Can Viagra and Cialis Be Beaten? Two New Drugs Say "Yes"

Wednesday, February 11 2009

February 11, 2009

For a while there, it looked like we would never see another drug manufacturer challenge the highly competitive market for erectile dysfunction (ED) drugs. The two big dogs, Viagra and Cialis, control 90 percent of the annual revenue for the $3.7 billion market. Levitra controls the rest.  

Now, within a matter of weeks, two new potential ED drugs have come out of the woodwork. This blog highlighted Rexahn's drug named Zoraxel late last month. And now, VIVUS (which also provides prescription urethral suppository Muse, as well as Actis, a latex constriction loop) has announced a second Phase 3 trial for their ED drug named Avanafil.  

It has been more than five years since the FDA approved a drug for ED, and that was for Cialis back in November of 2003. It has taken Cialis five years, but its $1.44 billion in annual worldwide sales is now approaching Viagra's $1.93 billion. 

All things being equal, Levitra is generally considered to be just as effective as Viagra and Cialis, but it seems Levitra/Bayer/Glaxo Smith-Kline are not willing to ante up to try to take a bigger slice of the market. They seem happy with their $300+ million annual return.

Viagra has been around for more than 10 years, has the history and tradition of a grizzled veteran. Cialis lasts for up to 36 hours and is a rising star.

So one has to ask:  How much room is there for another new kid on the block? Sure, sheer curiosity may provide a quick buck or two, but how many of the 25+ million men who have used Viagra, most with success, will even waver? Hard to say, but the number is sure to grow when the Viagra patent for active ingredient Sildenafil Citrate expires in March, 2012.

At that point, generic versions are sure to find a way to market, and once they are FDA-approved, prices for ED meds are sure to drop quite a bit -- which should make fun in the bedroom more economical.

Although Zoraxel and Avanafil are probably at least a couple years away from the market, their introduction could shake things up depending on how they are priced, and what new benefits they provide. As far as Avanafil is concerned, here is the scoop from the VIVUS press release concerning Phase 3 trials for diabetics.

"Early data suggest that avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options."

That's the question, how many men are searching for new options. There are already three proven medications, and who needs one that doesn't last as long? Success for Avanafil may depend on how quickly it works. The other ED meds can start working in about a half an hour, sometimes even sooner. You can compare Viagra, Cialis and Levitra here.

The success of Zoraxel may hinge on the fact it apparently may have less side effects. Every pill needs a plug, and without it, success is not a given. Just ask Levitra/Bayer. They have no gimmick, and they've been lapped like a race car equipped with a V-6.

Considering how much money it takes to get these medications to market, there will be lots of pressure for success from investors, to say the least. It will be interesting to see how these ED medications attempt to set themselves apart from the rest. And considering the competition, they might need more money for marketing than they did for research and development.

Brian Bujdos