Pfizer entered an agreement potentially worth more than $2.8 billion to jointly develop and market Merck KGaA's investigational anti-PD-L1 antibody MSB0010718C for multiple cancer types, the companies announced Monday. Under the deal, Pfizer will make an upfront payment of $850 million to Merck, with the latter eligible to receive regulatory and commercial milestone payments up to approximately $2 billion.
Albert Bourla, group president of Pfizer's vaccines, oncology and consumer healthcare businesses, remarked that "immuno-oncology is a top priority for Pfizer," adding "this alliance enables us to significantly accelerate the timeframe of our development programmes and move into the first wave of potential immuno-oncology based treatment regimens." Pfizer and Merck said they will investigate MSB0010718C as a single agent as well as in various combinations with the companies' portfolios of approved and investigational oncology therapies. The drugmakers will jointly fund all development and commercialisation costs, while all revenues from any anti-PD-L1 or anti-PD-1 products generated from the collaboration will be shared equally.
Merck, which indicated in September that it was seeking a partner for MSB0010718C, is currently conducting two clinical development programmes for the therapy. A Phase I study in more than 550 patients with multiple types of cancers is ongoing, with interim data demonstrating a complete response and partial responses in patients with non-small-cell lung cancer (NSCLC) and ovarian cancer. In addition, a Phase II trial is being conducted evaluating MSB0010718C in patients with metastatic Merkel cell carcinoma.
"Early results...are impressive and consistent with the results seen with the class of PD-1 and PD-L1 antibodies," commented Mikael Dolsten, president of Pfizer's global R&D. The companies said that they will collaborate on up to 20 immuno-oncology clinical development programmes for MSB0010718C, which are expected to commence in 2015, including up to six trials that could be pivotal for potential marketing applications. For related analysis, see ViewPoints: Indispensible nature of immuno-oncology showcased by Pfizer's mega-deal.
The drugmakers added that they will also combine resources and expertise to advance Pfizer's anti-PD-1 antibody into Phase I trials and will co-promote Xalkori (crizotinib) in the US and several other key markets. Pfizer's Xalkori has been approved by the FDA for the treatment of patients with metastatic NSCLC whose tumours are ALK-positive. Belén Garijo, chief executive of Merck's pharmaceutical division, noted that the transaction "is the largest deal in the pharmaceutical industry for a single asset in this stage of development," adding the agreement "enables Merck to accelerate its entry into the US oncology market."
Earlier this year, Pfizer cited experimental immuno-oncology drugs, including the anti-PD-L1 therapy MEDI4736, as part of its rationale for pursuing an acquisition of AstraZeneca, although its attempts were ended in May. For related analysis, see Spotlight On: The immuno-oncology licensing landscape.
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