Tag: Coronavirus vaccine

Will Gilead price its coronavirus drug for public good or company profit?

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Gilead Sciences Inc faces a new dilemma in deciding how much it should profit from the only treatment so far proven to help patients infected with the novel coronavirus.

The drugmaker earned notoriety less than a decade ago, when it introduced a treatment that essentially cured hepatitis C at a price of USD 1,000 per pill.

Public outrage over the cost of Sovaldi in 2013 – despite that it was a vast improvement over existing equally expensive therapies – ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since.

That backlash has subsided considerably in the midst of the coronavirus pandemic, during which drugmakers’ efforts to develop vaccines and treatments is considered essential to battling a disease that has infected some 3.7 million people and killed over 258,000 worldwide.

Gilead is now in the spotlight again after data showed its antiviral drug remdesivir helped reduce hospital stays for COVID-19 patients, and the US authorized wide emergency use of the therapy. Wall Street analysts say remdesivir could generate USD 750 million or more in worldwide sales next year, and USD 1.1 billion in 2022, assuming the pandemic continues. But Gilead, and other drugmakers, will need to avoid the appearance of taking advantage of a global health crisis to rake in profit, according to pharmaceutical industry consultants and former regulators.

Also Read: Gilead says open to collaborate with govts, drug firms to make Remdesivir globally available

“This is a tremendous opportunity for drug manufacturers,” to improve the industry’s image, said Ed Schoonveld, a drug pricing expert at consulting firm ZS Associates. “There has been an overwhelmingly negative focus on drug prices.”

Gilead Chief Executive Daniel O’Day, in the post just over a year, is proceeding with caution. The company is donating enough remdesivir for at least 140,000 patients for distribution by the US government to hospitals nationally.

At a meeting with President Donald Trump in the White House on Friday, O’Day pledged to make the therapy available to those in need.

Gilead also aims to increase worldwide manufacturing to supply over a million coronavirus patients by year-end, rising to several million in 2021, if required. The company has not disclosed its pricing plans.

“I think this will certainly help the industry’s reputation,” O’Day said on a recent conference call with investors. “I’m not suggesting that there won’t continue to be focus and pressure on drug pricing … but it’s being done now in a way where we can have an appreciation for the innovation the industry brings.”

Gilead on Tuesday said it was talking with chemical and drug manufacturers to produce remdesivir for Europe, Asia and the developing world through at least 2022. The company said it was negotiating voluntary licenses with generic drugmakers in India and Pakistan, who would produce a lower-cost supply of remdesivir for developing countries.

FEDERAL MARCH IN?

Estimates of a fair price for remdesivir in the United States, where drugmakers generally charge the most for a new therapy, vary widely.

The Institute for Clinical and Economic Review (ICER), which assesses effectiveness of drugs to determine appropriate prices, suggested a maximum price of USD 4,500 per 10-day treatment course based on the preliminary evidence of how much patients benefited in a clinical trial. Consumer advocacy group Public Citizen on Monday said remdesivir should be priced at USD 1 per day of treatment, since “that is more than the cost of manufacturing at scale with a reasonable profit to Gilead.”

Some Wall Street investors expect Gilead to come in at USD 4,000 per patient or higher to make a profit above remdesivir’s development cost, which Gilead estimates at about USD 1 billion.

Gilead shares have risen about 20 percent since the beginning of the year, largely on hopes for remdesivir. That compares with a drop of 12 percent for the broad S&P500 Index.

Some experts warn that a much higher US price for remdesivir would put Gilead back in the crosshairs on drug pricing. In a more extreme scenario, the company could risk federal or state government action to march in and invalidate the medicine’s patent protection in the name of public health and issue mandatory manufacturing orders.

The US government has never invoked those rights. But it has sued Gilead over patents on two of its widely-used HIV drugs that received federal funding grants while in development.

“If there is ever a time when those issues might arise, this would be that time,” said Eric Katz, CEO at consulting firm HealthTech GPS, which advises the industry on pricing.

Katz, a former official at the US Food and Drug Administration and the Centers for Medicare and Medicaid Services, said the government could make similar arguments over remdesivir, which was originally developed to treat Ebola with federal funding, and is now being studied in a trial backed by the National Institutes of Health.

Democratic lawmaker Lloyd Doggett of Texas, chairman of the House Ways and Means Health Subcommittee, sent Gilead a letter this week demanding the company detail its plans for remdesivir, including supply issues, disclosure of taxpayer investment in the drug’s development, and purchase and pricing arrangements.

“American taxpayers have made a big investment in remdesivir, but now in return, those who need treatment may get only a big bill while Gilead gets a big payoff,” Doggett warned.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Coronavirus highlights: 72 inmates in Mumbai’s Arthur Road jail test positive; close to 54,000 cases in India

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Coronavirus Updates LIVE: Close to 54,000 positive patients in India, Maharashtra and Gujarat have most cases

The nationwide tally of COVID-19 cases neared 54,000 on Thursday with more people testing positive for the deadly virus infection in Tamil Nadu, West Bengal, Uttar Pradesh, Andhra Pradesh and Rajasthan among other states, but the number of those having recovered also crossed 15,000. At least 4,500 new cases have been detected across the country since Wednesday morning, figures announced by different states and union territories showed. The nationwide death toll has now risen to 1,783, while fatalities were also reported from paramilitary forces. Maharashtra and Gujarat top the nationwide tally, Tamil Nadu has now crossed the 5,000 mark with 580 new cases reported during the day. The death toll of the southern state has reached 37, with two more women succumbing to COVID-19 during the day.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Coronavirus treatment: List of drugs showing promise in fight against COVID-19

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Researchers are studying several types of drugs to treat the novel coronavirus or COVID-19 that has spread to over 200 countries, taking a massive human toll of nearly 2.6 lakh as of Wednesday morning. About 37 lakh positive cases have been identified, including almost 50,000 cases in India.  Most drugs being worked upon are repurposed and are largely anti-viral drugs used previously to treat other conditions. For instance, Favipiravir, or Avigan was used to treat influenza in Japan. Likewise, Remdesivir was tested on Ebola.

Here’s a list of some of the drugs which are being used to treat the patients of coronavirus and are in advanced trial stages:

Gilead’s Remdesivir: Gilead last week received the US Food and Drug Administration’s emergency use authorization for using remdesivir as a treatment against COVID-19, after the drugmaker provided data showing the drug had helped COVID-19 patients. Remdesivir was previously available only for patients enrolled in clinical trials or those cleared to get the drug under expanded use and compassionate use programs. The company is in discussions with chemical and drug manufacturers to produce the drug for Europe, Asia and the developing world through at least 2022.

Favipiravir: Marketed under the brand Avigan, the drug works by preventing the virus from replicating in cells. It was developed in 2014 by Fujifilm Toyama Chemical, a unit of Fujifilm Holdings, as an influenza drug. Japanese PM Shinzo Abe wants the drug approved for COVID-19 in May. The country is ramping up its stockpile and is expected to ship the drug to 43 countries for clinical studies on its effectiveness. Fujifilm began a phase 2 clinical trial in Massachusetts in April. Both China and Japan have been studying favipiravir to treat the deadly virus for months. It also has been tested in Italy, and a trial is set to begin in India.

Lopinavir-Ritonavir: The duo belongs to a class of drugs known as HIV protease inhibitors and generally used in combination. Ritonavir increases (“boosts”) the levels of lopinavir. This helps lopinavir work better. The drug helps to decrease the amount of HIV in a body so that the immune system can work better, lowering the chances of getting HIV complications. A Wuhan study this year (2020) found that the ritonavir/lopinavir combination was not effective in combating Covid-19. But study results indicated a potential by repurposing the drugs.

Hydroxychloroquine or HCQ: The antimalarial drug attained instant stardom in mid-March when US President Donald Trump dubbed it as a game-changer for the treatment of COVID-19. The optimism with the drug as an even effective medicine to ward off infection too has faded with regulators and scientists raising concerns about potential side effects. The drug was initially developed as an antimalarial variant for patients who were sensitive to chloroquine. It is also used to reduce inflammatory responses in illnesses like rheumatoid arthritis, lupus, and Porphyria cutanea tarda (PCT).

Plasma therapy: Another treatment, while not a drug, that has shown promise is plasma therapy.  The method uses convalescent plasma which is extracted from the blood of recovered COVID-19 patients. This plasma contains antibodies that neutralize SARS-CoV-2.

Besides, scientists are also working on developing vaccines based on isolating anti-bodies. For instance, Israel’s Biological Research Institute has claimed that it has isolated an antibody that could be effective in treatment against coronavirus.

In a separate development, a team of Italian scientists from the company Takis was able to isolate antibodies in mice that blocked the virus from infecting human cells. Testing was carried out at Rome’s Spallanzani Institute.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

PM reviews status of India’s efforts in coronavirus vaccine development

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Italian scientists claim to have developed vaccine that neutralises coronavirus in human cells

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A team of Italian scientists has claimed to have developed a couple of vaccines that they claim neutralises the novel coronavirus in human cells.

This could be among the most visible progress amongst the hundreds of vaccine candidates that are being tested around the world against the virus that has caused a global pandemic and visibly sunk the economy into a recession.

The report on Arab News, quoting Italian news agency ANSA, said a team of scientists from the company Takis was able to isolate antibodies in mice that blocked the virus from infecting human cells.

Testing was carried out at Rome’s Spallanzani Institute.

CNBCTV18.com could not independently verify claims made in the report.

The vaccine candidates currently being developed are based on the genetic material of DNA protein “spike”. Researchers said the vaccine will be injected intramuscularly which will be followed by a brief electrical impulse.

“Researchers believe that this makes their vaccine particularly effective for generating functional antibodies against the “spike” protein, in particular in the lung cells, which are the most vulnerable to coronavirus,” the report said.

The report quoted Luigi Aurisicchio, CEO of Takis, as saying that the company was keen to collaborate internationally to speed up the process of development of the vaccine.

Also read: Israeli defence lab claims breakthrough in coronavirus treatment, says report

The coronavirus pandemic has put the global scientific community in mission mode to develop a vaccine. Ordinarily, it takes at least five years to develop a vaccine but experts say that period could be shorter in this case.

“It could be as little as 9 months or as long as two years,” billionaire Bill Gates whose foundation is heavily involved in combating diseases around the world.

In a recent note, Gates said he was particularly excited by the RNA and DNA novel approaches in developing a vaccine.

The approach has been tested for diseases like malaria but COVID-19 could possibly be the first disease for which it may actually be implemented.

“Rather than injecting a pathogen’s antigen into your body, you instead give the body the genetic code needed to produce that antigen itself. When the antigens appear on the outside of your cells, your immune system attacks them—and learns how to defeat future intruders in the process. You essentially turn your body into its own vaccine manufacturing unit,” Gates said.

But Gates warned that a road to a safe and efficacious vaccine is long, not least because of the progress that needs to be made, besides later manufacturing them at scale.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Nifty Pharma index rallies nearly 30% after 21 years; smallcap stocks outperform largecaps

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The coronavirus pandemic produced a challenging crisis for all sectors except one i.e. pharmaceuticals. The pharma sector was in pain since late-2018 and slipped about 69 percent to the March lows this year. However, the tables have turned for this space after the onset of huge demand for the coronavirus treatment.

In April, the Nifty Pharma index soared nearly 30 percent. Such a similar rally was seen back in 1999 when the index had surged nearly 32 percent in a month.

Investors have suddenly rushed to bank on the pharma stocks over anticipation of pharma companies coming up with a treatment/vaccine to stop the spread of coronavirus.

The most rally till now has been witnessed in the smallcap pharma stocks like AstraZeneca Pharma, Suven LifeSciences, Solara Active Pharma and others which have zoomed over 100 percent. While large cap like Sun Pharma, Glenmark, Lupin, Cipla, Aurobindo Pharma and Biocon have rallied between 30-60 percent in April.

The big rally is also due to government’s move of including pharma drugs in essential services. After the announcement of nationwide lockdown, people started panic buying, stocking up drugs and other health related products. This high demand will bring in a positive flow of revenues for the pharma companies and their effort of doubling production.

“While pharma manufacturing operations are now running at 45-50 percent efficiency levels, supply-side logistical issues have largely resolved. The government has laid out a plan to invest Rs 100 billion to incentivise
API production in India; both, small-scale manufacturers and large
pharma companies will be incentivised,” said Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance (IPA) to IIFL Securities.

Most brokerages believe that the demand visibility of the pharma sector will continue in the future too.

Nirmal Bang in its report said the sector is on track with suppliers resuming and sustaining operations. “In view of an improving situation, we revise our target valuation multiples. We are also anticipating a favourable shift in demand for made-in-India pharmaceutical products as countries look to diversify their supply chain,” it added.

The supply of anti-malaria drugs along with others to the US has helped the country to treat some of its COVID-19 patients. For more drug exports, the US Food and Drug Administration (USFDA) is clearing more and more manufacturing facilities in India.

In fact, in 40 days, USFDA has cleared 11 facilities in India, said Jefferies. It also said the US health regulator would clear most warning letters in 18 months

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

J&J strikes deal with Emergent BioSolutions on coronavirus vaccine manufacturing

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Johnson & Johnson said on Thursday it had struck a deal with Emergent BioSolutions Inc to use its manufacturing facilities to help in an effort to make more than 1 billion doses of a vaccine it is testing to stop the novel coronavirus.

The US healthcare conglomerate said the deal was the first in a series of prospective global partnerships to accelerate manufacturing of its experimental COVID-19 vaccine candidate, even before it has a signal that it works.

J&J plans to start human testing by September, with an eye on having it ready under an emergency use authorization in early 2021, far quicker than the typical 18-month period that it takes for vaccines to be tested, approved and then manufactured.

Under the deal, valued at about USD 135 million, Emergent said it would provide drug substance manufacturing services and was reserving large-scale manufacturing capacity.

J&J and the US government are investing USD 1 billion to create enough manufacturing capacity for the experimental vaccine candidate to stop the virus that has killed nearly 185,000 people around the globe.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Dr Reddy’s: Not working on Remdesivir generic; eyeing HCQ opportunity

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Dr Reddy’s shares have risen over the past few days on speculation about the company being in the early stages of developing a generic version of anti-viral Remdesivir, owned by Gilead. The stock has risen around 32 percent over the last month and is at a 52-week high.

Remdesivir is an experimental anti-viral drug being studied for Ebola, and in some cases, used on a compassionate ground against COVID-19.

GV Prasad, CEO and Co-Chairman of Dr Reddy’s told CNBC-TV18 that his company had no rights to work on a generic version of Remdesivir as Gilead still owned the patent. Prasad also said his company was not in talks with Gilead for contract manufacturing of Remdesivir, or for any licensing agreement.

Prasad said the company was looking at opportunities in other drugs which are being explored for treating COVID-19. Anti-malarial drug hydroxychloroquine or HCQS is one such. Dr Reddy’s is currently selling it in the US through a local partner. So far, Dr Reddy’s had not been selling it in India, but could look at it if there is strong demand. Besides the HCQS the company sells in the US, there is no COVID-19 drug that Dr Reddy’s is associated with.

Prasad said his company was facing a shortage of the active pharmaceutical ingredients (APIs) for HCQS, since its supplier is in Europe. But for the industry in general, supply was not an issue, he said.

The other drug which is being explored as a cure for COVID-19 is Ivermectin which is currently used for treating head lice. Exploring this drug as a cure for COVID-19 is at early stages with human trials not having commenced.

When asked specifically about Ivermectin, Prasad said his company continued to explore all non-patented drugs.

He is of the view that for finding a cure to COVID-19, one needs to reposition existing drugs first, followed by vaccines and try novel drugs only as the last resort.

Drug repositioning is a drug development strategy predicated on the reuse of existing licensed drugs for new medical indications. According to Prasad, repositioning existing drugs already might have a higher chance of success and novel drugs won’t be an immediate solution. The novel drugs being tested for COVID-19 include Gilead’s Remdesivir and Fujifilm’s influenza antiviral drug Avigan.

On manufacturing, Prasad said Dr Reddy’s US sites and factories were functioning, and the staff at the offices were working from home. Back home, there were some logistics issues in the initial days of the lockdown, but those have been overcome and the factories are now operating at “good” capacity, Prasad said.

He said the pace of approvals for its US drugs were progressing at a ‘normal’ rate. Similarly, Prasad said too much should not be read into the recent spate of Establishment Inspection Reports received by multiple Indian facilities over the past few days. The EIRs received according to Prasad were for the facilities which had ‘reasonably good’ inspections. For the industry as a whole, the quality of systems and level of compliance have matured resulting in these successful inspections, Prasad said.

On the fundamentals of the business, Prasad said due to the recent disruptions, his company was slightly late in responding to the queries issued by the USFDA on their two key drugs in the US pipeline — contraceptive drug Nuvaring generic and multiple sclerosis drug Copaxone generic. They are in the process of finishing some work in order to reply to the queries on these two drugs within a few weeks. There is a renewed focus on India, Prasad said. This would not be acquisitions alone but through pipeline development and marketing as well.

Also, catch here all the latest updates and trends on the novel coronavirus with CNBC-TV18.com’s coverage of the pandemic.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Coronavirus cure: Human trials on Bharat Biotech’s COVID-19 nasal-drop vaccine to begin in 4 months

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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As countries struggle to contain the conronavirus pandemic, scientists and pharma companies across the world are racing against time to develop a vaccine to beat the deadly virus. The Wall Street Journal reported that over 140 experimental drug treatments and vaccines for COVID-19 are in the development stage and 11 of these are already in various stages of clinical trials.

Pulitzer winning author, scientist and oncologist Dr Siddhartha Mukherjee on Monday said that a vaccine is still a long way to come. However, he stressed that there has been some progress on anti-viral therapies based on anti-bodies that may prove effective against the virus.

In India, Pune-based Serum Institute last week said that it hopes to begin human trials for its vaccine by the end of the year. And now, another Indian vaccine manufacturer is throwing its hat into the ring.

Hyderabad-based Bharat Biotech, which has been working on developing a intra-nasal drop vaccine for COVID-19, has initiated testing in the US in collaboration with the University of Wisconsin-Madison and vaccine developer FluGen. The company is hoping that its CoroFlu vaccine is ready for human trials by end-2020.

Speaking to CNBC-TV18, Dr Krishna Ella, Chairman and MD of Bharat Biotech said, “We are working with one of the COVID-19 nasal-flu vaccines in collaboration with University of Wisconsin. We have completed R&D experiments and now it is going through animal trials. We are looking at animals because as the vaccine has some problems similar to that of dengue. So, you need to be cautious in animal testing to ensure the safety of people.”

“We chose a nasal strategy because the flu and COVID-19 or any other respiratory pathogen enters through the nose and gets into the lungs. So, it it best to enhance mucosal immunity, which is one of the best immunity the human body can produce against any infectious disease. Hence, the nasal dose is the best option for mucosal immunity and that will last longer and protect against any infections,” he added.

Speaking about bottlenecks in terms of R&D in India, Ella said, “Animal testing will take another two-three months to check if everything is alright, the immunogenosity is alright and the efficacy – it protects against the challenge of the virus. We need to establish the above thee points and that is happening at the moment at Madison-Wisconsin. The reason we have to do this abroad is because we do not have animals in the country [India]. If we want to import animals, then it takes about a year. So, I do not think we can do a lot of R&D in the country, that is one of the bottlenecks we face as Indian manufacturers.”

According to Ella, the vaccine platform they are working on has already been proven in phase-two human trials. “FluGen has completed using the vaccine. We are already working on cell culture, vector and have established the safety profile of the product. We have easier ways to fast track a lot of things. We expect that in the next four months human clinical trials would begin.”

“We have already established the dose required for humans. This gives a lot of confidence to move forward faster,” he pointed out.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Govt prohibits export of hydroxychloroquine as ICMR recommends it for coronavirus prevention

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The government through a notification on Wednesday prohibited the export of hydroxycloroquine and formulations made from hydroxycloroquine after Indian Council for Medical Research (ICMR) in a statement earlier this week recommended the use of the anti-malarial drug for those at a high risk of contracting coronavirus.

The policy regarding their export was free until Wednesday, but now stand prohibited.

The drugs are primarily used for prevention and treatment of malaria, however, ICMR has recommendation its use in fighting the COVID-19 pandemic that has claimed 10 Indian lives so far. The number of people infected with coronavirus has crossed 500 in the country.

Their export will be permitted under three conditions listed in the government notification.

1. Export will be allowed from the SEZ/EOU units and in cases where export is made to fulfil export obligation under any advance license issued on or before the date of this notification [i.e. March 25, 2020]
2. Export will be allowed in case of shipments where Irrevocable Letter of Credit (ICLC) has been issued before the date of this notification or in case where full advance payment has been received by the exporter in India against specific shipment, subject to admission of documentary evidence.
3. Exports will also be allowed to other countries on humanitarian grounds on case to case basis on the recommendation of Ministry of External Affairs.

Globally, the coronavirus pandemic has claimed more than 18,000 lives, while upwards of 400,000 people have been infected by the contagion.

No vaccines for the virus are available so far, but China and the United States have started human trial of a possible vaccine.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow