AZ suing US regulator to prevent Crestor generics

AstraZeneca is suing the US regulator in a bid to prevent cheap generics of its big-selling statin, Crestor (rosuvastatin) from hitting the market next month.

The Anglo-Swedish company has also licensed two drugs to LEO Pharma, as part of an ongoing strategy to sell off developmental drugs that are not a priority.

AZ’s lawsuit filed earlier this week relates to US labelling regulations, which the company says will require any rare orphan drug indications to be listed on any generic competitors.

The lawsuit argues that all indications should be included in the label of any generic, meaning that an orphan drug market exclusivity clause will kick in and keep out competition until May 2023.

Generics have in the past got round this problem in similar situations by simply omitting orphan indications from the label. US sales of the drug topped $2.8 billion in 2015.

Japan’s Otsuka Pharmaceuticals last year advanced a similar argument to try and block competition for its Abilify (aripiprazole) – but lost the case.

Meanwhile, AZ announced it has sold its eczema drug, tralokinumab, to LEO Pharma for $115 million up front and up to $1 billion in commercial milestones, plus royalties.

AZ has retained rights to tralokinumab in respiratory disease and any other indications outside of dermatology.

It has also cancelled a licence with Valeant to develop and commercialise psoriasis drug brodalumab in Europe and handed those rights to LEO.

Last September, AstraZeneca and Valeant entered an agreement granting Valeant an exclusive licence to develop and commercialise brodalumab globally, outside Japan and certain other Asian countries where the rights are held by Kyowa Hakko Kirin Co., Ltd.

Valeant will continue to lead development and commercialisation of brodalumab in the US and all other markets included in the original agreement.

AZ said the changes will allow it to take advantage of LEO's "strong track record" of marketing dermatology products in Europe.