Keeping tabs on Covid-19: New manufacturing collaborations in big pharma support efforts to fight pandemic and influenza antiviral drug to cure covid-19 approved for manufacture

Collaborations between companies are further strengthening the industry’s manufacturing capabilities and capacity to advance with a covid-19 vaccine

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To mark eight months since the World Health Organization declared Covid-19 a public health emergency and an international concern in March 2020, Pharma IQ highlights how pharma companies are continuing to take action on information, science, leadership and resourcing in an effort combat the pandemic in this week’s update.

Humanigen and Thermo Fisher join forces to expand manufacturing for Covid-19 therapeutic candidate

Humanigen, a clinical stage biopharmaceutical company, has partnered with Thermo Fisher Scientific to scale up manufacturing delivery of its lead drug candidate lenzilumab, currently in a Phase 3 registration study in patients with Covid-19, to support a potential Emergency Use Authorization (EUA).

As part of the agreement, Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and ensure Humanigen can pursue an “aggressive” strategy that commercializes the drug before the end of 2020.

Cameron Durrant, Chief Executive Officer of Humanigen, said: “Manufacturing preparation, precision and expertise are critical as we execute on an aggressive strategy, pending a potential EUA from the US Food and Drug Administration, to deliver a Covid-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier.”

“Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory,” Durrant added.

Anti-influenza drug meets primary endpoint in Phase 3 clinical trial for Covid-19 in Japan

Fujifilm Toyama Chemical, has announced the primary endpoint has been met in a Phase 3 clinical trial of the Avigan Tablet, an antiviral medication used to treat influenza in Japan.

The company conducted a randomized, placebo-controlled, single-blind comparative study to evaluate the efficacy and safety of Avigan. Clinical trial results from close inspection of body temperature, oxygen saturation and chest images of Covid-19 patients with non-severe pneumonia showcased that the drug drastically alleviated their symptoms.

Fujifilm Toyama Chemical confirmed: “With a statistically significant difference (p value = 0.0136), that the administration of Avigan to Covid-19 patients with non-serious pneumonia demonstrates shorter time to resolution. The adjusted hazard ratio showed 1.593 (95 per cent confidence interval of 1.024 – 2.479) with no new safety concerns noted in the trial.”

Fujifilm Toyama Chemical plans to conduct a detailed analysis of the data obtained in this trial, and will work to file Application for Partial Changes to include the additional indication in as early as October 2020.

Approved for manufacture and sale in Japan as an influenza antiviral drug, Avigan, selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it is expected that Avigan may have an antiviral effect on the new coronavirus, as they are RNA viruses of the same type as influenza viruses.

To meet the requests of the Japanese government to increase stockpiles of Avigan, and by other countries to supply the drug, the Fujifilm Group released a statement advising they are working to increase production of Avigan in collaboration with strategic partners and will work to deliver the treatment drug to Covid-19 patients as soon as possible.

CMO partners with Johnson and Johnson to reinvigorate fill and finish to fight Covid-19

Grand River Aseptic Manufacturing (GRAM), an injectable contract development and manufacturing organization, has entered into an agreement with Janssen Pharmaceuticals of Johnson and Johnson to support the manufacture of its SARS-CoV-2 vaccine candidate.

As part of the agreement with Janssen, GRAM is working to transfer the manufacturing process of the SARS-CoV-2 vaccine to its new, state-of-the-art facility, in addition to expanding its domestic fill and finish capacity for Covid-19 vaccines and therapeutics for companies that have agreements with the federal government to meet its Operation Warp Speed goals.

The agreement with Janssen is one example that displays GRAM offering technical transfer support and fill and finish manufacture in an effort to achieve a vaccine candidate.

Tom Ross, President and CEO of GRAM, said: “Should [the SARS-CoV-2] vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the Covid-19 pandemic alongside Johnson and Johnson is an extraordinary privilege.”

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