AZ buys back rights to Crohn's candidate from Allergan, ahead of AbbVie merger

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Allergan is selling rights to its Crohn’s disease drug brazikumab back to AstraZeneca in a move to satisfy regulators ahead of its merger with AbbVie.

The two companies have axed an R&D agreement with Allergan over brazikumab in Crohn’s disease and ulcerative colitis, bringing the drug back in to AZ’s pipeline.

AbbVie already markets Humira (adalimumab) in Crohn's and ulcerative colitis, as well as a host of other inflammatory disease indications, and regulators believe having a likely successor in its pipeline would give it too much sway over a highly lucrative market.

Originally developed by Amgen, AZ’s MedImmune unit sold the rights to brazikumab to Allergan for $250 million in late 2016, giving a worldwide licence to develop and market the drug.

Depending on achievement of certain sales and development goals, Allergan was also due to pay AstraZeneca up to $1.27 billion under the agreement.

The transaction is expected to complete in the first quarter of 2020, subject to regulatory approvals associated with AbbVie’s proposed acquisition of Allergan and its timely completion.

Financial details of the termination were not disclosed but Allergan will pay an estimate of the total costs expected to be incurred by AZ until completion of development of brazikumab in Crohn’s disease and ulcerative colitis.

Brazikumab binds to the IL-23 receptor and works by selectively blocking the IL-23 immune signal and preventing intestinal inflammation.

In phase 2 trials, brazikumab showed a clinical effect at week eight in tumour necrosis factor-resistant Crohn’s patients and is being assessed in the phase 2b/3 INTREPID programme comparing it with placebo or AbbVie’s Humira (adalimumab).

It is also being tested against Takeda’s Entyvio (vedolizumab) and placebo in ulcerative colitis.

Under a previous agreement with the original developer AZ must pay Amgen a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched, which includes the original inventor royalty.

Other than this, AstraZeneca will own all rights and benefits arising from the product with no other payments due to Amgen.

Hypertension meds are latest to be sold off

In a separate announcement AZ said it plans to sell off a portfolio of old hypertension medicines to Atnahs pharma, which specialises in buying generics and developing new formulations for markets for them.

Atnahs will make an upfront payment of $350m and may also pay future sales-contingent payments of up to $40m between 2020 and 2022.

The portfolio includes Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination).

The agreement excludes rights in the US and India, which were previously divested, and in Japan, which will be retained by AstraZeneca.

AZ has an ongoing strategy of selling older approved drugs, and using the proceeds to reinvest in its pipeline of potential new drugs.