LONDON--Generic competition started on March 2 in Europe for Merck & Co.'s blockbuster antihypertensive, Cozaar (losartan), heralding the expected precipitous decline in revenues from the widely used branded product.
Cozaar and Hyzaar (losartan plus hydrochlorothiazide) brought in $3.6 billion in sales for Merck in 2009 - roughly 13 percent of overall revenues. The impending loss of sales, as well as those from other products facing generic competition, was a major reason for last year's acquisition of Schering-Plough.
Patent protection on losartan ran out on March 1 in the UK and a handful of other countries, and is expiring over the next few weeks elsewhere in the region. Teva Pharmaceuticals, for example, announced it was launching generic versions of Cozaar on March 2 in the UK, Hungary and Spain, and in 10 other countries, including Germany, France and Italy, over the next few days. The product was approved through the EU's decentralized procedure.
Other companies launching generic versions of Cozaar and/or losartan plus HCTZ in the UK include Sanofi-Aventis' generics division, Winthrop Pharmaceuticals and Consilient Health. Numerous others are expected to announce similar plans over the next few weeks in the UK and elsewhere in Europe.
Merck won't be the only Big Pharma affected by Cozaar's genericization, though. Others with branded angiotensin II antagonists - Novartis sells Diovan (valsartan) - also will be hit by the presence of cheaper generic versions of losartan. The prices of the generic losartan products launched this week already are around 50 percent less than those for Cozaar and Diovan, and are expected eventually to fall 80 percent to 90 percent below the branded price.
Merck warned on its Feb 16 earnings call of a significant decline in future Cozaar/Hyzaarsales, with the loss of patent protection in major European markets expected during the first quarter of this year, and in the U.S. in April.
Chief Financial Officer Peter Kellogg said the erosion in sales was expected to be rapid, and that sales from new product launches were not expected to compensate for declining sales of Cozaar, as well as Temodar (temozolomide) during 2010; patent protection on Temodar, a treatment for symptoms of brain tumors, expired in the EU last year. Kellogg also noted that, although the company had not yet given specific earnings guidance for this year, 2010 was expected to be a "positive year" with regard to earnings.
The merger with Schering-Plough is expected to save Merck around $3.5 billion annually in expenses. And Schering-Plough's major marketed products will not face generic competition until 2014, patching over some of the sales hole left by patent expirations. Merck also is launching several products worldwide, such as the antipsychotic, Saphris (asenapine) and the muscle relaxant reversal agent, Bridion (sugamadex), to replenish near-term revenues.
Merck chose March 1 to outline its late-stage R&D pipeline, which now contains more than 40 drugs and vaccines in Phase II and III development. The pipeline in the cardiovascular area is possibly the strongest in the industry, although it only includes one antihypertensive, MK-0736. Other cardiovascular products in late-stage development include a thrombin receptor antagonist, vorapaxar, acadesine for ischemic reperfusion injury, and Tredaptive (MK-524A) and MK524B, combination products containing laropiprant and niacin, for atherosclerosis.
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- John Davis (j.davis@elsevier.com)
