A new first-in-class antibiotic has been recommended in the UK for treatment of severe Clostridium difficile infection (CDI).

New guidance from Public Health England recommends Dificlir (fidoxamicin) from Astellas for adults with severe CDI and high risk of recurrence, or for recurrent CDI.

This makes the drug available for those CDI patients who are at highest risk, including those with multiple conditions.

CDI, a bacterial infection, is predominantly hospital-acquired and is potentially fatal, with 27,000 cases in the UK each year leading to 3,000 deaths.

In clinical trials, Dificlir showed similar efficacy and safety to the current standard treatment, vancomycin, but more than halved the rate of recurrence.

Recurrence of CDI is the greatest problem encountered in treatment of the infection, occurring in up to 25% of patients within 30 days of treatment.

The NHS has identified CDI control as a key aspect of patient safety, with targets for reduction in cases that may be enforced by financial penalties.

The targets demand a reduction in CDI infections over 2013/2014 of 30% (on average) for acute trusts and 21% (on average) for CCGs.

Dr Simon Goldenberg, consultant microbiologist, said the new guidance was “a huge step forward in being able to improve the overall management of CDI,” offering a “very welcome” opportunity to “bring down rates of infection”.

Graziella Kontkowski, founder of the patient group C-diff Support, noted that while CDI rates have fallen in hospitals they have risen in the community. She described the new guidance as “good news for patients” that “will encourage a more rigorous approach to reducing both new and recurrent cases of the infection.”

We’re often plagued by the idea that somehow – perhaps in a different city, company or even civilisation – we could be reaching new, higher, dizzier heights. Especially when you see rival colleagues using the latest mobile, tablet devices or driving off into the sunset in that brand new hatchback – yes, the one with the heated seats you saw on Top Gear last month – and giving you an obscene salute as they do so.

But is there any definitive way of knowing if you’d be better off somewhere else? Of course, there are those generic online tools that give you the average salary of every Londoner under the age of 90. But they are probably not the best benchmarking tools to use when plucking up the courage to ask your boss for a pay rise, during one of those awkward appraisals. Although, there is another way.

The Pf Company Perception, Motivation and Satisfaction Survey – which is now in its 12th year – provides a comprehensive temperature check on the essential elements of everyday working life for those toiling away in the medical sales sector. It gives those working within the pharmaceutical industry in the UK the opportunity to have their say on what matters the most to them.

The Survey has now been completed by more than 14,000 medical sales professionals since it was first launched in 2001. It accurately portrays the views of the industry on important motivation and satisfaction factors such as remuneration, bonuses, work-life balance, job security and company culture. Pharmaceutical bosses can also see how long their staff actually spend on CRM systems whilst in the field and also discover whether employees have had their head turned by that eye-catching aqua blue sports car and are ready to jump ship.

Yet it’s not just pharmaceutical companies who bene t from the results. The Survey is a friend to all. Much like a Swiss army knife, it has various tools and attributes to help those who access it. It’s a pen knife one minute slashing dated contracts of employment then a bottle opener the next popping open the bubbly to celebrate an improved Employer of Choice ranking place.

The Employer of Choice

Another facet to the Survey is the coveted Employer of Choice rankings. Respondents are asked to choose the company they’d most like to work for within the industry – bar their own of course! ­The company chosen the most wins the Employer of Choice gong. Simple.

In recent years it’s been a two horse race for the EoC accolade. Boehringer Ingelheim and Roche have got toe-to-toe for the top spot since 2007. But it’s been Boehringer which has come out on top for the last six years as the company which is deemed to be the most desirable to work for within the industry. Nick Doe, Sales Director, BI, says the credit must be placed at the company’s skilled workforce for keeping the company in the prized top spot for so long. “It is a real credit to everyone in our field force, our managers and all at Boehringer Ingelheim who are dedicated to putting the patient at the centre of the everything we do.”

The Employee

One experienced key account manager – who wished to remained anonymous, from a medium-sized pharmaceutical company – used the salary comparison tool to negotiate an improved deal after finding out she was being paid less than her industry counterparts. “I was quite surprised actually when I first read in Pf that I was being paid less than other people doing my job in the industry. In fact, I always considered myself to be well paid for the job that I do. For that reason I’d never really explored what other KAMs with the same level of experience were on – especially as I’d been with my company for a few years. I just assumed we’d all be on around the same figure. However, when I read one of the articles on salary in Pf and realised I could be getting more money elsewhere I couldn’t just ignore that fact.

“I went to speak with my superior to discuss a pay rise and showed him the comparison with other key account managers with my level of experience and how much more money they were receiving compared to me. Discussing money is always a tricky subject but the facts and figures were there in black and white to support my case. Thankfully the matter was addressed pretty swiftly. I’m so glad I took part in the survey and read the survey articles. Without the Pf Survey results I’d still be underpaid and none the wiser.”

Anonymous Key Account Manager from a medium-sized pharmaceutical company: you’re welcome.

The Employer

€The results from the Survey may have seen certain pharma companies having to dig a little deeper into their pockets to ensure valued staffŠ members are kept happy and motivated. But the data resulting from the survey results is valued in other ways. It’s not only field-based employees who keep a keen eye on the main motivating factors which matter to respondents. Pharma companies use these to entice hot talent away from competitors and keep their own main players happy.

When employees at Astellas raised concerns around a recent change to the car policy one year, the survey witnessed the biggest ever shift in one parameter when it acted upon the suggestions of staŠff and improved its company car scheme. Astellas wasn’t the only pharma company to listen to its staffŠ after the survey results were published.

Lundbeck UK calls upon its staffŠ to voice opinions on important decisions – a move which has seen them outscore industry rivals in a number of parameters. “€The scores that we have had for the latest survey results are significantly higher than that of our industry colleagues,” Helen Carberry, Lundbeck UK Head of Human Resources and Development said.

“We consistently outperform in the industry averages. Ratings for ‘belief in products’ is really strong and that is our highest satisfactory score. Also, for ‘company culture’ we are almost double the score across the industry in that parameter,” Helen added.

Yet these top-of-the-table rankings have not come about by chance, as explained by Helen. “We do have a real focus on people here at Lundbeck UK,” she said. “It’s something which is important to us because that is ultimately how we achieve our results. We have high levels of loyalty and commitment within the organisation, and our own internal satisfaction survey highlights that.

“In terms of our strategy, there are three pillars which support everything that we do. One of those pillars is being great place to work. We set out this year, very much like the 12 months prior to that, that our focus is on delivering excellent results, delivering value to customers, whilst also being a great place to work. As part of that, developing people and living our culture are the two main foundations which support that strategic pillar of being a great place to work. People are really, really important to us.”

This was re™flected as Lundbeck UK was awarded the Best Companies One Star Accreditation in 2012. € The company now aims to build on the success of its survey results as it adapts to the changing market place in the UK. “We are a lean organisation, which means we are very, very ™ exible. We have developed a structure that can be either built on as and when new products come through or simply added to over time. Lundbeck UK can only go from strength to strength.”

€The 2013 Company Perception, Motivation and Satisfaction Survey can now be completed at www.pharmasurvey.co.uk. It is managed by Dr B Payne of Conker Statistics (a fellow of the Royal Statistical Society) and provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment. Confidentiality is of paramount importance and your anonymity is therefore guaranteed. It takes only minutes to have your say at pharmasurvey.co.uk.

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.

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!

Astellas Pharma Europe has chosen an English site to house its new UK and European headquarters.

Offices in Chertsey, Surrey, have been picked by the Japanese pharmaceutical company, which has called its decision an act of faith in the British economy.

Ken Jones (pictured), President and Chief Executive of Astellas Pharma Europe, said the site shows “the confidence” the company has in the UK and it “marks a new chapter” for the organisation.

The firm was previously based in smaller offices in Staines, which employed several hundred people.

The move comes at a time when Astellas said it is now actively employing more staff and hopes to fill the site within the next five years. The company also revealed it is planning to launch ten new products in Europe by 2017.

“Astellas has long been out-performing the market and whilst bigger pharma firms are seeing their revenue shrink from patent expiries, we are seeing ours grow with new products and new areas of interest,” said Ken Jones.

“The UK is in tough times much like the rest of Europe, but we are working hard to get through adversity via innovation.”

The new HQ will be focused on sales and marketing for the company’s key disease areas in urology and transplantation medicines, and its future focus on oncology.

NICE has launched its new medicines advice service to provide “high quality” evidence to the NHS and patients in England on the latest treatments or those with new or updated indications.

The summaries do not constitute formal guidance but aim to support the managed introduction of new drugs for commissioners, budget holders and groups such as prescribing committees.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said the summaries “take the process a step beyond the regulatory requirements” for new treatments to be prescribed.

Summaries are produced by NICE’s Medicines and Prescribing Centre, who expect to publish advice on up to 20 new medicines annually.

Medicines will be considered for summary either at the point of product launch, or up to 12 months in advance of being launched.

Astellas’ Dificlir (fidaxomicin) for the treatment of Clostridium difficile infection (CDI) is the first medication covered as part of the new service. Dificlir is the first in a new class of macrocylic antibiotics recently licensed by the EMA for CDI.

The evidence summary concludes that Dificlir, based on evidence from two randomised controlled trials, is non-inferior to vancomycin in curing patients with mild to severe CDI. Also, its side-effect profile appears similar to that of oral vancomycin and may have advantages in reducing the rate of recurrence.

A new antibiotic to treat C. difficile infection (CDI) has been approved for restricted use by the Scottish Medicines Consortium (SMC).

Dificlir (fidoxamicin) from Astellas Pharma is accepted within NHS Scotland for treatment of adults with a first CDI recurrence on the advice of a specialist.

SMC declined to approve the drug for first-line use in adults with severe CDI.

The decision was based on clinical trial data showing Dificlir to be similar in efficacy to vancomycin (the standard treatment) as a first-line therapy for CDI, but twice as effective in treating recurrent CDI.

CDI is a serious healthcare-acquired infection often linked to use of broad-spectrum antibiotics. It increases hospital stays by three days and treatment costs by 50% on average, with complications including bowel surgery.

In Scotland, which has suffered a number of CDI outbreaks, the disease affects over 2,000 people each year, costing over £2m and causing death in 10% of cases.

Dificlir is an oral medication that acts locally on C. difficile bacteria in the gut, blocking their metabolism and reducing the growth of the infection.

Professor Robert Masterton, Director of the Institute of Healthcare Associated Infection at the University of the West of Scotland, said: “With the increasing elderly population the threat of further CDI outbreaks cannot be ignored. It is important that we employ all possible measures to contain this disease. Widespread and early access to the new antibiotic fidaxomicin will, I believe, make a real difference.”

An Astellas spokesperson said the company would continue to gather data to support the use of Dificlir as a first-line CDI therapy.

Astellas’ Dificlir (fidaxomicin), the first new treatment of the hospital super-bug Clostridium difficile infection (CDI) in 50 years, has been launched in the UK.

Dificlir is a first in class antibiotic which Astellas claims halves the rate of recurrence in patients with CDI compared to existing treatment options.

Professor Robert Masterton, Director of the Institute of Healthcare Associated Infection at the University of the West of Scotland, has “high hopes” the treatment will “provide a significant benefit to patients in the UK”.

CDI affects approximately 27,000 people in the UK every year. It costs the NHS an estimated £270m annually to treat the infection.

Recurrence of CDI occurs in up to a quarter of patients within 30 days of initial treatment with existing options.

According to Astellas, clinical trial data showed Dificlir to have a higher clinical cure rate compared to the standard option of care, vancomycin, in patients taking other antibiotics.

The clinical cure rate for patients receiving concomitant antibiotics who received Dificlir was 90.0% compared to 79.4% for patients taking vancomycin.

Also, in those receiving concomitant antibiotics during treatment and/or follow up, treatment with Dificlir compared with vancomycin was associated with 12.3% fewer recurrences.

Graziella Kontkowski, Founder of the C-diff Support patient organisation, said the treatment was a “breakthrough for patients” with CDI but “even more so for those suffering recurrences of the infection.”

Astellas’ oral antibiotic Dificlir may help to treat C. difficile infections (CDI) in cancer patients receiving chemotherapy, according to new studies.

Dificlir (fidaxomycin) may offer this patient group better prospects of clinical cure and sustained clinical cure with less risk of recurrence than vancomycin, the current standard treatment for CDI.

Cancer patients are particularly at risk of CDI due to their long hospital stays and the negative impact of chemotherapy on immunity.

A recent phase III trial showed Dificlir to be more effective than vancomycin in preventing recurrence of CDI, a major issue in treatment of the dangerous ‘superbug’.

Post-hoc analysis of data from that and another trial focused on 183 patients with CDI who had a current diagnosis of cancer. This sub-group showed higher rates of clinical cure (97.3% versus 87.5%) and sustained clinical cure (83.6% versus 61.3%) as well as reduced rates of recurrence (14.1% versus 30.0%) when treated with Dificlir rather than vancomycin.

Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne, Germany, commented: “Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling pre-existing conditions. Treatment options that reduce the burden of CDI, and in particular recurrence, will allow clinicians to focus their efforts on treating the cancer.”

“Results from key Phase III trials and the post-hoc analysis demonstrate the effectiveness of Dificlir as a novel and effective treatment in patients with CDI, but also in high-risk populations, such as patients with cancer,” said Ken Jones, CEO of Astellas Pharma Europe.

Dificlir, first developed by Optimer Pharmaceuticals, is exclusively licensed to Astellas Pharma Europe for development and commercialisation in Europe.

UK-based Astellas Pharma Europe is a subsidiary of Tokyo-based company Astellas Pharma.

Astellas’ oral antibiotic Dificlir offers potential benefits over the standard treatment for C. difficile infection (CDI), according to a new phase III study.

Dificlir (fidaxomicin), which gained EC approval in December 2011, shows a lower rate of recurrence and better sustained response than vancomycin, the current standard of care.

The new treatment has potential to address the growing problem of recurrent and persistent CDI in hospitals and care homes.

Recurrence of CDI occurs in up to 25% of patients within a month of treatment and is the most serious problem in treatment of the disease, according to the European Society of Clinical Microbiology and Infectious Diseases.

In the phase III trial Study OPT-80-004, 5089 adults with CDI in seven European countries and North America received oral Dificlir or oral vancomycin for 10 days.

The results over 30 days showed that Dificlir achieved a lower level of CDI recurrence (12.7% versus 26.9%) and a better level of sustained response or clinical cure without recurrence (76.6% versus 63.4%) than vancomycin.

Professor Oliver Cornely, Medical Director of the Clinical Trial Centre at the University of Cologne, Germany, said: “The high percentage of patients experiencing CDI recurrence remains one of the biggest barriers to improving the management of this severe and sometimes life-threatening condition.

“In this study, Dificlir significantly reduced disease recurrence compared to vancomycin, the current standard of care, showing real promise as an effective treatment alternative for patients with CDI.”

Ken Jones, President and CEO of Astellas Pharma Europe, said: “The results of this study reinforce the strong data we have already seen for Dificlir and support its position as a new and exciting treatment option for CDI.”

Dificlir, first developed by Optimer Pharmaceuticals, is exclusively licensed to Astellas Pharma Europe for development and commercialisation in Europe.

UK-based Astellas Pharma Europe Ltd is a European subsidiary of Tokyo-based company Astellas Pharma Inc.