1st Oct 2019 08:32
(Alliance News) - AstraZeneca PLC on Tuesday said it has agreed to sell commercial rights for stomach treatment Losec to Cheplapharm Arzneimittel GmbH for around USD243 million on completion plus milestones of up to USD33 million in 2021 and 2022.
Astra also disclosed it had received a complete response letter from the US Food & Drug Administration for COPD drug PT010. These letters are sent when the FDA decides it will not approve an application in its current form.
The company submitted a new drug application for PT010, a possible new treatment for chronic obstructive pulmonary disease, including data from a phase 2 Kronos trial.
Astra "will now work closely with the FDA regarding next steps", which includes submitting a review of results from its Ethos phase 3 trial, which was incomplete at the time of the first application submission.
PT020 was approved in Japan in June 2019 and is under priority review in China.
The FTSE 100 drug major will sell the global rights to Losec, which reduces stomach acid production and is used to treat gastrointestinal reflux and ulcers. However, the rights sale will exclude "China, Japan, the US and Mexico".
The divestment also includes drugs containing Losec's active ingredient, omeprazole, which are marketed by Astra of its collaborators under the names "Acimax, Antra, Mepral, Mopral, Omepral and Zoltum".
Astra will still manufacture and supply Losec and associated medicines and commercialise the drug where it still has the rights.
Ruud Dobber, executive vice president of BioPharmaceuticals at Astra, said: "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. 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."
Shares in Astra were down 1.1% at 7,179.00 in London on Tuesday morning.
By Anna Farley; [email protected]
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