The easy way in

LONDON—Two very different bits of insight recently issued by data and analytics company GlobalData, one regarding COVID-19 and the other on the topic of schizophrenia, serve as reminders of the importance of easier administration methods for therapeutics, not to mention the market opportunities therein.

On the COVID front, GlobalData notes that ease of administration as well as dual protection (that is, local and systemic immunity) can drive novel intranasal vaccine adoption. Both aspects are “promising drivers” for people to potentially embrace these vaccines, GlobalData notes, “particularly at a time when the mammoth task of prospective large-scale vaccination is the need of the hour in the wake of the current COVID-19 pandemic.”

According to the company’s observations in early November 2020, late-stage clinical trials of intranasal COVID-19 vaccines were expected to begin in India by the early stages of this year. Recently, India-based Bharat Biotech signed a licensing and distribution agreement with Washington University School of Medicine in St. Louis for a novel single-dose intranasal vaccine in all markets except the United States, Japan and Europe, marking its second collaboration on intranasal vaccines. Also, Serum Institute of India has already started manufacturing Codagenix’s live-attenuated intranasal CDX-005 vaccine.

“Although several parenteral vaccines for COVID-19 are expected to be launched post successful clinical trials, the actual efficacy and durability of immunity in real-world populations is uncertain,” noted Sasmitha Sahu, a pharma analyst at GlobalData. “Despite India being the single largest manufacturer of vaccines in the world, it will be a mammoth task to cater to a world population of nearly eight billion. Hence, alternative routes of vaccination like intranasal route of administration are gaining more research attention owing to their easy and non-invasive mode of administration.”  

Also important is that an intranasal route of vaccination can trigger both local mucosal and systemic immunity in order to provide more comprehensive protection.  

GlobalData’s drug database shows that there are 17 intranasal vaccine candidates in pipeline across multiple diseases, in Phase 2 trials and above, as well as eight marketed intranasal prophylactic vaccines, including three in India for influenza.

Added Sahu: “The benefits of intranasal vaccines are yet to be fully realized in any other indication except in influenza. Regardless of the dearth of efficacy data, the growing number of trials of intranasal vaccine candidates is a confirmation for the need of alternative modes of delivery.”

However, unlike the influenza virus which replicates in the lower respiratory tract, COVID-19 virus was found to replicate in the nasal cavity and the upper respiratory tract.  

“Traditional non-parenteral modes of vaccination like intranasal and oral do not need specific expertise for administration, facilitating rapid administration to large patient numbers, particularly during pandemics,” Sahu said. “Historically, other mucosal routes of vaccination have shown better adoption and compliance like in the case of oral polio vaccine that ultimately led to a better outreach of mass vaccination and complete eradication of the disease in populous nations like India.

“Due to novelty of these vaccines, appropriate dosage and formulation, designing proper delivery strategies and adequate real-world data around their safety and effectiveness on a periodic basis will be the other key factors that could favorably impact the adoption of intranasal vaccines.”

On a totally different therapeutic track—and this time involving needles—GlobalData also had thoughts on schizophrenia treatment and ease of administration, with the impetus for its opinion being the submission by Janssen for an extension to its marketing authorization application to the European Medicines Agency regarding its product paliperidone palmitate 6-Monthly (PP6M) for the treatment of schizophrenia in adults.

“Antipsychotic medication are the most prescribed in schizophrenia, however, compliance to these prescribed medicines is very low,” noted Alessio Brunello, a managing pharma analyst at GlobalData. “Many versions of extended release paliperidone palmitate are approved globally and GlobalData forecast global sales of the drug to reach $5.3 billion in 2026.”

GlobalData points out that this lack of compliance presents an unmet need in the schizophrenia market. Normally, of course, injection isn’t a route typically associated with greater compliance in any therapeutic application, given the aversion of many people to needles. But the key here is frequency.

“Compliance remains a major issue in schizophrenia, as key opinion leaders (KOLs) explained that when patients begin to feel better, they tend to stop taking their medication. Due to the challenges of maintaining medication adherence in patients with schizophrenia, long-acting injectable (LAI) drugs are becoming an increasingly popular means of drug delivery, based on the theory that a reduced dosing frequency will allow for a reduced administration burden and achieve better rates of adherence,” Brunello observed.

Importantly, patients who are non-adherent are more than 10 times as likely as patients who are adherent to relapse and four times more likely to require hospitalization. And the example of PP6M may be one that other companies should consider following.

“PP6M could have an advantage and likely fulfill a sizeable portion of this unmet need as, if approved, PP6M will be the first long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Furthermore, KOLs mentioned that drugs with a longer duration of action would increase compliance, while also having an enhanced safety profile and/or improved efficacy,” Brunello emphasized. “LAIs are becoming an increasingly popular choice and are being increasingly prescribed by KOLs due to the vastly increased compliance rates compared to oral dosing. In the past years, pharma companies have increasingly focused on LAI formulations of antipsychotic drugs; as such, this segment has provided significant sales growth, but is also becoming more and more competitive. As the LAI market continues to expand, novel LAI drugs will need to offer a significant advantage over the currently available LAIs.”