MorphoSys AG announces that they have entered into a global agreement with GlaxoSmithKline to develop and commercialize MOR103. MOR103 is MorphoSys's proprietary HuCAL-derived antibody against GM-CSF, which has concluded Phase 1/2 development in mild to moderate rheumatoid arthritis.
Under the terms of the agreement, GSK will assume responsibility for all subsequent development and commercialization of MOR103. As part of the agreement, MorphoSys receives an immediate upfront payment of EUR 22.5 million. On achievement of certain developmental, regulatory, commercial and sales-based milestones, MorphoSys would be eligible to receive additional payments from GSK of up to EUR 423 million, in addition to tiered, double-digit royalties on net sales.
"This transaction is a major milestone for MorphoSys. Our goal was to secure an agreement with a company having the commitment and expertise to turn MOR103 into a successful drug, and in GSK we have clearly found such a partner. We hope this alliance will result in a significant return on investment for the MOR103 program and to become a major value driver for MorphoSys," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.
"Today's announcement clearly illustrates our ability to take proprietary programs from target to clinical proof of concept and an attractive partnership. The pre-clinical and clinical data we have generated show that MOR103 has the potential to offer new treatment options for rheumatoid arthritis. We also believe that this molecule has potential in other indications as well. I'm delighted that with this agreement, MOR103 will progress to the next stage in its development," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
MOR103 has concluded a Phase 1 study in healthy volunteers and a Phase 1/2 clinical trial in mild to moderate rheumatoid arthritis patients. Additionally, MOR103 is currently being evaluated in a Phase 1b dose-escalation safety study in multiple sclerosis. MOR103 is an investigational medicine that is not approved for use anywhere in the world.
As a result of the transaction, MorphoSys increased its financial guidance for 2013. MorphoSys expects revenues of approximately EUR 68 million to EUR 72 million (previously EUR 48 million to EUR 52 million) and an EBIT of EUR -2 million to EUR +2 million (previously EUR -18 million to EUR -22 million). The original guidance did not include a successful out-licensing of any of the Company's proprietary development programs. Around EUR 20 million of the upfront payment of EUR 22.5 million shall be booked with signature. The remaining amount shall be distributed over 2013 and 2014 according to the development plan for the ongoing phase 1b MS trial of MOR103.