Indian drugmakers reducing dependence on China for APIs; Pfizer seeks FDA ok to store jab in standard freezers

Indian drugmakers reducing dependence on China for APIs; Pfizer seeks FDA ok to store jab in standard freezers

By PharmaCompass

2021-02-25Impressions: 1668

Indian drugmakers reducing dependence on China for APIs; Pfizer seeks FDA ok to store jab in standard freezers

This week, Phispers has lots of updates on the Pfizer-BioNTech vaccine. The two companies have asked the US Food and Drug Administration (FDA) to relax storage norms for their vaccine and allow it to be stored in pharmacy freezers, instead of ultra-low temperature freezers. And the FDA is likely to oblige, thereby bringing the vaccine within reach of more countries and people across the world. In Europe, people are turning down the Oxford-AstraZeneca vaccine and are asking for the Pfizer jab. And researchers have said that the second dose of the Pfizer vaccine could be delayed in order to cover all priority groups, as the first dose is being found to be highly protective.

Due to mounting cross-border tensions and disruptions to the supply of APIs from China in early 2020, several Indian drugmakers are looking to reduce their dependence on China-made APIs.

Meanwhile, Indian drug manufacturer Shilpa Medicare was placed on FDA import alert, after the company was issued a warning letter in October 2020. And Eli Lilly announced a global exclusive license agreement and strategic collaboration with Rigel Pharmaceuticals to co-develop and commercialize Rigel’s autoimmune and inflammatory diseases treatment. The deal is potentially worth around US$ 960 million.


Indian drugmakers look to reduce dependence on China-made APIs

Since June 2020, India and China have seen their relations sour due to skirmishes at the border. And the political situation has had a bearing on the pharmaceutical industry.

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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Even though India bears the tag of being the “pharmacy of the world” due to its massive production capacities of both generic drugs and vaccines, it has been hugely dependent on China for active pharmaceutical ingredients (APIs). In 2019, imports from China met half of its API needs.

However, after mounting cross-border tensions, Indian drug companies are looking to source APIs from local drugmakers, or are trying to manufacture them in-house, thereby reducing their dependence on the neighboring country.

According to a Reuters news report, executives at Indian drug companies such as Cadila Healthcare, Cipla, Sun Pharmaceutical and Biocon have said they are aggressively working on reducing their dependence on China for raw materials. One of the major reasons behind this strategic change was the disruption to supplies from China due to the pandemic. In early 2020, many Indian drugmakers had to scramble for ingredients to manufacture important drugs that were exported worldwide.

“Because of the anti-China sentiment ... most of the companies are working towards de-risking themselves in terms of making it clear that their supply chain linkages with China are limited,” Gaurav Suchak, supply head of Cadila, said during a conference.

“For the critical API molecules, the idea is to go for a backward integration where you are in control of that pie which is going to make the most impact on your business, and also to make sure that the entire value chain is secure,” the Cadila executive said.

Companies are also eyeing reliable local vendors who can promise consistency and competitive prices, he added.

Similarly, Cipla has launched an “API re-imagination” program in a bid to expand its own manufacturing capacities using recent government incentives. And a Biocon executive said that the company had a target on what percentage of revenue is “independent of China”.

“We are happy to say that by the last quarter, we were almost 50 percent completely independent of China,” the Biocon executive said. “That does not mean we will not source from China, but we are not dependent on China anymore.”


Pfizer seeks FDA go-ahead for storing its vaccine in pharmacy freezers

The Pfizer-BioNTech vaccine soon may not require ultra-low temperature freezers. Pfizer and BioNTech have asked the US Food and Drug Administration (FDA) to relax requirements for their Covid-19 vaccine and to allow it to be stored in pharmacy freezers.

The companies have submitted new temperature data to the agency to support an update to the current label of their vaccine, so that vials can be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks. The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF) and to be shipped in specially designed containers.

A Reuters news report said the FDA plans to approve Pfizer’s request to store its vaccine at standard freezer temperatures and is likely to announce the new guidance soon by modifying documents related to the emergency use authorization that was previously granted for the vaccine.

If the FDA gives its go-ahead to the jab for storage in pharmacy freezers, this could send a strong message to regulators worldwide and they are likely to follow suit. This will also bring the messenger RNA vaccine within reach of lower-income countries that do not have the capacity for deep freeze storage.

Europeans turn down Astra-Oxford jab: People in countries like France, Germany, and the UK are turning down the AstraZeneca vaccine in favor of the Pfizer jab. The reason behind this resistance, according to news reports, stems from clinical trial data that suggests Astra’s vaccine is less effective than the one from Pfizer.

In Germany, hundreds of thousands of doses of the Oxford-AstraZeneca shot have gone unused and officials in Austria and Bulgaria have described public resistance to the Astra vaccine.

In France, officials staggered vaccinations for health workers after several workers who had received the AstraZeneca vaccine called in sick and complained of flu-like side effects. Last month, French President Emmanuel Macron had expressed doubts about the effectiveness of the AstraZeneca vaccine, especially in people over 65 years of age. And in Sweden, two regions temporarily suspended the rollout of AstraZeneca vaccine after hospital staffers who had received one jab reported mild side effects.

However, there are some people in the UK who prefer the AstraZeneca-Oxford vaccine. “Theyve seen its inventors, the confident Sarah Gilbert and the calming Andrew Pollard, on television — and to them, the Oxford option just feels right,” a Washington Post report said.


Researchers suggest delaying Pfizer vaccine’s second dose to cover priority groups

In an article published in the New England Journal of Medicine, researchers have said that administration of the second dose of Pfizer-BioNTechs Covid-19 vaccine could be delayed in order to cover all priority groups, as the first dose is highly protective.

Some countries are grappling with low supplies of Covid vaccines and are looking at dosing patterns or volumes that differ from how the vaccines were tested in clinical trials. Moreover, the virus is killing “approximately 3,000 people in the United States per day” and the world has seen the emergence of several viral variants.

“One model shows that the expected number of Covid-19 cases would be significantly lower if more people were given a first dose, even if it came at the cost of deferring the second doses,” the NEJM article said.

The Pfizer vaccine had an efficacy of 92.6 percent after the first dose. And the findings were similar to the first-dose efficacy of 92.1 percent reported for Moderna’s mRNA-1273 vaccine.

“Some argue that any deviation from the protocol used in the clinical trials is unscientific,” the NEJM article said. “But the argument is based on an overly narrow definition of science. In both trials, the cases in the placebo and active vaccine groups began to diverge about 10 days after the first dose, with growing vaccine efficacy over time. By the day of the injection of the second dose, the efficacy of the first dose was somewhere in the range of 80 to 90 percent,” it added.

Similarly, a small study supported by the National Institutes of Health (NIH) shows that the immune response to the first vaccine dose in a person who has already had Covid-19 is equal to, or in some cases better, than the response to the second dose in a person who hasnt had Covid-19.

“While much more research is needed—and I am definitely not suggesting a change in the current recommendations right now—the results raise the possibility that one dose might be enough for someone whos been infected with SARS-CoV-2 and already generated antibodies against the virus,” Francis Collins, Director, NIH, said in a blog.

These findings come from a research team led by Florian Krammer and Viviana Simon, Icahn School of Medicine at Mount Sinai, New York. The researchers reasoned that for people whose bodies have already produced antibodies following a Covid-19 infection, the first shot might act in a similar fashion as the second one in someone who hasn’t had the virus before. There is also some anecdotal evidence that suggests that previously infected people were experiencing stronger evidence of an active immune response (sore arm, fever, chills, fatigue) than never-infected individuals after getting their first shots.

In its response to these findings, Pfizer said alternative dosing regimens of the vaccine had not been evaluated yet and that the decision resided with the health authorities.


Indian drug manufacturer Shilpa Medicare placed on FDA import alert

In early November, we had carried news of Shilpa Medicare being issued a warning letter by the US Food and Drug Administration (FDA) for violating current good manufacturing practice (CGMP) norms at its manufacturing plant in Telangana, India. In the warning letter, the agency said its inspectors had found significant deviations from standard manufacturing practices at Shilpas Unit-IV at Polepally village in Mahabubnagar district (in the state of Telangana) during the inspection held in February 2020.

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

Last week, there was news that the FDA has slapped an import alert on Shilpa Medicare's formulation plant in Telangana. The ban applies to all but three of its drugs, after the company failed to address problems cited in the warning letter issued in October 2020.

The three drugs that have been spared by the FDA in its alert are injectable azacitidine, cyclophosphamide capsules and erlotinib tablets. All these are chemotherapies for cancer. Interestingly, the three drugs account for the bulk of Shilpa Medicare’s sales. And injectable azacitidine is on the FDA’s list of drugs that are facing a shortage. Therefore, it’s unlikely that the import ban will have a serious impact on Shilpa. However, the alert could impact the growth of the company’s formulation business, which grew by 40 percent between 2019 and 2020

The import alert only applies to the company’s Telangana plant. Shilpa also operates two FDA-approved API plants in Raichur, India.


Eli Lilly buys rights to Rigels autoimmune therapy for up to US$ 960 million

Eli Lilly and Rigel Pharmaceuticals have announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s autoimmune and inflammatory diseases treatment, including its lead candidate — R552 — for potentially up to US$ 960 million.

Rigels lead therapy has completed early-stage trials and will begin mid-stage trials this year.

Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases, a press statement said.

As per the agreement, Rigel will receive an upfront cash payment of US$ 125 million, with the potential for an additional US$ 835 million in milestone payments.

R552 belongs to a class of drugs called RIPK1 inhibitors which target a critical signaling protein that regulates inflammation and cell death in tissues. It is a new approach to treat various autoimmune, inflammatory, and neurodegenerative disorders.

Under the deal, Lilly will foot the costs for the global commercialization of the therapy — R552 — and Rigel will have the right to co-sell the treatment in the United States.

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Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

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