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(Alliance News) - Hikma Pharmaceuticals PLC on Wednesday said it has resumed the launch of its generic version of a GlaxoSmithKline PLC asthma drug in the US, after the Food & Drug Adminstration approved an amendment.
Shares in Hikma were up 2.4% to 2,434.00 pence in London. Glaxo shares were up 1.0% at 1,339.00p.
Hikma made the amendment to its generic version of Advair Diskus because of new industry standards on packaging since the FDA approved the original application in December. The launch was then paused the following month.
The resumption will benefit Vectura Group PLC, which co-developed the drug with Hikma and is in line to receive royalties. Vectura highlighted Hikma's announcement in its own statement.
Advair Diskus is an inhalation powder for asthmatics. The first generic version in the US was approved in 2019, made by Mylan, which is now part of Viatris Inc. The drug had total US sales of USD2 billion in the year ended September 2020, according to a previous announcement by Hikma.
"We are very pleased to improve availability of this critical medicine for patients and healthcare providers in the US," Hikma Chief Executive Siggi Olafsson said.
Separately, Vectura announced a special dividend after winning a dispute with Glaxo over a different asthma drug, Ellipta.
Glaxo, which has paid Vectura GBP127.6 million so far after infringing its patents, has not appealed to the US Supreme Court meaning the litigation is now resolved, Vectura said.
Vectura decided to pay a GBP113 million special dividend, worth 19p per share, as it doesn't need the litigation proceeds for its growth plan. The company also will consolidate every six shares into five, to maintain share price comparability before and after the special dividend is paid.
Shares in FTSE 250 constituent Vectura were up 2.3% to 114.20p in London.
By Ivan Edwards; ivanedwards@alliancenews.com
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