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): April 3, 2007 (March 30, 2007)
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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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o 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
On March 30, 2007, Regeneron announced that it had entered into a non-exclusive
license agreement with Astellas Pharma Inc. (Astellas) granting Astellas certain
rights to use Regenerons VelocImmune® technology to discover human monoclonal
antibodies. Pursuant to the terms of the agreement, Astellas will make a $20
million upfront payment to Regeneron and Astellas will make up to five additional
annual payments of $20 million, subject to its ability to terminate the agreement
after making the first three additional payments or if the technology does not meet
minimum performance criteria. Regeneron is entitled to receive a mid-single-digit
royalty on any future sales of antibody products discovered by Astellas using
Regenerons VelocImmune technology.
A copy of the press release announcing the agreement is furnished as Exhibit 99(a)
to this Form 8-K.
Item 9.01 Financial Statements and Exhibits
(c) Exhibits
99(a) Press Release of Regeneron Pharmaceuticals, Inc. dated March 30, 2007.
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: April 3, 2007 |
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 March 30, 2007. |
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EX-99.A
Exhibit 99(a)
FOR IMMEDIATE RELEASE
ASTELLAS LICENSES REGENERONS VELOCIMMUNE®
TECHNOLOGY FOR DISCOVERING
HUMAN MONOCLONAL ANTIBODIES
Tokyo, Japan and Tarrytown, NY (March 30, 2007) Astellas
Pharma Inc. (Astellas; Headquarters: Tokyo, Japan; President & CEO:
Masafumi Nogimori) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN)
announced today that they have entered into a non-exclusive license
agreement that will allow Astellas to utilize Regenerons
VelocImmune® technology in its internal research programs
to discover human monoclonal antibody product candidates.
Astellas will pay $20 million upfront and will make up to five
additional annual payments of $20 million, subject to the ability to
terminate the agreement after making the first three additional
payments. Upon commercialization of any antibody products discovered
utilizing VelocImmune, Astellas will pay a mid-single-digit royalty
on product sales. Astellas will report the $80 million license fee
for the initial four years as an R&D expense on its income statements
for the fiscal year ending March 31, 2007.
VelocImmune is the centerpiece of Regenerons suite of technologies
for the discovery and development of fully human monoclonal
antibodies, said George D. Yancopoulos, M.D., Ph.D., President of
Regeneron Research Laboratories and Regenerons Chief Scientific
Officer. We are pleased that Astellas, a company with a clear
strategic commitment to developing therapeutic antibodies, has
selected the
VelocImmune platform for its internal development
programs.
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We are excited about this license agreement with Regeneron, said
Toshinari Tamura, Ph.D., Astellas Executive Vice President and Chief
Scientific Officer. As described in our recently announced medium
term plan, Astellas is building a new technological platform for the
development of antibody drugs, and VelocImmune will become an
important cornerstone for our R&D capabilities.
VelocImmune
Regenerons VelocImmune technology offers the potential to increase
dramatically the speed and efficiency of discovering fully-human,
therapeutic monoclonal antibodies. The VelocImmune platform
generates fully human monoclonal antibodies (hMAbs) to address
clinically relevant targets of therapeutic interest. The VelocImmune
mouse, unlike other hMAb mice, mounts a robust immune response that
is virtually indistinguishable from that of a wild type mouse,
resulting in a reliable and efficient platform for discovering fully
human monoclonal antibodies.
About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical
products. The organization is committed to becoming a global
pharmaceutical company by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. For more information on Astellas Pharma Inc., please visit
the companys website at http://www.astellas.com
About Regeneron Pharmaceuticals, Inc.
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.
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Regeneron has developed and validated a suite of inter-related
technology platforms VelociGene®,
VelociMouse®, and VelocImmune that the Company believes
can increase the speed and efficiency through which human monoclonal
antibody therapeutics may be discovered and validated. These
discovery platforms are designed to identify specific genes of
therapeutic interest for a particular disease or cell type and
validate targets through high-throughput production of mammalian
models. VelociGene uses a proprietary process to create genetic
modifications in a mouse in a precise and high-throughput manner and
was recently selected by the National Institutes of Health for use in
its Knockout Mouse Project. VelociGene allows Regeneron to produce
mouse embryonic stem (ES) cells rapidly for elucidating the function
of the altered genes. VelociMouse allows Regeneron scientists to
generate mammalian models directly from ES cells without the need for
chimeras or breeding. VelocImmune provides antibodies that address
the targets identified in the mammalian models that can be developed
as potential therapeutics. For more information on Regeneron, please
visit the companys website at www.regeneron.com.
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
agreements with the sanofi-aventis Group and Bayer HealthCare, 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, 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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Regeneron Contacts:
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Media:
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Investor Relations: |
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Kimberly Chen
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Charles Poole |
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Tel: 212 845 5634
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Tel: 914 345 7640 |
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kchen@biosector2.com
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charles.poole@regeneron.com |
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Astellas Contact: |
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Akihiro Tanaka, Ph.D. |
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VP, Corporate Communications |
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Astellas Pharma Inc. |
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Tel.: +81-3-3244-3201 |
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