Roche has abandoned its attempt to take over US biotech company Illumina after a year of increasingly bitter argument.

The pharmaceuticals and diagnostics giant has seen an increased cash offer and an attempt to take over the gene sequencing company’s board of directors fail.

Roche’s Chairman, Franz Humer (pictured), has indicated that Roche is interested in discussions with other biotech companies that have similar platforms.

Roche’s pursuit of Illumina has been likened by industry observers to Gollum’s doomed quest for his “precious” ring.

It began at the start of 2012, with Roche offering $5.7bn to acquire the US company – an offer described by Illumina as “grossly inadequate”.

Roche extended its deadline by two months and then increased the offer to $6.8bn, citing a positive “market reaction”.

The pharma giant urged Illumina’s shareholders to support the deal by electing Roche representatives to the biotech company’s board of directors.

“As a standalone company, Illumina’s future is far from certain,” commented Roche’s CEO, Severin Schwan, at that time.

However, the Illumina board’s annual meeting did not elect a majority of Roche supporters, and Illumina CEO Jay Flatley called the bid “opportunistic”.

Despite the predictions of industry experts that a deal would be struck, Humer has announced that Roche is no longer pursuing the biotech firm.

The Illumina takeover was a “nice to have”, not a “must have”, he claimed, and Roche was considering other specialists – such as Life Technologies and Oxford Nanopore Technologies – to provide its diagnostics division with a less costly gene sequencing platform.

Meanwhile, Illumina reports 20% revenue growth in the last quarter. It plans to expand into the increasingly profitable field of cancer diagnostics and targeted drugs.

Pharmaceutical and diagnostics giant Roche has appointed a new General Manager for its UK operation.

Jayson Dallas rejoins Roche UK, where he worked from 1998 to 2000, after 12 years in senior roles at Pfizer, Novartis and Genentech (a Roche subsidiary) in the US.

His appointment follows John Melville’s retirement after 12 years as Roche UK’s General Manager.

After qualifying as a doctor in his native South Africa, Dallas gained an MBA in the UK and then worked as International Medical Medical Marketing Manager at Hoffmann-La Roche for two years.

He leaves the role of Head of Global Product Strategy, Immunology & Ophthalmology, at Genentech in San Francisco, where he led the company’s Global Oncology Launch Excellence and Biosimilar Readiness initiatives.

“I look forward to reconnecting with old colleagues and friends as I return to the UK,” Dallas said.

“The next few years will provide many opportunities for Roche UK and I am excited at the prospect of how we can ensure that more patients can benefit from our innovative medicines, as the access to medicines agenda still remains of critical importance.”

Now more or less recovered from the festive break, Maxine Vaccine looks forward to the creative and rewarding possibilities of partnership (strictly in the business sense).

January is the worst month of the year. Back at work, no money, not much daylight, freezing rain and the memory of a festive break that was one long hangover. More breakups happen in January than in the rest of the year put together. It’s enough to drive you to drugs – not the ones you sell, of course, because you already know how rubbish they are.

But never mind! The pharma industry is glowing with thoughts of partnership and fruitful collaboration. Valentine’s Day has come a month early. That nice Mr Cameron said that for the UK to become the world’s leading hub for life science research and development, industry and the NHS need to work ‘hand-in-glove’ to find new solutions to the world’s pressing health problems.

If you listen carefully, you can just hear a faint harmonica playing in the cold January wind, and that supernatural twelve-string guitar weaving its spell. Hand in glove... It’s like being a teenager again. But is it true? Does the sun shine out of our pipeline? Does it really all depend on how near you stand to me? (Having shared hotel lifts with too many hungover male pharma reps in the past, I devoutly hope not.)

This week, Merck CEO Kenneth Frazier (I would) declared: “The future of the industry is going to be more partnerships.” He noted that the use of combination therapies for viral and other conditions made partnership between pharma companies necessary. The company intends to augment its pipeline through acquisitions, he said. “Typically, for Merck, the sweet spot has been earlier rather than later.” I was always a first-date girl myself.

Also this week, Roche CEO Severin Schwan (I also would) said the company was looking to acquire innovative products in the rapidly growing field of stratified medicine, where targeted drugs are developed alongside diagnostics that can select patients with the right genetic profile. Roche’s 2008 $3.4 billion purchase of diagnostic company Ventana “would certainly be a size, if the right opportunity came up, that we would look at,” he said. Just remember to send a photo to my phone.

The good life is out there somewhere, so stay on my arm you little pharma... but we know how that song ends. And if the Queen is dead, you can’t expect much in the way of royalties. Still, keep in touch. And have a good year.

Note: the views of Maxine Vaccine are not necessarily those of Pharmaceutical Field.

The new UK life science strategy and NHS innovation review, launched by the Government this month, has been praised by the UK medical technologies sector for its promotion of innovative research and the rapid uptake of high-value technologies.

The NHS Chief Executive’s review Innovation, Health and Wealth: accelerating adoption and diffusion in the NHS outlines a number of measures the NHS will take to work in partnership with industry in order to implement effective new medical technologies throughout the NHS.

The document draws in attention, in particular, to the potential of telehealth systems to improve the management of long-term conditions, reducing hospital admissions and GP visits and so reducing the overall cost of care while improving patient outcomes, as demonstrated by the recent Whole Systems Demonstrator project.

Other areas of medical technology highlighted by the innovation document include the use of fluid monitoring in acute care and the use of assistive technologies, including wheelchairs, to improve the access of disabled people to working and other everyday environments.

Peter Ellingworth, Chief Executive of the Association of British Healthcare Industries (ABHI), the leading UK medtech trade association, said: “I welcome the Government’s focus on the life science industry. As highlighted by the Prime Minister our sector is part of ‘the virtuous circle of health, wealth and well-being’ – a real growth area for the Government as well as having the potential to make a difference to patients through the innovation we bring.

“Measures such as reform to the tariff system, enforcement of NICE guidance and the development of a procurement strategy, if done properly, could make a real difference to the medical technology sector.

“ABHI will work with the Government to make sure that the measures outlined in the Innovation Review are translated into firm actions. The measures could make a real difference to the SMEs in our sector and it is crucial that we are able to take advantage of them and continue to grow.”

Doris-Ann Williams MBE, Chief Executive of the British in Vitro Diagnostics Association (BIVDA) and a member of the Innovation Review’s External Advisory Group, commented that the Government’s announcements “represent a crucial opportunity for the life sciences sector” – and that the life science strategy and the innovation review in combination “will reinforce a genuine partnership between industry, the NHS and government.”

“To accelerate the use of innovative technologies to benefit patients and the NHS, tangible and realistic proposals were needed,” she added. “The NICE Implementation Collaborative, an innovation scorecard and a commitment to examine reimbursement mechanisms for diagnostics will all help the IVD industry to do what it needs to do to turn the vision into reality.”

Tony Davis, Chair of health technology business support organisation Medilink UK, noted that the new life science strategy “sets the stage for telehealth and telecare technologies to be made available to every person with a long-term condition or in need of care in the UK, helping them manage their health while maintaining their independence.”

“Medilink UK has been working with industry, other trade associations and the Department of Health to accelerate the roll-out of telehealth and telecare services in the NHS and social care, which will enhance the lives of three million people over the next five years,” he concluded.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

The NHS is not using high-value diagnostic imaging and radiotherapy equipment to its full capacity and is failing to meet patient needs as a result, according to a report from the Government’s Public Accounts Committee.

The report, ‘Managing high value equipment in the NHS in England’, stated that poor co-operation between trusts is leading to a “scandalous” shortfall in provision of vital services such as post-stroke scans.

NHS Supply Chain has said it is working with the DH to address the issues raised by the report and the “significant challenge” of procuring costly but much-needed equipment.

The NHS in England spends approximately £50m per year on MRI and CT scanners and linear accelerators for radiotherapy. However, the Committee said, the use of this equipment to provide services is “fragmented and uncoordinated”.

The number of CT scans carried out per machine in a year was found to vary between 7,800 and 22,000, with availability ranging from 40–100 hours per week.

Shockingly, the report found that only 50% of stroke patients received a CT scan within 24 hours – an essential service for determining immediate treatment.

Margaret Hodge, Chair of the Committee, said the way high-value equipment is bought and used by the NHS “is not providing value for money”. She described the shortfall in post-stroke CT scans as “scandalous” and the inequalities in usage between regions as “unacceptable”.

“The Department of Health has got to look at how machines can be used more efficiently to make the best use of scarce resources,” she concluded.

The report highlights the challenge for the new NHS Commissioning Board to ensure that Foundation Trusts work together to ensure access to capital equipment.

Health Minister Simon Burns commented that more streamlined procurement of scanners had already begun: “The NHS has saved up to 15% on scanners by working with NHS Supply Chain to co-ordinate large orders over time with other trusts. This is the NHS working smarter.”

“We are currently working with the Department of Health to consider the recommendations in the report,” said Andy Brown, NHS Supply Chain’s Managing Director for Diagnostics. “Buying and maintaining equipment during times of budgetary restraint will provide a significant challenge for NHS trusts and our range of frameworks to plan, aggregate, purchase or lease and maintain high-end equipment will be invaluable to the NHS.”

Healthcare giant Abbott plans to split into two companies: one in diversified medical products and the other in research-based pharmaceuticals.

The diversified medical products company will include medical devices, diagnostics, nutrition and generic drugs, and will retain the Abbott name.

The research-based drug company will cover Abbott’s existing portfolio of proprietary pharmaceuticals and biologics.

Abbott’s cardiac stents and other vascular devices have made the company a global leader in interventional cardiology.

Miles D. White, Chairman and CEO of Abbott, will remain Chairman and CEO of the diversified medical products company, which aims to be one of the largest and fastest-growing investment opportunities in this area.

The Abbott medical products company, whose current annual revenue is estimated at $22 billion, will continue to aim for double-digit growth and geographic expansion, particularly in emerging high-growth markets.

Its existing portfolio includes laboratory, point of care and molecular diagnostics and medical devices for cardiovascular, diabetes and vision care. It will develop an extensive and broad-based pipeline of medtech.

“Today’s news reflects another dynamic change in our company’s 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns,” said Miles D. White.

“Abbott will be one of the largest and fastest-growing global diversified medical products companies, with a compelling portfolio of durable growth businesses in medical technology, branded generic pharmaceuticals and nutritionals. We will continue to grow our product lines, market share and global presence, especially in emerging markets.”

The transaction will take the form of a tax-free distribution to Abbott shareholders of a new publicly traded stock for the new drug company.

Abbott currently employs nearly 90,000 people and sells a wide range of products in more than 130 countries.

Read more on this story on Pharmaceutical Field.

Abbott Laboratories has revealed plans to separate into two companies, one focusing on diversified medical products and the other in research-based pharmaceuticals.

The new medical products company will contain the company’s current portfolio and retain the Abbott name with the unnamed research-based business including its current portfolio of proprietary pharmaceuticals and biologics.

Miles D. White, Chairman and CEO, Abbott, says the split is a “significant event” in the history of the company whilst “strengthening our outlook for strong and sustainable growth”.

Abbott says the research-based company, which raised almost $18bn in annual revenue, and the diversified medical products firm, with approximately $22bn in annual revenue, will become global leaders in their respective industries.

The research-based arm will include all branded generic pharmaceutical, devices, diagnostic and nutritional businesses. Abbott says it will have a sustainable portfolio of brands, including Humira, Lupron, Synagis, Kaletra, Creon and Synthroid, as well as a pipeline of innovative R&D assets.

Developed markets are expected to generate the majority of the company’s revenue with a sustained portfolio and advancing pipeline having the potential to deliver “accelerating revenue” in the future, Abbott says.

Its new diversified business will include established brands from its four main divisions: pharmaceuticals, nutritionals, diagnostics and vascular devices, where it says it is now the global leader in interventional cardiology.

Abbott believes it will be one of the “largest and fastest” investment opportunities with nearly 40% of sales coming from high-growth emerging markets.

Miles D White will continue as Chairman and CEO of Abbott with Richard A Gonzalez, currently the Executive Vice President, Global Pharmaceuticals, taking on the positions of Chairman and CEO of the unnamed company.

“The research-based pharmaceutical company will be a leader in its industry with a strong and sustainable portfolio of specialty medicines and a promising pipeline of future products,” said Mr. Gonzalez. “This business has been delivering market-leading performance and is well positioned for future success.”