Pfizer is suing Merck to try to block its new Lipitor-plus-Zetia combination drug.

The new pill will be similar to Merck’s Vytorin, combining the company’s own statin drug Zocor (simvastatin) with cholesterol medication Zetia.

Analysts expect a Lipitor/Zetia version to generate $500 million by 2015.

Pfizer has faced generic competition from various angles on its blockbuster cholesterol therapy. The company recently reached a settlement agreement with a number of pharmaceutical companies to delay the launch of generic versions of Lipitor (atorvastatin) in the UK until May 2012.

It has also allowed Ranbaxy Laboratories to sell its generic version of the drug on November 30^th as well as agreeing to supply an authorised generic to Watson Laboratories on the same day.

However, Pfizer still has some patents on Lipitor that aren’t due to expire for a few years, and is citing one of these in its case against Merck.

The company has stated the patent covering Lipitor's crystalline structure, which is due to expire in 2017, but Merck claims that its Lipitor-plus-Zetia pill won't infringe on the patent.

The lawsuit triggers a 30-month regulatory delay, during which time efficacy questions about Vytorin will be asked. A previous study has found no significant difference in arterial narrowing with Vytorin than with Zocor use alone.

A new study is due in 2013, and if the clinical data works against Vytorin, then a Lipitor/Zetia combo may not be as successful in the market as expected.

Draft guidance from NICE’s Diagnostics Assessment Programme, published for consultation, does not support the use of two genetic tests to diagnose familial hypercholesterolaemia (FH) or inherited high cholesterol.

The provisional recommendations do not support the use of Elucigene (from Gen-Probe) or LIPOchip (from Progenika) by the NHS in England to confirm a diagnosis or screen relatives of someone diagnosed with FH.

FH is caused by an inherited genetic mutation that reduces the rate at which cholesterol is cleared from the blood. The condition affects an estimated 100,000 people in the UK, and can result in coronary heart disease if not diagnosed and treated.

Currently, FH is diagnosed through a combination of clinical signs and DNA testing. The Elucigene and LIPOchip tests can only identify a subset of the genetic mutations that cause FH. Therefore, NICE’s Diagnostics Advisory Committee concluded that using CGA (comprehensive genetic analysis) for diagnosis of FH and targeted DNA testing for screening was more clinically and cost-effective than either test.

Professor Adrian Newland, Chair of the Diagnostics Advisory Committee, said the Committee considered that “even though Elucigene and LIPOchip are less costly tests than CGA, because they are less sensitive the cost savings would be more than offset by the lower health outcomes associated by false negative tests and the inability to undertake cascade testing using a targeted DNA test.”

However, he commented, “It remains the case that only a fraction of people in England are identified as having FH, often with tragic consequences for the majority who are not.” The provisional NICE clinical guideline was “a pragmatic blueprint” for preventing many unnecessary deaths through the use of CGA and targeted DNA testing.

The consultation closes on 23 August, and final guidance is expected in December.

Pfizer’s CEO Ian Read has ruled out any major mergers or acquisitions to replace the company’s falling revenue.

Annual sales are down some 60% after the loss of patent exclusivity on several key products.

But the CEO, who has been downsizing Pfizer since starting his role in December last year, told Bloomberg he is “not going to chase revenue at the destruction of capital” by selling units and buying back shares, since coming to the post in December 2010.

This shrinking style contrasts to the work of his predecessors Jeffrey Kindler, who bought Wyeth for $64bn in 2009, and Henry McKinnell, who bought Pharmacia for a similar price in 2002.

Mr Read stated that Pfizer will still look for licensing deals through partnerships with companies with treatments in mid- to late-stage testing.

Pfizer shares have climbed by approximately 14% since Mr Read took over.

Pfizer, based in New York, currently faces competition from cheaper generic medicines, led by cholesterol pill Lipitor.

Pfizer suffered a 1% reduction in revenue in Q2 after the loss of patent exclusivity for several products, most notably its cholesterol blockbuster Lipitor (atorvastatin).

Sales of the drug fell 8% to $2.59bn, but revenue still totalled $16.9bn after favourable exchange rates and the addition of King Pharmaceuticals.

Ian Read, President and CEO, says the company’s performance was “in-line with our expectations”.

The Q2 results exclude the recent sale of its Capsugel unit to KKR for $2.38 billion.

US revenues were down 9% to $6.7bn compared to the same period a year ago after the health reforms across the Atlantic cost the company $158 million. But the news was more positive as international sales were up 5%, despite a 3% operational decline.

International income represented nearly two-thirds (61%) of the company’s revenues in Q2, compared with 57% last year, after US sales dropped to 39%.

Generic alternatives of Effexor, Protonix and Zosyn in the US saw Pfizer’s Established Products unit sales drop by nearly a quarter (23%) to $631 million.

Primary Care unit revenues were driven by patent-protected products such as Lyrica, Spiriva and Pristiq, but still suffered a 10% loss compared to the year before to $586 million. Sales were impacted by the loss of exclusivity of Lipitor in Canada and Spain, plus Aricept in the US.

Revenue was also down 5% in the company’s Speciality Care unit and 3% in its Emerging Markets division following exclusivity rights for Lipitor expiring in Brazil and Mexico.

“Although results were impacted by losses of exclusivity of several key products in certain geographies, most notably in our Established Products business, I am pleased that many of our core products, primarily Lyrica, Enbrel and the Prevnar/Prevenar franchise, continued to perform well overall and the fundamentals of our business remain strong,” said Ian Read.

Sales of Lyrica (pregabalin) increased 19% to $908 million, Enbrel increased 13% outside of North America to $914 and Prevnar almost doubled its revenue (44%) to $821.

The company has now readjusted its financial expectation for 2011 increasing reported revenue up from $65.2 to $67.2 billion.