A Multicenter, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Insuman Comb 25 (Insulin Human) Versus Novolin® 30R Twice Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus Who Are Under Insulin Therapy

Primary Objective:
To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG)
To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus

Start Date01 May 2011

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Insulin Human(Sanofi)

100 Translational Medicine associated with Insulin Human(Sanofi)

100 Patents (Medical) associated with Insulin Human(Sanofi)

Literatures (Medical) associated with Insulin Human(Sanofi)

25 Apr 2020·Current topics in medicinal chemistryQ4 · MEDICINE

Natural Products as a Paradigm for the Treatment of Coxsackievirus - induced Myocarditis

Q4 · MEDICINE

Review

Author: Rajput, Roopali ; Gautam, Anju ; Sharma, Latika ; Khanna, Madhu

Coxsackievirus B3 (CVB3), a member of the Picornaviridae family, is considered to be one of the most important infectious agents to cause virus-induced myocarditis. Despite improvements in studying viral pathology, structure and molecular biology, as well as diagnosis of this disease, there is still no virus-specific drug in clinical use. Structural and nonstructural proteins produced during the coxsackievirus life cycle have been identified as potential targets for blocking viral replication at the step of attachment, entry, uncoating, RNA and protein synthesis by synthetic or natural compounds. Moreover, WIN (for Winthrop) compounds and application of nucleic-acid based strategies were shown to target viral capsid, entry and viral proteases, but have not reached to the clinical trials as a successful antiviral agent. There is an urgent need for diverse molecular libraries for phenotype-selective and high-throughput screening.

01 Jan 2016·European endocrinology

Recombinant Human Insulins – Clinical Efficacy and Safety in Diabetes Therapy

Review

Author: Sandow, Juergen ; Landgraf, Wolfgang

Insulin replacement therapy is the standard of care for patients with type 1 and advanced type 2 diabetes mellitus. Porcine and bovine pancreatic tissue was the source of the hormone for many years, followed by semisynthetic human insulin obtained by modification of animal insulin. With the development of recombinant DNA technology, recombinant (biosynthetic) human insulin became available in large amounts by biosynthesis in microorganisms (Escherichia coli, yeast) providing reliable supplies of the hormone worldwide at affordable costs. The purity and pharmaceutical quality of recombinant human insulin was demonstrated to be superior to animal and semisynthetic insulin and patients with diabetes could be safely and effectively transferred from animal or semisynthetic human insulin to recombinant human insulin with no change expected in insulin dose. The decision for change remains a clinical objective, follow-up after any change of insulin product is recommended to confirm clinical efficacy. This review provides a summary and retrospective assessment of early clinical studies with recombinant insulins (Insuman®, Humulin®, Novolin®).

18 Aug 2015·Analytical chemistryQ1 · CHEMISTRY

Differentiation of Generic Enoxaparins Marketed in the United States by Employing NMR and Multivariate Analysis

Q1 · CHEMISTRY

Article

Author: Mauri, Lucio ; Fareed, Jawed ; Guerrini, Marco ; Yates, Edwin A. ; Rudd, Timothy R. ; Naggi, Annamaria ; Macchi, Eleonora ; Torri, Giangiacomo

The U.S. Food and Drug Administration defines criteria for the equivalence of Enoxaparin with Lovenox, comprising the equivalence of physiochemical properties, heparin source material and mode of depolymerization, disaccharide building blocks, fragment mapping and sequence of oligosaccharide species, biological and biochemical assays, and in vivo pharmacodynamic profile. Chemometric analysis of the NMR spectra, utilizing both (1)H and (1)H-(13)C HSQC NMR experiments, of Lovenox and Enoxaparin, the latter being the generic version of the former, revealed that Lovenox and the four Enoxaparin compounds produced by Sandoz (Enoxaparin and Fibrinox), Winthrop, and Amphastar exhibit dissimilarities in terms of their composition. All of the collected samples had expiry dates between 2012 and 2015. These studies, in addition to chromatographic analysis, highlighted signatures that differentiated the branded material from the generic products.

News (Medical) associated with Insulin Human(Sanofi)

15 Dec 2023

·www.globenewswire.com

Press Release: EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa

EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa Paris, Geneva and Nairobi. December 15, 2023. Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense). This positive opinion is for the treatment in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa. This CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi). The CHMP first adopted in 2018, a positive opinion of Fexinidazole Winthrop as the first all-oral treatment , in adults and children six years of age or older and weighing at least 20 kg, of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) of the more common T.b. gambiense form of sleeping sickness found in West and Central Africa. Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment. Both forms of sleeping sickness are transmitted by the bite of infected tsetse flies, which are found in 36 African countries. It causes neuropsychiatric symptoms, including aggressiveness, psychosis, a debilitating disruption of sleep patterns that have given this neglected disease its name, and ultimately, death. Dietmar Berger, MD, PhDHead of Development and Chief Medical Officer, Sanofi“The CHMP’s positive opinion is another step forward in Sanofi’s commitment to help deliver innovative treatments to vulnerable patient communities impacted by sleeping sickness, a deadly neglected tropical disease. By working with WHO and DNDi, we have made tremendous progress in improving treatment outcomes and simplifying treatment delivery. This partnership and our donation of Fexinidazole Winthrop through Foundation S, reflect our mission to provide innovative treatments to patients, no matter where they live.” For the T.b. rhodesiense variant, Fexinidazole Winthrop is indicated as a 10-day, once-daily oral treatment. Data from DNDi’s Phase 2/3 clinical trial were recently presented at the European Congress of Tropical Medicine and International Health and showed that Fexinidazole Winthrop was highly effective in treating the T.b. rhodesiense form of sleeping sickness and is a safe alternative to the existing drugs. In periodic follow-up evaluations that continued for 12 months after treatment, only one patient (2.94%) with the advanced form of the disease had relapsed and required treatment with the arsenic derivative that is the standard of care for patients with the most severe stage of the disease. Dr Westain NyirendaPrincipal Investigator and physician at Rumphi Hospital in Malawi“T.b. rhodesiense sleeping sickness is a terrifying disease that progresses more rapidly than T.b. gambiense, killing quickly if untreated. Until now, due to the lack of innovation for this strain of sleeping sickness, old and toxic treatment options have to be administered in a hospital under strict surveillance. Having a simple and safer oral pill to treat this frightening disease will allow doctors to rapidly save lives. It will also help patients to trust the new treatment.” While humans are the main host of T.b. gambiense, T.b. rhodesiense is a zoonotic disease, meaning that the infection can spread from animals to humans. Cattle and wild animals such as bushbucks and zebras are the most common reservoirs for this disease. Movements of these animals – potentially sparked by droughts or changes in climate – could put new populations at risk of T.b. rhodesiense sleeping sickness. In some cases, tourists visiting game reserves have been infected with T.b. rhodesiense. Dr Olaf Valverde MordtClinical Project Leader for sleeping sickness, DNDi“We are already seeing how an all-oral treatment for T.b. gambiense sleeping sickness has simplified the treatment of this variant in countries like the Democratic Republic of Congo. Although there are comparatively few cases of T.b. rhodesiense, last year Ethiopia recorded its first cases since the 1970s. The drought at the time of the infections brought humans and cattle in closer proximity to tsetse flies’ habitat. Environmental changes could be one of the reasons behind this resurgence.” The CHMP opinion today paves the way for the update of WHO guidelines on treatment for sleeping sickness, and distribution by WHO of Fexinidazole Winthrop in African countries where T.b. rhodesiense is prevalent. Fexinidazole Winthrop will be donated to WHO by Foundation S, Sanofi’s philanthropic organization. Dr Ibrahima Socé FallDirector of Neglected Tropical Diseases, World Health Organization “The impact of climate change extends to the shifting geographical spread of vector-borne diseases such as sleeping sickness, heightening the likelihood of spillover events where diseases transfer from animals to humans. These shifts disproportionately affect the most vulnerable communities, underscoring the urgency of sustained investment in programs addressing NTDs. This includes the development of innovative tools and improved treatment methods. We extend our gratitude to our partners DNDi for their research for the most neglected and Sanofi for their ongoing support and contribution to these vital efforts.” Fexinidazole Winthrop has already been registered in the Democratic Republic of the Congo and Uganda as a treatment for T.b. gambiense and is recommended for use in a further 10 African countries: (Angola, Burkina Faso, Central African Republic, Chad, Congo, Côte d'Ivoire, Equatorial Guinea, Gabon, Guinea, and South Sudan). Dr Michelle HelinskiSenior Project Officer for Neglected Infectious Diseases at the European and Developing Countries Clinical Trials Partnership Association (EDCTP) “We congratulate the HAT-r-ACC consortium on developing a better treatment option for this truly neglected disease and are thrilled with the positive opinion by CHMP.” The DNDi clinical trial for T.b. rhodesiense was conducted by the HAT-r-ACC Consortium, with funding from the European and Developing Countries Clinical Trials Partnership Association (EDCTP2) programme supported by the European Union; Fundação para a Ciência e a Tecnologia from Portugal; Swiss Agency for Development and Cooperation (SDC), from Switzerland; Médecins Sans Frontières International; and UK International Development, United Kingdom; and other private foundations and individuals. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About DNDiThe Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives. dndi.org About HAT-r-ACCThe HAT-r-ACC consortium brings together a broad range of partners with expertise in sleeping sickness and capacity building in remote health settings. This research, training, and community engagement experience is essential to run the clinical trial in remote settings with a very small target population. The consortium partners include the Malawi Ministry of Health (MMoH), the Uganda National Health Research Organisation (UNHRO), the Makerere University in Uganda, Epicentre (MSF) in France, the Lisbon Institute of Hygiene and Tropical medicine (IHMT) in Portugal, the Institut de Recherche pour le Développement (IRD) in France, the WHO, and the Swiss Tropical and Public Health Institute (Swiss TPH). Sanofi Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com DNDi Media ContactFrédéric Ojardias in Geneva | +41 79 431 62 16 | fojardias@dndi.org Sanofi Forward-Looking StatementsThis 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 fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties 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, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release

Clinical StudyDrug Approval

04 May 2021

·www.pharmaceutical-technology.com

The evolution of the diabetes market: a look back at the past 20 years

It is the 100-year anniversary of scientists Frederick Banting and his assistant Charles Best discovering how to remove insulin from a dog’s pancreas. One year after their discovery, the first diabetes patient was treated with exogenous insulin, and since then insulin has been a dominating influence in diabetes care. As the therapeutic treatment of diabetes continues to modernise, and the number of people affected by insulin deficiency continues to increase, the centenary presents an opportunity to look back at the major developments that have occurred in this market. Over the past 20 years, the diabetes market has gone through significant changes. It is composed of several pharmaceutical classes that continue to drive total sales, including insulins, dipeptidyl peptidase (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter (SGLT) inhibitors, and generic therapies. Figure 1 shows the maturation of the diabetes market from 1999 to 2021, with the entrance of multiple pharmaceuticals poised to meet the unmet needs in the space. In the early 2000s, the predominant therapeutics were insulins and oral anti-diabetic therapeutics such as metformin, sulfonylureas, alpha-glucosidase inhibitors, and thiazolidines. These oral therapeutics accounted for 65% of the therapeutic market. Moving into the 2010s, many of the oral anti-diabetic therapeutics become generics, with branded DPP-4 inhibitors and GLP-1 receptor agonists making their debut. In type 2 diabetes (T2D) cases where exogenous insulin is not immediately necessary, the first line of treatment has remained these generic orals agents, as they are cost-effective and easily accessible. Metformin is the most common first-line treatment for the disease. Currently, SGLT-2 inhibitors and GLP-1 RAs aim to subvert the lines of T2D treatment, but they still face a struggle to do so due to metformin’s clinical profile, reputation, and price point. In 2020, oral generics accounted for about 15% of the diabetes market. The diabetes market has been lucrative for drug developers, as the disease is highly prevalent with growing patient numbers. Global pharmaceutical sales have increased sixfold since 2000 (as shown in Figures 2 and 3). DPP-4 inhibitor uptake was significant during the 2000s, increasing from 1.3% of the market to 15% in 2010. In 2015, AstraZeneca’s Onglyza (saxagliptin) and Takeda’s Nesina (alogliptin), had their cardiovascular (CV) risk profiles scrutinized, and the FDA advisory committee voted for a relabeling that reflected the increased risk of heart failure that they carry. Just a few days later, on April 27, 2015, Merck announced preliminary data that showed that its blockbuster drug Januvia (sitagliptin) has a neutral effect on CV health. Januvia subsequently became the market leader, but the increasing burden of diabetes requires more effective treatments with favorable CV profiles. Januvia faces patent expiry in 2022, and much of the class has been subject to generic erosion. In addition to the launch of generics, DPP-4s face increasing competition from the rise of GLP-1 RAs and SGLT-2 inhibitors. Its market share has remained around 15%. Since 2010, there have been many significant innovations that have augmented the diabetes market. GLP-1 RA sales have been increasing significantly due to increased patient compliance and the continued ease of administration. First-generation GLP-1 RAs, Novo Nordisk’s Victoza (liraglutide) and AstraZeneca’s Byetta (exenatide), began as daily injectables. In 2010, the GLP-1 RA class was 3.8% of the total diabetes market. Over the last 10 years there has been abundant innovation in the GLP-1 RA arena, with the rise of once-weekly injectables such as Eli Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Ozempic (semaglutide). In Q4 2019, Novo Nordisk’s Rybelsus (semaglutide) launched, making it the first daily oral GLP-1 RA. Ozempic and Trulicity were found to be useful at addressing comorbidities, including CV risk factors and obesity, both of which are highly prevalent in diabetes. At the beginning of 2020, Trulicity became the first T2D drug to be approved to reduce CV events in adults with and without CV disease. Subsequently, Ozempic received a label update to reduce major CV adverse event risks in T2D patients, and announced results from its STEP 4 trial demonstrating significant weight loss benefits. GLP-1 RAs are currently 15.3% of the market, and are expected to continue to grow. The launch of SGLT-2 inhibitors faced some difficulties, with the boxed warning given to Johnson & Johnson’s (J&J’s) Invokana (canagliflozin), for example, that has only recently been removed. Still, SGLT inhibitors are becoming treatment mainstays, not only in diabetes, but for CV and renal disease indications as well. In 2016, the FDA approved a new indication for Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin), making it the first diabetes drug to be approved to reduce the risk of CV death in adults with T2D. The SGLT inhibitor class provides improved glycemic control with the added benefits of low hypoglycemia risk, weight loss, and a reduction in blood pressure. The blood pressure lowering effect of SGLT-2 inhibitors is also seen in patients with chronic kidney disease and could further contribute to reduced renal burden. These benefits are critical to advancing diabetes disease management. SGLT inhibitors currently comprise 8% of the market, but there are challenges associated with their safety. They are associated with an increased risk of diabetic ketoacidosis and are thus not approved for use in type 1 diabetes (T1D) in the US, and restricted to overweight or obese T1D patients in the EU and Asia. Despite this risk, physicians believe that the CV benefits may outweigh the risk of diabetic ketoacidosis, as SGLT-2 inhibitors are increasingly prescribed for T2D and are even prescribed off-label for some T1D in the US. Insulin therapy has been the standard of care for T1D treatment since its discovery 100 years ago. In the early 2000s, Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s Novolog (insulin aspart), the first insulin analogs, were launched. Over the last 20 years, human insulins have mostly been replaced by analog insulins. In the last five years, second-generation versions of Novolog and Humalog have launched (Fiasp and Lyumjev, respectively). As insulin pump uptake increases globally, the rapid-acting insulins will take up a considerable market share in T1D, while the long-acting insulins will maintain their shares due to their use in T2D. The overall global insulin market growth has decreased from 59% of the market in 2010 to 34% of the market in 2020. This is particularly due to the entry and preference for non-insulin treatments in T2D and a decreased need for basal insulins in T1D as a result of increased pump usage. However, some more targeted adjunct therapeutics for T1D patients and the first disease-modifying therapeutics, such as Provention Bio’s preventative treatment teplizumab, are set to emerge. The launch of these therapeutics will offset some of the biosimilar erosion that the branded insulins will face, and will continue to drive market growth at an accelerated rate. Related Report Diabetes Get the Report Latest report from Browse over 50,000 other reports on our store. Visit GlobalData Store

Generic DrugBiosimilar

100 Deals associated with Insulin Human(Sanofi)

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KEGG	Wiki	ATC	Drug Bank
D03230	-	A10AF01 A10AD01 A10AC01	DB00030

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetes Mellitus	IS	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetes Mellitus	LI	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetes Mellitus	NO	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetic Coma	EU	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetic Coma	IS	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetic Coma	LI	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Diabetic Coma	NO	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Ketosis	EU	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Ketosis	IS	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Ketosis	LI	Sanofi-Aventis Deutschland GmbH	21 Feb 1997
Ketosis	NO	Sanofi-Aventis Deutschland GmbH	21 Feb 1997

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CN	Sanofi	01 May 2011

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