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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
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2007 (November 1, 2007)
REGENERON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| New York | 000-19034 | 13-3444607 | ||
| (State or other jurisdiction of Incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
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)) |
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| Item 8.01 Other Events. | ||||||||
| Item 9.01 Financial Statements and Exhibits. | ||||||||
| SIGNATURES | ||||||||
| Exhibit Index | ||||||||
| EX-99.1: PRESS RELEASE | ||||||||
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Item 8.01 Other Events.
On November 1, 2007, Regeneron Pharmaceuticals, Inc. issued a press release
announcing that it received notification earlier in the day from the U.S. Food and Drug
Administration (FDA) that the action date for FDA’s priority review of the Biologics License
Application (BLA) for rilonacept, the Interleukin-1 (IL-1) Trap, for the long-term treatment of
Cryopyrin-Associated Periodic Syndromes (CAPS) has been extended three months to February 29, 2008.
A copy of this press release is attached as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release dated November 1, 2007.
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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: November 2, 2007 | REGENERON PHARMACEUTICALS, INC. |
|||
| By: | /s/ Stuart Kolinski | |||
| Name: | Stuart Kolinski | |||
| Title: | Senior Vice President and General Counsel | |||
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Exhibit 99.1
Press Release
FOR IMMEDIATE RELEASE
PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA
Action Date on Biologics License Application Extended to February 29, 2008
Tarrytown, NY (November 1, 2007) — Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today
that it received notification earlier in the day from the United States Food and Drug
Administration (FDA) that the action date for FDA’s priority review of the Biologics License
Application (BLA) for rilonacept (IL-1 Trap) for the long-term treatment of Cryopyrin-Associated
Periodic Syndromes (CAPS) has been extended to February 29, 2008. The original action date under
the Prescription Drug User Fee Act (PDUFA) for the BLA was November 29, 2007.
On October 16, 2007, the FDA requested supplemental chemistry, manufacturing and controls
information. Regeneron provided this information to the FDA on October 26, 2007. The FDA
considers this additional information to be a major amendment to the rilonacept BLA, allowing the
extension of the action date under PDUFA regulations.
About Rilonacept
Interleukin-1 (IL-1) is a protein secreted by certain cells in the body. In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body’s immune system. In excess, it can be harmful and has been shown to be a key driver of inflammation in a variety of diseases, including CAPS.
Interleukin-1 (IL-1) is a protein secreted by certain cells in the body. In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body’s immune system. In excess, it can be harmful and has been shown to be a key driver of inflammation in a variety of diseases, including CAPS.
Rilonacept is a potent, long-acting, investigational agent that inhibits IL-1. It is designed to
attach to and neutralize IL-1 in the blood stream before the IL-1 can attach to cell-surface
receptors and generate signals that can trigger disease activity in body tissue. Once attached to
rilonacept, IL-1 cannot bind to the cell-surface receptors and, together with rilonacept, is
flushed from the body.
About Cyropyrin-Associated Periodic Syndromes (CAPS)
Cryopyrin-Associated Periodic Syndromes (CAPS) is a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). These autoinflammatory diseases are characterized by spontaneous and environmentally triggered systemic inflammation. Inflammatory symptoms in patients with FCAS and MWS include fever, chills, rash, fatigue, joint pain, and eye redness. Currently, there are no medicines approved for the treatment of CAPS.
Cryopyrin-Associated Periodic Syndromes (CAPS) is a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). These autoinflammatory diseases are characterized by spontaneous and environmentally triggered systemic inflammation. Inflammatory symptoms in patients with FCAS and MWS include fever, chills, rash, fatigue, joint pain, and eye redness. Currently, there are no medicines approved for the treatment of CAPS.
CAPS is caused by a range of mutations in the gene CIAS1 (also known as NALP3) that encodes a
protein named cryopyrin. This gene, and its causal relationship to FCAS and MWS, was discovered by
Dr. Hal Hoffman and colleagues at the University of California at San Diego. Dr. Hoffman and
others have studied the ability of IL-1 blocking agents to reduce signs and symptoms of CAPS, and
Dr. Hoffman served as the key advisor in the design and conduct of the Phase 3 rilonacept CAPS
program.
CAPS has been reported primarily in North America and Europe. There are no reliable prevalence
statistics for this disease. We estimate that the number of patients with CAPS in the United
States is between 200 and 500.
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 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 worldwide web site at www.regeneron.com
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 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 worldwide web site at www.regeneron.com
Forward Looking Statement — Regeneron
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-Q for the quarter ended June 30, 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.
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-Q for the quarter ended June 30, 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.
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Contact Information: |
||
Charles Poole |
Laura Lindsay | |
Investor Relations |
Corporate Communications | |
914.345.7640 |
914.345.7800 | |
charles.poole@regeneron.com |
laura.lindsay@regeneron.com | |
| Kimberly Chen | ||
| Media Relations | ||
| 212.845.5634 | ||
| kchen@biosector2.com |