Idera Pharmaceuticals, Inc. announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon initiation of a phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Under the terms of the agreement, the company is entitled to receive a payment of EUR 3.0 million (approximately $4.3 million) from Merck KGaA.

"We are very pleased with Merck KGaA's initiation of this randomized phase 2 clinical trial of EMD 1201081 in combination with cetuximab in patients with head and neck cancer," said Alice Bexon, MBChB, vice president of clinical development. "Under our collaboration with Merck KGaA, the use of EMD 1201081 with cetuximab is an important step forward in the development of our novel TLR9 agonists in combination with selected targeted agents for the treatment of solid tumours."

The company expects that it will receive the milestone payment of EUR 3.0 million (approximately $4.3 million based on the currency exchange rate on January 18, 2010) from Merck KGaA during the first quarter of 2010. The clinical trial is being conducted in eight countries, including the US.

Idera Pharmaceuticals entered into a worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany in December 2007 for the research, development and commercialization of Idera's Toll-like Receptor 9 (TLR9) agonists, including IMO-2055 (EMD 1201081), for the potential treatment of certain cancers. In addition to the clinical study announced, under the Company's collaboration with Merck KGaA, EMD 1201081 is currently being evaluated in a Phase 1b clinical trial in combination with Tarceva and Avastin in patients with advanced non-small cell lung cancer and in a Phase 1b clinical trial in combination with Erbitux and an irinotecan-containing treatment regimen in patients with colorectal cancer.

Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants.