The US government thinks pharmaceutical sales reps are not selling, but rather promoting. Maxine Vaccine asks whether the pharma industry could do itself a favour by agreeing.

It’s a hard life being a pharma industry CEO. There you are being passionate about improving patient outcomes and helping the weak and the wounded, and people look at you like you’re just in it for the profit. Don’t they realise those million-dollar bonuses are to compensate you for the sleepless nights you experience every time you make a few thousand people redundant? Can’t anyone feel your pain?

Then there is the emotional stress of a hostile takeover. Sometimes these little no-mark biotech companies just don’t know what’s good for them. And in the interest of those patient outcomes you feel passionately about, you have to show them the error of their ways by appealing directly to their shareholders to let you take over and take care of business. And are they grateful?

And then, just to add insult to injury, the interfering US government tells you that you should be paying your sales reps overtime because – wait for it – they’re not really selling at all. Outside salesmen are exempt from the US labour laws on overtime, because they get commission. But suddenly all your reps are claiming back pay for the ‘overtime’ they have spent schmoozing customers, talking trash on the phone and burning rubber on the highway – and the Labor Department is backing them up, saying they spend their working lives promoting products rather than selling them.

Hence the amusing exchange in the US Supreme Court where GSK’s lawyer said the plaintiffs were “two pharmaceutical sales representatives”. He clarified the point: “They were hired for a sales job. They were given sales training. They attend sales conferences. They are assigned to sales territory, and they are evaluated and compensated as salespeople.”

One of the court justices replied: “And they don’t do sales. Your long list sort of stopped one step short. They don’t make sales.”

Then another justice struck back with “They look like sales representatives to me.” We can be thankful she didn’t go into too much detail on that. I still have nightmares about the hotel bar at my first sales conference.

Rather cutely, she added that the work of drug sales representatives “includes dinners. Entertainment. Maybe golf. If you’re right, would the time on the golf course get time and a half?”

Enough already. It makes you want to move to a country where businessmen run the government instead of the other way round. Like the UK.

But every challenge is an opportunity, as you’ve told your board of directors a thousand times. And in this distinction between the salesman who exchanges goods for cash and the ‘detailer’ who influences purchasers to request your company’s products from a local pharmacy (or a not so local one, perhaps one thousands of miles away – but let’s not go there), there is a precious nugget of commercial insight for the 21^st century.

Your sales force do not sell. They manage key accounts. They access changing markets. They build partnerships with economic prescribers and healthcare managers. They build customised solutions. They position your company as a consultative partner in the provision of care.

Until it comes to pay day. Then they’re just jumped-up till girls and till boys with a few corporate perks. What do they expect?

The industry’s sales model has changed.

Has it?

Maxine’s views are not necessarily those of Pharmaceutical Field.

Former sales representative Alex Gorsky has been announced as the new Chief Executive Officer of Johnson and Johnson.

Mr Gorsky, who will start his new role on 26^th April, succeeds Bill Weldon, who has served as Chairman and CEO since 2002.

The outgoing CEO, who will remain as chair of the board, says the future of the company is now in “very capable hands”.

The new CEO began his career with J&J as a sales representative in 1988 with Janssen Pharmaceutica. He then progressed to positions of increased responsibility and was appointed President of Janssen in 2001 and then Company Group Chairman of J&J’s pharmaceuticals business in Europe, the Middle East and Asia two years later.

He briefly left the company to join Novartis in 2004, but returned four years later as Company Group Chairman and Worldwide Franchise Chairman for Ethicon in the medical devices business. In 2009, he was appointed Worldwide Chairman of the Surgical Care Group and to J&J’s Executive Committee. In January 2011, he was appointed Vice Chairman of the Executive Committee.

In his new role he will assume full management responsibilities for Johnson & Johnson and will also join the company’s Board of Directors.

Sheri McCoy, as Vice Chairman of the Executive Committee, will now report to Mr Gorsky when he assumes the role of CEO. She will continue to lead the Pharmaceuticals and Consumer Groups, and maintain responsibility for Information Technology.

“Our success at developing outstanding leaders from within is reflected in the selection of Alex to lead our great company forward,” said Bill Weldon. “Alex and Sheri are two extraordinary leaders.”

Pfizer’s Board of Directors has elected current President and CEO Ian Read as its new Chairman and Chief Executive Office with immediate effect.

Mr Read succeeds George Lorch in the role, who himself has been named as the Lead Independent Director of the Board.

A “deeply honoured” Mr Read thanked Mr Lorch for his services as chairman saying he had been a “valuable resource and advisor”.

“Working alongside Pfizer’s dedicated leaders and talented workforce, I remain confident in the strength of our business and of our late-stage pipeline,” said the new chair. “I believe in the future of this company and of our continued ability to deliver value to shareholders and to improve the global health and well-being of people around the world.”

In addition to Mr Read’s election, Marc Tessier-Lavigne and Helen Hobbs have also been promoted to the company’s board. However, Dr Michael Brown, a director since 1996, has notified the board of his intention to retire from his position in April 2012.

“We are pleased to welcome these two preeminent scientists to Pfizer’s Board of Directors,” said Mr Read. “Dr Tessier-Lavigne and Dr Hobbs have made extraordinary scientific contributions throughout their respective careers and will be tremendous assets to the company. The expansion of our board helps ensure that Pfizer will continue to benefit from a diversity of experience.

“We’d like to thank Dr. Brown for his service on the board and dedication to Pfizer over the past 16 years. His expertise and counsel on scientific matters in particular throughout his tenure have been invaluable to the company.”

Biopharmaceutical company Genzyme, part of Sanofi, has appointed William ‘Bill’ Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.

These two businesses make up Genzyme’s core focus following its integration with Sanofi.

David Meeker, Genzyme’s President and CEO, commented: “These appointments are a critical step in launching the new Genzyme. Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Bill Sibold has worked in the biopharmaceutical industry for two decades, primarily in commercial roles – including responsibility for the MS drugs Avonex and Tysabri. In eight years at Biogen Idec he rose to become Senior Vice President of US Commercial. He joins Genzyme from Avanir Pharmaceuticals, where he was the Chief Commercial Officer.

“Our goal is to build a world-leading multiple sclerosis franchise,” said Meeker. “Bill’s substantial commercial experience and his deep knowledge of the MS field will be critical to the launch of Lemtrada and Aubagio, two investigational therapies with the potential to transform the lives of people living with MS.”

Rogério Vivaldi joined Genzyme in 1997; his roles have included President of the company’s Renal and Endocrinology Business and President of Genzyme Latin America. As a doctor, he became a recognised expert on the rare Gaucher disease and its treatment.

“Rogério’s experience as a physician treating Gaucher patients in Brazil and his subsequent work in building our rare disease business in Latin America will provide both continuity and an energising new beginning for our global rare disease business,” noted Meeker.

Based in Massachusetts, US, Genzyme specialises in biopharmaceutical therapies for rare and debilitating diseases. As part of Sanofi, it benefits from the commercial reach of a leading global pharmaceutical company.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

The NHS Technology Adoption Centre (NTAC) has launched a new online system to help NHS and private health providers adopt proven medical technologies more quickly and effectively.

The new Generic Adoption Process (GAP) provides a detailed roadmap of the adoption process and access to the tools and resources needed.

GAP builds on the experience of NTAC’s Technology Implementation Projects over the past four years in improving the diffusion of proven medical technologies across the NHS.

Users of the GAP website are encouraged to navigate through each of its sections in order, thereby building relevant knowledge – however, they are free to navigate between sections as they wish.

The site is designed for use by health providers at all stages of the technology implementation process.

Sally Chisholm, CEO of NTAC, commented: “GAP has been tested by a number of key stakeholders from the NHS and industry. We believe this is a vital tool which will help drive widespread adoption of proven technologies, as GAP can provide unrivalled knowledge and information to those who do not choose to directly engage with NTAC on an implementation project, for example.

“The idea for GAP came from our recognition that there is a clear need for something which can equip clinicians, managers and other key stakeholders crucial to service development with the tools and resources they need to be able to drive change and innovation throughout the NHS.”

NTAC takes the view that the NHS often fails to adopt innovative medical technologies whose clinical and economic value is proven due to a lack of well-resourced and coordinated adoption pathways.

GAP is available at http://www.ntac.nhs.uk/GAP/GAP_Home.aspx

Revenue was up 10% in Q3 at Lundbeck to DKK 4.9 billion but profit from operations fell nearly a quarter (22%) after restructuring its R&D department.

Growth was driven by an increase in revenue from a number of its key products and milestone payments following the launch of escitalopram in Japan.

Ulf Wiinberg, Lundbeck’s President and CEO, says the company is “very pleased with yet another strong quarter” after its branded products delivered “solid results”.

Sales of Sabril increased by nearly half (47%) to DKK 77 million, compared to the third quarter in 2010, with revenue also up for Xenazine in the US by a fifth, compared with the same period, to DKK 191 million.

Lundbeck’s key products, Cipralex, Ebixa and Azilect, which grew 5%, 18% and 20% respectively, compared to the period last year, helped boost revenue from International Markets up 20% to DKK 901 million.

“We are now entering a new era with many new product launches,” said Ulf Wiinberg. “With the launch of Lexapro in Japan, the continued roll out of Sycrest and the forthcoming launch of OnfiTM in the US, we have expanded on our product diversification and strengthened our long term growth prospects substantially.”

Pfizer’s Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, Adsorbed]) has been launched in the UK for active immunisation of invasive disease caused by Streptococcus pneumoniae in adults aged 50 and over.

It becomes the first and only pneumococcal conjugate vaccine to be licensed for adults aged 50 and over after gaining a new indication from the EMA.

Dr George Kassianos, GP and immunisation lead for the Royal College of GPs and the British Travel Health Association, says its introduction is an “important achievement and step forward” for adult patients.

The vaccine was first licensed for infants and young children in December 2009 in Europe and used during the UK’s Childhood Immunisation Schedule in April last year.

The new indication provides a new treatment option for the prevention of adult invasive pneumococcal disease (IPD), which includes the potentially fatal bacteraemic pneumonia, meningitis and septicaemia.

Chris Head, CEO of the Meningitis Research Foundation, welcomed the vaccine’s launch in the UK. “The new license for Prevenar 13 provides an opportunity to protect adults over 50, who are more at risk of serious pneumococcal disease than younger adults,” he said.

Until Prevenar 13’s new indication, adults over 65 and those in clinical risk groups were treated with the pneumococcal polysaccharide vaccine. But in clinical trials, patients given Prevenar 13 had significantly higher antibody responses with the vaccine expected to protect against seven out of the most ten most comment serotypes which causes IPD.

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”