MacroGenics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced that it has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States, if approved.

Margetuximab is an investigational, monoclonal antibody derived from MacroGenics’ proprietary Fc-Optimization technology platform. A Biologics License Application (BLA) for margetuximab for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020.

“We believe that margetuximab if approved, could become a valuable treatment option for patients living with this devastating disease,” said Scott Koenig, M.D., PhD, President and CEO 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.”

Jim Lang, CEO of EVERSANA, added, “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. We will work closely with MacroGenics on each stage of the product launch and roll-out.”

Under the terms of the agreement, MacroGenics maintains 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 receives a co-exclusive right to conduct approved commercialization activities.

EVERSANA 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. Upon the potential approval of margetuximab, EVERSANA and MacroGenics will equally share in funding EVERSANA’s commercialization expenses. In exchange for co-funding these expenses, EVERSANA will earn future revenue share payments which shall be capped at 125% of EVERSANA’s cumulative service fees. The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions.