Merck Expands EGFR Targeted Portfolio by Acquiring Exclusive Worldwide License of Phase II Oncology Drug Candidate Sym004 From Symphogen

• A novel investigational antibody mixture targeting the epidermal growth factor receptor (EGFR)
• Current clinical program in advanced metastatic colorectal cancer and in squamous cell carcinoma of the head and neck builds upon the long history of scientific and clinical success with Erbitux and complements Merck’s existing EGFR franchise

Darmstadt, Germany, September 6, 2012 – Merck Serono, a division of Merck, Darmstadt, Germany, today announced that an exclusive worldwide license agreement was signed with Symphogen A/S, Copenhagen, Denmark, for Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). Sym004 is currently being evaluated in a Phase I/II trial for the treatment of patients with advanced KRAS wild-type metastatic colorectal cancer (mCRC) who have previously progressed on treatment with standard chemotherapy and a marketed anti-EGFR monoclonal antibody. In addition, a single-arm, open-label Phase II trial in patients with squamous cell carcinoma of the head and neck (SCCHN) who have failed anti-EGFR–based therapy is currently ongoing.

“Sym004 further strengthens our early development pipeline by adding a product that is thought to act via a proposed synergistic mechanism of action not previously studied, but more specifically, it has the potential to become a key asset complementing our already highly successful Erbitux franchise,” commented Dr. Susan Jane Herbert, Head of Global Business Development and Strategy for Merck Serono. “This collaboration once again reflects our strong commitment to fighting cancer and to providing new treatment options to patients.”

Under the agreement, Merck will gain exclusive worldwide rights to develop and commercialize Sym004. In exchange, Symphogen will receive from Merck an upfront payment of € 20 million as well as payments for clinical development, regulatory and sales performance milestones. Symphogen will also be eligible for potential royalties on net worldwide sales.

Sym004 is comprised of two antibodies that are not only designed to block ligand binding, receptor activation and downstream signaling but are also thought to elicit removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.1

“We believe that Merck is uniquely well positioned to develop Sym004 based on its deep knowledge of the EGFR area," said Kirsten Drejer, Chief Executive Officer of Symphogen. “This transaction further validates the antibody mixture approach as a highly attractive option.”

As of July 2012, 88 patients have been treated with Sym004 in clinical trials. The adverse events from preliminary clinical data include diarrhea, skin rash, mucosal inflammation, nausea, infusion-related reaction and hypomagnesemia. Exposure data from the patients, after weekly repeated infusions, do not indicate an anti-drug antibody response.

About Symphogen

Symphogen is developing antibody therapeutics (monoclonal, monoclonal mixtures and polyclonal) to help people with serious diseases and significant unmet medical needs. With its proprietary Symplex™ discovery, SymSelect™ lead selection and Sympress™ manufacturing platforms, the company captures the diversity and specificity of the natural immune response in rationally designed recombinant antibody mixtures. Symphogen is maturing a diversified pipeline of internal and partnered products across multiple indications including cancer, autoimmune and infectious disease. Symphogen is a private biopharmaceutical company headquartered in Copenhagen, Denmark, with a US subsidiary in Princeton, New Jersey. For more information, please visit www.symphogen.com.


About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurodegenerative diseases, oncology and rheumatology.


About Merck

Merck is a global pharmaceutical and chemical company with total revenues of €10.3 billion in 2011, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merckgroup.com


Georgina Hunt

Direct +44 (0)20 8439 9536
Fax +44 (0)20 8439 9537
 

Posted: September 2012


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