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$SNY Why AstraZeneca's and Sanofi's Bad News Could Be Great News for Pfizer and Moderna
https://fool.com/investing/2020/12/16/why-astrazenecas-and-sanofis-bad-news-could-be-gre/
JUST IN: $SNY Is Novavax Stock a Buy?
The COVID-19 pandemic has affected daily life in a number of ways, and a vaccine for the disease is probably our best hope for a return to normal. Thankfully, well over a dozen companies are working to develop a vaccine for the novel coronavirus at an incredible pace; one of these, Novavax (N...
Got this from SNY - Is Novavax Stock a Buy?
Here's Why Investors Should Follow Sanofi $SNY and GlaxoSmithKline's $GSK New #Coronavirus #COVID19
Collaboration
https://www.fool.com/investing/2020/04/30/heres-why-investors-should-follow-sanofi-and-glaxo.aspx
Moncef Slaoui, a former GlaxoSmithKline executive, will lead “Operation Warp Speed,” Trump’s push to accelerate the vaccine development process for COVID-19.
SNY partnered with GSK last April to make a Covid-19 vaccine.
Food for thought.
Innovation Pharmaceuticals Informed Next Phase of Brilacidin Coronavirus (COVID-19) Testing to Begin Week of May 4
Provided by GlobeNewswire
Apr 27, 2020 9:30 AM EDT
WAKEFIELD, Mass., April 27, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing of Brilacidin, the Company’s defensin-mimetic drug candidate, is scheduled to begin the week of May 4.
Sanofi warns Europe on Covid-19 vaccine
French pharma group has two candidates in pipeline
https://www.ft.com/content/5884987a-e1d1-476a-b538-368e2a915480
Sanofi would be able to deliver an effective vaccine within the next 18 months but warned that the bigger challenge would be ramping up production to meet potentially massive demand.
Sanofi Pasteur vaccine division employs about 10,000 people and has 12 factories globally. It has two Covid-19 vaccines in development: one of which is a traditional protein-based vaccine, and another known as an mRNA vaccine, which is a new type that promises to be faster to manufacture but remains as yet unproven.
Sanofi is also testing the efficacy of two of its drugs already approved for other uses against Covid-19, including the malaria drug hydroxychloroquine and Kevzara, which is usually used to treat rheumatoid arthritis.
On Friday, the company confirmed its goal for earnings per share to rise 5 per cent this year, after reporting higher first-quarter sales and profits buoyed by people stockpiling its drugs during the Covid-19 outbreak.
That first-quarter stockpiling boost will be “largely offset” by an expected slowdown in the second quarter.
Like-for-like revenue rose 6.6 per cent to €8.97bn in the quarter to March 30 driven by higher sales of over-the-counter medicines for pain and fever, and eczema drug Dupixent.
Net income rose 16.1 per cent to €2bn.
Small Trial Suggests Antimalarial Drugs Not Effective For Treating Coronavirus
KATHERINE SELEY-RADTKE, THE CONVERSATION
6 APRIL 2020
On Saturday the Food and Drug Administration approved the use of two antimalarial drugs, hydroxychloroquine and a related medication, chloroquine, for emergency use to treat COVID-19. The drugs were touted by President Trump as a "game changer" for COVID-19.
However, a study just published in a French medical journal provides new evidence that hydroxychloroquine does not appear to help the immune system clear the coronavirus from the body.
The study comes on the heels of two others - one in France and one in China - that reported some benefits in the combination of hydroxychloroquine and azithromycin for COVID-19 patients who didn't have severe symptoms of the virus.
I am a medicinal chemist who has specialized in discovery and development of antiviral drugs for the past 30 years, and I have been actively working on coronaviruses for the past seven.
I am among a number of researchers who are concerned that this drug has been given too much of a high priority before there is enough evidence to show it is indeed effective.
There are already other clinical studies that showed it is not effective against COVID-19 as well as several other viruses. And, more importantly, it can have dangerous side effects, as well as giving people false hope.
The latter has led to widespread shortages of hydroxychloroquine for patients who need it to treat malaria, lupus and rheumatoid arthritis, the indications for which it was originally approved.
The idea that the combination of hydroxychloroquine with an antibiotic drug, azithromycin, was effective against COVID-19 gained more attention after a study published on March 17. This study described a trial of 80 patients carried out by Philippe Gautret in Marseille, France.
Although some of their results appeared to be encouraging, it should also be noted that most of their patients only had mild symptoms. Furthermore, 85 percent of the patients didn't even have a fever – one of the major telltale symptoms of the virus, thus suggesting that these patients likely would have naturally cleared the virus without any intervention.
In another study, posted on medRxiv, which has not yet been peer-reviewed, Chinese scientists from Renmin Hospital of Wuhan University, in Wuhan, China, gave hydroxychloroquine to patients with only mild infections who were free of medical issues, similar to the Gautret study. The results showed that the 31 patients who received the drug showed a lessening of their symptoms 24 hours earlier than patients in the control group.
In addition, pneumonia symptoms improved in 25 of the 31 patients versus 17 of 31 in the control group. As noted in several of the comments associated with the manuscript, there are issues related to the translation of the paper, thus clouding interpretations of some of the results. The paper also appears to focus more on pneumonia than COVID-19. However, these issues may be cleared up or addressed once the paper finishes the peer-review process.
But two other studies have conflicting results.
A second French group, led by Jean-Michel Molina, has now tested the hydroxychloroquine-azithromycin combination treatment in 11 patients at the Hôpital Saint-Louis in Paris, France, and their results were strikingly different.
Like the Marseille study, the Molina trial was also a small pilot study. Molina and colleagues used the same dosing regimen as Gautret. In contrast, however, to the Gautret study, eight of the 11 patients had underlying health conditions, and 10 of 11 had fevers and were quite ill at the time the dosing began.
These Paris researchers found that after five to six days of treatment with hydroxychloroquine (600 mg per day for 10 days) and azithromycin (500 mg on day 1 and 250 mg on days 2 to 5), eight of the 10 patients still tested positive for COVID-19.
Of these 10 patients, one patient died, two were transferred to the ICU and another had to be removed from the treatment due to serious complications.
In addition, a similar study in China also showed no difference in viral clearance after seven days either with or without the hydroxychloroquine with the patients in the trial. This supports Molina's findings.
Thus, despite the recent approval of this drug for use against COVID-19, questions remain as to the efficacy of this treatment.
As Molina and colleagues note: "Ongoing randomized clinical trials with hydroxychloroquine should provide a definitive answer regarding the alleged efficacy of this combination and will assess its safety."
Katherine Seley-Radtke, Professor of Chemistry and Biochemistry and President-Elect of the International Society for Antiviral Research, University of Maryland, Baltimore County.
Malaria drug fails at hospital https://www.bloomberg.com/news/articles/2020-04-02/hyped-malaria-drug-not-showing-much-effect-at-one-paris-hospital
I think unfortunately because this is a Pharma stock now a biotech...sad I sold out today 30 min charts look toppy and thought this one would have already run...
I’m confused, I would of thought this would have moved more. What am I missing?
pill instead of vaccine
FDA about to speak...bought some here just in case gl2all.
Goldman Sachs rate Sanofi a buy.
Working on several new drugs plus a vaccine for virus .
News: $SNY Sanofi Is Paying a 172% Premium to Buy Synthorx -- and It Sounds Like a Good Deal for Both
On Dec. 9, pharmaceutical giant Sanofi (NASDAQ: SNY) said it's buying immuno-oncology company Synthorx (NASDAQ: THOR) for $2.5 billion to boost its cancer and autoimmune program. Considering the performance of Sanofi's businesses, the pipeline Synthorx brings to the ...
Got this from SNY - Sanofi Is Paying a 172% Premium to Buy Synthorx -- and It Sounds Like a Good Deal for Both
News: $SNY Here's Why Dermira Stock Popped Today
Shares of Dermira (NASDAQ: DERM) , a biopharmaceutical company, jumped at the beginning of today's trading session in response to good news from the Food and Drug Administration. Investors looking forward to a shortened review for the company's experimental eczema therapy drove the stock...
Find out more SNY - Here's Why Dermira Stock Popped Today
Time for puts - Zantac getting pulled from shelves.
Looking for a return to near $40.
News: $SNY 2 Biotech Stocks I Wouldn't Touch With a Broom
Drug development is a losing game full of highly trained professionals who would rather be lucky than talented at their jobs. This is because experimental new drugs fail so frequently that an entire career without one successful new drug discovery under their belts isn't uncommon. Doing everyth...
Got this from SNY - 2 Biotech Stocks I Wouldn't Touch With a Broom
BioNTech Teams up With Sanofi to Target Solid Tumors in $91.5 Million Deal...
As part of the deal, the French pharma giant will invest about $91.5 million in equity in BioNTech, a privately-held company. The investment follows BioNTech’s 2018 decision to exercise one of the option rights under the 2015 agreement to co-develop and co-commercialize the immuno-oncology candidate. The two companies will work to develop an investigational therapy that includes an mRNA mixture encoding immunomodulatory cytokines that are injected directly into the tumor. Local administration of immunotherapies to the tumor microenvironment provides the opportunity to stimulate innate and adaptive immune responses against tumors, while potentially avoiding toxicities related to systemic administration of immuno-modulatory therapeutics.
https://www.biospace.com/article/biontech-teams-up-with-sanofi-to-target-solid-tumors-in-91-5-million-deal/
Keep an eye on this sleeper with so much potential- a potential M&A target. IMO
Mymetics Corp. (otcqb: MYMX)
Imminent Catalysts:
1) Collaboration with Sanofi Pasteur(vaccine unit of giant pharma Sanofi) will conclude this year's (2018) end. Successful outcome will lead to either exclusive licensing deal of Mymetics' proprietary VLP platform for use in Sanofi's influenza vaccines or buyout.
2) Collaboration with Anergis,SA which preclinical results expected at year's (2018) end or 1st Q of 2019. A successful outcome will lead to exclusive worldwide licensing deal with Mymetics' proprietary VLP platform for use in all of Anergis' allergy immunotherapy vaccines.
3) MACIVIVA(Manufacturing for cold chain independent virosome based vaccines) of which Mymetics is leading a consortium of 4 other companies including giant CMO Catalent(NYSE:CTLT) using Mymetics' HIV-1 vaccine will conclude this month of November 2018.
4) A possibility of advancing Mymetics' HIV-1 vaccine to Phase Ib - II under the framework of MACIVIVA project.
GLTA
Consortium partner tweeted:
"Upperton abstract, entitled Developing Cold Chain Independent Vaccines - Spray-drying of Virosomes to Produce Dry Powder Formulations, has been Accepted for Poster presentation at the 2018 AAPS Annual Meeting to be held November 4-7, 2018 in DC"
Upperton abstract, entitled Developing Cold Chain Independent Vaccines - Spray-drying of Virosomes to Produce Dry Powder Formulations, has been Accepted for Poster presentation at the 2018 AAPS Annual Meeting to be held November 4-7, 2018 in DC
— Upperton Pharma Solutions (@UppertonLtd) July 20, 2018
Under-the-Radar R&D Biotech microcap with so much potential!
>>>Mymetics(otcqb:MYMX) - Sanofi Pasteur [vaccine unit of Sanofi(nyse:SNY)]<<<
short term catalyst ~June 2018 collaboration result/decision point!
Mymetics' (OTCQB:MYMX) extremely undervalued @ $ 0.04
>>> Vaccine Pipeline:
HIV
Malaria
Intranasal Influenza
RSV
Chikungunya
>>> Partnerships:
Anergis ---------------------------------------------------------- April 2018 - present
Sanofi Pasteur (vaccine unit of Sanofi : NYSE: SNY) --- Oct.2016 - present
Astellas Pharma (2nd Largest Japanese Pharma Co.)-- Jan.2014 - July 2016
Catalent (NYSE:CTLT) ---April 2015 - Present
Bachem (SIX:BANB) ------April 2015 - Present
Upperton, UK -------------- April 2015 - Present
Chimera Biotec, Germany-April 2015 - Present
Texas Biomedical Research Institute - Sept.2014 - Present
>>> Funding Organizations:
Bill & Melinda Gates Foundation - HIV-1 vaccine
PATH MVI ------------------------------ Malaria Transmission Blocking Vaccine
Swiss Tropical & Public Health Institute --- Malaria Vaccine
European Union Horizon 2020---------------MACIVIVA (Manufacturing Process For Cold-Chain Independent Virosome based Vaccines)-- Mymetics is leading a consortium of 4 other companies.
**** MACIVIVA *****
>>> MACIVIVA = Game Changer = Disrupting the vaccine industry worldwide!
MACIVIVA latest Progress' Reporting Period Posted: https://cordis.europa.eu/result/rcn/194900_en.html
Copy of latest MACIVIVA presentation (downloadable): https://www.mymetics.com/media-center/world-vaccine-congress-10-12-october-2017-barcelona/
>>> No More Pricks – Quick Dissolvable Tablet is Set to Disrupt the Vaccine Industry
http://investor.catalent.com/press-release/financial-news/no-more-pricks-%E2%80%93-quick-dissolvable-tablet-set-disrupt-vaccine-industry https://vimeo.com/217946374<<< click video insert
>>> Dr. Christopher Henney, currently Anthera Pharmaceuticals(ANTH) and Cascadian Therapeutics (formerly Oncothyreon) - recently acquired by Seattle Genetics, Chairman of the Board; Director at Cyclacel Pharmaceuticals and former Dendreon co-founder & CEO was once on board with this unknown microcap as Chairman of BOD but seems had a disagreement with the largest shareholder that led him and his Dendreon protege to leave in less than a year.
https://www.xconomy.com/san-francisco/2012/04/11/mymetics-ropes-in-dendreon-kpcb-vets-to-restart-vaccine-developer/
Share Structure:
Outstanding : 303.7million common shares (unchanged since 2014)
Float: ~ 91 million shares
>>> MYMX is leading this disruptive project.
https://cordis.europa.eu/docs/results/h2020/646/646122_PS/maciviva-project-concept.jpg
"click" on Company Overview: https://www.mymetics.com/about/
****taken from yahoo message board courtesy of nito****
April 16th 2018 - The Best Stock Investment For 2018 - Mymetics Corp. (MYMX)
https://askwarrenbuffet.blogspot.com/2018/02/the-best-investment-for-2018-is.html
Sanofi strikes again! 2nd acquisition deal this month. Who's Next?
"We can still do additional bolt on acquisitions," Chief Executive Olivier Brandicourt said on a call with reporters, adding that the company had a general target of EUR20 billion for acquisitions.
https://ih.advfn.com/p.php?pid=nmona&article=76572055
Microcap Mymetics Corp. (OTCQB:MYMX ) .03 on watch!
Partnerships:
Sanofi Pasteur (vaccine unit of Sanofi : NYSE: SNY) --- Oct.2016 - present
Astellas Pharma (2nd Largest Japanese Pharma Co.)-- Jan.2014 - July 2016
Catalent (NYSE:CTLT) ---April 2015 - Present
Bachem (SIX:BANB) ------April 2015 - Present
Upperton, UK -------------- April 2015 - Present
Chimera Biotec, Germany-April 2015 - Present
Texas Biomedical Research Institute - Sept.2014 - Present
Funding Organizations:
Bill & Melinda Gates Foundation - HIV-1 vaccine
PATH MVI ------------------------------ Malaria Transmission Blocking Vaccine
Swiss Tropical & Public Health Institute --- Malaria Vaccine
European Union Horizon 2020---------------MACIVIVA (Manufacturing Process For Cold-Chain Independent Virosome based Vaccines)--Mymetics is leading a consortium of 4 other companies.
"click" on Company Overview: https://www.mymetics.com/about/
*courtesy of nito from yahoo mymx message board*
https://finance.yahoo.com/quote/MYMX/community?p=MYMX
A bump on the road but still going!
SANOFI-MYMETICS collaboration result anytime now? Come on Mymetics bring the news!!! Will it be JV or Buyout???
Sanofi working on intra-nasal Fluzone to compete with Aztra Zeneca's Flumist?
"There are a number of quadrivalent options for consumers to choose from this season. One option that is available -- but which the CDC suggests you steer clear -- is AstraZeneca's nasal spray FluMist. Despite being a handy alternative to getting a shot,studies have suggested that FluMist simply isn't effective compared to the other flu vaccines being offered"
https://www.fool.com/investing/2017/02/11/flu-death-rates-just-hit-the-epidemic-threshold-bu.aspx
http://finance.yahoo.com/news/mymetics-starts-research-project-sanofi-100000417.html
http://www.mymetics.com/
"In 2017 and beyond we will continue to simplify and reshape the company," Chief Executive Oliver Brandicourt told journalists. "We will be supported by our current growth engine businesses: Sanofi Genzyme, vaccines and consumer healthcare".
http://finance.yahoo.com/news/drugmaker-sanofi-sees-weak-2017-082546194.html
The keyword is SIMPLIFY and that's exactly the partnership is all about. IMO, Sanofi is aiming of simplifying the old and traditional method of making their virus-based vaccines to reduce costs as well as improving effectiveness of their vaccines not to mention the broad range application of Mymetics' virosome-based VLP platform.
Is Mymetics the next acquisition target?
"In 2017 and beyond we will continue to simplify and reshape the company," Chief Executive Oliver Brandicourt told journalists. "We will be supported by our current growth engine businesses: Sanofi Genzyme, vaccines and consumer healthcare".
http://finance.yahoo.com/news/drugmaker-sanofi-sees-weak-2017-082546194.html
The keyword is SIMPLIFY and that's exactly the partnership is all about. IMO, Sanofi is aiming of simplifying the old and traditional method of making their virus-based vaccines to reduce costs as well as improving effectiveness of their vaccines not to mention the broad range application of Mymetics' virosome-based VLP platform.
Is Mymetics the next acquisition target?
SNY & Tiny $GOVX @ .06, $3.2M market cap featured in Zika article.
Feb 1, 2017:
Link:
http://www.pharmavoice.com/article/2017-2-zika-research/
Sanofi and Mymetics Corp. (otcbb:MYMX) partners for virosome influenza vaccine. The project is to evaluate influenza vaccines based on Mymetics' proprietary Virus Like Particle(VLP) technology platform versus Egg-based split vaccines.
http://ih.advfn.com/p.php?pid=nmona&article=73038267
Mymetics website: http://www.mymetics.com/
Sanofi Adds Costa Rica To Dengvaxia Approval List
http://marketexclusive.com/sanofi-sa-nysesny-adds-costa-rica-dengvaxia-approval-list/8377/?icd1
Sanofi Announces Positive Phase 3 Results for Investigational Titratable Fixed-Ratio Combination of Insulin Glargine and Lixi...
Source: PR Newswire (US)
PARIS, June 12, 2016 /PRNewswire/ -- Sanofi announced today the presentation of the results of the pivotal Phase 3 LixiLan-O and LixiLan-L clinical trials with the investigational titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide in adults with type 2 diabetes. Both studies met their primary endpoints, demonstrating statistically superior reduction of HbA1c (average blood glucose over the previous three months) with the titratable fixed-ratio combination versus comparators (lixisenatide and insulin glargine 100 Units/mL, respectively). The most frequent adverse events were nausea, vomiting and diarrhea.
Full results were presented on June 12 at the American Diabetes Association 76th Scientific Sessions in New Orleans, LA, U.S. Top-line results were previously reported in Q3 of 2015.
"These studies reflect Sanofi's commitment to innovative approaches in developing medicines intended to help patients meet their needs throughout their diabetes journey," said Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi. "We look forward to continuing to work with the FDA and EMA as they complete their reviews and to receiving their decisions."
The results of the LixiLan-O and LixiLan-L studies have been included in regulatory submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), with regulatory decisions anticipated in August 2016 (FDA) and Q1 2017 (EMA).
The presentation abstracts are titled:
Clinical Impact of Titratable Fixed-Ratio Combination of Insulin Glargine/Lixisenatide vs. Each Component Alone in Type 2 Diabetes Inadequately Controlled on Oral Agents: LixiLan-O Trial (NCT02058147) (Rosenstock, J et al. Oral presentation 186-O, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, U.S. at 8:45 a.m. on June 12, 2016).
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed-Ratio Combination vs. Insulin Glargine in Patients with T2DM: the LixiLan-L Trial (NCT02058160) (Aroda, V et al. Oral presentation 238-O, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, U.S. at 2:30 p.m. on June 12, 2016).
The proprietary name for the titratable fixed-ratio combination is under consideration. Its safety and efficacy have not been evaluated by any regulatory authority.
Results of Analyses
LixiLan-O
LixiLan-O investigated the efficacy and safety of a once-daily single injection of the titratable fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide versus treatment with either lixisenatide or insulin glargine 100 Units/mL alone 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 while other oral agents were discontinued.
After 30 weeks, the titratable fixed-ratio combination showed significantly greater reductions in HbA1c from baseline (8.1%) versus insulin glargine 100 Units/mL and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001), reaching mean HbA1c levels of 6.5%, 6.8%, 7.3%, respectively. More subjects reached target HbA1c <7% with the titratable fixed-ratio combination (74%) versus insulin glargine 100 Units/mL (59%) or lixisenatide (33%). Mean body weight increased with insulin glargine 100 Units/mL (+1.1kg), and decreased with the titratable fixed-ratio combination (-0.3kg; difference 1.4kg, p<0.0001) and lixisenatide (-2.3kg).
Documented (≤70 mg/dL) symptomatic hypoglycemia was similar with the titratable fixed-ratio combination (25.6% of patients; 1.44 events/year; E/Y) and insulin glargine 100 Units/mL (23.6% of patients; 1.22 E/Y), but lower with lixisenatide (6.4% of patients; 0.34 E/Y). With the titratable fixed-ratio combination, 9.6% of participants experienced nausea and 3.2% experienced vomiting; with insulin glargine 100 Units/mL, 3.6% of participants experienced nausea and 1.5% experienced vomiting; and with lixisenatide 24.0% of participants experienced nausea and 6.4% experienced vomiting.
LixiLan-L
LixiLan-L investigated the efficacy and safety of the titratable 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 while other oral agents were discontinued.
After 30 weeks, the titratable fixed-ratio combination showed significantly greater reductions in HbA1c from baseline (8.1%) versus insulin glargine 100 Units/mL (-1.1% versus -0.6%; p<0.0001), reaching mean HbA1c levels of 6.9% and 7.5%, respectively. More subjects reached target HbA1c <7% with the titratable fixed-ratio combination (55%) versus insulin glargine 100 Units/mL (30%; p<0.0001). Mean body weight increased with insulin glargine 100 Units/mL (+0.7 kg), and decreased with the titratable fixed-ratio combination (-0.7 kg; difference 1.4 kg, p<0.0001).
Documented (≤70 mg/dL) symptomatic hypoglycemia was similar with the titratable fixed-ratio combination (40% of patients; 3.0 events/year; E/Y) and insulin glargine 100 Units/mL (42.5% of patients; 4.2 E/Y). With the titratable fixed-ratio combination, 10.4% of participants experienced nausea, and 3.6% experienced vomiting; while with insulin glargine 100 Units/mL 0.5% of participants experienced nausea and 0.5% experienced vomiting.
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.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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 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, 2015. 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-announces-positive-phase-3-results-for-investigational-titratable-fixed-ratio-combination-of-insulin-glargine-and-lixisenatide-300283423.html
SOURCE Sanofi
Copyright 2016 PR Newswire
FDA Accepts Sanofi New Drug Application for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
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