September 7, 2017 / 6:51 AM / 2 years ago

Positive lung drug trial opens path to U.S. market for Circassia

LONDON (Reuters) - AstraZeneca said its drug Duaklir improved lung function in chronic obstructive pulmonary disease (COPD) patients in a new study, paving the way for likely approval in the U.S., where the commercial rights are held by Britain’s Circassia.

FILE PHOTO: The logo of AstraZeneca is seen on a medication package in a pharmacy in London April 28, 2014. REUTERS/Stefan Wermuth

Circassia acquired the U.S. rights to Duaklir and monotherapy COPD drug Tudorza from AstraZeneca in April, for up to $230 million plus royalties, before abandoning its ambition to develop an allergy franchise after a second trial failure.

AstraZeneca said it expected to submit the drug to U.S. regulators for approval in the first half of 2018.

Circassia’s Chief Executive Steve Harris said the study result was fantastic news.

“This is a great product that has very substantial potential that can help transform Circassia,” he said on Thursday.

“We are a small company competing with the big guys, but we think in our hands this product could be certainly in excess of $180 million of sales a year.”

Duaklir, a combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate, was approved in Europe in November 2014.

Harris said the addition of a combination therapy that treats moderate-to-very-severe COPD would be a perfect addition to Circassia’s portfolio.

Shares in the company, which were trading at 270 pence in June 2016 before it suffered its first allergy drug failure, were trading up 15 percent at 88.25 pence on Thursday morning, valuing the firm at 293 million pounds ($383 million).

($1 = 0.7644 pounds)

Editing by Kate Holton and Elaine Hardcastle

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