Hikma Pharmaceuticals Gets US FDA Approval For Generic Advair Diskus

Thu, 17th Dec 2020 18:10

(Alliance News) - Hikma Pharmaceuticals PLC said late Thursday that it has received approval from the US Food & Drug Administration for its generic version of GlaxoSmithKline PLC's Advair Diskus drug.

The regulator gave Hikma the all clear to launch 100 microgram, 50 microgram and 250 microgram and 500 microgram doses for the asthma treatment in the US.

The Jordan-founded drugmaker highlighted it has worked with inhaler drug delivery solutions provider Vectura Group PLC to develop the proprietary dry powder inhaler and formulation technology.

As a result of the approval, Vectura will receive a milestone payment of USD11 million which will be recognised in 2020, and will earn a mid-teen royalty on net sales of the product.

"The approval of our generic version of Advair Diskus marks an important milestone in our strategy to develop more complex respiratory products. Through the unwavering dedication of our employees and close collaboration with the Vectura team, we have developed a high quality and substitutable generic product for Advair Diskus that will improve availability of this critical medicine," said Hikma Chief Executive Siggi Olafsson.

"We are very pleased to have now launched this product and will leverage the investments we have made and the experience we have gained through this process to develop a range of respiratory and other complex treatment options for patients and healthcare providers, helping us to continue to put better health, within reach, every day," added Olafsson.

Hikma shares closed down 0.7% 2,467.00 pence on Thursday and Vectura shares ended up 1.4% at 115.20p.

By Arvind Bhunjun; arvindbhunjun@alliancenews.com