Northwest Biotherapeutics, Inc. Responds to Media Reports
BOTHELL, Wash., July 16, 2007 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. Northwest Biotherapeutics (the "Company" or "NWBT"), following up on its press release of July 9, 2007, wishes to address certain media reports and provide further information on the absence of certain stock sales activity and on the regulatory status of DCVax(R)-Brain in Switzerland and the recent authorization obtained for the product from the Swiss authorities.
Certain media reports have erroneously stated that Company shareholders Toucan Capital and/or Toucan Partners have sold shares in the Company at the time of the PIPE financing in April 2006, at the time of the recent AIM financing, or at other times. Such reports are incorrect. Neither Toucan Capital nor Toucan Partners has sold shares in the Company, and, to the Company's knowledge, neither of them has such sales pending or planned. Moreover, as stated in the Company's Form 8-K filed on June 18, 2007, and the Company's AIM Admission Document dated June 18, 2007, each of Toucan Capital and Toucan Partners entered into a lock-up agreement with the respect to the shares of the Company's stock held by them, pursuant to which they agreed not to sell any shares held by them for twelve months following admission of the Company's shares to trading on AIM on June 22, 2007.
Certain reports have also erroneously indicated that the Company has received a Marketing Authorization from the Swiss authorities. Such reports are incorrect.
As previously announced, the Company applied to the Bundesamt fur Gesundheit ("BAG" or "Office Federal de la Sante Publique") for an Authorization for Use ("Autorisation d'exploitation"). NWBT has received such "Autorisation" from the BAG as an import/export authorization ("Autorisation pour activites transfrontalieres avec des transplants"). This authorization is conditional upon certain implementation commitments that NWBT will have to fulfill before the import/export activity can proceed (e.g., finalizing its pending arrangements for a clean-room suite for processing of patients' immune cells.) The process of this fulfillment is under way.
The Authorization will allow the Company to export patients' immune cells and tumor tissue for vaccine manufacturing in the USA, and import the patients' DCVax(R)-Brain finished vaccine into Switzerland.
In the BAG's processing and decision on the Company's "Autorisation" application and data, Swissmedic ("Institut Suisse des Agents Therapeutiques") only conducted the inspection and did not conduct any evaluation of the safety or efficacy of DCVax(R)-Brain. Such evaluation by Swissmedic will be done within the assessment of a Marketing Authorization Application. The Company plans to apply for Marketing Authorization by the end of this year. A Marketing Authorization is processed and decided by Swissmedic rather than the BAG, is not limited to selected centers, and allows full marketing and commercialization.
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. is a US-based biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis.
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects," "believes," "intends," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the company's ability to successfully commercialize DCVax(R)-Brain in Switzerland (including, without limitation, the regulatory, clinical and market aspects of such commercialization), the company's ability to enroll patients in its Phase II clinical trial of DCVax(R)-Brain and complete the trial on a timely basis, the uncertainty of the regulatory and clinical trials processes, the timely performance of third parties, and whether DCVax(R)-Brain will demonstrate safety and efficacy. Additional information on these and other factors, which could affect the company's results, is included in its Securities and Exchange Commission ("SEC") filings and/or its AIM Admission Document and filings. Finally, there may be other factors not mentioned above or included in the company's SEC filings and/or its AIM Admission Document and filings that may cause actual results to differ materially those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACT: Linda F. Powers, +1-240-497-9024, or +1-240-497-4060
Web site: http://www.nwbio.com//
Ticker Symbol: (:NWBT)
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Posted: July 2007