Pfizer has signed a multi-billion dollar deal to develop one of Merck KGaA’s investigational drugs, MSB0010718C, an anti-PD-L1 antibody.
This agreement with Merck could be worth nearly $3 billion, with Pfizer paying £850 million up front and potential regulatory and commercial targets being set to pay out nother $2 billion on completion.
Pfizer want this deal to a catalyst for its rapidly expanding oncology business, while Merck will now gain access to the US market.
The general consensus between the two companies is that the product will be a treatment for multiple types of cancer and will jointly fund all the development and commercial costs as well as sharing all revenues equally.
Anti-PD-1 antibodies are a new type of cancer treatment on which many researchers are pinning their hopes – with Roche, AstraZeneca and Bristol-Myers Squibb all developing candidates for a market potentially worth up to $35 billion per year.
The world’s first licence was issued earlier in the year, being given to Ono Pharmaceutical’s product Opdivo (nivolumab) which is used to treat adults with unresectable melanoma.
There had been questions over Merck’s product, with EP Vantage suggesting that MSB0010718C “was seen as a serious laggard in the immuno-oncology race, but with today’s $850m endorsement from none other than Pfizer the doubts have been swept away”.
EP Vantage goes on: “Still, Pfizer itself risked becoming an also-ran in this fast-moving space, so it clearly needed to do something fast. The Merck deal was apparently plan B after the bid for AstraZeneca.”
AstraZeneca eventually rejected a long winded takeover attempt by Pfizer in May and although on the 26th of November Pfizer will have passed the cooling off period and make another offer for AZ, the market seems to suggest that they wont.
Albert Bourla, Pfizer group president vaccines, oncology and consumer healthcare businesses, insists: “Immuno-oncology is a top priority for Pfizer.”
There is an ongoing Phase I programme for MSB0010718C which has treated more than 550 patients, interim data for which demonstrated a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer.
Both Pfizer and Merck have up to 20 clinical development programmes in mind, this includes half a dozen of Phase II or III registartion trials which are expected to begin at the start of next year, using the drug as a single agent and in combination with products from their existing oncology portfolios.
Further results from the Phase I trial are expected to be presented at medical congresses in 2015. Meanwhile, an ongoing Phase II study is looking at the antibody in patients with metastatic Merkel cell carcinoma, a rare form 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,” explains Mikael Dolsten, president of Pfizer Worldwide Research and Development (WRD). “This promising foundation of research will form the basis of multiple registration trials.”
“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,” adds Bourla.
“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 tumour types,” says Belén Garijo, president and chief executive of Merck’s biopharmaceutical division Merck Serono.
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