From the Editor... When is a product approval not a product approval?
It would appear that when a company issues a press release entitled: “World's first therapeutic vaccine for brain cancer commercially available to patients in Switzerland,” it does not actually mean that the vaccine has been launched, or even approved, in Switzerland. This is the case with Northwest Biotherapeutics, which issued a press release under the above title on 9th July concerning its cancer vaccine, DCVax-Brain, which is being developed for the treatment of brain cancer. Following the press release, the company’s shares jumped by 34 per cent. The news followed reports in April that NWBio had filed for authorisation to commercialise, market and import/export DCVax-Brain at selected centres in Switzerland to treat patients with malignant brain cancers.
The 9th July release stated that NWBio had received “Authorization for Use” from the Swiss Institute of Public Health (Bundesamt für Gesundheit [BAG]) to make DCVax-Brain commercially available for the treatment of brain cancer patients in Switzerland. The company went on to proclaim that, as such, DCVax-Brain was the first commercially-available therapeutic vaccine for such cancers and that it intended to begin making the product available to patients in the third quarter of 2007. Indeed, the President and CEO of NWBio, Dr Alton Boynton, commented at the time: “We are delighted to be the first company to reach the market with a personalised therapeutic vaccine for brain cancers.”
One week after the first press release, on 16th July, the company issued a second release to, as NWBio stated, “address certain media reports… on the regulatory status of DCVax-Brain in Switzerland and the recent authorisation obtained for the product from the Swiss authorities.” The company claimed that certain media reports had erroneously indicated that NWBio had received marketing authorisation from the Swiss authorities. The company went on to clarify that it had in fact only received authorisation from the BAG on an import/export basis, which is conditional upon certain implementation commitments that the company will have to fulfil before the import/export activity can proceed. The process of this fulfilment is under way.
So, to clear things up, the authorisation that NWBio has received is to export patients’ immune cells and tumour tissue for vaccine manufacturing in the US, and import the patients’ DCVax-Brain finished vaccine into Switzerland. However, the words “import/export authorisation” were not included in the original press release. In addition, the original release had stated that the authorisation was granted in response to the company’s application in mid-February 2007 and was based upon clinical data, to date, and upon an extensive inspection by Swissmedic on behalf of the BAG. Swissmedic, however, only conducted an inspection and did not conduct any evaluation of the safety or efficacy of DCVax-Brain; such an evaluation by Swissmedic will be done within the assessment of an MAA. At this point, it is worth mentioning that the company has not even submitted an application for the official approval of DCVax-Brain in Switzerland, or anywhere else. One could suggest that the obvious conclusion to draw from this is that NWBio tried to overhype the authorisation it had received in Switzerland, by not clearly defining what it actually was, and then tried to blame the confusion on media reports. Any fair assessment surely has to lay fault with the misleading 9th July press release?
Matthew Dennis - Editor, Cancer Drug News
In this issue....
espicom.com
keyword:
CRACKER |
