Margetuximab has a Biologics License Application (BLA) for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy. The BLA is under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act goal date of December 18, 2020.
Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. It was designed to provide HER2 blockade, and has similar HER2 binding and antiproliferative effects as trastuzumab. Margetuximab is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer, and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART molecule) in various HER2+ indications.
“We believe that margetuximab, if approved, could become a valuable treatment option for patients living with this devastating disease,” noted Scott Koenig, M.D., Ph.D., president and chief executive officer of MacroGenics. “We are excited to partner with EVERSANA and leverage their integrated commercial services to efficiently launch margetuximab. We have been working closely with EVERSANA to fully align our commercialization strategies to educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics’ cash runway to fund our broader portfolio.”
Under the terms of the agreement, MacroGenics will maintain ownership of margetuximab, including all manufacturing, regulatory and development responsibilities for the product. This includes MacroGenics’ continued development of margetuximab in combination with immune checkpoint inhibitors in gastroesophageal cancer in the Phase 2/3 MAHOGANY study, as well as other ongoing studies.
EVERSANA will receive a co-exclusive right to conduct approved commercialization activities, and will utilize its internal capabilities to support sales and marketing, market access, channel management services, data and analytics, medical affairs and other patient access-related services. MacroGenics will book sales for margetuximab.
“We’ve built a suite of comprehensive commercial services for biopharmaceutical innovators like MacroGenics and look forward to entering this risk-sharing arrangement with MacroGenics to support the commercialization of margetuximab, if approved. Our partnership with MacroGenics puts the patient first by supporting broad market access and comprehensive patient support services,” added Jim Lang, chief executive officer of EVERSANA. “We will work closely with MacroGenics on each stage of the product launch and roll-out.”
If margetuximab is approved, EVERSANA and MacroGenics plan to equally share in funding EVERSANA’s commercialization expenses. EVERSANA will earn future revenue share payments, capped at 125% of EVERSANA’s cumulative service fees. The agreement is set to last five years following the date of FDA approval, and is subject to predefined termination provisions.