Elan bids to get MS drug back on sale
The company, which withdrew Tysabri from sale in February when it emerged two people who took the drug developed the fatal disease PML, said it will submit an application to US drug regulator, the Food & Drug Administration (FDA), in the coming weeks to have the treatment cleared for sale.
It also intends to submit a safety evaluation of Tysabri for the treatment of the debilitating Crohn's disease and rheumatoid arthritis.
The move follows confirmation last month that no new cases of PML have emerged. Almost 2,000 patients taking Tysarbi have undergone safety trials and Elan is encouraged by the findings.
Shares in Elan, which had gained early on, closed down almost 2.5% yesterday on the Irish market.
The shares are around two-thirds lower than the price before news emerged about the patients' death, which sent Elan shares plunging to levels not seen since an accounting scandal rocked it in 2002.
Getting Tysabri back on the market is vital for the Athlone-based company and Biogen Idec, the American drug company that has been developing the treatment with the Irish firm.
Industry analysts hailed the drug as a potential blockbuster when it was launched in November 2004 because clinical data suggested it was far more effective than existing treatments for multiple sclerosis.
Multiple sclerosis, which affects an estimated 400,000 Americans, is a progressive disease that can cause blurred vision, weakness, poor muscle coordination and loss of memory and other mental functions.
Goodbody Stockbrokers' phamaceutical analyst Ian Hunter wrote in a research note to clients yesterday: "We still believe that due process in the evaluation of Tysabri for the treatment of MS ... can be completed, and the drug back on the market, by early 2006."
Davy Stockbrokers said: "Our mid-2006 forecast for re-launch still looks appropriate in this light, though a more definitive view on timing still depends on the response of the FDA."
Biogen Idec spokeswoman Amy Brockelman said the drug "never lost" its original approval from the FDA, although it was withdrawn from the market.
"At this point, we do not expect we will need to conduct additional multiple sclerosis trials to return Tysabri to market," Ms Brockelman said.
Additional reporting by Reuters.
THE return of Tysabri to the market would be a major boost to Elan, which has suffered several setbacks in recent years.
The drug is one of just a handful the company has left in its stable, having sold off many of its products to keep the Athlone-based firm alive.
Elan's problems began more than three years ago when a Wall Street Journal report questioned the accounting practices at what was then Ireland's biggest company. That saw the shares lose nearly a third of their value on the day the story broke and prompted an inquiry by the American financial regulator, the SEC.
In mid-2002, as the SEC probed the company's books, chief executive Donal Geaney and vice-chairman Tom Lynch left the firm. They had been responsible for much of its development.
In a bid to stave off a cash crisis, much of Elan's businesses were sold off to pay creditors, while the workforce was also slashed as losses amounted to €2.3 billion in 2002.
Under new chief executive, Kelly Martin, the company has been reshaped, focussing on the remain products and new treatment.
The share price steadily recovered as the SEC inquiry ended, resulting in a payment of $15 million (€12.3m) by Elan, without admission of liability.
This year, however, Elan's share price crashed once more, wiping €5.5bn off its value in one day, after it emerged that two patients who had taken Tysabri had died after contracting PML.
As the company tried to limit the damage, Donal Geaney lodged a claim in the High Court seeking millions in damages after alleging unfair dismissal.
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