UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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): May 13, 2010 (May 12, 2010) |
| 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:
| c | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| c | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| c | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| c | 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 May 12, 2010, Regeneron Pharmaceuticals, Inc. issued a press release
reporting preliminary clinical trial results for two antibody product candidates
in development, REGN727, a fully human antibody that targets Proprotein
Convertase Subtilisin/Kexin type 9 (PCSK9), and REGN475, a fully human antibody
that targets nerve growth factor (NGF). A copy of this press release is filed as
Exhibit 99.1 to this Form 8-K and is incorporated herein by
reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release dated May 12, 2010.
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: May 13, 2010 | REGENERON PHARMACEUTICALS, INC. | ||
| By: | /s/ Stuart Kolinski | ||
| Name: | Stuart Kolinski | ||
| Title: | Senior Vice President and General Counsel | ||
Exhibit
Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated May 12, 2010. |
|
Exhibit 99.1
|
|
| FOR IMMEDIATE RELEASE | |
| Press Release |
|
Regeneron Provides Initial Data on Two
Antibody Product Candidates
More corporate and clinical updates to be
provided during company’s first Investor Day on July 15, 2010
Tarrytown, New York (May 12,
2010) -- Regeneron
Pharmaceuticals, Inc. (Nasdaq: REGN) today provided an
update on two antibody product candidates in its pipeline and scheduled its
first Investor Day to be held in New York City on July 15, 2010. Both product
candidates, REGN727 (SAR236553)
and, REGN475 (SAR164877) are
being developed with sanofi-aventis under a global, strategic collaboration to
discover, develop, and commercialize fully human antibodies.
REGN727 (Anti-PCSK9)
REGN727 is a fully human antibody that targets Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), a naturally-occurring molecule involved in regulating cholesterol levels by modulating low-density lipoprotein (LDL) cholesterol receptors. In an interim efficacy analysis of a dose-escalating, randomized, double-blind, placebo-controlled, Phase 1 trial in healthy volunteers, REGN727 achieved substantial, dose dependent decreases of LDL (bad) cholesterol. The trial is ongoing with both intravenous and subcutaneous routes of administration being studied. At the highest dose tested to date, there was a highly significant lowering of mean LDL cholesterol that lasted for more than one month following a single dose, with a maximum mean reduction of more than 60%. There have been no serious adverse events and no dose limiting toxicities observed. Dose escalation is ongoing. Additional data will be presented at an upcoming Investor Day event.
REGN727 is a fully human antibody that targets Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), a naturally-occurring molecule involved in regulating cholesterol levels by modulating low-density lipoprotein (LDL) cholesterol receptors. In an interim efficacy analysis of a dose-escalating, randomized, double-blind, placebo-controlled, Phase 1 trial in healthy volunteers, REGN727 achieved substantial, dose dependent decreases of LDL (bad) cholesterol. The trial is ongoing with both intravenous and subcutaneous routes of administration being studied. At the highest dose tested to date, there was a highly significant lowering of mean LDL cholesterol that lasted for more than one month following a single dose, with a maximum mean reduction of more than 60%. There have been no serious adverse events and no dose limiting toxicities observed. Dose escalation is ongoing. Additional data will be presented at an upcoming Investor Day event.
REGN475 (Anti-NGF)
REGN475 is a fully human antibody that selectively targets nerve growth factor (NGF), a naturally-occurring molecule demonstrated to modulate pain. In an interim efficacy analysis of a randomized, double-blind, four-arm, placebo-controlled Phase 2 trial, in 217 patients with osteoarthritis of the knee, REGN475 demonstrated significant improvements at the two highest doses tested as compared to placebo in average walking pain scores over 8 weeks following a single intravenous infusion (p<0.01). Pain was measured by the Numeric Rating Scale (NRS), as well as the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function subscales.
REGN475 is a fully human antibody that selectively targets nerve growth factor (NGF), a naturally-occurring molecule demonstrated to modulate pain. In an interim efficacy analysis of a randomized, double-blind, four-arm, placebo-controlled Phase 2 trial, in 217 patients with osteoarthritis of the knee, REGN475 demonstrated significant improvements at the two highest doses tested as compared to placebo in average walking pain scores over 8 weeks following a single intravenous infusion (p<0.01). Pain was measured by the Numeric Rating Scale (NRS), as well as the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function subscales.
The primary endpoint of
this study is safety, and REGN475 was generally well tolerated. Serious
treatment emergent adverse events were rare and balanced between placebo and
drug arms with three events (5.5%) in the placebo group and four events (2.5%)
in the combined REGN475 groups. The most frequent adverse events reported among
patients receiving REGN475 included sensory abnormalities, arthralgias,
hyper/hypo-reflexia, peripheral edema, and injection site reactions. The types
and frequencies of adverse events reported were similar to those previously
reported from other investigational studies involving an anti-NGF antibody.
Additional data, which will include results following a second infusion at week
8, will be presented at an upcoming Investor Day event.
Preliminary analysis of
interim efficacy data from a Phase 2 trial of REGN 475 in the acute setting of
nerve root compression induced pain (acute sciatica) suggests that REGN475
therapy will not be effective in this setting.
“We are extremely pleased by the productivity
of our antibody collaboration with sanofi-aventis, and the progress of the NGF
and PCSK9 antibodies, in particular,” said Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer. “The collaboration is not yet three years
old, and we have been able to advance five antibodies into the clinic,
highlighting the power of our VelocImmune® technology. Both
REGN727 and REGN475 are being developed to address areas of high unmet medical
need and represent important new additions to our clinical
pipeline.”
Regeneron will provide
additional corporate and clinical updates at its first Investor Day in New York
City on July 15.
About REGN727
(Anti-PCSK9)
Coronary artery disease (CAD) remains the leading cause of death in the U.S. for both men and women and is a leading cause of death across the developed world. LDL cholesterol levels in the blood have been shown to correlate with coronary artery disease risk, and lowering LDL has been proven to reduce the risk of cardiac events, such as death and heart attacks, in patients with CAD. However, despite the relatively wide use of LDL cholesterol-lowering therapies, including the statin class of agents, coronary artery disease remains a leading cause of morbidity and mortality. REGN727 is a fully human monoclonal antibody intended to robustly lower LDL cholesterol through a novel mechanism of action. REGN727 is targeted at inhibiting PCSK9, which results in prevention of the degradation of LDL receptors in the liver and facilitates LDL clearance from the systemic circulation, thereby lowering LDL levels in the blood.
Coronary artery disease (CAD) remains the leading cause of death in the U.S. for both men and women and is a leading cause of death across the developed world. LDL cholesterol levels in the blood have been shown to correlate with coronary artery disease risk, and lowering LDL has been proven to reduce the risk of cardiac events, such as death and heart attacks, in patients with CAD. However, despite the relatively wide use of LDL cholesterol-lowering therapies, including the statin class of agents, coronary artery disease remains a leading cause of morbidity and mortality. REGN727 is a fully human monoclonal antibody intended to robustly lower LDL cholesterol through a novel mechanism of action. REGN727 is targeted at inhibiting PCSK9, which results in prevention of the degradation of LDL receptors in the liver and facilitates LDL clearance from the systemic circulation, thereby lowering LDL levels in the blood.
About REGN475
(Anti-NGF)
Despite the availability of several classes of pain relievers, millions of Americans continue to suffer from moderate to severe pain due to a variety of medical disorders (e.g., osteoarthritis, cancer, inflammation, neuropathic diseases, etc.). In addition to inadequate pain relief, patients may be exposed to the adverse effects of various pain medications, including gastrointestinal distress and bleeding, renal effects, interference with control of high blood pressure by antihypertensive agents, change in cognition, and constipation. REGN475 is a fully human monoclonal antibody against NGF (nerve growth factor), which is designed to block pain sensitization in neurons. The efficacy and safety of REGN475 are being evaluated in several Phase 2 studies in short-term pain settings, as well in the treatment of moderate to severe pain caused by osteoarthritis.
Despite the availability of several classes of pain relievers, millions of Americans continue to suffer from moderate to severe pain due to a variety of medical disorders (e.g., osteoarthritis, cancer, inflammation, neuropathic diseases, etc.). In addition to inadequate pain relief, patients may be exposed to the adverse effects of various pain medications, including gastrointestinal distress and bleeding, renal effects, interference with control of high blood pressure by antihypertensive agents, change in cognition, and constipation. REGN475 is a fully human monoclonal antibody against NGF (nerve growth factor), which is designed to block pain sensitization in neurons. The efficacy and safety of REGN475 are being evaluated in several Phase 2 studies in short-term pain settings, as well in the treatment of moderate to severe pain caused by osteoarthritis.
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 Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
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 Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. 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. These include, among others,
risks and timing 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 (a number of
other companies are developing product candidates targeting PCSK9 and NGF and we
expect these areas to be highly competitive), 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 terminated without any product success, and risks associated with
third party intellectual property. 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, 2009 and Form 10-Q for the quarter ended March 31, 2010.
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:
| Michael Aberman, M.D. | Peter Dworkin |
| Investor Relations | Corporate Communications |
| 914.345.7799 | 914.345.7640 |
| michael.aberman@regeneron.com | peter.dworkin@regeneron.com |