Bayer Opens First Cell Therapy Manufacturing Facility to Advance Regenerative Medicines on a Global Scale

• $250 million (USD) plant will help produce transformational cell and gene therapies on a global scale
• Creating readiness for first production runs of potential commercial launches, including bemdaneprocel (BRT-DA01), BlueRock Therapeutics’ investigational cell therapy for Parkinson’s disease as well as product supply for late-stage clinical trials
• New plant helps break industry-wide bottleneck in manufacturing capacity for regenerative medicines
• 100,000 sq. ft. building advances Bayer’s sustainability efforts – first fully electric manufacturing plant in Bayer’s global pharmaceutical manufacturing network

BERLIN, Germany & BERKELEY, Calif.--(BUSINESS WIRE)-- Bayer AG announced today the opening of its first Cell Therapy Launch Facility in Berkeley, California to create the capacity to bring cell therapies to patients on a global scale. The $250 million (USD), 100,000-square-foot facility will supply the material required for late-stage clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson’s disease. In addition, it includes space for a second module of production suites to support additional cell therapies as Bayer’s portfolio advances. BlueRock Therapeutics LP is a clinical stage, cell therapy company and wholly owned, independently operated subsidiary of Bayer AG.

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“Cell therapy represent a groundbreaking class of medicines and is an area where Bayer is making a significant investment to research potentially transformative treatment approaches for people with unmet medical needs,” said Sebastian Guth, President of Bayer U.S.A. and Pharmaceuticals North America, and member of the Pharmaceutical Executive Committee. “Our new cell therapy facility represents true innovation in product development and manufacturing in addition to contributing to Bayer’s sustainability goal as our first fully electric pharmaceutical manufacturing plant.”

The new Cell Therapy Launch Facility is part of a transformation at the company’s dedicated biotechnology site in Berkeley, where Bayer has invested nearly USD 500 million in infrastructure over the past five years.

“Our teams are driving innovation in late-stage development and manufacturing with a goal of bringing transformational cell and gene therapies to patients on a global scale, and this facility will enable us to make it real,” said Jens Vogel, Sr. Vice President and Global Head of Biotech for Bayer’s Pharmaceutical Division. “Bayer is collaborating with biotech innovators, academia, and equipment and automation suppliers to establish platforms that would help bring more therapies to patients faster.”

Bayer’s global biotech organization recognizes the importance of helping innovators transfer their product candidates from the laboratory bench to the clinical study and commercial launch settings. The Biotech team provides its biologic development and manufacturing capabilities for Bayer’s larger biotherapeutics portfolio, including commercial products and late-stage protein and cell therapies in development. As part of Bayer’s larger mission of “Health for All,” the company is now also helping early-stage U.S. and European companies to enable patient trials and commercial launches through its BioPartnering Solutions offerings.

“Having access to this Cell Therapy Launch Facility is central to our goal to deliver impactful cell therapies from our pipeline to patients in need,” said Seth Ettenberg, President & CEO of BlueRock Therapeutics. “Our team is excited to be working shoulder to shoulder with Bayer’s biotech scientists and manufacturing experts as we look to scale up manufacturing for our first investigational therapy, bemdaneprocel for Parkinson’s disease, as it advances through clinical trials.”

The new Cell Therapy Launch Facility, launched in conjunction with manufacturing day in the United States, is among several recent investments to advance Bayer’s biologic pipeline of protein therapeutics, cell and gene therapies including a new Cell Culture Technology Center and Cell Therapy Labs. The new Cell Therapy Launch Facility features flexible, modular space for cell culture, viral transduction and automated filling of cell therapies leveraging Biotech@Bayer expertise in iPSC and CAR-T characterization, process development, analytics and clinical to commercial production.

Beyond Berkeley, the company’s global biotech network includes biologic development, manufacturing science, industrialization and advanced manufacturing engineering teams in Wuppertal and Leverkusen, Germany; and Basel, Switzerland; with a full complement of labs and clinical production suites.

About bemdaneprocel and Parkinson’s Disease

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from pluripotent stem cells (PSC) that are human embryonic stem cells. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to reform neural networks that have been severely affected by Parkinson’s and restore motor and non-motor function to patients. Planning is underway for BlueRock Therapeutics’ Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.

Parkinson’s disease is a progressive neurodegenerative disorder caused by the death of nerve cells in the brain, leading to decreased dopamine levels. At diagnosis, it is estimated that patients have already lost 50-80% of their dopaminergic neurons. The loss of these neurons leads to a progressive loss of motor function and symptoms such as tremors, muscle rigidity, and slowness of movement. Even with medication, the symptoms of Parkinson’s disease can fluctuate during the course of the day. According to the Parkinson’s Foundation, more than 10 million people worldwide suffer from Parkinson’s disease, with approximately one million living in the United States. There is no cure, and the effectiveness of current treatments decreases over time.

About BioPartnering Solutions for Biotech Innovators in U.S. and Europe

Through Bayer’s BioPartnering Solutions, innovators can leverage industry-leading biotech process development and biomanufacturing capabilities to make their therapeutic candidates a reality. Bayer’s highly skilled Biotech teams and infrastructure – which includes preclinical, clinical and commercial launch scale manufacturing – are available to advance promising cell therapy, monoclonal antibody and protein therapeutic candidates from the discovery bench to patients. Through BioPartnering Solutions, Bayer provides early-stage companies with a single source of IND- and BLA-enabling development; bioprocess and biochemical engineering; clinical and commercial manufacturing. A range of complementing support service functions such as supply chain management, procurement, quality, and CMC strategy support for regulatory filings are also available. For more information visit: https://www.bayer.com/en/us/BioPartneringSolutions.

About Bayer’s Biotech Campus in Berkeley, CA

Innovation happens in communities which foster it. Bayer has a 46-acre site located in Berkeley, CA where a team of about 1,000 employees drives the development and manufacturing of traditional protein therapeutics as well as novel cell and gene therapies. It has also served as the global commercial supply center for manufacturing and supplying Bayer’s biotherapeutics for people living with hemophilia A around the world for 30 years.

During today’s event, Bayer celebrated its continuing relationship with the City of Berkeley through a 30-year extension of its Development Agreement which will support up to one million square feet of additional infrastructure. Through the agreement, Bayer will invest more than $30 million in the local community – in career technical education; initiatives focused on health equity, economic resiliency and climate action; and more. For more information visit: https://www.bayer.com/en/us/berkeley-site-updates.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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