This is an update to my story: “German Merck, flying under Street’s radar, gets no respect; but not for long”
Germany’s Merck KGaA and partner Pfizer Inc. came away with their first FDA approval of the checkpoint inhibitor avelumab, making it the fourth drug in this category to make it to the market. They beat out AstraZeneca PLC, which will now angle for its first approval of durvalumab as the 5th checkpoint.
The FDA gave out its approval for Merkel cell carcinoma under an accelerated approval process. The therapy, the first for a rare form of skin cancer, has also been given breakthrough drug status. The drug is currently in 30 clinical programs as the two players look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.
The approval marks another big advance for Pfizer, which paid $850 million upfront to partner with Germany’s Merck–a record sum. The approval of this anti-PD-L1 IgG1 monoclonal antibody also marks a major win for Merck KGaA, which has suffered through more than a decade without a blockbuster. Merck KGaA also came away with a package of regulatory and commercial milestones on avelumab worth up to $2 billion when it tied up with Pfizer in 2014.