AstraZencca (AZ) is to cut 1,600 jobs in a global restructuring of its R&D operation, including 700 UK jobs and 650 in the US.

In the UK, AZ will shut down its R&D operations at Alderley Edge and relocate over 1,000 jobs to a new global HQ in Cambridge.

In the US, it will shift its Global Medicines Development Group from Delaware to Maryland.

The restructuring, which will take three years to complete, will concentrate the company’s R&D operations in three key global centres.

It follows a quarter in which global sales fell by 16% due to patent expiry – and while AZ continues to see R&D as a vital function it is keen to reduce costs.

AZ’s long-term growth has resulted in a structure that Mene Pangalos, Executive VP for Innovative Medicines, described as “too spread out and too diffuse”.

Research work at the Alderley Park site, which Zeneca took over in 1993 as a divestment from ICI, will cease. Some 700 non-R&D roles will remain at the site, while 1,600 R&D roles will be relocated and 550 will be cut.

This decision contrasts with the prospect in October 2012, when AZ secured a £5m grant from the Regional Growth Fund to develop a bioscience park at Alderley Park and Martin Mackay, AZ’s President of R&D, claimed: “Alderley Park is a site of critical importance to our global R&D organisation.”

The current decision to focus R&D in Cambridge reflects the growing importance of biotech clusters for global pharma.

Pascal Soriot (pictured), CEO of AZ, commented: “Cambridge, which boasts strong links with London-based research institutions, is a world-renowned bioscience hotspot that rivals the likes of San Francisco and Boston.

“I believe the investment greatly increases the chances that the next generation of innovative medicines will be invented and manufactured in Britain.”

The global market in statins, once the pharmaceutical industry’s lead blockbuster products, is predicted to decline by 40% in the next five years.

The forecast by GBI Research of a negative CAGR of 7.2% up to 2013 for the cholesterol-lowering drugs is based on prospects of generic erosion, weak pipelines and failing prescriber confidence.

The decline in the statins market shows that the shift of healthcare towards prevention and management of long-term conditions is not without pitfalls for the pharma industry.

Statins, which lower cholesterol levels by targeting an enzyme in the liver, have been hailed as ‘wonder drugs’ that could radically reduce the global incidence of cardiovascular events.

Routinely prescribed for ‘high-risk’ patients such as people with high blood pressure or diabetes, statins have also been linked to reduced risk of bowel cancer and reduced death rate from influenza.

However, their global market declined from $23.7 billion in 2004 to $20.5 billion in 2011 (a negative CAGR of 2.5%), due largely to patent expiry.

The report predicts a much steeper decline in the statins market over the next five years, for four reasons:

• Patent expiry – the generic share of the statins market is predicted to grow from 11% in 2011 to 34% in 2018.

• Austerity health budgets – spending on prevention is likely to be cut back.

• Weak product pipelines – the ‘me-too’ nature of most statins betrays a lack of potential for innovation.

• Increased use of alternative drugs.

Medical writer Ben Goldacre has argued that the marketing of statins in terms of relative risk reduction glossed over the low absolute risk reduction they offer, and left the products open to a backlash over side-effects.

Statins are associated with both symptomatic side-effects (including digestive disorders) and potential ones (including increased risk of type 2 diabetes).

As the overall statins market declines, the report says, individual products will struggle to gain or keep a place within it: “The global statins market has reached the competitive stage of its lifecycle, with many branded and generic drugs competing with each other on price.”

Bristol-Myers Squibb’s anti-platelet therapy Plavix (clopidogrel) has become the latest blockbuster to lose patent protection in the US.

A mainstay of heart disease treatment since 1997, Plavix faces immediate generic competition from Cardinal Health.

BMS, who markets Plavix in partnership with Sanofi, has said it will cease promoting the drug immediately following patent expiry.

Used together with aspirin, Plavix is the standard blood-thinning therapy for people who have suffered a heart attack.

The product earned BMS $7.1bn in 2011, a third of the company’s revenue.

BMS has decided not to follow the example of Pfizer, who promoted Lipitor extensively for six months after its US patent expiry, because the usual six-month exclusivity to one generic supplier will not apply.

The reason is that the first authorised supplier of generic clopidogrel, Apotex, forfeited its exclusivity period due to unlicensed sales in 2006.

As a result, seven companies have already received tentative approval to sell generic clopidogrel in the US. Cardinal Health plans a next-day launch. A spokesman for Sun Pharmaceutical Industries said the company would lose no time: “I would not be surprised if there was a stopwatch involved.”

BMS’s 2011 annual report predicted “a rapid, precipitous and material decline in Plavix net sales” following expiry of its US patent.

The company has developed a new blood-thinning drug, Eliquis, in partnership with Pfizer. Its FDA approval for stroke prevention is expected in June.

The Association of the British Pharmaceutical Industry (ABPI) has launched a new regional partnership team to build relationships with the NHS.

The team of five industry professionals will work with the SHA clusters to develop regional partnership projects and promote patient access to innovative medicines.

At the ABPI’s annual conference in London, where the new team was announced, ABPI Chief Executive Stephen Whitehead placed emphasis on the role of partnership in supporting medical innovation.

The role of the partnership team builds on the recommendations of the Government’s Innovation Health and Wealth report to improve the adoption and diffusion of innovative medical products and services.

The team will consist of five experienced industry professionals: one for each of the four SHA clusters in England and a fifth to provide strategic oversight. They will work to promote innovation and healthcare improvement at a regional level, not specific companies or products.

Stephen Whitehead said the partnership team would “make an invaluable contribution to the work of the NHS and the pharmaceutical industry”.

He added that “I firmly believe partnership working is the future of healthcare in the UK,” and predicted the new initiative would “signal the beginning of many more projects” in which the industry and the NHS would work together to improve healthcare.

“We are pleased to support this new initiative and we look forward to working with our partners in the pharmaceutical industry to encourage the adoption and diffusion of new medicines that help improve the lives of patients,” commented Mike Farrar, Chief Executive of the NHS Confederation and a longtime champion of joint working.

“In our ongoing work with the ABPI and ABHI, I have witnessed first-hand how working as a team can deliver significant patient benefits above and beyond what can be delivered by any party in isolation. That is why I am firmly behind greater partnership working.”

Whitehead also placed the new partnership in the context of a drive to ensure that the NHS embraces innovative medicines as part of the solution to the crisis of increasing need and shrinking budgets.

In a memorable statement, he told the conference: “Generic medicines do save us money, but it is innovation that saves lives. We have to be careful not to focus on cost saving when we should be focusing on patients. The effective use of innovative new medicines can often reduce costs elsewhere in the healthcare system by reducing the need for expensive primary and secondary care.

“In fact, with diseases like Alzheimer’s placing an increasing burden on NHS resources, the development of new medicines by the pharmaceutical industry will be pivotal in not only fighting disease but ensuring the financial burden they impose doesn’t cripple the healthcare system.”

Recent figures, he said, show that NHS spending on new medicines is rising at a much slower rate than its spending on generics. The NHS will save £3bn from 2010 to 2014 due to patent expiry – but if those savings are not reinvested in innovative medicines, both the industry and medical care will be held back.

He concluded: “If we do not create the right environment for innovation in the UK, we will run the very real risk of failing to develop treatments which address the challenging disease burdens we face in the future.”

Whitehead’s statement strongly backs up the industry strategy of beating the recession through pipeline development (recently voiced by the leaders of GSK and Eli Lilly), calling on the NHS and other health provider systems to look beyond cost-cutting to the value of better healthcare.

Teva UK has launched generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel and the extended-release Seroquel XR on the first day of patent expiry.

The launch follows the decision by a UK court that the patent on Seroquel XR, extending the brand’s exclusivity, is not valid.

The new generic Quetiapine and Quetiapine (Sondate) XL were also launched on the day that AZ lost its appeal against the FDA’s decision to allow generic competition to Seroquel in the US.

Quetiapine is indicated for treatment of schizophrenia and moderate to severe manic episodes, while Quetiapine XL is indicated for treatment of schizophrenia and bipolar disorder and for adjuvant treatment of major depressive disorder in patients whose response to antidepressant monotherapy is sub-optimal.

Both generics are available on Teva’s PriceWatch service, which matches the lower of Teva’s list price and the month’s average market price.

Kim Innes, Teva UK’s Commercial Director, said: “With the launch of Quetiapine and Quetiapine XL, we’re making more medicines accessible for more people. Launches like these help towards saving the NHS over GBP9bn on generic prescriptions.”

The Seroquel brand accounted for 17% of AstraZeneca’s revenue in 2011, with sales of $5.7bn including Seroquel XR sales of $1.49bn. The Seroquel patent cliff in Europe and the US is expected to impact severely on AZ in 2012.

Teva UK is part of Israel-based Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer.

AstraZeneca’s patent on an extended-release version of its blockbuster antipsychotic drug Seroquel (quetiapine) has been ruled invalid by a British court.

The patent would have given Seroquel a new lease of patent exclusivity in the face of generic competition from Teva and other companies.

The decision comes nine days after AZ’s decision to sue the FDA for allowing generic competition to Seroquel in the US.

The UK patent on Seroquel expires on 23 March 2012. The formulation patent of AZ’s extended-release version, Seroquel XR, would last until May 2017.

The Seroquel XR patent was challenged by Accord Healthcare, Intas Pharmaceuticals, Hexal and Sandoz and Teva UK, leading to a court ruling that the patent is invalid in Britain.

The company’s share value fell by half a percent in London following the verdict.

AZ filed suit against the FDA on March 13, seeking to block the agency from allowing generic competition to Seroquel in the US until December 2 2012.

Seroquel is facing patent expiry in the US from March 26, with generic versions due to be released on the same day.

The Seroquel brand accounted for $5.7bn, 17% of the company’s total revenue in 2011, with Seroquel XR sales totalling $1.49bn.

AstraZeneca is anticipating a revenue drop of more than 10% in 2012, largely due to the Seroquel patent cliff in Europe and the US.

Arrow Generics UK has launched generic versions of AstraZeneca’s Zomig (Zolmitriptan) and Zomig Rapimelt (Zolmitriptan Orodispersible) in the UK and France.

Arrow, part of the Watson Group, released the generics after the patent expired for the two treatments indicated for patients with migraine headache with or without aura.

Last year, the two treatments had sales in the UK and France of around $107 million in the two markets, according to IMS Health data.

The two generics are also set to be launched in the Nordic region later this month on the date of expiry.

Joining Zolmitriptan and Zolmitriptan Orodispersible, Arrow has also launched a generic alternative of GSK’s Naramig (Naratriptan) – indicated for the same condition.

Ranbaxy has launched its generic version of Pfizer’s Lipitor in four major EU markets with temporary exclusivity.

The Indian company’s generic atorvastatin has been launched in Germany, Italy, Sweden and the Netherlands ahead of its EU patent expiry in May.

The launch follows a 2008 agreement with Pfizer that Ranbaxy could launch its generic atorvastatin exclusively while Lipitor was still protected, in return for dropping a patent challenge.

Ranbaxy launched its generic version of the cholesterol-lowering drug in the US in November 2011, with a 180-day exclusivity period that is now ending. The generic caused fourth-quarter US sales of Lipitor to fall by 42% relative to the same quarter in 2010.

The market for statins remains highly lucrative despite concerns over their potential side-effects, including an increased risk of type 2 diabetes. Lipitor is the highest-selling drug in Italy, with annual sales of $377m.

Ranbaxy will sell its generic atorvastatin in Germany through its subsidiary Basics GmbH, with marketing assistance from Daiichi Sankyo.

From the end of May, other companies will be able to launch generic versions of Lipitor in the EU.

Belgian biopharma company UCB has predicted that patent expiry will strongly affect its European growth in 2012.

While UCB’s blockbuster epilepsy drug Keppra faced little generic competition in Europe following its patent expiry in 2011, the company predicts a 50% sales fall for the product in 2012.

However, the company’s CEO said its focus on severe diseases of the immune system and CNS has helped to insulate it against economic austerity.

UCB saw its revenues rise by 1% to €3.25bn in 2011, but predicts a fall of nearly 5% to €3.1bn in 2012.

According to a UCB spokesman, Keppra faces competition from more than 100 generic substitutes in 2012, and its European sales can be expected to fall by 50%.

Delays in the launch of generic alternatives protected Keppra in 2011, when its global sales increased by 3% despite its patent expiry.

UCB’s CEO, Roch Doliveux, said that its commitment to therapy areas such as epilepsy and immunology had shielded the company from the impact of European austerity: “We still have the means in Europe for many years to come to pay for severe healthcare issues, and that’s what we’re addressing.”

Last year, UCB benefited from increased sales of three products: Vimpat for epilepsy, Neupro for Parkinson’s disease and restless legs syndrome, and Cimzia for Crohn’s disease and rheumatoid arthritis (RA).

Doliveux also argued that value-based pricing – due to be adopted by the NHS in 2014 – is not a good model to support innovation. He argued that the current PPRS system is “a very robust system that a lot of countries have tried to copy, and PPRS works well.”

Among non-UK companies, UCB is the leading non-British investor in UK pharmaceutical R&D.

The European biosimilars market is expected to reach nearly $4 billion by 2017 after the expiration of patents and other intellectual rights opens new opportunities, a new report predicts.

Frost & Sullivan’s Analysis of European Biosimilars Market predicts the industry will record annual growth of more than 50% in the next five years as physicians and patients search for cheaper medication.

Srinivas Sashidhar, a Frost & Sullivan Research Analyst, says the next decade “opens up opportunities for biosimilars to enter the market and increase industry competition”.

The report notes that the biosimilars manufacturing industry is at a nascent stage. The market earned revenue of around $172 million in 2010, research found.

However, while there are plenty of opportunities for growth, the market will require sizeable investment – especially smaller firms. Complex production processes, expensive materials and rigorous clinical trials require significant investment, the report adds.

“The need for considerable financial outlays will hinder the entry of small biotech firms in particular,” warns Mr Sashidhar. “On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market.”

Another obstacle the market faces is high manufacturing costs. But, the report says, viable prospects for licensing agreement between companies should overcome this. “Access to sales and marketing capabilities can be achieved through collaborations between pharmaceutical companies and specialty biotech firms with technical expertise,” said Sashidhar. “Companies can build sales and marketing capabilities in-house and ensure effective marketing support for the commercialisation of biosimilars.”

If the market is to realise its potential in the next decade, the report advises effective sales communication to the scientific community, coupled with continuous promotional activities as well as close and constant interaction with doctors and pharmacists.