Northwest Biotherapeutics says it's cracked the door open to a market in Germany for its controversial--and unproven--dendritic vaccine for brain cancer. The Bethesda, MD-based company announced that German health regulators have OK'd a special hospital exemption that allows the sale of the drug for all glioma brain cancers. And while no reimbursement price has been negotiated yet, the biotech says it plans to reap a premium on a drug that patients can purchase out of their own pocket.
The exemption, which the biotech is hoping will lead to more such advances in other European countries, comes ahead of even interim data from a closely watched study of the therapy. The biotech has been touting the individual success stories of patients in a Phase I/II study of DC-Vax, noting the cases where people lived well beyond the usual 14.6-month median survival time. But skeptics note that there are no clinically decisive study results (while cancer studies often produce anecdotal signs of efficacy, regardless of the ultimate outcome), and Reuters reports that the data from its initial tiny study couldn't be considered statistically significant because of the trial's small size and "informal nature."
DCVax-L has attracted warring bands of admirers and critics. The company's stock ($NWBO) has surged more than 80% in the past 6 months as investors both panned and praised the cancer vaccine. Northwest BIO CEO Linda Powers has fed the speculation with claims that the drug is a blockbuster in the making. And she tells Reuters' Ransdell Pierson in an interview that the drug is worth more than the $65,000 to $70,000 a year that Merck gets for Temodar, based on the "informal" data.
Those kinds of unsubstantiated claims, though, are exactly why the company often finds itself in the cross hairs of critics like Adam Feuerstein at The Street. Dendritic cancer vaccines, which promise to marshal an immune system attack on cancer, have a poor record in the clinic. In addition, the biotech had been expected to release interim data from an ongoing study last month. But that has yet to materialize, sparking another dustup between the company's backers and attackers.
The sale of an unproven cancer vaccine directly to desperate and dying patients, meanwhile, isn't likely to win the company many new friends.
By the time the market closed on Monday, shares were up almost 30% on the news, which can only add more fuel to the flames.
- here's the release
- here's the Reuters story