Lilly Diabetes and Disney Publishing Worldwide (DPW) have expanded their US collaboration to bring educational materials to children with type 1 diabetes and their families worldwide.

The educational resources will include a series of books featuring Mickey Mouse and his friend Coco the monkey, who has type 1 diabetes, to be translated and distributed initially in 18 countries.

The UK has recently seen an increase (as yet unexplained) in type 1 diabetes – a genetic auto-immune condition – among children, and lack of effective patient education has been identified by Diabetes UK as a significant problem.

The materials produced by the Lilly-Disney partnership will be available from diabetes healthcare professionals, and will aim to guide families in meeting the challenge of type 1 diabetes control in children.

Effective control of type 1 diabetes requires a blend of medication (injected insulin), carefully managed diet and exercise, and regular monitoring and dose adjustment. For many families, managing the condition in a child is disruptive and traumatic.

Speakers at the recent UK conference Diabetes: A Call to Action emphasised that a strict focus on blood glucose targets can be counter-productive, and that control needs to be integrated with a healthy and positive lifestyle. The Lilly-Disney materials reflect this philosophy, focusing on management of opportunities rather than on negative restrictions.

“We are excited to be part of this effort to bring informational material about type 1 diabetes to kids around the world who are living with the disease,” said Andrew Sugerman, Executive Vice President of DPW. “Lilly Diabetes’ expertise with the disease, combined with Disney’s tradition of great storytelling, gives us an opportunity to inspire and motivate children and families with type 1 diabetes.”

Andrew Hodge, Vice President, International of Lilly Diabetes, commented: “Lilly Diabetes’ objective is to bring safety, health, comfort and a bit of magic to children worldwide. We saw the positive impact our collaboration with Disney Publishing Worldwide had on families living with type 1 diabetes in the US over the last two years, and we are excited to expand our reach globally.”

Reports from America claim Eli Lilly is set to reduce its sales force in the US by nearly a third ahead of key patent expiries for Cymbalta and Evista.

According to the Wall Street Journal, up to 1,000 sales staff will be made redundant by the end of July as the company combats falling revenues streams.

It’s believed that the job losses will come from a combination of internal sales staff and contractual workers, claimed a person “familiar with the matter”, the paper said.

Cymbalta and Evista earned the company $6bn in sales last year, around 43% of overall US sales for the Indianapolis-based company. But those sales are expected to fall significantly when Cymbalta, a treatment for depression and anxiety, is exposed to generic competition in the US this year and osteoporosis treatment Evista follows in 2014.

Lilly has already lost around $5bn in sales after its schizophrenia drug Zyprexa lost patent protection and its pipeline has so far failed to produce any potential new ‘blockbuster’ brands.

New draft NICE guidance recommends giving tamoxifen or Evista (raloxifene) to women with a family history of breast cancer as a preventative drug.

The provisional guidance update makes new suggestions for genetic testing, screening and preventative treatment in women at high risk of breast cancer.

If confirmed by NICE, the recommendations would mean the first use of a drug by the NHS to prevent breast cancer.

Breast cancer is diagnosed in 50,000 women in the UK each year. Women with a sister and a mother or aunt who have developed breast cancer before the age of 50 are considered at high risk of developing the disease for genetic reasons.

Breast cancer is also likely to occur earlier, and to be harder to treat, in this patient class, who are fewer than 1% of women aged under 30.

Genetic testing can identify either of two mutant genes that are linked to increased risk of breast cancer, as well as ovarian cancer.

NICE emphasises the need to reduce the incidence of breast cancer in high-risk women. It estimates that for every 1000 women treated with tamoxifen or Evista for a five-year period, there would be 20 fewer cases of breast cancer.

However, the drugs have side-effects including increased risk of blood clots, so their preventative use would need to be carefully considered.

Tamoxifen was developed by AstraZeneca but has long been off patent. Lilly’s Evista came off patent more recently. Neither drug has UK marketing authorisation for prevention of breast cancer.

Chris Askew, Chief Executive of the charity Breakthrough Breast Cancer, said the draft guidance was “a historic step for the prevention of breast cancer”.

Eli Lilly has resumed sole development and commercialisation rights to a new insulin analogue formerly covered by its diabetes alliance with Boehringer Ingelheim.

The alliance, formed two years ago, centred on four pipeline compounds relevant to major aspects of diabetes treatment.

The basal insulin analogue LY2605541will now progress to clinical trials under Lilly’s sole control.

The two companies are still working together to develop and commercialise three products including Trajenta (linagliptin), a drug for type 2 diabetes.

The partnership aimed to provide a broad portfolio of drugs for people with diabetes, but Lilly has now opted to shift LY2605541to its own drug portfolio.

Lilly will continue with the planned clinical trials of LY2605541, which will support regulatory submissions and evaluate the new drug’s safety, efficacy and differentiation.

Encouraged by the phase 1 and 2 clinical trial data for LY2605541, Lilly hopes to present phase 3 data and gain regulatory approval in 2014.

Enrique Conterno (pictured), President of Lilly Diabetes, said: “Boehringer Ingelheim is an important partner in our strategy to provide a broad portfolio of diabetes medicines, and our diabetes alliance remains strong.

“There is no group of patients with whom Lilly has a deeper history than those impacted by diabetes. If approved, this basal insulin analogue will be an important addition to the Lilly portfolio.”

Eli Lilly, the first company to commercialise insulin, has a long history of innovation in diabetes treatment.

The standard cognitive test used for trials of drugs for Alzheimer’s disease is not accurate, UK researchers have found.

The ADAS Cog test, which scores patients on an aggregate of 11 components (such as language use and naming objects), underestimates the progress of dementia and variance between patients.

The report suggests that some Alzheimer’s drugs, including ones that ‘failed’ clinical trials, may be more effective than was thought.

In particular, the test is unreliable as a means of tracking the early stages of dementia, where drug interventions are likely to have most impact.

Researchers from Plymouth University examined 675 ADAS Cog test results for people with mild Alzheimer’s disease at zero, six, 12, 18 and 24 months.

Analysis of the scores at component level revealed a ‘ceiling effect’ in relation to eight abilities: from 32–83% ‘passed’ the component with equivalent scores.

A follow-up study used Rasch analysis, a technique for evaluating aggregated tests, to confirm the flaw and suggest improvements: parts of the ADAS Cog need to be more difficult, and the overall scoring method needs reworking.

“It is impossible to say precisely the extent to which the ADAS Cog’s flaws have undermined the numerous clinical trials in which it has been used,” said study leader Professor Jeremy Hobart.

“It has been used, unchanged, for many years and its apparent contribution to suboptimal trials has led a number of drug companies to rethink their strategies.

“However, it is very clear that in its current form the ADAS Cog underestimates cognitive differences between people and changes over time.”

The test “is not working in people with mild Alzheimer’s disease,” he concluded.

The ADAS Cog was recently used in the ‘unsuccessful’ drug trials of Lilly’s solanezumab and Pfizer and J&J’s bapineuzumab.

Joint working has been recognised as a driver of therapeutic innovation at the second annual Quality in Care (QiC) Diabetes awards.

Partnerships between Eli Lilly UK and NHS and voluntary sector organisations were commended in an event that stressed the contribution of cross-sector work to the QIPP agenda.

Held at Sanofi’s UK headquarters in Guildford, the QiC Diabetes awards highlighted innovation and good practice in UK diabetes care.

A partnership between Lilly and diabetes charity JDRF to develop an educational programme on type 1 diabetes for schools was highly commended in the Best Cross-Organisational Partnership category.

Lilly was also commended for its partnership with Royal Surrey County Hospital NHS Trust to develop the ‘Piecing Together Diabetes’ clinician training tool, a jigsaw that helps staff to improve inpatient diabetes care.

“The awards have provided a unique platform to showcase good practice and innovation from across the country,” said Anna Morton, Director of NHS Diabetes. “We are all working under increased pressure and uncertainty and the examples highlighted have shown how despite adversity, high-quality diabetes care can still be achieved.”

Caroline Horwood, diabetes division director at Sanofi, commented: “We witnessed some inspirational work last year, and it is heartening to see that 2012 brings some new award categories and a 50 per cent increase in the number of entries.”

Quality in Care is a series of programmes aimed at recognising good ideas for improving care quality and productivity, in line with the QIPP agenda, and sharing them across the NHS.

India’s health ministry has claimed that ‘systemic improvements’ in the country’s drug approval procedures are needed, following a report on alleged corruption.

The parliamentary report alleges irregularities in the approval of drugs from major pharmaceutical companies, including major gaps in clinical evidence.

Companies including Eli Lilly and Bayer have challenged the accuracy of the report, which focuses chiefly on the failings of India’s drug regulator.

The Central Drugs Standard Control Organization (CDSCO) lacked adequate staffing or resources, the report found, and there was evidence of a “collusive nexus” between its officials, drug companies and medical experts.

An example cited was CDSCO’s acceptance of three expert opinions on Bayer’s anti-thrombosis drug rivaroxaban that were identical copies. Bayer responded that it had not played “any role in selecting these experts or evaluating their opinions”.

The report also claimed that CDSCO routinely approved drugs that were not approved in the EU or the US due to lack of clinical evidence.

Critically, it said that of 39 CDSCO-approved drugs it surveyed, 11 had not been tested on patients in different ethnic groups – a key requirement of approval in India.

An example was Lilly’s lung cancer drug pemetrexed – but the company insisted the drug had been tested on a large multi-ethnic patient base.

Irregularities claimed in the approval of drugs from Lundbeck, GSK and Novartis were similarly denied by the companies concerned.

The controversy reflects the growing importance of India and other ‘emerging markets’ for the global pharma industry.

Three leading pharmaceutical companies are working with the US National Institutes of Health (NIH) to find new indications for failed drugs.

Pfizer, AstraZeneca and Eli Lilly have joined a research programme that aims to speed innovative drug development by using existing compounds.

The programme will seek to match these compounds to newly discovered genetic disease pathways to identify accidentally pre-targeted drugs.

NIH Director Dr Francis Collins pointed to a familiar example: the first effective HIV treatment, AZT, was an unsuccessful cancer drug.

Such discoveries, he said, have been “sort of serendipitous” – but the goal of the new research programme is to replace serendipity with systematic analysis.

Recent research has identified the genetic causes of 4,500 diseases, but so far targeted treatments have only been developed for 250 of these.

The three drug companies have agreed to each make available at least 24 ‘failed’ drugs (withdrawn or never launched) that passed safety tests, making their testing in new indications relatively easy.

Scientists will apply for NIH grants to study specific drugs.

To simplify the legal framework, the programme allows the companies to retain ownership of their drugs while the researchers can patent their own discoveries.

The NIH will invest about $20m in the programme in its first year, and hopes for support from more pharmaceutical companies in the future.

Both GlaxoSmithKline (GSK) and Eli Lilly are investing in new pharmaceutical research facilities in the UK.

GSK has provided £12m to help fund a new sustainable chemistry research facility, focusing on pharmaceutical research, at Nottingham University.

Lilly has launched new neuroscience research facilities at its Erl Wood R&D campus in Surrey, at a cost of £5.4m.

Both initiatives reflect the industry’s renewed confidence in partnership with the academic sector, triggered in part by the new ‘patent box’ legislation.

Known as the GlaxoSmithKline Carbon-Neutral Centre for Sustainable Chemistry, the new building at Nottingham University is intended to stimulate collaborations with other institutions and industry partners.

The new building, scheduled for completion in 2014, will be carbon-neutral, made from natural materials and rely on renewable energy sources.

Sir Andrew Witty, CEO of GSK, said: “The carbon-neutral laboratory will help affirm the UK as a global hub for the future of the life sciences industry. This is an opportunity to invest further in science in the UK, rethink how we approach the drug discovery process and play a role in contributing to environmental stewardship.”

“This development will be transformational in several ways,” commented Professor David Greenaway, Vice-Chancellor of the university. “The building will break new ground in sustainable construction, while the centre of excellence will shape the future of drug discovery.”

The initiative was praised by David Willetts, Minister for Universities and Science. “This new laboratory is an excellent example of collaboration between universities and industry,” he said. “It shows how businesses can benefit from the knowledge and expertise of our world-leading research base and will help keep us at the very forefront of life sciences.”

Eli Lilly’s new research facilities at Erl Wood will house 130 staff, many already employed at the site.

The investment reflects Lilly’s aim of strengthening its neuroscience portfolio, especially for the treatment of Alzheimer’s disease.

Dr Jan Lundberg, President of Lilly Research Laboratories, commented: “The UK is a great place to do bioscience research. Not only does the UK benefit from have a strong research base, the government is also able to maintain a stable pricing and reimbursement system.

“As well as financial incentives for R&D, this demonstrates that the UK government has a commitment to maintain its position as a global leader in attracting pharmaceutical investment.”

Lilly’s involvement in neuroscience research goes back two decades. The company’s drug solanezumab, currently in phase III development, has potential to slow the progression of Alzheimer’s disease.

Dr Lundberg also emphasised the importance of partnership between industry and academia. “Collaboration is absolutely essential to ensure innovative new medicines reach patients,” he said. “The science behind drug discovery is becoming more challenging.”

Novartis is expected to overtake Pfizer and become the biggest manufacturer of prescription medicines by 2018, according to new consensus data.

Research by EvaluatePharma estimates Novartis will record sales of more than $50bn in six years’ time, with its eye care business Alcon and generic unit Sandoz driving growth.

But the outlook is not good for US-based companies with only Pfizer remaining in the top five by 2018 and Sanofi, GSK and Roche maintaining a strong presence.

Data found that despite generic competition on Diovan and Glivec and disappointment from key projects such as Gilenya and its new respiratory franchise, Novartis is expected to record annual growth between 2011 and 2018 of 1.2%.

This is in contrast with AstraZeneca whose annual sales are expected to drop from $32.4bn in 2011 to $22.1bn in 2018 representing a negative growth of 5.3%.

Gilead Sciences is expected to experience the biggest increase in annual growth of the top fifteen companies with data showing sales will rise from $8.1bn to $15.7bn at a rate of 9.9% per year.

Novo Nordisk is also forecast to enter the top 15 ranked companies for the first time due to an increasing demand for its diabetes medicines. Annual growth is expected to be 7% until 2018 with sales totalling nearly $20bn.

One of the biggest casualties, data found, will be Eli Lilly. The Indianapolis research-based company currently claims to be the 10th biggest pharmaceutical company in the world. But Lilly fails to make the top 15 companies after research found a drop in sales will see it fall to 17th place by 2018. But researchers did note that Lilly’s Alzheimer’s candidate, solanezumab, could reverse the trend if it successfully enters the lucrative market.

Lilly will be replaced in the list by German healthcare giant Bayer, which also enters the top 15 global companies for the first time, with annual sales of around $16.5bn by 2018 boosted by Xarelto.