FORM 8-K
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 and Exchange Act of 1934
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Date of Report (Date of earliest event reported): September 8, 2006 (September 7, 2006)
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REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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New York
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000-19034
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133444607 |
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification Number) |
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777 Old Saw Mill River Road, Tarrytown, New York
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10591-6707 |
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(Address of principal executive offices)
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(Zip Code) |
(914) 347-7000
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of registrant under any of the following provisions:
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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)) |
Item 8.01 Other Events
On September 7, 2006, the Company issued a press release announcing that it was
awarded a five-year grant from the National Institutes of Health (NIH) as part of
the NIHs Knockout Mouse Project. The press release is included as Exhibit 99(a)
to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits
99(a) Press Release of Regeneron Pharmaceuticals, Inc. dated September 7, 2006.
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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REGENERON PHARMACEUTICALS, INC.
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Dated: September 8, 2006 |
By: |
/s/ Stuart Kolinski
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Stuart Kolinski |
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Vice President and General Counsel |
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Exhibit Index
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Number |
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Description |
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99(a)
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Press Release of Regeneron Pharmaceuticals, Inc. dated September 7, 2006. |
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EX-99.A
Exhibit 99(a)
FOR IMMEDIATE RELEASE
NIH SELECTS REGENERON FOR KNOCKOUT MOUSE PROJECT
Regeneron Will Use its VelociGene® Technology to Target 3,500 Genes
Over Five Years, Providing New Models of Human Diseases
Tarrytown, NY (September 7, 2006) Regeneron Pharmaceuticals, Inc. (Nasdaq:
REGN) announced today that it has been awarded a five-year grant from the
National Institutes of Health (NIH) as part of the NIHs Knockout Mouse
Project. The goal of the Knockout Mouse Project is to build a comprehensive
and broadly available resource of knockout mice to accelerate the
understanding of gene function and human diseases. Regeneron will use its
VelociGene® technology to take aim at 3,500 of the most difficult
genes to target and which are not currently the focus of other large-scale
knockout mouse programs.
Regeneron has also agreed to grant a limited license to a consortium of
research institutions, the other major participants in the Knockout Mouse
Project, to use components of Regenerons VelociGene technology in the
Knockout Mouse Project.
Regeneron will generate a collection of targeting vectors and targeted mouse
embryonic stem cells (ES cells) which can be used to produce knockout mice.
These materials will be made widely available to academic researchers without
charge. Regeneron will receive a fee for each targeted ES cell line or
targeting construct made by Regeneron or the research consortium and
transferred to commercial entities.
VelociGene is Regenerons proprietary technology for creating any genetic
modification in a mouse in a precise and high-throughput manner. VelociGene
is one of a suite of inter-related and validated technology platforms that
Regeneron has created to build and accelerate its therapeutic drug discovery
and development programs. The platforms also include
VelocImmuneÒ, Regenerons proprietary technology for
creating fully human, therapeutic, monoclonal antibodies.
This NIH grant is great news for Regeneron and the Lower Hudson Valley,
said U.S. Senator Charles E. Schumer. The new federal funding will help
propel Westchester to the forefront of breakthroughs in medical research,
answering important questions about the function of the genes that make up
our bodies. Regenerons work will have the potential to further new medical
treatments that will benefit New York and the entire country.
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Knockout mice are laboratory mice in which researchers have deactivated, or
knocked out, a specific gene of interest by disrupting or replacing it with
an artificial piece of DNA. The loss of the gene leads to changes in the
physical and/or biochemical characteristics of the mouse, such as appearance
or behavior. By identifying and studying these changes, researchers can
determine the role of each gene in the mouses physiology and development.
These mice can then be used to develop better models of human diseases, such
as cancer, heart disease, neurological disorders, and diabetes.
Under the NIH grant, Regeneron will be entitled to receive a minimum of $17.4
million over a five-year period. The Company will receive another $1 million
to optimize its existing C57BL/6 ES cell line and its proprietary growth
medium, both of which will be supplied to the research consortium for its use
in the Knockout Mouse Project. Regeneron will have the right to use, for any
purpose, all materials generated by Regeneron and the research consortium.
I am delighted NIH has decided to award this grant to Regeneron
Pharmaceuticals as part of their Knockout Mouse Project, said Congresswoman
Nita M. Lowey. These federal funds will allow researchers in the Lower
Hudson Valley to explore medical advances never before imagined and answer
some of the most important questions about the function of the human body.
Regenerons work will have the potential to dramatically advance medical
treatments and help eradicate some of the worlds most devastating diseases
and conditions.
We are pleased that the NIH has selected VelociGene, one of Regenerons key
technology platforms, for the advancement of the Knockout Mouse Project,
said George D. Yancopoulos M.D., Ph.D., President of Regeneron Research
Laboratories. VelociGene, when combined with our suite of inter-related
technology platforms, particularly VelocImmune, is helping provide Regeneron
with our next generation of therapeutic drug candidates. My congratulations
to the Head of our VelociGene Division, David M.Valenzuela, Ph.D., and the
rest of our team for developing these breakthrough technologies and leading
our efforts to work with the NIH on this very important project. We believe
this NIH initiative has the potential to build on the information generated
by the genomic sequencing efforts led by the Human Genome Project, allowing
it to be used to understand the function of individual genes and to develop
new treatments for human diseases.
VelociGene®, VelociMouse and VelocImmune®
Regeneron has developed and validated a group of technology platforms that
the Company believes can improve its ability to develop new product
candidates. These discovery platforms are designed to identify specific
genes of therapeutic interest for a particular disease or cell type and
validate targets through high-
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throughput production of mammalian models.
VelociGene uses a proprietary and high-throughput process to remove genes
(creating gene knockouts) or introduce extra gene copies (creating
transgenics), rapidly producing mouse embryonic stem cells for elucidating
the function of the altered genes. Utilizing the VelociMouse technology,
Regeneron scientists can generate mammalian models directly from ES cells
without the need for chimeras or breeding.
Regenerons VelocImmune platform generates fully human monoclonal antibodies
(HuMAb) to address clinically relevant targets of therapeutic interest
identified in the mammalian models. The VelocImmune mouse, unlike other
HuMAb mice, mounts a robust immune response that is indistinguishable from
that of a wild type mouse, resulting in a more reliable and efficient
platform for creating fully human monoclonal antibodies for the treatment of
human diseases.
About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and
intends to commercialize therapeutic medicines for the treatment of serious
medical conditions. Regeneron has therapeutic candidates in clinical trials
for the potential treatment of cancer, eye diseases, and inflammatory
diseases, and has preclinical programs in other diseases and disorders.
This news release discusses historical information and includes
forward-looking statements about Regeneron and its products, programs,
finances, and business, all of which involve a number of risks and
uncertainties, such as risks associated with preclinical and clinical
development of our drug candidates, determinations by regulatory and
administrative governmental authorities which may delay or restrict our
ability to continue to develop or commercialize our drug candidates,
competing drugs that are superior to our product candidates, unanticipated
expenses, the availability and cost of capital, the costs of developing,
producing, and selling products, the potential for any collaboration
agreement, including our agreement with the sanofi-aventis Group, to be
canceled or to terminate without any product success, risks associated with
third party intellectual property, and other material risks. A more complete
description of these and other material risks can be found in Regenerons
filings with the United States Securities and Exchange Commission (SEC),
including its Form 10-K for the year ended December 31, 2005 and Form 10-Q
for the quarter ended June 30, 2006. Regeneron does not undertake any
obligation to update publicly any forward-looking statement, whether as a
result of new information, future events, or otherwise, unless required by
law.
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Contacts: |
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Investors:
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Media:
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Charles Poole
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Lauren Tortorete
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914.345.7640
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212.845.5609 |
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charles.poole@regeneron.com
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ltortorete@biosector2.com
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