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Prescription Products ABOUT 34
http://www.sanofi.us/l/us/en/layout.jsp?scat=5668F5DC-416D-4978-A1B6-989FEE5957CB
Today : Friday 6 November 2015
Click Here for more Sanofi-Aventis Charts.
PARIS and THE WOODLANDS, Texas, Nov. 6, 2015 /PRNewswire/ -- Sanofi and Lexicon Pharmaceuticals (NASDAQ: LXRX), Inc. announced today that they have entered into a collaboration and license agreement for the development and commercialization of sotagliflozin, an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for people with diabetes.
"This agreement with Lexicon reinforces our commitment to helping people living with diabetes," said Pascale Witz, Executive Vice President, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure. "Adding sotagliflozin to our portfolio, which includes medicines at virtually every stage of the treatment pathway, highlights our focus on providing a large and diverse set of therapeutic options for people with this disease."
The developmental medicine sotagliflozin (LX4211) is currently being studied in two pivotal Phase 3 trials in type 1 diabetes, which are expected to report top-line results during the second half of 2016. Phase 3 trials in type 2 diabetes are expected to begin in 2016. Sotagliflozin has previously shown encouraging results in exploratory (Phase 2) studies, including reduction of blood sugar (HbA1c), improvement in glycemic variability and reduced meal-time insulin dose compared with placebo in type 1 diabetics. Phase 2 studies exploring treatment in people with type 2 diabetes, including those with renal impairment, showed lowering of blood sugar (HbA1c), weight loss and blood pressure improvements. No increase in hypoglycemic events was seen with sotagliflozin compared to background therapy in the Phase 2 program. The adverse event profile in the Phase 2 program was similar to other products in this class and reflective of the urinary glucose excretion associated with sotagliflozin's inhibition of SGLT-2.
These results indicate that sotagliflozin could have the potential to become an important option among oral anti-diabetic medicines and provide a strong rationale for the further investigation of this compound as a treatment for people with diabetes.
"Lexicon firmly believes in the potential of sotagliflozin for patients living with diabetes. It has been our strategy to focus our resources on the development of sotagliflozin for type 1 diabetes and to pursue a strategic partnership with respect to type 2 diabetes only if it would strengthen stakeholder value under a fully integrated diabetes program. We believe this arrangement with Sanofi achieves that objective," said Lexicon President and Chief Executive Officer Lonnel Coats. "Sanofi's patient-centric focus in diabetes, and its rich history of innovation in diabetes, make it an exceedingly attractive partner which is well positioned to unlock the full potential of sotagliflozin for patients living with diabetes. Also consistent with our strategy, Lexicon will continue to lead the development of sotagliflozin for type 1 diabetes and have rights to participate in the commercialization of sotagliflozin for type 1 diabetes in the United States."
Under the terms of the agreement, Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties of net sales of sotagliflozin.
Sanofi obtains an exclusive worldwide license to develop, manufacture and commercialize sotagliflozin. Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. Sanofi will be responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.
The agreement is subject to customary filing and review under the Hart-Scott-Rodino Antitrust Improvements Act.
The investigational agent described above is currently under clinical development and its safety and efficacy have not been evaluated by any regulatory authority.
About Sanofi
Sanofi, a global 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 Lexicon
Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.
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 and Lexicon'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 and Lexicon, 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, including the timing of clinical trials, the uncertain predictive nature of clinical trials with respect to subsequent clinical trials, 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, Sanofi's and Lexicon'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, as well as those risks and uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi and with the SEC made by Lexicon, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F and in Lexicon's annual report on Form 10-K for the year ended December 31, 2014. Other than as required by applicable law, Sanofi and Lexicon do not undertake any obligation to update or revise any forward-looking information or statements.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sanofi-and-lexicon-pharmaceuticals-to-collaborate-on-sotagliflozin-an-investigational-new-oral-medicine-for-people-with-diabetes-300173985.html
Sanofi will organize a Meet Management Seminar at its Headquarters in Paris on November 6, 2015.
A live webcast of the plenary session will be available from 8:30 to 10:00 am CET.
Senior management representatives will provide a business update and outline a roadmap towards 2020. We will also present the latest progress of our R&D pipeline.
Call in numbers
France: +33 (0) 1 70 77 09 42
UK: +44 (0) 203 3679 453
US: +1 855 402 7761
Replay numbers
France: +33(0)1 72 00 15 00
UK: +44(0) 203 3679 460
US: +1 877 642 3018
Conference code: 296324#
11:30pm pst ?
http://en.sanofi.com/investors/events/corporate/2015/2015-11-06_IR_Seminar_Meet_Management.aspx
Sanofi and Hanmi Announce License Agreement To Develop Portfolio of Long-Acting Diabetes Treatments
Sanofi-Aventis (NYSE:SNY)
Intraday Stock Chart
Today : Thursday 5 November 2015
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PARIS and SEOUL, South Korea, Nov. 5, 2015 /PRNewswire-USNewswire/ -- Sanofi and Hanmi Pharmaceutical Co., Ltd. announced today a worldwide license agreement to develop a portfolio of experimental, long-acting diabetes treatments.
Under the terms of the agreement, Hanmi will receive an upfront payment of €400 million and is eligible for up to €3.5 billion in development, registration and sales milestone, as well as double digit royalties on net sales. Sanofi will obtain an exclusive worldwide license to develop and commercialize 1.) efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonists (GLP1-RA); 2.) a weekly insulin and 3.) a fixed-dosed weekly GLP-1-RA/insulin drug combination. Collectively, these therapeutic offerings are known as the "Quantum Project" utilizing Hanmi's proprietary Long Acting Protein / Peptide Discovery Platform LAPSCOVERY technology. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China.
"The agreement to develop these three investigational diabetes medicines confirms Sanofi's long-term commitment to people with this disease," said Pascale Witz, Executive Vice President, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure. "We now have the opportunity to expand our existing portfolio by including medicines that are administered weekly as well as daily, which could extend our reach in basal insulin and expand our GLP-1-RA and GLP-RA/insulin combination prospects. In these ways, we aim to complement our current offerings and work to serve a broader patient population."
The Quantum Portfolio is based on Hanmi's proprietary LAPSCOVERY (Long Acting Protein/
Peptide Discovery) Technology which is a platform technology that prolongs the duration of action of biologics. The objective is to minimize the frequency of treatment and the dose required, thereby potentially lowering the adverse event rates and optimizing efficacy, according to Hanmi.
"We are pleased that Sanofi with its long heritage and as a proven leader with solid track of success in diabetes, has recognized the value of Hanmi's Quantum Project," said Dr. Gwan Sun Lee, CEO/President of Hanmi Pharmaceutical. "We are confident that we have found the right partner and are excited for the potential this license agreement with Sanofi will bring to the development of Hanmi's Quantum Project and possibilities this could offer to people with diabetes."
Hanmi presented data from five clinical and non-clinical studies on efpeglenatide at the 75th ADA Scientific Session in June. For more information, see here.
The agreement is subject to customary closing conditions including review under the Hart-Scott-Rodino Antitrust Improvements Act.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global 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 Hanmi Pharmaceutical Co., Ltd.
Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The Company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 20 percent of its sales in R&D and has over 20 programs in clinical development in three main areas: 1) novel long-acting biologics based on the Company's LAPSCOVERY™ platform including weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project) in diabetes and obesity; 2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs. More information on Hanmi is available at www.hanmipharm.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 initiatives 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sanofi-and-hanmi-announce-license-agreement-to-develop-portfolio-of-long-acting-diabetes-treatments-300173137.html
SOURCE Sanofi
Copyright 2015 PR Newswire
The current CEO of SNY has to drop Afrezza or except ownership.
I think he will drop it on 11/6/15. IMHO.
The Clock Is Ticking for MannKind
Sales of the inhalable insulin Afrezza continue to disappoint, and that could spell trouble for the heavily indebted company.
MannKind (NASDAQ:MNKD) is set to report its third-quarter financial results on Nov. 9, but its marketing partner Sanofi (NYSE:SNY) has already issued its third-quarter update, and unfortunately for investors, its results don't bode well for MannKind.
Struggling to get a foothold
When Afrezza received FDA approval last year, expectations that it would become a commercial success were high, because the insulin market is worth billions of dollars annually and Afrezza's inhalable formulation had many people thinking diabetics would flock to it to avoid mealtime injections.
That thinking was bolstered when Sanofi signed on last summer to market Afrezza through its highly successful diabetes sales team, a team responsible for turning Sanofi's long-lasting insulin, Lantus, into a multibillion-dollar-per-year blockbuster.
However, hope that Afrezza would deliver a big win for MannKind investors have been mostly dashed, as sales have failed to materialize in any significant way since Sanofi began pitching it in February. In the first quarter, Afrezza sales were roughly $1.1 million, in the second quarter sales were just about $2.2 million, and last Thursday, Sanofi delivered additional bad news when it reported that Afrezza sales had stalled quarter over quarter at 2 million euros, or about $2.2 million at current exchange rates.
Mounting losses
Anticipating a flood of demand, MannKind invested heavily in infrastructure and personnel, and now those investments are taking a big toll on the company's balance sheet.
Last year, MannKind spent $100 million on R&D and $79.4 million on selling, general, and administrative costs, and despite significant layoffs and cutbacks so far this year, MannKind still reported total operating expenses of $24 million in the second quarter. Additional cost-cutting over the summer should allow for MannKind to report an additional decline in operating expenses for the third quarter, but given Afrezza's third-quarter performance, the company's losses probably continued mounting in Q3.
If so, then that's bad news for investors, because MannKind already owes a lot of money to bond investors, its founder, Al Mann, and Sanofi, which is lending MannKind money to cover its share of losses associated with Afrezza. In Q2, MannKind borrowed $15.4 million from Sanofi under that arrangement, bringing the total amount that it's borrowed from Sanofi to $28.4 million. Even after removing deferred payments from Sanofi that are tied to its collaboration deal that appear as liabilities for accounting purposes, overall, MannKind still has about $300 million in liabilities as of June 30.
Because MannKind owes a lot more to its lenders than the $107 million in cash on the books exiting June, the company boasts a worrisome current ratio of 0.43, and since that current ratio provides a quick look at how able a company would be to pay off short-term creditors, a reading below 1 makes me wonder how long MannKind can continue in its current form.
Looking ahead
Investors will get more color into MannKind's financial condition when it reports its own results next week, and if MannKind can't demonstrate that it's cutting expenses quick enough or can't convince investors that it has a good handle on how to overcome disappointing demand for Afrezza, then investors may see shares fall even further than they already have, especially if people begin thinking that Sanofi will exit its relationship with it. In any event, because MannKind's balance sheet isn't bulletproof and Afrezza has yet to catch on, this stock is too risky for new investors to consider buying.
I estimate that SNY can reduce losses in 2016 from it's diabetic unit by 8% by dropping AFREZZA
******Under the current partnership terms, Sanofi can drop MannKind and Afrezza on Jan. 1, 2016. The product's poor performance in the third quarter and its anticipated drag on future sales, as outlined Thursday, makes that option more likely.
*****Mannkind's (MNKD) flopping inhaled insulin Afrezza is contributing to the deteriorating diabetes unit at Sanofi (SNY - Get Report) , the global pharmaceutical giant acknowledged Thursday.
Sanofi said diabetes sales decreased 6.6% in the third quarter to €1.8 billion, or $1.975 billion, dragged down mainly due to lower sales of its Lantus basal insulin in the U.S.
The nascent commercial launch of Afrezza continues to resemble a train wreck. MannKind's signature product contributed only €2 million to Sanofi's sales in the third quarter. That's flat with second quarter sales despite Sanofi's upgraded efforts to convince U.S. doctors to prescribe the inhaled insulin to their diabetes patients. Through nine months of 2014, Afrezza sales have totaled €5 million, well below Sanofi's expectations.
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Sanofi now expects global diabetes sales to decrease 6-7% for 2015. The mid-term outlook for the company's most important business unit is no better, warned Sanofi CEO Olivier Brandicourt on a conference call Thursday morning:
"Given the change in the U.S. market dynamics, and as part of the strategic business review we've just undertaken, we've also taken a fresh look at the mid-term prospects for the diabetes franchise. Accounting for recent market trends, we now project global diabetes sales over the period of 2015- 2018 to decline at an average annualized rate of between 4% and 8%," he said.
"Approximately half of this revision is attributable to insulin glargine, and the other half is related to reduced expectations for Afrezza, Lyxumia and a de-prioritisation of our Blood Glucose Monitoring systems," added Brandicourt.
Sanofi has scheduled an investor meeting for Nov. 6 to unveil a company-wide reorganization plan. On Thursday's call, Brandicourt said changes to the diabetes unit will figure prominently in the company's restructuring.
Under the current partnership terms, Sanofi can drop MannKind and Afrezza on Jan. 1, 2016. The product's poor performance in the third quarter and its anticipated drag on future sales, as outlined Thursday, makes that option more likely.
MannKind shares were falling 4% to $3.64 in Thursday trading. Earlier this week, MannKind dual-listed on the Tel Aviv Stock Exchange in order to attract new investors and prop up its damaged stock price.
SNY will discuss diabetes on NOV 6, 2015
I heard 3 meds will be discontinued by year end 2015
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sanofi-grew-sales-and-business-eps-in-q3-2015-300168693.html
This has good video
Sanofi's Q3 bombshell: Diabetes sales drop, and will keep dropping through 2018
Sanofi racked up big third-quarter gains in emerging markets, its Genzyme unit sales were up almost one-third, and vaccines and animal health delivered growth, too. Overall sales increased by 3.4% to €9.6 billion, lower than analysts expected, but only slightly. And earnings topped estimates by a couple cents per share. But what got most of the attention in the French drugmaker's Q3 release?
Its falling diabetes sales--and its expectation that they'll continue on that downward trajectory. Lower sales of Sanofi's longtime best-seller Lantus--in the U.S. because of higher-than-expected rebates, in Europe because of biosimilar competition--dragged the company's diabetes franchise down by 6.6%.
Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q® Due to Potential Inaccurate Dosage Delivery
Sanofi Reports Positive Top-Line Results in Second Pivotal LixiLan Phase III Study
Date : 09/14/2015 @ 8:00AM
Source : PR Newswire (US)
Stock : Sanofi (SNY)
Quote : 49.32 -1.54 (-3.03%) @ 4:09PM
Sanofi Reports Positive Top-Line Results in Second Pivotal LixiLan Phase III Study
PARIS, Sept. 14, 2015 /PRNewswire/ -- Sanofi announced today that the LixiLan-L Phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin. The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/mL. Overall, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 Units/mL and lixisenatide.
"This study examined an important possible use of this investigational medicine," said Richard M Bergenstal MD, Executive Director, International Diabetes Center at Park Nicollet, Minneapolis, Minn., U.S. "The result highlights that this could provide a treatment option for the roughly fifty percent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment."
LixiLan-L investigated the efficacy and safety of the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide versus treatment with insulin glargine 100 Units/mL over a 30 week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study. Full results will be communicated in a future scientific forum.
Sanofi previously announced in July 2015 that the LixiLan-O study met its primary objective over a 30 week period in 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent.
"The Phase III LixiLan-O and LixiLan-L clinical trials were initiated at the beginning of 2014 to explore the safety and efficacy of our investigational fixed-ratio combination when used before and after basal insulin, respectively," said Elias Zerhouni, MD, President, Global R&D at Sanofi. "These studies reflect Sanofi's commitment to developing and evaluating medicines intended to meet patient needs throughout their journey with diabetes."
Regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union.
What is Lantus® (insulin glargine injection) 100 Units/mL?
Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
•Do not use Lantus to treat diabetic ketoacidosis.
Important Safety Information For Lantus (insulin glargine injection) 100 Units/mL
Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Lantus.
Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.
Before starting Lantus, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breast-feeding or planning to breast-feed.
Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure, it may get worse while you take TZDs with Lantus. Your treatment with TZDs and Lantus® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including:
•Shortness of breath
•Sudden weight gain
•Swelling of your ankles or feet
Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements.
Lantus should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.
While using Lantus, do not drive or operate heavy machinery until you know how Lantus® affects you. You should not drink alcohol or use other medicines that contain alcohol.
The most common side effect of insulin, including Lantus, is low blood sugar (hypoglycemia), which may be serious and life threatening. It may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.
Lantus may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have:
•A rash over your whole body
•Swelling of your face, tongue, or throat
•Trouble breathing
•Shortness of breath
•A fast heartbeat
•Extreme drowsiness, dizziness, or confusion
•Sweating
Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.
Please see accompanying full prescribing information for Lantus or visit www.Lantus.com.
About Lixisenatide
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an investigational product in the U.S. It was resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sanofi-reports-positive-top-line-results-in-second-pivotal-lixilan-phase-iii-study-300142108.html
SOURCE Sanofi
Copyright 2015 PR Newswire
More SNY Messages
Sanofi Announces New Corporate Structure
By Nick Kostov
PARIS--Sanofi SA on Wednesday announced a new corporate structure that the French pharmaceuticals company said would make it more efficient and optimise growth, as the company's new chief executive puts his stamp on the business.
Sanofi, which in February named Olivier Brandicourt as its new chief executive, said it is organising itself into five global business units, with the structure set to be implemented in January 2016. Sanofi didn't say if the move would lead to any staff cuts or how much would be saved.
"The new organization simplifies and focuses Sanofi to optimize growth," said Mr. Brandicourt.
The company will now be divided along the lines of general medicines and emerging markets, specialty care, diabetes and cardiovascular, Sanofi Pasteur and Merial. Sanofi had listed seven businesses in its 2014 earnings.
Sanofi named Mr. Brandicourt CEO in February, appointing a pharmaceutical veteran to lead one of the world's largest drug and vaccine makers as it faces stiff competition and prepares to launch crucial new products.
Mr. Brandicourt's appointment ended months of speculation over who would take the reins at the French drug maker after the abrupt ouster of Christopher Viehbacher in October.
Sanofi said it aims to launch six new medicines in 2015 and approximately one every six months between 2016 and 2018.
Sanofi Announces that First LixiLan Phase III Study Met Primary Endpoint
PARIS, July 29, 2015 /PRNewswire/ -- Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL. Overall, the fixed-ratio combination had a safety profile reflecting those of lixisenatide and insulin glargine 100 units/mL.
"Meeting the primary objective of this important Phase III study highlights the potential clinical value of this investigational therapeutic option," said Dr. Elias Zerhouni, President, Global R&D at Sanofi. "We look forward to advancing the LixiLan program and bringing this combination of insulin glargine and lixisenatide to patients."
The Phase III LixiLan clinical development program began in Q1 2014 and consists of the LixiLan-O and LixiLan-L trials. LixiLan-O investigated the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide versus treatment with either lixisenatide or insulin glargine 100 units/mL over a 30 week period in 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent. Treatment with metformin was continued for all participants throughout the study. Full results will be communicated in an appropriate scientific forum.
The ongoing LixiLan-L study investigates the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide versus treatment with insulin glargine 100 units/mL over a 30-week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on a basal insulin with or without oral anti-diabetic drugs. Only metformin, if taken, was continued throughout the study. The study will be completed in Q3 2015.
Following an analysis of results from both Phase III studies, LixiLan-O and LixiLan-L, Sanofi will determine the next steps in the regulatory process. Currently, regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union.
What is Lantus® (insulin glargine injection) 100 Units/mL?
Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
•Do not use Lantus to treat diabetic ketoacidosis.
Important Safety Information For Lantus (insulin glargine injection) 100 Units/mL
Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Lantus.
Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.
Before starting Lantus, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breast-feeding or planning to breast-feed.
Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure, it may get worse while you take TZDs with Lantus. Your treatment with TZDs and Lantus® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including:
•Shortness of breath
•Sudden weight gain
•Swelling of your ankles or feet
Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements.
Lantus should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.
While using Lantus, do not drive or operate heavy machinery until you know how Lantus® affects you. You should not drink alcohol or use other medicines that contain alcohol.
The most common side effect of insulin, including Lantus, is low blood sugar (hypoglycemia), which may be serious and life threatening. It may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.
Lantus may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have:
•A rash over your whole body
•Swelling of your face, tongue, or throat
•Trouble breathing
•Shortness of breath
•A fast heartbeat
•Extreme drowsiness, dizziness, or confusion
•Sweating
Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.
Please see accompanying full prescribing information for Lantus or visit www.Lantus.com.
About Lixisenatide
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lixisenatide is currently approved in over 50 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an investigational product in the U.S. It will be resubmitted to the Food & Drug Administration (FDA) in the third quarter of 2015.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Sanofi SA 2Q 2015 -- Forecast
Sanofi-Aventis (NYSE:SNY)
Earnings figures are scheduled to be released July 30.
Bulls Say
OSeveral products in the company's pipeline
address diseases where there are no current
treatments or use a novel mechanism of action,
which should allow for strong pricing power.
OThe FDA rejection of the new competing insulin
degludec should mean Sanofi will have the bestin-
class insulin in the most important market
through 2015.
OWith an industry-leading position in the insulin
market, Sanofi's Lantus and next-generation
insulin Toujeo are poised for robust growth in
emerging markets as the diabetic patient
population grows due to increasing obesity
trends.
Bears Say
OSanofi's strong entrenchment in China could
come under duress as Chinese officials are
aggressively reviewing pharmaceutical marketing
practices.
OThe patents on Lantus expire between 2014 and
2015 and while significant generic competition is
not expected due to complexities of insulin
manufacturing, a major push by generic firms
could be detrimental to a key product for Sanofi.
OBranded biosimilars of Lantus are expected
from Merck and Eli Lilly, which could create a major
drag on earnings growth post 2017
MS drug has the potential to change lives (12/15/14)
FORT WORTH — Sundie Ellis, 40, is busy again, working full time for the first time in years.
"Before Lemtrada, I worked about three or four hours a day," she said. "Now I work a full day — plus I help out around the house, which is not something I could do."
Multiple sclerosis triggered serious nerve pain, exhausting fatigue, and mental confusion in Ellis for 11 years. She took 15 medications daily just to function.
In desperation, she traveled to Germany in April to receive infusions of a drug called Lemtrada for five consecutive days. The once-a-year therapy has the potential to help alleviate MS symptoms.
In some cases, lost function has been restored.
Lemtrada was not approved by the Food and Drug Administration for use in the United States when Ellis made her transatlantic journey.
It wasn't the potential for serious side effects — including kidney failure and thyroid cancer — that led to the FDA decision. Rather, Lemtrada had not been tested in double-blind, placebo-controlled studies, like most other drugs.
Lemtrada did have years of testing, however, and had been approved for use in 40 other countries. Many MS patients were willing to travel overseas and pay for the drug out of pocket, at a cost of more than $100,000.
Ellis said not long after the therapy, she stopped needing most of the medications she had been taking.
"And any time you get rid of one medicine, you get rid of the side effects that come with it," she said. "So it was kind of lifting of symptoms, and the day was better."
In November, the FDA approved Lemtrada for use in the U.S.
"Its biggest effect is to give people hope," Ellis said.
Now, she says she has hope and energy to live life again. When she needs another infusion next year, she'll only have to travel down the street — not to Germany — to get it.
http://www.wfaa.com/story/news/health/2014/12/15/lemtrada-approved-for-treatment-of-multiple-sclerosis-in-us/20451859/
[MEI brought this story to my attention]
Genzyme’s Lemtrada Approved by the FDA (11/14/14)
- Approval Establishes Genzyme’s MS Franchise in the U.S. with Two Approved Products; Follows Global Approvals -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
“Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment.”
The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif® (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.
“The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders.
Lemtrada is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy). This program has been developed to ensure that access to Lemtrada in the U.S. is only through certified prescribers, healthcare facilities and specialty pharmacies and to also ensure that patients are enrolled in the REMS program. The program is intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion. The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada.
“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option.”
Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis.
First approved in September 2013 in the European Union, Lemtrada is approved in more than 40 countries. Additional marketing applications for Lemtrada are under review by regulatory agencies around the world.
The FDA approval of Lemtrada marks Genzyme’s second MS treatment approval in the United States. Genzyme received FDA approval of its once-daily, oral Aubagio® (teriflunomide) for the treatment of relapsing forms of MS in September 2012. Aubagio is approved in more than 50 countries, and is under review by additional regulatory agencies. Between clinical trials and commercial use, approximately 30,000 patients have been treated with Aubagio.
Multiple sclerosis is estimated to affect more than 2.3 million people globally. There are approximately 400,000 people living with MS in the United States.
Important Safety Information About Lemtrada for U.S. Patients
Serious and life-threatening autoimmune conditions such as immune thrombocytopenia (ITP) and anti-glomerular basement membrane disease can occur in patients receiving Lemtrada. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals in patients who receive Lemtrada. Lemtrada is associated with serious and life-threatening infusion reactions. Lemtrada can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage anaphylaxis and serious infusion reactions. Lemtrada may be associated with an increased risk of malignancy, including thyroid cancer, melanoma and lymphoproliferative disorders. The Lemtrada REMS Program, a comprehensive risk management program with frequent monitoring, is being implemented to help mitigate these serious risks.
The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions and also noting Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada is contraindicated in patients with Human Immunodeficiency Virus (HIV) infection.
U.S. Indication and Usage
Lemtrada is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
Please click here for full U.S. Prescribing Information for Lemtrada, including boxed warning and contraindications.
As part of its continued commitment to MS patients, Genzyme’s MS One to One® program will provide information about multiple sclerosis, Lemtrada and other relevant resources. MS One to One is available and staffed by dedicated MS nurses and highly trained representatives who can provide support for individuals living with MS, their health care providers, family and loved ones. For more information about these support services, call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) Monday through Friday, from 8:30am – 8:00pm ET. Information and support are also available at www.MSOnetoOne.com
About Lemtrada™ (alemtuzumab)
Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab depletes circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes.
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rate (0.18 for Lemtrada and 0.39 for interferon beta-1a (p<0.0001) a 55 percent relative reduction. The difference observed in proportion of patients with disability progression at year two did not reach statistical significance (8 percent for Lemtrada and 11 percent for interferon beta 1-a (p=0.22)), a relative risk reduction of 30 percent. The percent of patients remaining relapse-free at year two for Lemtrada was 78 percent vs. 59 percent for interferon beta-1a (p<0.0001). The percent change in T2 lesion volume from baseline did not reach statistical significance (-9.3 for Lemtrada and -6.5 for interferon beta 1-a, p=0.31).
In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates (0.26 for Lemtrada and 0.52 for interferon beta 1-a, p<0.0001, a 49 percent relative reduction). The proportion of patients with confirmed six-month disability progression was significantly lower for Lemtrada (13 percent for Lemtrada vs. 21 percent for interferon beta 1-a, p=0.0084), a 42 percent relative risk reduction. The percent of patients remaining relapse-free at year two for Lemtrada was 65 percent vs. 47 percent for interferon beta-1a (p<0.0001). The percent change in T2 lesion volume from baseline did not reach statistical significance (-1.3 for Lemtrada and -1.2 for interferon beta 1-a, p=0.14).
Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialization in multiple sclerosis. Bayer Healthcare receives contingent payments based on global sales revenue.
About Aubagio® (teriflunomide)
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
U.S. Indication and Usage
Aubagio (teriflunomide) is a once-daily, oral therapy indicated for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally once-daily.
Important Safety Information About Aubagio for U.S. Patients
The Aubagio label includes the risk of hepatotoxicity and, teratogenicity (based on animal data). In the United States, this information can be found in the boxed warning.
In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. Serious events may include decreased white blood cell count, peripheral neuropathy, hyperkalemia, skin reactions and increased blood pressure. The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.
Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide. ALT should be monitored monthly for at least 6 months in patients who start treatment with Aubagio.
Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception and in patients who are taking leflunomide. Aubagio is not recommended for breast-feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia.
Please click here for full U.S. Prescribing Information for Aubagio, including boxed warning and contraindications.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
About Sanofi
Sanofi, a global 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).
Genzyme®, Aubagio® and MS One to One® are registered trademarks, and LemtradaTM is a trademark of Genzyme Corporation. Rebif® is a registered trademark of EMD Serono, Inc. All rights reserved.
http://www.businesswire.com/news/home/20141114006073/en/Genzyme%E2%80%99s-Lemtrada-Approved-FDA#.VGfkKth0zIU
Quote:SNY/NVO/LLY—More on the competitive landscape in diabetes:
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCQQFjAA&url=http%3A%2F%2Fblogs.wsj.com%2Fpharmalot%2F2014%2F10%2F28%2Fsanofi-diabetes-outlook-signals-an-undisciplined-price-war-may-erupt%2F&ei=-cBaVO7iJMyyoQT30YGoDQ&usg=AFQjCNHQD878MVZWf9c-44r6rnplMW862w&bvm=bv.78677474,d.cGU&cad=rjt
The plans that show Lantus rotting due to its new competition.
Any discussion on the past few days? My opinion is that once the dust settles (soon) we will see a boom in price when they get a new CEO and roll out the originally anticipated plans
At Four Years, Treatment Effect Maintained in More Than Two-Thirds of Patients Who Received Genzyme’s Lemtrada in Pivotal Studies (9/11/14)
- In approximately 70 percent of patients, disability scores improved or remained stable for an additional two years beyond the two-year pivotal multiple sclerosis studies -
- Approximately 70 percent of patients treated with Lemtrada did not receive a third course of treatment through the second year of the extension –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today positive interim results from the second year of the extension study of Lemtrada™ (alemtuzumab) for multiple sclerosis.
In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada was given as two annual courses, at the start of the study and 12 months later. Approximately 70 percent of patients who received Lemtrada in the pivotal studies did not receive further treatment with Lemtrada through the second year of the extension study. No new safety signals were identified. These data will be presented today at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) meeting in Boston.
“These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,” said Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge. “The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier.”
Extension Study Results
The Phase III trials of Lemtrada were randomized, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with relapsing-remitting multiple sclerosis who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
More than 90 percent of the patients who were treated with Lemtrada in the Phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.
The following interim results are from the second year of the extension study for patients who previously received Lemtrada in the two-year pivotal studies:
• In year four, the annualized relapse rates for patients who received Lemtrada in CARE-MS I and CARE-MS II were 0.14 and 0.23, respectively. These rates were comparable to the annualized relapse rates for those patients who received Lemtrada in the pivotal trials.
• Through year four, 74 percent of patients in CARE-MS I and 66 percent in CARE-MS II had improved or stable disability as measured by the Expanded Disability Status Scale (EDSS).
• Through year four, 83 percent and 76 percent of patients who received Lemtrada in the pivotal trials, respectively, did not experience six-month sustained accumulation of disability – meaning they did not experience a worsening of their disability that persisted for six continuous months in the four years of observation.
• Approximately 70 percent of patients treated with Lemtrada in the pivotal studies did not receive a third course of treatment in years three and four.
“MS is a devastating disease and patients remain in need of new treatment options that may offer greater efficacy. These new data reinforce the transformative potential of Lemtrada,” said Genzyme President and CEO, David Meeker, M.D. “It is encouraging to see the durable efficacy and manageable safety of Lemtrada maintained two years into the extension study.”
Safety results from the second year of the extension study were reported. No new risks were identified. As previously reported, there were two deaths in the extension study. One was from sepsis and the other was presumed accidental and deemed unrelated to study treatment. Over four years, approximately 2 percent of patients treated with Lemtrada in the pivotal trials developed immune thrombocytopenia (ITP), all of whom responded to treatment. Patient monitoring for autoimmune disorders is incorporated in all Genzyme-sponsored trials of Lemtrada.
The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus, diarrhea, chills, dizziness, and flushing), infections (upper respiratory tract and urinary tract), and thyroid disorders. Autoimmune conditions (including immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid disease) and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will help support early detection and management of these identified risks.
About CARE-MS
The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
About LemtradaTM (alemtuzumab)
Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil, Argentina, Chile and Guatemala. Lemtrada is currently not approved in the United States. The U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its application seeking approval of Lemtrada, and Genzyme expects FDA action on the application in the fourth quarter. Marketing applications for Lemtrada are also under review in other countries.
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® is a registered trademark and LemtradaTM is a trademark of Genzyme Corporation. Rebif® is a registered trademark of EMD Serono, Inc.
About Sanofi
Sanofi, a global 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).
http://www.businesswire.com/news/home/20140910006620/en/Years-Treatment-Effect-Maintained-Two-Thirds-Patients-Received#.VBFAyNh0zIU
Genzyme’s Lemtrada Approved in Argentina for Treatment of Multiple Sclerosis (6/30/14)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
“The Lemtrada clinical trial data demonstrating the treatment’s positive impact on relapse rates and disability progression support its potential as a transformational new treatment for relapsing-remitting multiple sclerosis,” said Norma Deri, M.D., Hosptial Fernandez, Buenos Aires, Argentina. “The approval of Lemtrada is good news for people living with active MS, who are in need of additional treatment options that may offer greater efficacy.”
Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. In addition to Argentina, Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil and Guatemala. Lemtrada is currently not approved in the United States. Genzyme recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its application seeking approval of Lemtrada. Genzyme expects FDA action on the application in the fourth quarter.
More than 2.3 million people worldwide have been diagnosed with MS, including approximately 8,000 people in Argentina.
Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
"We are pleased by the continued global support for Lemtrada," said Genzyme President and CEO, David Meeker. "We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review."
The Lemtrada clinical development program included two randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus, diarrhea, chills, dizziness, and flushing), infections (upper respiratory tract and urinary tract), and lymphopenia. Autoimmune conditions (including immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid disease) and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.
About LemtradaTM (alemtuzumab)
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® is a registered trademark and LemtradaTM is a trademark of Genzyme Corporation. Rebif® is a registered trademark of EMD Serono, Inc.
About Sanofi
Sanofi, a global 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).
Sanofi Forward Looking Statemen
http://www.businesswire.com/news/home/20140630005366/en/Genzyme%E2%80%99s-Lemtrada-Approved-Argentina-Treatment-Multiple-Sclerosis#.U7NsCYlOWUk
How is that related to SNY?
Andy, you really need to take your meds, seriously? Following me on other boards is called stalking. Get help pal!
No we don't. Implant has the only TSA approval that matters. My guess is they will be bought out shortly. You need to check yourself. You have know business even stating an opinion on anything after your lph debacle. I'm serious.
If only IMSC could make 1/10th money SNY makes. We both know that won't happen.
I feel it will do a lot better then lph. I remember you were telling everyone how great they and ended up losing a lot of folks a lot of money, after their sec shutdown.
Patent cliff subsiding. Future earnings growth?
Genzyme Receives Complete Response Letter from FDA on Lemtrada™ (alemtuzumab) Application
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Sanofi-Aventis (NYSE:SNY)
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Today : Monday 30 December 2013
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Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.
A Complete Response Letter informs companies that an application is not ready for approval. FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada.
Genzyme strongly disagrees with the FDA’s conclusions and plans to appeal the agency’s decision.
“We are extremely disappointed with the outcome of the review and the implications for patients in the U.S. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease,” said Genzyme President and CEO, David Meeker, M.D. “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile. This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.”
Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies around the world.
Sanofi does not anticipate that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 will be met.
FDA Grants Priority Review for Genzyme’s Cerdelga™ (eliglustat), an Investigational Oral Therapy for Gaucher Disease
Sanofi-Aventis (NYSE:SNY)
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Today : Wednesday 11 December 2013
Click Here for more Sanofi-Aventis Charts.
- Second Major Regulatory Filing Following EMA Acceptance in Late October -
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1. As previously announced, the European Medicines Agency in late October validated Genzyme’s marketing authorization application (MAA) for eliglustat in the EU.
Genzyme is developing eliglustat, a capsule to be taken twice daily, to provide an effective oral treatment alternative for adult patients with Gaucher disease type 1, and to provide a broader range of treatment options for Gaucher patients and physicians. Genzyme’s clinical development program for eliglustat represents the largest clinical program ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries.
“The acceptance of our applications for Cerdelga represents another important milestone in our commitment to understand and respond to the needs in the Gaucher community, providing more choice for the treatment of patients,” said Genzyme’s President and CEO David Meeker, M.D.
The marketing applications for Cerdelga are based on two positive Phase 3 studies for eliglustat, ENGAGE, which included patients new to therapy, and ENCORE which included patients switching from enzyme replacement therapy. The submissions also include four years of safety and efficacy data from the eliglustat Phase 2 study.
About Gaucher disease
Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. People with Gaucher disease do not have enough of the enzyme, ß-glucosidase (glucocerebrosidase) leading to the accumulation of its substrate, glucosylceramide. As a result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and symptoms. The most common form of Gaucher disease, type 1, generally does not affect the brain.
About eliglustat
Eliglustat, an investigational new drug, is a novel ceramide analog given orally and was designed to partially inhibit the enzyme glucosylceramide synthase, resulting in reduced production of glucosylceramide. Glucosylceramide is the substance that builds up in the cells and tissues of people with Gaucher disease. The concept was initially developed by the late Norman Radin, MD, from the University of Michigan. In pre-clinical studies, the molecule, developed with James A. Shayman, MD, also from the University of Michigan, has shown high potency and specificity.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® and Cerdelga™ are registered trademarks of Genzyme Corporation. All rights reserved.
About Sanofi
Sanofi, an integrated global 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).
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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Genzyme
Lori Gorski, 617-768-9344 office
508-410-0104 mobile
Lori.gorski@genzyme.com
Sanofi Pasteur's Fluzone High-Dose Vaccine Significantly More Effective Than Standard Dose Fluzone Vaccine in Preventing Influenza in Adults 65 Years of Age and Older
http://ih.advfn.com/p.php?pid=nmona&article=58945531
LYON, France, Aug. 26, 2013 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced topline results of a large-scale, multi-center efficacy trial in people 65 years of age and older showing a superior clinical benefit of Fluzone® High-Dose (Influenza Virus Vaccine) relative to the standard dose of Fluzone vaccine in preventing influenza.
Today's announcement reflects the positive findings related to the primary endpoint for the study population. Further data analyses of secondary endpoints are ongoing, including an evaluation of the relative efficacy based on the match of the vaccine strains to circulating influenza virus strains. Sanofi Pasteur anticipates submitting the full clinical study report to the FDA for review by early 2014 and will seek a modification to the label for Fluzone High-Dose vaccine reflecting the superior efficacy data in adults 65 years of age and older.
"We are pleased that this study demonstrates the superior relative efficacy of Fluzone High-Dose vaccine compared to Fluzone vaccine in preventing influenza in older adults," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "This efficacy trial complements the previous evidence of superior immune responses for Fluzone High-Dose vaccine compared to Fluzone vaccine and reaffirms the Phase III safety data in this population that were the basis for FDA licensure of Fluzone High-Dose vaccine in 2009."
In the study, Fluzone High-Dose vaccine was 24.2 percent more effective in preventing influenza in adults 65 years of age and older than Fluzone vaccine. The results met the pre-specified primary objective of the study, demonstrating statistically superior efficacy for Fluzone High-Dose vaccine. Additionally, the study results suggested consistent clinical benefit across the study years, influenza virus types, clinical illness definitions, and laboratory methods of influenza confirmation. This large, multi-year trial also reaffirmed the safety of Fluzone High-Dose vaccine as demonstrated in previous studies.
"Influenza vaccines have been shown to offer public health benefits in preventing influenza and its complications in all age groups; however, older adults still have the highest rates of influenza-related hospitalization and death despite having high immunization rates," said John Shiver, Senior Vice President, Research and Development, Sanofi Pasteur. "This led Sanofi Pasteur to develop Fluzone High-Dose vaccine, which this trial has confirmed provides better protection against influenza compared to Fluzone vaccine in people 65 years of age and older."
Fluzone High-Dose vaccine was licensed in the United States by the Food and Drug Administration (FDA) in December 2009 based on the vaccine's safety profile and superior immunogenicity compared to Fluzone vaccine. Immunogenicity (the ability of a vaccine to trigger the body to produce antibodies against an infectious agent) is commonly used to evaluate vaccines in clinical trials. Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin antigen per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin antigen per strain of influenza virus in standard dose Fluzone vaccine. Fluzone High-Dose vaccine was licensed by the FDA under an accelerated approval process to address the medical need in older adults. As a requirement of the accelerated approval pathway, Sanofi Pasteur embarked on this large-scale, two-season, confirmatory efficacy trial, involving more than 30,000 participants 65 years of age and older, to evaluate the clinical benefit of Fluzone High-Dose vaccine compared to Fluzone vaccine in the prevention of influenza disease.
About Influenza Disease in People 65+ Years of Age
Research has shown that the immune system weakens as people age. Older adults are not only more susceptible to infections, but also less responsive to vaccination. When infected with the influenza virus, they are less able to mount an effective immune response to neutralize the attack. Compared to younger adults, people 65 years of age and older suffer disproportionately from seasonal influenza disease and its complications, including severe illness leading to hospitalization and death. Although this group comprises only 15 percent of the U.S. population, on average it accounts for 65 percent of the estimated 226,000 hospitalizations and 90 percent of the 3,000 to 49,000 deaths attributed to seasonal influenza and its complications each year. The first baby boomers began to turn 65 in 2011 and, by the year 2030, the number of adults 65 years of age and older is anticipated to double and surpass 70 million people, comprising 20 percent of the U.S. population. Thus, better prevention of influenza in older adults can have a significant impact on public health, quality of life, and healthcare costs.
About Fluzone High-Dose Vaccine
Indication
Fluzone High-Dose vaccine is an inactivated influenza virus vaccine given for active immunization in persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Approval of Fluzone High-Dose vaccine is based on superior immune response relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine have not yet been reviewed by FDA.
Safety Information
The most common side effects to Fluzone High-Dose vaccine include pain, swelling, and redness at the injection site; fever, headache, fatigue, and muscle aches. Other side effects may occur. Fluzone High-Dose vaccine should not be given to anyone with a severe allergic reaction to any vaccine component, including eggs or egg products, or to a previous dose of any influenza vaccine.
The decision to give Fluzone or Fluzone High-Dose vaccine should be based on the potential benefits and risks if Guillain-Barre syndrome has occurred within six weeks of receipt of a prior influenza vaccine. Vaccination with Fluzone or Fluzone High-Dose vaccine may not protect all individuals.
Before administering Fluzone High-Dose vaccine or Fluzone vaccine, please see full Prescribing Information available at www.sanofipasteur.us or www.vaccineshoppe.com.
American-Diabetes-Association-Annual-Meeting Updates
Update on Sanofi Diabetes and in particular on the investigation on new insulin U300.. Insightful
Read here
SNY’s 4Q12 results will be announced on Feb 7. For further info, go to: http://en.sanofi.com/investors/investors.aspx . Regards, Dew
Can someone please tell me when Sanofi's next quarterly report is made public? Also, how would I find this information on my own; for the future? Thank you in advance! John
FDA extends NDA review of NVO’s degludec and degludecplus by three months:
#msg-6408031
The new PDUFA date for both products is 10/29/12.
These drugs are NVO's attempt to compete with SNY's blockbuster, Lantus.
Sanofi Cuts Jobs, Consolidates U.S. Facilities: #msg-68616715.
SNY and BIIY : anouncements same time? head to head competition for MS dollars..Why do they call them big pharma for?
Sanofi-Aventis reports Alemtuzumab significantly reduces relapses in multiple sclerosis vs interferon Beta-1a in a Phase III study (SNY) 35.63 : Co and its subsidiary Genzyme announce new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab to Rebif in patients with relapsing-remitting multiple sclerosis. New data show that 78% of patients treated with alemtuzumab remained relapse-free for two years, providing statistically significant improvement over interferon beta-1a (78% vs 59% at two years) and meeting this secondary endpoint. Additional findings from the CARE-MS I study presented today include other secondary endpoints that suggest positive outcomes with alemtuzumab. Improvement in Multiple Sclerosis Functional Composite scores was observed in alemtuzumab-treated patients, as compared to interferon beta-1a (0.12 vs 0.05 mean change from baseline at year two). MSFC is a composite measurement of physical and cognitive function.
1:21AM Biogen Idec and Abbott (ABT) present positive data for Daclizumab HYP from select Phase 2B trial (BIIB) 108.84 : Biogen (BIIB) and Abbott (ABT) announce additional results from the SELECT Phase 2b trial in people with relapsing-remitting multiple sclerosis. Results showed that DAC HYP, administered subcutaneously once every four weeks, met the trial's primary endpoint by significantly reducing the annualized relapse rate by 54% in the 150 mg dose group and 50% in the 300 mg dose group compared to the placebo group at one year. In addition to meeting the primary endpoint, both doses of DAC HYP met key secondary endpoints, including measures of magnetic resonance imaging. In a sub-study for a pre-specified subset of patients, both 150 mg and 300 mg of DAC HYP provided a significant reduction in the cumulative number of new gadolinium-enhancing lesions between weeks eight and 24 (69%; 78%). Both doses also provided a significant reduction in new or newly enlarging T2 hyperintense lesions (70%; 79%). In a tertiary endpoint, both 150 mg and 300 mg of DAC HYP also significantly reduced the number of new Gd+ lesions on the week 52 MRI (79%; 86%).
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