On November 17, 2014 Merck KGaA reported that it has entered into a global agreement with Pfizer to co-develop and co-commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple tumor types to accelerate the two companies’ presence in immuno-oncology (Press release Merck KGaA, NOV 17, 2014, View Source [SID:1234500969]).

The asset will be developed as a single agent as well as in various combinations with Pfizer’s and Merck KGaA, Darmstadt, Germany,’s broad portfolio of approved and investigational pipeline candidates. The two companies will also combine resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1 trials. As part of the agreement, Merck KGaA, Darmstadt, Germany, will co-promote Pfizer’s XALKORI, a medicine to treat non-small cell lung cancer, in the United States and several other key markets.

Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, Darmstadt, Germany, stated: “We live up to our promise to strengthen all three pillars of our business: Healthcare, Performance Materials and Life Science. After this year’s acquisition of AZ Electronic Materials and the proposal to acquire Sigma-Aldrich, we have now turned the focus on healthcare. The agreement with Pfizer is a very important milestone in taking our pharma pipeline forward.”

“Collaborating globally with Pfizer will allow us to benefit from the strengths and capabilities of both companies in immuno-oncology, further accelerating this promising asset in the race to address the needs of cancer patients across multiple tumor types. Up to 20 high priority immuno-oncology clinical development programs are expected to commence in 2015, including pivotal registration studies,” continued Belén Garijo, President and Chief Executive Officer of the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, and Executive Board Member Elect. “On top of that, the global alliance will enable Merck to gain an early entry into the US oncology market as well as to strengthen our existing oncology business in several other important global markets.”

There are currently two clinical development programs underway evaluating the anti-PD-L1 antibody of Merck KGaA, Darmstadt, Germany. In a Phase 1 trial, more than 550 patients have been treated with MSB0010718C across multiple types of cancers. As part of the Analyst and Investor Day hosted by Merck KGaA, Darmstadt, Germany, on September 18, 2014, interim data were presented from the ongoing Phase 1 study demonstrating a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer. Additional data are expected to be presented at medical congresses in 2015. There is also an ongoing Phase 2 trial evaluating this antibody in patients with m-Merkel cell carcinoma, a rare form of skin cancer.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany, will receive an upfront payment of $ 850 million (around € 680 million) and is eligible to receive regulatory and commercial milestone payments up to $ 2.0 billion. Both companies will jointly fund all development and commercialization costs and all revenues obtained from selling any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be shared.

“Our strategic focus in the immuno-oncology space will be significantly enhanced through this global alliance, giving us the financial firepower to fully leverage the potential of our anti-PD-L1-compound” said Stefan Oschmann, Chief Executive Officer Pharma and Vice Chairman Elect of the Executive Board of Merck KGaA, Darmstadt, Germany. “The success of the anti-PD-L1 program and the value recognised by Pfizer is a clear reflection of the progress we have made on our R&D pipeline in recent years.”

“This global alliance enables Pfizer and Merck KGaA, Darmstadt, Germany, to join forces and combine complementary strengths with the goal of meeting the needs of patients with multiple types of cancer,” said Albert Bourla, Group President Vaccines, Oncology and Consumer Healthcare Businesses, Pfizer. “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. 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 regimens.”