This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biotech Stock Mailbag: Vivus

Resubmitting Qnexa to the FDA in late October -- the new, new guidance -- really isn't that much of a change from the old guidance. And Vivus has always told investors to expect a second FDA advisory panel meeting.

Penile burning!

I knew that would get your attention. It certainly got mine. "Penile burning" is the most common side effect reported by men who used Apricus Biosciences' (APRI - Get Report) erectile dysfunction cream Vitaros in two phase III studies.

Apricus doesn't bring up "penile burning" much, if at all, when the company talks about the commercial prospects for Vitaros. No wonder. It's bad enough for a guy to have erectile dysfunction (ED) in the first place, but when the drug used to treat the embarrassing ailment also causes unwanted "heating" down there… well, let's just say Vitaros may not be the ED treatment option of choice.

Don G. comments, "Every article you write involving Apricus Biosciences gives off the impression that you think Apricus is destined for failure."

True, and now you know why.

Vitaros is a cream containing the blood vessel-dilating drug alprostadil. Health Canada, that country's equivalent of the FDA, approved Vitaros as a treatment for erectile dysfunction in November 2010. Apricus, however, says it won't start selling Vitaros until the end of the year in part because the company is hoping to sign on a marketing partner.

Apricus has been promising a Vitaros partner for months. The commercial viability of a premium-priced ED cream was always suspect because of easy-to-take and effective pills like Pfizer's (PFE) Viagra and Eli Lilly's (LLY) Cialis. The looming entry of a cheap, generic version of Viagra is also a problem.

But let's not also understate the penile burning issue as a commercial hurdle that Apricus may find insurmountable -- and which may be keeping potential partners on the sideline.

Vitaros caused mild to moderate and transient penile burning in 25% and 23% of men, depending on the dose used, in two phase III studies, according to data included in the Vitaros label approved by Health Canada.

Penile burning is the most commonly reported side effect associated with Vitaros, along with penile erythema (redness) and penile itching. Vitaros was also reported to cause vaginal burning by the sex partners of men who used the cream in the clinical trials. [The Vitaros label is not available on the Health Canada web site but regulators made it available to me after I requested a copy.]
2 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
AMAG $66.39 0.29%
AEZS $0.17 -5.80%
APRI $1.33 -3.60%
CLSN $2.21 -0.90%
KERX $7.52 0.27%

Markets

Chart of I:DJI
DOW 17,614.90 +16.70 0.09%
S&P 500 2,097.58 -0.46 -0.02%
NASDAQ 5,114.8610 -0.5210 -0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs