Pharmaceutical Technology Editors

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients in a March 23, 2021 press release.

The combination antibody treatment was found to reduce the risk of hospitalization or death in high-risk COVID-19 patients by a significant amount when compared with placebo. The antibody cocktail met all key secondary endpoints in the Phase III trial, including the ability to reduce symptom duration by four days.

“Today's results show the important medical benefit casirivimab and imdevimab may provide to people with COVID-19 by significantly reducing their risk of hospitalization and death,” said Levi Garraway, Roche’s chief medical officer and head of Global Product Development, in the press release. “New infections continue to rise globally with over three million reported cases last week, so this investigational antibody cocktail may offer hope as a potential new therapy to high-risk patients—particularly in light of recent evidence showing that casirivimab and imdevimab together retain activity against key emerging variants. Together with our partner Regeneron, we are grateful to the patients and investigators who have participated in ongoing clinical trials and look forward to discussing the growing body of evidence with health authorities and to bringing the treatment to as many people as possible.”

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Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

Phase III Trial Data Demonstrates Potency of Antibody Cocktail Against COVID-19

On March 22, 2021, AstraZeneca released US Phase III trial data for its COVID-19 vaccine, AZD1222, that the independent data safety monitoring board (DSMB) found to have potentially included outdated information from the trial, providing an incomplete view of the efficacy data.

The data showed a 79% vaccine efficacy at preventing symptomatic COVID-19, a 100% efficacy against severe or critical disease and hospitalization, comparable efficacy across ethnicity and age, with 80% efficacy in participants aged 65 years and over, and favorable reactogenicity and overall safety profile, AstraZeneca said in the March 22, 2021 press release. The trial included 32,449 participants, 141 of which had symptomatic cases of COVID-19.

Following the DSMB’s findings, AstraZeneca released a statement on March 23, 2021 that clarified the data released were based on a pre-specified interim analysis with a data cut-off of Feb. 17, 2021.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” AstraZeneca said in a company press release. “We are now completing the validation of the statistical analysis.”

According to the statement, the company plans to share its primary analysis with the most up to date efficacy data with the DSMB within 48 hours.

The findings of the DSMB in the US add to the current woes for AstraZeneca, which is also dealing with rising belief among European populations that the vaccine is unsafe due to recent reports about blood clots in some recipients of the vaccine. According to the latest figures from YouGov, more people in Germany, France, Spain, and Italy now believe the AstraZeneca vaccine to be unsafe compared with those who believe it to be safe.

However, regulatory authorities in the United Kingdom and Europe have 

 that the benefits of the AstraZeneca vaccine continue to outweigh the risk of side effects, with no causal link between the vaccine and thromboembolic events established.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

AstraZeneca COVID-19 Vaccine Woes Continue as Questions are Raised over US Trial Data 

on March 23, 2021 that use of ivermectin to prevent or treat COVID-19 outside of well-designed clinical trials is not supported by the data. EMA conducted a review of published laboratory studies, observational studies, clinical trials, and meta-analyses for ivermectin and found that current evidence was not sufficient to support the use of the drug outside clinical trials. According to the agency, laboratory studies showed that the drug could block SARS-CoV-2 replication but at higher concentrations than the currently authorized dose, and higher doses might increase side effects.

According to the agency, ivermectin is used to treat parasitic worm infestations and skin conditions such as rosacea. It is not authorized for use to prevent or treat COVID-19 in the European Union.

The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.

EMA Advises Against Use of Ivermectin for COVID-19 Outside of Clinical Trials 

FDA announced on March 22, 2021 that it has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.

The warning letters outline the illegal marketing of unapproved drugs labeled as containing CBD and emphasize the fact that FDA has not approved any over the counter (OTC) drugs containing CBD, and none of the products being distributed meet the requirements to be legally marketed without an approved new drug application, FDA said in a press release. The letters also mention that CBD has known pharmacological effects on humans and cannot be legally marketed as an inactive ingredient in OTC drug products that have not been reviewed and approved by the FDA. The companies’ failure to comply with current good manufacturing practices was also cited in the letters.

"The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country," said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the press release. "It's important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD's safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health."

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

FDA Issues Warning Letters to Companies Illegally Selling CBD Products

In CPhI’s post-pandemic report, it has been predicted that there will be strong progression in pharma innovation, with breakthroughs in multi-modal disease therapies anticipated during the next five years, a transformative effect of messenger RNA (mRNA) platforms, and significant growth in contract services due to a rise in investigational new drug applications (INDs).

Three experts were involved in a roundtable discussion providing innovator perspectives on post-pandemic trends. The experts involved in the discussion were Valdas Jurkauskas, vice-president, Technical Operations at Black Diamond Therapeutic, Bikash Chatterjee, CEO for Pharmatech Associates, and Parrish Galliher, managing director, BioProcess Technology Group, a division of BDO USA.

Jurkauskas forecasted an increase in demand for contract services from Phase I to Phase II, thanks to the surge in INDs being submitted with FDA. “First, if we look at the numbers of studies, they are significantly higher than what we’ve seen before,” he said in a March 10, 2021 press release. “Secondly, in 2020, accelerated development became the new norm for pharma. So, we now see large volumes of studies and the majority of them are on accelerated regulatory pathways … With accelerated pathways, you get a massive jump in scale because there is this aspiration to file an application in Phase II. Therefore, the increase of services demand is very rapid from Phase I to Phase II.”

Over the next four to five years, Chatterjee stated that the release of drug therapies for a multi-modal disease state, which are notoriously difficult to gain traction on. Additionally, he raised the application of artificial intelligence (AI) as a catalyst for innovation in the future and stressed the more immediate impact of automation on manufacturing in the discussion.

Although Galliher predicted a potential for record levels of development should all the relevant factors come together suitably, he also warned of the strain on contract development and manufacturing organization capacity with biotechs potentially needing to look for alternative manufacturing strategies to progress targets. “What we now hear is a lot of activity around building your own capacity versus outsourcing, with biotech exploring building first early stage and then later stage manufacturing facilities. Understandably, that has resulted in a re-examination of the economics of plants and what types of facilities are best,” he added in the press release. “Obviously single-use becomes very attractive as a less expensive initial option.”

“These findings are hugely exciting for CPhI audiences—both exhibitors and visitors—and we are hosting the online event CPhI Discover in May with the specific goal of helping our communities meet, source, partner, and discover,” stated Nicola Souden, brand manager at Informa Markets, in the press release. “This will be crucial in sustaining industry growth and bringing increasing numbers of therapies to patients … Despite the challenges of the pandemic era, industry-wide partnering and collaboration is flourishing, and it is a dynamic time with potential record levels of growth and innovation expected in the medium term.”

CPhI’s post-pandemic report predicts strong progression in pharma innovation, with breakthroughs in multi-modal disease therapies, a transformative effect of mRNA platforms, and significant growth in contract services.

CPhI Report Predicts Strong Growth in Contract Services

Mecart, a manufacturer of turnkey modular cleanrooms, announced on March 22, 2021 that it has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization, making it the first North American panel manufacturer to gain FM-4882 certification for panels with non-combustible core for cleanroom occupancy.

According to a company press release, the 4880 FM Approvals Room Test evaluates the fire performance of insulated building panel assemblies and interior finish material, while the Approval Standard FM 4882 applies to interior wall and ceiling materials used in cleanrooms and pharmaceutical manufacturing that are susceptible to smoke damage.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.