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By PharmaCompass
2020-10-29
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This week, we have news on Gilead’s antiviral drug remdesivir bagging the full approval of the USFDA to treat Covid-19, despite WHO’s Solidarity Trial asserting that it showed little or no effect on mortality or length of hospital stays among patients. Eli Lilly’s chairman, Dave Ricks, said he believes the company’s coronavirus antibody treatment will still be beneficial to Covid-19 patients, despite the US government putting an early end to a study on it.
In Covid-19 vaccine-related news, Pfizer said it does not have data yet from the late-stage trial of its shot. The release of data is now likely to happen after presidential elections in the US. The FDA has said vaccine developers that gain EUA won’t require a pre-approval inspection. Trials of AstraZeneca-Oxford vaccine continue despite death of a volunteer in Brazil. And the FDA appears to be developing cold feet over EUA of vaccines. Instead, the FDA maybe exploring the idea of using the expanded access program in early days of Covid vaccine rollouts.
In non-Covid news, Bayer has made a big bet on gene therapy by acquiring Asklepios Biopharma for US$ 4 billion. Indian drugmaker Aurobindo Pharma has sold vitamin firm Natrol to New Mountain Capital and its affiliate Jarrow Formulas Inc. And its subsidiary — AuroLife Pharma — received a warning letter from the FDA for its New Jersey unit.
Remdesivir wins FDA approval, poor results in WHO trial notwithstanding
Last week, we had reported that the World Health Organization’s Solidarity Trial showed that Gilead’s much-touted antiviral drug— remdesivir — appeared to have little or no effect on the mortality or length of hospital stays among patients with Covid-19. Soon, there was news that remdesivir, which is sold as Veklury in the US, has bagged approval of the US Food and Drug Administration (FDA) to treat Covid-19.
The nod has made remdesivir the first drug to bag a full approval of the FDA to treat older children and adults who are hospitalized with Covid-19. In May, remdesivir had received an emergency use authorization (EUA) for a broader population that included hospitalized pediatric patients weighing 3.5 kg or more.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic,” FDA Commissioner Stephen Hahn said in a press statement.
Three randomized controlled trials formed the basis for Veklury’s approval, the FDA said. The agency’s announcement also details Veklury’s potential side effects, which include elevated liver enzymes and liver injury, as well as allergic reactions. More information is needed about the risk of these serious adverse events as well as safety in pediatric and other vulnerable populations, noted the FDA in its summary review of the Veklury data.
Eli Lilly still confident of Covid antibody treatment, despite end to hospital study
In a huge setback to one of the most promising treatment approaches for Covid-19, the US government officials put an early end to a study testing an Eli Lilly antibody drug for people hospitalized with Covid-19. The National Institute of Allergy and Infectious Diseases (NIAID), which had sponsored the study, said there is low chance that the drug would prove helpful for hospitalized patients.
Two weeks ago, independent monitors had paused enrollment in the study due to a possible safety issue. However, NIAID officials did not verify a safety problem.
The US President Donald Trump had received a similar experimental, two-antibody drug from Regeneron Pharmaceuticals on an emergency basis when he took ill due to the novel coronavirus earlier this month.
Dave Ricks, the chairman of Eli Lilly, hasn’t lost hope on the antibody treatment. Ricks told CNBC that Lilly’s coronavirus antibody treatment can still be beneficial to Covid-19 patients, despite the recent end to a government-run study. He said the antibody treatment appears to be more effective in people who are in the earlier stages of their diagnoses.
“It’s disappointing, of course. We would have liked to have shown a benefit in the hospital. It doesn’t appear that that benefit is there, so this chapter of that study will close.”
Earlier this month, Eli Lilly had submitted an emergency use application (EUA) to the US Food and Drug Administration (FDA) for this antibody treatment.
Quality problems at NJ plant: US drug-safety inspectors have found continuing quality-control problems at a New Jersey plant Eli Lilly is using to help produce its Covid-19 antibody therapy. This poses a potential obstacle to Lilly meeting its goal of producing 1 million doses by the end of the year.
In an October 2 memo, FDA compliance officers wrote that findings from an inspection of the facility in July and August “support a major failure of quality assurance.” They noted that Lilly planned to make its antibody therapy at the plant and said the inspection group “feels it is still imperative that FDA take action.”
Bayer bets big on gene therapy with US$ 4 billion purchase of Asklepios Biopharma
In the latest effort by a Big Pharma to develop a new generation of cell and gene therapies, Bayer has struck a deal to acquire Asklepios BioPharmaceutical for an upfront payment of US$ 2 billion. Asklepios, popularly known as AskBio, is a fast-moving pioneer in gene therapy. The deal includes an additional US$ 2 billion in milestones.
The deal will give Bayer control of an adeno-associated virus (AAV) gene therapy platform. AskBio’s portfolio includes investigational pre-clinical and clinical stage development candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases such as therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical candidates for hemophilia and Duchenne muscular dystrophy.
With this acquisition, the German drugmaker also vests control of AskBio’s contract development and manufacturing business — Viralgen. AskBio was founded in 2001 by Jude Samulski, a pioneer of AAV vectors. Since then, AskBio has built an AAV platform and an associated high-yield cell line. It has worked with Columbus Venture Partners to establish its gene therapy manufacturing capacity.
AskBio provided the self-complementary DNA technology used in Novartis’ approved gene therapy Zolgensma. For Bayer, this acquisition represents a major investment on treatments that can transform fields of medicine. The deal is likely to close in the fourth quarter of 2020.
Aurobindo sells vitamin firm Natrol; receives warning letter for New Jersey unit
Aurobindo Pharma is selling its US step-down subsidiary, Natrol, to New Mountain Capital and its affiliate, Jarrow Formulas Inc. The Indian generic drugmaker said it will sell Natrol’s business assets as a going concern. Natrol is a wholly-owned subsidiary of Aurobindo Pharma USA.
In a statement issued this week, Aurobindo Pharma said the all-cash transaction was valued at US$ 550 million. However, the company said the transaction is subject to customary closing conditions and regulatory approvals and is expected to be closed by next January.
Natrol is a profitable business which Aurobindo Pharma had acquired in December 2014. The annual sales of Natrol for 12 months ending in March 2020 stood at US$ 156.66 million while the net worth amounted to US$ 82.41 million.
Founded in 1980 as a cosmetics company, Natrol evolved over the last few decades into a leading US vitamin, mineral and supplement manufacturer. Its product range also includes herbs and botanicals, multivitamins, specialty and sports nutrition, among others, to manage and maintain good health. Aurobindo plans to use the proceeds from the sale of Natrol to reduce debt and fund new strategic initiatives.
Meanwhile, a wholly-owned step-down subsidiary for Aurobindo Pharma — AuroLife Pharma — has received a warning letter from the US Food and Drug Administration (FDA) for its New Jersey unit. The oral solid manufacturing facility is situated in Dayton. In June this year, the same unit had been issued an Official Action Indicated (OAI) status.
“The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest,” Aurobindo Pharma has said, adding that it believes the existing business from this facility will not be impacted.
Vaccine Update: Pfizer says no trial data yet; FDA says EUA allows vaccine makers to skip pre-approval inspection
Drugmaker Pfizer Inc said on Tuesday it does not yet have data from the late-stage trial of the Covid-19 vaccine it is developing with Germany’s BioNTech. Pfizer’s CEO Albert Bourla had earlier said the company could release data on whether or not the vaccine works as early as this month.
Pfizer said there had not yet been enough infections in the 44,000-volunteer trial to trigger an analysis of whether or not the vaccine works. An independent panel will conduct the first analysis when it reaches 32 infections. Bourla said after it has enough data for analysis, it typically takes five to seven days before the company can publicly release the data. This means the release of data is likely to happen after the election.
Earlier, US President Donald Trump had said a vaccine could be available before the November 3 election. In recent weeks, his administration has said that one vaccine will be ready this year.
“For us, the election is an artificial milestone,” Bourla said. “This is going to be not a Republican vaccine or a Democrat vaccine. It will be a vaccine for the citizens of the world.”
Vaccine makers can skip FDA’s pre-approval inspections: The vaccine developers that gain emergency use authorization (EUA) need not go through a pre-approval inspection. FDA regulations don’t require a pre-approval inspection for products seeking EUA, informed Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office.
Weir said vaccine developers seeking an EUA will have to submit complete details of their manufacturing process and show that they’ve established a quality control unit.
Astra vaccine trials to continue, despite volunteer death: Last week, Brazilian health authority ANVISA had reported the death of a volunteer in a clinical trial of the Covid-19 vaccine being developed by AstraZeneca and Oxford University. However, soon there were reports that the trial would continue despite the death of the volunteer.
According to a report, the FDA couldn’t rule out a link between AstraZeneca’s vaccine and side effects observed in one patient. However, the agency did not find the vaccine responsible for them.
Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment “there have been no concerns about safety of the clinical trial.” According to a source quoted by Reuters, the volunteer was part of the control group that was given a meningitis shot. He had not received the vaccine.
Meanwhile, there were reports that AstraZeneca’s candidate could elicit immune response in older patients. Early results suggest the candidate could trigger an immune response in those most vulnerable to serious illness.
Immunogenicity blood tests performed on a subset of older participants showed that the vaccine candidate induced antibody and T-cell responses in older patients. The results are consistent with earlier data which showed the candidate achieved “robust immune responses” in adults between 18 and 55 years old, a report published in Financial Times said.
“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told Reuters.
EMA to grant nod to vaccines with 50 percent efficacy: The European Medicine Agency has said it would approve a vaccine against Covid-19 even if trials showed it was effective in less than half the people who take it. This is lower than the threshold the US Food and Drug Administration (FDA) is likely to apply in assessing vaccine candidates for the US population.
In an article published in the Wall Street Journal, officials said EMA would be willing to approve a Covid-19 vaccine even if it showed a so-called efficacy rate below 50 percent, as long as the shots were safe enough to justify the benefits. Earlier, the FDA had said it expects a shot to demonstrate at least a 50 percent efficacy rate.
Approval by the EMA is valid in all 27 countries in the EU. It also applies to the UK until December 31 this year, when it formally leaves the bloc. No vaccine is 100 percent effective. Seasonal flu shots sometimes fail to protect even half of the people who receive them.
FDA develops cold feet over EUA of vaccines: According to reports, FDA is getting cold feet over the notion of issuing EUAs to allow for the widespread early deployment of Covid-19 vaccines. Instead, the agency may be exploring the idea of using expanded access — a limited program typically used for investigational drugs — in the early days of Covid vaccine rollouts.
A few weeks ago, the FDA was concerned about the possibility of unproven vaccines being pushed into the market prematurely due to pressure from US President Donald Trump. Now, the fear is that an early EUA could squander a one-time chance to determine how well the various vaccines work and which out of them works the best.
“We are concerned about the risk that use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval,” Marion Gruber, director of the FDA’s office of vaccines research and review, said. “And not only the first vaccine, but maybe even follow-on vaccines.”
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