A roundup of developments and latest news from Germany (AstraZeneca, Takeda) and India (Zydus Cadila).

Europe

AstraZeneca to Divest Rights to Cheplapharm for Seroquel Products in EU and Russia

AstraZeneca has agreed to the sale and license of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm, a German pharmaceutical company. Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in Europe and Russia.

Cheplapharm will make an upfront payment of $178 million to AstraZeneca and may also make future sales-contingent payments of up to $61 million. In 2018, Seroquel generated annual revenue in the markets covered by this agreement of $47 million, and Seroquel XR $61 million.

AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period.

The transaction is expected to close in the fourth quarter of 2019, subject to customary closing conditions and regulatory clearances.

Source: AstraZeneca 

Takeda Opens New Dengue Vaccine-Mfg Plant in Germany

Takeda Pharmaceutical has opened a new manufacturing plant in Singen, Germany for its dengue vaccine candidate, TAK-003. Takeda invested more than EUR 130 million ($144 million) and will employ up to 200 employees at the plant.

The sterile manufacturing plant will be used for formulation, fill–finish and secondary packaging of the company’s dengue vaccine candidate starting with the packaging line.

Takeda’s dengue vaccine candidate is currently in Phase III development. It is a live-attenuated tetravalent dengue vaccine being evaluated for preventing dengue fever caused by any of the four serotypes of the virus.

Initial construction activities started at the end of 2016, and the plant is now ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure.

Source: Takeda 

India

FDA Issues Warning Letter to Zydus Cadila’s Formulation Facility

The US Food and Drug Administration (FDA) has issued a Warning Letter to Zydus Cadila Healthcare, an Ahmedabad, India-based pharmaceutical company, for its formulation facility in Moraiya, India.

The company says it has taken multiple steps after the inspection to address the observations received from the FDA during the inspection. The company says it does not expect the Warning Letter to affect its existing business in the US and that existing product supplies from the Moraiya facility will continue.

After the inspection of the Moraiya facility, the company says it has successfully completed FDA audits of formulations manufacturing facilities in Baddi, India and API manufacturing facilities in Ankleshwar and Dabhasa, India this year (2019).

Source: Zydus Cadila