Pharmaceutical development and validation

Between 2013 and 2020 we expect that Xemed’s predominant customer will be the pharmaceutical industry. “Global asthma/COPD sales should grow to over $30 billion by 2012 and remain flat thereafter, with inhaled corticosteroid/long-acting bronchodilator combinations set to remain the leading class by value throughout. Anticholinergics will experience the strongest growth, particularly in COPD, to become the second-best selling class.” [Piribo2006] Pharmaceutical companies, eager to more rapidly validate the efficacy of their pulmonary drugs and bring them to market at lower cost, will employ high-value proven diagnostic imaging protocols whose expense can be justified by the billion-dollar potential of these drugs. They constitute the most significant commercial market for MagniXene™ products and PulmiXene™ services.

Enhancing statistical precision in drug trials can have extremely high value to drug companies as well as vast potential benefit to patients. Drug company representatives are optimistic that hyperpolarized xenon MRI measurements of regional lung functional microstructure can provide improved biomarkers of COPD phenotype and severity. The most useful near-term application would be for screening trial participants, identifying subjects most likely to benefit from certain therapies. Using hyperpolarized xenon in subject selection, they could reduce the required cohort numbers, thereby improving the statistical significance of trials and reducing cost. Once MagniXene™ lung function diagnostic measurements become FDA approved, they could become a component of the data in the study itself. Parameters of lung function measured with MagniXene™ could potentially be added to the list of recognized clinical endpoints for pharmaceutical trials.

The savings to pharmaceutical companies in cost and time could be enormous. Presently only changes in the Forced Expiratory Volume in one second (FEV1) and death rate constitute FDA recognized trial efficacy endpoints. The clearest pathway for MagniXene™ to provide a benefit for the US population and return a profit for Xemed is for Xemed to provide MagniXene™ diagnostic services that meet the requirements of the commercial pharmaceutical private sector for playing a supportive role in drug trials.