BETHESDA, Md., Jan. 27, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has entered into a set of agreements for large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax-L and DCVax-Direct products, development of infrastructure and key systems, and execution of product validation work required for any eventual regulatory approvals, with the Company's long-time contract manufacturer, Cognate Bioservices, Inc. ("Cognate").
The agreements include a DCVax-L Manufacturing and Services Agreement (the "DCVax-L Agreement"), a DCVax-Direct Manufacturing And Services Agreement (the "DCVax-Direct Agreement"), an Ancillary Services Agreement and a Manufacturing Expansion Services Agreement, as well as a Lock-Up Agreement (collectively, the "Cognate Agreements"). The Company previously announced plans for these agreements, and the program and capacity expansions that they will provide, in July, 2013, and during the remainder of 2013. The agreements were entered into on January 17, 2014.
In aggregate, these agreements provide for a comprehensive scale-up program for expansion of the Company's clinical programs in both the US and Europe, and for any compassionate use programs or other early access or expanded access programs which the Company might undertake. These agreements also provide for an extensive development program to carry out long-term preparations for eventual potential commercialization (including building the infrastructure, systems and logistics that will be needed), and to undertake the extensive product validations that will be required for a product to be considered for regulatory approval.Cell therapy products, such as personalized immune cell therapies for cancer, are especially challenging and complex. The regulatory requirements for such products are far more rigorous for Phase III clinical trials than for Phase II trials, and many companies trying to develop cell therapy products have great difficulty moving from Phase II to Phase III. Similarly, the regulatory requirements for cell therapy products are even more rigorous for commercialization than for Phase III trials. For example, even for products that have met the rigor required to proceed in Phase III trials, the further product validation work required for such products to be considered for commercial approval at the end of such Phase III trials requires well over a year of extensive and intensive work. Similarly, the infrastructure and systems for managing such cell therapy products for thousands or tens of thousands of patients (or more) are extremely demanding. To date, other companies have not successfully scaled up to such levels on a practical basis. By entering into this major development program now, the Company is getting an important head start.