We look back through the pages of Pf at what was happening in the pharma industry and the world five years and ten years ago.

March 2008

March 2008 was a turbulent month, with rioting in Tibet, bombing in Gaza, a Columbian raid on Ecuador, and the collapse of the Antarctic ice shelf. 

Arthur C. Clark, visionary author of 2001, died at the age of 90. The cinemas captured the mood of crisis, with a British SF film about a lethal virus sharing audiences with a satire on McCarthyism adapted from the work of Dr Seuss. New albums from Nick Cave, Bauhaus, Counting Crows and Nine Inch Nails underlined the disturbed mood, though Du†ffy’s Rockferry kept the UK public dancing around its increasingly empty handbags.

The lead article in the March Pf was ‘The changing face of sales’, an examination of the growing importance of networking and teamwork for medical sales professionals seeking to engage with the NHS. Sales has its own ‘open innovation’, and this article’s insights are still valid. Other articles looked at aspects of commissioning, compliance and coaching. In a new 

series, ‘Confessions of a medical representative’, our correspondent turned around a “lose-lose situation” with an honesty born of despair. A pro€file of Boehringer Ingelheim enticed the BI-curious by emphasising the company’s high levels of staff† retention and employee satisfaction.

The news section featured criticisms of the pharma industry – in particular, accusations of concealing evidence from clinical trials, promoting psychiatric drugs more widely than their e†ffectiveness justi€fied, and ‘evergreening’ (covertly blocking generic competition to brands). The ABPI declared the accusations unfounded. Some things never change.

March 2003

In March 2003, documents presented by the US government as proof that Iraq was developing a nuclear bomb were exposed as crude forgeries. None the less, the invasion began on schedule. Country rock band the Dixie Chicks told a London audience “We’re ashamed the President of the US is from Texas,” then went home to face a vicious backlash. Steps were taken worldwide to control the threat of SARS, a deadly form of pneumonia. Cinema audiences took comfort from the adventures of Piglet and the courage of a young Sikh woman leaving home to be

The March Pf examined the issue of flexible working, with new employment legislation helping companies and staff to tailor their contracts through job sharing, home working, flexitime and similar arrangements. Does that mean a better work-life balance or just a loss of job security? Managers at Pfizer, Abbott Laboratories and Alchemy discussed the flexible working arrangements they had introduced – all of which, in their experience, were full of win.come a footballer.

Other articles examined the skills needed for first-line sales management, explained how medical sales professionals can support GPs through the trauma of appraisal, and broke down the physician and nursing teams of a large hospital into manageable components for business engagement. A profile of Futures Resourcing explained its strategy of meeting the broad recruitment needs of clients and the long-term employment needs of candidates – from contract sales professionals to senior management – by functioning as a ‘total resourcing organisation’.

The news section featured Boehringer Ingelheim’s approval of a High Court judgement obliging parallel importers to respect product packaging and trademark rights. This was such good news, in fact, that Pf printed it twice: as industry news and again as product news. Other news stories included the new GP contract and the approval of Schering-Plough’s Remicade (infliximab) for treatment of two painful conditions, Crohn’s disease and ankylosing spondylitis, in the EU. These were covered once only, but with no less attention to detail.

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.

AbbVie’s Humira (adalimumab) is now available in the UK for treatment of paediatric Crohn’s disease (CD), a painful bowel disorder that can inhibit children’s growth.

The drug is licensed for treatment of patients aged six to 17 years with severe active CD who do not respond well to conventional therapies.

This new indication for a drug already used to treat arthritis and psoriasis offers the first new biological therapy for paediatric CD to gain EU approval in five years.

It also represents AbbVie’s first UK drug launch since its split from Abbott to form a stand-alone research-based biopharmaceutical company.

CD, which affects 90,000 people in the UK, is an inflammatory bowel disorder that causes severe pain and diarrhoea. In young patients, it can inhibit growth and the onset of puberty.

Conventional treatments include hospital-based injection of corticosteroids and immunomodulator drugs. Humira can be injected by children and their families outside the hospital, allowing for more flexible treatment with less disruption.

“Paediatric Crohn’s disease is a chronic bowel disease that may have a significant impact on a child or young person,” said Dr Richard Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Sick Children, Glasgow. “For patients who do not respond to standard therapies, this new treatment option addresses a significant unmet need.”

Richard Driscoll, Chief Executive of the charity Crohn’s and Colitis UK, commented: “Paediatric Crohn’s disease is known to be increasing in frequency among children and young adults of all ages. We welcome this new treatment that is being made available in the UK, as the symptoms can be very severe and have a significant debilitating effect on the child and their family.”

AbbVie separated from Abbott in early January as a manufacturer of research-based biological medicines.

Andrea Rappagliosi, Sanofi Pasteur MSD’s Vice President of Market Access, Health Policy & Medical Affairs, has been appointed President of Vaccines Europe.

Rappagliosi, who has held senior roles in EuropaBio and Vaccines Europe, is one of the new management team appointed by Jean Paul Kress when he became President of Sanofi Pasteur MSD in 2011.

The appointment reflects the importance of Sanofi Pasteur MSD as a major partnership between firms, and the only company in Europe to develop and manufacture only vaccines.

Vaccines Europe represents vaccine manufacturers within the European Federation of Pharmaceutical Industries and Associations (EFPIA), including Sanofi Pasteur MSD, AstraZeneca, Novartis, GSK, Crucell, Pfizer, Abbott and Baxter.

Rappagliosi joined Sanofi Pasteur MSD from GlaxoSmithKline in 2012, where he was Vice President of European Government Affairs.

He has 20 years’ experience in the pharmaceutical industry, and has served as Vice President of Vaccines Europe and Chairman of biotechnology trade association EuropaBio.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said: “Andrea's expertise will boost Vaccines Europe’s advocacy focus whilst highlighting Sanofi Pasteur MSD’s profile as a clear leader in vaccines in Europe.”

Sanofi Pasteur MSD is an alliance between Sanofi Pasteur, the vaccines division of Sanofi, and MSD (Merck Sharp & Dohme), combining the R&D capability of both companies to focus exclusively on vaccines.

Abbott has completed the separation of its research-based pharmaceutical business as planned to form AbbVie, a new independent biopharmaceutical organisation.

The pharmaceutical company announced back in October 2011 its intention to fragment its research efforts away from its medical products company.

Chairman and Chief Executive Miles D. White (pictured) said Abbott had taken the “most transformative action in its 125-year history” by completing the separation.

AbbVie has taken on a selection of Abbott’s products and now boasts a broad portfolio of treatments in areas such as immunology, virology and breakthrough therapies.

Despite the split, Abbott says it will remain one of the largest science-based healthcare companies with annual global revenues of around $22 billion.

“We wish our colleagues at AbbVie continued success as they become part of a new, independent company that is already making a significant difference, focusing on highly specialised, market-leading therapies for some of the world's most difficult-to-treat diseases,” said Miles White.

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.

As Santa starts to think about who he is going to reward for good behaviour, it would seem appropriate for Pf to look at which pharma companies deserve the biggest slice of Christmas cake, what made them stand out during 2012 and the resolutions they have for the New Year.

There can be no denying it’s been another turbulent twelve months for the pharmaceutical industry. Job losses across the majority of departments, generic exposure on key products and failing pipelines have been enough to make bosses choke on their deep-filled mince pies and turn to the brandy butter.
Yet there are still plenty of gifts under the tree to get excited about. Last year’s survey found that pharmaceutical employees continue to get paid well above the national average. Meanwhile, fewer people are looking to move company compared to the year before and pharma reps have maintained a belief in company culture, despite major departmental reforms.

Here is a selection of the standout companies who defied the recession to top the Employer of Choice charts.

Abbott

Offering an open and supporting environment where employees can develop a career path across a diverse portfolio of businesses, Abbott sees the development of its people as “key to long-term commercial success”. The company boasts an “exceptional compensation and benefits package”, plus strong pipelines for all its businesses, from biologics and molecular drugs to medical devices.

After being voted one of the Best Multinational Workplaces in Europe by the Great Place to Work® Institute and listed in the Dow Jones Sustainability World Index for the seventh consecutive year, the company hopes to build on these successes in 2013. The company adds that “ethics and compliance will continue to underlie” everything it does to continue to improve access to treatment for patients across the globe.

Astellas

Size matters at Astellas. It says it is “small enough to be agile but big enough to make a difference.” This, coupled with a focused approach, has enabled it to achieve category leadership in urology and transplantation and a major presence in the anti-infective market. Collaboration between all team members and customers is “key to achieving success as outlined in our core values of teamwork, adaptability and mutual respect,” the company says. 

A recent company survey showed that almost 90% of employees were proud to work for Astellas and would recommend the company to a potential colleague. Astellas successfully implemented two patient information campaigns within the last 12 months to address dispensing errors in transplant medicine, enhance patient safety and to increase over-active bladder awareness through an extensive campaign. 

Boehringer Ingelheim

After recently celebrating 50 years of being in the UK, Boehringer Ingelheim went on to top the EoC rankings for the sixth year in a row. BI was also ranked one of the best companies to work for in the 2012 Sunday Times Top 100 ‘Best Companies’ survey. Using a culture of transparency and respect for individuals, it aims to “empower people and listen to their ideas”. An excellent standard of training is complemented by the emphasis being placed on personal development and improvement.

The company will now be focusing its efforts on ‘Painting BI’s Future’ – a strategic review in response to the changing environment. Recommendations are now being further developed through the initiative, with eight cross-divisional teams exploring how to make the recommendations a reality. Additionally, ‘Making more health’ is a global partnership with Ashoka focused on identifying and supporting innovative health solutions. 

LEO Pharma

LEO’s unique Foundation status allows it to be financially independent and means that decisions are based on “what is best for the business in order to build long-term growth”, it says. This also provides a platform from which to implement focused, long-term R&D programmes – 17% of global annual turnover is allocated to R&D, enabling LEO to make fast decisions and respond quickly to innovative ideas.

The company has enjoyed a successful 2012 with double-digit sales growth in its two focus areas – Dermatology and Thrombosis – plus continued US growth and a robust pipeline. A series of patient-centric initiatives have also been successful. Ambitious plans have recently been released outlining how LEO intends to build a global and patient-centric organisation designed to bring it even closer to patients around the world and better listen and respond to their challenges.  

Napp Pharmaceuticals Ltd

Napp has two key strengths that underpin its commercial success: its people and the culture they create. The company believes that everybody should have the “opportunity and responsibility to perform to the best of their abilities”, which ensures employees are supported to develop and have the opportunity to play an active role in planning for its future.

The Company has introduced Napp Account Selling, an approach to key
account management through which all departments work together to find innovative ways to support the NHS in achieving its goals whilst ensuring business sustainability. In 2012, it launched a new respiratory product, and is committed to becoming a long-term partner to the NHS in respiratory medicine, whilst maintaining its position as a leader in pain and continuing to grow its oncology business – focusing on treatments for patients with blood cancers.

Roche Products Ltd

Roche says its values – integrity, courage to reach beyond boundaries and passion for they do – allow its employees to “express themselves in an open and respectful environment”. Its evolving business creates numerous internal opportunities both locally and globally for staff. Highlighting the importance of collaboration, Roche uses feedback, knowledge sharing, debate and co-operation as the foundation of its performance culture. The result, it says, is “one of the most exciting and open-minded places to advance your career”. 

After celebrating more than a century of innovation, the company continues to carefully balance long-term investment decisions with near-term deliverables. Roche continues to improve motivation through instilling energy, creativity and passion into all of its staff pursuits. Expertise in the field and leadership are displayed through a host of cross-industry initiatives to address inequalities in access to medicines for eligible patients.

The Pf Company Perception, Motivation and Satisfaction Survey – which launches in January 2013 – gives key account managers and their colleagues a chance to air their opinions on the good, the bad and the ugly sides of the industry.

The Survey also includes the coveted Employer of Choice guide – where respondents get the opportunity to voice who they’d most like to work for – not including their own company, of course!

Abbott and its foundation have provided $1 million in funding and product donations to help the support effort following Hurricane Sandy in the US.

Grants will be provided to a host of relief organisations and product donations issued to food banks and clinics along the east coast of America.

John B Thomas, Vice President, Investor Relations and Public Affairs, Abbott, and President of the Abbott Fund, said the donations would “help communities recover in the days and weeks ahead.”

Organisations including the American Red Cross, AmeriCares, Direct Relief International and World Vets have all been provided with grants. Direct Relief International and Feeding America were provided with product donations to help support residents in New Jersey, New York, North Carolina, South Carolina and Virginia.

The pharma company also supplied disaster relief packs earlier this year containing nutritional and medical products and advice to coastal communities at high risk of hurricanes.

Abbott Laboratories has agreed to pay a total of $1.6bn to settle federal and state charges of off-label marketing regarding its anti-seizure drug Depakote.

The company admitted actively promoting the unlicensed use of Depakote in nursing homes to sedate dementia patients from 1998 to 2006.

The US Government alleges that Abbott exploited a loophole in the legislation protecting elderly patients from inappropriate medication.

Abbott will pay $800m to settle civil allegations, a $700m federal criminal fine and $100m in state level consumer protection fines.

Depakote is licensed by the FDA as a treatment for epilepsy, migraine and manic episodes.

Abbott has pleaded guilty to ‘misbranding’ the drug as a treatment to control agitation and aggression in elderly dementia patients.

From 1998, the company trained a special sales force to promote the off-label use of Depakote to nursing homes.

This promotion continued despite a 1999 clinical trial that showed the drug caused drowsiness, dehydration and anorexia in elderly patients.

Abbott’s marketing highlighted the fact that Depakote was not included in a list of medications banned in nursing homes under by a 1987 law.

Representing one of four ‘whistleblower’ Abbott sales representatives, attorney Reuben Guttman said: “Abbott directed its sales force to get Depakote widely used in nursing homes, principally to neutralise older patients as a substitute for proper staffing.”

Deputy US Attorney General James Cole commented: “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

Nestlé has won the battle to purchase Pfizer’s nutritional business for $11.85 billion.

The sale follows Pfizer’s decision to sell its nutrition and animal health divisions to focus and invest in its pharmaceutical business.

Ian Read, Pfizer CEO, says the deal with Nestlé is “consistent with Pfizer’s intention to generate the greatest value for shareholders”.

Analysts had previously predicted a deal would be in the region of $10bn for the division which generated sales of $2.4bn last year.

It’s expected Pfizer’s veterinary division will be generate a higher fee than the nutritional business after its revenue totalled $4.2 billion in 2011. Novartis has already reportedly had a $16bn offer rejected by the company with Bayer also allegedly hoping to secure an $18bn deal.

Industry analysts now predict the generated revenue from the sales of the two divisions may be used to fund future large scale acquisitions such as Bristol-Myers Squibb and the Abbott pharma spin-off.