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

European Medicines Agency Approves Positive Opinion On Omeros' Pediatric Investigation Plan For OMS302

SEATTLE, July 2, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Medicines Agency (EMA) approved a positive opinion issued by the European Pediatrics Committee (PDCO) agreeing to the Company's Pediatric Investigation Plan (PIP) for OMS302. EMA's approval of PDCO's positive opinion is a prerequisite for submission of the OMS302 Marketing Authorization Application (MAA) and, on completion of the post-marketing pediatric study, leads to an additional six months of patent exclusivity for OMS302 in Europe. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery. 

Omeros' PIP provides a study plan to evaluate the drug's safety and efficacy in patients 13-17 years old. Omeros received a waiver for studying the use of OMS302 in patients younger than 13 years and a deferral to complete the clinical study following EMA approval. With completion of the study as specified under the PIP, Omeros will be eligible to receive an additional six months of marketing exclusivity for OMS302 in the European Union (E.U.). This six-month period would extend beyond the expiration of Omeros' patents directed to OMS302, which will expire in the E.U. in 2023 for issued patents and 2033 for patents expected to issue from currently pending patent applications. This six-month extension is in addition to a supplementary protection certificate, which together could provide up to another five and one half years of market exclusivity for OMS302. Omeros is pursuing a similar but separate process in the U.S. for studying the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in the U.S. Submission of the New Drug Application (NDA) for OMS302 in the U.S. will precede the MAA submission, and both applications will include additional stability data to extend expiry dating at the time of expected commercial launch.

1 of 2

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
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs