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Merck KGaA announced that it has entered into a worldwide licensing and collaboration agreement on behalf of its Merck Serono division with Idera Pharmaceuticals, Inc. of Cambridge, Massachusetts for the research, development, and commercialization of Idera’s Toll-like Receptor 9 agonists
DARMSTADT, Germany | December 19, 2007 | Merck KGaA announced today that it has entered into a worldwide licensing and collaboration agreement on behalf of its Merck Serono division with Idera Pharmaceuticals, Inc. of Cambridge, Massachusetts, USA (Nasdaq: IDRA) for the research, development, and commercialization of Idera’s Toll-like Receptor 9 (TLR9) agonists for the treatment of cancer.
Under the agreement, Idera has agreed to exclusively license the therapeutic oncology applications, excluding their use with cancer vaccines, of its lead TLR9 agonists, IMO-2055 and IMO-2125. In addition, Merck and Idera have agreed to engage in a research collaboration to identify a specified number of novel, follow-on TLR9 agonists, which will be derived using Idera’s chemistry-based approach and for which Merck will have the exclusive right to use in oncology applications other than cancer vaccines.
“Merck is committed to the development of innovative approaches to cancer therapies on a global basis and we expect that this collaboration with Idera will help us move toward that goal,” said Vincent Aurentz, Executive Board Member and Head of Portfolio Management and Business Development for the Merck Serono division. “We believe that TLR9 agonists represent a novel mechanism of action with great potential and we look forward to advancing their development for various oncology indications.”
“Merck is committed to the development of innovative approaches to cancer therapies on a global basis and we expect that this collaboration with Idera will help us move toward that goal,” said Vincent Aurentz, Executive Board Member and Head of Portfolio Management and Business Development for the Merck Serono division. “We believe that TLR9 agonists represent a novel mechanism of action with great potential and we look forward to advancing their development for various oncology indications.”
Under the terms of the agreement, Merck has agreed to pay an up-front license fee of $40 million (about EUR 28 million based on current exchange rates) to Idera. In addition, Idera is eligible to receive milestone payments of up to $381 million based on current exchange rates (EUR 264 million), depending on success in achieving clinical development and commercialization, as well as royalties on sales of any products developed and commercialized by Merck based on IMO-2055, IMO-2125 or the follow-on TLR9 agonists. The contract will take effect and the upfront fee will be paid following regulatory clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
“Idera has chosen to collaborate with Merck KGaA for the application of our TLR9 agonists in oncology because of its proven capabilities and success in developing novel therapies for cancer and its commitment to global research, development and commercialization in this area,” said Sudhir Agrawal, D. Phil., Chief Executive Officer and Chief Scientific Officer of Idera.
About IMO-2055
IMO-2055 is a novel DNA-based agonist of TLR9. It has been evaluated at multiple dose levels for safety and immunological activity in Phase I trials involving healthy volunteers and patients with refractory solid tumors. IMO-2055 is currently in a Phase 1b trial in combination with Tarceva® and Avastin® in patients with advanced non-small cell lung cancer and is being evaluated at two dose levels in a Phase IIa trial in patients with renal-cell carcinoma (kidney cancer). It also is being evaluated in combination with chemotherapy agents in a Phase I trial in patients with refractory solid tumors.
About IMO-2125
IMO-2125 is a second DNA-based TLR9 agonist and is of a class designed to induce high levels of interferon-alpha and other cytokines and chemokines. IMO-2125 currently is being evaluated in a Phase I trial in patients with chronic hepatitis C virus infection who have not responded to standard treatment. This indication is not included in the agreement with Merck.
About TLRs
Toll-like Receptors (TLRs) function in human immune cells as the sensors of pathogens. They recognize different microbial products present in pathogens such as bacteria, viruses and parasites, and mount an appropriate immune response against the foreign invaders. TLRs have also been shown to recognize endogenous ligands in autoimmune diseases. TLRs have become attractive targets for developing immune modulators to treat a number of illnesses, including cancers and infectious, respiratory and autoimmune diseases, and for use as vaccine adjuvants.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a drug discovery and development company that is developing drug candidates to treat cancer and infectious, respiratory, and autoimmune diseases, and for use as vaccine adjuvants. Idera’s proprietary drug candidates are designed to modulate specific TLRs, which are a family of immune system receptors. Idera’s pioneering DNA chemistry expertise enables it to identify drug candidates for internal development and creates opportunities for multiple collaborative alliances. For more information, visit www.iderapharma.com.
SOURCE: MERCK
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