R&D, East & West: Lilly invests in its global research network
pharmafile | July 10, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Asia, China, R&D, diabetes, lilly
Eli Lilly officially opened its new research facilities at its R&D base in Erl Wood in Surrey in April. The site near Woking in the south of England is the pharma company’s biggest R&D site outside the US, and has been conducting neuroscience drug discovery since the 1960s.
Erl Wood’s greatest claim to fame is that Lilly’s atypical antipsychotic Zyprexa (olanzapine) was discovered on the site. The announcement of continued investment in the site is particularly good news for the UK, as the last two years have seen companies such as Pfizer and AstraZeneca close research centres in the country, with the loss of thousands of jobs.
Lilly is building on its neuroscience research with a new facility to house scientists working on early drug development work. The £5.4 million building will house 130 staff across disciplines such as pharmacokinetics, clinical pharmacology and statistics.
This multidisciplinary team will work not just on neuroscience, but on compounds being developed across Lilly’s pipeline, including treatments in oncology and metabolic diseases, cardiovascular and musculoskeletal conditions.
Dr Jan Lundberg, head of R&D at Lilly said: “Lilly is proud of its history and heritage of pharmaceutical innovation in the UK at Erl Wood. This is the latest stage of an ongoing investment programme to ensure Erl Wood remains at the forefront of what is possible in life science research. It’s also a measure of Lilly’s commitment to developing the next generation of treatments for neurological conditions such as Alzheimer’s disease.”
Lilly’s work in neuroscience is split between the UK site and its research base in the US, with Alzheimer’s a major component within this work. Lilly’s drug solanezumab is currently in Phase III trials, with pivotal data expected in the next few months. This drug was discovered and largely developed in the US, and targets plaques created by beta amyloid in the brain, long thought to be key to the disease.
Researchers working on Alzheimer’s at Erl Wood are instead focused on another avenue of research, the role of the ‘tau’ protein. Tau is thought to cause tangles inside cells in the brain, and a drug which can prevent these from forming could be a useful component of future treatments.
Among Lilly’s 12 molecules in Phase III development, three are in neuroscience – edivoxetine for depression, pomaglumetad for schizophrenia and solanezumab for Alzheimer’s disease.
Lilly hopes these and other late-stage molecules will be able to replace blockbusters like Zyprexa, which saw its US patent expire in November last year. The most eagerly results are for Alzheimer’s candidate, solanezumab, which are due in Q3 this year.
One of the major factors in its decision to base the research site in the the UK is its world-class expertise in the field of neuroscience.
Lilly says around 75% of the UK’s neuroscience research and more than 30% of the EU’s neuroscience research comes from within 150 miles of the Erl Wood site, making it a strong centre for collaboration with academia and academic institutes.
To maximise these benefits, the site is home to the Centre for Cognitive Neuroscience, which brings together scientists from Lilly and academic researchers from the Universities of Bristol, Cardiff, Oxford and Cambridge as well as King’s College London and the National University of Ireland at Maynooth.
Neuroscience pipeline
• LY2062430 (solanezumab) is a biologic entity that binds to the mid-domain of soluble amyloid ß (Ab) proteins.
• LY2062430 is being studied for its potential to delay the progression of Alzheimer’s disease.
• LY2140023 monohydrate (pomaglumetad methionil) is a chemical entity agonist of the metabotropic glutamate 2/3 receptors.
• LY2140023 is being studied as a monotherapy for the treatment of schizophrenia.
• LY2140023 is also being studied as an add-on therapy for schizophrenia (Phase II).
• LY2140023 monohydrate (pomaglumetad methionil) is a chemical entity agonist of the metabotropic glutamate 2/3 receptors.
• LY2140023 is being studied as a monotherapy for the treatment of schizophrenia.
• LY2140023 is also being studied as an add-on therapy for schizophrenia (Phase II).
A further six molecules in Phase I are in development. Most eye-catching among these is a molecule aimed at treating Alzheimer’s disease which inhibits beta secretase – however, Lilly is currently releasing very little information about the candidate.
Lilly R&D in China
Lilly has opened its new R&D centre in China, which will be focused on discovering new treatments for diabetes. The new centre reflects a growing trend for global pharmaceutical companies to set up discovery and development centres in China, tapping into the country’s scientists, lower running costs and what will eventually be the world’s biggest market for pharmaceuticals.
The company says the research centre will focus on genetics novel mechanisms of action that can be tailored specifically for the Chinese population to delay the progression of the disease.
As the industrialisation and urbanisation of China continues apace, the country is expected to see an explosion in the number of people with type II diabetes. The disease already affects nearly 90 million people in China, making it one of the most significant national public health issues, with longer life expectancies, dietary changes and a sedentary lifestyle all contributing to the problem.
Differences in the genetic makeup of Asian patients may also play a role in diabetes development and progression, and exploring these differences is a priority for the Lilly China Research and Development Center( LCRDC), which employs around 150 scientists and staff hired primarily from China.
Lilly says the centre is the latest in a series of significant R&D investments in the field of diabetes care. “Conquering a devastating disease like diabetes requires innovation, collaboration and investment.
“The establishment of the Lilly China Research and Development Center demonstrates we are serious about discovering and developing desperately needed breakthrough medicines for Chinese people with diabetes,” said Jan Lundberg, executive vice president, science and technology, and president, Lilly Research Laboratories.
“We will do this by looking at diabetes in new and different ways and through collaborations with local academic research centres and partners that enable us to link Lilly scientists with scientists in China.
With an eagerness and optimism to explore new theories about disease development and progression, and potentially translate this to tailored diabetes medicines, I believe we will make a difference for people with diabetes, in China and around the world.”
Genetics and ethnic groups
Exploring the genetic profiles of Chinese, and eventually Asian, people with diabetes is a key area of research being conducted at the LCRDC. For example, Chinese people with diabetes have a significantly lower average body mass index (BMI) than do Americans with diabetes. Chinese people with diabetes also tend to have a higher prevalence of abdominal obesity, fatty liver and insulin resistance than do non-Asians with diabetes.
Research to better understand these characteristics may offer opportunities for discovering new medicines to treat diabetes. Lilly has just released Phase III data relating to Trajenta (linagliptin), its diabetes treatment which is already on the market, in a study specifically looking at its efficacy in black or African American patients with the condition.
This is the first published trial of a DPP-4 inhibitor specifically conducted in black or African American adult patients with type II diabetes.
“These findings support the efficacy and safety profile of linagliptin as a treatment option for African American adult patients with type II diabetes,” said lead investigator James Thrasher, FACE, Arkansas Diabetes and Endocrinology Center.
“As there may be differences in response to treatment among ethnic groups, an important finding of this trial is that the results are consistent with the A1C reduction seen in the linagliptin pivotal trials, which included a small sample of African American patients.”
African American adults are disproportionately affected by diagnosed diabetes. In the US, the risk of diabetes is 77% greater for non-Hispanic black adults, when compared to non-Hispanic white adults, with an estimated 18.7% (4.9 million) of all non-Hispanic black adults living with the disease.
The head of the new research site in China warned of how great a risk the disease poses there as well.
“Diabetes has reached epidemic proportions in China – there are more people in China with diabetes than in any other country in the world, with as many as three-quarters of them not having adequate control of their disease,” said Bei Betty Zhang, vice president, China Research and site head and general manager, LCRDC.
“The research community needs to better understand the genetic and environmental factors that underlie this epidemic so that we may discover medicines that address these factors.
“At the Lilly China Research and Development Center, we will explore innovative ways to address this unmet patient need, such as targeting pathways involved in disease pathophysiology and partnering with the Chinese academic network to investigate unique features of diabetes in Chinese patients, with the goal of discovering breakthrough treatments.”
In the near term, the work at the LCRDC will focus on evaluating a pool of highly-selective targets with the potential to deliver robust candidates, helping to feed the Lilly portfolio with novel treatment opportunities.
Presence in China
Like its competitors in pharma, Lilly knows it has to demonstrate a long-term commitment to the country in order to establish itself in China, which despite opening up to international business, remains a tightly controlled market, and one difficult for foreign businesses to penetrate.
Lilly is therefore keen to stress its already long history of operating in the country – its first sales reps were deployed in Shanghai in 1918, the first such position located outside the US. However, the last five to ten years has seen the greatest growth in investment, including the setting up of the Lilly China Drug Development & Medical Affairs Center in 2008.
Lilly is also building a new insulin production, packaging and warehouse facility in Suzhou which is expected to open this year.
Meanwhile Lilly has also just announced a discovery partnership with contract research organisation Covance which is to be located in China. The alliance will see Covance’s wholly-owned entity in China provide the LCRDC with a range of services, including pharmacology studies, pharmacokinetic screening and other pre-clinical research to test and evaluate potential new diabetes medicines.
The partnership in China is aligned with the global strategic alliance between Lilly and Covance, and will focus primarily on diabetes.
Phase III diabetes pipeline
• LY2189265 (dulaglutide) is a biologic entity being studied as a once-weekly treatment for type 2 diabetes.
• LY2605541 (novel basal insulin analogue) is a biologic entity that is a novel basal insulin analogue. LY2605541 is being studied for the treatment of type 1 and 2 diabetes..
• Empagliflozin (BI10773) is a chemical entity that inhibits the sodium glucose co-transporter-2 (SGLT 2). BI10773 is being studied as a treatment for type 2 diabetes.
• LY2963016 (new insulin glargine product) is a biologic entity that is a basal insulin. It is being studied for the treatment of type 1 and 2 diabetes.
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