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New drug approvals point to possible blockbusters

The Wall Street Journal reports on five potentially billion-dollar drugs that could win final FDA approval in 2008, helping both patients and shareholders of the products' manufacturers

According to a report in the US publication, The Wall Street Journal (WSJ), five potentially billion-dollar drugs could win final FDA approval in 2008, helping both patients and shareholders of the products' manufacturers.

The list includes the cholesterol drug Cordaptive from Merck & Co, the heart medication Kynapid (vernakalant) from Cardiome Pharma and the anaesthesia-complication drug Sugammadex from Schering-Plough.

Also, Swiss-based Roche hopes to introduce Actemra (tocilizumab) for rheumatoid arthritis (RA), and Progenics Pharmaceuticals and its partner Wyeth are awaiting approval of methylnaltrexone, aimed at preventing digestive problems caused by painkillers.

Kynapid from Cardiome Pharma would be the first new atrial-fibrillation drug approved by the FDA since 2000 and could generate sales of USD 1.4bn by 2015, according to the WSJ. The product is given intravenously, but the company is working on an oral form. The FDA had been expected to make a decision by 19 January 2008, but the agency said it needed more time.

Merck & Co's Cordaptive is a niacin drug similar to Abbott's Niaspan that lowers bad cholesterol and raises good cholesterol. The drug will not replace statins, says the WSJ, but could complement them. Sales could reach USD 1.5bn by 2015, according to market research company, Decision Resources.

Actemra from Roche is a new treatment for rheumatoid arthritis. It differs from existing drugs in that it blocks a protein called interleukin-6, making it an option for the patients who do not respond to other treatments. The main cloud on the horizon for the drug is its expense, which insurers and health services may not wish to cover. Despite this, Decision Resources reckon that Actemra sales could hit the blockbuster level of USD 1bn, by 2015.

Schering-Plough's Sugammadex reverses the effects of strong muscle relaxants given during surgery. The drug appears to help patients come out of anaesthesia more quickly and with fewer side effects than competing drugs. Sugammadex could be on sale in the US.by early summer.2008. By 2015, its yearly sales could exceed USD 1bn, according to the WSJ.

Methylnaltrexone from Progenics and Wyeth prevents constipation in people taking opiates. An injected version of the drug could be approved in April 2008 for hospice patients, who tend to receive high doses of painkillers. An oral version for a broader patient group is being studied. By 2012, sales should reach USD 1bn, according to Stifel Nicolaus analysts.

27th January 2008

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