New COVID 19 Treatment Options Amid Falling Reported New Cases

The proportion of countries reporting COVID 19 cases has been declining since mid-2022 even as testing for and reporting of new cases reduce hence impacting uptake of drugs and associated active pharmaceutical ingredients (APIs).

The World Health Organization (WHO) says in the first three weeks of August 2023, only 103 countries of the 234 reported cases of COVID-19 and even the accuracy of the reports may not represent the actual infection rate due to easing of testing and reporting protocols.

However, the waning in demand for pharmaceutical products in controlling the virus in response to easing of pressure from the spread of COVID-19 pandemic has not stopped leading international medicine makers from innovating on the application of antiviral drugs in eliminating the disease.

For example, American multinational pharmaceutical and biotechnology corporation, Pfizer Inc has successfully applied to FDA for approval of the oral antiviral Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid, which is the fourth drug and first oral antiviral pill approved by the FDA to treat COVID-19 in adults, is nirmatrelvir tablets co-packaged with ritonavir tablets. (1)

The Nirmatrelvir is an oval, pink immediate-release, film-coated tablets. Each of the tablets contains 150 mg of nirmatrelvir. The tablet has several inactive ingredients such as colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate.

Ingredients in the tablet’s film-coating include hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide.

Ritonavir on the other hand is a white film-coated ovaloid tablets each contains 100 mg of ritonavir. Some of the inactive ingredients in ritonavir include anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate.

Pfizer, which at the moment is undertaking a transition of Paxlovid to traditional commercial markets, indicated in May 2023 the US government “will continue to oversee the distribution of Paxlovid.”

However, FDA says Paxlovid is “not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.”

Across the COVID-19 treatment market, demand for pharmaceutical products has falling since 2022 with possible negative impact on the uptake of associated APIs.

For example, Pfizer says demand for the Paxlovid oral antiviral has been on the decline probably as global testing and reporting levels continue to reduce.

The company reported a 98% decline in Paxlovid revenues to US$8 billion for the second quarter of 2023 compared with the prior-year quarter “primarily driven by no second quarter U.S. sales in anticipation of transition to traditional commercial markets in the second half of 2023, and lower contractual deliveries in most international markets.” (2)

Paxlovid, which helps reduce illness severity, hospitalization rates, and deaths among a broad population of patients worldwide, is manufactured in three sites of Freiburg in Germany, Newbridge in Ireland and Ascoli in Italy.

The API, nirmatrelvir, is manufactured and its quality tested at the Ringaskiddy in Ireland, a site Pfizer says is “the default API manufacturing site for all new small molecule product launches.”

In early March 2023, Pfizer reported shipping 44 million treatment courses to 63 countries around the world of the Paxlovid drug. (3)

Previously, Pfizer had struck a deal with the US government to supply 20 million PAXLOVID treatment courses for 2022 and an additional 3.7 million treatment courses by early 2023.

Elsewhere, US Biotechnology company Moderna Inc’s revenues for the second quarter of 2023 was $344 million, a decline from the $4.7 billion posted in the same period in 2022, “mainly due to a decrease in sales of the Company's COVID-19 vaccine.” (4)

British-Swedish multinational pharmaceutical and biotechnology company, AstraZeneca plc, predicts a significant dip in revenues from COVID-19 medicines, Vaxzevria17 and COVID-19 mAbs18m, as vaccination levels increase and the pandemic plateaus across the globe.

References;

1. https://www.fda.gov/media/155052/download

2. https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf

3. https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2022/files/Pfizer_Annual_Review.pdf

4. https://investors.modernatx.com/news/news-details/2023/Moderna-Reports-Second-Quarter-2023-Financial-Results-and-Provides-Business-Updates/default.aspx

5. https://www.astrazeneca.com/content/dam/az/PDF/2023/h1/H1-and-Q2-2023-results announcement.pdf