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By PharmaCompass
2022-05-19
Impressions: 1991
In this week’s Phispers, Aurobindo Pharma’s oral manufacturing facility in Hyderabad, India, got hit by the US Food and Drug Administration's Form 483 with six observations.
After Covid, monkeypox appears to be yet another cause as cases of the viral disease were reported in Spain, Portugal, the UK and the US. In Covid news, the FDA authorized a booster dose of Pfizer-BioNTech’s Covid-19 vaccine for children between the ages of five and 11 years.
GlaxoSmithKline has changed its name in favor of the well-known three-letter acronym – GSK. The change is for the sake of simplicity. Novartis has consolidated all its contract manufacturing services into a new arm, called the Global Biotech Co-operations (GBTC).
In drug approvals, Eli Lilly’s diabetes drug Mounjaro (tirzepatide) bagged FDA’s nod as a treatment for adults with type 2 diabetes. The approval will help Lilly challenge market leader Novo Nordisk’s blockbuster drug Ozempic.
Australian giant CSL said the regulatory approval process of its US$ 11.7 billion Vifor acquisition has hit a snag. The approval process will now take “a few more months,” CSL said. Moderna said it can terminate its former CFO Jorge Gomez’s US$ 700,000 severance benefits if Gomez is found guilty of wrongdoing in a financial probe launched by his former employer, Dentsply Sirona.
In legal news, a French court has ordered Sanofi to pay over €400,000 (US$ 416,440) as compensation to a family whose child was diagnosed with a form of autism, said to be a side effect of its epilepsy drug valproate. The drug is marketed as Depakine in France. Indian drugmaker Emcure has moved court in the US, requesting it to toss out a US$ 950 million lawsuit filed by HDT Bio. The drugmaker had accused Emcure of stealing and using its RNA-delivery technology to develop a Covid-19 vaccine.
Aurobindo Pharma’s manufacturing unit in India hit with Form 483
Soon after Sun Pharmaceutical’s Halol manufacturing plant in Gujarat, India, received a Form 483 from the US Food and Drug Administration (FDA) with 10 observations, another Indian generics manufacturer faced a similar fate.
The FDA has slapped Aurobindo Pharma’s oral manufacturing facility in Hyderabad, Telangana, with a Form 483, with six observations. The agency had inspected the facility in Jedcherla, near Hyderabad, between May 2 and 10.
Aurobindo did not disclose details of the Form 483, but said it plans to respond to the FDA within the stipulated timeline. It said it will work with the agency to close the observations.
Since 2016, Aurobindo Pharma has received 14 Form 483s for different manufacturing facilities in Telangana. In January, the Indian drugmaker’s active pharmaceutical ingredient (API) manufacturing facility in Hyderabad had received a warning letter.
Months ahead of consumer health unit spin-off, GlaxoSmithKline says it’s just ‘GSK’
GlaxoSmithKline has announced it is changing its name in favor of the well-known three-letter acronym – GSK. The move to GSK is for simplicity’s sake, a source told Fierce Pharma. The London-based pharma had first announced its intention to change the name last month, while presenting the first quarter results of 2022.
“The London Stock Exchange and the New York Stock Exchange will reflect the change of name in due course,” the British pharma giant said. GSK is going ahead with the spin-off of its consumer healthcare unit, which has been christened Haleon. The demerger is expected to be completed in July. Haleon will include popular brands such as Sensodyne toothpaste, arthritis cream Voltaren, pain relievers Panadol and Advil, along with multivitamin Centrum.
CSL’s US$ 11.7 billion takeover of Vifor Pharma hits antitrust snag
In the largest biopharma deal of 2021, Australian giant CSL had announced the acquisition of 88-year-old Swiss drugmaker Vifor for US$ 11.7 billion (about 10.9 billion Swiss francs) in December.
CSL was expecting to close the acquisition in June this year. However, last week the company reported that the regulatory approval process has hit a snag.
While some antitrust authorities have approved the deal, some approvals are outstanding, Vifor said. The Swiss pharma, however, did not specify which regulators are undecided or if they have raised any specific concerns.
According to the Australia Financial Review, rulings from the US Federal Trade Commission, the European Competition Commission and the Swiss Takeover Board are still pending. The two companies said they will continue to work closely with the authorities and will provide an update as soon as they have more clarity on the timeline.
Worries of monkeypox outbreak grip Europe as Spain, UK, Portugal report cases
Europe has been concerned about growing cases of monkeypox, a rare viral infection similar to human smallpox, though known to be milder. Monkeypox was first reported in Congo in the 1970s and the number of cases in West Africa has increased during the last decade.
In Spain, 23 persons showed symptoms compatible with monkeypox, and health authorities there have issued an alert over a possible outbreak. Portugal is investigating over 20 suspected cases, five of which have been confirmed. And the UK has confirmed nine cases and one probable case. During the first week of May, a person in England had been diagnosed of monkeypox. The person had traveled to Nigeria.
The infection has also spread to the US – the country confirmed a case of monkeypox in a man who had recently traveled to Canada. According to the US Centers for Disease Control and Prevention (CDC), there are no specific treatments available for the infection, but monkeypox outbreaks can be controlled. Smallpox vaccine, cidofovir, ST-246, and vaccinia immune globulin (VIG) can be used to control a monkeypox outbreak.
FDA approves Lilly’s type 2 diabetes med Mounjaro, that will take on Novo’s Ozempic
Last week, the FDA approved Eli Lilly’s diabetes drug Mounjaro (tirzepatide) as a treatment for adults with type 2 diabetes. The approval will help Lilly challenge Novo Nordisk’s blockbuster drug Ozempic. Analysts estimate Mounjaro to bring in sales of US$ 4.9 billion by 2026.
In a clinical trial, Mounjaro outperformed the market leader’s Ozempic. It proved to be more effective in helping patients lose weight and in keeping their blood sugar levels under check than Ozempic. And last month, Lilly said a late-stage trial showed that the drug helped obese patients lose over 20 percent of their weight.
Mounjaro is administered as an injection under the skin once weekly. Lilly is yet to announce the price of the drug. The drugmaker plans to market Mounjaro separately for obesity.
Authorizes Pfizer’s Covid-19 booster for kids: The FDA has authorized a booster dose of Pfizer-BioNTech’s Covid-19 vaccine – Comirnaty – for children between the ages of five and 11 years. Children can take the booster five months after they have received their second dose.
Allows import of baby formula: In order to solve the nation-wide shortage, the FDA has allowed imports of baby formula from foreign makers that don’t usually sell in the US. Foreign infant formula companies will need to meet a list of safety and nutritional standards provided by the FDA to sell their products. The shortage was triggered by the closure of top infant formula maker Abbott Laboratories’ manufacturing facility in Sturgis, Michigan, in February after an inspection by the FDA found multiple issues, including a harmful bacteria. Abbott hopes to restart production in two weeks, pending an FDA approval.
Moderna to get back US$ 700,000 severance pay if probe finds former CFO guilty
On May 10, Jorge Gomez took over as Moderna’s chief financial officer (CFO). He quit the very next day after his previous employer – Dentsply Sirona – disclosed an internal probe related to financial reporting.
Despite working for a day as Moderna’s CFO, Gomez is going to take home US$ 700,000 in severance pay – his base salary for 2022. But Moderna said it can “terminate or suspend” the severance benefits and may “seek repayment of any and all payments” if Gomez is found guilty of wrongdoing or is required to pay a fine by Dentsply Sirona or the SEC.
Moderna added that Gomez has forfeited his US$ 500,000 signing bonus and US$ 4 million in equity awards. The incident has raised questions over the due diligence process followed by Moderna. Although Dentsply had initiated the probe in March, Moderna said it had no idea until Dentsply publicly disclosed it on May 10.
Moderna’s board chairman Noubar Afeyan said legalities had prevented Dentsply from revealing its probe earlier. "Both the process of recruiting and vetting and the process with which we reacted to the new facts that came out, were completely appropriate,” he said.
Sanofi to pay US$ 416,440 to family in France for epilepsy drug’s side effects
A French court has ordered Sanofi to pay over €400,000 (US$ 416,440) as compensation to a family whose child was diagnosed with a form of autism caused by epilepsy drug valproate. The drug is marketed as Depakine in France.
The court said the pharma giant, despite knowing that the drug can cause malformations and “neuro-behavioral disorders” in children if taken by pregnant women, failed to mention the risks in the drug’s attached leaflet.
The company said it will appeal the decision. The ruling is the first in France to link the drug with autism in an individual patient’s case. French health authorities estimate that the drug caused deformities in 2,150 to 4,100 children and neuro-developmental defects in up to 30,400.
Indian drugmaker Emcure asks US court to toss out lawsuit over Covid vaccine
In March, Seattle-based biopharma company HDT Bio Corp had sued Emcure Pharmaceuticals for US$ 950 million in the US, accusing the Indian generic drugmaker of stealing and using its RNA-delivery technology to develop a Covid-19 vaccine.
Now, Emcure has moved the court in Washington, requesting it to toss out the lawsuit. The Pune-based manufacturer of generic drugs sought the dismissal of the case saying the US court has no authority over an Indian company. Also, the complaint’s “bloated billion-dollar” demand shows that HDT is trying to damage Emcure’s reputation and create publicity for itself, Emcure said.
The pharma claimed the allegations levied by HDT arise from agreements between HDT and its subsidiary Gennova Biopharmaceuticals, over which it does not have any control. Back in 2020, HDT had partnered with Gennova to help with the development of its vaccine candidate in India. HDT later sued Gennova in the London Court of International Arbitration, accusing it of stealing and using its RNA-delivery technology.
After bagging deals during pandemic, Novartis plans to grow CMO business
Novartis has been in contract manufacturing for over 20 years. Over time, the Swiss drugmaker has honed its expertise in areas such as enzymes and antibiotics. During the Covid-19 pandemic, Novartis’ contract manufacturing arm signed production pacts with Roche, CureVac and BioNTech.
Now, Novartis has consolidated all its contract manufacturing services into a new arm, called the Global Biotech Co-operations (GBTC). Equipped with the latest technologies, GBTC can support not just manufacturing, but all steps of the drug lifecycle – from development, registration, marketing, market access and logistics to distribution. The CMO will also give companies access to Novartis’ global supply chain.
GBTC also works in the specialized areas of monoclonal antibodies, fragmented antibodies, nanobodies, antibody-drug conjugates, viral vectors, DNA and RNA. The CMO includes 15 biotech and cell and gene sites in Europe, the US and Asia.
Sells UK site, to lay off staff in Switzerland: As part of its restructuring, Novartis plans to eliminate hundreds of jobs in its home country, including 1,500 staff at production facilities in Basel, Stein, Locarno and Schweizerhalle. Another 700 service jobs in Basel are being redistributed to one of the five global centers in Dublin, Hyderabad, Kuala Lumpur, Mexico City and Prague. The Swiss pharma has also sold its Grimsby, UK, facility to Humber Industrials, a subsidiary of International Process Plants. Around 212 employees at the plant will lose their jobs. The Swiss pharma will transfer the site by late 2023.
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