Taxus Cardium Pharm Group Inc (fka CRXM)

[docj]

Business Strategy: Gene Bio is a small biotechnology research and development boutique, located in San
Diego, that operates with a near-virtual, cost-conserved operating structure. We have a small, highly
experienced team that is currently singularity focused on the successful clinical development and strategic sale
of Generx. This team has worked together on the scientific, medical and clinical development of Generx over the
past 15 years. Set forth below are the key contractors that will be utilized to complete the FDA-cleared Phase 3
Generx study:
(1) FujiFilm Diosynth Biotechnologies: FujiFilm Bio is a world scale operation located in College Park,
Texas. They have expertise in process development and cGMP manufacture of cell and gene therapy
products oncolytic viruses and virial vaccines. We have entered into a manufacturing agreement with
FujiFilm Bio to manufacture Generx supplies for the planned Phase 3 clinical study, and they also have
the current capability to commercially manufacture final Generx product following FDA approval. We
expect that it will take approximately one year to manufacture Generx supplies for the clinical study at an
estimated cost of $5.0 million. In addition, once the final Generx study product is manufactured, Gene
Bio will be required to conduct a preclinical biodistribution study in preparation for the submission of the
Generx Biologics License Application (BLA) with the FDA.
(2) Comac Medical: We are planning to enter into an agreement with Comac Medical, which is located
in eastern Europe, to conduct our final FDA-cleared, Phase 3 clinical study. Comac Medical will be
conducting the study at up to 35 clinical sites, that will include approximately 30 sites in eastern Europe
and Turkey and approximately five sites in the U. S. Based on a recently completed geographic survey,
Comac believes that it is feasible enroll up to all 225 patients during a 12-month recruiting period following
the availability of Generx from FujiFilm Bio. Based on this current plan, we estimate that this clinical
study will cost up to $10.0 million. A copy of this plan, as prepared by Comac Medical, is included in this offering document.