سانوفي: الفرق بين النسختين

[نسخة منشورة][نسخة منشورة]
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سطر 23:
 
تعمل سانوفي في [[بحث وتطوير|البحث والتطوير]]، [[صناعة وتسويق الأدوية]]، بالأخص في سوق الوصفات الطبية، لكن المؤسسة طورت [[أدوية متاحة بدون وصفة]]، وتغطي الشركة سبعة مجالات علاجية رئيسية وهي : [[مرض قلبي وعائي|الأمراض القلبية الوعائية]]، [[الجهاز العصبي المركزي]]، [[مرض السكري]]، [[الطب الداخلي]] (الباطني)، [[علم الأورام]]، [[تخثر الدم]] و[[اللقاحات]] (وهي أكبر منتجة للأخير في العالم خلال فرعها [[سانوفي باستيور]]).
 
==المنتجات==
===الأدوية والوصفات الطبية===
====المناعة الذاتية====
*[[قلم إيبنفرين]] <ref>{{cite web|url=http://www.kaleopharma.com/intelliject-inc-receives-fda-approval-for-auvi-qtm-epinephrine-injection-usp/|title=kaléo|website=kaléo}}</ref> [[حساسية]].<ref>Katie Thomas for the New York Times. 1 February 2013 [https://www.nytimes.com/2013/02/02/business/auvi-q-challenges-epipen-with-a-new-shape-and-size.html?partner=rss&emc=rss&pagewanted=all Brothers Develop New Device to Halt Allergy Attacks]</ref>
*[[تيريفلونوميد]] لمرض [[تصلب متعدد|التصلب المتعدد]]. وافقت عليها ادارة الاغذية والعقاقير في سبتمبر 2012.<ref>{{cite press release
|url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319277.htm |title=FDA approves new multiple sclerosis treatment Aubagio |publisher=US FDA |accessdate=2012-09-14}}</ref>
 
'''Product recall and effects''': The Epinephrine auto-injection devices made by Sanofi SA currently on the market in the U.S. and Canada were voluntarily recalled on 28 October 2015.<ref>{{cite web|url=http://www.cbc.ca/news/health/allerject-epinephrine-auto-injectors-recalled-by-drugmaker-sanofi-1.3293765|title=All Allerject epinephrine auto-injectors recalled|website=Cbc.ca}}</ref><ref>{{cite web|url=http://www.allerject.ca/Common/docs/en/Sanofi-Canada-Issues-Voluntary-Recall-of-Allerject.pdf|title=Sanofi Canada Issues Voluntary Nationwide Recall of Allerject Due to Potential Inaccurate Dosage Delivery|website=Allerject.ca|accessdate=22 September 2018}}</ref> The reason stated by Sanofi was that the products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug.<ref name="auvi-q.com">{{cite web|url=https://www.auvi-q.com/|title=Auvi-Q® (epinephrine injection, USP)|website=Auvi-q.com}}</ref><ref name="fda.gov">{{cite web|url=http://www.fda.gov/Safety/Recalls/ucm469980.htm|title=Recalls, Market Withdrawals, & Safety Alerts - UPDATED: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery|first=Office of Regulatory Affairs, Office of the|last=Commissioner|website=www.fda.gov|accessdate=23 May 2017}}</ref>
 
Sanofi US also added the following warning: If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition.<ref name="auvi-q.com"/>
 
In its news release on 28 October 2015, Sanofi Canada stated that it was "actively working with suppliers of alternative epinephrine auto-injectors to have a full stock available in Canada as soon as possible. Canadian customers were asked to immediately return the Allerject product to their local pharmacy to obtain an alternate epinephrine auto-injector."<ref>{{cite web|url=http://www.newswire.ca/news-releases/sanofi-canada-issues-voluntary-nationwide-recall-of-allerject-due-to-potential-inaccurate-dosage-delivery-538090301.html|title=Sanofi Canada Issues Voluntary Nationwide Recall of Allerject® Due to Potential Inaccurate Dosage|website=Newswire.ca}}</ref>
 
The U.S. Food and Drug Administration also filed a news release<ref name="fda.gov"/> confirming that the recall involves all Auvi-Q currently on the market in the U.S. The FDA release went on to provide information for consumers re: exchanging the device for another brand of product, also provided on the Auivi-Q web site. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new, alternate epinephrine auto-injectors with proof of purchase.
 
The alternate products expected to most commonly replace the recalled Sanofi devices are the EpiPens made by [[Mylan]] in the US and by Pfizer—under license from Mylan—in Canada.<ref>{{cite web|url=https://www.epipen101.ca/en/welcome|title=Welcome to EpiPen® 101|website=Epipen101.ca|date=2015-03-19}}</ref> Mylan already had an 85% market share of the auto-injectors in the US<ref>{{cite web|url=https://www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business|title=How Marketing Turned the EpiPen Into a Billion-Dollar Business|first=Cynthia Koons CynthiaLKoons Robert Langreth RobertLangreth|last=Reprints|website=Bloomberg.com}}</ref> in the first half of 2015. Maylan was expected to benefit from the recall by its competitor Sanofi, according to a report published in the Fierce Pharma newsletter of 2 November 2015: "....it is very hard to see Auvi-Q returning to the market, as it will need to be redesigned and face uphill battle to recapture patient trust after the recall," Bernstein analyst Ronny Gal wrote in a note to clients.<ref>{{cite web|url=http://www.fiercepharmamarketing.com/story/sanofis-auvi-q-recall-puts-mylans-rival-epipen-full-control-blockbuster-mar/2015-11-02|title=Sanofi's Auvi-Q recall puts Mylan's rival EpiPen in full control of blockbuster market - FiercePharma|website=Fiercepharmamarketing.com}}</ref> Gal also believes that the company will eventually have 95% of the Epinephrine auto-injector market, according to another Fierce Pharma report on 3 November 2015.<ref>{{cite web|url=http://www.fiercepharma.com/story/its-open-season-mylans-epipen-sanofi-teva-stumble/2015-11-02|title=It's open season for Mylan's EpiPen as Sanofi, Teva stumble - FiercePharma|website=Fiercepharma.com}}</ref>
 
====Cardiovascular====
*[[كلوبيدوغريل]] (Plavix, Iscover) for atherothrombosis
*[[إينوكسابارين]] (Lovenox, Clexane) for thrombosis (its biggest seller in 2008)<ref>{{cite web|url=http://en.sanofi-aventis.com/binaries/Sanofi_RA_EN_tcm28-24842.pdf|title=Annual Review 2008|publisher=Sanofi-Aventis|accessdate=2009-04-19}}</ref>
*[[Mipomersen]] (Kynamro), an [[علاج عكسي لاتجاه النسخ]] invented by [[Isis Pharmaceuticals]] and acquired by Genzyme in 2008 (pre-Sanofi)<ref>Lisa M. Jarvis for Chemical and Engineering News. 14 January 2008 [http://cen.acs.org/articles/86/i2/Isis-Genzyme-Heart-Drug-Deal.html Isis, Genzyme In Heart Drug Deal]</ref> and approved by the FDA in 2013 for the [[مرض نادر]] [[فرط كوليسترول الدم العائلي]].<ref>Andrew Pollack for the New York Times. 29 January 2013 [https://www.nytimes.com/2013/01/30/business/fda-approves-genetic-drug-to-treat-rare-disease.html?partner=rss&emc=rss F.D.A. Approves Genetic Drug to Treat Rare Disease]</ref>
*[[إربيسارتان]] (Aprovel, Avapro, Karvea) and [[راميبريل]] (Delix, Triatec, Tritace) for [[ارتفاع ضغط الدم]]
*[[أليروكوماب]] (Praluent) for heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease
*[[دوبيلوماب]] (Dupixent) for atopic disease
 
====Infectious disease====
* Antibiotics:
**[[سيفوتاكسيم]] (Claforan)
**[[ريفابنتين]] (Priftin)
**[[ليفوفلوكساسين]] (Tavanic)
**[[أموكسيسيلين/حمض الكلافولانيك]] (Amoklavin)
* Vaccines:
**Bacterial diseases:
***[[كوليرا]]
***[[خناق]]
***[[مستدمية نزلية]]
***[[لقاح المكورات السحائية]] (Menactra)
***[[سعال ديكي]]
***[[لقاح المكورة الرئوية]]
***[[كزاز]]
***[[سل]]
***[[حمى التيفوئيد]]
**Viral diseases:
***[[التهاب الكبد الوبائي أ]]
***[[التهاب الكبد ب]]
***[[إنفلونزا]]
***[[التهاب الدماغ الياباني]] (Ixiaro)
***[[حصبة]]
***[[نكاف]]
***[[شلل الأطفال]]
***[[داء الكلب]]
***[[حصبة ألمانية]]
***[[جدري الماء]]
***[[حمى صفراء]]
***[[جدري]] - eradicated in 1980 (vaccine produced as a measure in response to the threat of bioterrorism)
 
====Metabolic====
* [[غليمبريد]] (Amaryl) for [[سكري النوع الثاني]]
*[[إنسولين]] (Insuman) for [[السكري]] and type 2 diabetes mellitus
*[[أنسولين غلوليزين]] (Apidra) and [[إنسولين غلارجين]] (Lantus) for [[السكري]]
*[[Risedronic acid]] (Actonel) for [[هشاشة العظام]] and [[مرض بادجيت]]
*[[سيفيلامير]] hydrochloride (Renagel and Renvela) for [[مرض الكلى المزمن]]
*[[carmustine]] implants (Gliadel) for cancer
 
====Neurology====
*[[Sodium hyaluronate]] (Hyalgan) for [[تحليل الدم]]
*[[حمض الفالبرويك]] (Depakine) and [[حمض الفالبرويك]] (Depakote) for [[صرع]]
*[[زولبيديم]] (Ambien, Ambien CR, Myslee, Stilnoct, Stilnox, Zolfresh, Zolt) for [[أرق]]
*[[أليمتوزوماب]] (Lemtrada) for [[تصلب متعدد]]
*[[تيريفلونوميد]] (Aubagio) for [[تصلب متعدد]]
 
====Oncology====
*[[ألفوزوسين]] (Xatral/Uroxatral) for [[ضخامة البروستات]]
*[[Cabazitaxel]] (Jevtana) for prostate cancer
*[[Plerixafor]] (Mozobil), [[macrocycle]] approved by the [[إدارة الغذاء والدواء (الولايات المتحدة)]] for peripheral blood stem cell mobilizer for non-Hodgkins lymphoma and multiple myeloma in December 2008<ref>{{cite press release |url=http://www.prescribingreference.com/news/showNews/which/MozobilApprovedForNonHodgkinsLymphomaAndMultipleMyeloma121801 |title= Mozobil approved for non-Hodgkin’s lymphoma and multiple myeloma |date=18 December 2008 |publisher=''Monthly Prescribing Reference''| accessdate=3 January 2009}}</ref>
* [[أفليبيرسيبت]] (ZALTRAP) [[حمض نووي معاد التركيب]] [[بروتين اندماجي]], approved in metastatic colorectal cancer in combination with other agents in 2012.<ref name=ZaltrapFDA/>
*[[كلوميفين]] (Clomid) for [[العقم عند المرأة]]
*[[دوسيتاكسيل]] (Taxotere) for [[سرطان الثدي]], [[سرطان الرئة]] and [[سرطان البروستاتا]]
*[[أوكساليبلاتين]] (Eloxatin) for [[سرطان القولون]]
*[[Sarilumab]] (Kevzara) for blood tests, [[سرطان الرئة]] and [[سرطان البروستاتا]]
*[[Vandetanib]] (Caprelsa) for breast, colorectal cancer and female infertility
 
====Pain====
*[[كودين]] (Solpadol) for [[ألم مزمن]]
*[[كيتوبروفين]] (Bi-profined) for pain
 
====Diabetes====
*[[إنسولين غلارجين]] (insulin glargine) for [[السكري]] and [[السكري]] [[السكري]]
*[[إنسولين غلارجين]] (insulin glargine) for type 1 and type 2 diabetes mellitus
*[[أنسولين غلوليزين]] (insulin glulisin) for type 1 and type 2 diabetes mellitus
 
====Over the counter====
* [[فيكسوفينادين]] (Allegra, Telfast) and [[تريامسينولون]] (Nasacort) for [[حساسية الأنف]]
* [[باراسيتامول]] (Novaldol)
* [[كربونات الكالسيوم]] (Maalox, an [[مضاد الحموضة]])
 
The company also produces a broad range of over-the-counter products, among them [[فيكسوفينادين]], [[مروخ]] for muscle pain, [[Gold Bond medicated powder|Gold Bond]] for skin irritation, and [[Selsun Blue]] dandruff shampoo. These brands were acquired in 2010 when Sanofi-Aventis purchased [[Chattem]].
 
===Pipeline===
As of the summer of 2013, Sanofi was in a race with [[أمجن]] and [[فايزر]] to win approval for a [[PCSK9]], a protein that slows the clearance of [[بروتين دهني منخفض الكثافة]] (LDL) cholesterol - the form of cholesterol that leads to heart attacks.<ref>Gina Kolata for the New York Times. 9 July 2013 [https://www.nytimes.com/2013/07/10/health/rare-mutation-prompts-race-for-cholesterol-drug.html?partner=rss&emc=rss&pagewanted=all Rare Mutation Ignites Race for Cholesterol Drug]</ref> Sanofi's drug was discovered by [[ريجينيرون (شركة)]] and is called [[أليروكوماب]].<ref>[http://www.regeneron.com/regn727 Alirocumab on Regeneron's website] {{Webarchive|url=https://web.archive.org/web/20120416102019/http://www.regeneron.com/regn727 |date=16 April 2012 }}</ref> An FDA warning in March 2014 about possible cognitive adverse effects of PCSK9 inhibition threw the competition into disarray, as the FDA asked companies to include neurocognitive testing into their [[مراحل التجارب السريرية]] clinical trials.<ref>John Carroll for FierceBiotech 7 March 2014 [http://www.fiercebiotech.com/story/regeneron-sanofi-and-amgen-shares-suffer-fdas-frets-about-pcsk9-drug/2014-03-07 UPDATED: Regeneron, Sanofi and Amgen shares suffer on FDA's frets about PCSK9 class]</ref>
 
In fall 2013 Sanofi announced that another candidate from its collaboration with Regeneron, the monoclonal antibody against the interleukin 6 receptor, [[sarilumab]], had better efficacy than placebo in its first Phase III trial for rheumatoid arthritis.<ref>John Carroll for FierceBiotech 22 November 2013 [http://www.fiercebiotech.com/story/regeneron-sanofi-hit-trio-goals-first-phiii-test-rheumatoid-arthritis-drug/2013-11-22#ixzz2yojrEVlP Regeneron, Sanofi hit a trio of goals in first PhIII test of rheumatoid arthritis drug]</ref>
 
===Management===
* Olivier Brandicourt, [[رئيس مجلس الإدارة]], [[الرئيس التنفيذي]]<ref>Noemie Bisserbe for the Wall Street Journal. 20 Feb. 2015 [https://www.wsj.com/articles/sanofi-appoints-olivier-brandicourt-chief-executive-1424383378 Sanofi Names Olivier Brandicourt CEO]</ref>
* Jean-François Dehecq was the [[مدير عام]] of Sanofi from its creation in 1973 until 2007.
* After a two-month search, Sanofi has its replacement for longtime [[مدير المالية]] Jérôme Contamine, who is retiring at the end of September. The drugmaker is bringing on Jean-Baptiste Chasseloup de Chatillon, formerly the CFO of French automaker [[مجموعة بي أس إيه]], for the role.<ref>{{cite web |last1=Sagonowsky |first1=Eric |title=Sanofi recruits veteran French auto executive to replace outgoing CFO Contamine |url=https://www.fiercepharma.com/sanofi-recruits-new-cfo-to-replace-outgoing-contamine |website=FiercePharma |accessdate=4 July 2018}}</ref>
 
===Stockholders===
As of 31 December 2013:<ref name="AR2013">{{cite web |url=http://en.sanofi.com/Images/35795_20-F_2013.pdf |archive-url=https://web.archive.org/web/20140326200214/http://en.sanofi.com/Images/35795_20-F_2013.pdf |dead-url=yes |archive-date=26 March 2014 |title=Annual Report 2013 |accessdate=13 April 2014 |publisher=Sanofi-Aventis }}</ref>{{Rp|185}}
* Breakdown of share ownership: 8.93% by [[لوريال]], 0.27% [[أسهم الخزينة]] and 1.31% [[stock option|employees]]. The remaining 89.49% were [[شركة عامة]].{{Efn-ua|name=Total|[[توتال]] reduced its stake to less than 5% in 2011.<ref>MarketWatch 29 April 2011 [http://www.marketwatch.com/story/total-cfo-says-firm-cut-sanofi-stake-to-under-5-2011-04-29 Total CFO says firm cut Sanofi stake to under 5%]</ref>}}
 
 
== الشركات التابعة ==