Many companies claim to have revolutionised therapy in areas of unmet clinical or medical need. Sanofi's head of diabetes Pierre Chancel, however, having overseen the global launch of Lantus – the world's first 24-hour, once-daily insulin therapy for type 1 and type 2 diabetes – is perhaps in a clear position to speak from direct experience of delivering genuine therapeutic revolution.
Last year, Sanofi achieved €4,960m in sales from its flagship insulin brand, a far cry from its forerunner Farbwerke Hoechst, which 90 years ago was the first in Europe to provide insulin on a large-scale with constant purity and quality. However, today there's something else on his mind: China and other emerging growth markets.
Until Sanofi Diabetes established a formalised platform for research into the prevalence of diabetes in China, in partnership with the Chinese Diabetes Society, there was no systematic record of any type 1 diabetes in China.
It also seems that just one-third of people living with diabetes in emerging countries is even diagnosed. The vast majority have no idea they're living with something that without treatment is an early killer.
“Understanding emerging markets isn't all about bringing solutions. It's also about building awareness and improving diagnosis through education. The first thing to do is to help people become aware of diabetes, its long-term effects and treatments. The type 1 diabetes situation in China is the same in Africa, where we know the hard reality is that children are dying from this disease before they can be diagnosed.”
|Member of the Global Leadership Team, Sanofi|
|Senior Vice President Global Diabetes, Sanofi|
|Senior Vice President in Global Marketing and Access, Aventis|
|Managing Director of Aventis Operations, UK and Ireland|
|Marketing Director Theraplix, Rhône-Poulenc|
|Business Unit Manager for CNS, Rheumatology and HRT, Rhône-Poulenc|
|Pharmacy graduate, Institut de Pharmacie Industrielle, Paris, France|
Picture the real China
Sanofi, of course, continues to focus on diabetes in developed markets, where the incidence of type 2 diabetes continues to escalate rapidly each year.
“Yet today more people have diabetes worldwide than live in the US,” Chancel notes. “There is a skyrocketing diabetes epidemic in emerging countries. Just because the healthcare systems are less able to pay for the latest treatments, we are not released from our responsibility to make affordable innovations accessible in these regions, as well as the support programmes necessary to help people find and optimise treatment.”
He singles out China as a particular challenge: how does a large international pharmaceutical firm with headquarters in Paris make a worthwhile difference on the front line?
“It is vital to have direct local contact, to understand the people and the science, and to work in partnership as an engine delivering solutions specific to these challenges. In fact, Sanofi was one of the first of what the Chinese would say were 'foreign' pharmaceutical businesses to set up in China around 30 years ago, which gave us time to really understand the needs of Chinese people with diabetes and we are already a trusted partner in China.”
He is also keen to emphasise the importance of people on the ground: “We have established a group of 60 people in Shanghai to focus on discovery and development in Asia, plus around 2,000 diabetes local reps in China, which is similar to our number in the US today.”
Partnerships and programmes
Partnership is another essential facet in Sanofi's ambition to support and increase the efficacy of the efforts to educate and diagnose, first among the company's priorities.
“As a pioneer in the field of diabetes, we proactively support a number of initiatives in China. The China Initiative for Diabetes Excellence (CIDE) programme is a five-year disease management programme led by the Chinese Heath Ministry.”
There is no single magic solution to treating diabetes. You can't just take one pill and you're fine for the rest of your life
A strong public-private partnership between Sanofi and the Chinese Diabetes Society (CDS), the Centre of Disease Control (CD) and the World Health Organization (WHO) Collaborating Center at the International Diabetes Center will promote the career development of 500 experts in the field, providing world-class clinical and research training programmes.
“This is an unprecedented programme drawing upon Chinese and international best practice, aiming additionally to train 10,000 community and county doctors.”
Meanwhile, Sanofi's '3C Study of Type 1 Diabetes in China' partnership with the International Diabetes Federation (IDF) continues to deliver evidence of the coverage, cost and care of type 1 diabetes in China.
“As there is no formalised organisation for type 1 diabetes in China, our work with the IDF aims to create the foundation for a registry, in order to advocate improved diagnosis and disease management,” Chancel adds.
ORBIT (Observational Registry for Basal Insulin Treatment) is a study focused on type 2 diabetes in China and the result of Sanofi's partnership with the CDS and George Institute for Global Health.
“This programme will recruit 20,000 people in China with type 2 diabetes currently uncontrolled on oral anti-diabetic drugs, in order to evaluate the effectiveness and safety of the use of basal insulin in this patient population. It is the largest of its kind to assess and correct insulin usage through improved understanding among Chinese patients, physicians and nurses.”
Chancel is also anticipating opening the Scientific Programme at a the upcoming China Innovation Summit later this month. The first of its kind event will involve key opinion leaders (KOLs), senior Sanofi management and policy makers to share their expertise and discuss key topics for diabetes in China, along with a media event for key journalists.
Affordable access to solutions
Beyond these key education and awareness initiatives, Chancel is also spearheading significant investment into China's infrastructure, including a $90m project to install a high-tech Lantus cartridge aseptic production line in the Beijing Economic Technological Development Area. Opened recently by Sanofi group CEO Chris Viehbacher, this facility is designed to manufacture nearly 50 million units per year of the company's flagship Lantus SoloStar pen.
Putting diabetes on the map in Asia is a key part of this, he notes, recalling a high-profile media event in Hong Kong in 2012, which saw Sanofi together with over 300 people with diabetes (and their families) set a Guinness World Record for the most people to test an insulin pen (Lantus SoloStar) in one place (Prince of Wales Hospital).
Considering itself an active member of Chinese society, Sanofi Diabetes is driven by a responsibility to work with government, the scientific community and patients to control the diabetes epidemic of diabetes, Chancel asserts.
Building on this, he acknowledges not only the need for investment in local processes and jobs, but also the vital need to provide innovative diabetes treatments and devices to the local population in emerging markets.
“What we need for emerging countries are solutions that are provided at fair cost. In the real world this means as cheap as possible, but that does not mandate that we lower our standards. Our new AllStar insulin pen for instance, launched in India last November and will be made accessible in other emerging markets, is designed specifically to serve the needs of people with diabetes in emerging markets – industry gold-standard pen technology with a cost multiple lower than for developed markets, accordingly.”
Designed and developed in India for Asian people living with diabetes, he cites this as an example of “how we are making not only medicines but also devices and delivery systems accessible to people in these regions”.
Chancel is also confident about its prospects: “Not only is this much higher quality than what was previously available, but everyone using Lantus in India will be using this pen. In China, with its complex, multi-layered healthcare provision, we have also adopted a two-tier pricing offer to ensure our products are affordable. So we have the Lantus SoloStar disposable pen as one option, plus the new AllStar pen.”
Integrated solutions as the emerging future
His vision for the coming years is that Sanofi will bring integrated and personalised solutions to Chinese patients, including oral anti-diabetic drugs, insulins, glucose monitoring devices, plus further enhanced services to help patients achieve better outcomes.
“There is no single magic solution to treating diabetes. You can't just take one pill and you're fine for the rest of your life, as it is an evolving and complex disease. It doesn't need to be complicated, but there is a clear and significant benefit to integrating the various options.”
Key among these for Sanofi is Lyxumia (lixisenatide), the company's new GLP-1 receptor agonist, which is planned for first launch in Germany following European approval and has been accepted for review by the US Food and Drug Administration (FDA).
“With a single daily injection and only one step to maintenance dose, Lyxumia offers a positive addition to the Sanofi portfolio as a simple new tool to help patients with type 2 diabetes further reduce HbA1c, with the benefit of weight loss and limited risk of hypoglycaemia.”
The company sees particular potential for Lyxumia as a combination with basal insulin in those patients whose type 2 diabetes (as measured by HBA1c levels) remains uncontrolled due to poorly controlled post-prandial glucose (PPG), despite controlled fasting plasma glucose (FPG).
Added to this innovation is its burgeoning blood glucose monitoring business, buoyed by last year's launch of its BGStar and iBGStar monitors; the latter offering connectivity with Apple's iPhone and iPod Touch devices in a bid to optimise their convenience for users.
In looking forwards, Chancel briefly brings to mind the heritage, starting in the 1920s with 'Hoechst insulin', that underlines everything the company does today and will do tomorrow.
“Does our heritage really impact our future? Of course it does. Hoechst was an innovator, but more than that it was committed to transforming science, both homegrown and in partnership with others, into safe, effective medicines that ultimately improved the health and lives of many millions of people worldwide. Our ambition is a direct succession within this spirit, which is why we have developed a whole portfolio of integrated solutions for diabetes management worldwide, and it's why we are pioneering new affordable solutions in many emerging markets such as China and India.”