AstraZeneca offloads Losec rights, advances PT010 in US

AstraZeneca has agreed to sell the global commercial rights for Losec (omeprazole) and its associated brands, excluding China, Japan, the US and Mexico, to Cheplapharm Arzneimittel, it announced on Tuesday.

It also announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding its New Drug Application for ‘PT010’, which it described as an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).

The FTSE 100 pharmaceuticals giant said the Losec divestment included medicines containing omeprazole marketed by AstraZeneca or its collaborators under the Acimax, Antra, Mepral, Mopral, Omepral and Zoltum medicine names.

It said AstraZeneca would continue to manufacture and supply Losec and its associated medicines and commercialise the medicine in markets where it still holds the rights.

Cheplapharm would pay AstraZeneca around $243m (£197.94m) on completion of the agreement, plus sales-contingent milestones of up to $33m in 2021 and 2022.

Income arising from the upfront payment would be reported in the company's financial statements in 2019 as other operating Income.

In 2018, Losec sales in the countries covered by the agreement totalled $98m, the majority of which were in emerging markets.

The agreement did not change AstraZeneca’s financial guidance for 2019, the board said, and as there were no closing considerations to the transaction, the agreement became effective upon signing.

“This agreement forms part of our strategy of reducing the portfolio of mature medicines to enable reinvestment in our main therapy areas, accelerating the number of innovative new medicines for patients with high unmet medical need,” said Ruud Dobber, AstraZeneca’s executive vice-president of biopharmaceuticals.

“We already have an excellent relationship with Cheplapharm, and their strong European presence and global distribution network will help ensure continued patient access to Losec.”

On the complete response letter from the FDA, AstraZeneca said PT010 was a combination of budesonide, glycopyrronium and formoterol fumarate, with the new drug application including data from the phase 3 ‘KRONOS’ trial.

The company said it would now work closely with the FDA regarding the next steps, including submitting for review recent results from the second positive phase 3 trial - ‘ETHOS’ - which was not completed at the time the new drug application was submitted.

PT010 was approved in Japan in June as ‘Breztri Aerosphere’, a triple-combination therapy to relieve symptoms of COPD.

It was under regulatory review in China, where it had been granted priority review by the National Medical Products Administration, and was also under regulatory review in the European Union.