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The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.
Grünenthal, an Aachen, Germany-based privately owned pharmaceutical company, and Mesoblast, a Melbourne, Australia-based company specializing in allogeneic cellular medicines for inflammatory diseases, announced on Sept. 10. 2019 that they have entered into a strategic partnership to develop and commercialize MPC-06-ID, a Phase III allogeneic cell therapy candidate. The deal is potentially worth more than $1 billion.
The companies will develop the Phase III cell therapy for treating chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options. Under the partnership, Grünenthal will have exclusive commercialization rights to MPC-06-ID for Europe and Latin America.
Mesoblast will receive up to $150 million in upfront and milestone payments prior to product launch, as well as further commercialization milestone payments, which include commitments up to $45 million within the first year comprising $15 million on signing, $20 million on receiving regulatory approval to begin a confirmatory Phase III trial in Europe, and $10 million on certain clinical and manufacturing outcomes. Cumulative milestone payments could exceed $1 billion depending on the final outcome of Phase III studies and patient adoption. Also under the agreement, Mesoblast will receive tiered double-digit royalties on product sales.
Mesoblast is completing a Phase III trial for MPC-06-ID in the United States, which will read out in 2020. In a previous US Phase II trial, the company demonstrated that a single intra-discal injection of MPC-06-ID using a unit dose of 6 million allogeneic mesenchymal precursor cells (MPCs) resulted in meaningful and durable improvements for patients in pain intensity and functionality for at least three years.â¯
Grünenthal and Mesoblast have agreed on an overall development plan for MPC-06-ID to meet European regulatory requirements. As part of their plan, the companies will collaborate on the study design for a confirmatory Phase III trial in Europe. Meanwhile, the results of the two Phase III trials are expected to support both FDA and European Medicines Agency regulatory approvals for the cell therapy candidate in chronic low back pain due to degenerative disc disease.
“This is an exciting day for Grünenthal. Cell-based therapies offer a novel approach in pain management. They can potentially deliver meaningful lasting improvements to patients beyond symptomatic treatment by maintaining or even restoring physiological function. By teaming up with Mesoblast for the next generation of pain therapies for chronic low back pain due to degenerative disc disease, we are diligently executing our strategy: leveraging promising new therapeutic modalities and addressing patients with high unmet medical needs. This is an important next step in working towards our vision of a world free of pain,” said Grünenthal’s CEO, Gabriel Baertschi, in a company press release.
“We are very pleased to enter into this strategic partnership with Grünenthal, a world leader in innovative approaches to pain management. Together with Grünenthal we plan to bring an important new class of therapy for pain management to the many patients suffering with degenerative disc disease. This partnership is in line with our corporate strategy to team up with best in category commercial leaders to maximize market access for our innovative cellular medicines for the treatment of patients suffering from debilitating or life-threatening inflammatory conditions,” added Mesoblast chief executive Dr. Silviu Itescu in the press release
MPCs have generated great interest in clinical science and medicine due to their immunomodulatory effects and their role in tissue repair and regeneration, according to the companies. These cells have been shown to be effective in reducing inflammation and promoting the regeneration of host tissues through cell-to-cell interactions and secretion of a wide range of endogenous analgesic and anti-inflammatory molecules. In degenerative disc disease, these cells could contribute to regenerating physiological disc tissue by promoting the proliferation of host chondrocytes and their secretion of tissue matrix components. Among key characteristics of MPCs are their capacity for significant expansion in culture and their relative lack of immunogenicity. These properties facilitate their use as allogeneic, or “off-the-shelf”, therapeutics with well-defined release criteria and batch-to-batch reproducibility that meet stringent regulatory requirements. â¯