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
TheStreet Open House

ThromboGenics Receives Positive CHMP Opinion For JETREA®

Stocks in this article: THR

LEUVEN, Belgium, January 18, 2013 /PRNewswire/ --

Positive opinion clears the way for the potential EMA approval of JETREA ®   as the first pharmacological option for the tr eatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400  microns

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for JETREA ® (ocriplasmin), recommending JETREA ® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

VMT, in the US referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition. [ 1 ]      

JETREA ®, a recombinant form of a human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pulling between vitreous and macula that causes VMT. By dissolving these proteins, JETREA ® releases the traction, and helps to complete the detachment of the vitreous from the macula.

Alcon, a division of Novartis, acquired the rights to commercialize JETREA ® outside the United States in March 2012. ThromboGenics retains the rights to commercialize the drug in the US. In the US, JETREA ® has received FDA approval for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Earlier this week, ThromboGenics introduced JETREA ® in the US. The first patients have already received this novel treatment in multiple locations across the country.

" We are very pleased that the CHMP has provided a positive recommendation for JETREA ® for the treatment of VMT, including when associated with macular holes, " says Dr Patrik De Haes, CEO of ThromboGenics.  " With our partner Alcon, ThromboGenics, as the marketing authorization holder, will continue to work with the European Medicines Agency and the European Commission as it finalizes the JETREA ® European Marketing Authorization Application. Today, more than ever, we are convinced that VMT is an area of unmet medical need. With today ' s positive CHMP opinion, we anticipate a final decision by the European Commission within the next  2 to 3  months.  The decision will be applicable to all 27 European Union Member states plus  Iceland   and  Norway . Upon the Commission ' s final approval and completion of pricing and reimbursement, we intend to support our partner Alcon in making this novel treatment option available to patients in the EU as soon as possible, " De Haes concludes.

JETREA ® is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

VMT is caused by traction resulting from a persistent attachment of the vitreous (jelly-like material in the center of the eye) to the macula at the back of the eye. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
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 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

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