This Day On The Street
Continue to site
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: Zalicus, Amarin

Correction: The first version of this column stated incorrectly that Amarin has no composition of matter patents filed for AMR101. The company has both composition of matter and method of use patents. The column has been update to reflect the correct information.

BOSTON ( TheStreet) --I have a lot more to say about Amarin (AMRN) in this week's Biotech Stock Mailbag. The Hostile React-o-Meter spun outta control (!!!) in response to my column Wednesday discussing the high-level meeting that took place in June between FDA and Amarin executives.

Before I dive back into Amarin, however, let's discuss Zalicus (ZLCS) and the announcement that's expected soon of results from a mid-stage study of its rheumatoid arthritis drug Synavive.

@delta4_98 tweets, "Adam, I am curious to hear your opinion on ZLCS Synavive AR."

Zalicus was formerly known as CombinatoRx, and as the old name implies, the company believed combining old, generic and seemingly disparate drugs into a single pill could yield new treatments for a variety of diseases.

Synavive, also known as CRX-102, combines a low dose of prednisone, a commonly used and cheap steroid, with dipyridamole, a drug first approved in 1961 that is usually prescribed along with other drugs to prevent blood clots after heart surgery.

Prednisone is a standard therapy for rheumatoid arthritis patients along with other medications to reduce the painful swelling of joints. The idea behind Synavive is that dipyridamole and prednisone act synergistically, allowing a lower dose of prednisone in the combo pill to be just as effective and better tolerated compared to the higher dose of the steroid prescribed today.

Zalicus will be announcing top-line results from a phase IIb study of Synavive in the third quarter, most likely in August. The study enrolled 250 patients with moderate to severe rheumatoid arthritis and randomizes them to one of five treatments: Synavive (2.7 mg prednisone/360 mg dipyridamole), dipyridamole alone, prednisone (2.7 mg) alone, prednisone (5 mg) alone or a placebo.

The study lasts for 12 weeks, after which patients will be assessed for response using the Disease Activity Score in 28 Joints (DAS28), a common efficacy measure used in rheumatoid arthritis clinical trials.

Obviously, Synavive shouldn't have a tough time beating placebo so the more important comparison will be Synavive's activity compared against the drug's individual components and the 5 mg dose of prednisone. The latter is probably the most important hurdle in this phase II trial. Prednisone literally costs pennies per pill, so if Synavive can't demonstrate better efficacy with fewer side effects, its commercial potential dwindles to nothing.
1 of 7

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ZLCS $5.39 0.00%
AMRN $1.65 0.00%
GSK $42.42 0.00%
AAPL $93.24 0.00%
FB $117.81 0.00%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs