRI) is a public pharmaceutical company. We're listed on the Nasdaq under the symbol APRI. The company focuses on enhancing pharmaceutical products. Since its founding, the company has advanced many products through clinical development and also approval. We have in Canada, Vitaros for erectile dysfunction, a strong pipeline, and are close to receiving market authorization for Vitaros in Europe. In addition, we have three marketed products in the United States for oncology and oncology-supported care that we have acquired.
TWST: Would you talk about the technology involved in your NexACT systems and its related pipeline?
Dr. Damaj: At the core of Apricus is a drug-delivery technology called NexACT, which is a unique, patented small-molecule technology designed to allow drug delivery through what we call tight junctions that hold the cells together and allow the drug to go through the skin. And what NexACT technology allows is really for enhancing and allowing drugs that usually don't go through the skin or other routes, to go through the skin noninvasively and achieve higher levels in blood to achieve the efficacy needed from those drugs. And again, when you do that, you're able sometimes to use less of the drug, and if the drug has any side effects then you can have lower of those side effects. And the improvement that we really made possible with the NexACT technology - they hold the potential to provide compounds with what we call NCE-like differentiation, and NCE stands for new chemical entities, which have very strong patent protection.
TWST: Would you tell us about the company's plans to market Vitaros, a male erectile dysfunction product, as well as the female sexual arousal product called Femprox? What partnerships and relationships are in place for those products?
Dr. Damaj: Our strategy is really to develop and play an active role in the commercialization of our NexACT-enhanced formulations of proven and well-characterized drugs that usually address a large patient population. So to accomplish this the strategy is to work both independently through our own sales force for some of the products, as well as have partnerships with large pharmaceutical companies, such as our partners Abbott, Novartis, Sandoz, Warner Chilcott, as they share the same goals and have the right strategic sales force and marketing to push the drugs into the market.
TWST: Where will this lead Apricus? With the experience gained on these products, what are the next likely suspects?
Dr. Damaj: Our flagship product is a drug called Vitaros, which is approved in Canada. It's going to be launched the second half of this year with Abbott Laboratories, and it is currently the only topical treatment approved for erectile dysfunction in the world, and this product actually does not have the side effects that the oral PDE5, like Viagra, Cialis and Levitra have. It is the only product that we call an on-demand treatment, which the patients would add the product and within minutes the patients will have a response, and it's currently the only product that is safe and effective for the entire patient population that the oral PDE5 will not work for. I'm leading with this because this actually shows the strength of the technology and what we can do. Following on Vitaros' success, we have developed a very strong pipeline, is the second of which is Femprox for female sexual arousal disorder, which is a combination of our NexACT and Alprostadil.
It's a topical gel, which we already completed a Phase III clinical trials successfully. We're following with MycoVa, which is a combination of Terbinafine and NexACT for onychomycosis, which is a fungus infection of the nail. We have PrevOnco, which is a combination of lansoprazole and NexACT for hepatocellular carcinoma for cancer. In addition, we have acquired a series of drugs in the oncology and oncology-supportive care space, like Granisol, currently the only marketed and approved granisetron product for vomiting and nausea associated with chemotherapy and radiation therapy.
We have also Totect, which is the only drug actually approved for the treatment of extravasation of chemotherapy to help actually the survival of the patient and remove the excess of the chemotherapy that will destroy the tissues. So with this now, we have moved from a clinical-stage development company to what we call a commercial-stage company, and with a commercial-stage company, we do have our own revenues and pushing for more revenues.
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