A roundup of developments and latest news from Germany (AstraZeneca, Cheplapharm), India (Sun Pharmaceuticals), United States (Amneal, Eli Lilly and Company, Sanofi).

Germany

AstraZeneca Completes Agreement with Cheplapharm for Seroquel

AstraZeneca has agreed to divest its commercial rights to anti-psychotic medicines Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm Arzneimittel GmbH, a supplier of branded products based in Germany. 

Under the terms of the agreement, AstraZeneca has received a payment of $178 million from Cheplapharm. AstraZeneca may also receive future sales-contingent payments of up to $61 million. 

Seroquel and Seroquel XR are atypical anti-psychotic medicines with antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also approved in some markets for major depressive disorder and generalized anxiety disorder. AstraZeneca previously divested the rights to Seroquel and Seroquel XR in the UK, Japan and other major international markets. AstraZeneca agreed to divest the rights to the medicines in the US and Canada to Cheplapharm earlier in 2019.

Source: AstraZeneca

India

FDA Issues Form 483 to Sun Pharmaceutical’s Mfg Facility in India

The US Food and Drug Administration (FDA) has issued a Form 483 for Sun Pharmaceutical’s Halol, Gujarat, India manufacturing facility following a GMP inspection from December 3 to December 13, 2019. The FDA cited the facility with eight observations.

Sun Pharmaceutical says it is committed to addressing these observations promptly and remains committed to working closely with the FDA and enhance its GMP compliance on an ongoing basis.

Source: Sun Pharmaceutical

United States

Amneal To Acquire Majority Stake in AvKARE for $340 M

Amneal Pharmaceuticals, a generic-drug and specialty pharmaceutical company, has agreed to acquire a 65.1% majority interest in AvKARE, a manufacturer and wholesaler of pharmaceutical products, and its related affiliate, R&S Northeast, for $340 million.

AvKARE is a private label provider of generic pharmaceuticals for the US federal agency sector, primarily focused on serving the Department of Defense (DoD) and the Veterans Administration (VA). The company has relationships with more than 50 generic pharmaceutical vendors and offers a proprietary line of specially packaged products under its own labels. With the acquisition of AvKARE, Amneal will build upon its existing presence in the DoD and VA generics market.

Under the agreement, Amneal will acquire a majority interest in AvKARE through an unrestricted subsidiary, which will finance the purchase of AvKARE with a new $180-million senior secured term-loan facility, approximately $75 million of balance-sheet cash, and an approximately $44-million seller note, with the balance of the implied enterprise value contributed through the selling shareholders’ rollover interest in the newly formed subsidiary. The new debt financing will be secured by the newly formed unrestricted subsidiary and will not impact Amneal’s existing term-loan facility.

The transaction is expected to be completed in early 2020, subject to the satisfaction of customary closing conditions and approval from relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. Following the close of the transaction, AvKARE will operate on a standalone basis as an independent subsidiary of Amneal.

Source: Amneal

Lilly to Collaborate with DexCom for Diabetes Management System

Eli Lilly and Company has announced a global commercialization agreement to integrate the products of the glucose-monitoring product developer, DexCom, into Lilly’s personalized diabetes-management system, currently in development to advance the treatment of diabetes. Under the agreement, Lilly will use Dexcom’s continuous glucose-monitoring devices in both the pen- and pump-based platforms of the system being designed to help improve diabetes management.

The personalized diabetes-management system being developed will include both pen- and pump-based platforms. The goal of the pen-based platform is to integrate personalized data from a prefilled, disposable insulin pen with data from glucose-sensing technologies into a compatible software application. Personalized data is transferred from the pen via an optional attachment. The goal of the pump-based platform, which is a hybrid-closed loop system, is to use integrated devices (an insulin pump, continuous glucose monitor and a dedicated handheld controller or smartphone application that controls the system) to automate insulin dosing.

Source: Eli Lilly and Company

Sanofi Pasteur Awarded $226-Million Vaccine Contract by US Government

Sanofi Pasteur, the vaccines global business unit of Sanofi, has entered into an agreement with the US Department of Health and Human Services (HHS) to increase the company’s domestic pandemic influenza vaccine production capabilities based in Swiftwater, Pennsylvania.

The contract is supported by federal funds from the Biomedical Advance Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS.

The contract will support the clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine to help enhance US. and global pandemic preparedness.This investigational pandemic vaccine will utilize the same recombinant technology as Sanofi’s Flublok Quadrivalent (influenza vaccine A and B strains). In addition, the contract will expand the site’s role as a center for pandemic preparedness by adding both recombinant and adjuvant manufacturing alongside current egg-based manufacturing.

Flublok Quadrivalent is a vaccine indicated for the prevention of influenza disease in adults caused by influenza A and B strains. Sanofi says Flublok Quadrivalent is the only recombinant protein-based influenza vaccine approved by the US Food and Drug Administration uniquely providing an exact genetic match of hemagglutinin (HA) from each recommended vaccine virus. HA is the protein identified as key to stimulating immunity to influenza.

Source: Sanofi