Daily Archives: January 30, 2019

Sanofi: Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of Congo

  • Fexinidazole will contribute to international efforts to eliminate sleeping sickness, a fatal neglected tropical disease endemic to Africa, by 2020
  • It is the first all-oral treatment for sleeping sickness, and is effective for both stages of the disease
  • Democratic Republic of Congo bears the majority of the sleeping sickness disease burden, with around 85% of reported cases

PARIS and GENEVA – January 30, 2019 – Marketing authorization of fexinidazole for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT), more commonly known as sleeping sickness, has been granted in the Democratic Republic of Congo (DRC). This approval paves the way for the distribution of fexinidazole in endemic countries this year, with another submission planned in Uganda.

Sleeping sickness is usually fatal without treatment. Transmitted by the bite of a tsetse fly, it causes neuropsychiatric symptoms; including aggression, psychosis, and a debilitating disruption of sleep patterns that have given this neglected disease its name. About 65 million people in sub-Saharan Africa are at risk.

“I have a personal connection to sleeping sickness. Growing up in East Africa, my mother was always worried that sleeping sickness would impact us as a family,” says Ameet Nathwani, M.D., Chief Medical Officer and Executive Vice President Sanofi Medical. “The approval of fexinidazole in the Democratic Republic of Congo gives me great hope for our efforts to eliminate sleeping sickness by next year.”

The current treatment option for sleeping sickness, while effective, was burdensome for patients and health workers – requiring logistical challenges of hospitalization, especially challenging for people living in remote areas.

Fexinidazole is approved in the DRC as a 10-day once-a-day treatment for T.b. gambiense sleeping sickness (the most common form of the disease, found in West and Central Africa). Importantly, fexinidazole is the first all-oral treatment that works both for (i) the early stage of the disease as well as the (ii) second stage of the disease in which the parasites have crossed the blood-brain barrier, causing patients to suffer from neuropsychiatric symptoms. Fexinidazole could, therefore, eliminate the need for patients’ systematic hospitalization.

On 16 November 2018, The European Medicines Agency (EMA) adopted a positive scientific opinion of fexinidazole – a result of clinical trials led by the non-profit research and development organization the Drugs for Neglected Diseases initiative (DNDi) and an application submitted by Sanofi.

“We look forward to the implementation of fexinidazole as a first-line treatment and welcome this rapid approval of fexinidazole in the DRC very shortly after the EMA opinion, a testament to the dedication of the DRC Government through the Ministry of Health to eliminate HAT as a public health problem by 2020,” says Dr Nathalie Strub-Wourgaft, DNDi Director of Neglected Tropical Diseases. “This shows the value of Article 58, an innovative regulatory mechanism intended for the review of new medicines destined for use outside of the European Union.”

Sanofi had submitted a regulatory dossier to the EMA under Article 58 of Regulation 726/2004 in December 2017. By allowing for the participation of endemic countries (DRC and Uganda) and of the WHO in the evaluation of the fexinidazole regulatory dossier, approval under Article 58 also facilitates and could accelerate future national product registrations and patient access.

About sleeping sickness

The majority of sleeping sickness patients live in the Democratic Republic of Congo, where 85% of Trypanosoma brucei gambiense sleeping sickness cases were reported in 2017, followed by the Central African Republic, Guinea and Chad. The latest data released by the WHO in July 2018 confirm a sustained decrease in the number of new cases. Only 1,447 new cases were reported to the WHO in 2017 compared to 2,164 cases in 2016 and 9,870 cases in 2009. But the history of sleeping sickness is marked by resurgence, interspersed by decades where the disease has seemed largely under control. In its roadmap on neglected tropical diseases published in 2012 and supported the same year by the London Declaration, the WHO included sleeping sickness, and targets its elimination as a public health problem by 2020.

About DNDi

A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular human African trypanosomiasis, leishmaniasis, Chagas disease, filarial infections, mycetoma, paediatric HIV, and hepatitis C. Since its creation in 2003, DNDi has delivered eight treatments. Fexinidazole is the first new chemical entity to be successfully developed by DNDi.

DNDi’s fexinidazole programme is supported by grants from the Bill & Melinda Gates Foundation, USA; UK aid, UK; Dutch Ministry of Foreign Affairs (DGIS), The Netherlands; Federal Ministry of Education and Research (BMBF) through KfW, Germany; French Development Agency (AFD), France; German Corporation for International Cooperation (GIZ) on behalf of the Federal Republic of Germany, Germany; Ministry of European and Foreign Affairs (MEAE), France; Médecins sans Frontières; Norwegian Agency for Development Cooperation (Norad), Norwegian Ministry of Foreign Affairs, as part of Norway’s in-kind contribution to EDCTP2; Republic and Canton of Geneva, International Solidarity Office, Switzerland; Spanish Agency for International Development and Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; UBS Optimus Foundation, Switzerland; Brian Mercer Charitable Trust, UK; Stavros Niarchos Foundation, USA and other private foundations and individuals from the HAT campaign.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life


Media Relations Contact
Anna Robinson
Tel.: +33 (0)1 53 77 46 46
mr@sanofi.com

DNDi Media Relations Contact
Ilan Moss
Tel.: +1 646 266 5216
imoss@dndi.org

Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com

Moyette Gibbons
Tel.: +41 79 940 9017
mgibbons@dndi.org


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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Attachment

Sanofi : Le fexinidazole, premier traitement entièrement par voie orale contre la maladie du sommeil, approuvé en République Démocratique du Congo

  • Le fexinidazole contribuera aux efforts déployés à l’échelle internationale en vue d’éliminer la maladie du sommeil – une maladie tropicale négligée, fatale et endémique en Afrique – à l’horizon 2020
  • Premier médicament entièrement par voie orale efficace contre les deux phases de la maladie du sommeil
  • La République Démocratique du Congo est le pays où se concentre la majorité des cas de maladie du sommeil, avec près de 85% des cas notifiés

PARIS et GENÈVE – Le 30 janvier 2019 – La République Démocratique du Congo (RDC) a délivré une autorisation de mise sur le marché au fexinidazole pour le traitement de la trypanosomiase humaine africaine (THA) ou maladie du sommeil causée par le parasite Trypanosoma brucei gambiense. Cette approbation ouvre la voie à la distribution du  fexinidazole, cette année, dans les pays où la maladie du sommeil est endémique, sachant qu’une autre soumission réglementaire est également prévue en Ouganda.

La maladie du sommeil est généralement fatale en l’absence de traitement. Transmise par la piqûre d’une mouche tsé-tsé, elle se caractérise par des symptômes neuropsychiatriques comme un comportement agressif, une psychose et des perturbations invalidantes du sommeil, d’où le nom qui a été donné à cette maladie négligée. Environ 65 millions de personnes sont menacées par cette maladie en Afrique subsaharienne.

« Ayant grandi en Afrique de l’Est, je connais très bien la maladie du sommeil. Ma mère craignait toujours que cette maladie ne frappe notre famille », a déclaré le Dr Ameet Nathwani, Chief Medical Officer et Vice-Président Exécutif, Affaires Médicales Sanofi. « L’approbation du fexinidazole en République démocratique du Congo nous permet aujourd’hui d’espérer que les efforts déployés en vue d’éliminer la maladie du sommeil seront couronnés de succès d’ici à l’année prochaine »

Le traitement actuel contre la maladie du sommeil, bien qu’efficace, est très contraignant pour les patients et les personnels de santé car il nécessite l’hospitalisation des malades, soulevant d’importantes difficultés logistiques, en particulier pour les personnes vivant dans des régions reculées.

Le fexinidazole est approuvé en République démocratique du Congo à raison d’une prise par jour pendant 10 jours pour le traitement de la maladie du sommeil causée par le parasite T.b. gambiense (la forme la plus fréquente, qui se retrouve dans les pays d’Afrique de l’Ouest et d’Afrique centrale). Il s’agit surtout du premier traitement entièrement par voie orale qui agit à la fois contre 1) la phase précoce de la maladie et 2) sa deuxième phase, lorsque le parasite a franchi la barrière hématoencéphalique entraînant l’apparition de symptômes neuropsychiatriques. Le fexinidazole pourrait par conséquent éliminer les hospitalisations systématiques des patients.

Le 16 novembre 2018, l’Agence européenne des médicaments (EMA) a rendu un avis scientifique favorable au sujet de la demande de mise sur le marché du fexinidazole, se fondant sur les résultats des essais cliniques menés par la Drugs for Neglected Diseases initiative (DNDi), une organisation de recherche et développement à but non lucratif, et sur le dossier soumis par Sanofi.

«Nous sommes impatients de déployer le fexinidazole pour le traitement de première intention de la maladie du sommeil et très heureux que la RDC l’ait approuvé aussi rapidement après l’avis rendu par l’EMA. Cette rapidité d’action traduit l’engagement du gouvernement congolais à travers son Ministère de la santé d’éliminer la THA comme problème de santé publique d’ici 2020 », souligne le Dr Nathalie Strub-Wourgaft, Directrice du programme des maladies tropicales négligées de DNDi. «Cela prouve la valeur de la procédure d’évaluation prévue par l’article 58, un mécanisme réglementaire innovant réservé aux nouveaux médicaments destinés exclusivement aux pays hors de l’Union européenne. »

Sanofi a soumis le dossier du fexinidazole à l’évaluation de l’Agence européenne des médicaments en décembre 2017, dans le cadre de la procédure qui régit les demandes visées à l’article 58 du règlement européen n° 726/2004. Aux termes de cette procédure, les pays d’endémie (RDC et Ouganda), ainsi que l’OMS, ont participé à l’évaluation du dossier du fexinidazole, ce qui facilite et pourrait accélérer l’enregistrement du médicament dans les différents pays et sa mise à la disposition des patients.

À propos de la maladie du sommeil

La majorité des patients atteints de la maladie du sommeil vivent en République démocratique du Congo, où se concentraient 85% des cas causés par le parasite Trypanosoma brucei gambiense notifiés en 2017. Viennent ensuite la République centrafricaine, la Guinée et le Tchad. Les dernières données publiées par l’OMS en juillet 2018 confirment le recul du nombre de nouveaux cas. Seulement 1 447 nouveaux cas ont été notifiés à l’OMS en 2017, contre 2 164 en 2016 et 9 870 en 2009. L’histoire de cette maladie est toutefois marquée par des résurgences, suivies de plusieurs dizaines d’années au cours desquelles elle semble largement sous contrôle. La feuille de route de l’OMS pour les maladies tropicales négligées, publiée en 2012 et soutenue la même année par la Déclaration de Londres, a inscrit la maladie du sommeil au rang des maladies à combattre et prévoit de parvenir à l’éliminer en tant que problème de santé publique d’ici à 2020.

À propos de la DNDi

DNDi est une organisation à but non lucratif, spécialisée dans la recherche et le développement de nouveaux traitements contre les maladies négligées, en particulier la trypanosomiase humaine africaine, la leishmaniose, la maladie de Chagas, les filarioses, le mycétome, le VIH pédiatrique et l’hépatite C. Depuis sa fondation en 2003, DNDi a développé huit médicaments. Le fexinidazole est la première nouvelle entité moléculaire que DNDi développe avec succès.

Le programme de DNDi pour le développement du fexinidazole est financé par la Fondation Bill et Melinda Gates (États-Unis), le ministère du Développement international du Royaume-Uni, le ministère des Affaires étrangères des Pays-Bas, le ministère fédéral allemand de l’Éducation et de la Recherche par le biais de la banque KfW, l’Agence française pour le développement (AFD), l’Agence allemande de coopération internationale (GIZ), le ministère français des Affaires Étrangères et Européennes (MEAE), Médecins sans frontières, l’Agence norvégienne de coopération au développement (Norad), le Service de la solidarité international de la République et du Canton de Genève (Suisse), l’Agence espagnole de coopération internationale pour le développement (AECID), la Direction suisse du développement et de la coopération (SDC), la Fondation suisse UBS Optimus, le Brian Mercer Charitable Trust (Royaume-Uni), la Fondation Stavros Niarchos (États-Unis), ainsi que d’autres fondations privées et des particuliers qui ont apporté leur soutien financier à la campagne THA.

À propos de Sanofi

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique.

Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde.

Sanofi, Empowering Life, donner toute sa force à la vie.


Relations Presse Sanofi
Anna Robinson
Tél.: +33 (0)1 53 77 46 46
mr@sanofi.com

Relations Presse DNDi
Ilan Moss
Tél.: +1 646 266 5216
imoss@dndi.org

Relations Investisseurs Sanofi
George Grofik
Tél.: +33 (0)1 53 77 45 45
ir@sanofi.com

Moyette Gibbons
Tél.: +41 79 940 9017
mgibbons@dndi.org


Déclarations prospectives – Sanofi
Ce communiqué contient des déclarations prospectives. Ces déclarations ne constituent pas des faits historiques. Ces déclarations comprennent des projections et des estimations concernant la mise sur le marché et autre potentiel de ce produit, ou concernant les recettes futures envisagées pour ce produit. Ces déclarations prospectives peuvent souvent être identifiées par les mots « s’attendre à », « anticiper », « croire », « avoir l’intention de », « estimer », « planifier » ou « espérer», ainsi que par d’autres termes similaires. Bien que la direction de Sanofi estime que ces déclarations prospectives sont raisonnables, les investisseurs sont alertés sur le fait que ces déclarations prospectives sont soumises à de nombreux risques et incertitudes, difficilement prévisibles et généralement en dehors du contrôle de Sanofi, qui peuvent impliquer que les résultats et événements effectifs réalisés diffèrent significativement de ceux qui sont exprimés, induits ou prévus dans les informations et déclarations prospectives. Ces risques et incertitudes comprennent notamment les actions et contretemps réglementaires inattendus, ou généralement des réglementations étatiques, qui peuvent affecter la disponibilité ou le potentiel commercial de ce produit, l’absence de garantie que ce produit sera un succès commercial, les incertitudes inhérentes à la recherche et développement, les futures données cliniques et l’analyse des données cliniques existantes relatives à ce produit, y compris postérieures à la mise sur le marché, les problèmes inattendus de sécurité, de qualité ou de production, la concurrence de manière générale, les risques associés à la propriété intellectuelle, à tout litige futur en la matière et à l’issue de ces litiges, la volatilité des conditions économiques, ainsi que les risques qui sont développés ou identifiés dans les documents publics déposés par Sanofi auprès de l’AMF et de la SEC, y compris ceux énumérés dans les rubriques « Facteurs de risque » et « Déclarations prospectives » du document de référence 2017 de Sanofi, qui a été déposé auprès de l’AMF ainsi que dans les rubriques « Risk Factors » et « Cautionary Statement Concerning Forward-Looking Statements » du rapport annuel 2017 sur Form 20-F de Sanofi, qui a été déposé auprès de la SEC. Sanofi ne prend aucun engagement de mettre à jour les informations et déclarations prospectives sous réserve de la réglementation applicable notamment les articles 223-1 et suivants du règlement général de l’Autorité des marchés financiers.

Pièce jointe

A total of 1 357 convicts were sentenced during the period of 1 July to 31 December 2018

Two investigating officers of the South African Police Service (SAPS)’s Family Violence, Child Protection and Sexual Offences (FCS) Investigations Unit under the Detective Services Division, were given the National Commissioner’s Special Awards.

Pretoria:Between 1 July and 31 December 2018, the South African Police Service’s Family Violence, Child Protection and Sexual Offences (FCS) Investigations Unit under the Detective Services Division, achieved numerous convictions of criminals with regard to crimes against women and children, which included murder, rape and child pornography. A total of 1 357 accused persons were given 371 life sentences and over 4 629 years’ imprisonment by the courts in 838 cases.

Two of the investigating officers who contributed to the above total number of convictions, are Detective Constable Tlala John Mokoena and Detective Captain TT Bvuma, both from Gauteng. They received the National Commissioner’s Special Awards in recognition of their commitment, hard work and outstanding achievements. Their dedication to their work has ensured that survivors of the heinous crimes they investigated � rape, murder and child pornography � believe in the police to bring them justice, thereby restoring the communities’ confidence in the police and the law.

The successes of Detective Constable Mokoena of the FCS’s Serial and Electronic Crime Investigation Unit, include six serial rapists who were sentenced to a combined 17 life sentences and more than 800 years’ imprisonment. He is also responsible for the recent conviction of the Soweto Taxi Rapist, Gift Lebohang Mokwena. Detective Constable Mokoena has been promoted from the rank of ‘Constable’ to that of ‘Warrant Officer’, with effect from 1 February 2019.

Detective Captain Bvuma on the other hand, was allocated a case of rape to investigate in 2016. As a seasoned detective, he managed to link the suspect he had arrested to 13 other rape cases, in a reign of terror that started in 2014. The suspect was eventually convicted on 52 charges including rape, kidnapping and assault, and was sentenced to 15 life sentences and 105 years’ imprisonment.

Crimes against women and children have always been a priority for the South African Police Service and the 2018/2019 financial year was declared as the year to especially focus on crimes against women and children.

The FCS Units around the country consist of dedicated members who go beyond the call of duty to ensure that the survivors of these heinous crimes � rape, murder and child pornography � are treated with the utmost care and respect to avoid secondary victimisation. Bringing the perpetrators of crimes against women and children to book, is the only reward that the FCS investigating officers need, as explained by Detective Constable Mokoena, Being able to solve a case and ensuring a hefty sentence, bring survivors of rape and families of those that have been murdered, some form of closure, and that is what we are always striving to achieve.

The FCS Units also conduct awareness campaigns at schools and communities to preach the gospel of children’s safety, and to sensitise the communities about the realities of the scourge of crimes against women and children.

The SAPS calls on parents and caregivers to report all crimes committed against children, as failure to report such knowledge, may result in the prosecution of the parent/caregiver or anyone older who had known about the incident.

The SAPS would also like to warn women who report false cases of rape, assault et cetera, to refrain from doing so as once a case has been reported, the police waste much needed resources as well as their time, which could have been diverted to where they are really needed. Those found to be doing this, will be charged with perjury and will be prosecuted.

Source: South African Police Service

Drought Threatens Thousands of Flamingo Chicks in S. Africa

CAPE TOWN, SOUTH AFRICA Rescuers are moving hundreds of dehydrated lesser flamingo chicks from their breeding ground at a drought-stricken South African dam to a bird sanctuary in Cape Town, to save them from death by starvation and lack of water.

Their birthplace, Kamfers Dam in the Northern Cape, is one of only three breeding grounds for the famously pink birds in southern Africa, the other two being in Namibia and Botswana, according to researcher Katta Ludynia.

The rescued chicks take three to four months to fledge, and it is not yet clear whether they will eventually be released back into the wild in Cape Town or transported back hundreds of kilometers to their home in Kimberley, she said.

“There are still several thousand birds breeding in the dam in areas that still have water,” said Katta Ludynia, research manager at the Southern African Foundation for the Conservation of Coastal Birds (SANCCOB). “It now depends on the water levels whether these birds will pull through.”

Ludynia said the sanctuary was caring for around 550 chicks, most of them dehydrated when they arrived Monday after having been abandoned by parents who went off in search of food.

The chicks are being moved to the sanctuary by plane and road. SANCCOB is one of several centers across South Africa caring for around 2,000 chicks that were rescued from the dam.

Although it hosts the biggest population of lesser flamingoes in southern Africa, Kamfers Dam, north of Kimberley, is often dry and depends mainly on rainwater. It also gets some water from a sewerage works that releases water into its wetlands.

“The dam in Kimberley is so important because it is manageable, so we can secure the water level there. That might be the only site the flamingos can breed in southern Africa, if the drought continues in other areas,” Ludynia said.

Source: Voice of America

Drought Threatens Thousands of Flamingo Chicks in S. Africa

CAPE TOWN, SOUTH AFRICA Rescuers are moving hundreds of dehydrated lesser flamingo chicks from their breeding ground at a drought-stricken South African dam to a bird sanctuary in Cape Town, to save them from death by starvation and lack of water.

Their birthplace, Kamfers Dam in the Northern Cape, is one of only three breeding grounds for the famously pink birds in southern Africa, the other two being in Namibia and Botswana, according to researcher Katta Ludynia.

The rescued chicks take three to four months to fledge, and it is not yet clear whether they will eventually be released back into the wild in Cape Town or transported back hundreds of kilometers to their home in Kimberley, she said.

“There are still several thousand birds breeding in the dam in areas that still have water,” said Katta Ludynia, research manager at the Southern African Foundation for the Conservation of Coastal Birds (SANCCOB). “It now depends on the water levels whether these birds will pull through.”

Ludynia said the sanctuary was caring for around 550 chicks, most of them dehydrated when they arrived Monday after having been abandoned by parents who went off in search of food.

The chicks are being moved to the sanctuary by plane and road. SANCCOB is one of several centers across South Africa caring for around 2,000 chicks that were rescued from the dam.

Although it hosts the biggest population of lesser flamingoes in southern Africa, Kamfers Dam, north of Kimberley, is often dry and depends mainly on rainwater. It also gets some water from a sewerage works that releases water into its wetlands.

“The dam in Kimberley is so important because it is manageable, so we can secure the water level there. That might be the only site the flamingos can breed in southern Africa, if the drought continues in other areas,” Ludynia said.

Source: Voice of America