Merck to file cholesterol combination in 2003
pharmafile | October 23, 2003 | News story | |
Merck has revealed its plans for double-digit growth for 2003 including a new cholesterol pill combining its blockbuster Zocor with Schering-Plough's recently approved Zetia.
Chief Executive Raymond Gilmartin told an analyst briefing that the company would overcome the problems that had stunted growth in 2002, with the approval of Singulair AR for allergic rhinitis expected in early 2003, as well as the filing of Zocor/Zetia and the US launch of arthritis drug Arcoxia towards the end of the year.
Regulatory delays to Arcoxia's US launch, doubts about the accounting practices of soon to be sold subsidiary Merck Medco and several patent expiries all seriously depressed the company earnings in 2002.
Some analysts do not share the company's optimism, however, doubting that it can turn around a disappointing year and hit its minimum 10% growth target for 2003.
Zocor was the world's biggest drug in 2001 with sales of $6.7 billion and continues to grow as it approaches patent expiry. The recent Heart Protection Study has been the key factor behind the growth, proving its life-saving properties in heart and stroke patients, data that the company hopes to include on US labelling during 2003.
Schering-Plough has now launched its cholesterol absorption blocker Zetia in the US and Germany, where it is known as Ezetrol. Although the drug has demonstrated its efficacy in combination with all the marketed statins, the company has now pinned its hopes on the single pill combination with Zocor.
Mr Gilmartin said Zetia had provoked considerable interest from US doctors with statin patients who had "hit the wall" and were unable to reach their cholesterol lowering targets.
Merck's most immediate goal is the FDA approval of a new allergic rhinitis indication for Singulair AR in early 2003. If approved, the drug will represent the first new treatment class for the condition in more than decade, prompting Merck to estimate sales growth of 40%.
Some analysts are sceptical the drug can achieve the target, with market leader Claritin having recently switching to the low-cost OTC market. Equally under scrutiny is the company's COX-II blockbuster Vioxx, with recent research linking high doses to an increased risk of coronary heart disease.
Dr Peter Kim was recently appointed as the company's new head of R&D, and will oversee the development of a number of promising products in the pipeline. Emend, an anti-emetic for chemotherapy patients, diabetes compound MK-767 licensed from Kyorin, and Emend (aprepitant) for depression are among those in phase III development.
