Pharmaceutical Technology Editors

Emmes, a global clinical research organization (CRO) headquartered in Maryland, announced on March 10, 2022 that it has acquired Casimir, a Massachusetts-based CRO. The acquisition marks Emmes’ fourth major acquisition in just over a year.

Casimir focuses on outcome measures of disease progression and treatment benefits and has experience in more than 20 rare diseases. It is specifically known for its efforts in remote data capture for Duchenne Muscular Dystrophy (DMD) using its Duchenne Video Assessment tool, which is also being used to explore a variety of other neurogenerative/neuromuscular diseases. 

Emmes also prioritizes the research of rare diseases, establishing the Orphan Reach Emmes’ Rare Disease center for drug development and clinical research. The acquisition of Casimir further establishes Emmes as a leading CRO in rare and orphan diseases and expands its research and development capabilities.

“The combination of Emmes and Casimir will provide our clients access to full-service protocol design, strategy and trial execution services, not only for rare diseases, such as DMD, but also for a variety of myopathies and neurological conditions,” commented Rhonda Henry, president of Emmes’ BioPharma Group. “Casimir is known for its virtual clinical trials and remote assessments that minimize the burden on patients and caregivers. This is something that we will build upon in other Emmes studies, as our goal is to utilize more and more real-world evidence to improve data quality and information for doctors when treating their patients.”

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Emmes has acquired Casimir, marking its fourth major acquisition.

Emmes Acquires Rare-Disease CRO Casimir

Sanofi and Seagen announced on March 16, 2022, an exclusive collaboration agreement to design, develop, and commercialize novel antibody-drug conjugates (ADCs). The companies will use Sanofi’s monoclonal antibody technology and Seagen’s ADC technology to investigate up to three cancer targets.

“This collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with the potential of bringing renewed hope to cancer patients and their families,” said John Reed, global head of R&D, Sanofi, in a company press release. “We look forward to joining forces with Seagen to collaboratively design and develop promising medicines by advancing antibody-drug conjugate science.”

“We are excited to be working with Sanofi, a global biopharmaceutical leader, to identify new ways to potentially address unmet medical needs of cancer patients,” said Clay Siegall, president and CEO, Seagen, in the press release. “Jointly developing novel ADCs by combining antibodies from Sanofi with Seagen’s proprietary ADC technology, aligns with our strategic priorities to expand the global potential of our pipeline with new first- or best-in-class programs.”

Per the terms of the agreement, the companies will co-fund global development and equally share any resulting profits. Additionally, Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. According to the press release, Sanofi has already selected the first target.

Sanofi and Seagen have entered an agreement to investigate three cancer targets.

Sanofi and Seagen Announce ADC Development Collaboration

Catalent announced on March 16, 2022 that a $30 million (€27 million) project at its facility in Limoges, France has been completed. The project focused on biopharmaceutical development, drug product fill/finish services, and packaging.

The project has modernized the Limoges site to support large molecule programs and increase capacity for small molecule injectable dosage form development. The expansion includes the installation of a new small-to-mid-scale flexible filling line, which is able to handle vials, syringes, or cartridges under barrier isolator technology. Enhancements to analytical and quality control laboratories have also been included, which supports clinical packaging, cold storage, and regulatory capabilities.

The Limoges site will expand Catalent Biologics’ global network with early-phase integrated clinical development and small-scale commercial manufacturing, which will be able to transfer to late-stage and larger-scale commercial supply from its other facilities in Europe and North America progressively. The site is also anticipated to add up to 80 additional jobs through the expansion.

“This investment has transformed the Limoges site into a world-class facility to support the development of early phase and small-scale commercial biologic drugs, and offers customers integrated services to accelerate programs towards and through the clinic, and ultimately to market,” commented Mike Riley, Catalent’s president, Biotherapeutics, in the press release.“Even prior to completion, multiple clinical and commercial customers have already signed contracts for programs to be undertaken at the site. Limoges will now work closely with other Catalent facilities in Europe and the US to provide globally integrated solutions for a range of therapies.”

Catalent has announced the completion of a $30 million project at its facility in Limoges, France focused on biopharmaceutical development and drug product manufacturing. 

Catalent Completes $30 Million Project for Biopharmaceutical Development and Manufacturing in Limoges, France

Kindeva Drug Delivery, a contract development and manufacturing organization, and Viatris announced FDA approval of Breyna (budesonide and formoterol fumarate dihydrate inhalation aerosol) on March 16, 2022. A drug-device combination product indicated for patients with asthma or chronic obstructive pulmonary disease (COPD), this product is the first FDA-approved generic version of AstraZeneca’s Symbicort.

The drug-device combination product is a metered-dose inhaler that contains both budesonide, a corticosteroid that reduces inflammation, and formoterol, a long-acting bronchodilator that relaxes muscles in the airways to improve breathing. Two inhalations, twice a day, are designed to prevent symptoms in both diseases. Breyna will be available in two strengths: 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, director of the Office of Generic Drugs in FDA Center for Drug Evaluation and Research, in a press release from the organization. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”

According to a company press release, Breyna is indicated for treatment of asthma in patients six years or older and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. The indication was granted to Mylan Pharmaceuticals, a subsidiary of Viatris.

“The FDA final approval of Breyna, the first FDA-approved generic version of Symbicort, is an exciting milestone both for our company and the many patients living with asthma and COPD,” said Michael Goettler, CEO, Viatris, in the press release. “Our success with this partnership and approval is yet another proof point of the impact of our Global Healthcare Gateway which enables us to join with Kindeva to provide patients in need with new options.”

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.

FDA Approves Generic Version of AstraZeneca’s Symbicort to Treat Asthma and COPD

BioMed X, a German independent research institute, announced on March 15, 2022 a collaboration with Merck KGaA, Darmstadt, Germany on a new research project, “Regulatory T Cell Dysfunction in Autoimmunity and Inflammaging” (TDA). TDA is the second collaborative project in immunology and eighth general joint research program between the companies since 2013.

TDA’s main objective is to understand the molecular mechanisms governing immune senescence and metabolic dysfunction in regulatory T cells and other T cell subsets that are shared in autoimmunity and aging.

“Regulatory T cells (Tregs) are crucial for maintaining self-tolerance and preventing autoimmune disease,” explained Dr. Gorjana Rackov, group leader of team TDA, in a press release. “During aging, cellular senescence of Tregs and their dysfunctional state may contribute to age-related diseases fueled by chronic inflammation in the elderly – also called ‘inflammaging’. Our goal is to improve patient outcomes by delivering new targets and novel therapeutic approaches for autoimmune disease treatment and for balancing immune responses in the elderly.”

The next big frontier in immunology research is understanding human disease biology in the context of human tissue microenvironment and at the level of single cells,” added Christian Tidona, founder and managing director of BioMed X. “This new project allows us to further deepen our expertise in immunology research and to lay the groundwork for new therapeutic concepts for the treatment of chronic inflammation in autoimmune patients and the elderly.”

BioMed X and Merck KGaA, Darmstadt, Germany announced their collaboration on a research project to study T-cells and autoimmunity.

BioMed X Institute and Merck KGaA Start Second Research Project in Immunology

Envirotainer, which provides cold-chain solutions for air transportation of pharmaceuticals, announced on March 11, 2022 that the first commercial shipment using the new Releye RAP container has been successfully completed. Swiss WorldCargo, a carrier of intensive care pharmaceuticals, handled the consignment. The Releye RAP containers are temperature-controlled and allow for live monitoring during air freight, enabling insight into product condition, location, and progress of the shipment.

Three RAP units and two RAP e2 units successfully traveled from Basel, Switzerland to JFK airport in the US. The shipment was able to be monitored throughout the entire journey due to the integrated live monitoring system. In case of a critical occurrence, Envirotainer’s Control Tower service allowed a global team of operators to be ready to respond within minutes.The Releye RAP sets a new standard for temperature-controlled, large capacity solutions.

Envirotainer and Swiss WorldCargo have successfully completed the first commercial shipment using a new temperature-controlled air freight solution.