Rocco Verducci

Indevus Pharmaceuticals: Nebido Has Lost Its Libido

Steve,

The FDA, by design, exercises extreme caution with respect to their evaluation and approval of drugs since the health of every American is potentially at risk. Additionally, their judgment is devoid of the commercial zeal that investors have about a particular product. If we had to shoulder the responsibility of evaluating a drug and observing the consequences of prematurely approving a drug that should have had a more rigorous screening, I truly believe that most would err on the side of caution.

There are presently testosterone products that are available that are delivered through safer delivery systems (i.e. transdermally). What I would be more concerned with is the potential that androgen therapy has for increased risk of benign enlargement of the prostate or that it may promote the growth of existing cancer of the prostate. However, the once every three month injectable regimen does confer a patient-centric advantage in terms of convenience.

Although the indication for Nebido is for hypogonadism (Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, muscle loss and weakness, depression, as well as an increased risk of osteoporosis), the name Nebido suggests that its primary function will be to elevate the libido in men. I do believe that the phosphodiesterases (e.g. Viagra, Levitra and Cialis) will still maintain their market preeminence and support by physicians since they have specificity for the primary problem associated with erectile dysfunction (ED) without the potential of increasing the risk associated with androgens.

If the parent company continues on its track of developing innovative compounds, it is likely that a large pharma or biotech company will either partner with them or enter into some equity agreement.

Ciao,