CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 19, 2007--Idera
Pharmaceuticals, Inc. (Nasdaq: IDRA) announced today that it has
entered into a worldwide licensing and collaboration agreement with
Merck KGaA of Darmstadt, Germany, 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 cancer vaccines, of its
lead TLR9 agonists, IMO-2055 and IMO-2125. In addition, Idera and
Merck KGaA 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 therapy 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 KGaA has agreed to pay an
upfront 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 KGaA using
IMO-2055, IMO-2125 or the follow-on TLR9 agonists. The contract will
take effect and the upfront fee will be paid following, and subject
to, 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
their commitment to global research, development and commercialization
in this area," said Sudhir Agrawal, D. Phil., Chief Executive Officer
and Chief Scientific Officer of Idera. "This collaboration adds Merck
KGaA's experience and resources to the development of our TLR9
agonists in oncology and provides us with additional capital to
advance our internal TLR-targeted drug discovery and development
programs. We look forward to working closely with Merck KGaA to
realize the potential of TLR9 agonists in cancer therapy."
About IMO-2055
IMO-2055 is a novel DNA-based agonist of TLR9. IMO-2055 has been
evaluated at multiple-dose levels for safety and immunological
activity in Phase 1 trials involving healthy volunteers and patients
with refractory solid tumors. IMO-2055 is currently in a Phase 1b
trial in combination with Tarceva(R) and Avastin(R) in patients with
advanced non-small cell lung cancer and is being evaluated at two dose
levels in a Phase 2a trial in patients with renal cell carcinoma.
IMO-2055 also is being evaluated in combination with chemotherapy
agents in a Phase 1 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 presently 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 KGaA.
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 diseases, including
cancers and infectious, respiratory and autoimmune diseases, and for
use as vaccine adjuvants.
About Merck KGaA
Merck of Darmstadt, Germany, is a global pharmaceutical and
chemical company with sales of EUR 6.3 billion in 2006, a history that
began in 1668, and a future shaped by 30,962 employees in 61
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 free shareholders own the remaining
approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was
expropriated and has been an independent company ever since.
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. Internal programs include IMO-2125,
a lead candidate for treating infectious diseases, and discovery-stage
compounds for autoimmune diseases. Idera has identified DNA-based
compounds which have been shown to act as antagonists to TLRs 7 and 9
in preclinical studies and are being evaluated in preclinical disease
models of lupus, collagen-induced arthritis and multiple sclerosis.
Idera is collaborating with Novartis International Pharmaceutical,
Ltd. for the discovery, development, and commercialization of TLR9
agonists for the treatment of asthma and allergy indications. Idera is
also collaborating with Merck & Co., Inc. for the use of Idera's TLR7,
8 and 9 agonists in combination with Merck & Co.'s therapeutic and
prophylactic vaccines in the areas of oncology, infectious diseases,
and Alzheimer's disease. Merck & Co. of the U.S. is not related to
Merck KGaA of Germany. For more information, visit
www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Idera Pharmaceuticals, Inc. that involve a number of risks and
uncertainties. For this purpose, any statements contained herein that
are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words
"believes," "anticipates," "plans," "expects," "estimates," "intends,"
"should," "could," "will," "may," and similar expressions are intended
to identify forward-looking statements. There are a number of
important factors that could cause Idera's actual results to differ
materially from those indicated by such forward-looking statements,
including whether the collaboration with Merck KGaA will be successful
and whether the Company will receive any of the milestone payments
provided for under the collaboration; whether products based on
Idera's technology will advance into or through the clinical trial
process on a timely basis or at all and receive approval from the
United States Food and Drug Administration or equivalent foreign
regulatory agencies; whether, if the Company's products receive
approval, they will be successfully distributed and marketed; whether
the results of preclinical studies will be indicative of results that
may be obtained in clinical trials; whether the Company's
collaborations with Novartis and Merck & Co. will be successful;
whether Idera's cash resources will be sufficient to fund the
Company's operations, including product development and clinical
trials; and such other important factors as are set forth under the
caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q filed
on November 13, 2007, which important factors are incorporated herein
by reference. Idera disclaims any intention or obligation to update
any forward-looking statements.
CONTACT: Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
chris@macbiocom.com
SOURCE: Idera Pharmaceuticals, Inc.
