By: AllPennyStocks.com News

Tuesday, February 12, 2013

The pharmaceutical business is starving for new therapies and technologies to shepherd in the next wave of treatments to combat diseases. Subsequently, large pharmaceutical companies are dolling-out increasing amounts of money to try and get an edge on competitors as they slowly fall one by one off the so-called patent cliff, costing them billions of dollars annually as blockbuster drugs lose protection from generics. Make no mistakes about it; the cliff is steep and expensive. Of the $860 billion in global sales of pharmaceuticals in 2010, 133 drugs accounted for about 34 percent, or nearly $300 billion, of total sales. 13 of those drugs, or 9.8 percent, face patent expiration in the next five years. In 2013 alone, EvaluatePharma estimates drugs generating $29 billion annually will lose patent protection. Included in this group are Eli Lilly & Co.’s (NYSE:LLY) antidepressant Cymbalta and diabetes drug Humalog, Biogen Idec Inc.’s (Nasdaq:BIIB) multiple sclerosis drug Avonex (although Biogen contests that it has extended the patent) and Purdue Pharma’s chronic pain drug OxyContin.

Taking the hit in 2012 were drugs such as Sanofi SA’s (NYSE:SNY) blockbuster blood thinner Plavix and Pfizer Inc.’s (NYSE:PFE) cholesterol drug Lipitor, which accounted for almost 16 percent of Pfizer’s total drug sales in 2010.

As the competition continues to stiffen in drug development, another pathway to prosperity that is catching the attention of the investment community is through improvements in drug delivery systems, or the means to get therapeutics into the body. These new technologies address fundamental challenges of pharmaceutical companies not only in developing novel therapeutics, but also potentially extending intellectual property rights on existing drugs.

Many companies are still relying upon dissolvable coatings or hydrophilic matrix processes to deliver drugs over time, but the next generation of drug delivery entails many different methodologies that appear far superior. For example, Unilife Corporations (Nasdaq:UNIS) is focused on innovative injectable drug delivery systems and owns a broad portfolio of proprietary device technologies entrenched in the injectable arena. Corporate products include prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors and more.

The company has developed new bolus injectors, a new class of disposable, wearable devices for the subcutaneous administration of high-dose volume or high viscosity biologics. For manufacturers of peptides and other types of biologics, getting the correct recipe of volume and viscosity for drug delivery can be a significant hurdle, a problem that Unilife is remedying with its auto-injector.

Once called “patch-pumps” or similar, the new age of devices have been re-branded as bolus injectors and are far superior to legacy models in delivering a precise dose over a designated time frame and can handle a wide range of viscosity levels. Once used the devices are simply disposed.

Not only do the bolus injectors offer an opportunity for Unilife to penetrate traditional markets for existing drugs by providing a potential alternative to drugs relegated now to delivery only in IV format in a clinical setting, they, importantly, position the company to provide options for pharmaceutical companies looking to develop drugs in larger doses or concentrations.

Only one component of Unilife’s portfolio, the company estimates the bolus injector market alone could breach the $500 million mark in the next few years. The company does face challenges pertaining to breaking into the market and from stiff competition across several of their products. Fighting for market share in the same space are other small caps like Retractable Technologies Inc. (AMEX:RVP) and bigger Antares Pharmaceutical, Inc. (Nasdaq:ATRS), a company that Mad Money’s Jim Cramer said he didn’t like how competitive the industry is.

Taking a more unique approach, which drastically limits competition, and coming in with a far less expensive price tag per share, Crown Marketing Pharmaceuticals (OTCQB:CWNM) purports to have the “most advanced, yet elegantly simple approach to Controlled Drug Delivery.” The company’s CDDT (Controlled Drug Delivery Technology) is a patented delivery system built upon mathematically programming the rate of diffusion to deliver medications over a specified period of time.

With its CDDT, Crown has bridged a wide gap left by traditional methods of ingestible drug delivery and developed a technology that could revolutionize the pill industry. Why? Because today’s technologies of coating medications only work when the coating stays intact. Cracks or breaks can present a significant health risk to the patient. Hydrophilic matrices, which rely upon stomach acids and fluids to breakdown the matrix and release the medication, do not account for differences in individual patient’s bodies, presenting a risk of toxicity or decreased bioavailability of the medication.

In layman’s terms, while there have been some advancements in oral drug delivery, the standard of care today still doesn’t work right. Crown Marketing Pharmaceuticals realized the weaknesses and has built a better mousetrap.

Harnessing the principals of Chaos Theory and chemical potentials and applying them to a new manufacturing process, Crown’s platform is demonstrating a far superior spectrum and reliability of pharmacokinetic profiles. Crown’s technology is based on the observation that a device coated with an impervious membrane, with one or more orifices and of a defined geometry, releases molecules in an organized, predictable, and controllable manner utilizing compound-specific chemical potential energy along gradients. The modeling equations take into consideration the basic laws of diffusion, as well as the biochemical profiles of the drugs and excipients tested.

What the CDDT delivers is a high level of flexibility for pharmaceutical or neutraceutical manufacturers in matching chronotherapeutic requirements without significant investment in new manufacturing machinery or complex chemical diffusion matrix formulations.

Crown has validated its technology through in vitro and in vivo experiments demonstrating the ability to generate nearly-constant and controlled concentrations of drug at the orifice over a selected period of time. Mathematical modeling makes the release kinetics extremely predictable, while the novel design permits controlling kinetics at both ends of the delivery period, allowing fine-tuning of the kinetic profile to match pharmacodynamic expectations (including the magnitude of initial bolus and duration of release).

The possible uses for this technology canvas every pill that is ingested, giving it a particularly impressive – and somewhat unprecedented – upside. The company said on January 31 that it is also targeting the lucrative diabetes industry after completing laboratory research with positive results using its CDDT with Metformin, the most widely prescribed diabetes drug on the market today. Although the most commonly administered, patients have notoriously complained about the side effects, such as diarrhea, nausea and vomiting, and the bad taste and odor of Metformin. Because of the CDDT, Crown believes that it can reduce many of these unpleasant side effects.

Global Metformin sales totaled $1.6 billion in 2012.

The broad range of benefits, endless applications and novel nature of Crown’s technology seems to give it a competitive advantage over any peers. As aforementioned, big pharma is hungry to re-stock dwindling portfolios and revenue streams. The CDDT promises precise targeting and more therapeutic benefits, potentially leading to decreased dosages, reduced side effects and a means to breathe life into the cash cows that typically contract by at least 50 percent upon patent expiration.

These are two game-changing technologies offered by companies with tiny market valuations compared to potential, making them worthy of a far closer examination. Proper due diligence is, as always, encouraged.

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