BETHESDA, Md., March 12, 2013 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax ® personalized immune therapies for solid tumor cancers, announced today that the Company has taken a key step in building Europe-wide arrangements for manufacturing and distribution of DCVax. This represents a major area of competitive differentiation and strength for NW Bio.
The Company and its partners have completed a 7-month process of obtaining the necessary regulatory and institutional approvals in both Germany and the U.K. to expand the scope of the manufacturing in Germany of the Company's DCVax-L product for brain cancer. The scope is being expanded in two major ways: in its geographical reach, and in the product categories covered.
Geographically, these approvals for expanded scope of German manufacturing will enable DCVax-L to be produced in Germany and supplied across borders to the U.K. for the clinical trials. Getting this important cross-border arrangement in place is a key step towards building a Europe-wide distribution network for DCVax products. Although Europe has a common market, the manufacturing and supply of medical products (and especially products composed of living cells such as immune cells) across borders must meet detailed regulatory and institutional requirements in all countries involved.This approval for cross-border supply of DCVax-L is in addition to the manufacturing capacity in the U.K. already developed by the Company with its partner, Kings College London. Such cross-border supply and distribution will provide valuable flexibility to draw upon manufacturing capacity in either the U.K. or Germany as needed. It will also enable economies of scale for serving all of Europe. In regard to the product categories, these approvals will enable DCVax-L to be produced in Germany not only for the Phase III clinical trial, but also for Hospital Exemption cases under Section 4b of the German Drug law (similar to compassionate use in the U.S.) Separate regulatory applications and authorizations are required, at both the Federal and local levels, for the manufacture of products for Hospital Exemption (Section 4b) versus for clinical trials. The Company and its partner, Fraunhofer IZI, already received the manufacturing authorization for the Phase III clinical trial last summer, as the culmination of a 1-1/2 year process of technology transfer, regulatory applications, regulatory review and inspections.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV