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Pharma & Bio Ingredients
With a focus on the company's near term product opportunities ViRexx will reduce internal research expenditures in excess of 65% as compared with the planned research expenditures for the 2007/08 time horizon. The company is now projected to operate with an average monthly expenditure rate of under $900,000. As part of this plan ViRexx will:
• Focus research expenditures on near term product opportunities,
• Control expenditures on longer term opportunities by partnering or licensing earlier stage programs to maintain clinical and commercial timelines,
• Reduce overall expenditures to minimize the level of additional capital required, and
• Maximize the allocation of existing capital prior to the data analysis of the two ongoing Phase III OvaRex MAb trials.
ViRexx will accelerate business development efforts by identifying a joint venture partner for its lead Chimigen(TM) vaccine, HepaVaxx B Vaccine. Partnering the HepaVaxx B Vaccine program prior to a Phase II trial will provide the benefit of a partner with late-stage clinical development expertise and commercial experience in regions, such as Asia, that have the highest incidence of hepatitis B. The Company will reduce its research activities outside of its near term product opportunities and accordingly will reduce its full time equivalents (FTE) in its research division by seven, resulting in an overall FTE count of 23 at ViRexx.
The plan calls for the Company to achieve a number of significant milestones with its existing capital resources. Over the next 12 months the Company expects to reach the following milestones:
• Completion of the data analysis of two pivotal Phase III trials of OvaRex MAb,
• Completion of GMP manufacturing of a clinical batch of Occlusin 500 Device,
• Completion of a Phase II study of immune response to OvaRex MAb,
• Initiate technology transfer, scale up, and preparation for the manufacture of OvaRex MAb with ViRexx's European supply partner, Tecnogen,
• Completion of the Phase I Occlusin 50 Injection trial,
• Submission of an Investigational Trial Application for a Phase I study of the Occlusin 500 Device study,
• Completion of the Phase I HepaVaxx B Vaccine trial,
• Submission of a regulatory filing for a HepaVaxx B Vaccine Phase II trial.
ViRexx continues to demonstrate progress on its clinical and business development objectives. The Company recently signed manufacturing, licensing and distribution agreements for OvaRex® MAb between the Company's wholly owned Irish subsidiary, ViRexx International Corp., with Defiante Farmaceutica, Lda. and Tecnogen S.C.p.A., both subsidiaries of Sigma-Tau Pharmaceuticals, Inc. of Rome, Italy, for the remaining unlicensed European territories.
