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FDA safety review to hold up Moderna’s vaccine for teens; FDA raises concerns at Biocon’s Malaysia site
This week, Phispers has more updates from Merck. The drugmaker has temporarily withdrawn its pre-merger notification and report form and plans to refile it in order to give the US authorities more time for review. In the meantime, several large investors have expressed reservations about the Merck-Acceleron deal. Merck has also tied up with bio-research company Synthekine and said it expects around US$ 7 billion in sales from its experimental Covid-19 drug — molnupiravir — through 2022-end, provided it bags FDA’s emergency use authorization soon.
In regulatory news, even though Indian biopharma giant Biocon had insisted that FDA’s Form 483 issued to its Malaysian site that makes Semglee — the first interchangeable biosimilar insulin product for treatment of diabetes — would not hinder its plans, the agency posted the document online which reveals several non-compliance issues at the plant.
In a first ever trial win for drug companies facing thousands of lawsuits pertaining to the opioid overdose crisis, a California judge this week said he would rule against several large counties that accused Johnson & Johnson, Teva Pharmaceutical Industries, Endo International and AbbVie of fueling the US opioid epidemic. And Bayer said the European Patent Office (EPO) has maintained the company’s patent for its best-selling stroke prevention pill Xarelto, extending its intellectual property rights until January 2026.
In Covid news, the director of the US Centers for Disease Control and Prevention (CDC) has backed the broad use of Pfizer-BioNTech’s Covid-19 vaccine in five to 11 year olds, clearing the way for administering the vaccine to this age group from November 3. The FDA had authorized the vaccine last week. However, the agency said it needs more time to complete its assessment of Moderna’s EUA filing for the use of its vaccine among adolescents aged 12 to 17 years.
FDA’s Form 483 to Biocon’s Malaysia site reveals poor aseptic monitoring, leaky drains
Indian biopharma major Biocon’s Malaysian subsidiary — Biocon Sdn Bhd — has come under the US Food and Drug Administration’s regulatory lens multiple times in the last three years. In 2019, the agency flagged problems during a pre-approval inspection of three of its units in Malaysia that make insulin glargine drug substance among other things. And in February 2020, post another inspection, the FDA had made three observations in its Form 483.
In July this year, Biocon Biologics (a subsidiary of Biocon) and Viatris finally bagged the FDA approval for Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product. The interchangeability tag allows the drug to be a substitute for Sanofi's Lantus at US pharmacy counters.
However, soon after that approval, Biocon received FDA's Form 483 for its insulin facility in Malaysia in a rare out-of-the-country inspection post the pandemic. The Form 483 cited six observations that needed to be addressed. The site makes Semglee.
The company, however, insisted that the Form 483 would not hinder its plans. In a statement issued in September, the company said: “We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan, which will be submitted to the US FDA in the stipulated time. We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US.”
Now, a month after Biocon was handed the Form 483, the agency has posted the documents online that reveal lackluster conditions. The Form 483 highlights an unqualified distribution system, inadequate aseptic monitoring and leaky drains, among other issues at its Malaysian subsidiary.
The FDA’s first observation is heavily redacted. However, after going through the text in between the grey boxes, it seems that the site’s distribution system was not qualified or validated, nor was it tested for quality. The company failed to properly sanitize the environmental monitoring plates of the restrictive access barrier. Failure to do so can negatively impact the quality of the product, the FDA said. Leaky drains were left unresolved, and the cleaning processes were deemed deficient, the agency said.
“The procedure fails to elevate repeated alert level excursions that should include a trend investigation in mitigation of an aberrant condition and documentation of corrective action,” says the Form 483.
CDC, FDA clear way for inoculating 5 to 11 year olds in US with Pfizer’s Covid jab
This week, the director of the US Centers for Disease Control and Prevention (CDC) backed broad use of Pfizer-BioNTech’s Covid-19 vaccine in five- to 11-year-old children, clearing the way for administering the vaccine to this age group from November 3.
Last week, the US Food and Drug Administration (FDA) had authorized the Pfizer vaccine — Comirnaty — for kids in that age group.
The endorsement opens up the vaccine to a population of 28 million children in the US. The Pfizer dosage for children is one-third the size of the one given to those 12 years and older. The second of the two-shot series is to be administered three weeks after the first.
Meanwhile, Pfizer has raised the full-year sales forecast for its Covid-19 vaccine by 7.5 percent to US$ 36 billion. The drug behemoth has signed deals with countries for booster doses and has received clearances from regulators for administering the vaccine in children.
FDA safety review to hold up Moderna’s Covid-19 vaccine for teens until 2022
While Pfizer’s messenger RNA vaccine bagged FDA’s emergency use authorization (EUA) in young kids, the agency said it needs more time to complete its assessment of Moderna’s EUA filing for the use of mRNA-1273 among adolescents aged 12 to 17 years.
According to Moderna, FDA is reviewing reports suggesting the coronavirus vaccine made by Moderna can cause heart problems in some adolescents. The FDA wants to “evaluate recent international analyses of the risk of myocarditis after vaccination,” Moderna said. The review could take until January 2022.
Myocarditis, or inflammation of the heart muscle, has cropped up as a side effect for mRNA Covid-19 vaccines.
Only last week, Moderna CEO Stéphane Bancel had said the EUA for adolescents could come “within weeks,” and that children could start receiving the Moderna vaccine before Christmas.
But Moderna’s plans to file an EUA request for the pediatric population (which it defines as six to 11 years of age) will also be delayed, while the agency completes its adolescent review.
“The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said in a statement.
Merck delays Acceleron buyout to give FTC more review time; big investors step up opposition to deal
For several weeks, Merck has been in the news for its oral antibody treatment — molnupiravir — and for its bid to acquire Acceleron.
This week too, there was much news from Merck. In September, Merck had announced it has entered into a definitive agreement through its subsidiary to acquire Acceleron for around US$ 11.5 billion. But last week, the company said it has temporarily withdrawn its pre-merger notification and report form which provides more information about large M&A deals to the Federal Trade Commission (FTC) and the US Department of Justice to allow the FTC more time for review.
The refiling gives Merck a chance to extend the tender offer time for collecting the required shares from Acceleron investors. The tender offer is now scheduled to expire on November 18 as opposed to November 10.
Meanwhile, several large investors have expressed reservations about the Merck-Acceleron deal. Avoro Capital Advisors, which owns a 7 percent stake in Acceleron, had earlier released a statement claiming that Merck’s offer undervalues the company. Darwin Global Management, which owns a 3.8 percent stake in the company, and Holocene Advisor have said they won’t tender their shares. And this week, Farallon Capital Management, which owns more than 4 percent stake in Acceleron, said it appreciated the value the management team has created and the strategic position it has achieved. But it said it doesn’t support the terms of the sale.
However, Bristol Myers Squibb, Acceleron’s largest shareholder with an 11.5 percent stake, reportedly plans to tender its share.
Ties up with Synthekine: Merck is also widening its reach in therapies for autoimmune diseases by investing in Synthekine, a bio-research company that develops engineered cytokine therapeutics. As per the worldwide collaboration and research agreement, Merck can exclusively take advantage of Synthekine’s surrogate cytokine agonist platform to discover, develop, and sell new cytokine-based treatments for up to two cytokine targets. The companies will first look into potential therapies for autoimmune illnesses but can later go into immunology, oncology, and other indications. Merck will pay Synthekine upfront, plus another one-time payment if a second target is identified. Synthekine stands to receive as much as US$ 525 million in milestones and royalties from net sales for every target achieved. The pact comes a few months after Synthekine raised more than US$ 100 million in funding.
Forecasts US$ 7 billion in sales from molnupiravir: Last week, Merck said its experimental Covid-19 drug — molnupiravir — could bring in between US$ 5 billion and US$ 7 billion in sales through 2022-end, assuming it gains FDA’s emergency use authorization soon. Last month, Merck released data on molnupiravir that showed how it halved the chances of dying or being hospitalized for those most at risk of developing severe Covid-19 when given early during the illness. FDA advisers will meet in November to vote on whether the drug should be authorized or not. If cleared, molnupiravir will become the first oral antiviral treatment for Covid-19.
J&J, Teva, Endo, AbbVie post first win in opioid case as California judge rules in favor
In a first ever trial win for drug companies facing thousands of lawsuits pertaining to America’s opioid crisis, a California judge this week said he would rule against several large counties that accused Johnson & Johnson, Teva Pharmaceutical Industries, Endo International and AbbVie of fueling the opioid epidemic.
This is the first time a judge or jury has rejected claims by states or local governments that ex-opioid makers should be held liable for the US opioid epidemic, which has claimed the lives of almost 500,000 Americans over the last two decades.
The Orange County Superior Court Judge Peter Wilson rejected claims that units of the four drugmakers duped doctors and patients about the addictiveness of opioid painkillers and created a so-called “public nuisance” tied to the medications.
During a months-long, non-jury trial, Santa Clara, Los Angeles and Orange counties and the city of Oakland argued the advertising deployed by these companies led to billions of opioid-based pain pills flooding their communities and a rise in overdose deaths. They said the companies should pay more than US$ 50 billion to cover the costs of abating the public nuisance they created, plus penalties.
But Wilson said even if the drugmakers’ marketing contained any misleading statements, the counties put forward no evidence to show that their promotional activities caused any medically inappropriate prescriptions to be written.
J&J settles most Risperdal lawsuits: J&J has settled most of the lawsuits it faced from thousands of men who claimed its anti-psychotic drug Risperdal caused them to develop excessive breast tissue. The drugmaker said it has recorded US$ 800 million in expenses in connection with the agreement.
Last week, J&J said in a filing with the US Securities and Exchange Commission that it reached a settlement in principle in September to resolve “substantially all” of the roughly 9,000 cases it faced over Risperdal.
Bayer wins EU patent extension for Xarelto; DOJ seeks info on Novartis’ Entresto
Last week, Bayer said the European Patent Office (EPO) had maintained the company’s patent for its best-selling stroke prevention pill Xarelto (rivaroxaban), extending the patent’s expiry date by almost two years.
The company said several drugmakers had opposed the drug’s patent, but EPO extended Bayer's intellectual property rights until January 2026.
In 2020, Xarelto generated around US$ 6.93 billion in revenue and Bayer took home US$ 4.58 billion of that sum, while Johnson & Johnson made around US$ 2.35 billion.
The decision will prevent almost all EU countries and certain non-EU states, such as the United Kingdom and Switzerland, from launching rivaroxaban.
Meanwhile, in a third quarter regulatory filing, Swiss drugmaker Novartis has revealed the US Department of Justice is seeking documents as far back as 2016 related to the marketing, pricing and payments to doctors for Entresto. Since 2015, Entresto has proven to be a blockbuster, bringing in US$ 924 million in sales during the past quarter — a 46 percent increase from the corresponding period last year.
However, the US government is questioning the company’s sales practices and is demanding information. It’s not yet clear whether this process will lead to formal litigation against the company, Novartis said.
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