November 17, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Pfizer Inc. , and Merck KGaA, headquartered in Darmstadt, Germany, jointly announced today that the two companies had entered into a global development deal for an investigational anti-PD-L1 antibody. The compound is currently in development by Merck KGaA as a possible treatment for several different cancer types.
Under the terms of the deal, Pfizer will pay Merck KGaA an upfront payment of $850 million. They are also eligible for regulatory and commercial milestone payments that could hit $2 billion. The two companies will share in funding all development and commercializing costs and all revenues made from selling any anti-PD-L1 or anti-PD-1 products.
Currently Merck KGaA has two clinical development programs working on their anti-PD-L1 antibody. Approximately 550 patients are enrolled in a Phase 1 trial with MSB0010718C for various cancer types. Some of the data for non-small cell lung cancer and ovarian cancer was presented on Sept. 18, 2014 at the company’s Analyst and Investor Day.
A second, Phase 2 trial is being conducted to evaluate the antibody in patients diagnosed with metastatic Merkel cell carcinoma, a rare type of skin cancer.
“Early results for Merck KGaA’s PD-L1 in patient trials are impressive and consistent with the results seen with the class of PD-1 and PD-L1 antibodies,” said Mikael Dolsten, president of Pfizer Worldwide Research and Development and EVP of Pfizer in a statement. “This promising foundation of research will form the basis of multiple registration trials.”
As part of the agreement, the companies plan to collaborate on up to 20 immuno-oncology clinical development programs starting in 2015. Those will include up to six Phase 2 and Phase 3 trials.
“This global alliance enables Pfizer and Merck KGaA to join forces and combine complementary strengths with the goal of meeting the needs of patients with multiple types of cancer,” said Albert Bouria, group president Vaccines, Oncology and Consumer Healthcare Businesses of Pfizer in a statement.
“Immuno-oncology is a top priority for Pfizer. Combining this promising anti-PD-L1 antibody with Pfizer’s extensive portfolio of small molecules and antibodies, provides an opportunity to potentially broaden the use of immunotherapy for patients with cancer and rapidly expand our oncology business,” he said. “In addition, this alliance enables us to significantly accelerate the timeframe of our development programs and move into the first wave of potential immuno-oncology based treatment regimes.”
In addition, Pfizer and Merck KGaA will work together to push Pfizer’s anti-PD-1 antibody into Phase trials. They will also co-promote Pfizer’s XALKORI in the U.S. and other markets. XALKORI (crizotinib) is used to treat anaplastic lymphoma kinase-positive non-small cell lung cancer that has metastasized.
