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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 18, 2007
Idera Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in its Charter)
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Delaware
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001-31918
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04-3072298 |
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(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.) |
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167 Sidney Street, Cambridge, Massachusetts
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02139 |
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(Address of Principal Executive Offices)
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Zip Code) |
Registrants telephone number, including area code: (617) 679-5500
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
Item 1.01. Entry Into a Material Definitive Agreement
Exclusive License Agreement
On December 18, 2007, Idera Pharmaceuticals, Inc. (Idera or the Company) entered into an
exclusive, worldwide license agreement with Merck KGaA (Merck) to research, develop and
commercialize products containing Ideras toll-like receptor 9 (TLR9) agonists for the treatment
of cancer, excluding cancer vaccines (the Licensed Field).
Under the terms of the agreement, Idera granted Merck worldwide exclusive rights to Ideras
lead TLR9 agonists, IMO-2055 and IMO-2125, and to a specified number of novel, follow-on TLR9
agonists to be identified by Merck and Idera under a research collaboration, for use in the
Licensed Field.
Under the terms of the agreement, Merck agreed to pay Idera,
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an upfront license fee in Euros having a value of $40 million as of the clearance of
the transaction under the Hart-Scott-Rodino Antitrust Improvements Act ; |
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development, regulatory approval, and commercial success milestone payments of up to
264 million Euros (currently $381 million) if products containing Ideras TLR9 agonist
compounds are successfully developed and marketed for multiple therapeutic applications
in the Licensed Field; and |
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royalties on net sales of products containing Ideras TLR9 agonists that are
marketed; |
Idera has agreed that neither it nor its affiliates will, either directly or through a third party,
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develop or commercialize any TLR9 agonist for use in the Licensed Field; |
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develop or commercialize develop IMO-2055 for use outside the Licensed Field, except
as part of vaccine products in the fields of oncology, infectious diseases and
Alzheimers disease, which Idera is pursuing under its collaboration with Merck and
Co.; and |
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conduct Phase III clinical trials of IMO-2125 as a monotherapy or commercialize
IMO-2125 as a monotherapy inside and outside the License Field. |
These restrictions will not limit Ideras ability to research, develop and commercialize vaccine
products containing IMO-2055 in the fields of oncology, infectious diseases and Alzheimers
disease, and to research, develop and commercialize IMO-2125 outside the Licensed Field as a
combination therapy or as a vaccine product.
During the period in which Idera provides follow-on TLR9 agonists, the parties agreed to form
a joint research committee, consisting of an equal number of members from Idera and Merck, to
facilitate Ideras delivery of such compounds.
Under the terms of the agreement, Merck is obligated to pay Idera royalties, on a
product-by-product and country-by-country basis, until the later of the expiration of the patent
rights licensed to Merck and the tenth anniversary of the products first commercial sale in such
country. If the patent rights expire in a particular country before the tenth (10th) anniversary
of the products first commercial sale in such country, Merck shall continue to pay Idera royalties
at a reduced royalty rate until such anniversary. In addition, the applicable product royalties
may be reduced if Merck is required to pay royalties to third parties for licenses to intellectual
property rights. The product royalties may also be reduced if off-label sales by Idera, its
affiliates or licensees of products containing IMO-2125 reach or exceed a specified threshold in
the Licensed Field. Mercks royalty and milestone obligations may also be reduced if Merck
terminates the agreement based on specified uncured material breaches by Idera.
The agreement may be terminated by either party based upon material uncured breaches by the
other party or by Merck at any time after providing Idera with advance notice of termination.
The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements
Act.
The Company believes, based on its current operating plan, that its existing cash, cash
equivalents and short-term investments, including the $40 million upfront payment that Merck has
agreed to pay, will be sufficient to fund its operations through at least 2009.
Forward Looking Statement
This current report on Form 8-K contains forward-looking statements concerning the Company
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 the Companys
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 the Companys 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 the Company will complete enrollment of clinical
trials or announce trial results in the time expected; whether, if the Companys 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
Companys collaborations with Novartis and Merck will be successful; whether Ideras cash resources
will be sufficient to fund the Companys operations, including product development and clinical
trials; and such other important factors as are set forth under the caption Risk Factors in
Ideras 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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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IDERA PHARMACEUTICALS, INC.
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Date: December 20, 2007 |
By: |
/s/ Sudhir Agrawal, D. Phil.
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Sudhir Agrawal, D. Phil. |
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Chief Executive Officer
and Chief Scientific Officer |
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