Radius, 3M Drug Delivery Systems Announce Exclusive Agreement for Development, Commercialization of Transdermal Delivery of BA058 for Osteoporosis
<0> LaVoie GroupRadiusDavid Connolly, 617-374-8800or3M Drug Delivery SystemsArina A. Paoli, 651-733-5615 </0>
(“Radius”) and 3M Drug Delivery Systems are pleased to announce 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. “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. “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.
Radius is a biopharmaceutical company focused on developing and commercializing advanced therapeutics to support healthy aging. We aspire to improve the quality of life in older adults by treating age-related conditions.
Radius is committed to the development of advanced therapeutics for the large and underserved osteoporosis market. The Company’s lead product candidate, BA058-SC, is in development to reduce the risk of complications associated with osteoporosis, such as fracture. In Phase 2 trials, BA058-SC has demonstrated an effect on building bone. The Company also has a next-generation transdermal patch, BA058-TD, being developed as a short wear-time delivery vehicle intended to improve patient compliance with convenience and ease of use, as well as a product in development to treat symptoms associated with menopause.
3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop pharmaceuticals using 3M’s inhalation or transdermal drug delivery technology including microneedles. 3M offers a full range of feasibility, development and manufacturing capabilities combined with regulatory guidance to help bring products to market. In-house resources, including toxicology, regulatory expertise, quality assurance, operations, and marketed product support, are available for each step of the development and commercialization process. This depth of resources is one reason why more than 50 percent of all metered-dose inhalers worldwide and 60 percent of all transdermal systems in the United States utilize 3M drug delivery technology. For more information, please visit or call 1-800-643-8086.
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