Safety of anti-depressants challenged

by JoelLane 30. April 2012 17:07

Pf product news Prozac and other blockbuster antidepressants have harmful long-term side-effects, according to a Canadian study.

Increasing serotonin levels may elevate mood, the researchers said, but it also interferes with growth, circulation and digestion and can cause strokes.

The study, the first whole-body audit of SSRIs, questions the cost-benefit analysis underlying best-selling brands such as Prozac.

Researchers at McMaster University, Ontario, studied the impact of elevated serotonin levels on all the body processes regulated by the hormone. They found that SSRIs had a range of negative long-term effects:

• developmental problems in young children

• sexual dysfunction and infertility in adults

• severe digestive problems such as IBS

• higher risk of stroke in the elderly.

With regard to the last of these, three studies have indicated that elderly anti-depressant users are more likely to suffer fatal strokes than non-users.

The study authors concluded that the classic argument in favour of SSRI use that it corrects a ‘chemical imbalance’ is false and dangerous.

Paul Andrews, evolutionary biologist and lead study author, commented: “We need to be much more cautious about the widespread use of these drugs. Millions of people are prescribed anti-depressants each year, and the conventional wisdom about these drugs is that they’re safe and effective.”

He emphasised that the evidence of harmful side-effects has been available for a long time, but has been ignored because of the persuasive impact of the ‘chemical imbalance’ model.

“The thing that’s been missing in the debates about anti-depressants is an overall assessment of all these negative effects relative to their potential beneficial effects,” he noted. “Most of this evidence has been out there for years and nobody has been looking at this basic issue.”

A previous study by Andrews and his team had found that SSRIs did not have lasting positive psychological effects: after the cessation of medication there was a strong tendency to relapse.

This finding led to a BMJ article’s statement that SSRIs did not correct any ‘imbalance’, but only created a drug-induced state within which the symptoms of depression were masked.

Featured article: The double act

by IainBate 30. April 2012 15:31

There’s never been a greater need to impress customers and make them understand the value pharmaceutical companies offer. Following on from his article on the concept of mass customisation, Apodi’s Tony Swift discusses how this theory can also be applied to two customer segments: the patient and the GP.

The double act - Pharmaceutical Field With the reduced number of blockbuster products entering the market, many sales and marketing departments are tasked with gaining market share for products and services that may have similar characteristics to competitor products. These departments are skilled at identifying traditional routes to market with the result that the promotional strategies deployed are often quite similar from one company to the next. The only real differentiator may be how much budget each company is willing to allocate to support respective products.

However, some companies are starting to implement mass customisation strategies, because as Jack Welch, former CEO of General Electric stated: “We have only two sources of competitive advantage: 1) The ability to learn more about our customers faster than the competition, and 2) The ability to turn that learning into action faster than the competition”. These companies are focusing on identifying what value means to each individual customer, collating that information effectively and delivering the value in an efficient and economic way.

The patient

Traditionally, pharmaceutical companies have focused on engaging with GPs and other payer stakeholders rather than on building relationships with the end user – the patient. However, companies are realising that engaging with patients can lead to improved adherence results, better compliance and more appropriate use of their product. The attempts to engage with patients vary in levels of sophistication. At a basic level, companies are investing in digital IT platforms where websites attempt to inform patients about the therapy area and the products available. These sites might also attempt to improve adherence through reminder systems such as emails and texts to encourage compliance.

More sophisticated solutions now aim to identify key characteristics of patients and their behaviour and to customise the offering to them. For example, by identifying why a particular type of patient fails to adhere, the offering can be customised to that patient. By having a clear understanding of why people fail to comply, a company can then identify groups of patients whose reasons for non-compliance are very similar – i.e. one group responds better to online health monitoring, another to reminder systems, another to better education etc. As a result, each individual patient is allocated to a group and the adherence offering is then customised to each group.

Successful implementation of adherence programmes which include customised solutions to patients is still quite rare. The reasons for this may differ. However, I believe it all starts with the product-centred cultures that are prevalent in many companies. Historically, companies have been focussed on winning market share and new customers. Whilst this, of course, still remains important, many companies now have to focus on customer retention, customer loyalty and customer satisfaction. Where this strategy is in its infancy, many companies look to IT for salvation – if only it were that simple! Customer Relationship Management (CRM) is more than deploying similar marketing techniques and new information technology. It needs new skills, systems, processes, behaviours – in fact, a CHANGE IN CULTURE. This can only be driven by the leadership of the business once it has decided that CRM and mass customisation are a strategic imperative.

This new strategy, if executed effectively, can lead to a range of new tactical initiatives in the area of patient adherence, such as improved technology, clinician-based call centres, education programmes, patient acquisition programmes, patient service programmes and so on. With the appropriate systems and processes, these initiatives can be developed to provide real customised value to patients.

The GP

Because pharmaceutical companies have been engaging with GPs for many years, mass customisation programmes aimed at GPs rather than patients should be easier to deliver. They know where GPs are, often know them personally and still have access to many – although the ability to engage is declining quickly.
Currently, however, successful customisation programmes aimed at GPs are few and far between. The reasons are similar to those above and result from the product-centred nature of most pharmaceutical companies. This product-centred approach can impact on the daily life of GPs in numerous ways, including:

  • The traditional detail deployed by many sales representatives when visiting GPs.
  • The practices, processes and systems that define ‘sales excellence’ in the industry.

An example of this is a detailed follow up I reviewed recently for a company. This was an extremely professional piece of work that identified the impact of the visits of a sales force on GPs. Multiple questions were asked about the ability of the representative to convey the product’s characteristics and benefits – and from this point of view the exercise was worthwhile.

However, there were few questions based around what value each visit had created for individual GPs. The assessment was almost solely based on the product and what was important to the company, rather than what value could be created for the customer both now and in the future.

For companies wishing to deploy VALUE-BASED MASS CUSTOMISATION, the following key initial steps could prove useful. These steps would run alongside more product-focused activities, not replace them.

  1. Build a structure based on Customer Account Managers driving key messages and value to targeted healthcare professionals.
  2. Develop a segmentation strategy for identifying segments of GPs based on value characteristics.
  3. In each interaction with GPs, identify what value characteristics are important and allocate to a segment – commit to developing a mutual LEARNING RELATIONSHIP where knowledge of the therapy area, product and patient outcomes are paramount.
  4. Access IT systems where the value identified can be saved and distributed to key management and marketing professionals – some existing CRM systems can be customised to make this happen.
  5. Develop value solutions that can be quickly deployed to individual GPs – these can include additional services, product support, access to Key Opinion Leaders, clinician staff training, and services that improve the patient experience.

The role of IT

IT has a vital role in the development of value-based mass customisation strategies. I recently spoke to an expert in the industry, Charles Roots of Actis Sales Technologies, who explained that:

  • Successful implementation of CRM projects needs input from senior management, IT departments and marketing departments. Technology implementation must be aligned with the business strategy and, in the area of mass customisation, with the whole initiative of providing value to customers one at a time. If only one of the above parties is included in the implementation process, the strategic benefits that could be obtained often fail to materialise
  • Some organisations believe that installing technology is the determining step in the drive to a more customer and value-focused organisation. However, it is clear that truly successful companies understand that the process begins with a strategy to transform the company from a traditional selling organisation to an organisation where delivering value and developing learning relationships comes first. In these companies, IT becomes a very powerful enabler of business strategy.

Conclusion

Many commentators have noted that the pharmaceutical industry is at a crossroads. With fewer blockbusters, governments facing huge financial challenges and health services looking for more value for money from all suppliers, times are hard. This is causing difficulties in the marketplace and many people have lost jobs in the resulting turmoil. Company leaders are under pressure to maintain and increase profitability and restructuring is increasingly common.

And yet comparatively, healthcare budgets are being protected and there has never been a greater need for a positive contribution from the pharmaceutical industry. Despite the distrust that has arisen between the industry and the NHS, enlightened leaders from both parties understand how a partnership between the two is of critical importance.

Whilst researching for this series of articles, it has become clear to me that this partnership can only prosper if the industry is willing to, and be allowed to, engage with the NHS in a positive and economically viable way. I believe pharmaceutical companies should play their part by focusing on delivering real value to all key stakeholders, including patients, GPs and other payer stakeholders. That is not to say this is absent in the industry, but there is no doubt that more can be done.

For those companies embarking on such a journey, the impact on customers (NHS and patients) could be dramatic. But it will also benefit employees of such companies. The vast majority of people want to do something worthwhile and being able to see how their work creates value for the customer and improves patient outcomes is just about as rewarding as it gets.

Tony Swift is the Managing Director of Apodi. He may be reached on tony.swift@apodi.co.uk.

Charles Roots is the Managing Director of Actis Sales Technologies. He may be reached on charles.roots@actisst.com.

Array BioPharma appoints new CEO

by JoelLane 30. April 2012 15:15

Ron_Squarer_CEO_Array_Biopharma (resized) US company Array BioPharma Inc. has appointed Ron Squarer as CEO.

Ron Squarer’s 20-year career in the pharmaceutical industry has included a range of commercial, development and leadership roles

The appointment reflects Array’s ambitions as a developer of targeted drugs for cancer and inflammatory disorders.

Squarer, 45, joins Array from Hospira, where he was Chief Commercial Officer after being Senior VP, Global Marketing and Corporate Development. He was previously Senior VP, Global Corporate and Business Development, at oncology specialist Mayne Pharma, acquired by Hospira in 2007.

Earlier, he held senior management positions at Pfizer and SmithKline Beecham (now GSK).

“I am delighted to join Array, a recognised leader in small molecule drug development,” commented Ron Squarer. “Array is an exceptional company with 10 Array-invented drugs in phase 2, as well as outstanding people, a strong cash position and uniquely productive discovery and development capabilities.”

Kyle Lefkoff, Executive Chairman of Array, said: “Ron’s appointment is the culmination of the Board’s comprehensive selection process to identify the best executive to lead Array to the registration and commercialisation of our oncology and inflammation portfolio.”

Jazz agrees $700m EUSA deal

by IainBate 30. April 2012 15:10

Pharma Industry News

Jazz Pharmaceuticals has entered into a definitive agreement to acquire EUSA Pharma for a deal which could be worth up to $700m.

The deal will see Jazz pay $650m in cash plus a further potential $50m if EUSA’s lead product Erwinaze (asparaginase Erwinia chrysanthemi) achieves US sales targets next year.

Bruce Cozadd, Chairman and CEO of Jazz, said that EUSA is a “compelling strategic fit” and the deal expands the company’s “global footprint and marketed product portfolio”.

The acquisition will provide the biopharmaceutical company with an expanded product portfolio of specialty pharmaceutical products and an enhanced commercial platform.

EUSA, founded in 2006, currently has a portfolio which includes ten oncology, critical care and oncology supportive care products currently marketed directly in the US and Europe and via distributors in other countries.

It is headquartered in the US and UK with approximately 180 employees and has operations in the US at Pennsylvania, in the UK at Oxford and in Lyon, France.

Its lead product Erwinaze is a life-saving treatment for patients with acute lymphoblastic leukaemia (ALL).

“The combination of Jazz Pharmaceuticals and EUSA Pharma would bring together two highly successful businesses, with teams who are passionate about providing patients with access to vital specialty therapies,” said Bryan Morton, founder, President and CEO of EUSA Pharma.

“There is a strong fit between our two companies’ products, people and values, and the combination would represent a positive transaction for the patients we serve, our collective employees and our shareholders.”

The proposed acquisition has been approved by both boards of directors and is now subject to satisfaction of customary closing conditions and regulatory approvals.

NHS priority is to devolve commissioning power, Lansley says

by JoelLane 30. April 2012 14:57

Professor Malcolm Grant The NHS Commissioning Board will make the devolution of commissioning power to the CCGs its first priority, according to Health Secretary Andrew Lansley.

The Board will focus on making a “shift of power from national and regional organisations to CCGs, Health and Wellbeing Boards, local providers and patients,” Lansley said in a letter to Board chairman Malcolm Grant (pictured).

The statement has reassured supporters of the NHS reforms that the NHS Commissioning Board will not seek to centralise commissioning power.

The accumulation of powers by the national authority had been widely criticised as running counter to the principle of locally-based commissioning.

Lansley listed the Board’s responsibilities, starting with the transference of power to local organisations.

He went on to list its other priorities as establishing the commissioning landscape, developing specific commissioning and financial management capabilities, and developing “excellent relationships”.

His letter also said that as many CCGs as possible should be authorised without conditions by April 2013.

Malcolm Grant commented to the Health Service Journal that the Board’s task was to create a “transformatively different” NHS while implementing the QIPP agenda – which, he said, would be “a long process of really hard work”.

He also noted that “very close to 100%” of CCGs would be authorised by April 2013, though subject to varying conditions according to their capability.

Finally, he observed that the impending culture change in the NHS means even if some current NHS managers stay in their current roles, “it doesn’t necessarily follow they will behave in the same way.”

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Novo to appoint new chairman in 2013

by IainBate 30. April 2012 13:57

Pharma Appointment Novo Nordisk expects to appoint Dr Göran Ando as its new chairman next year after its existing chair Sten Scheibye was elected to the board of the Novo Nordisk Foundation.

Mr Scheibye is expected to become Chairman of the Foundation’s board in 2013 and has since become a non-independent director of the Novo Nordisk board.

The outgoing chair said Dr Ando has “impressed all of us with his expertise and insights” since he joined the leadership committee in 2005.

The experienced Dr Ando has been re-elected to Novo’s board of directors several times, most recently this year, during his seven year stay on the committee.

The 63-year-old has previously held senior positions at Pharmacia, now Pfizer, and at Glaxo. He has served as Vice Chairman of the Board since 2006.

“I am very pleased that Göran Ando is prepared to take over the chair in 2013 and thereby ensure a smooth transition,” said Sten Scheibye.

Sten Scheibye was first elected to the Novo board in 2003. He became vice chair a year later and was appointed Chairman in 2006.

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Appointments

Video: Genzyme drives Sanofi Q1 results

by IainBate 30. April 2012 12:10

An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Jérôme Contamine, Executive Vice President, Chief Financial Officer discusses the Q1 results.

Jérôme Contamine discusses Sanofi's Q1 figures

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News

Genzyme drives Sanofi Q1 results

by IainBate 30. April 2012 12:01

Pharma Industry News An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Christopher Viehbacher, Sanofi CEO, said the “strong performance” in the first quarter was “driven by Genzyme, our growth platforms, and cost savings”.

However, Sanofi still expects profits to be down by around 12% to 15% on last year’s figures as a result of generic exposure of major brands.

Overall sales were up 7% compared to the same period last year after revenue in emerging markets increased by nearly a tenth (9.9%), and its pharmaceuticals division was boosted by increased sales in its diabetes and oncology businesses.

First quarter sales in pharmaceuticals reached €7.3bn, an increase of 8.8%, driven by the performance of diabetes drug Lantus which saw sales rise 17.2% to €1.1bn. But generic competition on Plavix, Lovenox and Taxotere hit sales, despite increased demand for Apidra, Eloxatin and Jevtana.

The ‘new Genzyme’ recorded sales of €400m in Q1 – up by 13.7%. Sales of Fabrazyme were up by half to €47m, with Cerezyme up by 5.8% to €149m and sales of Myozyme/Lumizyme also increasing by 17% to €112m.

Sanofi’s own generics business generated an increase of sales after the recent launch of the authorised generic Lovenox saw revenue grow by 6.5% to €439m.

Vaccine sales were down slightly (0.2%) to €617m after the delayed timing of supply of flu vaccines in the Southern Hemisphere. However, the news was better for Sanofi’s consumer health division as it achieved record sales of €805m.

New erectile dysfunction drug gains FDA approval

by JoelLane 30. April 2012 11:41

Pf product news A new, more rapid-acting erectile dysfunction (ED) drug that is currently being assessed by the EMA has gained FDA approval.

Stendra (avanafil) from Vivus can take effect within 15 minutes, phase 3 clinical trials with over 1350 patients have shown.

The newest addition to the class of ED drugs that includes Viagra, Levitra and Cialis, Stendra is targeted more at patients who engage in casual sex.

The FDA approval is the first gained by US company Vivus, which has licensed the US marketing rights to Stendra from Mitsubishi Tanabe Pharma of Japan.

Stendra will be available in three doses, all of which have been shown to provide statistically significant improvements in erectile and sexual function.

Like other phosphodiesterase type 5 (PDE5) inhibitors, Stendra improves penile blood flow – but it offers a faster action than its rivals.

The drug’s side-effects are characteristic of PDE5 inhibitors: headache, flushing and cold symptoms. However, Stendra clears the body more rapidly than other drugs in its class.

Dr. Ira Sharlip, Professor of Urology UC San Francisco, commented: “Quick onset of action is important to men.” He noted that Stendra was likely to appeal most to ED sufferers “whose opportunities for sexual activity are more casual”.

A marketing authorisation application for Stendra was accepted by the European Medicines Agency (EMA) on March 26.
“The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED,” said Francesco Montorsi, Director of the Urology Research Institute in Milan, Italy.

“The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market.”

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