Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
What's the fate of Emergent's plants?
This week, Emergent BioSolutions revealed another round of layoffs, as well as the closing of two facilities — its Baltimore-Bayview drug substance manufacturing facility and its Rockville, Maryland drug product facility.
In Emergent’s first quarter earnings call, the company’s newly-appointed CEO, Joe Papa, said the sites the company chose to keep — Winnipeg, Canada and Lansing, Michigan — were picked because they were “streamlined” and had the most manufacturing flexibility. In terms of the two sites Emergent is closing, Papa, responding to a question, said the company “had multiple offers on one site, albeit it was a small site,” but would not reveal further details.
The Rockville facility, at 70,000 square feet, is the smallest of the two sites. It was being used fordrug product manufacturing for vaccines and therapeutics. The facility has the capabilities to fill, lyophilize, inspect, label, package and store vaccine products, according to Emergent’s website.
The famed Bayview facility — which was expanded to 112,000 square feet in 2017 — had been designed as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by BARDA in 2012. This granted Emergent $163 million over eight years to build capacity that could accommodate rapid domestic production and was the driving force behind the 2017 expansion project.
The facility gained national attention after a very public batch failure involving the J&J COVID vaccine in March 2021. This was quickly followed by an FDA site inspection that triggered a 3-month shutdown, a congressional investigation, the termination of Emergent's government-backed AstraZeneca contract and an early end to its involvement with the CIADM program.
But the site has since made strides in its quality improvement, and recently the FDA listed the facility as “no action indicated” (NAI), meaning it's in full compliance with CGMPs.
Given the industry’s scramble for fill-finish capacity, it makes sense that someone would snap up the Rockville site first. But as the country also squares off against lofty reshoring expectations laid out by the Biden Administration (reshoring 25% of small molecule API production within five years), I’d imagine the Bayview facility would also have some utility. It will be interesting to see who grabs the reigns. —Karen Langhauser
ADC win for Pfizer, Genmab and women everywhere
This week, the FDA granted full approval for Tivdak, an ADC co-developed by Pfizer and Genmab, to treat recurrent or metastatic cervical cancer following chemotherapy.
This approval was based on the promising results of clinical trials showing its efficacy in treating advanced stages of this disease. Each year, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die from the disease in the U.S.
The cancer stage at diagnosis is crucial for determining the prognosis and treatment options. Early detection typically leads to higher survival rates, with a 5-year survival rate of about 92% for the earliest stage of invasive cervical cancer. In stage 3 cervical cancer, where the disease has spread, the 5-year survival rate drops to about 58%. For stage 4 cervical cancer, which has spread to distant organs like the lungs or liver, the survival rate falls to approximately 17%.
Advanced cases, particularly those that recur or metastasize, may require more targeted therapies like Tivdak. Tivdak combines a monoclonal antibody that targets tissue factor, found in high levels on cancer cells, with a potent chemotherapy drug, monomethyl auristatin E (MMAE), connected by a cleavable linker. This design allows the drug to be delivered directly to cancer cells, minimizing the impact on normal cells.
The full approval of Tivdak in the treatment of cervical cancer was confirmed after the global phase 3 innovaTV 301 trial demonstrated improved overall survival rates for patients with recurrent or metastatic cervical cancer compared to chemotherapy alone.
Research on women's health is significantly underfunded compared to conditions predominantly affecting men, as revealed by data from a study by the National Institutes of Health published in 2021. An analysis on the study shared by Nature points out the severe neglect of women's health conditions, despite the potential high returns on increased funding.
The study also shows that while disorders like migraine and endometriosis rank high in terms of health burden for women, they receive far less funding compared to conditions like HIV/AIDS and substance misuse, which more commonly affect men.
Tivdak’s approval brings progress toward bridging these funding and research gaps and highlights the importance of focusing on conditions that disproportionately affect women. — Andrea Corona
