The largest manufacturer of the generic version of Lipitor has been forced to halt production after glass particles were found in certain batches of tablets.

The US FDA announced that Ranbaxy Pharmaceuticals had ceased production of atorvastatin after fragments the size of sand contaminated the popular generic.

Ranbaxy, a subsidiary of Daiichi Sankyo, said “the probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out.”

More than 40 batches of the generic have now been recalled, although the FDA said it had not received any reports of patients being harmed by the contamination.

The New Jersey-based company (part of India-based Ranbaxy Laboratories) declined to reveal where the contaminated drugs were manufactured or why the problem occurred. However, the FDA said that the company has now stopped making the pill’s active ingredient – which is made in India – until an investigation has been completed.

It is not the first time that the quality of Ranbaxy’s products has come under scrutiny. The company has been working under a US court-ordered consent decree after a number of manufacturing issues were found at sites in America and in India. The decree prevents Ranbaxy from producing any more medication at these sites until it meets US standards.

Ranbaxy became one of the first generic manufacturers of the cholesterol lowering Lipitor when the blockbuster drug lost patent protection in November 2011. It now holds a market share of approximately 43%, according to IMS Health data.

Nearly half a billion pounds will be cut from the NHS drugs budget as part of the QIPP savings agenda, according to a new DH report.

Forecasts included in The Quarter, a report which reviews NHS QIPP targets, predict that up to £477m will be saved from the prescribing budget by April 2013.

Savings will be generated by a number of treatments losing patent protection in 2011/12 allowing the NHS to purchase cheaper generic alternatives.

AstraZeneca’s Seroquel (quetiapine) and Pfizer/Eisai’s Aricept (donepezil) are two products used throughout the NHS which recently lost patent protection. Pfizer’s Lipitor (atorvastatin), one of the biggest components of NHS drugs expenditure, came off-patent in May and will also contribute to the savings.

The report shows that the NHS saved £1.2bn in the first quarter of the financial year and is on track to meet its £5bn savings target this year. Cutbacks on drugs spend are predicted to be the second biggest saving behind efficiencies coming from acute services.

The expected £477m savings is down on the £700m saved on the medicines bill the year before – when the NHS made £5.8bn of savings through the QIPP agenda.

Teva has cancelled its plans to join the already crowded market for atorvastatin, the generic version of Pfizer’s fading blockbuster Lipitor.

The global generics leader will collaborate with Indian companies Ranbaxy and Dr. Reddy’s to promote the cholesterol-lowering drug in the US market, without offering its own version.

The decision, according to Teva, came down to two factors: increasing competition and limited manufacturing capability.

Since Lipitor’s patent expiry in November 2011 (US) and May 2012 (EU), eight companies (including Pfizer) have launched generic versions of atorvastatin.

In addition, the drug was likely to dominate Teva’s manufacturing facilities for active ingredients and pill formulations.

Pfizer has stopped marketing Lipitor where its patent has expired, meaning that the brand’s $13bn annual revenue is up for grabs.

Teva Americas CEO William Marth said: “It’s a tough decision, a hard decision not to launch at this time. That doesn’t mean that sometime in the future we may not launch atorvastatin.”

Referring to the challenge of manufacturing the world’s most widely prescribed drug, he added that the reason for the decision was “when we looked at our product, we only had it in the 30-tablet bottle”.

Ranbaxy has earned $600m from atorvastatin in the US under the company’s 180-day exclusivity period (now expired) as the first generic supplier. Half of that went to Teva by agreement.

A generic formulation of Pfizer’s blockbuster Lipitor (atorvastatin) has been launched in the UK on the first day of its patent expiry.

Indian pharmaceutical company Ind-Swift, in collaboration with its marketing partner Wockhardt UK, wasted no time in releasing the drug to gain market share.

Sirjiwan Singh, Wockhardt UK Managing Director, said the generic’s prompt launch was down to the partnership between the two companies.

“With increase in demand for cost effective drug for cardiovascular diseases, this generic launch is an excellent example of collaboration efforts of the two companies in leveraging on mutual strengths and competencies,” he said.

Lipitor, used for the treatment of high cholesterol and the prevention of heart attack, is the best selling drug in pharmaceutical history.

Pfizer recently admitted defeat in its fight against generic competition against the drug when it decided to cease marketing the product in the US. However, it is still expected to promote Lipitor in emerging markets, where increased demand may still generate billion dollar sales.

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.

Pfizer has dropped attempts to market its cholesterol-lowering drug Lipitor (atorvastatin) in the US, nearly five months after its patent expiry.

The company said its post-expiry marketing campaign had been successful, but generic erosion of the Lipitor brand would soon escalate.

The decision is a milestone in the history of the world’s best-selling drug, used to help prevent cardiovascular events in high-risk patient groups.

Pfizer has ceased negotiating new contracts to sell Lipitor to health providers in the US or promoting it through sales representatives or advertising.

Following its US patent expiry on 30 November 2011, Pfizer invested $87m in sustaining the brand through doctor marketing, advertisements and price rebates. The strategy succeeded in retaining 33% of market share, bringing in $383m in the first quarter of 2012.

However, the second wave of generic atorvastatin following Lipitor’s patent expiry in the EU in May has prompted Pfizer to give up on the brand that at one time accounted for a quarter of its revenue.

The company will continue to promote the drug in emerging markets, including China, where it could still earn billions of dollars.

Teva UK has launched a generic atorvastatin tablet on the day after the expiry of UK patent protection on Pfizer’s cholesterol-lowering drug Lipitor.

According to the British Generic Manufacturers Association (BGMA), buying generic alternatives to Lipitor could save the NHS up to £350m per year.

Pfizer could lose 85% of its UK revenue from Lipitor by the end of this year.

Atorvastatin is the most widely prescribed statin, used in millions of patients worldwide to help prevent cardiovascular disease.

Kim Innes, Commercial Director at Teva, commented: “Millions of prescriptions are written each year in the UK for atorvastatin, and the availability of the generic will save the NHS millions of pounds each year.”

“The expiration of Pfizer’s patent exclusivity on Lipitor is hugely significant for the NHS and a demonstration of the valuable role generic drugs play in patient care in the UK,” said Warwick Smith, Director General of the BGMA.

Responding to recent claims that generics harm innovation, he argued: “It is generic competition that sustains innovation. Without competition from generic products, originators could continue to make their money out of established products and the patent system would simply not work effectively.”

Pfizer continued to suffer from generic exposure on its former cholesterol blockbuster Lipitor in Q1 2012 after overall sales and earnings both dropped.

Reported revenues fell 7% to $15.4bn and net income decreased by nearly a fifth (19%) after sales of Lipitor fell by almost half (42%) to just under $1.4 billion.

Ian Read, Pfizer Chairman and CEO, said he was “pleased” with the results after witnessing growth in “certain brands” and “key geographies”.

Biopharmaceutical sales decreased 8% to just over $13bn as revenue for Lipitor in the US dropped by nearly three-quarters (71%) to $383 million.

Sales of Prevenar 13 dropped by 6% to $941m, Xalatan fell by 42% to $227m with Novasc also recording a fall in revenue by 6%, compared to the same period last year.

The news was better for Lyrica up 16% to $955m, whilst Enbrel earned $899 million outside the US and Viagra generated a 6% rise in sales to earn $496m.

As a result of the losses, Pfizer has adjusted its revenue guidance for the full year from $60.5-$62.5 billion to $58-$60 billion.

Frank D’Amelio, Chief Financial Officer, said the adjustment reflects Pfizer’s recent $11.58 deal with Nestlé for its nutrition business. He commented: “We remain on-track to finalise a strategic decision for our Animal Health business this year and continue to expect that any separation of that business will occur between July 2012 and July 2013.

“Further, this quarter we continued to prudently allocate our capital by returning over $3.3 billion to our shareholders in first-quarter 2012, through $1.6 billion in dividends and $1.7 billion from the repurchase of 77 million shares.”

Pipeline or P45? Blogger Maxine Vaccine asks whether the pharma industry is willing to put its money where its mouth is regarding its strategy for surviving the recession.

As the global recession spirals further out of control and the UK looks set to follow Greece, Spain and Ireland into deeper crisis, the online Pf readers’ poll asked: What’s the best way forward for the pharma industry?

The response has been impressive: 84 % ticked ‘Collaboration to enter specialist areas’, 16% ticked ‘Cheap generics and biosimilars’, and nobody agreed with ‘Cutting back to survive austerity’.

To be honest, the second answer was just us being sarcastic. We didn’t expect anyone to say that was a good thing. And the third answer, though bleak, so clearly reflects the realpolitik of the industry in 2012 that we expected it to be a strong contender – though we hoped confidence in the collaboration model would outweigh it.

So it’s quite striking to see that none of our respondents thought austerity measures were the answer. But is their view supported by the leaders of the industry?

On the face of it, yes. John Lechleiter, CEO of Eli Lilly, said recently: “I don’t think we can save our way out of the enormous challenge we face. The best course is to maintain our focus on advancing our pipeline.”

But in 2012 Lilly has announced a global salary freeze for most of its employees, including the CEO (whose bonus package remains at a tidy $16.4 million), after a quarter in which its ‘blockbuster’ antipsychotic Zyprexa lost 44% of its former market due to generic competition.

Pfizer is similarly talking a ‘pipeline’ game, but is reducing its employees’ redundancy terms from 12 to 8 weeks as a prelude to further layoffs, and may split into branded and generic drug businesses. The Lipitor patent cliff may have been seen from a long way off, but the parachute didn’t open.

Dashiell Hammett – author of that immortal satire on the commercial mentality, The Maltese Falcon – said that he took up drinking when he realised that what people say has nothing to do with what they do. Some of us may wonder what took him so long.

In recent years, the pharma industry has taken steps to repair its reputation with the public – who have never exactly seen pharma as the place where you go to learn integrity and honesty. In particular, much attention has been given to industry codes of practice on dealings with customers. From luxury flights to biros and biscuits, the industry is cultivating a new image as the Puritans of the commercial world.

But has trust between management and staff in the pharma industry improved? Are companies treating their employees better? Is the representation of staff within the industry stronger? You tell me. And wait for the Pf Survey 2012 results to find out how your peers feel.

Meanwhile, if – like us – you are genuinely impressed by the emerging culture of cross-sector collaboration and partnership, it may be worth just keeping two words in mind. Hostile takeover.

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

NHS spending on drugs fell in 2011 due to patent expiry affecting a number of major products – and 2012 will see the trend accelerate.

The NHS in England spent £8.81bn on prescription drugs in primary care last year, compared to £8.83bn in 2010, according to the NHS Information Centre.

This fall, which reflects pressure on GPs to reduce their drug budgets, contrasts with the previous trend of drug spending increasing by 3–4% each year.

Therapy areas where the NHS pharmaceutical market was strongly affected by patent expiry in 2011 include cardiovascular care and CNS disorders – while diabetes care showed a new trend towards the selection of cheaper drug classes.

Cardiovascular drugs showed the steepest drop in sales: from £1.51bn in 2010 to £1.35bn in 2011. A major factor in this was the generic erosion of the anti-platelet drug Plavix from Sanofi and BMS, revenues from which fell from £46m to £12m.

By contrast, NHS spending on Pfizer’s statin Lipitor increased by £5m to a massive £310.8m – but that blockbuster will fall over the patent cliff in May, with wholesale shifting of GPs to generic versions expected.

The NHS spent £1.95bn on drugs for CNS disorders last year, but this therapy area is facing major generic erosion due to the recent patent expiry of AstraZeneca’s antipsychotic Seroquel and Pfizer and Eisai’s Alzheimer’s drug Aricept, which between them cost the NHS £170m in 2011.

In diabetes care, growing demand and the impact of new treatments is balanced by growing cost pressure forcing a retreat to older and cheaper drugs.

On the one hand, spending on Novo Nordisk’s new injectable GLP-1 drug Victoza increased from £9.6m to £21.9m last year, while AstraZeneca’s new oral medicine Januvia saw its revenue rise from £27m to £45m.

On the other hand, NHS spending on Novo Nordisk’s fast-acting insulin NovoRapid fell from £63.4m to £62.7m last year, due to pressure from the National Prescribing Centre to switch to the cheaper isophane insulin.

The UK pharmaceutical market thus faces both generic erosion and a new trend towards the choice of drug classes that reduce costs, but may not represent the standard of care.