Merck KGaA licences new cancer candidate
pharmafile | September 10, 2012 | News story | Research and Development, Sales and Marketing | Cancer, EGFR, Merck KGaA, oncology
Merck KGaA has signed a worldwide licence agreement with Danish company Symphogen which could expand its portfolio of drugs targeting the epidermal growth factor receptor (EGFR).
Sym004 is an investigational antibody mixture which has a similar function to Merck’s existing anti-EGFR blockbuster Erbitux (cetuximab).
Merck is forking out €20 million up front to develop the drug and will be liable for further milestone and royalty payments to the Copenhagen-based private biopharma company, if Sym004 is successful.
It is currently in a Phase I/II trial to treat patients with advanced KRAS wild-type metastatic colorectal cancer (mCRC) who have previously progressed with standard chemotherapy and an anti-EGFR drug.
Current treatments for mCRC include Erbitux, Roche’s Avastin (bevacizumab) and Amgen’s Vectibix (panitumumab).
Erbitux – which brought in sales of $1.1 billion last year – also has a licence to treat head and necks cancers and is seeking a new European licence for EGFR-positive lung cancer.
The appeal of Sym004 is obvious for Merck, since Erbitux operates in a lucrative area which is a hotbed of competition from other established brands and wannabe competitors.
Last month the FDA approved Sanofi and Regeneron’s Zaltrap (ziv-aflibercept), in combination with chemotherapy, for mCRC patients whose tumours have progressed after an oxaliplatin-containing chemotherapy regimen.
Industry analysts expect Zaltrap to have peak annual sales of around $300-400 million – although this is far below what Erbitux is making for the same indication.
Avastin, which has a number of licences including colorectal cancer and renal cell carcinoma, also works as an anti-VEGF inhibitor and is a long-established drug amongst oncologists.
Bayer and Onyx’s colorectal cancer drug regorafenib is also being tested for mCRC, and has shown that it increased overall survival for late-stage patients compared to Avastin.
Merck hopes that Sym004 will also be able to expand its reach: 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,” said Susan Jane Herbert, Merck Serono’s head of global business development and strategy.
Sym004 comprises two antibodies designed to block ligand binding, receptor activation and downstream signalling and which may also remove EGFR receptors from the cancer cell surface by degrading them.
“More specifically, it has the potential to become a key asset complementing our already highly successful Erbitux franchise,” Herbert added.
Adam Hill
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