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

German Institute For Quality And Efficiency In Health Care (IQWiG) Publishes Dossier Evaluation Within Early Benefit Assessment Process Of PIXUVRI® (pixantrone)

SEATTLE, March 1, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the private German Institute for Quality and Efficiency in Health Care (IQWiG) has published its report on the preliminary benefit assessment of PIXUVRI ® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI in the European Union (E.U.) for this indication based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. In its evaluation of the manufacturer submission, IQWiG concluded that no additional benefit could be determined for PIXUVRI because there is no standard of care with limited comparator data within the guidelines IQWiG follows. The Federal Joint Committee (G-BA) is the ultimate authority in determining reimbursement for drugs in Germany. Public comment on IQWiG's assessment report can be submitted to the G-BA until March 22, 2013. The G-BA is scheduled to hold a public hearing on April 8 or 9, 2013 and then decide on the innovation score and the additional benefit vs. the self-assigned comparator therapies in the second quarter of 2013. IQWiG's current assessment has no immediate impact on the reimbursement of PIXUVRI or physician's ability to prescribe this new treatment in Germany.

"PIXUVRI is the first medicinal product approved in the E.U. for treatment of patients with multiply relapsed or refractory aggressive NHL that addresses an unmet medical need," said James A. Bianco, M.D., President and CEO of CTI. "Importantly, the IQWiG assessment has no current impact on a physician's ability to prescribe PIXUVRI for patients in Germany. The reimbursement process in Germany is designed to allow companies and external experts in treatment of the disease to have an opportunity to provide clarification on the benefits of the drug to G-BA during the hearing process. The G-BA will then make a final independent decision as to whether or not there is an additional benefit. We believe PIXUVRI offers patients suffering from aggressive NHL a safe and effective therapy, where there currently is no standard of care."

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

1 of 4

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 $93.64 -0.11%
FB $118.57 0.84%
GOOG $698.21 0.75%
TSLA $241.80 0.43%
YHOO $36.53 -0.19%


Chart of I:DJI
DOW 17,891.16 +117.52 0.66%
S&P 500 2,081.43 +16.13 0.78%
NASDAQ 4,817.5940 +42.2360 0.88%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs