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Novartis COX2 taken off Australian market

The Therapeutic Goods Administration regulatory body of Australia rejects the registration of Novartis' COX2-inhibitor painkiller Prexige over liver-related toxicity

The Therapeutic Goods Administration regulatory body of Australia (TGA) has rejected the registration of Swiss-headquartered Novartis' COX2-inhibitor painkiller Prexige (lumiracoxib) over liver-related toxicity.

Up to the 10 August, the TGA had received eight reports of serious liver-related adverse reactions to the drug, including two deaths and two liver transplants, according to a press statement given by Dr Rohan Hammett, the TGA's principal medical adviser.

The safety concerns in Australia follow those in the US related to the now infamous COX2 drug, Vioxx (rofecoxib). US-based Merck & Co, which manufactured the drug, withdrew it from the global market in Q3 2004 after clinical studies demonstrated elevated risks of heart attacks and stroke.

In April 2005, Pfizer took its Bextra (valdecoxib) product over similar cardiac scares. Both firms are still involved in lawsuits from injured patients or families of those that died. Only Pfizer's Celebrex (celecoxib) remains on the US market.

Prexige was approved in Australia in July 2004, but had only recently become widely available since winning reimbursement status.

Novartis is collaborating with the Australian regulator, but said it believed that Prexige had a positive benefit/risk profile in the treatment of appropriate patients with osteoarthritis and acute pain.

In the US, the FDA will decide whether to approve Prexige in September 2007, but the majority of analysts doubt that the ruling will be positive.

Since Prexige won EU approval in 2006, the company has begun marketing it in the region. Approval for the drug is still pending in the Swiss market.

Since Prexige was launched, more than seven million prescriptions have been written globally, according to Novartis. The drug racked up worldwide sales of USD 52m in H1 FY07. Shares in the company closed at CHF 64.95 (USD 53.71) on 10 August and so far in 2007 the stock value has dropped over six per cent.

14th August 2007

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