VMS Rehab Systems.Inc., recently reported on the status of its generic drug treatment development program for male health disorders at its majority-owned Amsterdam, Netherlands-based pharmaceutical firm, BioPharmcor BV. BioPharmcor is currently formulating and developing a line of drug products keyed to advancing men’s health and has two operating subsidiaries, BioPharmcor in Warsaw, Poland, and VMS Rehab Systems Inc. in Ottawa, Canada.

Men’s health as a medical category refers to conditions and illnesses unique to men, such as prostate cancer, erectile dysfunction (ED), and benign prostatic hyperplasia (BPH).

Erectile dysfunction, which can be caused by a variety of underlying medical conditions, including elevated blood pressure (hypertension), high cholesterol levels, heart disease, and diabetes, as well as by unhealthy lifestyle choices like smoking, dietary habits leading to obesity, and a lack of physical fitness and exercise, affects more than 40 percent of men over the age of 40 (ergo, the “40 over 40” rule), and is increasingly common in men over age 50.

Likewise, as men age the prostate tends to  enlarge, resulting in a condition called benign prostatic hyperplasia (BPH or “enlarged prostate”) that can block or obstruct urine flow and result in difficulties emptying the bladder, slow urine flow, and dribbling or leakage, and are referred to as lower urinary tract symptoms (LUTs). According to European Association of Urology guidelines released in 2011, BPH occurs in up to 90 percent of men in their ninth decade, and, in many cases,  lifelong medical management of ED and BPH will be required — though both come with excellent rates of success and safety.

Biopharmcor says its corporate mission is to provide effective and affordable treatment for ED and BPH by offering men, initially within Europe and parts of North America,  low-cost, effective and safe medication options that are first-line treatment choices of both European and North American best-practice guidelines.

In September 2015, VMS Rehab Systems announced the appointment of Dr. Anthony Bella, a leading expert on urologic disorders in men, as chief medical officer (CMO) for BioPharmcor, the company’s early stage generic pharmaceutical business in Amsterdam.

In making the appointment announcement, Michael S. Wexler, chairman of VMS Rehab Systems, said, “Anthony Bella is an outstanding urologic medical clinician and surgeon with a broad reputation for his knowledge and expertise in the Men’s Health sector that spans the globe. We are confident that Dr. Bella will provide the leadership required to build out a pipeline of generic drugs that will consolidate BioPharmcor’s market position in providing first line treatment for chronic urologic and Men’s Health issues.”

A urologic surgeon, Dr. Bella brings to the company extensive medical training and knowledge in the treatment of patients suffering from the most serious urological disorders and/or diseases. In addition to his medical and surgical practice at the University of Ottawa, Dr. Bella has held the Greta and John Hansen Chair in Men’s Health Research since 2009. Additionally, he led a urology-focused research laboratory as an associate scientist, Neuroscience, Ottawa Health Research Institute at the University of Ottawa, from 2007 to 2013. Dr. Bella has published more than 100 research articles and book chapters, served as visiting professor or invited lecturer globally, and presented work at major international meetings in his field of specialty on more than 200 occasions.

BioPharmcor estimates that the market for ED drug remedies is approximately $4.5 billion worldwide, and the company last week confirmed that it is in the final development and testing stages of its generic tadalafil product. Human clinical trials are planned to demonstrate the bioequivalence of tadalafil against the marketed patented product (Cialis) to support market approval submissions in a number of countries.

According to the U.S. National Institutes of Health’s Medline Plus, tadalafil belongs to a class of medications called phosphodiesterase (PDE) inhibitors that work to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation, which can allow for an erection. These inhibitors are also used to improve exercise ability in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness), and work by relaxing blood vessels in the lungs to allow blood to flow more easily.

A company spokesperson says in a release that “BioPharmcor’s generic tadalafil will be sold at significantly lower prices than the approved patented drug, making BioPharmcor’s generic drug accessible to a broad constituency of men in global markets who currently cannot afford to pay for the higher priced name brand product.”

Once a patent for a proprietary drug expires, generic drug manufacturers such as BioPharmcor can start to produce their own version of the drug, typically at a fraction of the cost of the original branded product.

BioPharmcor estimates that in large developed markets, generic pharmaceuticals save today’s healthcare consumers billions of dollars at retail pharmacies, and the saving  rises dramatically with the use of generic drugs by hospitals. The company cites market projections that the value of the total global generics sector will rise to $358 billion in 2016, representing more than 18 percent of all pharmaceuticals sold, and  at a projected compound annual growth rate (CAGR) of 9.7 percent between 2011 and 2016. The men’s health component of the global generic drugs market is currently 4–5 percent, and is forecast to grow at the rate of 4.1 percent per year, reaching about $12.5 billion by 2017.

By lowering the cost of providing therapeutic treatment for men suffering from urologic disorders, BioPharmcor expresses confidence that its product line of generic ED and BPH drugs will find ready consumer markets throughout the EU and elsewhere. The company acknowledges that, while the overall market for physician prescribed ED and BPH medications in Poland and the rest of the EU has lagged behind North American markets, it is anticipated that BioPharmcor’s revenue and profit potential will increase once the requisite market approvals for its generic version of ED and BPH drugs are obtained.

For more information, visit www.vmsrehabsystemsinc.com.

Sources:
VMS Rehab Systems Inc.
BioPharmcor BV
U.S. National Institutes of Health (NiH) Medline Plus