Merck highlights updated pipeline
pharmafile | November 11, 2011 | News story | Sales and Marketing | CETP inhibitor, Merck, cholesterol, pipeline
Merck has showcased its most promising drug candidates, and says it expects to make eight US filings in the next two years.
The firm’s late-stage pipeline consists of 32 Phase II and Phase III candidates including new molecular entities and combination programmes for Alzheimer’s disease, diabetes and hepatitis C.
Merck highlighted six novel candidates in various stages of development being evaluated for the treatment of atherosclerosis (anacetrapib), type II diabetes (MK-3102), prevention of herpes zoster (V212), psoriasis (MK-3222), hepatitis C (MK-5172) and Alzheimer’s disease (MK-8931).
In Phase III is the promising new cholesterol treatment, Anacetrapib. The drug is a novel reversible and selective cholesteryl ester transfer protein (CETP) inhibitor, the same class as the ill-fated torcetrapib, which Pfizer had once seen as a potential blockbuster, but abandoned in 2006 after safety problems.
Late stage trials of Pfizer’s drug showed a raised number of ‘all cause mortality’ in trial patients taking the drug, which some signs that it caused raised blood pressure in some patients. No such problems have been seen with Merck’s candidate, but results from the large Phase III outcomes study REVEAL for the treatment of atherosclerosis, will not be ready until 2015.
Other notable late-stage candidates include osteoporosis treatment odanacatib; insomnia drug suvorexant; and its V503 cervical cancer vaccine.
The firm also confirmed its commitment to the biosimilars units, which makes generic forms of biologic drugs.
The process of developing and gaining approval of biosimilars is far more complicated than producing small molecule generics, but Merck said it would push ahead with a biosimilar version of Amgen’s big selling arthritis drug Enbrel.
Slipping in the league tables
Analysts at EvaluatePharma predict Merck will slip down the pharma league table next year. The company is currently the fourth biggest drugmaker by revenue, but will fall to sixth place next year, with forecast annual growth of just 1 per cent.
This represents a major fall from its highest position of second in 2009, where it was just behind Pfizer for the top spot.
The company is dealing with last year’s patent losses of its two big selling drugs, the hypertension treatments Cozaar and Hyzaar, which together made the company $3.6 billion in 2009.
It will also have to deal with the impending patent loss of its biggest selling asthma drug Singulair that made the firm $5 billion in 2010, which will be exposed to generic erosion in the US next year.
It will be relying on its new potential blockbuster hep C drug Victrelis to help offset its patent losses, but it is in a major competition with J&J and Vertex’s Incivek.
Both drugs were launched this year, but Incivek looks to be pulling ahead already, earning $420 million in sales for its first quarter, whilst Victrelis only brought in $31 million.
EvaluatePharma say that Merck will “struggle to grow its drug business” in the coming years, and does not expect its $41 billion mega-merger with Schering Plough to help its shore up its portfolio in the short-term.
The company also received a knockback from the FDA earlier this week when the regulator asked for more information on its oral contraceptive MK-8175A, and the ophthalmic drug tafluprost.
Ben Adams
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