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Chinese prices of APIs increase dramatically; former Operation Warp Speed head accused of sexual harassment
This week, Phispers has more updates on the AstraZeneca-Oxford vaccine which continues to be mired in controversies. Earlier this week, Astra had said its jab was found to be 79 percent effective in preventing symptomatic illness in a large trial in Chile, Peru and the US. However, an independent monitoring panel in the US expressed concerns about the efficacy data. And now, Astra has pegged the efficacy rate a tad bit lower — at 76 percent.
In other news, China and India are having a face-off in the API battlefield as prices out of China are increasing and India is focusing on increased domestic production of bulk drugs. The UK drugs regulator has said it will resume on-site inspections from March 29. After opposition from the Republicans, the US Senate finally confirmed the nomination of Xavier Becerra as HHS secretary by a narrow vote. Russia’s RDIF entered into agreements with several Indian drugmakers to produce the Sputnik V vaccine, even as the EU said it does not need the vaccine. And Moncef Slaoui, former head of America’s Operation Warp Speed, was accused of sexual harassment by a former colleague at GSK. He was subsequently removed from the board of Galvani, a joint venture between Verily and GSK.
Chinese prices of APIs, key intermediates increase dramatically, paracetamol price almost doubles
China and India have had border-related skirmishes over the last one year. But now, the two nations seem to be fighting it out in the API battlefield. Since November 2020, prices out of China for active pharmaceutical ingredients (APIs) and key intermediates to manufacture them have started increasing dramatically. The same trend was seen in April 2020, when several Chinese units and trade corridors had been shut due to the pandemic.
Indian drugmakers import around 70 per cent of their total bulk drug requirements from China. In 2018-19, they had imported bulk drugs and intermediates worth US$ 2.4 billion from China.
According to data shared by the Indian industry, the price of paracetamol has jumped by over 100 per cent since November. In an interview with CNBC-TV18, Priyanka Chigurupati of leading paracetamol manufacturer, Granules India, shared that the increase comes as the two key raw materials used to manufacture paracetamol have seen a price rise by over 60 percent.
Para aminol phenol (PAP), a key building block for producing paracetamol, is witnessing a supply shortage as “one of the Chinese facilities has shut down and this is the company that produces about 46 percent of the overall PAP capacity in the world,” Chirugupati said. In addition, she mentioned that the Chinese have also increased their own captive consumption of PAP because of an increase in the demand for paracetamol.
According to Indian drugmaker Ultra Drugs, the prices of the enzyme rutoside, which is used in making formulations to relieve pain and inflammation, have gone up by 223 per cent. Similarly, prices of APIs for the antibiotic ornidazole have risen by 44 percent. Prices of bulk drugs for several vitamins have jumped too. For instance, mecobalamin (vitamin B12) has seen a rise of around 40 per cent.
In February, the Indian government had rolled out the Production Linked Incentive (PLI) scheme for drugs and had chosen 11 pharmaceutical companies to make key starting materials, drug intermediates and APIs under the scheme. Some Indian companies have committed to setting up facilities to produce products like PAP with supplies scheduled to commence within this year. However, setting up capacities take time. Until then, the supply chain will be dependent on China.
Former head of America’s Operation Warp Speed accused of sexual harassment
Moncef Slaoui, former head of Operation Warp Speed (OWS), who was on the board of Galvani — a joint venture between Verily and GlaxoSmithKline — has been fired from the company board due to allegations of sexual harassment. The alleged harassment occurred several years ago when Slaoui was an employee of GSK, the company said.
Slaoui worked for GSK for 30 years, and held several senior positions at the company. He ran research and development and then vaccines at the Brentford, UK-headquartered drugmaker. He was also the former scientific director of the Covid-19 vaccine development efforts at OWS.
In a statement, GSK said it was first made aware of the allegations in a letter in February. It initiated a probe into the allegations by an external law firm, Morgan Lewis. The company said the investigation “substantiated the allegations and is ongoing.”
“Since February, the highest levels of our company have been working to understand and address what happened,” GSK CEO Emma Walmsley wrote in a note to employees. “Protecting the woman who came forward and her privacy has been a critical priority throughout this time. This will continue. I respect and admire her courage and strength. I’ve spent many nights lately putting myself in her shoes. More than anything, this simply should not have happened.”
In a statement issued on Wednesday, Slaoui apologized to the woman who came forward with the allegations, saying he felt “terrible” that his actions “put a former colleague in an unfortunate situation.” He also said he was taking a leave of absence from his “current professional responsibilities effective immediately” to “focus on his family.”
After rebuke, Astra says its jab was 76% effective at preventing symptomatic illness
Last week, we had carried an article on the AstraZeneca-Oxford vaccine and the crisis of confidence it was facing in Europe, following certain episodes of adverse events. Since then, there have been several updates on the vaccine. On Monday, Astra said its jab was found to be 79 percent effective in preventing symptomatic illness in a large trial in Chile, Peru and the US. This news had reportedly paved the way for Astra to apply for an emergency use authorization (EUA) in the US.As per the data, the vaccine was also 100 percent effective against severe or critical disease and hospitalization, and was safe, Astra and Oxford had said. This data of the late-stage human trial of more than 32,000 volunteers across all age groups, was expected to give credence to the Astra vaccine after results from a separate late-stage trial released last year had raised questions about the robustness of the data.
However, in a rare rebuke, the National Institute of Allergy and Infectious Diseases (NIAID) in the US said on Tuesday that the Data and Safety Monitoring Board (DSMB) (an independent monitoring panel) was concerned by information released by Astra on initial data from its Covid-19 vaccine clinical trial.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” an NIAID statement said. It urged Astra to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data was made public, as quickly as possible.
On its part, Astra said it will engage with DSMB to share its primary analysis and will publish up-to-date results from its major US Covid-19 vaccine trial within 48 hours. On Wednesday, Astra said its vaccine was 76 percent effective at preventing symptomatic illness in a new analysis of its major US trial — a tad bit lower than the level announced on Monday.
“The primary analysis is consistent with our previously released interim analysis and confirms that our Covid-19 vaccine is highly effective in adults,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca said in a statement.
Astra jab in Europe: The World Health Organization and the European Medicines Agency (EMA) have helped allay safety concerns raised in Europe earlier this month, and several European countries have resumed using the shot. On March 18, EMA’s safety committee had concluded its preliminary review of the vaccine and had said its benefits in combating Covid-19 outweigh the risk of side effects. And that the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it.
Meanwhile, the battle between the European Union and the UK over the jab took a fresh turn recently, when the EU said it takes requests to export Astra’s vaccine to the UK “very severely” and will probably reject them until the drugmaker fulfills its delivery obligations to the bloc. The EU has its own contracts with AstraZeneca which are currently not being respected, and any vaccines and ingredients produced in European factories will for now be reserved for local deliveries, an EU official said.
In fact, the EU has threatened to block millions of vaccines to the UK, after telling AstraZeneca to speed up deliveries to the block or face bans. A recent move reportedly puts some 19 million doses on the line. The UK defense secretary Ben Wallace, on the other hand, said EU must honor its vaccine contracts.
UK regulator to resume onsite inspections by March-end
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) had suspended the on-site good practices inspection program on January 5, 2021 in response to Covid-19 restrictions. The MHRA is now resuming its on-site UK inspection program from March 29.
“The guidance is designed to allow the MHRA to fulfill their public health duties, whilst following the current government guidelines and minimizing risk to personal safety. We will continue to prioritize inspections linked to the UK government’s Covid-19 response or any other potential serious public health risk,” MHRA wrote in the updated guidance.
The MHRA Inspectorate will continue to use a combination of remote and on-site inspection approaches. “Inspections in all settings will usually be pre-notified with a minimum of 14 days’ notice to enable Covid-19 risk mitigation planning to take place with the inspected site/organization,” MHRA has said.
As inspections are planned, MHRA will work to determine which portions of an inspection can be completed remotely, ideally through electronic access to needed documentation and paperwork in advance of the physical inspection.
When short notice or unannounced inspections are necessary for public health reasons, inspectors will discuss Covid-19 risk mitigation measures with the organization on arrival. The inspection will be performed by the minimum number of inspectors, following social distancing norms.
US Senate confirms nomination of Xavier Becerra as HHS secretary
After facing significant opposition from the Republicans, the nomination of Xavier Becerra recently got confirmed by the US Senate as the Secretary of Health and Human Services (HHS) by a narrow vote of 50-49.
Becerra will be the first Latino to lead HHS and will oversee all federal health agencies, including the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). In fact, he will be responsible for carrying out Biden administration’s health agenda.
Until recently, Becerra was California’s attorney general and before that a Democratic congressman. He faced significant opposition from the Republican Party ever since he was nominated. Critics of Becerra had targeted his support of abortion rights and had pointed to his lack of a healthcare background, terming his nomination as unqualified. As California’s attorney general, he had sued the Trump administration dozens of times over healthcare, the environment and other issues.
As the HHS Secretary, Becerra will have a major role to play in the Covid-19 vaccine rollout. He will also play a role in Biden administration’s plans to create a Medicare-like public healthcare option.
Russia forges more alliances for its vaccine; fake Sputnik doses found in Mexico
India, the world’s largest vaccine maker, has become one of the biggest producers of the Sputnik V shot outside Russia. For producing the Sputnik V vaccine, Russia’s RDIF (short for Russian Direct Investment Fund) sovereign wealth fund has reached agreements with various Indian drugmakers — such as Gland Pharma, Stelis Biopharma, Hetero and Virchow Biotech.
Other countries producing Sputnik include Brazil, China and South Korea.
Virchow Biotech will produce up to 200 million doses a year of the Sputnik V vaccine in India. RDIF said full-scale commercial production will start after completing the transfer of technology in the second quarter.
Similarly, Bengaluru-headquartered Stelis Biopharma will make 200 million doses of Sputnik V. Stelis will commence supplies from September 2021.
Last month, India’s Dr Reddy’s Laboratories Ltd (DRL), which ran small clinical studies of Sputnik V in the country, sought emergency-use approval for the vaccine. However, India’s drug regulator had rejected the application citing lack of data. The regulator is expected to take up DRL’s application once again this month.
Sputnik V has shown 91.6 percent efficacy in trials, which is much higher than the efficacy shown by two other vaccines being currently administered in India — CoviShield and Covaxin.
Meanwhile, authorities in Mexico have seized a batch of fake doses of Russia’s Sputnik V vaccine. RDIF said: “Analysis of the photographs of the seized batch, including the design of containers and labels, suggests that it is a fake substance which has nothing to do with the original vaccine.”
The fake batch of 5,775 doses was seized at Campeche International Airport in Mexico, a government statement said.
‘EU doesn’t need Sputnik V’: The European Union does not need Russia’s Sputnik V vaccine for Covid-19 and can achieve immunity across the continent using European production, a leading EU executive said on Sunday. These comments have provoked a backlash from the vaccine maker.
The European Commission has been criticized for a slow vaccine rollout when the bloc faces a rise in cases. The European Medicines Agency (EMA) launched a rolling review of the Sputnik V vaccine earlier this month.
“We have absolutely no need of Sputnik V,” Internal Market Commissioner Thierry Breton, who heads the EU executive’s vaccine task force, told a television channel. “Today, we clearly have the capacity to deliver 300 to 350 million doses by the end of June and therefore by July 14 ... we have the possibility of reaching continent-wide immunity,” he said.
In a series of Twitter posts, the Sputnik V vaccine maker accused Breton of being “clearly biased”.“If this is an official position of the EU, please inform us that there is no reason to pursue EMA approval because of your political biases. We will continue to save lives in other countries,” a Sputnik V Twitter post said.
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