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.

Novo Nordisk has launched Tresiba (insulin degludec), a new basal insulin for adults with type 1 or type 2 diabetes, in the UK.

Tresiba controls HbA1c levels as effectively as the standard basal insulin Lantus (insulin glargine) while posing less risk of nocturnal hypoglycaemic episodes.

It is also the first basal insulin to allow flexibility in injection time, as it has a 42-hour action, requiring only a minimum of 8 hours between injections.

Compared to Sanofi’s Lantus, Tresiba has been shown to reduce the incidence of nocturnal hypoglycaemia in patients with type 1 diabetes by 25%, and in insulin-naive patients with type 2 diabetes by 36%.

The overall rate of hypoglycaemia was similar for both types of insulin – but nocturnal episodes are particularly dangerous because they are harder to treat. Severe hypoglycaemic episodes are estimated to be responsible for 6% of deaths in people with diabetes under the age of 40, and half of such episodes take place at night.

Professor Melanie J Davies, Professor of Diabetes Medicine, University of Leicester, said: “Many of my patients have difficulty taking their insulin at exactly the same time each day, for reasons which we can all sympathise with and understand. For example, picking children up from school or working irregular shifts at work.

“It is thus very useful that there is now an insulin which, because of its longer duration of action, is able to offer patients a bit more flexibility in terms of timing of their dose without compromising either their glycaemic control or risk of hypoglycaemia.”

Tresiba is available in two FlexTouch pens: FlexTouch U100 (1–80 units per dose) and FlexTouch U200 (2–160 units per dose).

Sanofi’s new paediatric six-in-one vaccine, the first in liquid form, has been recommended by the European Medicines Agency (EMA).

The new vaccine will be marketed as Hexyon by Sanofi Pasteur MSD in western Europe and as Hexacima by Sanofi Pasteur in eastern Europe.

It confers protection against pertussis (whooping cough), hepatitis B, diphtheria, poliomyelitis, tetanus and the HIB bacterium.

GSK’s Infanrix Hexa is currently the only six-in-one child vaccine on the market, with global revenues of £775m last year.

The EMA’s approval of Sanofi’s previous vaccine, Hexavac, was withdrawn after its effectiveness in protecting against hepatitis B was questioned.

According to Sanofi Pasteur, Hexyon has “a similar high immunogenicity profile for all antigens” to Infanrix Hexa, while its liquid formulation makes it more convenient for injection.

It will be used for primary and booster vaccination of infants aged six weeks to 24 months.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said the recommendation “validates the clinical data supporting the vaccine’s effective and safe use for infants. Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process."

Olivier Charmeil, the head of Sanofi Pasteur, predicted the new vaccine would be a “key growth driver” for the company in 2013.

Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

A new injectable drug has been approved for use in the EU to help control type 2 diabetes, alongside basal insulin or oral medication.

Lyxumia (lixisenatide) from Sanofi is the first once-daily prandial GLP-1 receptor agonist, a drug that stimulates the pancreas to produce more insulin during meals.

Licensed by Sanofi from Danish biotechnology company Zealand Pharma, Lyxumia can improve blood glucose control by reducing the ‘peaks’ induced by meals.

It is indicated for adjunctive use together with basal insulin or an oral glucose-reducing drug when these alone do not deliver effective control.

The approval was based on the GetGoal clinical trial programme, which involved more than 5,000 patients with type 2 diabetes and showed that Lyxumia achieved a marked post-prandial reduction in blood glucose and a significant long-term HbA1c reduction.

It also helped to reduce body weight, and its side-effects (nausea and vomiting) were short-lived. Risk of hypoglycaemia was limited.

“Patients with Type 2 diabetes are not all alike,” said Dr Filip K. Knop of Gentofte Hospital, University of Copenhagen. “One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose.

“Adding a short-acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose, like once-daily Lyxumia, may be a good way of getting these patients back at target without increasing the risk of hypoglycaemia.”

Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA): it enhances the action of GLP-1, a naturally occurring peptide hormone that is released while eating a meal and stimulates insulin secretion by pancreatic cells.

Sanofi has in-licensed the drug from Zealand Pharma, who will receive low double-digit percentage royalties on global sales.

The European Commission has granted a marketing authorisation in the EU for Zaltrap to treat adults with metastatic colorectal cancer that is resistant or has progressed after initial treatment.

The decision was based upon evidence from Phase III trial data which showed Zaltrap to be the first and only agent to statistically significantly improve survival in combination with FOLFIRI chemotherapy after an oxaliplatin regimen.

Colorectal cancer is the most common cancer in both men and women in Europe and is the second leading cause of cancer death.

The treatment is marketed by Sanofi and Regeneron Pharmaceuticals.

Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology, thanked “physicians, patients and their families” for their efforts in getting the injection approved.

“We are thrilled to provide a new therapy that further extends the lives of patients with metastatic colorectal cancer and look forward to working with European health authorities to ensure patients have access to Zaltrap,” he said.

Dr George Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added that the treatment “provides a new option to address the unmet medical need” across Europe.

Zaltrap received approval by the US FDA back in August 2012 following a priority review by the agency. It is also under review with other health regulators across the world.

Sanofi has responded to protests against the withdrawal of its drug Campath by restoring access for a limited number of patients with multiple sclerosis (MS).

Campath (alemtuzumab) is approved for treatment of leukaemia but is prescribed off-label for treatment of MS.

To offset the effects of its withdrawal from the market, prior to a rebranding, Sanofi has agreed to make 201 vials available for MS patients in the UK.

In September 2012, Sanofi’s subsidiary Genzyme withdrew Campath to allow a new version, Lemtrada, to be licensed for treatment of MS in the UK.

This meant both that the drug’s price would increase by a factor of 15–20 and that a gap would be created in its availability.

There was widespread protest from doctors, including a letter to the Health Secretary from three specialists warning that patients could miss the window of ‘therapeutic opportunity’, with serious medical consequences.

One of the letter’s authors, Professor John Zajicek, commented that Sanofi’s approach was “morally corrupt”.

Genzyme has agreed to supply a further 201 vials of the drug for the patients of six specialists who were using it as a treatment for MS – however, it will not be available for new patients.

Professor Zajicek said the company’s response was “disappointing”, with Genzyme setting conditions that “don’t make sense”.

The decision to rebrand Campath was based on clinical trials that showed it to be more effective against MS than the current treatment, interferon beta-1a.

Researchers at the University of Cambridge said the drug had a “transformative” effect, and could be given to two-thirds of patients newly diagnosed with MS.

Genzyme stated that gaining regulatory approval for alemtuzumab as a treatment for MS was the best way to ensure patient access.

However, critics have predicted that its price as a licensed drug in this indication will be 15–20 times as high as its current price (which follows patent expiry).

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.

Biotech company Genzyme has appointed Brendan Martin as General Manager for UK and Ireland, with responsibility for all commercial activities.

Brendan Martin joined Genzyme in 2002 and established its lysosomal storage disorders business in Ireland before becoming the company’s Business Unit Director in 2007 and Deputy General Manager for UK and Ireland in 2010.

He replaces Paul Drohan, who leaves Genzyme after 17 years to return to Canada and pursue other opportunities.

Robin Kenselaar, Head of Genzyme EMEA, said: “Brendan’s appointment as General Manager UK and Ireland comes at a key time for the business as it builds its multiple sclerosis franchise and continues to develop in rare diseases.

“In his Genzyme career to date, Brendan has shown he is a leader with the experience, energy, vision and commitment to patients needed to move us forward.”

Part of the Sanofi group, Genzyme in the UK focuses on rare inherited and immune diseases, with a commercial base in Oxford.

Its UK manufacturing facility in Haverhill in Suffolk is a major global distribution centre for the company’s products for genetic diseases.

Genzyme has been a leading global biotech company for 30 years.

Most of the leading pharmaceutical companies are improving access to their medicines in the developing world, a new report shows.

The Access to Medicine Index identifies GSK, J&J and Sanofi as the companies doing most to make their drugs available and affordable in poorer countries.

Better pricing deals and development of drugs for neglected diseases are among the areas of company activity praised by the report, but the management of drug trials in developing companies is criticised.

GSK, which topped the Index in 2010, remains in front though its overall rating is only slightly higher. J&J and Sanofi have significantly improved their ratings.

The major Japanese firms are bottom of the league, as well as being absent from such initiatives as the WHO campaign to fight neglected tropical diseases.

In its third year, the Netherlands-based Index notes that companies are showing better internal organisation in relation to drug access issues.

Of the 20 largest pharma companies, 17 have improved access to their drugs in the developing world since 2010: they are developing more relevant drugs and doing more to facilitate patient access to them.

In particular, more companies are using tiered pricing schemes to make products more affordable for certain countries or population groups – most notably Gilead, whose HIV drugs are used worldwide.

However, the Index states that companies could do more to support generic versions of their drugs and adapt drug packaging to local needs.

It also notes that the outsourcing of clinical trials to Contract Research Organisations lacks transparency and control, with only four companies (GSK, Sanofi, Eisai and Merck & Co.) saying they enforce ethical codes.

Wim Leereveld, CEO of the Index, said: “Access to medicine is a multi-faceted challenge and the pharmaceutical industry has a critical role. While it has made strides in many areas, companies that have sector-leading practices also show us there is more the industry can contribute.”