DosePro...The most differentiated subcutaneous delivery system available today...and ready to add sustainable competitive advantage to your drug products.
Interested in generating in vitro data on DosePro delivery and stability with your drug? We can quickly put in place a material transfer agreement and initiate a DosePro technical assessment. In a matter of just a few weeks you can review in vitro delivery results and implement a stability protocol.
Market Research and Business Case Support
We have designed and sponsored numerous market research projects examining injectable therapies and drug delivery with patients, physicians, and payers. We can support your team in designing and conducting the right market research projects to help select the right delivery system for your market. In addition, we can assist in model development and forecasting in order to support your evaluation to confirm that DosePro offers the right value proposition for your business situation.
Battelle, the world's largest independent research and development organization, has partnered with us in a co-marketing agreement to offer the DosePro technology to pharmaceutical partners for developing innovative injectable products. Battelle's integrated science and technology services include industry-leading formulation capabilities and leading-edge medical device development expertise which can apply DosePro to deliver viscous formulations and customize the user interface. To learn more, click here.
Once you’ve confirmed that DosePro is the right fit for your product opportunity, we will work with you to put in place a commercial license for the DosePro technology. The terms and conditions agreed in the license allow for the opportunity to exploit the product developed using DosePro in a field specifically defined in the commercial agreement. Under the terms of the commercial agreement, you own the product enabled by the license to DosePro, and subsequently receive the patent protection of the patent portfolio of DosePro. Commercial terms for the license are typical for drug delivery technologies, consisting of a license fee, milestone payments, and a royalty on sales. The value of the license payments will be consistent with the value added by the DosePro technology to the commercial product opportunity.
Product Development, Clinical and Regulatory Support
We have developed Sumavel DosePro based upon the DosePro technology, including all CMC, clinical development, and regulatory affairs. We can work with your team to establish the right product development approach, clinical program, and regulatory strategy for your DosePro-enabled product candidate. Our clinical team has designed and implemented studies ranging from pilot pharmacokinetic studies, usability trials, pivotal bioequivalence, and Phase IV with DosePro. A DMF for the DosePro technology platform is on file with the FDA, which can be referenced in the U.S. drug product filing by the sponsor.
Clinical and Commercial Manufacturing
Clinical supplies for most Phase 1 and 2 clinical trials can be supported by us and our existing manufacturing operation. Likewise, Phase 3 trials for most drugs can be supplied by our commercial supply chain, as well as commercial product supply within our capacity plans or with investment as supported by the partner. In the event that the partner aims to manufacture and release final product in-house or at another location, we and our supply chain will work together in the planning and implementation of a technology transfer program to the location of choice. This would include all documentation, processes, controls, and equipment necessary to perform the unit operations being transferred in, up to and including validation, with economic terms determined upon definition of the scope of the transfer.