Global Pharma Briefs: News from Europe, Asia and the US

By Emily Forster -

January 16, 2020

A roundup of developments and latest news from Germany (Bayer, WuXi Biologics), South Korea (Avacta, Daewoong), and US (Hikma, ANI Pharmaceuticals).

Germany

Bayer, WuXi Biologics in Acquisition Agreement for Bayer’s Drug-Product Mfg Plant

Bayer and WuXi Biologics, a biologics CDMO, have jointly announced an acquisition agreement under which WuXi Biologics Germany GmbH will take over the operations of one of Bayer’s final drug-product manufacturing plants in Leverkusen, Germany, and purchase the associated equipment, in combination with a long-term lease contract for the building.

Based on a manufacturing agreement to be negotiated, the plant would be operated by WuXi Biologics and serve as a back-up site for the final product manufacturing of Bayer’s Kovaltry, an antihemophilic factor (recombinant) while Bayer’s drug-substance and drug-product facility in Berkeley, California, will remain the major site for the manufacturing and filling of it.

The transaction is expected to be concluded in the coming months subject to the satisfaction of customary closing conditions. Financial details were not disclosed.

Source: Bayer, WuXi Biologics

South Korea

Avacta and Daewoong Form Immunotherapy Joint Venture for Cell and Gene Therapies

Avacta, a developer of cancer immunotherapies, and Daewoong Pharmaceutical, a South Korea-based pharmaceutical company, have agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop cell and gene therapies incorporating Avacta’s proprietary platform Affimer biotherapeutics, which are designed to enhance immune-modulatory effects.

The joint venture will develop a new class of mesenchymal stem cells (MSCs), used in the treatment of autoimmune and inflammatory diseases, that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients by reducing inflammatory or autoimmune responses. Daewoong will provide the joint venture with access to its proprietary technology for generating allogeneic MSCs from a single donor to treat a large number of patients. This proprietary technology facilitates developing cell therapies as “off-the-shelf” products. Avacta will develop Affimer proteins against several undisclosed targets, which will be transferred to the joint venture to be incorporated into MSCs. The resulting engineered MSCs will have broad ranging therapeutic utility depending on the Affimer proteins’ intended therapeutic purposes.

Avacta’s research and development costs will be fully covered by the joint venture, and Avacta retains the rights to commercialize the Affimer proteins outside of the field of cell therapies. Avacta’s shareholding in the joint venture is 45% with Daewoong holding 55%, and the joint venture will be operationally managed by Seng-ho Jeon, CEO of Daewoong, with a board composed of representatives of both Avacta (Alastair Smith, CEO and Matthew Vincent, Vice President, Business Development and Strategy) and Daewoong.

Source: Avacta

US

ANI Pharmaceuticals Acquires Generic Products from Amerigen Pharmaceuticals

ANI Pharmaceuticals, a specialty pharmaceutical company of branded and generic drugs, has acquired the US portfolio of 23 generic products from Amerigen Pharmaceuticals, a manufacturer and developer of generic pharmaceutical products, for $52.5 million in cash at close and up to $25 million in contingent profit-share payments over the next four years.

The contingent payments are earned when annual gross profit exceeds a minimum threshold and are earned on a subset of the acquired products. The acquired portfolio includes 10 commercial products, three approved products with launches pending, four filed products and four in-development products as well as a license to commercialize two approved products. The transaction was funded from cash on hand.

Source: ANI Pharmaceuticals

Hikma, Arecor Form Pact to Co-Develop Injectable Drug

Hikma Pharmaceuticals, a generic-drug company, and Arecor, a pharmaceutical company with proprietary drug-delivery technology, have agreed to co-develop a new, ready-to-use injectable medicine in the US through Hikma’s affiliate, Hikma Pharmaceuticals USA Inc.

The product, which will be announced prior to launch, is being developed using Arecor’s proprietary drug-formulation technology platform Arestat, which enhances the properties of approved therapeutic proteins and peptides to deliver new reformulations of existing, complex products. Hikma will seek approval for the product under the US Food and Drug Administration’s 505(b)(2) regulatory pathway, with filing expected in 2021. A 505(b)(2) application is a type of new drug application to obtain the approval of a new drug that contains similar active ingredients to a previously approved drug and is used for changes in dosage form, strength, route of administration, formulation, dosing regimen, or new indication.

Under the terms of the royalty-based agreement, Arecor will receive an upfront payment and further payments on the achievement of development, regulatory and commercial milestones. Hikma will be responsible for the manufacture and commercialization of the product.  Arecor retains the right to develop and commercialize the product in certain markets outside the US.

Source: Hikma, Arecor