MetPril™ product summary
About Hypertension and Diabetes Diseases
The prevalence of these two co-morbidities is substantial. According to the American Heart Association, 33% of U.S. adults have high blood pressure, known as hypertension, and about 8% of those also suffer from diabetes. Diabetes is defined as patients who do not produce enough insulin to convert sugars and starches into energy needed for daily life. The physical nexus for these two co-morbidities is obesity and a sedentary lifestyle which appear to play a role in both diseases.
While changes in lifestyle are often recommended before active therapeutic intervention, early diagnosis and broad medical understanding for these two conditions leads to early drug intervention. Over the last 20 years, clinical research has made significant progress in defining quantitative criteria when physicians should consider patients for active medication. About 60% of adults who suffer from hypertension and diabetes are actively treated with medication.
The Market
The market opportunity for hypertension and Type II diabetes treatments ranks among the largest opportunities in the pharmaceutical industry. The estimated global market for hypertension agents is about $23 billion whereas for Type II diabetes medication revenues amount to about $20 billion.
There are many subcategories of therapies within these markets. Within hypertension, angiotensin receptor blocker treatments rank among the largest categories, accounting for about 55% of hypertension revenues. For Type II Diabetes patients, “glitazone” therapy continues to be the preferred treatment modality. However; there appears to be recent safety and efficacy concerns which have affected the utility of glitazones. The market opportunity for the combination treatment of hypertension and diabetes is very large.
About MetPril™
MetPril™ is a therapy developed to treat both hypertension and Type II diabetes in one convenient “PolyCap” capsule. PolyCap™, a multi-chambered capsule designed by MicroDose for the co-administration of two oral therapies, is an ideal drug delivery technology to treat these co-morbidities. MetPril™ combines one of the most popular treatments for hypertension with an approved and safe treatment for Type II diabetes. Co-administration of these two therapies ensures patient compliance and reduces the “pill burden” which often afflicts the elderly population. Further, MetPril’s diabetic treatment component is an alternative to selected novel Type II diabetes treatments for which there have been growing safety and efficacy concerns.
Given the importance of third party payors in determining market potential, MicroDose sponsored a survey of selected managed care organizations to ascertain their views on MetPril’s pricing, promotional strategy and drug formulary acceptance. Survey responders indicated that MetPril™ could receive a quick formulary review, be treated and reimbursed as a branded product, and commented that our suggested product pricing would be attractive and thereby sufficient to support active product promotion.
Development Status
Preclinical work has been completed and the infrastructure for GMP manufacture of clinical and early stage commercial supplies has been put in place.
Because MetPril™ comprises two FDA approved active pharmaceutical ingredients which are already routinely co-prescribed (co-administered), MetPril’s FDA approval strategy is expected to be expeditious with minimal development cost or risk. This strategy has been confirmed at a pre-IND meeting with the FDA which provided guidance on the development and clinical requirements for product approval. Should the clinical trial meet the FDA’s bioequivalent end-points and be approved, MetPril ™ may be eligible for three years of exclusivity thereby delaying potential generic substitution.