Pharmaceutical Technology Editors

Merck, known as MSD outside of the United States and Canada, announced on Oct. 27, 2021, that it would enter into a voluntary licensing agreement with the Medicines Patent Pool (MPP) to facilitate affordable global access to molnupiravir, an investigational COVID-19 antiviral medicine. The agreement aims to facilitate broad access for molnupiravir use in 105 low-and middle-income countries.

Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that is designed to inhibit the replication of SARS-CoV-2. Invented by Emory University, it is being developed jointly by Merck and Ridgeback Biotherapeutics for the treatment of mild-to-severe COVID-19 in adults who are at risk for progressing to severe COVID-19. Merck and Ridgeback Biotherapeutics recently submitted an Emergency Use Authorization for molnupiravir to FDA, which could make it the first oral antiviral medicine available for COVID-19 therapy.

This agreement will allow MPP to further license non-exclusive sublicenses to manufacturers (MPP License), diversifying the manufacturing base for the supply of quality-assured or World Health Organization (WHO)-prequalified molnupiravir to countries covered by the MPP License. Merck, Ridgeback Biotherapeutics, and Emory University will receive no royalties for sales of molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by WHO.

“The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis,” said Charles Gore, executive director, MPP, in a Merck press release. “This transparent, public health-driven agreement is MPP’s first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others.”

“Merck’s mission to save and improve lives is a truly global commitment,” said Frank Clyburn, executive vice-president and president of Human Health, Merck, in the press release. “This agreement with MPP is another important element in our [multifaceted] strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live, including in countries where governments face greater challenges to finance healthcare.”

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Merck’s agreement with the Medicines Patent Pool (MPP) aims to facilitate affordable global access for molnupiravir.

Merck and MPP Enter Into License Agreement for Investigational Oral Antiviral COVID-19 Medicine

SGS announced the official opening of its new clinical pharmacology research center in Antwerp, Belgium, on Oct. 26, 2021, and the completion of an expansion at its biosafety testing site in Glasgow, UK, on Oct. 28, 2021.

The newly built SGS Clinical Pharmacology Unit (CPU) in Antwerp is aimed at early phase research. The facility’s strategic location next to the University Hospital of Antwerp (UZA) reinforces scientific collaboration between SGS and a network of specialists and techniques. The CPU is a sustainable facility with a capacity of 110 beds. Study participants can stay in two-to-eight person rooms or in individual rooms and have access to comfortable living and leisure areas. Follow up during first-in-human testing of new drugs will be conducted in a high-care room. In addition, two specialized quarantine units are available for controlled investigation of infection models or controlled human infection models (CHIM). The SGS CPU conducted the first malaria challenge studies in Belgium with its own developed H3N2 (flu) virus.

The CPU also contains a good manufacturing practice (GMP) production unit with level D, C, and B clean rooms for sterile-study drug preparations. It also houses a centrally located laboratory for complex sample processing and use of the latest bed-side monitoring (telemetry). The safety and mechanisms of action of the potential drug under study are mapped.

"Our proximity to Antwerp University Hospital means that expertise is never far away. By joining forces, we are strengthening and broadening our capabilities for early phase clinical research. This new and innovative facility positions SGS at the forefront of clinical research and helps us contribute to a healthier and safer society over the coming years," said John Pype, SGS Benelux managing director, in a company press release.

"Challenge studies will continue to play a key role in the development of drug and infectious disease vaccines in the future. These studies can be a crucial time-saving step in the clinical development of antiviral drugs, for example, by showing efficiency and safety in a controlled environment quickly and safely. That is why we have also decided to focus on expanding our quarantine capacity. This will enable us to conduct studies with a wide range of study participants more efficiently and quickly," said Annick van Riel, director Clinical Pharmacology Unit, SGS, in the press release.

Meanwhile, the expansion at SGS’ Glasgow biosafety testing site is aimed at helping to accelerate quality testing and reduce turnaround time. The expansion project, which began in March 2021 and was completed in September 2021, adds 550 m

 of space and 16 biosafety level 2 (BSL-2) laboratories to the facility.

New equipment installed at the site include BSL-2 cabinets, enzyme-linked immunosorbent assay technology, cell culture equipment for virus detection, and real-time polymerase chain reaction testing equipment. The Glasgow expansion completes previous rounds of investment in 2020 and 2019, which increased capacity for cell bank testing and routine bulk harvest for vaccines, gene and cell therapies, monoclonal antibodies, and other recombinant protein-based biological medicines.

"Most notably, the Biosafety Center of Excellence in Glasgow has participated in the batch-testing and release of over [one] billion doses of COVID-19 vaccine, helping to increase vaccine access and bring the global population out of the pandemic," said Archie Lovatt, site manager & scientific director, SGS, in a company press release.

SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.

SGS Opens New Clinical Research Site in Belgium and Expands Biosafety Testing Capacity in UK

Moderna announced positive results from its KidCOVE study on the effects of its COVID-19 vaccine (mRNA-1273) in children aged six to under 12 on Oct. 2, 2021. According to a company press release, the interim analysis demonstrated a robust neutralizing antibody response following two 50-µg doses of the company’s mRNA-1273 vaccine.

KidCOVE was a Phase II/III, randomized, observer-blind, placebo-controlled expansion study that measured the effectivity of the mRNA-1273 vaccine in 4753 children. The study found that the neutralizing antibody geometric mean ratio (GMR) between children and young adults from the Phase III COVE study was 1.5, with a seroresponse rate of 99.3%—a difference of 0.6%.

According to the press release, these results meet the co-primary immunogenicity endpoints for one month after the second dose. The vaccine was deemed to be well-tolerated with a safety and tolerability profile comparable to the COVE study.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged [six] to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, CEO, Moderna, in the press release. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.

Moderna Announces Positive Results in Study On COVID-19 Vaccine in Children 

Charles River Laboratories announced a planned expansion of the Charles River Accelerator and Development Lab (CRADL) in Cambridge, Mass., on Oct. 20, 2021. In addition to a 30,000 ft² expansion to its existing facilities on Binney Street, a new 18,000 ft² location is being planned.

CRADL is a ready-to-use vivarium rental space used in various animal studies that is intended to eliminate concerns of animal husbandry and daily vivarium management. CRADL also provides access to Charles River’s existing portfolio of 

 support services such as transgenic model creation, animal health surveillance, and more.

“In the biopharmaceutical industry, both infrastructure and staffing can be prohibitively expensive and take significant time to develop,” said Julie Freebersyser, director of CRADL operations at Charles River, in a company press release. “CRADL alleviates that burden by providing best-in-class vivarium space and management to both emerging and established institutions. By outsourcing their vivarium space, researchers can focus on research, instead of logistics.”

The planned expansion will expand the capacity of the Charles River Accelerator and Development Lab (CRADL).

Charles River Laboratories to Expand Vivarium Capacity in Cambridge

In conjunction with National Chemistry Week (Oct. 17- 23, 2021), Spectrum Chemical Mfg. Corp scientists compiled a list of their top 10 chemicals impacting quality of life, according to the company’s Oct. 2021 press release. This list is based on multiple factors, including contributions to saving lives, ending suffering, and enabling technological advancements that have provided more communication channels, improved access to information, and modernized the healthcare industry.

The “Top 10 Chemicals that Have Impacted Quality of Life”, as selected by Spectrum Chemical Mfg. Corp scientists, are as follows:

“Chemistry plays an essential role in improving the quality of life, as highlighted by the many chemists, scientists, and medical professionals playing a key role in the battle against COVID-19 and other diseases,” said Russell Kneipp, COO, Spectrum Chemical, in the press release.

National Chemistry Week is an annual event to build public awareness of the importance of chemistry to quality of life.

Spectrum Chemical scientists give a shout-out to 10 chemicals impacting quality of life in conjunction with National Chemistry Week.

Spectrum Chemical Names Top 10 Chemicals Impacting Quality of Life

Bristol Myers Squibb (BMS) announced on Oct. 21, 2021, that the European Commission (EC) approved its drug Opdivo (nivolumab) as a complementary treatment to fluoropyrimidine- and platinum-based combination chemotherapy in adult patients with certain types of gastric or esophageal cancer. Nivolumab is a programmed death-1 immune checkpoint inhibitor that is designed to use one’s immune system to help restore the anti-tumor immune response.

According to a company press release, EC’s decision was made following a Phase III trial that evaluated nivolumab. The study found a clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients given nivolumab who had unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. These results were found in patients whose tumors expressed a combined positive score greater than or equal to five.

The study evaluated OS and PFS rates among patients who received nivolumab and chemotherapy relative to patients who received only chemotherapy. According to BMS, median OS was 14.4 months in patients receiving nivolumab vs. 11.1 months in those receiving chemotherapy alone, while median PFS was 8.31 months in patients receiving nivolumab vs. 6.05 months chemotherapy alone.

“This approval marks a great achievement for many patients with gastric, gastroesophageal junction, and esophageal adenocarcinomas, who now have a new treatment option that has demonstrated superior overall survival compared to the long-standing standard of care,” said Ian M. Waxman, development lead, Gastrointestinal Cancers, BMS, in the press release. “With limited advances for [human epidermal growth factor receptor 2]-negative gastric cancers made in the past 10 years, we are especially pleased to move the field forward and introduce this [nivolumab]-based combination for patients in the European Union.”

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.