Healthcare Newsletter November 2021
Research advancements have engendered multiple therapeutic alternatives for COVID-19, from developing novel molecules to re-purposing, multiple strategies have been utilized by pharma giants and stakeholders. The landscape has been evolving with long term data for some of the candidates either strengthening the said application claim or paving way for other candidates. Innovators have also pursued licensing of the drugs to generic manufacturers to expedite access in LMICs and LICs.
Pfizer’s Paxlovid, COVID-19 oral anti-viral candidate PF-073211332, in combination with low dose of ritonavir, an HIV medicine, has emerged as one of the potential oral treatments, with Phase 2/3 clinical data indicating 89% reduction in risk of hospitalization or death. Phase 2/3, EIC-HR focused towards study on non-hospitalized adult patients with COVID-19, with high risk of progression of severity, began in July 2021. Interim analysis for the trial was released during November first week. The study was performed over 28 days on 1881 enrolled adults, with no deaths among the cohort who received PAXLOVID as compared to 10 (1.6%) deaths in control cohort. In order to receive Emergency Use Authorization, the company will be submitting the data as part of rolling submission to US FDA. The candidate, if approved by regulatory authorities, will be prescribed as an at-home treatment having potential to reduce severity of illness and eliminate nine out of ten hospitalizations. The candidate, is first of its kind, an oral anti-viral with SARS-CoV-2-3CL protease inhibitor.
Post release of the interim analysis data for PAXLOID, Pfizer and Medicines Patent Pool (MPP) entered a voluntary license agreement to undertake sub-licensees for the supply of the candidate to expand access in low and middle countries, to work towards equitable access for COVID-19 treatment. MPP will facilitate additional production and distribution of the investigational anti-viral post approval from regulatory authorities, by granting sub-licenses to selected generic manufactures worldwide, enabling supply to 95 countries, including all low- and lower-middle income countries and a few upper-middle-income countries in Sub- Saharan Africa. Pfizer will not be receiving royalties on sales in low-income countries and will waive royalties in other countries. MPP and Pfizer joining forces to enable access of COVID-19 drug in LMICs wasn’t the first one, it followed Merck and MPP entering a license agreement for molnupiravir earlier in October 2021, another oral antiviral COVID-19 medicine, for the treatment of mild to moderate COVID-19 in adults at risk, at affordable price range as well. 105 countries have been included under the agreement, to expand access of the drug post regulatory approval.
It is optimistic to see big pharma companies readily entering non-exclusive license agreements, in order to enable increased access at affordable price range, leveraging selected generic medicines manufacturers around the globe. Significance of such drugs can potentially be high in reducing the disease burden in these countries and load on their healthcare systems, which historically have seen increased pressure due to rise in hospitalization.
Xevudy (sotrovimab), another COVID-19 treatment effective in reducing hospitalization and death risk, received approval from Medicines and Health Products Regulatory Authority (MHRA) for people with mild to moderate COVID-19 infection and are at risk of developing severe disease. GSK and Vir Biotechnology product, sotrovimab, is the second monoclonal antibody receiving MHRA’s nod following Ronapreve. Clinical data indicates single dose of Xevudy reduced the risk of hospitalization and death by 79% in high-risk adults with COVID-19. It is administered by intravenous infusion for over 30 mins, approved for administration in individuals aged 12 and above. The US Government signed an agreement with GSK and Vir Biotechnology to purchase sotrovimab under a total value of USD 1 billion, bringing in more than 750,000 doses. Sotrovimab is FDA EUA authorized for the treatment of mild to moderate COVID-19 patients. The companies are undertaking pre-clinical studies to analyze the effect of the therapy over multiple variants of concern, including Delta and recently emerged Omicron. Pre-clinical data supports that sotrovimab retains activity against key Omicron mutations, a SARS-CoV-2 variant. The emergence of Omicron, a variant of concern, is recent and has already spread globally in nearly 38 countries. Albeit, limited information is available currently on transmissibility, disease severity and other relevant factors, multiple companies have initiated research and development activities against Omicron variant of concern, including Moderna, BioNTech, Novavax and Johnson & Johnson.