Let’s stay together

by JoelLane 7. March 2012 14:40

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BBC Radio’s File on 4 warns that patchy and under-funded diabetes care is depriving patients of access to essential tests and treatments. Maxine Vaccine looks at the vital importance of the integrated care model for patients, doctors and the drug industry.

A recent Radio 4 programme looked at the reasons why people with diabetes die an average of 10 years (for type 2) or 20 years (for type 1) earlier than the rest of the population. It identified the core reason as being financial pressure on GPs to cut costs on diagnostic tests and specialist referrals.

The programme said that fewer than 50% of patients receive all of the diagnostic tests recommended by NICE – and that, even where patients are failing to control their diabetes, GPs routinely fail to refer them for specialist advice until it’s too late and they are facing blindness, kidney failure or limb amputation.

Diabetes is the most prevalent chronic disease in the UK, and the one whose prevalence is growing fastest, due to poor diet and lack of exercise. Typically of long-term condition management, diabetes care requires a combination of diagnostic testing, self-monitoring and medication adjustment. The days when the only treatment question was ‘Insulin or pills?’ are long gone. Many type 1 and type 2 diabetes patients are on combination drug therapies, even if they have no comorbidities or complications.

And diabetes does not stay the same. Blood glucose levels change progressively, and there are cyclic changes within the day and the year. The ABC of diabetes control is dosage adjustment. Just being on a fixed dose of a single medication, or even of multiple medications, is never a long-term answer. If you sell diabetes products, you know that optimal use depends on continuous monitoring and frequent guidance. And sub-optimal use delivers poor outcomes.

In other words, drug use in diabetes care – as for other long-term conditions – only works as part of an integrated care model where crucial variables are monitored and complications are diagnosed early. Not all GPs understand this well, and NHS financial management appears not to get it at all.

On the radio 4 programme, a GP was asked why so many diabetes patients die or suffer disability due to a lack of timely diagnostic tests and referrals. His answer was: “Money.”

Speaking to Diabetes UK, Baroness Young said: “A colossal amount of money is already being spent on diabetes – about 10 per cent of the NHS budget – but too much of it is being used to treat the complications of diabetes rather than to prevent those complications developing in the first place.

“It is time to stop just talking the talk on diabetes healthcare and start walking the walk.”

Pharma companies can help by being proactive when it comes to helping healthcare providers think constructively about dosage adjustments, drug combinations and long-term outcomes. Novo Nordisk is a leading diabetes care product supplier partly because it pays so much attention to the relationship between drugs and monitoring, and making sure that both sides of the equation are delivered in a user-friendly manner. Its reps are working overtime (Don’t push it – Legal Ed.) to explain these issues to doctors and nurses.

Needless to say, the Government’s vision of integrated care is a system where the local foundation trust says “Social services will cover this” and the local authority says “The NHS will cover this” and community-based healthcare goes down the toilet. I’m sorry, but that’s how it is.

In a bygone era, diabetes was known as “the pi**ing evil” because polyuria was its defining symptom. In this era of NHS rationing and atomised healthcare, it could be termed “the taking the pi** evil” – and diabetes drugs, no matter how well developed and sold, could be termed “the therapy pi**ed up the wall”.

For the sake of future generations, don’t let it be that way.

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

Shire starts Vyvanse Phase IV trials

by IainBate 7. March 2012 14:19

Pharma Industry News Shire has initiated two Phase IV clinical trials to assess the efficacy of Vyvanse (lisdexamfetamine dimesylate) against Johnson & Johnson’s Concerta (methylphenidate HCl).

The head-to-head studies will include more than 1,000 patients and aim to explore the differences in effectiveness between the two to allow relevant stakeholders to make informed choices.

Dr Jeffrey Jonas, Senior Vice President of R&D at Shire, says the trials are “important to further our understanding” between the two products frequently prescribed for ADHD.

There are currently no trials that compare the efficacy of the two products. This, Shire says, makes evidence-based treatment decisions a challenge.

The two trials are randomised, double-blind, multi-centre, parallel-group, active-controlled studies. They will explore any differences in efficacy between the two in patients with ADHD aged between 13 to 17.

One trial will employ a dose optimisation design, and the other employ a forced-dose titration schedule. The results are expected in 2013.

“It is important for practicing physicians to have access to information on comparative efficacy of different approved medications when developing a personalised treatment approach for individuals with ADHD,” said Dr Jeffrey Newcorn, Associate Professor of Psychiatry and Paediatrics, Mount Sinai School of Medicine. “I expect the data from these studies may aid prescribers in making individualised treatment decisions for their adolescent patients with ADHD.”

Vyvanse was approved for use in the US in July 2007 for the treatment of children with ADHD aged 6 to 12. In April 2008 it was approved for use in adults, and in November 2010 for adolescents aged between 13 and 17 with ADHD.

Sanofi launches 2012 patient bursary

by IainBate 7. March 2012 12:41

Pharma Industry News Sanofi has launched its UK Patient Group Bursary for a second year running pledging £50,000 to relevant support bodies.

Applications are welcomed from all types of patient groups with three chosen applicants receiving grants worth £25,000, £15,000 and £10,000.

Steve Oldfield, Sanofi’s UK General Manager, says the company is once again “delighted to demonstrate our support to patient groups”.

The 2011 bursary scheme focused on support groups that were developing capacity to deliver health services to the NHS; improving and promoting patient empowerment and information; and reducing health inequalities. Breakthrough Breast Cancer and the Multiple Sclerosis Trust shared last year’s £50,000 fund.

However, following feedback from the scheme’s panel of expert judges, three successful applicants will share this year’s bursary.

Applications from local groups, social enterprises and professional associations are all welcome. The three successful applicants will need to demonstrate that their programmes can deliver improvements in patient empowerment and information.

“We are excited to be rolling out this programme for a second year and we look forward to continuing our work in partnership with patient groups, delivering the aim of bringing about improvements in patient empowerment and information,” said Mr Oldfield.

Mr Oldfield will chair the panel of judges and will be joined by Baroness Pitkeathley OBE, Labour Deputy Speaker in the House of Lords, the broadcaster and author Baroness Neuberger and Baroness Morris of Bolton OBE, Conservative Deputy Speaker in the House of Lords and former shadow spokesperson for health.

Applications are now invited until Friday 27th April 2012. The judging panel will meet in May to assess these and decide upon the winning patient bodies.

Further information on the Patient Group Bursary can be found on Sanofi’s website.

Novo Nordisk sued by US reps for overtime

by JoelLane 7. March 2012 12:23

Pf industry news Novo Nordisk is facing a $70m lawsuit on behalf of its US drug sales force, claiming back payments for overtime.

The lawsuit, filed on behalf of two plaintiffs and a class of sales representatives, alleges that the Danish company is in breach of New York and federal law.

According to law firm Sanford Wittels & Heisler (SWH), the company requires its sales force to work more than 40 hours per week while incorrectly classifying them as ineligible for overtime payments.

Novo Nordisk, a world-leading supplier of diabetes care products, reported a net profit of $3.04bn for 2011 – an 18% increase from 2010, the law firm claims.

The two plaintiffs are pharmaceutical sales representatives based in New Jersey and Texas who are claiming back payment for overtime under the Fair Labor Standards Act (FLSA) and/or the New York State overtime laws.

The class action lawsuit identifies two classes: the FSLA class includes all Novo Nordisk sales reps employed in the US since March 2009, while the New York State law class includes all sales reps who have worked for the company in New York between March 2006 and the present (unless they opt out of the action).

SWH attorney Steven L. Wittels stated that Novo Nordisk “misclassifies its sales representatives as salaried employees exempt from the benefits of federal and state overtime laws, when in fact, they are not exempt at all.”

This lawsuit follows a similar claim against Novo Nordisk filed in California in July 2011 on behalf of drug sales reps.

A number of major pharmaceutical companies have recently been sued by sales professionals for back overtime pay. While Bayer, Roche and Wyeth have won their respective cases, Novartis has lost.

Alkermes gets new commercial chief

by IainBate 7. March 2012 12:20

Pharma Industry News Alkermes has appointed the experienced Mark Stejbach to the newly created position of Chief Commercial Officer, and as a member of the executive management team.

Mr Stejbach will be responsible for the biohpharma company’s commercial activities for products such as Vivitrol and the commercial strategies for its late-stage pipeline.

Richard Pops, Chief Executive Officer of Alkermes, says the company hopes the new recruit will “accelerate and expand” the Dublin-based company’s commercial activities.

The 46-year-old has more than 25 years’ experience in biotech and pharmaceutical marketing, sales, managed care and finance. He most recently served in a similar role at Tengion after working as the Vice President of Managed Care Marketing at Merck & Co between 2005 and 2008.

“I am thrilled to join Alkermes at this extremely exciting time for the company, and I see tremendous potential for Vivitrol as well as the robust pipeline of new product candidates,” commented Mark Stejbach. “I look forward to enhancing the company’s commercial capabilities to achieve its ultimate goal of bringing unique and compelling medicines to patients in need.”

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Boehringer boosts its manufacturing power

by JoelLane 7. March 2012 11:24

Pf industry news Boehringer Ingelheim plans to invest €17 million in its biopharmaceutical drug development and manufacturing capabilities in Europe.

The expansion of its facilities in Biberach, Germany, and Vienna, Austria, will reinforce Boehringer’s position as the industry’s leading contract manufacturer.

By investing in cell culture and microbial technologies for drug development, Boehringer will also strengthen its relationship with the biotech sector.

The new investment follows years of building the company’s capacity for contract manufacture of biopharmaceuticals through its cell culture facilities in Biberach and its microbial fermentation facility in Vienna.

The money will cover cell line and microbial strain development, as well as process development in contract drug manufacturing, and will be used to expand Boehringer’s Good Manufacturing Practice capabilities in these areas.

At the Biberach site, the investment will support the company’s ‘Lean to Clinic’ programme for monoclonal antibody projects, aiming to deliver drug candidates ready for clinical testing within 13 months.

At the Vienna site, it will advance Boehringer’s proprietary technologies, including its plasmid DNA manufacturing platform and its biotech collaborations with Pfenex and VTU Technology.

“The expansion has been tailor-suited to fully meet our customer demands in cell culture and microbial process science, especially for our rapidly expanding preclinical project portfolio with biotech companies,” said Dr Dorothee Ambrosius, Boehringer’s Senior VP for Biopharmaceuticals Global Process Science.

“This is another milestone within our contract manufacturing strategy, securing technology leadership and towards increased flexibility and customer orientation.”

Boehringer accounts for 23% of contract manufacturing capacity in the global biopharmaceuticals sector.

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