pSivida surges on regulatory news

19/12/2013 - 12:45

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Shares in biotech company pSivida Corp surged more than 50 per cent today on positive regulatory news from the United States, making up most of the losses it suffered in a dramatic fall in October.

Shares in biotech company pSivida Corp surged more than 50 per cent today on positive regulatory news from the United States, making up most of the losses it suffered in a dramatic fall in October.

The share price jumped by 1.76 cents to 5.1 cents.

The trigger for the shares surge was an announcement that its licensing partner, US-based Alimera Sciences, has entered into ‘labelling’ discussions with the US Food and Drug Administration for Iluvien, which is used to treat the eye disease diabetic macular edema.

Alimera said that as a result of the labelling discussions, a scheduled January 2014 meeting with the FDA was no longer necessary.

The January meeting was set up after the FDA ruled in October that a new drug application for Iluvien could not be approved in its current form.

That ruling sparked a collapse in pSivida’s share price from a high of 5.6 cents in early October to a low of 2.5 cents later in the month.

The FDA had indicated in October that new clinical trials would need to be completed together with at least 12 months of follow-up for approved patients.

However, Alimera has now indicated that new clinical trials will not be required.

It intends to provide safety data from patients in the UK and Germany and address concerns regarding the facility at which Iluvien is manufactured.

Should the FDA approve Iluvien, pSivida is entitled to a $25 million milestone payment from Alimera and 20 per cent of defined net profits.

Iluvien was approved earlier this year in six countries in Europe and is currently being sold in the UK and Germany, while sales in France are expected to commence early next year.

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