Patent and trademark firm Harrison Goddard Foote (HGF) has recruited AstraZeneca’s Principal Patent Attorney as its new Patent Director.

Mike Nelson has joined HGF’s pharmaceutical team, based in its Leeds office, where his industry experience will assist clients in building a commercial development strategy around their patents and brands.

HGF covers intellectual property (IP) protection for new drug molecules, formulations, drug delivery technologies and life cycle management.

Jonathan Couchman, a partner at HGF, commented: “In pharmaceuticals, we are one of a few European IP firms able to provide high level commercial and technical excellence to the industry, and with Mike Nelson we can build further on this existing platform, especially in commercial strategy.”

“HGF is currently one of the fastest growing intellectual property specialists in the UK,” said Mike Nelson. “This growth stems from its proactive approach and understanding of its client’s business needs. Together with the considerable technical expertise and industrial experience of its attorneys, HGF provides clients with an unrivalled intellectual property service.”

HGF advises on all aspects of IP from its offices in Aberdeen, Glasgow, Edinburgh, Leeds, London, Birmingham, Oxford, Manchester, Sheffield and York. It has six specialist business groups including pharmaceuticals.

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.”

The NHS is placing too much emphasis on ‘breakthrough drugs’ rather than on diverse and incremental innovation, according to the ABPI.

An updated report on pharmaceutical innovation commissioned by the UK trade association warns that by focusing on unique medical solutions, the NHS risks narrowing the scope of medicines.

ABPI Chief Executive Stephen Whitehead (pictured), launching the report, commented: “I fear for the future of UK medical research.”

The Many Faces of Innovation was commissioned by the ABPI from the Office of Healthcare Economics, updating a 2005 report commissioned by EFPIA.

As well as providing new case studies, the updated report places pharmaceutical innovation in the context of the UK health economy of 2012.

The report attacks the dichotomy between ‘breakthrough’ and ‘me-too’ products, arguing that innovation can be incremental – especially where ‘stratified’ medicine is concerned.

In addition, innovation has several dimensions: it could bring “advances in health gains”, “cost savings in health services” or “advances in patients’ and/or carers’ convenience”.

Finally, medical research benefits from multiple companies tackling the same problem – so it’s not helpful for there to be only one ‘winner’.

The report implicitly criticises NICE for assuming that each medical problem has one ‘best’ solution and that ‘value’ has a single metric.

The forthcoming medicine pricing negotiations will mark a watershed for the industry, Whitehead said: “If we minimise the reward for innovation in the UK, then our manufacturers will go abroad. Our industry, our economy, and our healthcare system will suffer – UK patients will suffer.”

India and China are set to become the drug industry’s global hubs for Contract Manufacturing Organisations (CMOs).

The governments of both countries have changed their business and regulatory frameworks to encourage pharmaceutical outsourcing from other countries.

A new report from business intelligence source GBI Research says the global drug CMO market will grow steadily as Western pharma companies outsource their production to Asia.

The global drug CMO market is predicted to grow from $26bn in 2010 to $60bn in 2018, with outsourcing of biologics and generics being the main growth areas.

India and China in particular have benefited from the development of factories that meet global regulatory criteria for drug manufacturing.

In 2005, India’s Biotechnology Policy simplified procedures for regulatory clearance and granted exemptions from import duties and service taxes, while a new patent regime made it easier for pharmaceutical companies to protect their intellectual property rights in India.

China’s State Food and Drug Administration (SFDA) has stated contract drug manufacturing to be a long-term economic goal. The legal framework for contract manufacturing in China on behalf of countries outside China was introduced in 2001 and refined in 2003.

Sherilyn McCoy, vice-chairwoman of Johnson & Johnson’s pharmaceuticals division, has quit pharma to become CEO of cosmetics giant Avon.

McCoy, who has been with J&J for 30 years, was considered a leading contender for the CEO role in February but was passed over in favour of Alex Gorsky.

The pharma industry veteran will need to turn Avon around: the iconic brand has been dogged by falling profits and a bribery investigation, and recently turned down a $10bn buyout offer from fragrance company Coty.

Fred Hassan, Avon’s lead director, said: “The board conducted an extensive search among many world-class candidates, and Sheri emerged as the clear choice to take Avon into the future.”

He praised McCoy’s “strategic and finely honed operational skills, significant turnaround track record, global experience and people leadership” as well as her “consistent record of outperforming against new challenges”.

At J&J, McCoy rose through various executive roles over 27 years to become chairwoman of the pharmaceuticals division in 2009, successfully focusing it on new products in areas of unmet medical need (including stroke prevention and prostate cancer) to see it through the patent expiry of several key products.

Though widely tipped to replace Bill Weldon as CEO this year, McCoy lost out to Alex Gorsky, vice-chairman of J&J’s executive committee.

“I am extremely honored and excited to join Avon – a great company with an iconic brand and so much clear potential,” said McCoy. “I look forward to working with the team to develop and execute a roadmap to achieve the next phase of growth for the company.”

McCoy replaces Andrea Jung, the longest-serving female executive of a Fortune 500 company, who commented: “We are thrilled to have someone of Sheri’s caliber assuming the leadership of Avon.”

Abbott Laboratories has given the name AbbVie to the research-based pharmaceuticals business it intends to spin out later this year.

The division of Abbott into two separate companies, one for pharmaceuticals and one for diversified medical products, was announced in October.

The Abbott brand name will stay with the medical products company.

“The beginning of the name connects the new company to Abbott and its heritage of pioneering science,” explained Richard Gonzalez, Chief Executive of AbbVie. “The ‘vie’ calls attention to the vital work the company will continue to advance to improve the lives of people around the world.”

AbbVie’s product portfolio, which includes such major brands as arthritis drug Humira, HIV drug Kaletra and cholesterol-lowering drugs Tricor and Niaspan, brings in almost $18bn per year in revenue.

The new company also has R&D assets in hepatitis C treatment, immunology, chronic kidney disease, women’s health, oncology and neuroscience, including four projects currently in phase III.

This strong pipeline is expected to help it survive the loss of patent protection for Humira, Tricor and Niaspan between now and 2012.

The Government’s new strategy to support growth in the life sciences and innovation in healthcare aims to have industry working ‘hand-in-glove’ with the NHS to change care pathways and transform service delivery. Is this the new deal that the pharma industry has been waiting for – or just a sweetener for the medicine of NHS spending cuts?

The Government’s new strategy for the UK life sciences was presented by Prime Minister David Cameron to an audience of leaders from pharma and other life science sectors. Cameron announced measures to support early-stage research, make more NHS patient data available for clinical trials and improve the implementation of NICE guidance. He stated: “The endgame is for the NHS to be working hand-in-glove with industry as the fastest adopter of new ideas in the world.”

The background to the new strategy is complex. It builds on the ‘blueprint’ published in 2009 by the Office for Life Sciences, a ‘virtual department’ launched by the previous Government. The dissolution of the OLS and the abolition of the Regional Development Agencies had left a gap in the life science innovation landscape which the new strategy aims to fill.

In addition, the strategy is a response to calls from the Work Foundation and other expert sources for more investment in the ‘knowledge-based industries’ – and to a growing recognition of the clinical and commercial potential of ‘stratified medicine’: personalised drugs and companion diagnostics based on the new technology of genetic profiling.

Finally, the strategy seeks to improve the confidence of life science companies in the UK market at a time of upheaval and hardship. NHS spending will be subject to unprecedented constraints, and the envisaged growth of private healthcare will not rapidly counter the impact of this on the market for medical products. By promising a better commercial environment for life science companies in the UK, the Government hopes to stop the industry taking its business elsewhere.

From research to market
In December 2011, the Government published two closely related strategy documents: Strategy for UK Life Sciences and Innovation Health and Wealth: Accelerating adoption and diffusion in the NHS. The two documents came from different departments (the BIS and the DH respectively) and will be implemented through separate arrangements, but are two sides of the same coin.

The Strategy document speaks of the need to place the UK at the forefront of global medical R&D. Key measures announced include:

• In early 2012, MHRA will consult on proposals for a new Early Access Scheme to ease the route to market for ‘breakthrough therapies’.
• The Government will invest £180m in a new Biomedical Catalyst Fund to support early-stage research and a further £130m specifically to support R&D in stratified medicine.
• Pending consultation, the NHS constitution will be amended to allow companies conducting “approved research” to use anonymised NHS patient data, and to approach patients who may be eligible to participate in clinical trials.

The document notes that the UK life science industry (pharmaceuticals, biotechnology and medical technology) “is growing faster than the economy as a whole and is a key source of high-skill, high-tech jobs”. However, it comments that the time and cost of developing new treatments are increasing rapidly, and that the industry’s reliance on huge research establishments is not sustainable as products and their markets become more specialised.

Life science companies, the document promises, “will be able to operate in a streamlined regulatory framework, enabling quick entry to the market for new discoveries and innovations”. The Government will “nurture innovation through the translational funding gap,” and more generally will work to build “a life sciences ecosystem” that integrates the academic, industry and clinical sectors.  

Investments in clinical research infrastructure include the establishment of a new Cell Therapy Technology Innovation Centre in London; a new technical hub for bioinformatics in Cambridge; a number of academic health science networks across the country; and a national NIHR ‘Bioresource’ that builds on the existing facilities.

The £130m investment in stratified medicine by the Medical Research Council will consist of: £60m over three years to investigate disease mechanisms, particularly for chronic diseases; 60m over the next four years to support collaborations between academia, industry and clinicians to develop targeted treatments; and £10m to support work with AstraZeneca, who have made 22 compounds available to academic researchers.

The £180m Biomedical Catalyst Fund, invested by the MRC and the Technology Strategy Board, is intended to “nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms”. The document refers to the ‘open innovation’ model, whereby companies engage with partners in a wider R&D environment.

The Government will introduce a new Seed Enterprise Investment Scheme in 2012 offering 50% income tax relief on investments in small early-stage companies. In 2013, it will introduce an above the line R&D tax credit to attract large-scale investment in innovation.

The proposed new Early Access Scheme for ‘breakthrough’ drugs would typically be “available for drugs prior to authorisation but at the end of Phase III trials”, but could be extended to an earlier stage in some cases. The scheme would give patients access to drugs (and ensure reimbursement) where “there is a high unmet clinical need”, the likely benefits outweigh the known risks, the product is cost-effective for the NHS, and “the UK economy” will benefit.

In general, the measures outlined in the Strategy document shift the goalposts for the pharma industry only slightly, but could make a significant difference to some companies and R&D initiatives. They will promote the development of stratified and personalised medicine – and while the additional funding is very limited, the various measures could add up to a change in the innovation climate.

Changing patient pathways
The Strategy document argues that to facilitate innovation, the NHS needs to be “the ‘pull’ behind the industry ‘push’ for new therapeutic innovations”. The Innovation document expands on that statement, detailing measures to improve patient access to significant new therapies. It places more overt emphasis on medical devices than on drugs, but has major implications for the pharmaceutical sector.

The foreword by Sir David Nicholson, NHS Chief Executive, calls for a “commitment to innovation” in the NHS. He lists several opportunities open to the NHS to pioneer new treatments, including the “revolution in genome sequencing to monitor cancer and deliver personalised treatments; and to transform the detection, diagnosis and treatment of infectious diseases”.

The document states the economic case for innovation, both within healthcare (as a means of delivering care more cheaply and effectively) and in a wider context (by creating business growth and export opportunities). It emphasises the concept of the ‘value proposition’, whereby price is based on the value delivered by the product in use, including any changes it enables in the care pathway.

A number of priorities are identified for improving the climate for innovation in the NHS: reducing variation, compliance with NICE guidance, incentives, investment, procurement and adoption of ‘high impact innovations’. The document sums these up by saying: “We need an entirely new relationship with industry based on partnership, not just transactions.”

For the pharma industry, the most important changes outlined relate to NICE appraisals. The Government plans to:

• Introduce a NICE Compliance Regime to ensure rapid and consistent implementation of NICE guidance.
• Require that NICE technology appraisal recommendations are incorporated into relevant local NHS formularies in a planned way.
• Establish a NICE Implementation Collaborative, including industry representatives, to support prompt implementation of NICE guidance by helping NHS organisations to develop solutions and helping companies to optimise their value proposition to the NHS.

The Government will develop the tariff further in the direction of payment for outcomes. It will double its investment in the Small Business Research Initiative, and improve the protection of intellectual property. The NHS Confederation will work with the ABPI and the ABHI to establish an Innovation Pipeline Project that will drive “the adoption and diffusion of proven technologies in areas of high clinical need”. Finally, the new Clinical Commissioning Groups (CCGs) will have “a legal duty to promote innovation”.
The document concludes that having “a single model for driving transformation and change” will “avoid the problems of fragmentation and duplication that have previously beset the system”. Despite the impressive measures that precede it, this statement may give industry pause for thought. In an increasingly fragmented and diverse NHS, with Foundation Trusts competing for business and CCGs facing severe budgetary pressures, how can a single model for the adoption of innovation be either defined or enforced?

Deal or no deal?
Much of the Government’s life science strategy is aimed at emerging SMEs in the biotech and medtech sectors, rather than pharma companies (which tend to be larger and better-established). However, as drugs become more specialised and targeted, the dividing lines will blur – and what benefits a small biotech firm may benefit a pharmaceutical partner or parent company. Open innovation is the key to personalised medicine, and expertise is increasingly transferable between sectors.

The measures outlined in the Strategy document have less for the pharma industry than might at first appear, but the reverse is true of the Innovation document. In combination, they represent a significant initiative for the industry. There are opportunities for pharma companies in the stimulus offered to stratified medicine; in the emphasis on the value proposition and the patient pathway; in the prospect of early patient access to certain drugs; and in the more effective implementation of NICE guidance. The sharing of NHS clinical data with companies, which dominated press coverage of the new strategy, will also be of value.

What neither document explains is how the strategy will play out in a health system where private health providers play an increasingly major role, both in providing NHS care and in providing alternatives to what the funding-starved NHS can afford. A few days after launching the life science strategy, the Government passed legislation allowing NHS hospitals to allocate 49% of their beds to private patients. The new health providers may be crucial in determining whether the strategy is truly a new deal for industry or just a bribe.

Global healthcare giant Covidien has appointed Mark Trudeau, currently CEO of Bayer Healthcare, as the President of its new pharmaceuticals business.

Trudeau, who has also been appointed a senior VP of Covidien, will lead the company’s pharma segment in its development as a separate US company with a new name.

He succeeds Matthew K. Harbaugh, Chief Financial Officer for Pharmaceuticals, who has been interim President since November 2010 and will continue as CFO of the business.

Covidien’s pharma business is a leading supplier of generics, opioid pain medications and bulk paracetamol, and is expected to focus on the growing pain management drug market.

With a US background and 25 years’ experience in the pharma industry, Trudeau is President and CEO of Bayer Healthcare, and also of Bayer Healthcare Pharmaceuticals US Region. He was formerly interim President of Bayer’s Specialty Medicine Global Business Unit.

Trudeau worked at Eli Lilly and Abbott Laboratories before joining Bristol-Myers Squibb, where he served in a number of marketing and regional management roles before becoming a Senior VP and General Manager of the BMS Immunology Division.

“Mark has an impressive track record of success in the pharmaceuticals industry, including valuable experience outside the US,” said José E. Almeida, President and CEO of Covidien. “We are delighted he is joining Covidien to lead the Pharmaceuticals segment, where he will play a critical role in fulfilling our vision of delivering unmatched value to our customers.”

Based in Dublin, Ireland, Covidien is a leading global supplier of pharmaceuticals, medical devices and medical supplies. In December 2011 the company announced plans to spin off its pharma business into a stand-alone public company via distribution of stock to its US shareholders. The transition is expected to be complete within 18 months.

Biotech company Amgen and pharma company Watson Pharmaceuticals are collaborating to develop and commercialise a number of biosimilar antibody-based products in the oncology field.

Amgen will develop the products with funding and expert support from Watson, who will also manage their commercialisation.

The products developed through the collaboration will be sold under a joint Amgen/Watson label.

Founded in 1980, Amgen was one of the first biotech companies to take new therapies all the way from the laboratory to the patient. Watson is an integrated global specialty pharmaceutical company focused on urology and women’s health.

According to the two US companies, the collaboration demonstrates that biosimilars are distinct from generics, requiring more infrastructure and expertise for their development.

Under the terms of the agreement, Amgen will take primary responsibility for developing, manufacturing and launching the biosimilars. Watson will contribute up to $400 million in co-development costs, providing development support and sharing risks.

Watson will also manage the commercial life cycle of the biosimilars, and will receive royalties from product revenues and sales milestones.

“The pairing of Amgen's 30 years of experience in biologics together with Watson’s substantial generics and specialty pharmaceutical experience and complementary commercial and distribution capabilities provides great potential for worldwide patient access to high-quality oncology biosimilar medicines," said Amgen President Robert A. Bradway.

Paul Bisaro, Watson’s President, commented: “This collaboration places Amgen and Watson in an unparalleled position in the global biosimilars market by capitalising on best-in-class capabilities in both innovative biologics and specialty pharmaceuticals and generics.

“We believe that biosimilars are the next frontier in the evolution of the healthcare market, and we are prepared to bring all of our resources to bear in this collaboration to ensure this partnership can most effectively compete in the biosimilar space.”