Radius Health, Inc. and 3M Drug Delivery Systems have announced an exclusive partnership agreement for development and commercialization of BA058-transdermal (TD).
BA058 is a novel, synthetic proprietary peptide analog of human parathyroid hormone related protein or “hPTHrP,” a bone building anabolic compound with the potential to treat patients with osteoporosis at high risk of fracture.
This agreement updates the general development agreement announced in May 2011 by the two companies for BA058-TD.
BA058-transdermal (TD) is being studied in a Phase 2 clinical trial in healthy postmenopausal women with osteoporosis at 10 clinical centers.
BA058-TD is a short-wear time patch based on 3M's patented Microstructured Transdermal System technology.
The transdermal patch is expected to combine ease of use, convenience and self-administration attributes of a patch with the bone building efficacy of the BA058 compound.
“We are excited that 3M Drug Delivery Systems, which has long demonstrated a commitment to quality, safety and innovation, is partnering with us to bring a novel approach of drug delivery to the underserved osteoporosis patient population,” said Michael Wyzga, Radius president and chief executive officer.
Wyzga continued, “Our study data for BA058-TD showed that a five-minute wear time of the patch delivers peak drug levels consistent with subcutaneous injection and we hope to see increased patient compliance with 3M’s innovative technology.”
3M Drug Delivery Systems has partnered with pharmaceutical companies worldwide for more than 50 years, providing customized solutions to drug delivery.
“We are pleased to be part of Radius’ mission of advancing therapeutics for healthy aging with its deep expertise in osteoporosis,” said Ingrid Blair, MTS/TDD business vice president of 3M Drug Delivery Systems.
Blair continued, “With this exclusive agreement, 3M and Radius demonstrate our commitment to this innovative therapeutic treatment and this unique drug delivery mechanism. We believe this new drug potentially will improve the health of patients with severe osteoporosis and that 3M’s microneedle patch technology may improve medication compliance among patients.”
BA058 is also being studied as a daily subcutaneous injection (BA058-SC) in a Phase 3 study with 2,400 patients for fracture prevention in women with postmenopausal osteoporosis at high risk of fracture.
Phase 2 human testing of the injectable BA058-SC showed that BA058 significantly increased bone mineral density (BMD) at the lumbar spine and femoral neck (a common osteoporotic fracture site located in the hip joint) after six months of therapy.