Original from: Businesswire

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Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which will create more than 250 additional high-skilled jobs at Pfizer’s Kalamazoo site. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.

“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “By increasing production at our Michigan facility, we are both helping patients around the world and expanding important manufacturing innovation to the U.S. This investment builds upon our $5 billion of investments across our manufacturing and distribution portfolio since 2017 to support the ongoing growth of U.S. manufacturing leadership.”

RSMs are the raw materials that are chemically converted into API, which is the active ingredient in a medicine. Producing PAXLOVID requires a significant amount of manufacturing capacity across all aspects of the production process. To date, Pfizer has shipped 12 million courses of PAXLOVID across 37 countries, including 5 million courses shipped to the U.S., and has manufactured almost 17 million treatment courses total. The significant investment being made in stateside API and RSM production for nirmatrelvir will allow Pfizer to increase supply capacity for PAXLOVID as needed to help meet global demand. With this new investment, Kalamazoo will be among the world's largest producers of API, with the capacity to produce 1,200 metric tons annually.

“Pfizer’s $120 million expansion in Kalamazoo creating 250 good-paying jobs to support the manufacture of PAXLOVID will build on Michigan’s economic momentum,” said Governor Gretchen Whitmer. “Pfizer’s Kalamazoo facility also made some of the first doses of the vaccine, and now this proud Michigan company will play an even more critical role in the fight against COVID-19. By creating opportunities for Michiganders, Pfizer is helping us grow our economy, create good-paying jobs, and help families.”

Pfizer also plans to expand its Modular Aseptic Processing (MAP) sterile injectable pharmaceutical production facility in Kalamazoo with a phase two investment. The expansion adds to the initial investment of $450 million in phase one to build a 400,000-square-foot production facility and further establishes Kalamazoo as one of the most technically advanced sterile injectable pharmaceutical production facilities in the world.

“Pfizer’s Kalamazoo facility has been at the forefront of pharmaceutical manufacturing for more than 135 years through the legacy company Upjohn,” said Mike McDermott, Chief Global Supply Officer, Pfizer. “The Kalamazoo facility uses some of our most innovative manufacturing technology and has been essential in Pfizer’s fight against COVID-19, producing nearly one billion doses of COVID-19 vaccine at the site to date. Through this expansion, we will continue to invest in the next generation of manufacturing and supply chain resilience.”

Results from Pfizer’s EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study showed an 88% reduction in COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID compared to placebo within five days of symptom onset. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 60 countries across the globe to treat high-risk COVID-19 patients.

To learn more about Pfizer’s manufacturing and global supply, visit www.pfizer.com/pgs.

About the EPIC-HR Final Results 
In the final analysis of the primary endpoint from all patients enrolled in EPIC-HR, an 89% reduction in COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset was observed, consistent with the interim analysis. In addition, a consistent safety profile was observed.

0.7% of patients who received PAXLOVID were hospitalized through Day 28 following randomization (5/697 hospitalized with no deaths) compared to 6.5% of patients who received placebo and were hospitalized or died (44/682 hospitalized with 9 subsequent deaths). The statistical significance of these results was high (p<0.0001). In a secondary endpoint, PAXLOVID reduced the risk of hospitalization or death from any cause by 88% compared to placebo in patients treated within five days of symptom onset; 0.8% of patients who received PAXLOVID were hospitalized or died through Day 28 following randomization (8/1,039 hospitalized with no deaths) compared to 6.3% of patients who received placebo (66/1,046 hospitalized with 12 subsequent deaths), with high statistical significance (p<0.0001). In the overall study population through Day 34, no deaths were reported in patients who received PAXLOVID as compared to 13 deaths in patients who received placebo. In the EPIC-HR trial, in a secondary endpoint, SARS-CoV-2 viral load at baseline and Day 5 have been evaluated for 1,574 patients. After accounting for baseline viral load, geographic region, and serology status, PAXLOVID reduced viral load by approximately 10-fold relative to placebo when treatment was initiated within three days of symptom onset, indicating robust activity against SARS-CoV-2 and representing the strongest viral load reduction reported to date for an oral COVID-19 agent.

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Fewer serious adverse events (1.6% vs. 6.6%) and discontinuations of study drug due to adverse events (2.1% vs. 4.2%) were observed in patients dosed with PAXLOVID compared to placebo, respectively.

All other secondary endpoints for this study are available on clinicaltrials.gov (NCT04960202) and EudraCT (2021-002895-38).

Source: Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the U.S.