UK's Profile Therapeutics Inhaler Approved In U.S.
LONDON (Reuters) - Britain's Profile Therapeutics, which makes inhalers to treat respiratory illnesses, said on Wednesday it had got regulatory approval from the U.S. Food and Drug Administration for its Prodose aerosol inhaler.
Profile added it was still in talks that may or may not lead to a formal offer being made for the company. It has not named the potential buyer.
"The FDA approval for Prodose is an important step forward in our regulatory strategy in the U.S. and paves the way for our regulatory submission for Prodose HandHeld later this year," Chief Executive John Lisle said in a statement.
The Prodose inhaler is already used in Europe to deliver Promixin, the firm's inhaled antibiotic treating cystic fibrosis and Ventavis, Schering AG's product for pulmonary hypertension.
Profile is working on a mini-nebuliser, the HandHeld, which will deliver the same drugs in a more portable form.
Shares in the company closed Tuesday at 41 pence, valuing it at 20.88 million pounds ($37.4 million).
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