AstraZeneca Sells off Seroquel Rights in U.S. and Canada

AstraZeneca inked a deal with Germany-based Cheplapharm Arzneimittel GmbH to sell the commercial rights to Seroquel and Seroquel XR in the U.S. and Canada. The two drugs are used mostly to treat schizophrenia and bipolar disorder and are no longer under U.S. and Canadian patent protection.

Cheplapharm will pay $35 million up front and make contingent payments on future sales of up to $6 million. Seroquel brought in $36 million in the U.S. and Canadian markets in 2018, while Seroquel XR created $79 million.

Both drugs are atypical anti-psychotics with antidepressant properties. Seroquel’s primary indications are schizophrenia and bipolar disorder. In some markets, Seroquel XR is also approved for major depressive disorder and generalized anxiety disorder.

Both drugs’ active ingredient is quetiapine fumarate. Seroquel is an immediate release formulation. Seroquel XR is an extended-release formulation.

AstraZeneca already divested rights to the drugs in the UK, Japan and other major international markets. Earlier this year, the company agreed to divest the rights to the drugs in Europe except the UK, and Russia, to Cheplapharm. That deal is expected to wrap before the end of the year.

“This divestment supports our strategy of reducing the number of mature medicines to enable reinvestment in our main therapy areas,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit for AstraZeneca. “Cheplapharm recently agreed to acquire the commercial rights to Seroquel and Seroquel XR in most European markets and Russia from AstraZeneca and this new agreement will help ensure continued patient access to this important established medicine in North America as well.”

Seroquel has something of a colorful history. More than 12 years ago, the U.S. Food and Drug Administration (FDA) accused AstraZeneca of “false or misleading” information about health risks associated with Seroquel in its marketing materials. Various states and consumers then sued the company. The company never admitted wrongdoing but paid out more than $1 billion in settlements by the end of 2011.

Off-label use was apparently for sleep problems or to decrease anxiety. However, the potential side effects were diabetes, heart arrhythmias and potentially irreversible movement disorders.

The drug remained a blockbuster for years, with sales of $3.6 billion from 2014 to 2016.

In other news, AstraZeneca reported last week that the FDA had accepted its supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for untreated extensive-stage small cell lung cancer (SCLC). SCLC is an aggressive, fast-growing type of lung cancer.

The sBLA is built on positive data from the Phase III CASPIAN clinical trial. It showed that Imfinzi with standard-of-care chemotherapy, such as etoposide with either cisplatin or carboplatin, showed a statistically significant and clinically meaningful improvement in overall survival compared to standard of care treatment alone. The risk of death was decreased by 27% with a median overall survival of 13 months for Imfinzi plus chemotherapy compared to 10.3 months for standard of care.

Imfinzi is a checkpoint inhibitor, a human monoclonal antibody that binds to PD-L1. The drug has been approved for previously treated patients with advanced bladder cancer in 11 countries, including in the U.S.