The Biopharmaceutical Business of Merck KGaA, Darmstadt, Germany, and Intrexon Announce Agreement for the Development and Commercialization of CAR-T Therapy

DARMSTADT, Germany, March 30, 2015 /PRNewswire/ -- The biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Intrexon Corporation (NYSE:XON), today announced an exclusive strategic collaboration and license agreement to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. This collaboration advances the comprehensive, science-driven strategy of Merck KGaA, Darmstadt, Germany, to develop innovative therapies that modulate the immune system's natural ability to fight tumors.

"The collaboration with Intrexon underlies the focus of Merck KGaA, Darmstadt, Germany, on innovation, and enhances its R&D technology portfolio in immuno-oncology," says Belen Garijo, President and CEO of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "Moreover, it showcases our commitment to developing therapies that have the potential to significantly evolve the way cancer is treated."

CAR-T cells are genetically engineered T-cells with synthetic receptors that recognize a specific antigen expressed on tumor cells. When CAR-T cells bind to a target, an immunological attack against the cancer cells is triggered.

Utilizing Intrexon's cell engineering techniques and RheoSwitch^® platform, the collaboration aims to develop leading-edge products that empower the immune system in a regulated manner to overcome the current challenges of CAR-T therapy.

The agreement provides Merck KGaA, Darmstadt, Germany exclusive access to Intrexon's proprietary and complementary suite of technologies to engineer T-cells with optimized and inducible gene expression, as recently strengthened by a license agreement with the University of Texas MD Anderson Cancer Center.

Intrexon will be responsible for all platform and product development until IND filing. Merck KGaA, Darmstadt, Germany will nominate targets of interest for which CAR-T products will be developed. Merck KGaA, Darmstadt, Germany will also lead the IND filing and pre-IND interactions, clinical development and commercialization. In addition, Intrexon has the opportunity to explore targets independently, granting Merck KGaA, Darmstadt, Germany opt-in rights during clinical development.

"Merck KGaA, Darmstadt, Germany is an ideal partner in CAR-T for us because of their long-term perspective, extraordinary character, worldwide reach and commitment to leadership in immuno-oncology," says Randal J. Kirk, Chairman and CEO of Intrexon. "We look forward to working together to benefit patients through the creation of a leading franchise in this very promising field."

Under the terms of the agreement, Intrexon will receive an upfront payment of $115 million. For the first two targets of interest selected by Merck KGaA, Darmstadt, Germany, Intrexon will receive research funding and is eligible to receive up to $826 million development, regulatory and commercial milestones, as well as tiered royalties on product sales.  In addition, Intrexon is also eligible to receive further payments upon achievement of certain technology development milestones.

In the United States and Canada, the biopharmaceutical businesses of Merck KGaA, Darmstadt Germany, operate as EMD Serono.

About EMD Serono

EMD Serono is the U.S. and Canadian subsidiary of Merck KGaA, Darmstadt, Germany's biopharmaceutical business. A leading US biopharma company, EMD Serono is focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

For more information, please visit www.emdserono.com

About Merck KGaA, Darmstadt Germany

Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 11.3 billion in 2014. Around 39,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.

CONTACT: Cory Tromblee 781-681-2393

SOURCE Merck KGaA

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