‘At risk’ pharma alliances in the time of a pandemic

Against the backdrop of the Covid-19 pandemic, the business strategy that’s increasingly visible is that of “at risk” alliances.

So, there’s the Covid-probable vaccine candidate from Oxford University on which the UK and US governments are putting their money, for instance, even as it goes through different phases of clinical trial to assess its efficacy against the virus. The idea is to be able to source vaccines literally off-the-shelf, when and if the trials conclude successfully.

But the “if” does not seem to limit the swathe of alliances being linked during the pandemic.

AstraZeneca and Serum, for example, are manufacturing the Oxford vaccine candidate “at risk”, as trials are under way.

There’s GlaxoSmithKline (GSK) and Johnson & Johnson (J&J), also working to get their respective vaccine candidates deployable from the get-go.

Early starter on Covid-alliances, Gilead Sciences’ experimental anti-viral remdesivir has Governments and companies keen on it.

Gilead subsequently formalised voluntary licences (VL) with a clutch of Indian and Pakistani generic drugmakers, allowing them to make the drug and sell in select regions, particularly in the developing world.

The slew of developments come even as public health advocates campaign that Covid-19 related drugs, medicines and technology be equitably accessible around the world, without barriers of high price or patent protection. Especially so, when funds for research and manufacturing scale-up are from Government or public health-oriented trusts.

At no profit

An AZ spokesperson explains that while the company recognises the vaccine may not work, it is committed “to progressing the clinical programme with speed and scaling up manufacturing at risk.” It is working with Governments and partners to navigate regulatory approvals, have a manufacturing network and get the vaccine ready for as many people, the spokesperson says. On pricing concerns, the spokesperson adds that the company is committed to make the vaccine equitably available “at no profit during the pandemic because this is a global public health emergency. It is right that during this period the vaccine is provided at no profit.” Similarly, a J&J spokesperson says the company is to begin “at risk” production on its vaccine candidate and committed “to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.”

J&J’s collaborations include those between its Janssen Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health & Human Services, and the Beth Israel Deaconess Medical Center (BIDMC).

BARDA and J&J committed over $1 billion to co-fund vaccine research and development efforts, including pre-clinical, clinical development and upscaling of clinical activities. The investigational vaccine’s first-in-human trials are to begin ahead of time in July.

GSK too has many collaborations towards a vaccine, including one with Sanofi to develop and manufacture a Covid vaccine using technology drawn from both companies. They have committed to “manufacturing 100s of millions of doses by the end of 2021 (if successful),” according to the spokesperson. GSK will manufacture the adjuvant doses.

GSK has committed to reaching one billion doses of adjuvant next year for potential use across the range of its Covid collaborations. Given the “unprecedented need” for these vaccines, “GSK has started manufacture of the adjuvant at risk,” it has said. The company is also in discussions with Governments and global institutions about funding for production and supply of the adjuvant. The company did not expect “to profit from sales of its portfolio of collaborations” for Covid-vaccines made during this pandemic phase, it has said, “as profit generated will be invested in support of coronavirus-related research and long-term pandemic preparedness, either through GSK’s internal investments, or with external partners.”

On remdesivir, Gilead hopes competition would drive down costs. Here too, the voluntary licences given to generic companies to make remdesivir were royalty-free in the pandemic period or till a pharmaceutical product or vaccine was approved to treat Covid, the company has said.

Call for transparency

Public health voices agree that companies and Governments are working at record speed to develop products against Covid. But greater transparency is needed in outlining the rationale behind funding companies and getting commitments from them on making products accessible for all, they add. There is discomfort in the selective nature of alliances and the indication that the bonhomie would last only as long as the pandemic did. How this strategy unravels will depend on the fate of the vaccines and medicines and whether the “at risk” wager works and a product is approved eventually. The experience, however, will help tailor global responses to future public health emergencies.

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