The U.S. Food and Drug Administration (FDA) is a tough bird, no doubt about it. When it comes to meeting all of the rules and stringent guidelines, most investors only think about the safety and efficacy of a drug, but there is much more to it. Current Good Manufacturing Practices (CGMP) also play a large role in bringing a drug to market and, subsequently, keeping it on the market.
PharmStar Phamaceuticals is on top of the guidelines and looking to possibly move into a new facility to accelerate the marketing of its main drug, AQUAPRIN™. AQUAPRIN™, an FDA-approved Over-the-Counter (OTC) liquid pain reliever in development since 1993, is a liquid derivative of aspirin based on a patent-pending formula. The product is designed to dissolve nearly instantly in just 1.5 ounces of water, which can be absorbed into the bloodstream up to 10 times faster than traditional OTC pain relievers, and with little to no stomach upset.
Presently based in Rocky Mount, NC, the Company is contemplating a move to an over three-acre site and 24,000 square foot building for production and research activities in Wilson, NC. While the PharmStar facilities now meet all the FDA CGMP guidelines, there is a shared component for which PharmStar is responsible for all materials that are on the premises. A stand-alone facility where PharmStar is the only tenant makes more sense. The move could provide greater economic benefits as well as accelerate the commercialization process to bring AQUAPRIN to market. Additionally, the property which the management is considering is strategically located in a professional industrial park near a third-party pharmaceutical testing facility. Also, it is close to many pharmaceutical companies, such as Merck; Sandoz, a division of Novartis; Perdue Fredrick; Natures Bounty; and GlaxoSmithKline, making talented pharmaceutical production and research personnel readily available for hire.
Investors should not fear an increase in outstanding shares according to PharmStar CEO Howard Phykitt. Mr. Phykitt addressed this concern in the PharmStar press release announcing the negotiations in stating, “The Company has received an offer to purchase the building, and is currently assessing the offer. I made a commitment to shareholders when we restructured the capitalization table that the Company has no need to dilute its common stock for at least the next six months. This decision will not affect that commitment.”
Investors have been rallying around PHAR throughout 2011. The share value dropped to an all-time low in the final days of 2010 to touch $0.004, but then steadily rose to a 2011-high of $0.06 in March. While off the highs, the share price appears to be holding steady in the 3 cent range; presently trading at $0.037 heading towards the close of today’s trading. There is a sizable amount of outstanding shares as nearly one billion currently exist according to OTC Markets, but the float is only listed at a paltry 12.45 million.
Interested parties can learn more about PharmStar and its business developments by visiting www.pharmstarinc.com