Several generic versions of BMS’s blockbuster blood thinning drug Plavix (clopidogrel) have been released in the US after patent protection expired.

The FDA has approved a number of manufacturers that are now able to supply the treatment, which generated sales of $6.8 billion in the US last year for BMS and its partner Sanofi.

BMS, which earned a third of its revenue from Plavix, said last week it would no longer promote the drug following the loss of patent protection.

However, it will reduce the monthly cost of the treatment from $100 to $37 in an attempt to hold some market share, according to the Wall Street Journal.

Mylan Pharmaceuticals is in the driving seat to take advantage of BMS’ loss with the generic manufacturer ready to ship its products across the country.

Alongside Mylan, Teva, Apotex, Aurobindo Pharma, Roxane Laboratories, Sun Pharmaceuticals Industries, Torrent Pharmaceuticals, Dr Reddy’s Laboratories and Gate Pharmaceuticals have also been approved by the FDA to supply clopidogrel.

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.

An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Jérôme Contamine, Executive Vice President, Chief Financial Officer discusses the Q1 results.

An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Christopher Viehbacher, Sanofi CEO, said the “strong performance” in the first quarter was “driven by Genzyme, our growth platforms, and cost savings”.

However, Sanofi still expects profits to be down by around 12% to 15% on last year’s figures as a result of generic exposure of major brands.

Overall sales were up 7% compared to the same period last year after revenue in emerging markets increased by nearly a tenth (9.9%), and its pharmaceuticals division was boosted by increased sales in its diabetes and oncology businesses.

First quarter sales in pharmaceuticals reached €7.3bn, an increase of 8.8%, driven by the performance of diabetes drug Lantus which saw sales rise 17.2% to €1.1bn. But generic competition on Plavix, Lovenox and Taxotere hit sales, despite increased demand for Apidra, Eloxatin and Jevtana.

The ‘new Genzyme’ recorded sales of €400m in Q1 – up by 13.7%. Sales of Fabrazyme were up by half to €47m, with Cerezyme up by 5.8% to €149m and sales of Myozyme/Lumizyme also increasing by 17% to €112m.

Sanofi’s own generics business generated an increase of sales after the recent launch of the authorised generic Lovenox saw revenue grow by 6.5% to €439m.

Vaccine sales were down slightly (0.2%) to €617m after the delayed timing of supply of flu vaccines in the Southern Hemisphere. However, the news was better for Sanofi’s consumer health division as it achieved record sales of €805m.

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.

Sanofi is set to cut up to 450 jobs after deciding to close its manufacturing plant in Fawdon, Newcastle by 2015.

The plant produces billions of tablets each year but will close after Sanofi suffered a decline in European sales last year and generic competition to Plavix.

In a statement, Sanofi said the move had been made “in the context of an adverse economic climate and the challenging pharmaceutical market in Europe”.

It is understood the company is now beginning a 90-day consultation period with staff and unions.

Products including Plavix, Xatral and Epilem are currently manufactured at the site. Sanofi opened a new packaging plant at the site in 2009, bringing its investment to £100m in more than eight years.

However, it suffered a reduction in sales of Plavix last year, which were down from €641m in 2010 to €414m in 2011.

“Under the proposal the plant, which makes solid dose oral medications mainly for UK and European markets, would be scheduled to close by mid-2015,” said the statement.

“The products manufactured at the Fawdon site have been adversely impacted by other factors, including generic competition, resulting in a fall in demand and production volumes.”

Staff, upon hearing the announcement, left the plant in tears. Unite’s Bob Bolam said the decision had come as a surprise to employees and the union. “We are looking to work with the company to mitigate any losses and to help the surrounding area which is obviously going to be devastated by the loss of the jobs,” he said.

Sanofi currently employs around 1,800 people in the UK, including 300 staff at its UK headquarters in Guildford.

Sanofi and Bristol-Myers Squibb have been awarded more than $442 million in damages after Apotex was found to have infringed the patent rights on blockbuster drug Plavix (clopidogrel bisulphate).

The payment follows the decision of the US Court of Appeals for the Federal Circuit in October 2011 and ends a ten-year legal dispute between the companies.

French-based Sanofi, who will receive $270m of the settlement, and BMS say they are both “pleased” that their rights have been upheld and that Apotex has made a “reparation” of the harm it caused by the launch of the “at-risk” generic.

The two were also awarded $1.2 million in post-judgement interest and $900,000 in costs in addition to the damages award.

The settlement ends the final phase of patent litigation between Sanofi, Bristol-Myers Squibb and Apotex which dates back to March 2002. Canadian-based Apotex launched a cheaper generic version of Plavix in 2006 whilst the legal challenge to the patent was being decided in court.

Chris Viehbacher, CEO, Sanofi, says the ruling shows it “pays to defend your intellectual property”.

Plavix – which will become the world’s best-selling drug when Pfizer’s Lipitor loses its remaining patent protection – generated €7bn in sales last year. However, it will be exposed to generic competition when its own patent expires in the US in May 2012.

Mr Viehbacher said the company was considering its plans in the coming months for the loss of revenue on the blood-thinning drug. Protection has already been lost in Europe, but Sanofi will maintain exclusivity in Japan until 2015.

French pharmaceutical giant Sanofi is looking to its drug pipeline, including products from the recently-acquired Genzyme business, to ensure the company’s growth in a year when patent expiries are forecast to cut its profits by 15%.

Sanofi CEO Chris Viehbacher (pictured) said that 2012 had been “marked in red” in his personal diary as the year when cardiovascular drugs Plavix and Avapro would fall over the patent cliff.

Sanofi has filed five new drugs for regulatory approval in the US and Europe in the last seven months, which Viehbacher claimed was “a record for the industry”.

The company plans to launch 18 new drugs by the end of 2015 – and moving forward, to adopt an ‘open innovation’ approach to R&D through partnership with biotech companies and academic organisations.

The acquisition of biotech company Genzyme for $20.1bn in April 2011, which increased Sanofi’s costs for the year by 5.6%, promises to deliver a range of new therapies for rare diseases.

Viehbacher said that Genzyme’s new treatment for relapsing MS, Lemtrada, was a potential market-leading product, with its filing for US and EU regulatory approval expected in the second quarter of 2012.

In 2012, generic competition on blood-thinning drug Plavix and hypertension drug Avapro in the US is expected to cost Sanofi $1.86bn profit, up to 15% of its global total.

“2012 has been marked red in my diary for years,” Viehbacher commented. “We cannot compensate for that in one year but we can compensate over time. As we come out of the cliff, Sanofi is extremely well positioned for growth.”

Sanofi’s fourth-quarter profit in 2011 rose by 13%, due to the Genzyme acquisition and an 18% increase in sales of its Lantus insulin, which exceeded $1bn in quarterly sales for the first time.

The FDA’s recent approval of a new manufacturing facility in Framingham, Massachusetts, will enable Genzyme to resolve problems with production of two rare-disease medicines.

Sanofi has identified growth prospects in six ‘platform’ areas where products are less vulnerable to patent expiry: vaccines, diabetes care, biological therapies for rare diseases, emerging markets, consumer healthcare and veterinary medicine.

A new formulation of the long-acting insulin Lantus, Sanofi’s biggest-selling drug, is currently going through a phase III clinical trial programme.

“2011 was a key year in transforming Sanofi,” Viehbacher said. “We successfully acquired and integrated Genzyme, our growth platforms recorded double-digit growth, we delivered cost savings as planned and submitted filings to regulatory authorities for five new products.

“Beyond the remaining patent cliff in 2012, the robust performance of our diversified growth platforms, the reduced exposure to future patent expiries and progress on R&D position Sanofi for a period of sustainable growth.”

To see Chris Viehbacher discussing Sanofi’s 2011 performance and prospects for 2012 and beyond, click here

Bristol-Myers Squibb saw net sales increase 7% to $5.5 billion in the final quarter of 2011, and record annual sales up 9% to $21.2bn.

Sales in the US increased 8% to $3.6bn with international sales also up by 4% after Onglyza, Sprycel, Orencia and Baraclude all saw revenue increase in the quarter.

Lamberto Andreotti, Chief Executive Officer, BMS, said the “solid financial results” conclude a “very good year” for the New York-based biopharmaceutical company.

But the company expects global sales in 2012 to fall to between $17.2bn and $18.2bn after the exclusivity of Avapro expires in March and Plavix expires in May.

In the final quarter of 2011, gross margin as a percentage of net sales improved by nearly three-quarters (74.9%). R&D costs remained flat at a $1bn with marketing, selling and administrative functions also slightly over a billion pound. Advertising and product promotion increased slightly in Q4 to $285m.

Global sales between October and December were led by Onglyza – which saw sales increase in the quarter by 110%. Sprycel saw sales rise by 34%, Orencia by 27% and Baraclude by a fifth. Skin cancer treatment Yervoy also generated sales of $144m.

The year concluded with BMS receiving approval for Yervoy and for kidney transplant drug Nulojix in the US and Europe, and for Eliquis in Europe for the prevention of venous thromboembolic events.

“Our delivery of several important new products to patients, the ability of our productive R&D organisation to build an innovative and diverse pipeline, and our continued commitment to business development gives us confidence in our future,” said Lamberto Andreotti.

Health authorities will be forced to prescribe patients with treatments recommended by NICE instead of cheaper alternative generics, Health Secretary Andrew Lansley has said.

The move is an attempt to end current ‘postcode prescribing’ and to prevent a number of PCTs ‘blacklisting’ expensive treatments such as Lipitor and Crestor.

Mr Lansley promised MPs that he would introduce an “effective compliance regime” to prevent cheaper alternatives being prescribed to patients who need them the most.

PCTs have been ‘blacklisting’ expensive branded treatments preventing doctors from prescribing them in an attempt to save money. Health authorities have favoured cheaper generic alternatives, despite research demonstrating these to be less effective and producing more side effects.

A study involving patients that switched from Lipitor to a generic simvastatin found that dangerous ‘bad’ levels of cholesterol increased by five to six per cent.

An additional survey last year revealed that at least 14 different treatments which had been recommended by NICE had been ‘blacklisted’. These include Plavix and Pradaxa.

Speaking in the House of Commons, Mr Lansley said patients would be able to receive recommended treatments regardless of where they lived. “We will make certain that where NICE gives a positive appraisal for medicine that it is automatically included,” said the Health Secretary.

“We will establish an effective compliance regime on NICE appraisals and establish a new NICE implementation collaborative to make it happen.”