- Merck KGaA Initiates Phase 2 Clinical Trial in Patients with Head and Neck Cancer -CAMBRIDGE, Mass., Jan 19, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today 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(R)) 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 tumors."
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
U.S.
About the Collaboration
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 today, under the Company's collaboration with
Merck KGaA, EMD 1201081 is currently being evaluated in a Phase 1b
clinical trial in combination with Tarceva(R) and Avastin(R)
in patients with advanced non-small cell lung cancer and in a Phase 1b
clinical trial in combination with Erbitux(R) and an
irinotecan-containing treatment regimen in patients with colorectal
cancer.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious
diseases, autoimmune and inflammatory diseases, cancer, and respiratory
diseases, and for use as vaccine adjuvants. Our proprietary drug
candidates are designed to modulate specific Toll-like Receptors, which
are a family of immune system receptors that direct immune system
responses. Our pioneering DNA and RNA chemistry expertise enables us to
create drug candidates for internal development and generates
opportunities for multiple collaborative alliances. 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 results
obtained in preclinical studies and early clinical trials will be
indicative of results obtained in future clinical trials; 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 Company's collaborations with Merck KGaA and an affiliate of Merck &
Co., Inc. will be successful; whether the patents and patent
applications owned or licensed by the Company will protect the Company's
technology and prevent others from infringing it; whether Idera's cash
resources will be sufficient to fund the Company's operations; and such
other important factors as are set forth under the caption "Risk
Factors" in Idera's Quarterly Report on Form 10-Q for the three months
ended September 30, 2009, which important factors are incorporated
herein by reference. Idera disclaims any intention or obligation to
update any forward-looking statements.
Erbitux is a registered trademark of ImClone Systems, a wholly-owned
subsidiary of Eli Lilly and Company. Tarceva is a registered trademark
of OSI Pharmaceuticals, Inc. Avastin is a registered trademark of
Genentech, Inc.
SOURCE: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
