Merck, Symphogen sign Sym004 license agreement

Merck, Symphogen sign Sym004 license agreement

4:43 AM, 10th September 2012
Merck, Symphogen sign Sym004 license agreement

DARMSTADT, GERMANY: Merck has signed an exclusive worldwide license agreement 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 singlearm, 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.  

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. 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.

“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. This collaboration once again reflects our strong commitment to fighting cancer and to providing new treatment options to patients,” said Dr Susan Jane Herbert, Head of Global Business Development and Strategy, Serono division, Merck.

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