Global Pharma Briefs: News from AstraZeneca, Merck KGaA, and Viatris

By Miranda Greenberg -

July 29, 2021

A roundup of news from Africa (BioNTech), China (Merck KGaA) and the US (AstraZeneca, Regeneron, Viatris, Takeda, BlueRock Therapeutics, and others).

Africa

BioNTech in Project for mRNA Malaria Vaccine; Evaluates Mfg in Africa
BioNTech, a Mainz, Germany-based immunotherapy company, is launching a project to develop an mRNA-based malaria vaccine and is evaluating setting up either internal or partnered manufacturing operations in Africa.

To develop an mRNA-based malaria vaccine, BioNTech says it will assess multiple vaccine candidates featuring known malaria targets, such as the circumsporozoite protein, as well as new antigens discovered in preclinical research. The most promising mRNA vaccine candidates will be selected for clinical development. The start of the clinical trial for the first vaccine candidate is planned for the end of 2022.

The company also says it is exploring possibilities to set up mRNA manufacturing facilities, either with partners or on its own, in Africa. The facilities would manufacture various mRNA-based vaccines upon approval to ensure sustainable supply operations. BioNTech plans to co-locate its African manufacturing capabilities with the technology transfer hubs under development by the World Health Organization (WHO), in alignment with the African manufacturing strategy created by the Africa Centers for Disease Control and Prevention. This strategy aims to expand the capacity of low- and middle-income countries to manufacture contemporary vaccines end-to-end and scale up production to increase global access.

Source: BioNTech


China

Merck KGaA Names Former Roche Executive as Head of China 
Merck KGaA has named Hong Chow, currently CEO of Roche Pharmaceuticals in China, as Head of China & International of its Healthcare business sector, effective October 1, 2021.

In this role, Ms. Chow will lead China, Japan, the regions of Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, and the franchise of Cardiovascular, Metabolism & Endocrinology, and the Global Business Innovation team. Ms. Chow will serve as a member of the Healthcare Executive Committee and be based in Shanghai, China.

Ms. Chow is currently CEO of Roche Pharmaceuticals in China. She is also a member of the Supervisory Board at Beiersdorf AG. Prior to joining Roche, she held various leadership roles at Bayer Healthcare across China, Asia-Pacific, and Europe.

Source: Merck KGaA


US

AstraZeneca, Regeneron To Develop Small-Molecule Drugs for Obesity
AstraZeneca and Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, have entered into a collaboration to research, develop, and commercialize small-molecule compounds to treat obesity and related co-morbidities.

The small-molecule drug candidates will target GPR75, a member of the G protein-coupled receptor family, to potentially address obesity and related co-morbidities. The collaboration builds on the recent discovery from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated soon after discovery of the target.

The companies will evenly split research and development costs and share equally in any future potential profits.

Source: AstraZeneca and Regeneron


Viatris Wins Dismissal of Kansas EpiPen Lawsuit
Viatris has announced that a federal district court in Kanas has granted Mylan's motion to dismiss in a lawsuit brought against Mylan and Pfizer by KPH Healthcare Services on behalf of an asserted class of direct purchasers of EpiPen products, auto-injector-based epinephrine products for treating adverse allergic reactions. Viatris is the company formed from the merger of Mylan and Pfizer’s Upjohn. Pfizer’s generic and established medicines business.

Viatris reported that court agreed with the company's argument that KPH lacked legal standing to assert the claims in its lawsuit and dismissed the case in its entirety with an option for KPH to file a limited amended complaint within 30 days.

Source: Viatris


TakedaTo Launch Company To Develop Norovirus Vaccine
Takeda and Frazier Healthcare Partners, a private-equity firm, have entered into a collaboration to launch HilleVax, a bio/pharmaceutical company to develop and commercialize Takeda’s norovirus vaccine candidate, HIL-214 (formerly TAK-214).

HIL-214, which is a virus-like-particle (VLP) vaccine candidate, completed a Phase IIb field efficacy trial. To date (as reported on July 29, 2021), the candidate has been studied in nine human clinical trials with safety data from over 4,500 subjects and immunogenicity data from over 2,000 subjects.

Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to HIL-214 globally outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. Takeda will retain commercialization rights in Japan, and HilleVax will integrate certain Japan development activities into its global development.

Source: Takeda


Bayer’s BlueRock Therapeutics Names New President, CEO
BlueRock Therapeutics, a New York-based developer of cell therapies in neurology, cardiology and immunology and a wholly owned and independently operated subsidiary of Bayer, has announced that Emile Nuwaysir, Ph.D., its current President and CEO, will transition to the position of BlueRock Board Chair, effective August 1, 2021, and its current Chief Scientific Officer, Seth Ettenberg, Ph.D., will assume the role of President and CEO.

Under Dr. Nuwaysir’s leadership since 2017, BlueRock has grown from a small, preclinical startup to a clinical-stage company with over 200 employees in two countries.

Since joining BlueRock in 2020, Dr. Ettenberg has been an leader of the Research organization, helping to shape the pipeline and advance BlueRock’s cell andgene platform.

Source: Bayer


Capsida Biotherapeutics Opens New Gene-Therapy Mfg Facility
Capsida Biotherapeutics, a Thousand Oaks, California-based bio/pharmaceutical company developing adeno-associated virus gene therapies, has opened a new gene-therapy manufacturing facility in Thousand Oaks.

The 15,000-square-foot manufacturing facility includes two ballroom production suites, a fill suite, and a quality-control laboratory. The facility will employ between 40 and 50 people.

Source: Capsida Biotherapeutics


Nexus Pharmaceuticals Opens New Drug-Product Mfg Facility
Nexus Pharmaceuticals, a Lincolnshire, Illinois-based bio/pharmaceutical company, has opened a new manufacturing facility in Pleasant Prairie, Wisconsin.

Construction of the facility began in August 2019 and was completed in 2021, with commercial production expected to commence in 2022. The Phase I investment of $100 million supports a new manufacturing facility with technology that includes an isolator system and multiple lyophilization (freeze-drying) machines. The full, multi-phase project is expected to be completed in 10 years (as reported on July 27, 2021), with an estimated total investment of $250 million.

The facility is expected to create 77 new jobs in a variety of job functions in manufacturing and science by 2022 and 400+ new local jobs long-term. Nexus plans to partner with local institutions to provide job training and career and research opportunities.

Source: Nexus Pharmaceuticals


Alloy, Echo Investment Form New Company for Antibody Therapeutics
Alloy Therapeutics, a Boston, Massachusetts-based drug-discovery services company, and Echo Investment Capital, an Oklahoma City, Oklahoma-based investment firm, have formed a new biomanufacturing company, Wheeler Bio, for antibody therapeutics.

With an initial focus on antibody therapeutics, Wheeler’s biomanufacturing programs will integrate with Alloy Therapeutics’ preclinical antibody platforms and discovery capabilities. Wheeler’s development, operations, and business headquarters are located in Oklahoma City and are supported by a pilot lab inside Alloy’s Boston facility.

Wheeler launched its Boston-based operations in the first quarter of 2021 and will open its 35,000-square-foot facility in Oklahoma City in the fourth quarter of 2022.

Source: Alloy Therapeutics