Potential Market

Target Market:  MV is routinely used in hospitals for both simple and highly complex surgeries (over 20M cases in US/year, 0.01-6% mortality) and in the ICU (1.1 M cases in US/year, 10-60% mortality).  VXB is an innovative treatment that will create a new market and overtake existing, ineffective symptom-oriented therapies for treating VILI.

Sales/Marketing Strategy:  In 2015, biologics were 7 of the top 8 selling medications in the US, with therapeutic mAbs achieving total sales of $>60B (over 50% of the global pharmaceutical drug market) which outpace the growth rate of small molecule drugs.  With non-existent therapies to treat VILI and subsequent high ICU mortality rates, we expect VXB to have an initial high market penetration of 25%.  Prophylactic administered therapy upon placement on MV will not only improve outcome, it will also improve market penetration as VXB is established as the standard of care.  Cost savings to hospitals will also encourage reimbursement to hospitals/physicians to drive additional market penetration.

Competitors: Several research grade anti-NAMPT monoclonal antibodies are available from biotechnology companies or antibody manufacturers, but their antibodies are not human or humanized for clinical therapy, nor have they been designed or demonstrated to be neutralizing mAbs. Despite their benefit in rheumatoid disease, TNF-a antibody therapies (i.e. Afelimomab) failed to improve outcome in early sepsis trials in the 1990’s. Based on the continued interest in such therapies and advances in genetics (polymorphisms), additional sepsis trials to test these agents are now being considered.

Competitive Advantage:  Unlike many failed drugs that target one downstream cytokine (i.e. TNF-a, IL-1b, IL-6), we are targeting a novel upstream target that reduces the multiple-cytokine “storm” which mediates the inflammatory response.  Furthermore, biologics have outpaced small molecule drugs in the therapeutics market due to their improved target specificity and safety for a more predictable likelihood of clinical trial success.  We have a license on an issued utility patent (US 12/842,773) and have several jointly-owned antibody composition patents pending with Gennova Biopharmaceuticals.