Dendreon Has Competition: Northwest BioTherapeutics Gains Cancer Vaccine Approval

While there has been tremendous hype and controversy surrounding companies developing cancer vaccines, including Dendreon (DNDN) and Cell Genesys (CEGE), a tiny Swiss biotech company took center stage on Monday. Northwest BioTherapeutics (NWBO.OB) announced that the Swiss Institute of Public Health had cleared its dendretic-cell vaccine, DCVax®-Brain, for commercial launch for treatment of brain cancer.

According to the company;

In clinical trials, both newly diagnosed and recurrent brain cancer patients treated with DCVax®-Brain had more than double the survival time of patients who did not receive DCVax®-Brain (to over 33 months and continuing -- median not yet reached -- for newly diagnosed patients). In addition, unlike chemotherapy, DCVax®-Brain does not cause any debilitating side effects.

The stock more than tripled on the news, gaining 250% to end trading at $7.33 a share. Volume surged more than 100 times the 3-month daily average! What's ironic however, is the fact that the company is cleared to manufacture the vaccine in the U.S. and commercialize it in Switzerland, which according to the company;

"...increasingly noted for medical tourism, and is easily accessible for many medical tourists."

So, it is possible that the company will produce the vaccine in the U.S., and end up selling it to Americans in Switzerland, at much higher prices! The company is currently conducting Phase II trials in both the U.S. and EU, but expects final results by end of 2008.

The company is also cleared to investigate its DCVax® Technology platform in various other cancers, including a phase III trial for prostate cancer. This should make Dendreon investors a little nervous. The company's DCVax® Technology has tremendous advantages over competing cancer vaccine platforms. According to the company;

DCVax® products are personalized treatments, made by combining a patient's own master immune cells (dendritic cells) with cancer biomarkers derived from or displayed by the patient's own tumor.

and;

DCVax® products will be cost-effective. The key to their cost-effectiveness is a proprietary batch manufacturing process pioneered by NWBT, through over 10 years of development, under which a single manufacturing run is used to produce at least 3 years of personalized treatments for a particular patient. The treatments are stored frozen in single-dose vials, ready for use on an off-the-shelf basis for that patient. Such storage is highly reliable and low cost. By doing only one manufacturing run, and thereafter having the product available off-the-shelf, NWBT is able to keep the costs of its personalized vaccines at a level that can enable product pricing in a range comparable to other cancer drugs.

So, not only is Northwest BioTherapeutics producing a personalized vaccine to the individual patient, but it's also storing a 3 year stock pile for that patient at low cost.

The next couple of years look to be very promising for Northwest BioTherapeutics, but investors must be wary. Even following Monday's jump in share price, the company still has a tiny market cap of only $32 million. If you thought Dendreon shares are wild, think again!

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