Exclusive-Germany OKs Northwest Bio Brain Cancer Drug, Shares Soar.
Germany has granted Northwest Biotherapeutics Inc special permission to sell its experimental brain cancer drug in the country, the company said, and its stock jumped as much as 36 percent.
The tiny U.S. biotech received a special "hospital exemption" in Germany, allowing Northwest to sell the injectable drug for five years even though it has not completed its late-stage trial of the immunotherapy, Chief Executive Officer Linda Powers said in an interview. She said the company, which would also have the right to seek renewal of the exemption after five years, has not yet requested or received formal marketing approval for its product. . .
The exemption in Germany allows Northwest to sell DCVax-L through hospitals and their outpatient clinics for patients with all severities of cancer that begin in the brain, even though it is only being tested in patients newly diagnosed with the most severe form of the disease, called Glioblastoma multiforme
(GBM).
It is the first hospital exemption in Germany for a product never previously on the market, Powers said. She hopes it will encourage other European nations to look favourably on DCVax-L.
The European Union has encouraged member countries to create the hospital exemptions as a way of fostering use of breakthrough biotechnology drugs that have not yet won formal marketing approval.
Patients taking DCVax-L in small informal trials, along with standard care, lived 2.5 times as long as typically seen with patients taking standard treatment alone.
http://www.nytimes.com/reuters/2014/03/10/business/10reuters-northwestbiotherapeutics-cancer.html?hp
