UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 29, 2008 (February 27, 2008)
REGENERON PHARMACEUTICALS, INC.
| New York | 000-19034 | 13-3444607 | ||
| (State or other jurisdiction of | (Commission File No.) | (IRS Employer Identification No.) | ||
| Incorporation) |
777 Old Saw Mill River Road, Tarrytown, New York 10591-6707
(Address of principal executive offices, including zip code)
(914) 347-7000
(Registrant’s 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:
| 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)) |
Item 8.01 Other Events.
On February 27, 2008, Regeneron Pharmaceuticals, Inc. issued a press release
announcing it received marketing approval from the U.S. Food and Drug Administration for ARCALYST™
(rilonacept) Injection for Subcutaneous Use, an interleukin-1 blocker, for the treatment of
Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome
(FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. A copy of this press
release is filed as Exhibit 99.1 to this Report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press Release dated February 27, 2008. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 29, 2008 | REGENERON PHARMACEUTICALS, INC. |
|||
| By: | /s/ Stuart Kolinski | |||
| Name: | Stuart Kolinski | |||
| Title: | Senior Vice President and General Counsel | |||
Exhibit Index
| Number | Description | |
| 99.1 | Press Release dated February 27, 2008. |
Exhibit 99.1
FDA Approves Regeneron’s ARCALYST™ (rilonacept) for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
First therapy approved for this rare, hereditary, inflammatory disease
Regeneron to host conference call on Thursday morning, February 28, 2008 at 8:30 a.m. Eastern Time
Tarrytown, NY (February 27, 2008) — Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today
announced it has received marketing approval from the U.S. Food and Drug Administration (FDA) for
ARCALYST™ (rilonacept) Injection for Subcutaneous Use, an interleukin-1 blocker, for the treatment
of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory
Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. ARCALYST is
the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory
conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye
redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at
any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
ARCALYST is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS.
In the pivotal clinical development program, patients treated with ARCALYST experienced a greater
improvement in overall symptom scores than patients treated with placebo. These improvements were
sustained over time with continued ARCALYST treatment. The most commonly reported adverse
reactions reported with ARCALYST were injection-site reaction and upper respiratory tract
infection.
“The approval of ARCALYST represents a major advance in the treatment of CAPS patients,” said Hal
Hoffman, M.D., Associate Professor, University of California, San Diego and a leading expert on
CAPS. “Much-needed treatment will now be available to patients suffering from debilitating CAPS
symptoms. I hope that the approval of ARCALYST will also contribute to increased awareness of this
rare disease which currently is frequently misdiagnosed and insufficiently treated.”
Regeneron expects to launch ARCALYST, its first commercial product, within the next 30 days.
“This approval exemplifies Regeneron’s commitment to discover, develop, and commercialize important
medicines for patients suffering from serious diseases, such as CAPS. I would like to
take this opportunity to thank the clinical investigators and CAPS patients participating in our
studies, the FDA, and everyone at Regeneron for their collaborative effort in making ARCALYST
available to patients who need it,” said Leonard S. Schleifer, M.D., Ph.D., Regeneron’s president
and chief executive officer. “We recognize that ARCALYST may help address a significant unmet
medical need that exists among CAPS patients and are therefore committed to helping these patients
obtain access to this new treatment.”
About Cryopyrin-Associated Periodic Syndromes (CAPS)
Recently, medical researchers have identified and described a group of rare, inherited,
auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three
related conditions make up the broader disease known as CAPS: Familial Cold Auto-inflammatory
Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease
(NOMID). ARCALYST is not indicated for use in, and has not been studied in, patients with NOMID.
CAPS are characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye
redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at
any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
CAPS are generally caused by autosomal-dominant mutations (changes) in the NLRP-3 (previously known
as CIAS1) gene and resultant alterations in the protein, cryopyrin, which it encodes. Cryopyrin,
active in circulating, infection-fighting, white blood cells, controls the production of a protein
called interleukin-1 (IL-1). As part of the body’s infection-fighting defense system, IL-1
circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory
cells. Researchers have found that alterations in the cryopyrin protein lead to over-production of
IL-1, resulting in an inflammatory response and the symptoms of CAPS. Most, but not all, patients
with CAPS have the NLRP-3 gene mutation.
The incidence of CAPS has been reported to be approximately 1 in 1,000,000 people in the United
States.
About ARCALYST™ (rilonacept)
ARCALYST is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in
Cryopyrin-Associated Periodic Syndromes (CAPS). In the pivotal clinical development program for
ARCALYST, change in disease activity was measured using a composite symptom score composed of a
daily evaluation of rash, feelings of fever/chills, joint pain, eye redness/pain, and fatigue.
Patients treated with ARCALYST experienced an improvement in overall symptom scores as compared
with patients treated with placebo. These improvements were sustained over time with continued
treatment with ARCALYST. The most commonly reported adverse reactions reported with ARCALYST were
injection-site reaction and upper respiratory tract infection.
ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS),
including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in
adults and children 12 and older. IL-1 blockade may interfere with immune response to infections.
Serious, life-threatening infections have been reported in patients taking
ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking
ARCALYST with tumor necrosis factor inhibitors is not recommended because this may increase the
risk of serious infections. Treatment with ARCALYST should not be initiated in patients with
active or chronic infections. Patients should not receive a live vaccine while taking ARCALYST.
It is recommended that patients receive all recommended vaccinations prior to initiation of
treatment with ARCALYST. Patients should be monitored for changes in their lipid profiles and
provided with medical treatment if warranted. Hypersensitivity reactions associated with
ARCALYST™ (rilonacept) administration have been rare. Please see the full Prescribing Information
for ARCALYST, available online at www.regeneron.com/ARCALYST-fpi.pdf
Conference Call
Dr. Leonard Schleifer, President and Chief Executive Officer of Regeneron, and other members of
senior management will host a conference call to discuss the approval to market ARCALYST. The
interactive call will be held at 8:30 a.m. Eastern Time on Thursday, February 28, 2008 and can be
accessed live through the Regeneron website at www.regeneron.com on the presentations page of the
Investor Relations section. The call, including the question and answer session, can also be
accessed by dialing:
Domestic Dial-in Number: (800) 798-2884
International Dial-in Number: (617) 614-6207
Participant Passcode: 19033960
International Dial-in Number: (617) 614-6207
Participant Passcode: 19033960
An archived version of the conference call will be available for 30 days on the company’s website
at www.regeneron.com on the presentations page of the Investor Relations section.
About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and commercializes therapeutic
medicines for the treatment of serious medical conditions. In addition to ARCALYST, its first
commercialized product, Regeneron has therapeutic candidates for the potential treatment of cancer,
eye diseases, and inflammatory diseases and has preclinical programs in other diseases and
disorders. Additional information about Regeneron and recent news releases are available on
Regeneron’s website at www.regeneron.com.
Forward Looking Statement
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 Regeneron’s filings with the United States
Securities and Exchange Commission (SEC), including its Form 10-K for the year ended
December 31, 2007. 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.
# # #
Contact Information: |
||
Charles Poole
|
Laura Lindsay | |
Vice President, Investor Relations
|
Media Relations | |
914.345.7640
|
914.345.7800 | |
charles.poole@regeneron.com
|
laura.lindsay@regeneron.com | |
| Lauren Tortorete | ||
| Media Relations | ||
| 212.845.5609 | ||
| ltortorete@biosector2.com |