Pfizer's New Agreement with the Federal Government Adds 3.7 Million Courses of Paxlovid to the Government's Program. To date, Pfizer has contracted to deliver 20 million courses, with the latest batch scheduled for delivery early next year.
Figure 1 Pfizer Announcement (Source: Pfizer Official Website)
The contract for 3.7 million courses provided by the Ministry of Defense is worth just under $2 billion, in line with Pfizer's initial agreement with the U.S. government, where the cost for the first 20 million patients was approximately $10.6 billion, with a net revenue of about $530 per course.
Paxlovid is still under Emergency Use Authorization, and in February this year, Paxlovid had a PDUFA (Prescription Drug User Fee Act) date commitment with the FDA. But even as an emergency authorized drug, Paxlovid has accounted for a significant portion of Pfizer's business this year. In its latest quarterly report, Pfizer reiterated the guidance of $22 billion for this antiviral drug Paxlovid this year.
This acquisition comes as Pfizer is investing millions of dollars in its manufacturing plant in Michigan to increase the production of the active ingredient in Paxlovid. Meanwhile, the U.S. National Institutes of Health also plans to conduct a trial of the drug Paxlovid in a study on its impact on long COVID patients, which is set to begin in January 2023.
As the number of cases surged dramatically,
Pfizer to Sell Paxlovid in China
China Pharmaceutical Heavyweight Announcement on December 14: Signed Import and Distribution Agreement with Pfizer for the COVID-19 Treatment Drug Paxlovid in the Chinese Market,The validity period starts from December 14 this year to November 30 next year, meaning that the introduction and distribution of Paxlovid will be entirely handled by Sinopharm for nearly a year.
Figure 2: Announcement from China Pharmaceutical (Source: East Money Network)
Many people saw the above announcement and conflated "China Pharmaceutical" with "Sinopharm," but they are not the same. China Pharmaceutical is a company primarily engaged in wholesale. Although both it and Sinopharm Group are central state-owned enterprises, the former belongs to the China General Technology Group. Data from Tianyancha shows that the largest shareholder of China Pharmaceutical is China General Technology (Group) Holding Co., Ltd., which holds 31.92% of the shares.
Relevant industry insiders claim that Paxlovid is currently supported by China's national medical insurance. As a prescription drug, Paxlovid can only be obtained through a doctor's diagnosis and prescription at a hospital. Regarding how to purchase Paxlovid, the insider stated that it first depends on whether the hospital has Paxlovid in stock, and secondly on the patient’s condition—prescriptions may be issued if the patient’s symptoms are suitable for this medication. Meanwhile, not all hospitals have this drug; designated treatment hospitals are more likely to be prepared.
China National Pharmaceutical Group Corporation stated in a filing submitted to the Shanghai Stock Exchange that the company signed an agreement with Pfizer on Wednesday to import and distribute Paxlovid in China. The statement noted that the agreement took immediate effect and will expire on November 30, 2023. Further terms were not disclosed.
Pfizer's partnership with China National Pharmaceutical Group has been ongoing for some time. An agreement signed earlier this year shows that the mainland operations related to Paxlovid in China will be handled by China National Pharmaceutical Group. Additionally, in August, Pfizer signed a five-year agreement with Zhejiang Huahai Pharmaceutical Co., Ltd., one of the largest pharmaceutical companies in China, to manufacture and sell Paxlovid in the country.
In the deal with Huahai, both parties agreed that Pfizer will provide the raw materials to manufacture nirmatrelvir (the antiviral component of the drug) and ritonavir, which can slow the breakdown of the antiviral drug in the body. Huahai will manufacture and combine the two into Paxlovid. Pfizer stated that it is working to expedite the supply of its COVID-19 antiviral drug Paxlovid in China to ensure sufficient availability for patients amid a surge in cases across the country.
The efficacy of the "miracle drug" Paxlovid remains to be observed.
A large real-world efficacy study on the COVID-19 treatment drug Paxlovid published in August 2022 found that:Paxlovid treatment significantly reduces hospitalization and mortality rates among older infected individuals, but no obvious benefits were observed in relatively younger participants aged 40-64.
Figure 3 Research results (Source: [4])
Among 109,254 patients who met the study eligibility criteria, only 3,902 (4%) received nirmatrelvir during the study period. The key finding of the study was that adults aged 65 years or older had significantly lower rates of hospitalization and death due to COVID-19 compared to younger individuals receiving nirmatrelvir, regardless of vaccination status. The former group had 14.7 cases per 100,000 person-days, while the latter had 15.2 cases per 100,000 person-days, with adjusted hazard ratios (aHR) of 0.27 and 0.74, respectively. In the current study, the observed risk of hospitalization due to Omicron was notably lower, whereas it was higher in the EPIC-HR trial conducted during the Delta variant wave.
In patients aged 65 years or older, those treated with nirmatrelvir had significantly lower rates of hospitalization and death due to Covid-19 compared to untreated patients. However, there was no evidence of treatment effectiveness found in younger individuals.
Patients receiving Paxlovid treatment may also experience relapse, and doctors should closely monitor the rebound of critically ill patients receiving Paxlovid treatment and extend the treatment duration. For critically ill COVID-19 patients, a Paxlovid treatment course may be a feasible and safe strategy. Further research is needed to determine the etiology of COVID-19 rebound and its relationship with Paxlovid treatment.
References:
[1]https://endpts.com/us-set-to-pay-nearly-2b-for-pfizers-covid-19-treatment-paxlovid-in-2023/
[2]https://finance.yahoo.com/news/us-government-orders-additional-doses-131123340.html
[3]https://finance.eastmoney.com/a/202212192591754358.html
[4]Arbel R, Wolff Sagy Y, Hoshen M. Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge. N Engl J Med. 2022 Aug 24. doi: 10.1056/NEJMoa2204919. Epub ahead of print. PMID: 36001529.
