DARMSTADT, Germany - Monday, November 17th 2014 [ME NewsWire]
Merck and Pfizer will jointly develop and commercialize Merck’s anti-PD-L1
Joint investment and combined strengths and capabilities will further maximize potential of Merck’s asset in the highly competitive anti-PD-1 / anti-PD-L1 space
Up to 20 high priority immuno-oncology clinical development programs expected to commence in 2015, including pivotal registration studies
Alliance accelerates Merck’s entry into the US oncology market
(BUSINESS WIRE)-- Merck (MRK GY) (FWB:MRK) announced today that it has entered into a global agreement with Pfizer Inc. (NYSE:PFE) 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 will also combine resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1 trials. As part of the agreement, Merck 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 Merck’s Executive Board 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 Merck’s biopharmaceutical division Merck Serono 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 Merck’s anti-PD-L1 antibody. 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 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. For more information, please visit www.clinicaltrials.gov.
Under the terms of the agreement, Merck 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. “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 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.”
Merck invites investors and analysts, as well as media and the general public to view and listen to a webcast of a live conference call at 2 p.m. CET today.
Notes for editors
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Interview with Belén Garijo, President and Chief Executive Officer of Merck Serono and Executive Board Member Elect.
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Merck is a leading company for innovative, top-quality high-tech products in the chemical and pharmaceutical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of around € 11.1 billion in 2013. Around 39,000 employees work for Merck in 66 countries to improve the quality of life for patients, to further the success of customers, and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.
Cautionary Note Regarding Forward-Looking Statements
Certain statements made herein may be deemed to be solicitation materials in respect of the proposed acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany. The proposed acquisition will be submitted to the stockholders of Sigma-Aldrich for their consideration on December 5, 2014. In connection therewith, on November 3, 2014, Sigma-Aldrich filed a definitive proxy statement with the SECand began mailing the definitive proxy statement to its stockholders of record as of the close of business on October 29, 2014. BEFORE MAKING ANY VOTING OR ANY INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and stockholders may obtain free copies of the proxy statement, any amendments or supplements thereto and other documents containing important information about Sigma-Aldrich, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Sigma-Aldrich will be available free of charge on Sigma-Aldrich’s website at http://investor.sigmaaldrich.com under the heading “Financial Information—SEC Filings”. Stockholders of Sigma-Aldrich may also obtain a free copy of the definitive proxy statement by contacting Sigma-Aldrich’s Investor Relations Department at (314) 898-4643.
Sigma-Aldrich and certain of its directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Sigma-Aldrich is set forth in its proxy statement for its 2014 annual meeting of stockholders, which was filed with the SEC on March 21, 2014, its annual report on Form 10-K for the fiscal year ended December 31, 2013, which was filed with the SEC on February 6, 2014, and in subsequent documents filed with the SEC, each of which can be obtained free of charge from the sources indicated above. Other information regarding the participants in the proxy solicitation of the stockholders of Sigma-Aldrich and a description of their direct and indirect interests, by share holdings or otherwise, is contained in the definitive proxy statement and other relevant materials filed with the SEC.
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