WINDSOR, ONTARIO--(Marketwire - May 26, 2012) - At its annual convention in Windsor, Ontario, the Canadian Union of Public Employees (CUPE) Ontario raised more than $30,000 in donations from members in less than ten minutes. Deletes also called on the national union to match the funds, which were raised to support CUPE Local 966, whose Ontario Works unit has been on strike since May 3.
"It is always incredible to see the generosity of our members, especially when it comes to showing solidarity with workers who are standing up to an unfair employer," said CUPE Ontario President Fred Hahn. "CUPE Local 966 members give so much of their time and energy to support workers and community groups all over Ontario. These donations are just one small way of letting those workers know how much they are appreciated by us all."
More than 500 members of CUPE Local 966, mostly women, are on strike for respect and equality with other workers in the Region.
"We are overwhelmed by the generosity of our fellow CUPE brothers and sisters in Ontario," said Mary Jo Falle, president of CUPE Local 966. "When you're on the picket line this kind of support is a real boost to your spirits."
Delegates also committed to joining the picket lines in Peel on June 1 to support the striking workers.
CUPE Ontario is the province's largest union. It represents more than 230,000 workers in five main sectors: health care, school boards, municipalities, social services and universities.
FOR FURTHER INFORMATION PLEASE CONTACT:
CUPE Communications
Craig Saunders
416-576-7316
Source: Canadian Union of Public Employees (CUPE) - Ontario
PARIS and TARRYTOWN, New York, May 26, 2012 /PRNewswire/ --
Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced additional positive results from a Phase 2 trial of SAR236553/REGN727 (Study 1003, NTC01266876) in patients with heterozygous familial hypercholesterolemia (heFH). SAR236553/REGN727 is a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in clinical development. The results from this study were published online in The Lancet,[1] and also presented at a late-breaking oral session at the 80th European Atherosclerosis Society Congress (EAS) in Milan, Italy.[2] Positive, top-line results from this study were announced in November 2011.[3]
The trial randomized 77 patients with heFH whose LDL-cholesterol (LDL-C) levels remained uncontrolled on statin therapy with or without ezetimibe. Across the four different dosing regimens tested, patients receiving SAR236553/REGN727 for 12 weeks achieved a mean LDL-C reduction from baseline of 28.9% to 67.9%, compared to 10.7% in patients receiving placebo (p<0.05). In addition, in the most intense dose regimen tested where the greatest LDL-C reduction was observed (150 milligrams [mg] every two weeks), 93.8% of patients achieved LDL-C levels lower than 100 mg/dL (2.59 mmol/L), compared to 13.3% of patients on placebo, and 81.3% reached LDL-C levels lower than 70 mg/dL (1.81 mmol/L), compared to none on placebo.
There were no serious adverse events (SAE) on active treatment, while a single SAE was recorded for a patient in the placebo group. There were no elevations in liver function tests (LFT) >3 times the upper limit of normal (ULN) and no cases of elevated creatinine kinase (CK) were reported. The most common adverse event reported was injection-site reaction.
"Heterozygous familial hypercholesterolemia is a common, serious, and often undiagnosed cause of early heart disease. There remains a high degree of unmet need in these patients as a large percentage are unable to reach optimal LDL-C goals despite being on maximal lipid-lowering therapy," said Evan A. Stein, M.D., Ph.D., Director of the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio, and Principal Investigator of the study. "These data suggest that SAR236553/REGN727 may provide a new option, on top of existing therapies, to lower LDL-cholesterol and finally reach LDL-C goals for these difficult-to-treat patients."
Sanofi and Regeneron also announced today that based on discussions with the U.S. and European regulatory authorities, they intend to initiate a global Phase 3 program with SAR236553/REGN727 in June. This will be the first Phase 3 program of an investigational drug targeting PCSK9.
"These data, along with recently presented data in patients with hypercholesterolemia, further support our belief that blocking PCSK9 with our antibody has the potential to offer a novel mechanism for lowering LDL-cholesterol in a broad range of patients," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. Dr. Elias Zerhouni, President, Global Research & Development, Sanofi, added: "Our global Phase 3 program will include patients with high unmet medical need, such as patients with familial hypercholesterolemia or with elevated cardiovascular risk who cannot reach their LDL-cholesterol goals with current standard therapies. The program reflects our excitement and commitment to develop this potential therapeutic option for these patients."
About PCSK9
PCSK9 is known to be a determinant of circulating LDL-C levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess LDL-C from the blood.[4] Moreover, traditional LDL-lowering therapies such as statins actually stimulate the production of PCSK9, which limits their own ability to lower LDL-C.[5] Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-C.
About SAR236553/REGN727 and the Phase 2 Heterozygous Familial Hypercholesterolemiatrial
SAR236553/REGN727 is a fully human monoclonal antibody directed against PCSK9, administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood, SAR236553/REGN727 increases the number of free LDL receptors which can bind to circulating LDL-C and clear it from the bloodstream. SAR236553/REGN727 was created using Regeneron's VelocImmune® technology.
Study 1003 was a randomized, double-blind, placebo-controlled, dose-finding study in patients with heFH. The primary objective of the trial was to assess the efficacy of various subcutaneous doses and dosing regimens of SAR236553/REGN727 on LDL-C in patients with heFH. Seventy-seven patients were randomized to either placebo or one of four active dose regimens of 150 mg at four-week intervals (Q4W), 200 mg Q4W, 300 mg Q4W, or 150 mg at two-week intervals (Q2W). At baseline, all patients had LDL-C greater than or equal to 100 mg/dL (2.59 mmol/L) and were on stable daily statin therapy (the type and dosage of statin was at the discretion of the investigator) with or without ezetimibe, for at least six weeks prior to screening. The majority of patients, 77%, were taking a high intensity dose of a statin, and 71% were also taking ezetimibe 10 mg at the time of the screening visit and throughout the trial. Despite this aggressive therapy, the mean baseline LDL-C for all study participants was approximately 155 mg/dL (4 mmol/L). The primary endpoint of the study was the change in LDL-C from baseline over the 12-week study period. Patients were followed for a total of 20 weeks for safety.[2]
About Heterozygous Familial Hypercholesterolemia
HeFH is an inherited disease that is characterized by very high LDL-C levels and familial patterns of increased risk of premature coronary artery disease and heart disease-related death due to these elevated LDL-C levels. The majority of these patients have inherited abnormalities in the gene for the LDL receptor. This results in a decreased ability to clear LDL-C from the blood and consequently leads to high levels of LDL-C in the blood that can accelerate the initiation and progression of atherosclerosis.[6] As a result of the severe elevations in LDL-C, many of these patients cannot reach treatment goals with existing therapies. A recent analysis of 1,249 heFH patients found that only 21% were able to achieve a treatment goal of <2.5 mmol/L (<97 mg/dL).[7] It is estimated that 1 in 500 people worldwide carries a genetic mutation that is responsible for heFH.[6]
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, 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 the FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion. Phase 3 studies are in progress with EYLEA® in a third indication, and with product candidate sarilumab. Earlier-stage clinical programs are underway with nine additional monoclonal antibodies. 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 http://www.regeneron.com.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 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 Regeneron's product candidates and research and clinical programs now underway or planned, including without limitation SAR236553/REGN727, unforeseen safety issues resulting from the administration of products and product candidates in patients, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's product and drug candidates, competing drugs that may be 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 license or collaboration agreement, including Regeneron's agreements with the Sanofi Group 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 Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2011 and Form 10-Q for the quarter ended March 31, 2012. 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.
References
- Stein EA, et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet 2012 May 26. [Epub ahead of print].
- Stein EA, et al. A randomized, double-blind, placebo-controlled trial of the safety and efficacy of a monoclonal antibody to PCSK9, REGN727/SAR236553, in heterozygous familial hypercholesterolemia patients on a stable statin dose with or without ezetimibe therapy. (NCT:01266876). Presented at the 80th EAS Congress, Milan, Italy; May 26, 2012. Abstract #1398.
- Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia. Press release available at: http://investor.regeneron.com/releasedetail.cfm?ReleaseID=622543. Last accessed 20 May 2012.
- Steinberg D & Witztum JL. Inhibition of PCSK9: A powerful weapon for achieving ideal LDL cholesterol levels. PNAS 2009;106:9546-7.
- Konrad RJ, et al. Effects of currently prescribed LDL-C-lowering drugs on PCSK9 and implications for the next generation of LDL-C-lowering agents. Lipids Health Dis 2011;10:38.
- Citkowitz E. Familial Hypercholesterolemia. Available at: http://emedicine.medscape.com/article/121298-overview#showall. Last accessed 30 April 2012.
- Pijlman, AH et al. Evaluation of cholesterol lowering treatment of patients with familial hypercholesterolemia: a large cross-sectional study in The Netherlands. Atherosclerosis 2010;209:189-94.
Contacts:
Sanofi:
Media Relations Investor Relations
Marisol Peron Sébastien Martel
Tel: +33(0)1-53-77-45-02 Tel: +33(0)1-53-77-45-45
Mobile: +33(0)6-08-18-94-78 E-mail: IR@sanofi.com
E-mail: marisol.peron@sanofi.com
Regeneron:
Media Relations Investor Relations
Peter Dworkin Manisha Narasimhan, Ph.D.
Tel: +1-914-847-7640 Tel: +1-914-847-5126
peter.dworkin@regeneron.com manisha.narasimhan@regeneron.com
SOURCE Sanofi and Regeneron Pharmaceuticals, Inc
WINDSOR, ONTARIO--(Marketwire - May 26, 2012) - Members of the Canadian Union of Public Employees (CUPE) Ontario this week re-elected Kingston paramedic Jenn Mizerovsky to the union's executive board.
Mizerovsky was elected at the CUPE Ontario Convention in Windsor, Ontario, which was attended by more than 1100 members and staff from across the province.
"I'm grateful that CUPE members chose to return me to the board for another term. I will do my best to stand up for all workers and for the public services all our communities rely on every day," she said. "And I'm really excited that I will be able to continue working to raise the profile of paramedics across the province. Paramedics work long, hard, dangerous hours and our work is too often undervalued and overlooked."
Mizerovsky, mother of a 14-year-old daughter, has worked as a paramedic since 2004 and in January was elected as the first female President of CUPE Local 1842, which represents paramedics in Hastings and Prince Edward counties. An active member of her community, she volunteers coaching high school athletics and volunteered as a medic for the Arctic Games in Nunavut.
CUPE Ontario is the province's largest union. It represents more than 230,000 workers in five main sectors: health care, school boards, municipalities, social services and universities.
FOR FURTHER INFORMATION PLEASE CONTACT:
CUPE Communications
Craig Saunders
416-576-7316
Source: Canadian Union of Public Employees (CUPE) - Ontario
Seven Senators pledge their support for U.S. ratification of the CRPD
WASHINGTON, May 26, 2012 /PRNewswire-USNewswire/ -- Today, seven United States Senators issued a statement of bipartisan support for United States ratification of the Convention on the Rights of Persons with Disabilities.
(Logo: http://photos.prnewswire.com/prnh/20110601/DC11812LOGO)
"The Convention was undertaken with the same goals as America had in enacting the ADA: to empower individuals with disabilities to achieve economic self-sufficiency, independent living, and inclusion and integration into all aspects of society. While we have fostered considerable progress through international collaborations, far too many people with disabilities languish under their countries' insufficient governmental frameworks. Ratification of the CRPD will be a huge step forward in enhancing the lives of people with disabilities around the world," stated Joan Durocher, NCD's General Counsel and Director of Policy.
Ratification of the CRPD will allow U.S. participation at the CRPD Conference of States Parties and permit the U.S. to appoint a member of the CRPD Committee. Through these mechanisms, the U.S. can influence guidance on the implementation of the treaty and lend its expertise as more countries develop their own disability rights laws.
Marylyn Howe, NCD Board Member, added, "In both our mandated advisory role and that of promoting policy that enhances the lives of people with disabilities, the National Council on Disability (NCD) was pleased to support the efforts of the United States throughout the development of the Convention."
By being a signatory to this historic document, and submitting it to the U.S. Senate for ratification, the United States provides its clear support for the principles of the Convention. NCD urges the Senate to expeditiously ratify this historic treaty. Upon ratification, the United States will join more than 140 other countries in committing themselves to protecting the rights of people with disabilities.
The public announcement of the support for ratification by this bipartisan group of U.S. Senators can be found here: http://www.mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.PressReleases
About the National Council on Disability: NCD is a small, independent federal agency comprised of 15 Presidentially-appointed, Senate-confirmed Council Members and a small staff, who advise the President, Congress and other federal agencies on disability policy, programs, practices, and procedures.
SOURCE National Council on Disability
WINDSOR, ONTARIO--(Marketwire - May 26, 2012) - Vern Andrus, a Cobourg resident for nearly three decades, was elected to the Canadian Union of Public Employees (CUPE) Ontario executive board at the union's convention, which wrapped up in Windsor today.
More than 1,100 CUPE members and staff from across the province attended the 49th annual convention from May 23 to 26, voted to re-elect Andrus to represent them as one of six members-at-large on the board.
A member of CUPE 5555, Andrus works as head custodian in an elementary school for the Kawartha Pine Ridge School Board, ensuring students learn in a clean and safe environment. He also serves as secretary-treasurer of his Local.
"I have been a union activist for over 30 years. I believe now more than ever, we need to continue the fight to protect and save all jobs, especially with the austerity measures of the Ontario Liberals and the trade agreements that are being secretly negotiated by the Harper government," said Andrus.
CUPE Ontario is the province's largest union. It represents more than 230,000 workers in five main sectors: health care, school boards, municipalities, social services and universities.
FOR FURTHER INFORMATION PLEASE CONTACT:
CUPE Communications
Craig Saunders
416-576-7316
Source: Canadian Union of Public Employees (CUPE) - Ontario
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