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Feliza Mirasol

Eli Lilly and Company (Lilly) announced on Oct. 2, 2023 that it received a complete response letter (CRL) from FDA for the biologics license application (BLA) for lebrikizumab, a candidate for treating moderate-to-severe atopic dermatitis (eczema).

The letter cited findings that arose during the multi-sponsor inspection of a third-party, contract manufacturing organization that included a monoclonal antibody drug substance used in lebrikizumab. However, the CRL stated no concerns about the clinical data package, safety, or label for lebrikizumab. No other marketed or pipeline Lilly products are affected, according to a company press release.

Lilly has submitted data from three studies (ADvocate 1, ADvocate 2, and Adhere), which included more than 1000 adults and adolescents, from ages 12 to older, who have moderate-to-severe eczema and who were unable to control symptoms with topical medicines or other systemic treatments.

"We are confident in lebrikizumab's potential to help people living with eczema and in the clinical data that supports our submission package for the medicine," said Patrik Jonsson, Lilly executive vice-president, president of Lilly Immunology and Lilly USA, and chief customer officer, in the press release. "We will continue to work closely with the third-party manufacturer and [FDA] to address the feedback in order to make lebrikizumab available to patients."

News of the CRL occurred within the same week that Lilly announced 

a major $1.4-billion acquisition of radiopharmaceutical company, POINT Biopharma Global

. This acquisition will boost Lilly’s oncology pipeline with both clinical and preclinical-stage radioligand therapies under development for treating cancers.

Articles

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Lilly Receives Complete Response Letter from FDA for Lebrikizimab

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Ginkgo Bioworks announced a collaboration on Sept. 27, 2023 with Pfizer under which Pfizer will use Ginkgo's proprietary RNA technology to advance the discovery and development of novel RNA molecules across priority research areas.

Pfizer will pay Ginkgo an upfront payment. Ginkgo is eligible to receive research fees and development and commercial milestone payments. All told, the company may receive up to an aggregate total of $331 million across three programs. In addition, Ginkgo is entitled to potential royalties on sales further downstream.

Ginkgo's RNA technology combines high-throughput screening that evaluates the behavior of RNA constructs with a multi-parameter design framework. The technology allows the company to identify novel natural and synthetic elements that are optimal for a particular application. Ginkgo will apply its technology to achieve efficient production, circularization, improved stability, and enhanced translation of each RNA construct.

"RNA therapeutics are proving to be an important platform to advance the world of scientific innovation, and with progress in synthetic biology we have the potential to create new RNA treatments that may benefit patients worldwide," said Will Somers, head, Biomedicine Design, Pfizer, in a company press release. "Access to Ginkgo's proprietary platform will help enable Pfizer to search for novel and exciting RNA constructs with improved stability and expression that could lead to more effective treatments."

"Billions of patients around the world have already benefited from advances in RNA-based technologies. We're thrilled to be able to help enable the discovery and development of novel drugs using this powerful modality by applying our platform technologies, which are designed to program RNA for maximum therapeutic effect," said Jason Kelly, CEO and co-founder, Ginkgo Bioworks, in the release. "Ginkgo's approach enables and accelerates discovery across different disease areas and modalities for our partners, who bring deep expertise in drug development."

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

Pfizer and Ginkgo Bioworks to Collaborate on Multi-Target RNA Discovery 

On Oct. 2, 2023, Advent International (Advent), a global private equity investor, and Warburg Pincus, a global growth investor, announced that they have completed their previously announced acquisition of Baxter International’s BioPharma Solutions (BPS) business for $4.25 billion in cash, subject to certain closing adjustments.

With the acquisition, the business will now be a standalone contract development and manufacturing organization (CDMO) and will operate under the name Simtra BioPharma Solutions (Simtra). Simtra will continue to offer the same solutions and capabilities that were available under the BPS name to ensure ongoing supply of critical pharmaceutical products worldwide, according to a company press release.

Simtra will continue to operate sterile contract manufacturing solutions, parenteral delivery systems, and customized support services to the pharmaceutical and biotech industries. Under a partnership with Advent and Warburg Pincus, Simtra will become a fully independent, end-to-end CDMO providing a range of services, from clinical development to commercial fill/finish. The team of approximately 1700 employees will also continue to operate manufacturing sites in Bloomington, Ind., and in Halle, Germany. New corporate headquarters will be established in New Jersey.

“I am thrilled to lead Simtra through this exciting time, augmenting the strong legacy that the team has built as part of Baxter,” said Franco Negron, who was announced as CEO of Simtra in August 2023, in the press release. “I look forward to collaborating with Advent and Warburg Pincus—two highly experienced investors within the healthcare space—to continue to grow Simtra’s mission-critical services across a variety of therapeutic areas. I am committed to delivering exceptional quality, service, and technical capabilities for our global customer-base, and am excited to partner with our dedicated Simtra team members as we begin this new chapter.”

“In partnership with Franco, the Simtra leadership team, and Warburg Pincus, we will strive to build on Simtra’s specialized capabilities and drive further product expansion that will ultimately benefit more patients with critical needs,” said John Maldonado, a managing partner at Advent, in the release.

“Simtra is well-positioned to accelerate its go-to-market strategy under the new brand, expand its drug development offering, and execute on capacity expansion,” said TJ Carella, managing director and head of Healthcare at Warburg Pincus, in the release.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Advent International, Warburg Pincus Complete $4.25 Billion Acquisition of Baxter’s BioPharma Solutions Business

On Sept. 28, 2023, Sartorius and UK-based startup SPARTA Biodiscovery (SPARTA) announced that they have entered into a partnership for SPARTA’s analysis platform. The platform helps speed the development, manufacture, and quality control of nanoparticles (small polymer or lipid capsules that act as carriers to deliver active agents to target cells) for biopharmaceutical drugs, including gene therapies, vaccines, and cancer drugs.

Under the agreement, Sartorius will invest up to £3.5 million (US$4.3 million) in a minority shareholding in SPARTA through Sartorius Ventures, its corporate investment unit. SPARTA, which was spun off from Imperial College London, developed its core technology, the single particle automated Raman trapping analysis, and developed a prototype for the platform at the college. The technology was established in the group of co-founder Professor Molly Stevens Fellow of the Royal Society, Fellow of the Royal Academy of Engineering. Single particle automated Raman trapping analysis uses spectroscopy to quickly and automatically analyze populations of individual nanoparticles at high throughput. Its mode of action helps accelerate nanoparticle development and optimize quality control during production, according to a company press release.

“The SPARTA platform will help customers optimize the design of nanoparticles at an early stage, even before the drug candidates move on to the clinic. We have teamed up to bring additional product commercialization and application expertise to the table to facilitate a swift transitioning from prototype to launch,” said Oscar-Werner Reif, head of corporate research and chief technology officer at Sartorius, in the press release.

“Often the challenge in bringing new therapies to life is not the development of new active agents, but safe and robust delivery of such agents into the body, e.g., through nanoparticles. We see an unmet need in R&D, manufacturing, and quality control in analyzing the composition of these nanoformulations. Together with Sartorius, we will be able to bring this technology to customers faster,” said Jelle Penders, CEO and co-founder of SPARTA Biodiscovery, in the release.

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.

Sartorius and SPARTA Biodiscovery Partner on Novel Nanoparticle Analysis Platform 

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced on Sept. 26, 2023 that it has opened two new good manufacturing practice (GMP)-grade messenger RNA (mRNA) drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The addition of these sites makes the company the first contract testing, development, and manufacturing organization (CTDMO) to offer integrated services for all stages of mRNA development, manufacturing, and commercialization, including products and testing, according to a company press release.

Under an ongoing €1 billion (US$1.06 billion) investment, the new sites are part of the company’s goal to advance mRNA technologies and build its global mRNA network and capabilities. The acquisitions of AmpTec in January 2021 (1) and Exelead in February 2022 (2) were also part of this investment.

The company has invested €28 million (US$30 million) into the new Darmstadt and Hamburg GMP mRNA drug substance manufacturing sites. The new facilities add 75 new jobs and provide mRNA services at all scales and applications, from pre-clinical to commercial scale. Services include analytical development and biosafety testing specifically designed for mRNA technologies. In addition, MilliporeSigma offers differentiated polymerase chain reaction-based technology for clinical and commercial mRNA manufacturing, which results in high-quality mRNA.

“mRNA has emerged as the breakthrough technology of this century, providing great promise to not only treat, but potentially cure, a wide array of diseases such as cancer, heart disease, and muscular dystrophy,” said Dirk Lange, head of Life Science Services, Life Science business sector of Merck KGaA, Darmstadt, Germany, in the press release. “We are now the first CTDMO to streamline the entire mRNA process for our clients.”

“As a researcher working on finding cures with mRNA technology and as a believer in its curative promise, collaborating with the Life Science business of Merck KGaA, Darmstadt, Germany has helped to advance my research in finding a cure by leveraging mRNA’s promise for muscular dystrophy,” Simone Spuler, head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité—Universitätsmedizin Berlin, in the press release.

1. Merck KGaA, Merck KGaA, Darmstadt, Germany, Announces Acquisition of AmpTec to Expand mRNA Capabilities for Vaccines, Treatments and Diagnostics. Press Release, Jan. 7, 2021.

2. Merck KGaA, Acquisition of Exelead Completed, Plans to Invest More Than €500 Million in Technology Scale-Up. Press Release, Feb. 23, 2022.

With the two new GMP-grade mRNA manufacturing sites in Germany, MilliporeSigma can now offer fully integrated mRNA services.

MilliporeSigma Opens Two New GMP Manufacturing Sites in Germany for mRNA Production

Polpharma Biologics, a biotech company headquartered in Poland, announced on Sept. 26, 2023 that the European Commission (EC) approved Tyruko (natalizumab), a biosimilar for treating relapsing forms of multiple sclerosis (MS). The biosimilar was developed by Polpharma Biologics and will be commercialized Sandoz, its collaboration partner.

According to a company press release, Tyruko is the first and only biosimilar for treating relapsing forms of MS in Europe. The specific indication for the product is as a single disease-modifying therapy in adults with highly active relapsing-remitting MS (RRMS), which is the same indication for which the reference biologic, Tysabri (natalizumab), is approved by the EC.

The approval is valid in all European Union member states, as well as the European Economic Area countries of Iceland, Liechtenstein, and Norway, and Northern Ireland under the Northern Ireland Protocol. Outside of Europe, Tyruko was approved in the United States by FDA in August 2023.

Meanwhile, a separate application for the use of biosimilar natalizumab in RRMS has been filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, and the company awaits a decision there as well.

“We are delighted that the European approval of Tyruko comes hot on the heels of approval in the [US], meaning that millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease,” said Michael Soldan, CEO, Polpharma Biologics Group, in the press release. “Tyruko is the second EMA [European Medicines Agency] and FDA-approved biosimilar produced by Polpharma Biologics and the first one developed entirely in-house. We’re building on this extensive scientific and manufacturing expertise to further advance our pipeline of other high-potential biosimilar targets.”

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.