Drug and vaccine development is a long and costly business that frequently fails to generate a profit for the companies involved. If this is widely appreciated within biopharma it probably needs repeating in light of calls – politically driven or otherwise – on the industry to “do something” about the coronavirus outbreak.
Given this harsh reality it is a minor miracle that Gilead has already managed to initiate two pivotal studies with its antiviral remdesivir. Numerous other biotech and diagnostic companies have been getting in on the Covid-19 act, EvaluatePharma shows, but in many cases enthusiastic press releases amount to empty words.
Vir, Epivax and Generex fall into the category of biotechs announcing the signing of deals aiming to develop vaccines or therapeutics targeting Covid-19. Of course, signing a deal is not the same as actually developing something, which will take a lot longer, but at least the effort is there.
There are more flagrant examples of jumping on the coronavirus bandwagon: Inovio, for instance, this week trumpeted the fact that it was “accelerating the timeline” for its Covid-19 vaccine; Innovation Pharmaceuticals presented a theoretical rationale backing one of its projects; Evelo is “considering developing” another asset; and Adma Biologics apparently has some relevant IP.
As is to be expected in biotech, fund-raisings are seldom far behind, especially if the purported news triggers a share price spike (Coronavirus stock hype proves infectious, February 27, 2020). Tonix and Co-Diagnostics, for instance, have this week raised cash in conjunction with coronavirus-related announcements.
Yet it is Pfizer that perhaps presents the most sober view. On Monday the world’s biggest drug company said it was screening its antiviral pipeline for possible hits; any identified would first need to undergo toxicology testing, Pfizer calmly spelled out, meaning that a clinical trial could start by the end of 2020.
|A selection of recent Covid-19 announcements|
|Biocryst||Assesses whether galidesivir could be a useful antiviral|
|Epivax||Accelerates Covid-19 vaccine development with UGA|
|Vir & Alnylam||Expand Covid-19 RNAi therapeutic collaboration|
|Generex & Epivax||To develop Ii-key peptide vaccines|
|Luminex||Working to automate detection of Covid-19|
|Takeda||To develop polyclonal hyperimmune globulin, and evaluate currently marketed and pipeline assets|
|Conduent||Introduced software to track, manage and report cases|
|Tonix||Raises $16m, two days after announcing Covid-19 collaboration|
|Heat Biologics||To develop Covid-19 vaccine|
|Adma Biologics||Notice of allowance for patents covering anti-coronavirus compositions|
|Inovio||Accelerates timeline for Covid-19 DNA vaccine INO-4800|
|Nascent Biotech||To study pritumumab as a potential therapeutic|
|Iktos & SRI||Collaborate on AI technology to discover new compounds|
|Gilead||Two phase III remdesivir studies (NCT04292899 & NCT04292730) go live on clinicaltrials.gov|
|Immunoprecise & EVQLV||AI collaboration on vaccine and antibody discovery|
|Innovation Pharmaceuticals||Gives rationale for developing brilacidin for Covid-19|
|Longhorn Vaccines & Diagnostics||"Encouraged by FDA" to help solve coronavirus testing bottleneck|
|Co-Diagnostics||To Provide Covid-19 tests to US CLIA labs|
|Applied DNA Sciences||Collaboration with Takis Biotech to identify vaccine candidates|
|Generex||Signs Contract with Beijing Zhonghua and Sinotek-Advocates to develop a Covid-19 vaccine|
|Pfizer||Screening antiviral compounds that inhibited replication of coronaviruses similar to Covid-19|
|Evelo||Considers developing EDP1815 for Covid-19|
|Cytodyn||Considers developing leronlimab, a CCR5 antagonist, for Covid-19|
|Cepheid & Sherlock Biosciences||Collaborate on molecular diagnostic tests|
|Source: EvaluatePharma & company statements.|
No doubt prominent vaccine developers like Glaxosmithkline, Merck & Co and Sanofi are on the case too, but the current situation’s unexpectedness means that it has little in common with, say, planning for a flu season.
In the case of flu preparations are made months in advance to identify relevant strains, and ensure sufficient manufacturing capacity and infrastructure to ship vaccines. Should the most virulent strain differ markedly there is rarely enough time to switch to a different vaccine within the same season.
A situation like Covid-19, where the virus is only just being characterised, no manufacturing capacity is in place, and the industry effectively has a standing start while incidence is rising exponentially, presents complexity on a completely different level.
This is not to say that development efforts should slacken. Apart from Gilead’s remdesivir, as of today Clinicaltrials.gov reveals 70 Covid-19 studies, virtually all sponsored by Chinese hospitals, testing everything from antivirals to vitamins and traditional Chinese medicine.
But pharma is not designed to be a fast-response unit, and it certainly is not a charity. By the time even a treatment like remdesivir becomes commercially available Covid-19 will have either abated or turned into a full-on pandemic.
Right now, given reports of people in South Korea congregating in their hundreds to buy face masks, for instance, less glamorous but no less important public education is key.