Part three: Sponsoring society meetings

Steve Gray answers your questions about compliance with the ABHI Code of Business Practice and other industry codes that govern commercial activity.

(This article is based on a query recently received from one of our clients. As you would expect, I have changed the details and used an imaginary company name. However, the concept is very real and demonstrates the need to work closely with customers in order to manage their expectations.)

Dear Steve:

For many years, MK Surgical Instruments has supported the MKSS (Milton Keynes Surgical Society) and has provided generous sponsorship to enable MKSS to hold its annual educational weekend for its members.

The MKSS Chairman has written to us to ask for funding for this year's society meeting. In return, we will be able to place an exhibition stand in the meeting area and join the delegates for the scientific sessions. We will also be able to join them for the Saturday afternoon excursion.

The agenda includes dinner on the Friday evening, and a meal at a local restaurant on the Saturday evening. Partners are welcome and the hotel has been carefully chosen to ensure they have a relaxing weekend, with access to the spa and leisure facilities. It is possible that some delegates might bring their families, as the Society strives to create a relaxed and friendly atmosphere.

Sponsorship by MK Surgical Instruments will be acknowledged on the agenda and will be announced at both the dinners. The Chairman of the Society assures us that our products are widely used by the majority of MKSS members.

Is there any problem with our sponsorship of this society meeting?

Steve says:

Historically, medtech companies might have been keen to support this kind of event. It's a fantastic opportunity to mingle with customers in an informal environment, which can be the basis of lasting business relationships. In addition, the profile for the product is high and the investment might be expected to generate a good return from the MKSS members.

However, times have changed. The compliance officer at MK Surgical Instruments should reject this particular opportunity, because there are numerous concerns about the arrangements. To begin with, the event does not meet the core ABHI principle of separation. There is a clear link between the provision of the funding and the comments about the use of company products. There is also a lack of separation between the social and educational aspects of the meeting. In fact, the primary reason for the event seems to be the social aspects, with the educational agenda merely forming an excuse for bringing the society members together.

The ABHI Code recognises the value that can be gained by sponsoring third party educational events: "Bona fide independent, educational, scientific or policy-making conferences promote scientific knowledge, medical advancement and assist in the delivery of effective healthcare. To these ends, members may support such events provided the educational conference content promotes scientific knowledge, medical advancement and the delivery of effective healthcare and is consistent with relevant guidelines established by professional societies or organisations for such meetings."

However, the Code clearly states that members should not facilitate the attendance of family members at educational events. It also states that members should avoid venues such as luxury hotels, and that they should exercise caution when choosing hotels with leisure facilities (such as spas). The best way to avoid complications is to construct the agenda so that there is no significant free time during the working day.

In the case of the MKSS event, the best course of action would be to work with the Chairman, explaining why the currently planned arrangements are difficult to reconcile with the requirements of the Code. Careful customer management may be able to reshape the agenda and arrangements so that this meeting and all future meetings are suitable for the company to sponsor. That would be a more appropriate win-win outcome than that originally envisaged by the Chairman!

Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd, an accredited provider of training services to the ABHI. www.compliance-hub.com

Do you have a compliance query for Steve Gray? If so, e-mail your question to us at joel.lane@medtechbusiness.co.uk. Your anonymity is guaranteed.

Managing your promotional budget presents difficult choices as the routes to market become more complex and varied. Charles Hughes, UK Field Sales Support Manager at Mediplus Ltd, argues that there is no substitute for developing an expert sales team and strong customer relationships.

In the medical devices sector, one of the most challenging business environments in the commercial world, directors and managers constantly ask: How can we make a difference: how can we set ourselves apart from the competition and become our customers' first choice when they are looking for the type of products we sell?

Increasingly, marketers are questioning whether they should spend thousands of pounds of the marketing budget on exhibitions - which are usually dominated by the global corporations, and rarely (if ever) capitalised on fully by the SME. Alternatively, should we buck the occupational trend of modern-day business and invest in quality personnel, born of a measured and calculated recruitment, retention and training strategy?

I believe that the companies most likely to hold the 'first choice' status have a sales team who are well renowned and respected by their customers - and are regarded as a solution provider and an integral part of their team. There is no substitute for supporting a quality range of products with high levels of customer service. It is the territory manager who is ultimately going to make a difference, by providing both of these aspects more effectively than anyone else.

Harrogate is my home

I regard a marketing budget as a luxury: something to cherish and use wisely. It's a carefully planned series of investments that identifies, through its implementation, a healthy return in the guise of increased sales. Or is it?

At the last national exhibition or conference you attended, you probably spent - what, £5,000... £7,000... £9,000 or so attending? What was your ROI? Might it be that the corporate giants have monopolised and captivated the intended audience of these events? Was your company right to think that the 300 NHS clinicians attending the free disco (including a complimentary bucketful of Pinot Grigio and a straw) would love them and buy their products for ever?

What the customers really want is very simple. They want to know how you can help them save time, save money and improve patient care. They don't want pens and Post-It notes: they want to be supported and taught how to be a better provider of healthcare. So how are we going to do that?

Don't call the doctor

Our healthcare market is fiercely competitive, with a multitude of companies fighting for small and varied amounts of business. Ever since it was discovered that a hospital could go 'into the red', there has been the inevitable excuse that this is a financially challenged system. The NHS has been in the red since Aneurin Bevan blessed us with it. Experts claim they can forecast illness, accidents, disease and death rates and their impending impact on the NHS for the next 25 years. I can only assume that these forecasters were trained to the very highest standard of forecasting during their apprenticeships in the Met Office.

The well rehearsed line "As you know, this hospital is seriously in the red" is always the first line of defence against the medical device representative - who just may be able to save them a thousand pounds per patient, rather than a penny per plaster! To be able to provide the NHS with the financial stability it craves, industry - now more than ever - has to work in partnership with it. We have to provide well-trained, appropriately qualified and respected territory managers who can assist the clinician in changing their practice for the better both clinically and economically. Clinicians, with the help of those controlling the budgets, must be provided with irrefutable clinical advantages and an evidence-based business case.

Once that has been achieved, it comes down to one thing: people.

Making the difference

Healthcare buyers are blessed with enormous choice. Catalogues full of 'me-too' products fall through their letter boxes every day. So what makes the difference? How do we set ourselves apart? It's the people, and the quality of the partnerships and relationships that actually exist.

We won a tender to be a 'preferred supplier' to a large Strategic Health Authority about eight months ago. The business was worth about £80,000 per annum. However, we have not seen a penny of it. Why? Even though the prices we submitted were acceptable, they have been buying their goods (for the most part identical to ours) from a company that also won the tender and was 50p per unit more expensive than us.

Why did this happen? Simple: the SHA had a sound and mutually beneficial partnership with the firm. They knew the representative by name and described him as a wonderful ambassador for his company. He was a respected consultant on his product area and was regarded as an integral part of the clinical team. He was the difference. He showed them how their hospital could save time and money and make things a lot better for the patient and the clinician.

It could have been Johnson & Johnson up against Smith & Nephew, or GE Healthcare against Vital Signs, or McDonald's against Burger King. All are large companies with many similar offerings. It was him: he made the difference.

Don't blame me

...it's not my fault we lost that tender. Who is to blame when we lose business? As an industry it's up to us, through superior field-based territory management, to help the NHS understand that there can be serious financial benefits to a small change in clinical practice. Here are two classic excuses:

1. The competitor was less expensive, and the specification clearly suggested that there was one main contender.

So why was your sales representative not the one whose relationship with the clinical and administrative personnel influenced the decision-making process? Many sales people take initial rejection too easily and regard hurdles as insurmountable. As their sales manager, you have a responsibility to show them how to manage the account. Regardless of how impressive they appear, you can save yourself a week of sleepless nights by regularly showing them how it should be done.

2. We didn't know the tender was coming out.

If your team maintained strong relationships with the decision-making committee, they would know when it was coming out and who the front runner was. Such is the size of the NHS procurement machine and the difficulties it faces, some tenders never come to any sort of conclusion. I know this: I've been there. But if you are secure in the quality of your key account knowledge, and you always ask your customers the key questions, you would have known this too. Right?

There are hubs and central procurement bodies and a myriad 'buying departments' that all get involved before the new forceps hit the Mayo tray. (Is it just me, or does everyone else send a quote to four different postcodes to sell kit to a hospital in a different county?) No matter what the size of your organisation, it is important to deal with the NHS decision-makers at the highest level.

But if your ground troops are not the best at what they do and are not already on the move, what is the point of an air strike? You have to be ground smart as well as air smart. You must be seen as a partner, not just a provider.

Lessons of history

I still firmly believe that even when we are dealing with e-tenders, central procurement, collaborative hubs, supply chains, etc, there is no substitute for the immortal and reliable, highly-regarded sales representative. To summarise:

• Take time and care when you recruit. Your sales team have to think the same way you do. You need to be able to mould them into technicians and masters of your craft.

• A well-trained, motivated, appropriately monitored territory manager providing affordable high-quality products with high levels of customer service is worth a thousand 'MBA manual' suggestions.

• The sales team must sell everything in their bag to everyone who matters, every single day. The best investment of time and money is getting to know your customers and their needs better than anyone else does.

One last thought: why don't all companies include a contact number on their website? Well, my customers tell me there are two likely reasons. One is that the company is not geared up to deal with humans. The other is that it simply regards people phoning up to spend their money on its products as a costly inconvenience. Is that how you want to be perceived?

Charles Hughes is UK Field Sales Support Manager at Mediplus Ltd. Based in High Wycombe, Mediplus develops medical devices for the urology, gynaecology, gastroenterology, anaesthetics and general surgery markets.

There is no substitute for supporting a quality range of products with high levels of customer service. It is the territory manager who is ultimately going to make a difference, by providing both of these aspects more effectively than anyone else.

London, 17-18 March 2010

The growing importance of medical devices and diagnostics for healthcare across Europe is shown both by the industry's higher profile with governments and by the increasing integration of the European medtech sector. Both were reflected in the first MDDexec (Medical Devices and Diagnostics Executive) Europe Sales and Marketing Excellence event, held at Regent's Park Marriott in central London. Formerly held in Boston, USA, this conference was being held in Europe for the first time.

The two-day event brought together senior executives from a number of leading medtech companies, as well as consultancies specialising in commercial strategy, to discuss how the industry can meet the challenges of rapidly-changing health systems through innovative sales and marketing. Presentations with Q&A sessions, workshops and networking breaks made for a busy and interactive conference, reflecting the vitality of an industry that is fully engaged in realising its potential to change the world.

Themes focused on by the speakers covered a wide range of issues, from providing "total healthcare solutions" to maximising the impact of a product launch. Some recurrent themes were evident: making customer service the driver of commercial activity; meeting the commercial and organisational, as well as clinical, needs of customers; and integrating the activities of all teams within a company.

The conference had five sponsors, all of which exhibited in the open meeting area: Global Sponsor ZS Associates (a global management consultancy firm specialising in sales and marketing); Gold Sponsors ConsultComplete (the strategy consulting group within strategic healthcare agency CMG), Interactive Media (a supplier of SaaS applications to the life sciences industry) and Model N (a global provider of revenue management solutions for the industry); and Workshop Sponsor Doctors.net.uk (the largest online network of medical professionals in the UK).

Seeing the bigger picture

The first day of Sales & Marketing Excellence focused on giving a strategic overview of the commercial issues facing medtech in Europe.

Margrit Lelieveld, VP Sales and Marketing, Philips Healthcare, spoke on moving from 'box selling' to being a true clinical solution provider. She described how, with the growing tendency of hospitals to outsource non-core functions, Philips Healthcare has increasingly moved towards managing the technology of hospitals through long-term contracts - thus providing a "total healthcare solution".

Baba Awopetu, Director Marketing Excellence, Stryker, discussed how medtech can respond to the changing healthcare landscape by embracing partnership and well-informed segmentation. "We need to focus on the problem we're solving," he argued, "not the product we're creating." He quoted recent evidence that 90% of healthcare customers will pass over the cheapest option in favour of one that adds value.

Rohan Fernando, Managing Principal, ZS Associates Europe, talked about redesigning commercial models to address the rise of the 'economic buyer'. He noted that "chaotic sales models are common" across Europe in the medtech industry - and that while sales strategy often fails to see the bigger picture, marketing often lacks regional insight and experience. His presentation led into a workshop on the challenges of updating medtech sales models.

Nadav Tomer, VP of Marketing, Cordis, offered a different emphasis: he argued for a "hunter" approach to medical device sales, with reps moving fast to target opportunities and be "in the right place at the right time". Trying to build complex, long-term relationships across a territory was not possible, he argued, in a market driven by immediate cost priorities. His presentation was a reminder that many customers are less receptive to long-term solution building than the industry would prefer.

Niels Skov, Managing Director, Europe, Model N, explained how revenue management solutions have enabled global healthcare companies to resolve difficulties with their pricing and contract management - and to approach the 'enlightened buyer' as an 'enlightened seller'. A case study examined how Boston Scientific has benefited from using the Rainmaker solution from Model N for pricing analysis.

Joseph Hartzell, Sales Force Excellence, Strategy and Systems Director, Medtronic International, discussed how SFE can be used to empower rather than control the sales team. He described the effectiveness of a "balanced" approach in which reps are asked to provide only key data, incentives are focused on results rather than process, and reps are given their own cumulative data. This both maximises the strategic value of SFE data and contributes to effective teamwork.

Simon Grime, Head of Healthcare Communications, Doctors.net, led a final workshop discussion on how medtech can engage with the "revolution" of online clinician networks. He gave an example: B.Braun generated 965 enquiries about a new product from a website with 14,000 members in a short space of time. There are clear opportunities, he argued, for companies to deliver educational and promotional material to this highly-motivated expert audience.

What value is worth

The second day's presentations focused on specific aspects of sales and marketing strategy, building on the perspectives shared on the first day.

Birgit Bergdoll, European HR Program Manager, BD, looked at the challenges of territory management in a "shrinking Europe" of protectionism and reduced public spending. She pointed to the growing importance of key account management and sophisticated customer segmentation in building organisational capacity, shifting "from an internal to an external focus".

Anton Cush, Global Manager, Sales Enablement, Covidien, discussed how sales teams can implement a company's value proposition. He emphasised the need for effective integration of the sales and marketing functions to define commercial relationships, enabling representatives to function as "partners" whose value proposition evolves continually in response to customer needs.

Marta Antonucci, VP CRM Marketing, EMEA, Boston Scientific, followed with a presentation on how 'added value' can give a company's products the edge. Innovation, she argued, is the key to blending quality and cost-efficiency in a way that drives brand referrals. As an example, she described how the service features of the Latitude system for remote patient management gave the 'added value' of an improved care network with active patient involvement.

Suzie Denton, Head of ConsultComplete, argued for an imaginative approach to product branding. In an increasingly difficult commercial environment, she argued, product differentiation needs to blend "rational" and "emotional" factors - so while marketing materials must be evidence-based, focusing on the human benefits of a product can help to strengthen its perceived advantage to the customer.

Keith Rowland, Marketing Director, Cook Medical, discussed the importance of segmentation and targeting. He suggested that medtech is a decade behind pharma in its awareness of "market-led" segmentation. Marketing and sales teams need to work together, he argued, to determine viable customer segments that enable representatives to access the whole of the market.

Mark Harvie, Marketing Director Medical Devices EMEA, Hospira, gave a final presentation on the focal point of marketing: the product launch. He commented that a common reason for medical device product failure is that the launch has no structured process and generates no "buzz". A company needs to work as a whole towards a launch, he argued, using all its channels of customer interaction to ensure the new product has maximum impact.

Shared world

The MDDexec Europe Sales & Marketing Excellence event was a dual first for the Medtech Business team: the first UK event we had attended that brought together the medical device and diagnostics sectors, and the first to address the issues facing the industry across Europe. Since the majority of medtech companies active in the UK are either based in Europe or selling into European markets, conferences like this play a crucial role in developing the UK medtech industry.

The Medilink UK Awards 2010: celebrating technologies that will change this decade's healthcare.

Innovative technologies for operating theatre lighting, dosage formulation, chronic disease management, oxygen therapy maintenance and medication delivery were recognised at the Medilink UK Awards 2010.

The annual Medilink UK Awards celebrate cutting-edge technologies, outstanding business achievements and international success in the UK life sciences sector.

Held at the Merchant Adventurers' Hall in York on the 11th March, the Medilink UK Awards 2010 were sponsored by Sandvik (which has just invested in an European centre of excellence in the UK).

The event was attended by key stakeholders in UK healthcare (industry, clinical and academic), who had the opportunity to hear from leading figures such as Sir Christopher O'Donnell, former Chief Executive of Smith & Nephew and current member of the Ministerial Medical Technology Strategy Group.

The national winners were selected from the winners of the regional Medilink Awards by a panel of judges from every region of the UK. They reflected the growing emphasis on home- and community-based treatments in the world's healthcare systems.

One step beyond

The HealthTech & Medicines KTN Innovation Award was won by Yorkshire-based Brandon Medical Ltd for its Quasar operating light: the first system to provide high colour rendition across the full visible spectrum, helping surgeons to see small differences in tissue colour. Brandon Medical produces medical lighting and other systems for use in operating theatres and critical care.

The UK Trade & Investment (UKTI) Export Achievement Award went to Nottingham firm R5 Pharmaceuticals, which has increased its export sales tenfold by accessing three new markets. The company provides dosage formulation and evidence services for drugs in tablet, capsule, powder, cream and liquid form.

The winner of the Department of Business Innovations and Skills (BIS) Growth in Sector Award was IntraHealth, based in Peterlee. Intrahealth provides primary care services for long-term conditions, including heart disease, chronic lung disease and anticoagulant monitoring, to 22 surgeries across the UK. In the past two years, the company's staff level has risen from 101 to 300.

The NHS National Innovation Centre Partnership with the NHS Award was given to Cardiff-based Invacare Ltd for its collaborative work to assist the self-management of oxygen needs. Invacare has developed the HomeFill oxygen system in partnership with Dolby Medical and NHS Oxygen Management. This allows patients to refill their mobile cylinders from their own oxygen store while still receiving oxygen, reducing their dependence on oxygen deliveries.

The Medilink UK Start-Up Award was won by InterVene Ltd, a specialist product developer from Sheffield. Intervene has created a female Luer lock hypodermic syringe, designed for oral and enteral medication delivery in response to a patient alert from the NPSA in March 2007. The company turned over £13,000 in its first year (2008) and is now turning over £1.5 million per year.

Spirit of science

The Medilink UK Awards are an important mark of achievement in the medtech sector, as they represent successive stages of regional and national recognition for companies from industry stakeholders.

Huw Roderick, Business Development Manager Respiratory at Invacare, commented: "To be recognised by fellow professionals and receive an award like this is fantastic. It gives you recognition and is an important stepping stone to move the product forward."

Graeme Hall, Managing Director of Brandon Medical, said: "We are thrilled to receive this national innovation award. Brandon Medical is dedicated to providing new innovations to improve hospitals and its patient care. Its great to see our investments in research and development recognised in this way."

Medilink UK is a network of regionally-based organisations working to raise the profile of the medical and healthcare sectors in the UK. Each regional organisation provides a range of support to its member companies.

The network includes BioBusinessNI, CELS, ERBI Ltd, HealthConnect, Health Tech and Medicines KTN, Medilink East Midlands, Medilink North West, MedilinkWM, MediWales, Medilink Yorkshire & Humber, Medilink Scotland and South East Health Technologies Alliance.

 
Medilink UK Awards 2010 winners

NHS Supply Chain has surprised many medtech companies, both in the scope of its activity and in its openness to innovative smaller companies. Mark Patterson, NHS Supply Chain's Strategy and Procurement Transformation Director, explains the organisation's dynamic role in the UK healthcare market.

NHS Supply Chain was set up with the remit of saving £1 billion from the NHS budget over 10 years. What means are you employing to deliver on that objective? What progress has been made? What can the medical technologies industry do to help?

We started the contract in October 2006 and are above target to achieve the savings that we outlined to the Department of Health. To date we have saved the NHS over £100 million, and obviously these savings will ramp up in the later years of the contract. To achieve such savings we have a number of key initiatives: aggregating NHS spend enables us to focus on price, which produces a large proportion of our savings; finding efficiencies within the supply chain; and looking at the buying behaviours within trusts, and helping them manage their inventories through our expertise in end-to-end supply chain management.

To aggregate spend, we work with trusts collaboratively. This benefits our relationships with suppliers, because if we can go to them with credible aggregated spend then we're going to achieve the best value pricing that we need to meet our customers' expectations.

We look at how we can strip costs out of the supply chain through our own internal processes to achieve back office savings and synergies across different departments. As a DHL organisation, our core capability is supply chain management. We look at both our distribution and transport costs and how we can leverage the wider DHL to ensure that we can deliver value to our customers.

We are working on a number of big projects that will deliver significant value to NHS trusts. Our capital planning offer has been in place since the start of the contract, but has really gained momentum over the past couple of years. We now manage complex procurement contracts within trusts. For example, a large new hospital may be built or a hospital may be having a large capital programme upgrade and therefore need to purchase a number of MRI scanners, CT scanners and items of operating theatre equipment. With our capital planning offer, they could save up to £140,000 on an MRI scanner through our contracting and work with suppliers as we can leverage the demand and aggregate it. Asking a supplier for a price of five or six MRI scanners also produces better value pricing for our customers.

Our Direct from Manufacturer (DFM) programme aims to save the NHS a considerable amount on certain product areas. The programme sees us developing a direct sourcing strategy that will result in us working directly with manufacturers. DFM is not about shifting production from the UK to offshore: it's about going directly to offshore manufacturers that have the capability and expertise to produce healthcare products and working directly with them. This initiative will help us have a more transparent supply chain and can save NHS trusts money on product costs.

Last year saw the first sale of a scanner through NHS Supply Chain. What types of product and service do you cover? Will your scope widen further in the future?

We purchase and supply a wide range of diagnostic and interventional equipment such as digital mamographers and heart valves. Our remit covers non-pharmaceutical healthcare products, food and capital equipment. We procure most equipment that is used in theatres, dental surgeries, audiology departments, for catering, orthopaedics (we're a large provider of orthopaedic joints and all the tooling required for them), rehabilitation equipment - and capital equipment, which includes the finance and maintenance agreements. We started with imaging capital, with MRI and CT scanners, and we've now broadened that to non-imaging capital: stretchers, operating tables, lighting, theatres and so forth.

Will the scope widen further in the future? We are currently focusing on what we need to deliver. There are other category areas that that we could get involved in, and if we choose to do so then we could write a business case for the Department of Health to outline the value that our service would deliver. However, there are parts of our remit that we don't have contract coverage for at the moment. For example, in the areas of renal and cardiology we only have a small number of contracts that don't cover the full range of products. So we are planning to widen our contract coverage in these areas over the next few years. We are looking to introduce more contracts to widen our range where we know that our customers need us to.

How successful has the Innovation Scorecard initiative been, for NHS Supply Chain and for medtech companies?

Very successful, and it has been very well received. We launched the Scorecard in October last year and to date we've received about 62 applications, which is a great response. We are doing a lot of marketing to get people to understand it more clearly - and more importantly for them, to understand the benefits of it. The first product coming through as a result of the Scorecard is a single-use tourniquet, designed to reduce the risk of hospital-associated infections during blood taking. So there's already the first Innovation Scorecard product!

About 10 per cent of the submissions we're working on have come from the medtech sector. Suppliers are always welcome to get in touch with us via the Supply Chain website - that's www.supplychain.nhs.uk/innovation. We're really looking to build on this initiative through 2010.

How does NHS Supply Chain interact with the medtech industry? Is it a two-way communication? How can suppliers improve this engagement?

We always welcome the opportunity to communicate and interact with our suppliers. We obviously have to be very clear about the legal requirements of the procurement process. We are always conscious of these requirements when we're out to tender, when tenders are live, and therefore when we can and can't communicate with suppliers. We have good communication with the trade bodies, especially in the medtech sector such as the ABHI and BHTA. We supported the ABHI's annual conference in November last year and have regular meetings to keep them abreast of developments in the sector.

We have regular dialogue with suppliers who are on contracts throughout their contract life and discuss issues such as product development and the supply of products, or operational issues such as control of inventories.

We also support a number of our suppliers at exhibitions - especially in the capital medtech area, where we have had trade stands and some of our key suppliers have supported us on them. We always aim to be as collaborative as possible within the public procurement rules.

We are very focused on delivering the best value service to the NHS, as service levels and providing value is what the contract was created to do. We encourage our suppliers to help us in our quest to deliver value by giving consistency in pricing across the market and being aware of new innovations. We are involved in the NHS innovation agenda, as we can identify where value can be improved through the introduction of new products and services - and we're looking to make improvements wherever we can.

We are very focused on delivering the best value service to the NHS. We encourage our suppliers to help us in our quest to deliver value by giving consistency in pricing across the market and being aware of new innovations.

Celgene Corporation has signed a merger agreement to acquire Abraxis BioScience for $2.9 billion.

The company hopes that the acquisition will further its strategy to become a global leader in oncology.

As part of the transaction, Celgene will acquire the rights to Abraxane (paclitaxel protein-bound particles for injectable suspension), which was approved by the EMA in 2008 for the treatment of relapsed or metastatic breast cancer. Abraxane has also received orphan drug designation for stage IIB-IV melanoma and pancreatic cancer.

“The acquisition of Abraxis BioScience is an exceptional strategic fit that will accelerate our strategy of becoming a global leader in oncology,” said Bob Hugin, Chief Executive Officer of Celgene Corporation. “We are excited by the opportunity to leverage our clinical, regulatory and commercial capabilities to provide metastatic breast cancer patients with an innovative treatment in Abraxane.”

Celgene will also acquire Abraxis’ innovative nanoparticle albumin bound (nab) technology, which enables the targeted delivery of chemotherapeutics to the tumour.

“Our nab technology platform is changing the treatment paradigm for difficult-to-treat cancers,” added Patrick Soon-Shiong, Executive Chairman of Abraxis BioScience. “In Celgene we have found the ideal partner to further expand the reach of Abraxane and our other treatments, in order to improve the lives of patients worldwide.”

The June meeting of the CHMP saw several new products recommended for marketing authorisation, including two generics and one ‘hybrid generic’.

The Committee adopted positive opinions on MSD’s atrial fibrillation Brinavess (vernakalant), Organon’s bipolar treatment Sycrest (asenapine) and Gilead’s Rapiscan (regadenoson), a pharmacological stress agent for radionuclide myocardial perfusion imaging.

A further two orphan medicines were approved: Pharming Group’s Ruconest (conestat alfa) for angioedema and Shire’s Vpriv (velaglucerase alfa), which was given an accelerated assessment due to an ongoing shortage of the currently authorised treatment for Gaucher disease.

A ‘hybrid generic’, a medicine that contains a known active substance, but is presented in a new pharmaceutical form, was also recommended for a marketing authorisation. PecFent from Archimedes Pharma is a fentanyl nasal spray for breakthrough cancer pain.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, commented: “This is a defining moment for Archimedes Pharma. Breakthrough cancer pain is a poorly served indication and affects up to 95% of all cancer patients with pain. Today’s announcement by the CHMP is an important step towards bringing a new treatment option to these patients in Europe.

“It also marks a step change in scale for Archimedes Pharma’s already successful European commercial operations and an important landmark in our development as a leading global specialty pharma company.”

The CHMP also issued positive opinions for Ibandronic Acid Teva in 50mg and 150mg doses, generics of Bondronat and Bonviva, and Telmisartan Actavis, a generic of Micardis.

A University of Nottingham spin-out company has developed a blood test that can help to detect cancer up to five years earlier than current testing methods, such as mammography and CT scans.

Doctors will know the result of their patient's test within one week of sending in a blood sample.

Oncimmune has developed a new immuno-biomarker technology that replicates the cancer proteins that trigger the body's reaction to the disease, and uses robotic technology to measure this response.

This new technology enables much earlier detection and is likely to transform the diagnosis and treatment of most solid cancers such as lung, breast, ovarian, colon and prostate cancers.

Oncimmune has used this science, based on the work of cancer specialist John Robertson, to create a commercial test. The first early cancer detection test to launch will be the test for lung cancer, EarlyCDT-Lung.

Geoffrey Hamilton-Fairley, Executive Chairman of Oncimmune, said: "We believe this test, along with the others we will launch in the next few years, will lead to a better prognosis for a significant number of cancer sufferers."

Initial research results were derived using blood samples from patients with breast cancer and from a group of high-risk women attending for annual mammography in Nottingham. The results showed that the signal could be detected not only in patients with cancer, but in some high-risk patients who would not be diagnosed with cancer for up to four years.

EarlyCDT-Lung will be launched in the USA this month and in the UK early next year. Further research will allow validation of the test in other solid tumour areas.

Boston Scientific has launched its Taxus Element paclitaxel-eluting coronary stent system in the EU, where its first implants have been carried out.

The Taxus Element, the company's third-generation drug-eluting stent, is made from a platinum chromium alloy, and has an innovative design and an advanced catheter delivery system.

It has received CE Mark approval with a specific indication for the treatment of diabetic patients.

The first European implants were performed by Corrado Tamburino, Chair of the Cardiology Department at Ferrarotto Hospital, Catania, Italy and Adrian Banning, Directorate Chair of Cardiac Services at John Radcliffe Hospital, Oxford.

"I have found the Taxus Element Stent to offer performance advantages in flexibility, visibility and deliverability over prior-generation stents," said Dr. Tamburino. "The platinum chromium alloy and new stent design used in the Element platform, together with the proven Taxus drug and polymer, represent a significant advance in coronary stenting."

"The diabetic indication for the Taxus Element Stent System provides an important benefit," said Dr. Banning. "Diabetic patients with coronary artery disease often have poorer outcomes after revascularisation procedures. The paclitaxel-based Taxus Element Stent has a unique mechanism of action that helps inhibit restenosis in high-risk patients with diabetes."

The Taxus Element Stent is designed specifically for coronary use. It brings together the performance advantages of the Element Stent platform and the long-term clinical success of the Taxus programme.

The platinum chromium alloy and innovative architecture of the new stent offer greater flexibility and radial strength, permitting thinner struts than in previous stents.

The results of Boston Scientific's Perseus clinical programme, declared in March, showed positive safety and efficacy outcomes for the Taxus Element Stent System compared to the Taxus Express Stent System.

 
Taxus Element stent

The use of magnetic resonance imaging (MRI) in medical research, diagnosis and treatment is threatened by new EU legislation on exposure to electromagnetic fields.

The exposure limits are based on poor evidence, according to a new report from the European Science Foundation that recommends that medical and research use of MRI should be exempt from the legislation.

The EC Electromagnetic Fields (EMF) directive limits the exposure of workers to EMF with frequencies in the range of zero to 300 GHz. These limits could prevent MRI research and severely hinder further development of this important medical imaging technology.

The report, which has been endorsed by the European Medical Research Councils, recommends an exemption from any limit values for MRI in clinical and research settings.

The EMF directive will come into effect in April 2012. The exposure limits would:

• stop healthcare staff giving help or support to patients, such as children, the elderly or those who are anaesthetised, during scans

• prevent the use of MRI for interventional and surgical procedures

• curtail research in the field of MRI treatment.

"The Directive is a blunt instrument," said Dr Stephen Keevil from King's College London, who co-chaired the report. "It sets exposure limits that either relate to harmless effects, or are well below the threshold at which any effects occur. 2012 is still some time away, but to effect change in the policy we need to act now.

"Safety is taken very seriously by the MRI community. The directive's aim of protecting workers is one that MRI researchers fully support, but its unintended effects are potentially disastrous. We're now working very closely with the European Commission to find a mutually acceptable solution."

 
MRI scanner