3M Signs Development Agreement; Updates Phosphagenics Collaboration


3M Drug Delivery Systems and Radius Health, Inc. recently announced an agreement to collaborate on the development of a transdermal delivery option of BA058, Radius’ novel, proprietary PTHrP (parathyroid hormone-related protein) analog, for the treatment of osteoporosis.

The BA058 Microneedle Patch will use 3M’s patented Microstructured Transdermal System microneedle technology to administer BA058 through the skin, as an alternative to subcutaneous injection. The BA058 patch is expected to combine the ease, convenience, and self-administration attributes of a transdermal patch with the speed and efficiency of a traditional injection. Terms of the agreement were not disclosed.

“Poor adherence to prescribed osteoporosis therapy is a common and serious problem. Patients who drop their treatment unknowingly place themselves at high risk of fracture, which exacts an enormous toll in terms of human and economic cost,” said C. Richard Lyttle, PhD, President and Chief Executive Officer of Radius. “By providing a more convenient treatment alternative to injection that can promote improved compliance, the BA058 Microneedle Patch will be well-positioned to drive expansion of the osteoporosis market.”

Radius’ BA058 Microneedle Patch product is currently undergoing Phase I clinical studies. The company’s recently concluded Phase II human testing of an injectable form of BA058 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 6 months of therapy, with greater BMD gains relative to Forteo, the reference drug used in the study.

“We are pleased to partner with Radius, a company with deep domain expertise in osteoporosis,” said Jim Vaughan, Division Vice President and General Manager of 3M Drug Delivery Systems Division. “This collaboration continues the validation of 3M’s microneedle patch technology and provides an excellent example of how our technology adds value for promising new therapeutic agents. We look forward to merging 3M’s innovative microneedle technology with Radius’ promising bone-building agent to bring this important new therapy to market.”

3M also announced that Melbourne drug delivery technology company Phosphagenics Limited is a step closer to commercializing its first-in-class oxycodone pain patch following successful completion of their initial global formulation development collaboration. 3M has refined Phosphagenics’ original oxycodone transdermal patch prototype and will commence the development of an improved version that will be used for next stage clinical trials. These trials are scheduled to commence later this year.

The development of the new patch has commenced at 3M’s laboratory in Minnesota. The Melbourne-developed technology has the potential to revolutionize the delivery of the powerful painkiller oxycodone using Phosphagenics’ proprietary TPM transdermal delivery technology.

Phosphagenics’ CEO Dr. Esra Ogru said the original patch prototype was very effective in human trials. But the technology has been boosted by an astounding five-fold improvement in delivering the drug through human skin during in vitro studies, resulting from the collaboration with 3M. This should substantially improve the commercial prospects for the patch.

“Working with 3M with its expertise in patch technology and manufacturing has enabled us to refine and significantly improve the delivery of the oxycodone patch,” she said.

Phosphagenics’ successful completion of the stage one 3M collaboration follows its November 2010 3M announcement. 3M is a multi-billion dollar science-based company producing thousands of products in more than 65 countries. It has a focus on healthcare with products sold in nearly 200 countries.

Dr. Ogru indicated the oxycodone patch development program remains a primary focus. “The oxycodone patch development is the core company pharmaceutical product, and its commercialization is the company’s number one imperative. It offers the best medium-term value inflection potential for the company,” she said.