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Merck post sales rise ahead of Singulair patent expiry

CEO Frazier joins pharma criticism of government cuts to healthcare systems

Merck & Co posted a 1 per cent growth in revenues to $12.3bn in the second quarter of 2012 ahead of the loss of patent protection for asthma blockbuster Singulair (montelukast) in the US early next month.
 
Net income declined 11 per cent to $1.8bn, mainly as a result of restructuring charges associated with Merck's cost-cutting drive, as well as a one-off tax benefit a year earlier, and the company has said it is maintaining its sales and earnings forecasts for 2012.

Ken Frazier, Merck's chief executive, joined many of his peers in this results season in acknowledging the negative effect of government austerity measures on growth, saying the "greatest longer term threat to the global healthcare system remains the rapidly increasing and unsustainable growth in costs".

Prescription drug revenues advanced 2 per cent to $10.6bn, with Singulair climbing 6 per cent to $1.4bn in its last quarter before the start of generic competition in the US, although cholesterol drug Vytorin (ezetimibe/simvastatin) fell 3 per cent to $445m.

Januvia (sitagliptin) for diabetes continued to stride ahead, with sales up 36 per cent to $1.06bn despite increasing competition in the DPP-4 inhibitor market. Line extension Janumet (sitagliptin/metformin) also contributed with sales up 28 per cent to $411m, and Merck is claiming 75 per cent global market share for the franchise overall.

There were also gains for HIV drug Isentress (raltegravir), which climbed 18 per cent to $398m, as well as hepatitis treatment Victrelis (boceprevir), cholesterol drug Zetia (ezetimibe) and the firm's human papillomavirus (HPV) vaccine Gardasil.

Merck is relying on its pipeline to help weather the loss of patent protection to Singulair, and has six projects due to reach the marketing application stage in the next 18 month.

Osteoporosis treatment odanacatib is due to be filed in the US and EU during the first half of next year and in Japan in the third quarter of 2013, said Frazier.  A phase III trial of the cathepsin K inhibitor was stopped earlier this month due to positive efficacy and safety signals.

Meanwhile, the firm is also gearing up to submit applications for suvorexant, a new first-in-class treatment for patients with insomnia; neuromuscular reversal agent Bridion (sugammadex); HPV-related cancer vaccine V503; novel cholesterol medicine Tredaptive (laropiprant/nicotinic acid); and vintafolide, a first-in-class oncology agent with potential in ovarian and lung cancers.

Other upcoming R&D milestones include the submission of additional data with the FDA for Atozet (ezetimibe/atorvastatin), and the start of phase III trials for once-weekly DPP-4 inhibitor MK-3102 and Alzheimer's candidate MK-8931, a BACE inhibitor.

"This focus on innovation and execution will drive long-term shareholder value," said Frazier.

30th July 2012

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