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): June 11, 2009 (June 8, 2009) |
| REGENERON PHARMACEUTICALS, INC. |
| (Exact Name of Registrant as Specified in Charter) |
| 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 1.01 Entry into a Material Definitive Agreement.
Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into two agreements with Novartis Pharma AG and Novartis Pharmaceuticals Corporation (collectively, “Novartis”), effective June 8, 2009, terminating and replacing a March 2003 Collaboration, License and Option Agreement (the “2003 Collaboration Agreement”). Under the 2003 Collaboration Agreement, Regeneron had the right to opt in to the development and commercialization, including the right to receive a specified share of the profits from sales, of Novartis’ interleukin-1 (IL-1) antibody product candidate, and Novartis had the right to opt in to the development and commercialization, including the right to receive a specified share of the profits from sales, of Regeneron’s second-generation IL-1 Trap.
Under the first agreement, called the IL-1 Antibody Termination Agreement, the parties terminated the 2003 Collaboration Agreement, including the opt-in rights discussed above. In exchange for eliminating Regeneron’s right to opt in to the development and commercialization of Novartis’ IL-1 antibody product candidate, Novartis agreed to pay Regeneron tiered royalties on future aggregate, worldwide annual net sales (“annual sales”) of certain Novartis IL-1 antibody products, including canakinumab (ACZ885), a fully human IL-1 antibody currently under regulatory review to treat cryopyrin-associated periodic syndrome (CAPS). The multi-tiered royalty rates in the agreement start at 4% and reach 15% when annual sales exceed $1.5 billion.
Under the second agreement, called the Trap-2 Termination Agreement, in exchange for eliminating Novartis’ right to opt in to the development and commercialization of Regeneron’s second generation IL-1 Trap, Regeneron agreed to pay Novartis tiered royalties on any future worldwide net sales of certain IL-1 blocking products sold by Regeneron, with the exception of Regeneron’s IL-1 Trap (also known as ARCALYST® (rilonacept) Injection for Subcutaneous Use), which is marketed and sold in the United States for the treatment of CAPS and is in Phase 3 clinical trials for the treatment of gout. In February 2004, Novartis terminated the 2003 Collaboration Agreement with respect to Regeneron’s IL-1 Trap. The royalty terms under the Trap-2 Termination Agreement are identical to those of the IL-1 Antibody Termination Agreement based on aggregate, worldwide, annual net sales of Regeneron’s covered products.
The press release dated June 11, 2009 issued by Regeneron announcing the execution of the two agreements by Regeneron and Novartis is attached as Exhibit 99.1 and is incorporated by reference into this Item 1.01.
Item 1.02 Termination of a Material Definitive Agreement.
The information set forth under Item 1.01, including the press release dated June 11, 2009 and attached as Exhibit 99.1, is incorporated by reference into this Item 1.02. The parties determined that it was in their best interest to terminate the 2003 Collaboration Agreement and replace it with the IL-1 Antibody Termination Agreement and the Trap-2 Termination Agreement as described under Item 1.01 above.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release dated June 11, 2009.
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: June 11, 2009 | 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 June 11, 2009 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
| Press Release |
Regeneron Converts Interleukin-1 Antibody Opt-In Rights to Royalty Agreement
Tarrytown, NY (June 11, 2009) -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today that it has entered into two royalty agreements with Novartis Pharma AG that replace a previous collaboration and license agreement.
Under the first royalty agreement, Regeneron is entitled to receive royalties on worldwide sales of Novartis’ canakinumab (ACZ885), a fully human anti-interleukin-IL1ß antibody currently under regulatory review to treat cryopyrin-associated periodic syndrome (CAPS) and in development for other inflammatory diseases. On the basis of the same agreement Regeneron waives its rights to opt-in to the development and commercialization of canakinumab.
Under the second royalty agreement, Novartis is entitled to receive royalties on worldwide sales of a second-generation interleukin-1 Trap, should Regeneron decide to proceed in the development of this Trap.
The financial terms of both agreements are identical in relation to stepped royalties to be paid on the basis of future sales. They do not include any upfront or milestone payments or any sharing of development expenses.
The royalty agreements replace a 2003 collaboration and license agreement under which Regeneron had the right to opt in to the development and commercialization of Novartis’ interleukin-1 antibody and Novartis had the right to opt in to the development and commercialization of Regeneron’s second-generation interleukin-1 Trap. That collaboration and license agreement has been terminated.
About Regeneron
Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company
that discovers, develops, and commercializes medicines for the treatment of
serious medical conditions. In addition to ARCALYST® (rilonacept)
Injection for Subcutaneous Use, its first commercialized product, Regeneron has
therapeutic candidates in clinical trials for the potential treatment of cancer,
eye diseases, inflammatory diseases, and pain, and has preclinical programs in
other diseases and disorders. Additional information about Regeneron and recent
news releases are available on Regeneron’s web site at
www.regeneron.com.
Forward Looking
Statement
This news release discusses
historical information and includes forward-looking statements about Regeneron
and its products, development programs, finances, and business, all of which
involve a number of risks and uncertainties, such as risks associated with
preclinical and clinical development of Regeneron’s drug candidates,
determinations by regulatory and administrative governmental authorities which
may delay or restrict Regeneron’s ability to continue to develop or
commercialize its product and drug candidates, competing drugs that are superior
to Regeneron’s product and drug candidates, uncertainty of market acceptance of
Regeneron’s product and drug candidates, unanticipated expenses, the
availability and cost of capital, the costs of developing, producing, and
selling products, the potential for any collaboration agreement, including
Regeneron’s 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, 2008 and Form 10-Q for
the quarter ended March 31, 2009. 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.
###
| Contacts Information: | |
| Peter Dworkin | Laura Lindsay |
| Investor Relations | Media Relations |
| 914.345.7640 | 914.345.7800 |
| peter.dworkin@regeneron.com | laura.lindsay@regeneron.com |
| Olga Flemming | |
| Media Relations | |
| 212.845.5636 | |
| oflemming@biosector2.com | |