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):
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February 1, 2006 (February 3, 2006) |
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
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(Commission File Number)
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(I.R.S. Employer |
incorporation)
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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
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Item 1.01
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Entry into a Material Definitive Agreement. |
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On February 1, 2006, Regeneron Pharmaceuticals, Inc. and
sanofi-aventis U.S., LLC (successor in interest to Aventis
Pharmaceuticals Inc.) entered into Amendment No. 4 (the Fourth
Amendment) to their Collaboration Agreement dated as of
September 5, 2003 (the Collaboration Agreement). The Fourth
Amendment added a new section to the Collaboration Agreement
granting each party a royalty free, non-exclusive license to
certain intellectual property discovered directly in connection
with research and development activities performed under the
Collaboration Agreement. |
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Item 8.01
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Other Events. |
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On February 2, 2006, Regeneron Pharmaceuticals, Inc. issued a
press release announcing preliminary results from an ongoing
phase 1 dose-escalation study of the Vascular Endothelial Growth
Factor Trap eye formulation (VEGF Trap Eye) in patients with
the neovascular form of age-related macular degeneration. A
copy of the press release is furnished as Exhibit 99.1 to this
Form 8-K. |
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Item 9.01
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Financial Statements and Exhibits. |
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(c) Exhibits |
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99.1 Press Release dated February 2, 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: February 3, 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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99.1
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Press Release dated February 2, 2006. |
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EX-99.1
Exhibit 99.1
FOR IMMEDIATE RELEASE
REGENERONS VEGF TRAP DEMONSTRATES POSITIVE
PRELIMINARY RESULTS IN PATIENTS WITH
AGE-RELATED MACULAR DEGENERATION
Phase 1 Preliminary Results to be Presented at the Angiogenesis 2006
Meeting sponsored by Bascom Palmer Eye Institute
Tarrytown New York, (February 2, 2006) Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced
today positive preliminary results from an ongoing phase 1 dose-escalation study of the Vascular
Endothelial Growth Factor Trap eye formulation (VEGF Trap Eye) in 18 patients with the
neovascular form of age-related macular degeneration (wet AMD). Patients have shown rapid,
substantial, and prolonged (up to at least 4 weeks) reductions in retinal thickness as measured by
optical coherence tomography (OCT). Patients in this trial have received a single dose of the VEGF
Trap at levels up to 2 milligrams (mg) intravitreally (direct injection into the eye). A maximum
tolerated dose has not been reached, and there has been no evidence of ocular inflammation.
Additional patients are now being tested at the 4 mg dose level. Patients are being followed for
three months after dosing.
Preliminary results of the study will be discussed in a presentation at 11:30 am (EST) on Friday,
February 3, 2006 at the Angiogenesis 2006 symposium sponsored by the Bascom Palmer Eye Institute
of the University of Miami Miller School of Medicine. Additional data from this study, including
longer follow up, will be presented at future scientific meetings. The presentation slides will be
posted to the Events page of Regenerons website, www.regeneron.com, at the time of the
presentation.
Age related macular degeneration is a major cause of vision loss and blindness in older
Americans, said Jesse Cedarbaum, MD, Vice President of Clinical Affairs at Regeneron. We are
strongly encouraged by these preliminary data
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indicating biological activity of the VEGF Trap Eye in patients with wet AMD. We look forward
to continued follow up from this study, as well as the initiation of additional studies in the near
future.
VEGF Trap Program in Eye Disease
VEGF is a naturally occurring protein in the body whose normal role is to trigger formation of new
blood vessels (angiogenesis) to support the growth of the bodys tissues and organs. It has also
been associated with the abnormal growth and fragility of new blood vessels in the eye, important
factors in the development of wet AMD.
The VEGF Trap is a protein-based product candidate that binds all forms of VEGF-A and the related
Placental Growth Factor (PlGF). The VEGF Trap is designed to block the interaction of these growth
factors with cell-surface receptors and prevent the subsequent formation of new blood vessels that
play an important role in eye diseases. Regeneron is independently developing the VEGF Trap
Eye, a specially purified and formulated form of the VEGF Trap, for clinical evaluation in eye
diseases by direct injection into the eye.
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
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, 2004 and Form 10-Q for
the quarter ended September 30, 2005. 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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