Carwyn Jones

A new online market research service for pharmaceutical marketers has been launched by Doctors.net.uk, the largest and most active network of medical professionals in the UK.

The qualitative research service includes unique real-time interaction with medical professionals, group discussions and the ability to show visuals or videos.

The service from medeConnect Healthcare Insight, the market research division of Doctors.net.uk, has many advantages over the traditional focus group approach, not least its ability to achieve quick turnaround times and its cost-effectiveness, says the company.

The qualitative service has been developed in response to the growing challenge of getting detailed information from hard-to-reach, geographically diverse and increasingly time-constrained clinicians.

Carwyn Jones, Head of Pharma at Doctors.net.uk, said: “Clinicians are at the forefront of driving improvements in patient care, and gaining the best possible understanding of their opinions and the issues they face is critical. This new research tool will support the pharmaceutical industry in achieving change and driving forward new initiatives. It will also enable better measurement of the success of existing campaigns or programmes of activity.

Iain Findlay, Managing Director of medeConnect, added: “Given there are no geographical or time limitations to whom we can survey, we can secure the participation of doctors who would not take part in traditional research due to their distance from a central research location or time restrictions. As a result we can reach a wider and fresher sample of medical professionals and delve deeper into issues regarding patient care.”

The European Commission has approved Exforge HCT, which combines the efficacy of three widely prescribed blood pressure treatments in a single pill.

The Novartis treatment combines in a once-daily pill the efficacy of the angiotensin receptor blocker valsartan (Diovan), the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide (HCT).

“Novartis is committed to helping patients improve their treatment compliance. Simplified treatment regimens and reduced pill burdens have been shown to help achieve this,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. “We are pleased that with the approval of Exforge HCT, a new 3-in-1 treatment for high blood pressure is now available to patients in the EU. With Diovan as the foundation of this new therapy, we are confident that it will become an important new treatment option.”

In the EU, Exforge HCT is indicated for substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of valsartan, amlodipine and HCT, taken either as three single-component formulations or as a dual-component and a single-component formulation.

Nearly half of Europeans suffer from high blood pressure, and up to 85% of these patients may need multiple medications to help reach treatment goals. One recent large-scale study showed that approximately 75% of patients achieved their blood pressure treatment goal after switching to a single-pill combination therapy.

“It is not uncommon for patients with severe hypertension, or those requiring stricter blood pressure control, to need three or more medications,” said Professor Rainer Düsing, Faculty of Medicine, University of Bonn, Germany.

“Now that this new single-pill triple-combination option is available, appropriate patients may find it easier to comply with their prescribed treatment regimens involving a once-daily single pill versus multiple medications, especially if it has also been proven to be highly effective at helping patients reach their blood pressure goals.”

The CHMP has issued a positive opinion for Micardis (telmisartan) as the first treatment in its class to reduce the risk of cardiovascular (CV) morbidity in high CV risk patients.

The drug was recommended for patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer Ingelheim, commented: “We are delighted to receive this positive opinion from the CHMP. This is an important development that may help physicians ensure that patients receive appropriate treatment tailored to their individual needs. If approved, Micardis will offer a much needed alternative to ACE inhibitors.”

The US Food and Drugs Administration (FDA) has previously approved Micardis for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from CV causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors.

Cardiovascular disease (CVD) is responsible for nearly one in three deaths worldwide and is the number one cause of death.

Eli Lilly and GE Global Research have achieved a significant advancement in cancer research, which could enable faster drug development at less cost.

Through the companies’ collaboration formed in October 2007, Lilly and GE research teams have developed tissue-based biomarker technology that for the first time can simultaneously map more than 25 proteins in tumours at the sub-cellular level.

This represents an important step in the development of personalised and more effective cancer treatments.

Currently, a diagnosis of cancer and the decision of which therapy to prescribe are based on the histology of the tumour and, in some cases, the expression of just one or two biomarkers inside the patient’s tumour.

With the new molecular pathology technology, researchers can now look at a visual map of the tissue sample, seeing a cancer cell’s comprehensive biomarker signalling pathway, and the interplay of signalling networks inside the tumour. The new technology has been tested successfully on colon and prostate cancer tissue samples and is believed to be applicable to all types of cancer.

“This new approach to molecular pathology unlocks information that has been hidden from doctors,” said Mark Little, Senior Vice President and Director, GE Global Research. “It was just two years ago that researchers at GE and Lilly set out to discover key protein biomarkers that would predict the likelihood that a medication would be effective in treating certain cancers. Our new mapping technology is designed to bring new therapies to market faster and to make sure that the right patients get the right medicines.”

Mapping a tumour’s complex biomarker network could allow researchers involved in drug discovery and the clinicians making treatment decisions to identify the most effective cancer therapies for patients, while avoiding those that are not as effective, saving time, money and providing a better patient experience.

“In cancer treatment, information is one of the most powerful tools that a doctor has at his disposal,” explained Dr Richard Gaynor, Vice President, Cancer Research and Clinical Investigation, Lilly Research Laboratories. “By identifying multiple biomarkers on a cell by cell basis, physicians will be able to make more informed choices on therapies to prescribe, as well as therapies to avoid, based on a patient’s specific type of cancer.

“Additionally, we believe that GE’s technology, advanced as a result of this collaboration, may lead to the ability to identify the stem cells within a tumour that we believe control the cancer. In doing so, we may be able to discover even more innovative, targeted therapies for the treatment of patients with cancer.”

YouTube’s latest pharma phenomenon is an apocalyptic campaign that features a zombified sales representative and threatens the end of ‘big pharma’s’ current business model.

The five short films form part of an anonymous US-based social media campaign called Pharmageddon 2012.

The campaign claims to highlight the main issues facing pharma marketing at the moment and in the future, due to threat of patent expiries, reduced clinician access and FDA restrictions on the marketing of products.

The campaign website claims: “By 2012, the pharmaceutical industry will experience the biggest shift in product marketing history. No one is prepared. It’s going to be pharmageddon.”

The first film of the ‘Zombie Rep’ series shows a disastrous doctor appointment, after which the doctor threatens that he “won’t see reps any more”. The following films feature a ‘lunch and learn’ session, some unconvincing product data and a demonstration involving the game Operation – each resulting in the rep’s eviction from the premises.

The final film entitled ‘Desperation’ shows the Zombie Rep stalking his key customer in the practice toilets and even awaiting him in his car. The final caption asks: “Was this really his fault? Or something much bigger?”

Another series of films entitled ‘Marketer from the future’ show a former ‘big pharma’ brand manager in 2013 threatening “the end of the world as we know it,” and predicts that generic drugs will “run rampant” following the patent expiry of blockbuster drugs in 2012. The films call for better training for representatives on product data and criticise the industry’s focus on marketing to patients.

Other films by the elusive Pharmageddon include ‘Smileor-ex’, a spoof product advertisement in which the product is claimed to be “indicated for allergies and happiness” and a warning is given that it “may cause delusions of grandeur”.

For more information, see www.pharmageddon2012.com, follow the campaign on Twitter and Facebook or see the YouTube films.

Roche has launched its novel biologic RoActemra in the UK, despite a negative opinion from NICE that leaves the drug unavailable on the NHS, and has published new trial data.

RoActemra (tocilizumab), a new product targeting the IL-6 pathway, has shown promising efficacy data in clinical trials in line with current first-line biologic therapies targeting tumour necrosis factor (TNF), says Datamonitor.

However, on October 1 2009 NICE announced its preliminary decision not to recommend tocilizumab for moderate-to-severe active rheumatoid arthritis (RA) in the UK.

Cost-efficiency was cited as the key factor for the drug’s rejection. Roche’s cost-effectiveness evaluation for tocilizumab put it below the £30,000 per quality-adjusted life year limit set by NICE; but the agency found fault with a number of calculations, including the lack of long-term data and non-inclusion of the impact of adverse events in the economic model.

The committee recommended that Roche conduct a head-to-head trial of tocilizumab versus rituximab.

Roche’s new data show that RoActemra, in combination with methotrexate (MTX), inhibits progression of joint damage in 83% of RA patients after two years, compared to just 66% of patients treated with placebo + MTX.

“These positive data clearly show the benefit of using tocilizumab, known as RoActemra, over the long term,” said top UK rheumatologist Professor John Isaacs, Institute of Cellular Medicine, Newcastle University.

“It is an innovative and exciting therapy, and a valuable addition to the treatments available to combat rheumatoid arthritis. RA is a chronic disease that can ultimately lead to severe disability, and so preventing joint damage is a major goal of therapy and vital to help patients maintain normal physical function.”

Despite this, Datamonitor has predicted a poor start for RoActemra, pointing out that Orencia was not backed by NICE and sales of the drug have not reached $1m in the UK, compared to its direct competitor MabThera (rituximab), whose sales are estimated at $12m.

Tyverb has been rejected by NICE for breast cancer, despite the manufacturer’s efforts to comply with the new guidance on treatments for small patient populations with a short life expectancy.

NICE has issued an Appraisal Consultation Document (ACD) rejecting oral Tyverb (lapatinib) in combination with capecitabine for the treatment of an aggressive form of advanced breast cancer (ErbB2-positive).

The decision to reject lapatinib follows an appeal in July this year that the Appraisal Committee should re-consider lapatinib under the Institute’s end of life (EOL) supplementary guidance.

The EOL guidance was specifically developed to help small numbers of patients who have only a few months to live to gain access to important new medicines. Manufacturer GSK submitted additional data demonstrating that lapatinib met all three of the EOL criteria.

However, although NICE recognised that lapatinib met the EOL criteria, the Appraisal Committee felt that it was still not a cost-effective use of NHS resources.

Simon Jose, General Manager, GSK UK, commented: “NICE developed additional criteria specifically to help secure greater patient access to new treatments that offer precious extra time at the end of life. It is disappointing that, despite acknowledging Tyverb meets these criteria and GSK offering to bear the cost of lapatinib for up to 12 weeks, NICE is still proposing to reject lapatinib. We will continue to offer our patient access programme to individual NHS Trusts to ensure patients have access to Tyverb.”

Lapatinib is funded in 18 other European countries, for the treatment of women whose advanced breast cancer has returned despite treatment with standard chemotherapy regimes including intravenous Herceptin (trastuzumab).

Dr Alison Jones, Medical Oncologist at the University College London Hospital and the

Royal Free Hospital, commented: “I am disappointed for all the women who would have benefited from lapatinib on the NHS. I have witnessed myself that lapatinib can extend the lives of these women. We are now left with very few effective treatment options in cases where Herceptin has stopped working.”

The ABPI and children’s charity Kids Company are launching a new campaign to raise awareness of the neurophysiological consequences of child abuse, maltreatment and neglect.

The new fundraising project, Peace of Mind – one neuron at a time, will be launched at a neuroscience symposium on Thursday November 5 at the Kids Company HQ in London.

Dr Richard Barker, Director General of the ABPI, said: “The partnership between the pharmaceutical industry and Kids Company connects two previously separated worlds and is more than symbolic. The ABPI is encouraging its members to interact on many levels including mentoring schemes and workshops.”

The Peace of Mind campaign represents the Kids Company’s first full research programme in collaboration with specialist research institutions and independent clinical researchers.

Specifically, the work will research into the impact of trauma and neglect on young people’s neurophysiological and psychological functioning, as well as how effective Kids Company’s therapeutic interventions are in terms of improving the outcomes for vulnerable children. This will help Kids Company, and others, to develop therapies and training that can transform children’s lives.

The symposium is specifically targeted at clinical and medical directors, NHS commissioners and members of the youth justice sector. The event will feature guest speakers Baroness Susan Greenfield, Professor Peter Fonagy, Dr Richard Barker and Camila Batmanghelidjh.

Guests will be offered a private view of the unique web-hosted Peace of Mind virtual brain, composed of one million socially networkable ‘neurons’, available to purchase by the general public from February 2010.

Pramipexole, the world’s most widely prescribed dopamine agonist for the treatment of Parkinson’s disease (PD), is now available in the UK as a single 24-hour dose.

Boehringer-Ingelheim’s once-a-day formulation, Mirapexin, is indicated for the treatment of the signs and symptoms of idiopathic PD, used alone or in combination with levodopa.

Pramipexole has also been shown to significantly reduce depressive symptoms in patients with PD.

In clinical trials, Mirapexin Prolonged Release was superior to placebo in patients with early PD10 and had comparable efficacy to pramipexole immediate release (three times daily) at the same daily dose.

Professor Andrew Lees, University College London, commented: “By providing effective treatment of PD from a convenient once-daily regimen, Mirapexin prolonged release represents an important new therapy option for all types of PD patients.”

One of the key benefits of prolonged release formulations is improved adherence. Patients with PD are likely to be elderly and suffering from co-morbidities such as back problems, arthritis and hypertension. Such conditions may also require pharmacological treatment and many patients will be taking several medications at the same time, leading to a complex dosing schedule.

Actavis have launched a unique sugar-free formulation Flucloxacillin oral solution.

In addition to the sugar-free product, Actavis will continue to supply Flucloxacillin 125mg/5ml and 250mg/5ml sugared oral solution.

Jonathan Wilson, a Director at Actavis, said: “Flucoxacillin sugar-free oral solution is another excellent addition to our portfolio of products. This innovative product offers customers and patients a sugar-free option for a well-established molecule.”

To support the launch, Actavis is communicating with all UK general practitioners and pharmacists, PCTs and hospitals, and is running an awareness campaign with Chemist & Druggist.