Imprimis Pharmaceuticals, Inc, a specialty pharmaceutical company, has completed the acquisition of intellectual property (IP) rights related to certain proprietary innovations from the compounding pharmacy operations of Ohio-based Buderer Drug Company. The acquisition allows Imprimis to pursue the commercial development of these proprietary innovations and also provides Imprimis with a right of first refusal on additional Buderer Drug Company intellectual property and drug development opportunities.
Buderer Drug Company, which has served the needs of patients and physicians in Ohio is a compounding pharmacy member of PCCA. This IP acquisition is the first to emerge from the Imprimis-PCCA relationship.
"Buderer Drug Company is a leading compounding pharmacy organization in the United States, and we are extremely pleased to announce this asset purchase," said Mark L Baum, Imprimis CEO. "This new relationship, which could lead to up to three new development programmes, is a good example of our plan to begin to leverage our agreement with PCCA into proprietary IP that may ultimately lead to the FDA approval of new medicines to address unmet patient needs. We are in the process of preparing filings with the USPTO related to the acquired assets and intend to communicate with the marketplace with more specificity in the near-term. Ultimately, we intend to develop and commercialize any drug development assets we decide to pursue by utilizing the US Food and Drug Administration (FDA) 505(b)(2) regulatory pathway. The 505(b)(2) pathway has the ability to significantly reduce both cost and duration of the FDA approval process, bringing quality medications more quickly to patients who need them."
"We are excited at the potential development and commercialization prospects of our ideas. We believe that Imprimis understands and appreciates the important role of the compounding pharmacist in the healthcare system. Further, Imprimis understands that the ideas we generate come from a 'boots on the ground' approach – dealing directly with doctors and their patients to address specific and often unmet patient needs. We also appreciate that some drugs are demonstrably difficult for compounders to make and that often times additional research and development is required before a drug can be used in humans, including more formal pre-clinical and clinical research. We are looking forward to strengthening the bond between our companies and working toward bringing these medicines through the FDA approval process, and then to the marketplace, where they can help people with a myriad of different medical conditions," said Matt Buderer, R.Ph., vice president and chief compounding pharmacist with Buderer Drug Company.
Compounding pharmacies work with physicians to develop medications for individual patients. Examples are alternative dosage strengths, or unique dosage forms, such as topical creams or gels, suspensions or solutions with more tolerable drug delivery vehicles.
Access to these formulations may be limited if patients don't live near a compounding pharmacy or cannot cover the out-of-pocket costs or if their physician is simply unaware of compounding options available to them. Baum said, "Commercialization of formulations developed by Buderer Drug Company by taking them through a regulated FDA process would in the long run allow more patients to benefit from these medications. At the same time, Imprimis respects the rights of pharmacists and physicians to continue to serve their patients' needs. Imprimis believes having an FDA-approved derivative of compounding's innovations will enhance the overall acceptance of compounding and develop new opportunities for compounders to serve patients."
Gus Bassani, Pharm. D., vice president of Consulting, R&D and Formulations with PCCA, and also an Imprimis board member, said, "Buderer Drug Company and its novel drug technologies are just one example of the depth of creativity and innovation possessed by PCCA's members. We've desired to create a pathway for our members' innovations that have commercial potential to get FDA approval. Imprimis has developed this pathway for PCCA pharmacy members and we hope to see more in the future."
Baum added, "We will continue to be open to the ideas, innovation and unique 'proximity to the patient' of the more than 4,000 compounding pharmacy members that are a part of the proprietary PCCA network worldwide."
Imprimis Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the commercial development of compounded drug formulations.
Professional Compounding Centers of America, Inc. (PCCA) is the independent compounding pharmacist's complete resource for fine chemicals, equipment, devices, flavors, ACPE-accredited training and education, pharmacy software, marketing, business and pharmacy consulting assistance.