02/21/2012
suto gout Regeneron Reports Fourth Quarter and Full Year 2011 Financial and Operating Results
/=5ULN, and one patient discontinued therapy due to a hypersensitivity reaction (rash).
Regeneron has filed an sBLA for EYLEA in central retinal vein occlusion (CRVO) in the United States, and was granted a Prescription Drug User Free Act (PDUFA) date of September 23, 2012. Bayer HealthCare plans to submit a similar regulatory application outside the United States in 2012 or early 2013.
2011 was a milestone year for Regeneron led by the approval and launch of EYLEA for the treatment of wet age-related macular degeneration in the United States, said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. The EYLEA launch is off to a strong start, with net sales of $24.8 million from launch on November 21 through December 31, 2011. We look to continue to build on this success through 2012, and we now forecast 2012 U.S. EYLEA net product sales of $250 million to $300 million.
suto gout Regeneron Reports Fourth Quarter and Full Year 2011 Financial and Operating Results,Welcome, $UserDisplayName
ARCALYST is a fusion protein that blocks the cytokine interleukin-1 (IL-1). ARCALYST is currently available for prescription in the United States 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. CAPS is a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and tigue.
TABLE 2 REGENERON PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) For the three months For the year ended December 31, ended December 31, 2011 2010 2011 2010 -------- -------- --------- --------- Revenues Sanofi collaboration revenue $ 77,032 $ 82,137 $ 326,609 $ 311,332 Other collaboration revenue 9,374 34,910 43,072 75,393 Net product sales 29,752 5,269 44,686 25,254 Technology licensing 5,892 10,038 24,858 40,150 Contract research and other 927 1,321 6,599 6,945 -------- -------- --------- --------- 122,977 133,675 445,824 459,074 -------- -------- --------- --------- Expenses Research and development 129,041 125,212 529,506 489,252 Selling, general, and administrative 36,349 20,641 117,261 65,201 Cost of goods sold 2,989 599 4,216 2,093 -------- --------- --------- 168,379 146,452 650,983 556,546 -------- -------- --------- --------- Loss from operations (45,402) (12,777) (205,159) (97,472) -------- -------- --------- --------- Other income (expense) Investment income 799 638 3,549 2,122 Interest expense (9,455) (2,458) (21,282) (9,118) (8,656) (1,820) (17,733) (6,996) -------- -------- --------- --------- Net loss before income tax benefit (54,058) (14,597) (222,892) (104,468) Income tax benefit (615) (1,132) -------- --------- Net loss $ (53,443) $ (14,597) $ (221,760) $ (104,468) Net loss per share, basic and diluted $ (0.58) $ (0.17) $ (2.45) $ (1.26) Weighted average shares outstanding, basic and diluted 91,797 87,405 90,610 82,926
REGN728, whose target remains undisclosed, is in a Phase 1 study.
- EYLEA® (aflibercept) Injection Launched in U.S.; Over 30,000 Vials Shipped to Physicians Since Launch - Full Year 2012 EYLEA U.S. Sales Forecast Increased from $140 - $160 million to $250 - $300 million - Consistent with Pre-announced Sales, EYLEA Net Product Sales were $24.8 million in Fourth Quarter 2011 - Two Supplemental Biologics License Applications Submitted in Fourth Quarter 2011
The Company reported total revenues of $123.0 million for the fourth quarter and $445.8 million for the year ended December 31, 2011. This includes EYLEA net product sales of $24.8 million for the fourth quarter of 2011. The Company reported a non-GAAP net loss of $34.0 million, or $0.37 per share (basic and diluted), for the fourth quarter and a non-GAAP net loss of $161.7 million, or $1.79 per share (basic and diluted), for the year ended December 31, 2011. Non-GAAP net loss excludes non-cash share-based compensation expense and non-cash interest expense related to the Companys convertible senior notes. The Company reported a GAAP net loss of $53.4 million, or $0.58 per share (basic and diluted), for the fourth quarter and a GAAP net loss of $221.8 million, or $2.45 per share (basic and diluted), for the year ended December 31, 2011.
In November 2011, Regeneron announced preliminary results from the Phase 2 heFH trial. In the primary efficacy analysis of the study, after 12 weeks of treatment, patients who received different dosing regimens of REGN727 achieved mean LDL cholesterol reductions from baseline ranging from approximately 30% to greater than 65%, depending on the dosing regimen of REGN727, compared to a mean reduction of 10% with placebo (p
Sarilumab (REGN88), an antibody to the interleukin-6 receptor (IL-6R), is in the Phase 3 stage of a Phase 2/3 study (MOBILITY) in rheumatoid arthritis (RA).
In July 2011, Regeneron and Sanofi announced results from Phase 2b trials in RA with sarilumab. The Phase 2b MOBILITY trial in RA demonstrated that patients treated with sarilumab in combination with a standard RA treatment, methotrexate (MTX), achieved a significant and clinically meaningful improvement in signs and symptoms of moderate-to-severe RA compared to patients treated with MTX alone. The MOBILITY study is a 306-patient, dose-ranging, multi-national, randomized, multi-arm, double-blind, placebo-controlled study, that compared five different dose regimens of sarilumab in combination with MTX to placebo plus MTX. The most common adverse events (>5%) reported more frequently in active treatment arms included infections (non-serious), neutropenia, and liver function test abnormalities. The types and frequencies of adverse events were consistent with those previously reported with IL-6 inhibition. The incidence of serious adverse events among the five sarilumab treatment groups and placebo group were comparable. Sarilumab also demonstrated significant benefit compared to placebo in secondary endpoints, including ACR 50, ACR 70, and DAS 28 scores, additional measures of clinical activity used in RA trials.
REGN668, an antibody to the interleukin-4 receptor (IL-4R), a target for allergic and immune conditions, is in a Phase 1b study in patients with atopic dermatitis and a Phase 2 study in eosinophilic asthma.
Cost of Goods Sold (COGS): In 2011,
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COGS was $3.0 million for the fourth quarter and $4.2 million for the full year 2011, compared to $0.6 million for the fourth quarter and $2.1 million for the full year 2010. The increase in COGS in 2011 was primarily due to the launch of EYLEA in the fourth quarter of 2011.ARCALYST® (rilonacept) - Gout
0.05 for all dose groups). In this trial, REGN727 was generally well tolerated over 12 weeks. The most common adverse event was injection site reaction and there were no serious adverse events on active treatment. Additional data from the 8-week post-treatment safety monitoring period will be presented at a future medical congress upon final analysis.
TARRYTOWN, N.Y., Feb. 13, 2012 /PRNewswire via COMTEX/ --Regeneron Pharmaceuticals, Inc.today announced financial and operating results for the fourth quarter and full year 2011 and provided an update on development programs.
Based upon these positive results from the VELOUR study, regulatory applications for marketing approval of ZALTRAP were submitted to the FDA and European Medicines Agency.
REGN421, an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.
Regeneron and Sanofi are finalizing plans for initiating a Phase 3 program for REGN727.
REGN475, an antibody to nerve growth ctor (NGF), has completed a Phase 2 trial in osteoarthritis of the knee. In December 2010, the FDA informed the Company that a case confirmed as avascular necrosis of a joint was seen in another companys anti-NGF prsuto gout Regeneron Reports Fourth Quarter and Full Year 2011 Financial and Operating Resultsogram. The FDA believes this case, which follows previously-reported cases of joint replacements in patients on an anti-NGF drug candidate being developed by another pharmaceutical company, provides evidence to suggest a class-effect and placed REGN475 on clinical hold. An FDA Arthritis Advisory Committee is scheduled to meet on March 12, 2012 to discuss possible safety issues related to anti-NGF compounds. There are currently no ongoing trials with REGN475 that are either enrolling or treating patients.
REGN910, an antibody to angiopoietin-2 (ANG2), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.
Contacts Information: Michael Aberman, M.D. Peter Dworkin Investor Relations Corporate Communications 914.847.7799 914.847.7640 michael.aberman@regeneron.com peter.dworkin@regeneron.com
ZALTRAP, also known as VEGF Trap, is a fusion protein that is designed to bind VEGF-A, VEGF-B, and PlGF, proteins that are involved in the abnormal growth of new blood vessels in solid tumors. ZALTRAP is being developed worldwide by Regeneron and its collaborator Sanofi for the potential treatment of patients with solid tumors.
TABLE 3 REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET LOSS TO NON-GAAP NET LOSS (Unaudited) (In thousands, except per share data) For the three months For the year ended December 31, ended December 31, 2011 2010 2011 2010 ----------- ----------- ----------- ------------------- GAAP net loss $ (53,443) $ (14,597) $ (221,7
Conference Call Information
TABLE 1 REGENERON PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (Unaudited) (In thousands) December 31, December 31, 2011 2010 ------------ ------------ ASSETS Cash, restricted cash, and marketable securities $ 810,550 $ 626,939 Accounts receivable from Sanofi 74,781 79,603 Accounts receivable - trade, net 28,254 2,314 Property, plant, and equipment, net 367,955 347,450 Other assets 42,043 33,126 ------------ ------------ Total assets $ 1,323,583 $ 1,089,432 LIABILITIES AND STOCKHOLDERS EQUITY Accounts payable, accrued expenses, and other liabilities $ 102,068 $ 61,008 Deferred revenue 300,250 340,579 Facility lease obligations 160,514 160,030 Convertible senior notes 275,019 Stockholders equity 485,732 527,815 ------------ ------------ Total liabilities and stockholders equity $ 1,323,583 $ 1,089,432
Product Revenues: Net product sales were $29.8 million for the fourth quarter and $44.7 million for the full year 2011, compared to net product sales of $5.3 million for the fourth quarter and $25.3 million for the full year 2010. The increase in net product sales is due to the approval and launch of EYLEA in November 2011. EYLEA net product sales for the fourth quarter and full year 2011 were $24.8 million. ARCALYST net product sales for the fourth quarter 2011 were $5.0 million, compared to $5.3 million for the fourth quarter 2010. ARCALYST net product sales for the full year 2011 were $19.9 million, compared to $25.3 million for the full year 2010 which included $20.5 million of ARCALYST net product sales made during 2010 and $4.8 million of previously deferred net product sales.
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2011 financial and operating results on Monday, February 13, 2012, at 8:30 AM. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link suto goutto the webcast may be accessed from the Events and Presentations page of Regenerons website at . A replay of the conference call and webcast will be archived on the Companys website and will be available for 30 days.
Non-GAAP and GAAP Net Loss: The Company reported a non-GAAP net loss of $34.0 million, or $0.37 per share (basic and diluted), for the fourth quarter 2011, compared to a non-GAAP net loss of $1.1 million, or $0.01 per share (basic and diluted), for the fourth quarter 2010. The Company had a non-GAAP net loss of $161.7 million, or $1.79 per share (basic and diluted), for the year ended 2011, compared to a non-GAAP net loss of $64.6 million, or $0.78 per share (basic and diluted), for the year ended 2010. Non-GAAP net loss excludes non-cash share-based compensation expense and non-cash interest expense related to the convertible senior notes.
In 2011, we also submitted supplemental Biologics License Applications (sBLA) to the FDA for EYLEA for the treatment of central retinal vein occlusion and for ARCALYST® for the prevention of gout flares in patients initiating uric acid-lowering therapies, said George D. Yancopoulos, M.D., Ph.D., Executive Vice President, Chief Scientific Officer, and President, Regeneron Research Laboratories. Regulatory actions on these sBLAs, as well as on a recently submitted BLA for ZALTRAP® for patients with previously treated metastatic colorectal cancer, are expected during 2012. Additionally, our collaborator Bayer HealthCare has submitted regulatory applications for EYLEA in Europe, Japan, and other countries, and our collaborator Sanofi has submitted a regulatory application for ZALTRAP in the EU. We are also pleased with progress in our pipeline, where ten antibodies are now in clinical development, including eight that are part of the Sanofi collaboration. Two antibodies - sarilumab for rheumatoid arthritis and REGN727 for hyperlipidemia - will be in Phase 3 testing in 2012.
Selling, General, and Administrative (SG&A) Expenses: In 2011, GAAP SG&A expenses were $36.3 million for the fourth quarter and $117.3 million for the full year, compared to $20.6 million for the fourth quarter and $65.2 million for the full year 2010. The higher SG&A expenses in 2011 were primarily related to higher selling expenses in connection with commercialization of EYLEA, higher SG&A headcount, higher recruiting and non-cash share-based compensation expense, and higher legal expenses in connection with our patent litigation with Genentech. In 2011, SG&A related non-cash share-based compensation expense was $6.3 million for the fourth quarter and $23.3 million for the full year, compared to $6.6 million for the fourth quarter and $17.6 million for the full year 2010.
Regeneron Forward-Looking Statement
This news release and/or the financial results attached to this news release include amounts that are considered non-GAAP financial measures under SEC rules. As required, we have provided reconciliations of these measures.
As previously reported in December 2011, initial data from the Phase 2 AFFIRM study in the first-line mCRC setting showed that in patients who received ZALTRAP in combination with the modified FOLFOX6 regimen (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin), the Progression Free Survival (PFS) rate at one year was similar to that seen in the standard therapy arm for patients who received the modified FOLFOX6 regimen alone. The safety profile of ZALTRAP was similar to what was seen in prior trials.
Research and Development (R&D) Expenses: In 2011, GAAP R&D expenses were $129.0 million for the fourth quarter and $529.5 million for the full year, compared to $125.2 million for the fourth quarter and $489.2 million for the full year 2010. The higher R&D expenses in 2011 were primarily related to higher R&D headcount, research and preclinical development activities, principally in connection with the Sanofi antibody collaboration, and higher non-cash share-based compensation expense. In 2011, R&D related non-cash share-based compensation expense was $9.2 million for the fourth quarter and $32.8 million for the full year, compared to $7.0 million for the fourth quarter and $22.3 million for the full year 2010.
REGN727, an antibody to Proprotein Convertase Substilisin/Kexin type 9 (PCSK9), a novel target for LDL cholesterol (bad cholesterol) reduction, is in Phase 2 studies. During 2011, three Phase 2 studies with subcutaneous regimens of REGN727 were initiated: (1) a randomized, double-blind, multi-dose, placebo controlled, 75-patient trial in patients with heterozygous milial hypercholesterolemia (heFH), (2) a randomized, double-blind, multi-dose, placebo controlled
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, 90-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia, and (3) a randomized, double-blind, multi-dose, placebo controlled, 180-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia and on stable doses of atorvastatin. The primary endpoint of each Phase 2 study is the change in LDL cholesterol from baseline compared to placebo over the study period.In December 2011, Regeneron and Bayer HealthCare also announced that in an integrated analysis of two parallel Phase 3 studies (VIEW 1 and VIEW 2) in patients with wet AMD, patients treated with EYLEA showed a sustained improvement in visual acuity at 96 weeks versus baseline with a safety profile similar to that reported in the first year of the study.
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Use of Non-GAAP Financial Measures: The Company believes that the presentation of non-GAAP measures is useful to investors because it excludes (i) non-cash share-based compensation expense which fluctuates from period to period based on ctors that are not within the Companys control such as the Companys stock price on the dates share-based grants are issued and (ii) non-cash interest expense related to the Companys convertible senior notes since this is not deemed useful in evaluating the Companys operating performance. Furthermore, management uses these non-GAAP measures for planning, budgeting, forecasting, in assessing historical performance, and in financial and operational decisions, and also may provide forecasts to investors on this basis. However, there are limitations in the use of these non-GAAP financial measures as it excludes certain expenses that are recurring in nature. Furthermore, our non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. The non-GAAP financial measures should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As previously reported in June 2011, in the Phase 3 study (called VELOUR) of ZALTRAP in previously treated metastatic colorectal cancer (mCRC) patients, the addition of ZALTRAP to the FOLFIRI chemotherapy regimen (folinic acid [leucovorin], 5-fluorouracil, and irinotecan) significantly improved both overall survival (HR=0.817; p=0.0032) and progression-free survival (HR=0.758; p=0.00007) compared to FOLFIRI plus placebo. A similar effect was seen with ZALTRAP therapy whether or not patients had received prior bevacizumab therapy.
In November 2011, Regeneron and Bayer HealthCare announced the initiation of a Phase 3 trial (SIGHT) evaluating the efficacy and safety of EYLEA in wet AMD in China. The SIGHT trial will include approximately 300 patients and will be the largest retinal trial conducted in China.
EYLEA, known in the scientific literature as VEGF Trap-Eye, is a fusion protein locally administered in the eye that is designed to bind Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PlGF), proteins that are involved in the abnormal growth of new blood vessels. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has rights to market EYLEA outside the United States, where the companies will share equally in profits from any future sales.
About Regeneron Pharmaceuticals
The Company reported a GAAP net loss of $53.4 million, or $0.58 per share (basic and diluted), for the fourth quarter 2011, compared to a GAAP net loss of $14.6 million, or $0.17 per share (basic and diluted), for the fourth quarter 2010. The Company had a GAAP net loss of $221.8 million, or $2.45 per share (basic and diluted), for the full year 2011, compared to a GAAP net loss of $104.5 million, or $1.26 per share (basic and diluted), for the full year 2010.
Regeneron plans on initiating a Phase 3 study in branch retinal vein occlusion (BRVO) in the first quarter of 2012.
Earlier this year, Regeneron and Bayer HealthCare initiated two Phase 3 trials of EYLEA in a third indication, diabetic macular edema (DME). The VISTA-DME U.S. trial has completed enrollment and the VIVID-DME global trial is enrolling patients.
Total Revenues: Total revenues were $123.0 million for the fourth quarter and $445.8 million for the full year 2011, compared to $133.7 million for the fourth quarter and $459.1 million for the full year 2010. Total revenues include total collaboration revenues of $86.4 million for the fourth quarter and $369.7 million for the full year 2011, compared to $117.0 million for the fourth quarter and $386.7 million for the full year 2010.
EYLEA® (aflibercept) Injection - Ophthalmologic Diseases
Cash Position: At December 31, 2011, cash and marketable securities totaled $810.6 million (including $7.7 million of restricted cash and marketable securities) compared to $626.9 million (including $7.5 million of restricted cash and marketable securities) at December 31, 2010. In October 2011, the Company completed a private offering of $400 million aggregate principal amount of 1.875% convertible senior notes. The net proceeds of the offering were $391.1 million after deducting the initial purchasers discount and offering expenses. In connection with the offering of the notes, the Company entered into convertible note hedge and warrant transactions with multiple counterparties. The net cost of the convertible note hedge transactions, after taking into account the proceeds received by the Company from the warrant transactions, was $23.7 million.
Clinical Programs Update
Since 2007, Regeneron and Sanofi have collaborated on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology.
Fourth Quarter and Full Year 2011 Financial Results
In November 2011, Regeneron announced that it received notification from the U.S. Food and Drug Administration (FDA) that the agency had approved EYLEA Injection for the treatment of patients with the neovascular form of age-related macular degeneration (wet AMD). The approval was granted under a Priority Review. During 2011, Bayer HealthCare submitted regulatory applications for marketing approval of EYLEA in wet AMD in the European Union and Japan. Wet AMD is the leading cause of acquired blindness for people over the age of 65 in the United States and Europe.
REGN1154, whose target remains undisclosed, will enter Phase 1 studies in the first quarter of 2012. Sanofi did not opt in to development of REGN1154. Regeneron has sole global rights to REGN1154, and Sanofi is entitled to receive a mid-single digit royalty on any future sales of REGN 1154.
Regeneron ended the year with approximately $811 million in cash and securities, following an offering of convertible senior notes in October 2011.
REGN1033, whose target remains undisclosed, will enter Phase 1 studies in the first quarter of 2012.
Interest Expense: In 2011, GAAP interest expense was $9.5 million for the fourth quarter and $21.3 million for the full year, compared to $2.5 million for the fourth quarter and $9.1 million for the full year 2010. In the fourth quarter and full year 2011, interest expense included $1.5 million of cash interest expense and $3.9 million of non-cash interest expense related to the Companys convertible senior notes, which were issued in October 2011.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manuctures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets two products in the United States, ARCALYST® (rilonacept) Injection For Subcutaneous Use and EYLEA® (aflibercept) Injection, and has filed regulatory applications with the U.S. Food and Drug Administration (FDA) for second indications for each of these products. A regulatory application has also been submitted to FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion. Phase 3 studies are in progress with EYLEA® in a third indication, with ZALTRAP® in a second indication, and with product candidate Sarilumab. Earlier-stage clinical programs are underway with nine additional product candidates. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at .
Initial data from the third Phase 2 trial, studying subcutaneous regimens of REGN727 in combination with atorvastatin in patients with primary hypercholesterolemia, will be available in the first half of 2012.
REGN846, whose target remains undisclosed, is being evaluated in a Phase 2a study in patients with atopic dermatitis. In July 2011, Sanofi elected not to continue co-development of REGN846, and Regeneron now has sole global rights to REGN846. Under the terms of the companies agreement, Sanofi remains obligated to fund REGN846 clinical costs through conclusion of a planned proof-of-concept trial and is entitled to receive a mid-single digit royalty on any future sales of REGN846.
Regeneron and Bayer HealthCare also initiated a Phase 3 trial in Asia in collaboration with the Singapore Eye Research Institute in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.
In the fourth quarter of 2011, Regeneron submitted an sBLA for ARCALYST for the prevention of gout flares in patients initiating uric acid-lowering therapy and was granted a PDUFA date of July 30, 2012. Regeneron owns worldwide rights to ARCALYST.
ZALTRAP® (aflibercept) - Oncology
In the VELOUR study, grade 3 or 4 adverse events (AEs) that occurred with a more than two percent greater incidence in the ZALTRAP arm than in the placebo arm included diarrhea, asthenia/tigue, stomatitis/ulceration, infections, hypertension, GI/abdominal pains, neutropenia, neutropenic complications, and proteinuria. Deaths on study treatment due to AEs occurred in 2.4 percent of patients in the ZALTRAP arm and in 1.0 percent of patients in the placebo arm.
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of EYLEA and ARCALYST and Regenerons product candidates, potential new indications for marketed products, and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regenerons late-stage product candidates and new indications for marketed products, determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize EYLEA and other product and drug candidates and possible new indications for marketed products, competing drugs that may be superior to EYLEA and Regenerons product and drug candidates and possible new indications for marketed products, uncertainty of market acceptance of EYLEA and Regenerons product and drug candidates and possible new indications for marketed products, unforeseen safety issues resulting from the administration of products and product candidates in patients, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, the potential for any license or collaboration agreement, including Regenerons agreements with Sanofi and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regenerons filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended September 30, 2011. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise, unless required by law.
Monoclonal Antibodies
In November 2011, Regeneron also announced preliminary results from the Phase 2 trial studying patients with primary hypercholesterolemia who were on stable doses of atorvastatin. In the primary endpoint of the study, after eight weeks of treatment, patients who received REGN727 plus atorvastatin 80 milligrams (mg) achieved a greater than 65% reduction in mean LDL cholesterol compared to a mean reduction of 17% for atorvastatin 80mg only (p
The following ten antibody candidates are currently in clinical development, eight under the collaboration with Sanofi:
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Lycopodium Cavatum 9C is an herbal supplement that primary promotes the passing of gas to prevent bloating and intestinal discomfort
(14.81 oz), Life Extension
Boiron Kali Carbonicum 9C is a product indicated for an array of uses including spine problems and menstrual or menopausal problems in women
Boirons Urtica urens 9C is a homeopathic remedy for skin rashes that results from food allergies.
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Below areSuto Goutrelated alternative medicine supplements and vitamins. Also explore information on
Life Extension Mix Consumers take dietary supplements to obtain concentrated doses of some of the beneficial nutrients (such as folic acid) that are found in fruits and vegetables.
Aspirin helps to maintain normal platelet aggregation in blood vessel
During strenuous exercise, large amounts of ATP, the bodys primary energy-carrying molecule, can be depleted in heart and skeletal muscle cells. D-Ribose is a sugar that is used by the body to synthesize nucleotides, ATP, nucleic acids, and glycogen.
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I use Cherry Fruit Extract to ward off Gout, which it does very effectively. If I miss a week of taking this supplement, I soon develop the gout.
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(315 tablets), Life Extension
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Dr Christophers Joint Formula (AR-1) works to effectively relieve symptoms associated with joint disorders and problems
Natures Way Yucca AR provides a blend of helpful herbs that treat inflammation and contribute to overall health and well-being.
(315 tablets), Life Extension
(enteric coated) (81 mg 500 tablets), Life Extension
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Arnica Montana 30X is a natural healing approach to relieve pain from traumatic injuries or surgery.
(1000 Tablets), Hylands
Ive been taking this for 10 months and I have been gout free. I have had great success with this product. As long as it keeps on working, I will keep on taking it.
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Life Extension Mix Powder without Copper- Consumers take dietary supplements to obtain concentrated doses of some of the beneficial nutrients (such as folic acid) that are found in fruits and vegetables.
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Sarsaparilla (smilax spp) is a tropical herb from Central America brought to Europe by Spanish Conquistadors for use in herbal medicines.
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1. Seacoast Health Encyclopedia statements or claims have not been evaluated by the FDA.View allhealth topics.
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Boirons Arnica Montana 9C is a natural anti-inlmmatory that works to provide relief from pain following injury or surgery.
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During strenuous exercise, large amounts of ATP, the bodys primary energy-carrying molecule, can be depleted in heart and skeletal muscle cells. D-Ribose is a sugar that is used by the body to synthesize nucleotides, ATP, nucleic acids, and glycogen.
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02/10/2012
MayoClinic.com? gout symtons
Housecall, our weekly general-interest e-newsletter, keeps you up to date on a wide variety of health topics with timely, reliable, practical information, recipes, blogs, questions and answers with Mayo Clinic experts and more. Our biweekly topic-specific e-newsletters also include blogs, questions and answers with Mayo Clinic experts, and other useful information that will help you manage your health.
When to see a doctor
Lingering discomfort.After the most severe pain subsides, some joint discomfort may last from a few days to a few weeks. Later attacks are likely to last longer and affect more joints.
Gout. American College of Rheumatology. Accessed Oct. 20, 2011.
Becker MA. Prevention of recurrent gout. Accessed Oct. 20, 2011.
The signs and symptoms of gout are almost always acute, occurring suddenly — often at night — and without warning. They include:
Seek medical care immediately if you have a fever and a joint is hot and inflamed, which can be a sign of infection.
Gout. The Merck Manuals: The Merck Manual for Healthcare Professionals. Accessed Oct. 20, 2011.
Intense joint pain.Gout usually affects the large joint of your big toe, but it can occur in your feet,
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ankles, knees, hands and wrists. The pain is likely to be most severe within the first 12 to 24 hours after it begins.Dietary Guidelines for Americans, 2010. U.S. Department of Health and Human Services. Accessed Oct. 25, 2011.
Zimmerman B. Gout. In: Ferri FF. Ferris Clinical Advisor 2012: 5 Books in 1. Philadelphia, Pa.: Mosby Elseviegout symtonsr; 2012. Accessed Oct. 24, 2011.
Demio PC. Gout. In: Rakel D. Integrative Medicine. 2nd ed. Philadelphia, Pa.: Saunders Elsevier; 2007. Accessed Oct. 24, 2011.
MayoClinic.com? gout symtons,
Hayman S, et al. Gout: Is a purine-restricted diet still recommended? Journal of the American Dietetic Association. 2009;109:1652.
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Becker MA. Clinical manifestations and diagnosis of gout. Accessed Oct. 24, 2011.
If you experience sudden, intense pain in a joint, call your doctor. Gout that goes untreated can lead to worsening pain and joint damage.
Questions and answers about gout. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Accessed Oct. 24, 2011.
Mayo Clinic is a not-for-profit organization and proceeds from Web advertising help support our mission. Mayo Clinic does not endorse any of the products and services advertised.
Yu K-H, et al. Dietary ctors associated with hyperuricemia in adults. Seminars in Arthritis and Rheumatism. 2008;37:243.
gout symtons HIDDEN Symptoms of Gout
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That is the conventional medical approach, then how about home remedies for gout? There are many so-called natural home therapy to treat gout, but how many of them actually work? Some can really deliver short term relief such as the cherries, baking soda, or some herbs. But none of them are actually dealing with the root cause of gout, which is hyperuricemia or high uric acid. You don&8217;t want something just treat the symptoms of gout, you need something that can remove it totally.
How effective are those advice? I have no right to comment on that. Most probably you will have to go through it to find out the answer. It is a very subjective issue, depending on each person&8217;s gout condition.
,colchicine,gout drug,gout medicine,home remedies,symptoms of gout
Before you try to get rid of the enemy, it is better to understand your enemy first. That will definitely save many unnecessary waste of time and efforts. The following site contain some really profound article about gout even many of the doctors do not know&8230;
gout symtons HIDDEN Symptoms of Gout,Eventually, the pain will go away, with or without the help of those gout drugs. Then come the most important phase of gout removal. At this stage, although the gouty inflammation is gone,
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but the urate crystals are still inside the joints and you are still having high uric acid level in your blood. This is when the &8220;cleaning job&8221; begins. Not only you have to lower your uric acid level, you also has to flush away the chemical residues of the gout drugs that left in his body. The best option of this purpose is through some natural remedies for gout.If you ask that question to a conventional doctor, he/she will definitely tell you to change your diet, drink plenty of water and prescribe you with some painkillers and a gout medicine known as Colchicine. If gout attack of gout re-occurs, then your doctor will increase the dosage of the painkillers and on top of that he/she may be will introduce another gout drug, allopurinol, which is said to be able to reducgout symtonse the uric acid level in your body to prevent future gout attacks.
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But there are so many so-called &8220;natural gout remedies&8221; out there that claim to be able to remove gout naturally. It is hard to tell which one actually works until you find out the truth of gout and the actual root of it. I strongly recommend you to read the the article in the following website, this guy tells you the truth of gout that your doctor will never tell you&8230;
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There are 2 phases of gout treatment. The first stage is that you have to deal with the current existing painful gouty inflammation and there is no natural remedies available for this (cherries can help a little), but if you really canngout symtons HIDDEN Symptoms of Goutot take the pain anymore and those oral pain killers il to work, then you might need your doctor to prescribe some steroid injections to deal with the pain. You must bear in mind that all those chemical gout drugs can bring long term side effects, especially to the liver and kidneys. Thus you must not consume them to often, and that is why you must get rid of the root of gout once and for all, which is the objective of 2nd phase.
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gout symtons Gout - Symptoms
Krishnan E, Baker JF, Furst DE, Schumacher HR. Gout and the risk of acute myocardial inrction.Arthritis Rheum. 2006 Aug;54(8):2688-96.
Dehghan A, KÃƶttgen A, Yang Q, et al. Association of three genetic loci with uric acid concentration and risk of gout: a genome-wide association study.
Zhang YQ, Chaisson CE, Chen CA, McAlindon TE, Hunter DJ. High Humidity and High Temperature Increase the Risk of Recurrent Gout Attacks: The Online Case-crossover Gout Study. Presentation Number 707. American College of Rheumatology Annual Scientific Meeting, Washington, DC, November 2006.
Huang HY, Appel LJ, Choi MJ et al. The effects of vitamin C supplementation on serum concentrations of uric acid: results of a randomized controlled trial.Arthritis Rheum. 2005 Jun;52(6):1843-7.
Symptoms of acute gouty arthritis include:
Acute gouty arthritis occurs when the first symptoms of gout appear. Sometimes the first signs of gout are brief twinges of pain (petit attacks) in an affected joint. These attacks can precede the actual full-blown condition by several years.
The information provided herein should not be used during any medical emergency or for thediagnosis or treatment of any medical condition. A licensed medical professional should beconsulted for diagnosis and treatment of any and all medical conditions. Call 911 for allmedical emergencies. Links to other sites are provided for information only -- they do notconstitute endorsements of those other sites. © 1997-A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.
An untreated attack will typically peak 24 - 48 hours after the first appearance of symptoms, and go away after 5 - 7 days. However, some attacks last only hours, while others persist as long as several weeks.
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Development of Chronic Pain.When gout remains untreated, the intercritical periods typically become shorter and shorter, and the attacks, although sometimes less intense, can last longer. Over the long term (gout symtonsabout 10 - 20 years) gout becomes a chronic disorder characterized by constant low-grade pain and mild or acute inflammation. Gout may eventually affect several joints, including those that may have been free of symptoms at the first appearance of the disorder. In rare cases, the shoulders, hips, or spine are affected.
The specific symptoms of gout depend on the stage of the disease. Gout is often divided into four stages:
Tophi are generally painless. However, they can cause pain and stiffness in the affected joint. Eventually, they can also erode cartilage and bone, ultimately destroying the joint. Large tophi under the skin of the hands and feet can give rise to extreme deformities.
gout symtons Gout - Symptoms,Asymptomatic means there are no symptoms. Asymptomatic hyperuricemia is considered the first stage of gout. MSU levels slowly increase in the body. This stage lasts for an average of 30 years.
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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997-A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.
Note: Hyperuricemia does not inevitably lead to gout. In ct, less than 20% of cases develop the full-blown arthritic gout disease.
Chronic Tophaceous Gout and Tophi.After several years, persistent gout can develop into a condition called chronic tophaceous gout. This long-term condition often produces tophi, which are solid depositgout symtons Gout - Symptomss of MSU crystals that form in the joints,
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cartilage, bones, and elsewhere in the body. In some cases, tophi break through the skin and appear as white or yellowish-white, chalky nodules that have been described as looking like crab eyes.Kidney Failure.Sudden overproduction of uric acid can occasionally block the kidneys and cause them to il. This occurrence is very uncommon but can develop after any of the following:
Not all of the kidney stones in patients with gout are made of uric acid. Some are made from calcium oxalate, calcium phosphate, or substances combined with uric acid. Uric acid stones can also form when you do not have gout or hyperuricemia.
MSU crystals form at normal body temperature when the concentration of uric acid in the blood reaches 7 mg/dL. At lower temperatures, MSU crystals form at lower concentrations of uric acid. Since blood temperature lls the further blood gets from the heart, gout usually strikes the toes and fingers first.
Most often symptoms start in one joint.
Choi HK, Ford ES, Li C, Curhan G. Prevalence of the metabolic syndrome in patients with gout: the Third National Health and Nutrition Examination Survey.
Hands or feet -- older patients, particularly women, are more likely to have gout in the small joints of the fingers.
Uric Acid Nephrolithiasis (Kidney Stones).Persons who have kidney stones that formed from uric acid are more likely to have higher levels of uric acid in their blood than in their urine. This suggests that gout is responsible for this type of kidney stones. Uric acid stones and other forms of kidney stones are present in 10 - 25% of patients with primary gout, a rate of more than 1,000 times that of the general population. In gout caused by other conditions (called secondary gout), the reported rate reaches 42%.
Underwood M. Diagnosis and management of gout.BMJ. 2006;332(7553):1315-9.
Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).Ann Rheum Dis.2006;65(10):1312-24.
Without treatment, tophi develop about 10 years after the initial onset of gout, although the occurrence can range from 3 to 42 years. Tophi are more likely to appear early in the course of the disease in older people. In the elderly population, women appear to be at higher risk for tophi than men. Certain people, such as those who are receiving cyclosporine after a transplant, have a high risk of developing tophi.
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Chronic Uric Acid Interstitial Nephropathy.Chronic uric acid interstitial nephropathy occurs when crystals slowly form in the structures and tubes that carry fluid from the kidney. It is reversible and not likely to injure the kidneys.
Keith MP, Gilliland WR. Updates in the management of gout.
Intercritical gout is the term used to describe the periods between attacks. The first attack is usually followed by a complete remission of symptoms, but, if left untreated, gout nearly always returns. Over two-thirds of patients will have at least one further attack within 2 years of the first attack. By 10 years, over 90% of the patients are likely to have repeat attacks.
Harvey Simon, MD, Editor-in-Chief, Associate Professor of Medicine, Harvard Medical School; Physician, Massachusetts General Hospital. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.
Zhang W, Doherty M, Bardin T, et al. EULAR evidence based recommendations for gout. Part I: Diagnosis. Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT).Ann Rheum Dis.2006;65(10):1301-11.
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