Our MicroCor PTH(1-34) product candidate contains the active ingredient in Eli Lilly’s Forteo® (teriparatide [rDNA origin] injection), which is approved for the treatment of osteoporosis. Forteo requires a daily self-administered injection and sharps (needle) disposal, and is required to be kept refrigerated.
A Phase 2a study of MicroCor PTH(1-34), conducted in healthy women aged 50 – 85, showed MicroCor PTH(1-34) to be safe and well tolerated, achieving comparable exposure to Forteo subcutaneous injections. Moreover, MicroCor PTH(1-34) successfully demonstrated changes in bone biomarkers associated with increases in bone mineral density and reductions in bone fractures.
MicroCor PTH(1-34) provides many commercial advantages, including simple, one-step, pain-free self-administration, short wear time, no refrigeration requirement, enhanced safety due to elimination of sharps and a favorable pharmacokinetic profile. Taken together, these features provide an opportunity to improve anabolic therapy and increase patient compliance in the treatment of osteoporosis.
Based on our clinical results and consultation with the FDA, we are pursuing a 505(b)(2) regulatory pathway for this product candidate. MicroCor PTH(1-34) is Phase 2b ready and we are actively seeking development and commercialization partners.
Osteoporosis Market Opportunity
The global osteoporosis market represents a significant opportunity, with growing revenues that are estimated to reach greater than $5.2 billion in the seven major markets by 2021. This growth is driven by both general population aging and the anticipated launches of several premium priced market entrants in the coming years. Current treatment is focused on the use of bisphosphonates as the first-line approach; however, these agents provide only anti-resorptive activity and are associated with significant GI side effects and other adverse outcomes. Treatment with exogenous PTH is the only anabolic treatment modality currently available for the treatment of osteoporosis. In 2015, Forteo achieved annual worldwide sales of greater than $1.1 billion despite its significant patient compliance and convenience challenges (daily subcutaneous injection, refrigerated storage). We believe MicroCor PTH(1-34) is the only integrated, single-step application PTH transdermal product in clinical development, and is well-positioned for success in this growing market.