Pharmaceutical Technology Editors

Novavax’s COVID-19 vaccine (Nuvaxovid) received a conditional marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) on Feb 3, 2022. The approval permits use of the vaccine in individuals 18 years and older in Great Britain.

"We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic," said Stanley C. Erck, president and CEO, Novavax, in a company press release. "We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the UK, as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program."

On the same day, Novavax also announced that they had received provisional approval from New Zealand’s Medsafe. Like MHRA’s conditional marketing authorization, Medsafe’s provisional approval allows the vaccine to be used in individuals 18 years or older.

Novavax is a recombinant, adjuvanted, protein-based vaccine designed to prevent SARS-CoV-2. According to a company press release, two pivotal Phase III clinical trials found that the vaccine demonstrated efficacy and had a reassuring safety profile. One of the trials totaled 30,000 participants, while the other had 15,000.

In addition to these approvals, Novavax announced that they had also applied for an Emergency Use Authorization from FDA on Jan. 31, 2021.

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Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

Novavax COVID-19 Vaccine Gaining Regulatory Ground

Piramal Pharma Limited’s Pharma Solutions business, a contract development and manufacturing organization (CDMO), announced on Feb. 8, 2022, that it is expanding its antibody-drug conjugate (ADC) capabilities with the construction of a new facility in Grangemouth, Scotland, and is upgrading its API infrastructure at its existing facility in Morpeth, England. These expansions and upgrades together amount to a total investment of approximately £55 million (US$75 million). The investment is intended to enhance the company’s UK-based drug development and manufacturing capabilities and create new employment opportunities for technical and operational staff.

The first phase of the Grangemouth site expansion includes the addition of two new ADC manufacturing suites, which are expected to be operational by the 2023 third quarter. The new suites will be added three existing suites. The building housing the suites was designed to accommodate further expansion, and future plans for expansion include the addition of a new sterile fill/finish suite dedicated to ADCs as well as two additional large-scale manufacturing suites capable of handling increased batch sizes. In addition, a new customer experience center is being constructed for clients visiting the site during development and/or manufacturing activities.

When the expansion is completed, ADC capacity at the Grangemouth site will be significantly increased. The new facility will be fully supported by analytical laboratories, including quality control, cell-based assay and enzyme-linked immune sorbent assay, and good manufacturing practice. The facility will also be supported by warehousing and administrative offices that will all be housed in a purpose-built facility.

“We are delighted to announce the capacity expansion of our Grangemouth facility in the U[nited] K[ingdom]. This new development will more than double our ADC production capacity, strengthening our ability to service customers throughout the entire drug lifecycle. The primary driver behind this investment is the demand for commercial ADCs, coupled with a strong pipeline for clinical materials,” said Peter DeYoung, CEO, Piramal Pharma Solutions, in a company press release.

The Grangemouth expansion represents an investment of £45 million (US$61 million), including a £2.4 million (US$3.3 million) grant from Scottish Enterprise, Scotland's national economic development agency. The expansion is expected to create approximately 40–50 new jobs.

The approximately £10 million (US$14 million) investment to upgrade API capabilities at the Morpeth site includes new equipment, infrastructure, and utility systems. The upgrade is intended to meet increased market demand from global API customers while also improving the company’s carbon footprint. Obsolete equipment will be replaced with new, energy-efficient alternatives. The company is directly investing £8 million (US$11 million), while the UK government is contributing £2 million (US$3 million) to this project.

“PPS is firmly committed to keeping pace with the market through expansions and investments, but we are working hard to do so with a focus on sustainable and environmentally-responsible practices. As we enhance our capabilities at sites in North America and India, similar plans are in place,” said DeYoung in the press release.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Piramal Pharma Solutions Expands and Upgrades UK Manufacturing Facilities

The European Medicines Agency (EMA) has started its evaluation of an application for the use of a booster dose of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, in adolescents aged 12–15 years.

As reported in a Feb. 8, 2022 press release, EMA’s Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data that has been submitted by the company responsible for marketing Comirnaty. The data that has been submitted includes real-world evidence from Israel.

Currently, the booster doses of Comirnaty are approved to be administered in patients aged 18 years and older. An application for a booster dose of the vaccines in patients aged 16–17 years is also ongoing.

EMA will provide further information and updates on the evaluation in due course.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

EMA Considers Adolescent Booster-Dose Application for Comirnaty

The European Medicines Agency (EMA) has revealed that it has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre, in a Feb. 9, 2022 press release.

The DARWIN EU Coordination Centre is aimed at the development and management of real-world healthcare data sources across the European Union (EU). Additionally, the center will be used to conduct scientific studies that are requested by medicines regulators and, later on, those that have been requested by other stakeholders.

It is hoped that the center will provide EMA and other national competent authorities in the region with access to valid and trustworthy real-world evidence. Many stakeholders are expected to benefit through this resource, which will support decision-making on the development, authorization, and surveillance of medicines. Furthermore, EMA expects that the center will be an invaluable resource for the preparation and response to future healthcare crises and pandemics.

The Erasmus University Medical Center Rotterdam will be working with EMA as a contractor on the establishment of the DARWIN EU Coordination Centre. More information is available on EMA’s website.

EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.

EMA Initiates DARWIN EU Coordination Centre

Sanofi announced on Feb. 4, 2022, that FDA approved Enjaymo (sutimlimab-jome) for adults with cold agglutinin disease (CAD). According to a company press release, the approval makes sutimlimab-jome the first and only drug designed to treat the destruction of red blood cells (hemolysis) in individuals with CAD.

CAD is a rare autoimmune hemolytic anemia caused by cold agglutinins binding to the surface of red blood cells. This causes the body to mistakenly attack otherwise healthy red blood cells, which can result in hemolysis. This can result in fatigue, weakness, shortness of breath, light-headedness, chest pain, irregular heartbeat, and various other potential complications. According to the press release, the disorder affects an estimated 5000 people in the United States.

Sutimlimab-jome is a humanized monoclonal antibody designed to selectively target and inhibit the complement 1 (C1) protein in the classical complement pathway. Through this, it inhibits the activation of the complaint cascade in the immune system, consequently inhibiting C1-activated hemolysis.

“Until now, people living with cold agglutinin disease haven’t had an approved treatment option to manage the constant destruction of red blood cells. Without healthy, viable red blood cells, a chain reaction of debilitating signs and symptoms can be triggered, starting with severe anemia,” said Bill Sibold, executive vice-president, head of Specialty Care, Sanofi, in the press release. “Enjaymo is the only approved treatment to inhibit red blood cell destruction in CAD and help stop the chain reaction from the start.”

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

FDA Approves Treatment for Rare Autoimmune Disorder

MaaT Pharma, a clinical-stage biotechnology company, announced on Feb. 8, 2022 that it had come to an agreement with Skyepharma, a French contract manufacturing and development organization, to build a new manufacturing facility. Estimated to be operational by 2023, the facility is set to be France’s largest specialized manufacturing facility for ecosystem microbiome-based therapeutics, according to a company press release.

The new manufacturing site will initially be 1500 m², allowing MaaT to increase its manufacturing capacities ten-fold. The size can also be doubled to 3000 m², depending on MaaT’s manufacturing needs. The facility will be designed to produce MaaT03X, MaaT’s new generation of drug candidates that use its unique proprietary microbiome ecosystem co-fermentation technology.

The facility will also be designed to produce several thousand enema’s of MaaT’s lead candidate, MaaT013, which is designed for graft-versus-host disease. Additionally, the facility will be able to produce several hundreds of thousands of capsules of the company’s second drug candidate, MaaT033, which is designed to improve survival in patients receiving allogeneic stem cell transplantation.

"As we enter Phase [III] with our lead product, MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch. We can look forward to expanding our product portfolio for cancer patients with serenity," said Hervé Affagard, co-founder and CEO of MaaT Pharma, in the press release. "This partnership is fully in line with France's ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader."

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.