This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Three Cheers for Alkermes Running a Depression Study in the U.S. of A.

Stocks in this article: ALKS TRGT

DUBLIN ( TheStreet) -- First thing I did after reading Alkermes' (ALKS) announcement about positive results from a mid-stage study of its depression drug ALKS 5461 was to make sure the company didn't enroll patients in India. Investors know from past, painful experience -- Targacept (TRGT) (ouch!) -- that depression drug studies run in India can't be trusted.

Whew... Alkermes conducted the study in the good ol' US of A. That's re-assuring.

Alkermes intends to move ALKS 5461, an once-daily pill that modulates opioid receptors in the brain, into pivotal phase III depression studies based on the results of the phase II study announced Wednesday.

Alkermes shares were up 9% to $27.80 in Wednesday trading.

The phase II study enrolled 142 patients diagnosed with major depression that was not well controlled with current medications. The patients were randomized to receive ALKS 5461 or a placebo as an add-on therapy to their existing anti-depression medication. After four weeks of treatment, ALKS 5461 significantly reduced depression symptoms compared to placebo using standard clinical measures, including the Hamilton Depression Rating Scale. The drug was well tolerated.

Detailed data from the study will be presented at a medical meeting in May, Alkermes said.

"The improvements in depressive symptoms observed in patients treated with ALKS 5461 in this study were clinically meaningful and among the most robust I have seen in a phase 2 study for depression in the past two decades," said Dr. Maurizio Fava, Director of the Depression Clinical and Research Program at Massachusetts General Hospital and an investigator in the study, in a statement.

Of course, investors have heard such exclamations about phase II depression drug studies before, only to be shattered when the benefits evaporated in larger, phase III studies. Still, expectations for ALKS 5461 were relatively low because there was so little prior clinical data on the drug to examine.

Unlike Targacept and its failed depression drug, Alkermes conducted its phase II study of ALKS 5461 at U.S. centers and with centralized raters to eliminate as much potential biased reporting of data as possible.

"Alkermes' pipeline is often overlooked by investors, and we've been saying that 2013 could begin to change this sentiment," said Cory Kasimov in a note to clients.

Alkermes is also conducting a phase III study of ALKS 9070, a once-monthly version of the blockbuster schizophrenia drug Abilify, with results expected in the second half of the year. ALKS 9070 trails a competing long-acting version of Abilify from Otsuka that was recently approved for use in the U.S.

Both ALKS 9070 and ALKS 5461 are essential elements in Alkermes' strategy to develop and market its own internally developed drugs and diversify revenue growth beyond royalties collected on its drug-delivery technology platform.

-- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,660.80 +303.93 1.75%
S&P 500 2,045.65 +32.76 1.63%
NASDAQ 4,722.1450 +77.8330 1.68%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs