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
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Portola Pharmaceuticals Receives Breakthrough Therapy Designation From FDA For Andexanet Alfa (PRT4445*), Investigational Factor Xa Inhibitor Antidote

Stocks in this article: PTLA

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2013 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced that it has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for andexanet alfa, its investigational Factor Xa inhibitor antidote. The FDA's breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. i Portola is pursuing an Accelerated Approval pathway for andexanet alfa, a first-in-class agent, and plans to initiate registration-enabling studies in 2014. By the year 2020, Portola estimates that the number of patients presenting to the hospital who could benefit from an antidote could approach 500,000 in the United States, Japan and the five largest European Union countries alone.

"The FDA's decision to designate andexanet alfa as a breakthrough therapy reaffirms the urgent need for an antidote to Factor Xa inhibitors, and we believe it demonstrates that andexanet alfa's properties and data distinguish it from currently used agents or others in development," said William Lis, Portola's chief executive officer. "Pro-coagulant agents being used in the absence of an antidote are unproven, have limited biological rationale for their effectiveness to reverse Factor Xa inhibitors, and have been shown to cause serious blood clots. Therefore, andexanet alfa marks an important advance in the field, and our goal is to bring it to market as quickly as possible."

The Company has previously reported data from its ongoing Phase 2 proof-of-concept studies  of andexanet alfa and the Factor Xa inhibitors Eliquis ® and XARELTO ®. Additional studies are ongoing with Lovenox ® (enoxaparin), Lixiana ® and Portola's investigational oral Factor Xa inhibitor, betrixaban, which is being studied in a Phase 3 clinical trial and has the potential to be the first oral Factor Xa inhibitor approved for venous thromboembolism (VTE) prevention in acute medically ill patients.

Phase 2 results to date have demonstrated andexanet alfa's ability to immediately reverse the anticoagulant activity of Factor Xa inhibitors by the administration of a short intravenous bolus. Additional data have shown that this reversal can be prolonged when necessary by the addition of an extended infusion of andexanet alfa. Unlike pro-coagulant agents or other compounds in development, once administration is stopped, andexanet alfa is rapidly cleared and anticoagulant therapy can be re-initiated, which is critical for patients who have pre-existing (underlying) prothrombotic conditions. Andexanet alfa's specific mechanism of action may also reduce the potential for serious adverse events and interactions with other commonly used drugs. No serious adverse events or antibodies to Factor Xa or Factor X have been observed in the ongoing Phase 2 studies.

1 of 3

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 17,814.94 -2.96 -0.02%
S&P 500 2,067.03 -2.38 -0.12%
NASDAQ 4,758.2520 +3.36 0.07%

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