Merck 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 as a potential treatment for multiple tumor types to accelerate the two companies’ presence in immuno-oncology.
The asset will be developed as a single agent as well as in various combinations with Pfizer’s and Merck’s broad portfolio of approved and investigational pipeline candidates. The two companies also will combine resources to advance Pfizer’s anti-PD-1 antibody into phase I trials. Merck also will co-promote Pfizer’s XALKORI, a medicine to treat non-small cell lung cancer, in the U.S. and several other key markets.
Karl-Ludwig Kley, chairman of the executive board of Merck, said, “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 now have 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,” said Belén Garijo, president and CEO of the biopharmaceutical division of Merck and executive board member elect. “Up to 20 high priority immuno-oncology clinical development programs are expected to commence in 2015, including pivotal registration studies. On top of that, the global alliance will enable Merck to gain an early entry into the U.S. oncology market as well as to strengthen our existing oncology business in several other important global markets.”
Two clinical development programs currently are underway evaluating the anti-PD-L1 antibody of Merck. In a phase I trial, more than 550 patients have been treated with MSB0010718C across multiple types of cancers. Interim data from the ongoing phase I study demonstrated a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer. Additional data are expected to be presented in 2015. There also is an ongoing phase II trial evaluating this antibody in patients with m-Merkel cell carcinoma, a rare form of skin cancer.
Merck will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments up to $2 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.
“This global alliance enables Pfizer and Merck 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.”