Steve Turley, Managing Director of Lundbeck, has been re-elected Chair of the European Medicines Group (EMG), the UK voice of pharmaceutical companies based in continental Europe.

Robin Bhattacherjee, General Manager of Actelion, was re-elected vice-Chair of the EMG; and Mike Sumpter, CEO of Servier Laboratories, was elected Treasurer.

Issues highlighted at the EMG’s twelfth AGM included the impact of NHS reform on European-based companies and European perceptions of the UK as a pharmaceutical market and research base.

The EMG’s 15 member companies are Actelion, Almirall, Bayer, Boehringer Ingelheim, Ferring, Lundbeck, Menarini, Merck Serono, Norgine, Novartis, Novo Nordisk, Roche, Sanofi, Servier and UCB.

Steve Turley (pictured) commented: “We have members ranging from the UK’s biggest pharmaceutical companies, through biotechnology specialists to emerging organisations. Yet we all share common challenges and can benefit from being able to view these through a European-focused lens.”

“How the implementation of the NHS reforms affects European-based companies is a key issue this year,” noted Robin Bhattacherjee.

“Upwards of 60% of the medicines our members have introduced in the last decade have not been subject to a NICE health technology appraisal, so... local decision making in the CCGs about the use of these remains a major focus for EMG.”

Mike Sumpter noted: “Globally the UK is viewed as a tough market where innovative new medicines aren’t adopted as readily as similar economies.

“We want to work closely with our NHS stakeholder partners to demonstrate that the UK and the NHS is worth investing in.”

Lundbeck is based in Denmark, Actelion in Switzerland and Servier in France; all three companies have major UK operations.

Final draft guidance from NICE recommends Xarelto (rivaroxaban) to treat pulmonary embolism (PE) and deep vein thrombosis (DVT) and prevent their recurrence.

The Bayer drug offers an alternative to warfarin, the standard treatment for dangerous internal blood clotting.

Xarelto presents fewer dose management challenges than warfarin, and has fewer interactions with other drugs and with foods.

DVT, an abnormal blood clot formation in the leg or pelvis, can lead to PE and other dangerous circulatory malfunctions that cause disability or death. Risk factors for DVT include prolonged travel and/or immobility.

Suspected PE is treated with an anticoagulant, usually initial injections of heparin followed by longer-term oral doses of warfarin. However, warfarin presents complex dose adjustment challenges and can interact dangerously with other medications and with foods.

NICE determined that Xarelto was cost-effective both as a treatment for PE and DVT over three, six or 12 months and as a lifelong treatment to prevent the recurrence of PE or DVT.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The regular monitoring and dose adjustment needed with warfarin, which needs regular visits to hospital or GP appointments, can be costly and inconvenient. Also, because warfarin has many drug interactions, it may be unsuitable for people with comorbidities. In addition, the Committee heard that warfarin has various food interactions which often require people to adjust and monitor their diet.

“Rivaroxaban therefore represents a significant potential benefit for people with PE and DVT because it avoids the need for initiation with heparin and the subsequent transition to warfarin.”

Final NICE guidance is expected in May 2013.

Bayer HealthCare has founded a new pan-European consortium for drug discovery, the European Lead Factory (ELF).

The five-year project will create a small molecule library to resource drug discovery projects based on targets from pharma and academic researchers.

Working with six other European pharma companies, Bayer will co-ordinate the compilation of 300,000 substances and contribute 50,000 of these.

A further library of 200,000 compounds will be developed by industry SMEs and academics.

The two libraries will make up a Joint European Compound Collection that will be accessible to all project partners, and to health organisations and SMEs.

Targets for drug discovery will be selected, through competitive calls, from those proposed by pharma companies and health providers.

“The European Lead Factory is an outstanding example of a project in which public-private partnerships enable collaborative drug discovery,” commented Hanno Wild, Senior VP and Head of Candidate Generation & Exploration at Bayer HealthCare Global Drug Discovery. “The platform brings together academia and industry as well as SMEs in a unique partnership aiming to discover innovative medicines.”

The project is part of the European Innovative Medicines Initiative (IMI), a partnership that supports industry and academics in collaborative research.

Michel Goldman, IMI Executive Director, said: “This unique project will give European researchers unprecedented access to industry chemical collections and facilitate the translation of their findings into actual treatments for patients.”

The ELF has 30 member organisations from pharma companies, SMEs and academia. Inspired by the increasingly successful ‘open innovation’ model, it aims to achieve a sustainable role in European drug development.

The project’s five-year budget of €196m is made up of €80m from the European Commission, €91m from participating pharma companies and €25m from other participants.

The 27th Pharmaceutical Marketing (PM) Society Advertising Awards had the largest number of entrants ever (350) and saw the event expanding into the digital and exhibition arenas.

Notable winners among the advertising agencies included Langland Advertising, which won in seven categories (with 10 commendations), and VCCP Health, which won in three categories (with two commendations).

Of 36 pharmaceutical companies competing for the PM Society Awards, the most successful was Abbott with four wins and five commendations.

Three pharmaceutical companies – Astellas, Bayer and Johnson & Johnson – won two awards each, and another five – CSL Behring, Eisai, Janssen, Sanofi Pasteur MSD and Takeda – won one each.

Neil Smith, PM Society Advertising Awards Chairman, commented: “As ever, the truly aspirational creative treatments stand head and shoulders above the rest and their success is reflected by our industry and healthcare judges.”

From over 50 campaigns entered for the Awards, the most successful on the day were Langland’s campaign for Abbott’s drug Hidrasec (four wins and one commendation); the same agency’s campaign for Bayer’s Sativex (two wins and two commendations); and Lime’s campaign for Astellas’ Protopic (one win and two commendations).

Remarkably, Concentric Advertising won both the Primary and the Secondary Care Target Awards for one advertisement.

Two of the most coveted awards were the Healthcare Industry Award, won by relative newcomer VCCP Health, and the Geoff Brook Innovation Award, snagged by the Woolley Pau Gyro agency.

New awards were presented in three digital advertising categories, and exhibition displays were recognised in a new category for the first time.

The lunchtime awards ceremony in London was hosted by broadcaster and former MP Gyles Brandreth.

The PM Society, which promotes marketing excellence in the healthcare and life science industries, is a non-profit organisation with members in over 230 UK companies.

In 2012 the Society launched Interest Groups addressing key challenges facing UK pharmaceutical marketers: market access, digital marketing, NHS partnerships, patient engagement and personal development.

Pf looks at how the pharmaceutical industry is working with WHO to transform the developing world by defeating neglected diseases such as sleeping sickness and river blindness.

In January 2012, the World Health Organisation (WHO) launched a roadmap to defeat 10 key neglected tropical diseases, with support from 13 major pharmaceutical companies. The campaign targets diseases that are widespread only in the developing world and form major barriers to the economic development of the affected countries. The companies pledged to work in partnership with WHO, governments and health and finance organisations to strengthen their drug donation programmes, support drug distribution and implementation, and increase R&D in this disease area.  

Trojan horses
Most neglected tropical diseases (NTDs) are carried by parasites (such as tsetse flies) or are parasites (such as flatworms), which makes them difficult to treat as parasites are well adapted to the biology of the host. The parasite often acts as a ‘Trojan horse’ introducing disease into the human body. While preventative measures such as sanitation are important for controlling infection, only effective drug treatment can strike at the lethal team of parasite and micro-organism. The challenge is not only to develop effective drugs, bu to ensure they reach the populations affected by the disease.

In the ‘London Declaration on Neglected Tropical Diseases’, WHO and 13 drug companies committed to these objectives for 2020: to eradicate guinea worm disease; make progress towards eliminating lymphatic filariasis, blinding trachoma, sleeping sickness and leprosy; and achieve control of schistosomiasis, river blindness, Chagas disease, visceral leishmaniasis, and soil-transmitted helminthes. The companies involved are Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Gilead, GSK, Johnson & Johnson, Merck KGaA, Merck Sharp & Dohme (MSD), Novartis, Pfizer and Sanofi.

Margaret Chan, Director General of WHO, said: “The efforts of WHO, researchers, partners, and the contributions of industry have changed the face of NTDs. These ancient diseases are now being brought to their knees with stunning speed. I am confident almost all of these diseases can be eliminated or controlled by the end of this decade.” For some of the world’s poorest nations, that means an end to a crippling burden of endemic disease.

As a Sanofi video commented, NTDs are neglected because the populations they affect are neglected. For the pharma industry, offering drug donation, training and education to defeat these diseases is an opportunity to put down roots in important future markets, as well as boosting the industry’s public image through concrete achievements. Despite the current global economic crisis, funding for neglected disease R&D has increased significantly since 2007. Corporate social responsibility is a key aspect of any global drug company’s strategy – especially for companies based in Europe
and the US, where reputation can be a difficult issue.

In May 2012, Dr Margaret Chan commented on work to fight schistosomiasis in Africa: “These Cinderella diseases, long ignored and underappreciated, are a rags-to-riches story. We can blanket this part of the world with medicines that rid every schoolchild of worms and eggs, parasites that interfere with their learning, impair cognitive development, and compromise their nutritional status.” Such achievements, which depend on the pharmaceutical industry, are of historic importance on the world stage.

River blindness
Onchocerciasis (river blindness) causes an estimated 270,000 people each year in Africa and elsewhere to lose their sight. Its biological audit trail is complex: a nematode worm enters the body through the bite of a blackfly; the worms spread through the body, carrying symbiotic bacteria; when the worms die, the bacteria trigger the human immune system, causing severe itching and damaging eye tissue. Some 37 million people are infected with river blindness.

The most successful treatment is MSD’s Mectizan (ivermectin), an oral medication that kills the parasite in its larval stage. On 11 October 2012 (World Sight Day), MSD celebrated 25 years of its programme to donate Mectizan for treatment of river blindness. Through this programme, progress has been made towards eliminating the disease in Nigeria, Uganda, Senegal, Mali and Sudan. MSD is committed to maintaining drug donations until the disease is eliminated.

The Mectizan Donation Programme has influenced the development of other initiatives to fight NDTs in two ways: its multi-sector partnership model and its use of community-directed intervention (CDI). Stakeholders working with MSD to build the programme include WHO, the World Bank, governments, NGOs and communities. The CDI strategy, whereby communities plan their own means of delivering treatment, has enabled Mectizan to be delivered to 75 million people in Africa each year.

Former US President Jimmy Carter commented: “In Africa, where it was once thought river blindness could only be controlled, strides are being made to completely eliminate the disease from a number of countries. Thanks to MSD, the commitment of endemic communities, and strong partnerships, we can now envision a world someday free of river blindness.”

A leading distributor of Mectizan in Africa is Sightsavers, an NGO committed to preventing blindness. Simon Bush, Sightsavers’ Director for NTDs, told Pf: “Sightsavers will, through its support to river blindness programmes in Africa, treat over 25 million people this year as well as playing our part in supporting a network of about one million community-directed distributors.

“We have also the proof of the elimination of transmission of the disease in Kaduna state in Nigeria, which shows that elimination of the disease can be achieved in Africa through treatment with Mectizan alone.” 
The contribution of MSD has been “vital”, Bush said: “Sightsavers would not be able to support the elimination of river blindness and blinding trachoma if it were not for the drug donation programmes. We would not have been able to go to scale.” The supply chain reaching from a major pharmaceutical company to a network of community-directed distributors, reaching through society and across the world, is expected to eliminate transmission of the disease in the targeted countries by 2021.

Blood fluke
Schistosomiasis (blood fluke) is a parasitic flatworm infestation. The larvae enter the body from fresh water sources, mature in the liver and travel through the blood vessels, laying eggs that trigger destructive immune reactions. The disease is estimated to affect 200 million people in Africa and to cause 200,000 deaths each year.

The only medicine with which all forms of schistosomiasis can be treated is Cesol (praziquantel) from Merck Serono (a division of Merck KGaA). In 2007, the company committed to donate 200 million Cesol tablets to WHO for distribution to school-age children primarily in Africa, and to support an awareness programme in schools. In January 2012, Merck Serono doubled its annual donation of tablets to 50 million, to be maintained until the disease is eliminated. It has committed to work with partners to develop a pre-school version of the drug.

Seven million children were treated with Cesol in 2012, bringing the total to 28 million. At the end of November, Merck Serono symbolically donated the 100 millionth Cesol table to WHO, and announced a new programme to distribute the medicine throughout Kenya.

The company’s CEO, Stefan Oschmann, said: “Merck Serono is committed to more effectively fighting neglected tropical diseases.” He added that partnership is the essence of the campaign: “The closer we co-ordinate the donation activities, research and development of new drugs, as well as the supply and distribution of drugs with each other, the more effectively we’ll be able to fight these diseases.”

Sleeping sickness
Trypanosomiasis (sleeping sickness) is one of the tropical world’s most feared diseases. It is spread by the bite of the tsetse fly and affects the brain, causing sleepiness, coma and death. Almost always fatal if untreated, sleeping sickness may be the real basis of the ‘zombie’ myth. But now, according to Dr Margaret Chan, “the stage is set for the elimination of sleeping sickness, a prospect that was unthinkable a decade ago”. For over ten years, Sanofi has worked with WHO to provide drugs and develop treatment protocols for the disease via the campaign ‘Human African Trypanosomiasis – Not Neglected by Sanofi’.

In 2011, Sanofi renewed its commitment to fighting sleeping sickness through a $25m donation, extending its partnership with WHO by another five years. The company donates three of the five drugs used to treat the disease. In January 2012, Sanofi announced a global partnership with Eisai and the Bill & Melinda Gates Foundation to eliminate five NTDs including sleeping sickness and lymphatic filariasis. In July, it noted that the sleeping sickness treatment programme had saved 170,000 lives and reduced the number of new cases from 30,000 in 2001 to 6,500 in 2011. By 2020, WHO has said, Africa may be clear of the disease.

Sanofi’s video from Chad illustrates the methods used to implement treatment. By funding mobile medical teams working in towns and villages, the campaign has brought daily drug therapy to people unable to travel long distances to the city hospitals. Seeing the effects of treatment within the community encourages other patients to be treated there. Sanofi is committed to providing the drugs and supporting their implementation until sleeping sickness is eliminated.

This month Bayer’s Rosie Sheppard slips on her leopard print driving gloves, checks her mirrors, eases her foot from the clutch and applies moderate pressure to the accelerator. After performing an immaculate emergency stop, she leans out of the window for a chat about her beloved Citroen.

Job title
E-detailing Representative.

Responsibilities
Detailing HCP’s online working.

Your car
A gorgeous white Citroen C1. I have always loved white cars, so immediately ordered the first one they could get me.

Owned since
January 2012.

Nickname
Baby Car.

Regular destinations
Waitrose, Tesco and the gym (thrice weekly). I do live close to York centre, so I take the bus or cycle as well.

Favourite gear change
The glorious transition from fourth to fifth.

Favourite destination
I should say the gym, but probably Waitrose.

Car’s best feature
It is so small that I kept losing it in car parks, so I added a ‘Nemo’ fish to the aerial for identification purposes.

Car’s most annoying habit
Not a single bad habit. Love is still in the air (conditioner).

Drive time
Radio 2.

In glove compartment
CDs, tissues, hand sanitizer, water and odd bits of detritus.

Word most used in car
Hmm, probably shouldn’t repeat it. It usually comes out while trying to get on the A19 roundabout. [Ed – is it ‘fiddlesticks’?]

Snack most consumed in car
Anything by Haribo.

On backseat
Two matching brollies in the side pockets and a spinning kit for the gym.

Most embarrassing incident
Many years ago, when I had evening meetings at a local hospital, you could usually stay in the consultant’s car park, as they left the barrier up. On one occasion, they had left it down, and I smashed through it, breaking the arm clean off. When I went inside to tell someone, they said just throw it in the bushes, no one will know. Honestly, I couldn’t find anyone to take it seriously, so that’s exactly what I did!

Favourite car memory
Going to our boat at Windermere every weekend, and my dad refusing to stop, as we had got ahead of the caravans. My brother and I took it in turns to be sick in a bucket... those roads were very curvy and nothing could keep dad from his boat.

Dream car
I am in the process of buying a Nissan Figaro as a summer car. They only made 20,000 of them in 1991, so ‘Baby Car’ will still be needed.

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”

NICE has changed its original decision on the use of Xarelto (rivaroxaban) as an option for deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE).

The Institute now recommends Xarelto’s use in final draft guidance after Bayer supplied requested data on the long-term clinical and cost effectiveness of the treatment.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the “additional information and analysis” convinced NICE’s Appraisal Committee.

Earlier this year in March, NICE issued draft guidance that failed to recommend Xarelto after concerns were raised about its use in the context of UK clinical practice.

However, Bayer supplied the requested information on patients who were assigned treatment durations of 3, 6 and 12 months and data on the drug’s cost effectiveness compared to existing options.

As a result, the Committee concluded that Xarelto is more clinically and cost effective than enoxaparin followed by a vitamin K antagonist for preventing recurrent VTE in people in whom treatment for up to 12 months is indicated.

There are believed to be more than 46,000 cases of acute DVT in England and Wales with that figure expected to rise to nearly 50,000 by 2016 due to the ageing population.

Xarelto was recently shortlisted for the globally acclaimed Prix Galien medal.

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.

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.