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 Exchange Act of 1934
Date
of Report (Date of earliest event
reported) October 18, 2006
REGENERON PHARMACEUTICALS,
INC.
(Exact name of registrant as specified in its charter)
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New York
(State or other jurisdiction of
incorporation)
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001-19034
(Commission File Number) |
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133444607
(I.R.S. Employer Identification Number) |
777 Old Saw Mill River Road,
Tarrytown, New
York 10591-6707
(Address of principal executive offices) (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 the 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)) |
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Item 1.01 |
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Entry into a Material Definitive
Agreement.
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On October 18, 2006, Regeneron Pharmaceuticals, Inc. and Bayer
HealthCare LLC entered into a license and collaboration
agreement to globally develop, and commercialize outside the
United States, the VEGF Trap for the treatment of eye diseases
by local administration (the VEGF Trap-Eye). Under the terms
of the agreement, Bayer will make an up-front payment of $75.0
million to Regeneron. In addition, Regeneron is eligible to
receive up to $110 million in development and regulatory
milestones, including a total of $40 million upon the initiation
of Phase 3 trials in defined major indications such as
age-related macular degeneration and diabetic macular edema.
Regeneron is also eligible to receive up to an additional $135
million in sales milestones when and if total annual sales of
the VEGF Trap-Eye outside the United States achieve certain
specified levels starting at $200 million.
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Regeneron and Bayer will share equally in any future profits
arising from the commercialization of the VEGF Trap-Eye outside
the United States. Within the United States, Regeneron is
responsible for any future commercialization of the VEGF
Trap-Eye and has exclusive rights to any future profits arising
therefrom. |
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Agreed upon development expenses incurred by both companies
under a global development plan will be shared as follows:
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2007: Up to $50.0 million shared equally; Regeneron solely
responsible for up to the next $40.0 million; over $90.0 million
shared equally.
2008: Up to $70.0 million shared equally, Regeneron solely
responsible for up to the next $30.0 million; over $100.0
million shared equally.
2009 and thereafter: All expenses shared equally.
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If the VEGF Trap-Eye is granted marketing authorization in a
major market country outside the United States, Regeneron will
be obligated to reimburse Bayer for 50% of agreed upon
development expenses that Bayer has incurred in accordance with
a formula based on the amount of development expenses and
Regenerons share of the collaboration profits, or at a faster
rate at Regenerons option. |
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Bayer has the right to terminate the agreement without cause
with at least six months or twelve months advance notice
depending on defined circumstances at the time of termination.
In the event of termination of the agreement for any reason,
Regeneron retains all rights to the VEGF Trap-Eye.
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A copy of the press release
announcing the agreement is furnished as Exhibit 99.1 to this Form
8-K.
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Financial Statements and Exhibits.
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(c) Exhibits |
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Item 9.01 |
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Agreement.
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99.1 Press Release dated October 18, 2006
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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: October 18,
2006 |
By: |
/s/ Stuart
Kolinski |
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Stuart Kolinski 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 October 18, 2006.
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EX-99.1
Exhibit 99.1
Bayer
HealthCare and Regeneron to Collaborate on VEGF Trap
for the Treatment of Eye Diseases
Regeneron
Retains U.S. Commercialization Rights, Receives
$75 Million Upfront, and Eligible for up to $245 Million of Milestone Payments
Leverkusen, Germany and Tarrytown, NY (October 18, 2006) Bayer HealthCare
(NYSE: BAY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced
that the companies have entered into a collaboration agreement for the global
development, and commercialization outside the U.S., of the VEGF Trap for the
treatment of eye disease by local administration (VEGF Trap-Eye). The VEGF
Trap-Eye, currently in Phase I and Phase II clinical trials, is a protein that
binds to or traps vascular endothelial growth factor (VEGF) and blocks its
activity. VEGF is thought to play a critical role in certain eye diseases.
The VEGF Trap is a great strategic fit for Bayer, underscoring our commitment
to specialty pharmaceuticals, said Arthur Higgins, Chairman of the Board of
Management, Bayer HealthCare. We are encouraged by the early clinical data
weve seen and believe the VEGF Trap has the potential to further transform the
treatment paradigm for patients suffering from diseases of the eye.
Under the agreement, Bayer and Regeneron will collaborate on the development of
the VEGF Trap-Eye through an integrated global plan that encompasses the
neovascular form of age-related macular degeneration (wet AMD), diabetic eye
diseases, and other eye diseases and disorders. The companies will jointly
commercialize the VEGF Trap-Eye outside the U.S and will share equally in
profits from ex-U.S. sales. Within the U.S., Regeneron has exclusive
commercialization rights in all indications and will retain 100% of all profits
from any such sales.
Principal financial terms of the agreement include:
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Bayer will make an upfront payment of $75 million to Regeneron. |
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Bayer and Regeneron will share initial global development costs
(totaling over $250 million over the next several years) as follows: |
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2007-2008: According to a formula based on total development costs
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2009 and thereafter: All expenses shared equally.
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If a VEGF Trap-Eye product is granted marketing authorization in a
major market country outside the U.S., Regeneron, from its 50% share of
VEGF Trap-Eye profits outside the U.S., will reimburse Bayer for 50% of
the development costs that Bayer has incurred. |
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Regeneron can earn up to $110 million in total development and
regulatory milestones related to the development of the VEGF Trap-Eye
for wet AMD and DME (or other major eye indications) and marketing
approvals in a major market countries outside the U.S. A total of $40
million of these milestone payments are due upon the initiation of
Phase 3 clinical trials in wet AMD and diabetic macular edema (DME). |
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Regeneron can earn up to $135 million in sales milestones when
total annual sales of the VEGF Trap-Eye outside the U.S. achieve
certain specified levels starting at $200 million.
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As an established leader in specialty pharmaceutical products, Bayer is an
ideal partner to help develop and commercialize the VEGF Trap outside the U.S.
for eye disease, said Leonard S. Schleifer, M.D., Ph.D., president and chief
executive officer of Regeneron. In recent years there have been important
advances in the treatment of serious eye diseases such as wet AMD, which is the
leading cause of vision loss and blindness among people over age 65. However,
there continues to be a need for additional treatment options. We look forward
to working together with Bayer to aggressively develop the VEGF Trap-Eye for
wet AMD, diabetic eye disease, and other eye diseases with unmet medical
needs.
About Wet AMD and the VEGF Trap-Eye
Age-related Macular Degeneration (AMD) and diabetes are the leading
non-infectious causes of acquired blindness. Patients with these conditions
can experience a gradual loss of vision due to the development of abnormal,
fragile new blood vessels in the back of the eye. There is a particular type
of AMD called wet AMD which accounts for approximately 90% of AMD-related
blindness, despite constituting only 10% of cases of AMD. Approximately 1.5
million people are affected with wet AMD in the United States and at least an
equal number in the rest of the world.
The development of the blood vessels which contribute to these conditions is in
part due to a secreted protein called Vascular Endothelial Growth Factor, or
VEGF.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, which lead to the
development of a number of eye diseases, such as wet AMD.
The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that
binds all forms of VEGF-A and related placental growth factor (PlGF). The VEGF
Trap-Eye is designed to block the interaction of these growth factors with
cell-surface receptors, thereby preventing the subsequent formation of the new
blood vessels that play an important role in the development of eye diseases
such as wet AMD. Currently the VEGF Trap is in a Phase II clinical trial for
the treatment of patients with wet AMD and a Phase I trial for the treatment of
patients with diabetic macular edema (DME).
About Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, Inc. 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. For more information on Regeneron, visit the Companys web site at
www.regeneron.com.
About Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the worlds leading,
innovative companies in the healthcare and medical products industry and is
based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to
some 9.4 billion euros and employed 33.800 people worldwide in 2005. The
company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new
Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and
Pharmaceutical divisions. Bayer Pharmaceuticals now has three business units:
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Hematology/Cardiology, Oncology and Primary Care. Bayer HealthCares aim is to
discover and manufacture products that will improve human and animal health
worldwide. The products enhance well-being and quality of life by diagnosing,
preventing and treating diseases.
Forward Looking Statements
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 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, 2005 and its 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.
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in our public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission (including our
Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.
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Media
Contacts: |
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Lauren Tortorete
Regeneron 1.212.845.5609 |
Dr. Michael Diehl Bayer
HealthCare + 49 214 30 58532
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Investor Relations: |
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Charles Poole Regeneron 1.914.345.7640
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