Generic Version of BPH Drug, Tadalafil, Being Readied for Testing in Clinical Trials

Generic Version of BPH Drug, Tadalafil, Being Readied for Testing in Clinical Trials

VMS Rehab Systems, Inc., reported that its generic drug subsidiary, BioPharmcor BV, in the final development and preclinical testing stages for it generic version of tadalafil, a potential first-line treatment for men with erectile dysfunction (ED) and benign prostatic hyperplasia (BPH).

The drug will next be evaluated in clinical trials to test its bioequivalence to Cialis, the brand name for tadalafil and an approved treatment for these conditions, the company announced in a press release. Tadalafil works by relaxing the muscles in the walls of blood vessels to increase blood flow.

Should bioequivalence be established and the use of generic tadalafil approved by regulatory agencies, BioPharmcor, which is based in the Netherlands, plans to market the drug initially within the European Union and in parts of North America as a safe, effective and lower-cost alternative to Cialis, which is produced by Lilly.

“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,” a company spokesperson said in the release. The company estimates the market for ED drug remedies alone to be $4.5 billion.

Although targeting select markets, at least initially upon approval, BioPharmcor expects its generic tadalafil will be well-received, as “generic medicines save the consumer today billions of dollars at retail pharmacies,” it said on its website, a “‘saving’ figure [that] rises dramatically when one considers the use of generic drugs by hospitals.”

Worldwide, the projected 2016 market value of generic drugs is expected to reach $358 billion, representing more than 18 percent of all pharmaceutical sales. The men’s health component is an estimated 4 percent to 5 percent of the total generic drug market.

VMS Rehab was established as a Canadian incorporated company in 1998, and is the controlling company of BioPharmcor BV. It operates through its office in Ottawa and affiliated BioPharmcor offices in Amsterdam, and Warsaw, Poland.

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