Market Place
FDA issues warning letter to Indiana Chem-Port’s India facility; Robert Califf appointed as FDA chief
After 13 months, the US Food and Drug Administration (FDA) finally has a commissioner – Robert Califf – even though the Senate voted him in with the narrowest margin.
This week’s Phispers also brings news that an FDA advisory committee has voted overwhelmingly against approving Eli Lilly and its Chinese partner Innovent Biologics’ lung cancer drug Tyvyt (sintilimab). The agency also issued a warning letter with five observations to Indiana Chem-Port’s manufacturing facility in Gujarat, India.
Last year, the FDA had updated the warning labels of three drugs belonging to a class of anti-inflammatory treatments known as JAK inhibitors, following increased risk of heart attacks and cancer. And now, the European Medicines Agency is following suit by reviewing all JAK inhibitors.
In other news, Teva is bracing itself to shell out up to US$ 3.6 billion to settle thousands of opioid lawsuits in the US. Novartis India has inked an exclusive sales and distribution pact with Dr. Reddy’s Laboratories to broaden access to its meds. However, the deal will lead to 400 job cuts in India due to role redundancies.
In Covid-19 news, Pfizer has delayed its application for an emergency use authorization of its vaccine for kids under the age of five years as it wants to wait for trial data on its third dose. And French pharma company Ipsen has become the latest drugmaker to divest its global consumer healthcare division – it sold the division to Mayoly Spindler for US$ 400 million.
US Senate confirms Califf as FDA commissioner for second time in nail-biting finish
In what is being seen as the most controversial confirmation process in the US Food and Drug Administration’s 115-year history, the US Senate on Tuesday voted 50-46 to confirm Robert Califf as the commissioner of the agency for a second time. This is the narrowest margin by which any FDA commissioner has been confirmed to the post.
The 70-year-old cardiologist had previously served as the FDA commissioner from February 2016 to January 2017. He is going to take over from long-time FDA veteran Janet Woodcock, who has been serving as the acting commissioner for the last 13 months.
Following his nomination by President Joe Biden in November, Califf faced criticism from both the Democrats and Republicans. While Republicans are against Califf’s “pro-abortion agenda,” some Democrats claimed he was too close to the pharmaceutical industry to regulate it impartially. The Democrats also cited the FDA’s approval of opioid drugs during his previous tenure, claiming it contributed to the opioid crisis.
Califf, who has spent the last two years at Google’s life sciences-focused sister outfit — Verily — as its head of clinical policy and strategy, is expected to be sworn in this week.
FDA issues warning letter to Indiana Chem-Port’s India API manufacturing facility
The FDA issued a warning letter with five observations to Indian drugmaker Indiana Chem-Port earlier this month following an inspection of its manufacturing facility in Gujarat, India, last year. The agency had inspected the facility between August 2 and 7.
In its observation, the agency said the drugmaker failed to ensure that equipment surfaces that came in contact with the active pharmaceutical ingredient (API) do not alter its quality. The drugmaker also failed to ensure the equipment used to make the APIs were “suitable” and correctly maintained.
The facility failed to show that its manufacturing process was consistent in meeting necessary quality standards. The company also did not validate written procedures for equipment cleaning and maintenance. Moreover, Indiana Chem-Port fell short on design of a documented, ongoing stability testing program that monitors the stability of drug ingredients. It also lacks a quality unit “independent” of production and fulfills quality assurance and quality control duties.
The agency found “numerous” signed and partially completed batch records missing a “controlled copy” stamp. It had also destroyed an API batch record for a certain drug ingredient lot, despite it being in circulation in the US. The FDA has recommended that the company enlist a manufacturing consultant.
FDA panel denies approval to Lilly’s lung cancer drug; recommends new trial
Last week, we had carried news about the FDA making up its mind to reject a cancer immunotherapy treatment – Tyvyt (sintilimab) – developed by Eli Lilly and its Chinese partner Innovent Biologics, ahead of an advisory committee meeting to discuss the lung cancer treatment. FDA had noted that Lilly-Innovent had not consulted the agency for trial design or conduct, including the selection of endpoint and control arm.
In a last-minute effort to sway the FDA’s advisory panel into approving Tyvyt, Eli Lilly offered 40 percent discount on the therapy. However, the discount failed to be of any help.
The Oncologic Drugs Advisory Committee on Thursday voted 14-1 against approving the drug. The panel recommended Lilly and its Chinese partner Innovent Biologics conduct a new trial that is applicable to the US population.
The panel’s decision was based on the trial’s lack of population diversity and the use of progression-free survival (or the time a patient lived without the disease worsening) as the study’s main goal instead of overall survival. It also cited the availability of other effective drugs, such as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, for denying approval.
The panel’s decision has dealt a serious blow to other Chinese drugmakers who wish to sell their products in the US market based on clinical trials carried out solely in China. There are at least 25 such applications either planned or under review by the FDA.
A “disappointed” Lilly said it will continue to work with the FDA. Innovent said it remains confident in the value of sintilimab.
Lilly-ImmunoGen revive cancer drug pact with US$ 1.7 billion deal: Four years after backing out of an antibody-drug conjugate (ADC) alliance with ImmunoGen, Eli Lilly is back on the table with a new deal worth up to US$ 1.7 billion.
Under the deal, Lilly will pay US$ 13 million in cash for exclusive rights to use ImmunoGen’s novel camptothecin technology to research, develop and commercialize ADCs against its chosen targets. ADCs are a class of drugs used to treat cancer. Lilly has an option to add additional targets for US$ 32.5 million. In total, ImmunoGen can receive up to US$ 1.7 billion in exercise fees and milestone payments, as well as royalties if any product reaches the market.
Teva may pay up to US$ 3.6 billion to settle opioid cases; 2021 sales down 6 percent
Teva is bracing itself to shell up to US$ 3.6 billion in cash and medicines to settle thousands of opioid lawsuits in the US, its chief executive Kåre Schultz has said.
The Israel-based drugmaker will likely pay between US$ 2.7 billion and US$ 3.6 billion over 15 years, Schultz said. The cash contribution is likely to be between US$ 1.8 billion and US$ 2.4 billion.
Schultz’s calculation is based on the settlement the drugmaker reached with Texas last week as well as the nationwide deal worth US$ 26 billion proposed by Johnson & Johnson and three major drug distributors.
As part of the settlement with Texas, the world’s largest generic drugmaker agreed to pay US$ 225 million to the authorities. Out of this, US$ 150 million will be in cash and US$ 75 million will be in products.
The CEO said Teva could reach a nationwide settlement within the next 12 months.
Meanwhile, Teva generated US$ 15.9 billion in 2021 sales, down six percent from 2020. It recorded US$ 4.1 billion in the fourth quarter, eight percent less than the amount it made in the same period last year.
EMA to review all JAK inhibitors following safety concerns from Xeljanz trial
After FDA updated the warning labels of three drugs last year that belong to a class of anti-inflammatory treatments, known as JAK inhibitors, due to a clinical trial report on Pfizer’s rheumatoid arthritis drug Xeljanz, the European regulatory agency has begun a safety review of the same class of drugs.
The European Medicines Agency (EMA) on Friday said it is reviewing all JAK inhibitors following results from a recent clinical trial of the same drug. The clinical trial showed patients on Xeljanz were likely to experience a heart attack, stroke or death and they also carried higher risks of developing cancer. The EMA has already updated Xeljanz’s labeling to reflect the higher risk of major cardiovascular events and cancer.
EMA’s decision was also influenced by a study of another rheumatoid arthritis drug — Eli Lilly’s Olumiant — that poses increased risk of major cardiovascular issues and deep vein thrombosis (blood clots).
EMA will carry out a review to determine whether these risks are associated with all JAK inhibitors authorized in the EU or not, and whether the marketing authorizations for these medicines need to be amended. Last week, FDA said it was considering tightening its restrictions on Xeljanz after reviewing the same data.
Three patients taking Biogen’s Aduhelm die: In November, Biogen had said it was investigating the death of a 75-year-old patient who was on Aduhelm. And now, a report by RBC Capital says three Alzheimer’s disease patients on Biogen’s Aduhelm have died. The deaths were registered through the FDA’s adverse event reporting system, known as FAERS. The report mentioned the patients had amyloid-related imaging abnormalities, or ARIA — a side effect that involves brain swelling and microbleeds and has been linked to Aduhelm — but added that there is no conclusive link between the drug and any of the deaths so far. Biogen said none of the three deaths have been linked to Aduhelm.
Pfizer delays FDA application for use of its Covid-19 vaccine in kids under five
Pfizer and BioNTech said last week that they are delaying their request to the FDA to authorize their Covid-19 vaccine for children under five years until early April.
The partners said they will wait for data regarding the efficacy of a third dose of the vaccine in this age group, adding that the results from the clinical study are expected in early April.
The FDA postponed a meeting of a panel of outside experts to look at vaccine data and make a recommendation on whether to authorize a two-dose series or not. The agency said it needed more data before weighing in on an emergency use authorization (EUA).
Pfizer and BioNTech had recently submitted data on the first two doses of a planned three-dose regimen, requesting the regulatory agency for an EUA. The submission came as a surprise as the partners had in December said two doses of the vaccine did not generate a strong immune response in children in the age group of two to four years.
Meanwhile, BioNTech CEO Ugur Sahin said the delivery of Pfizer-BioNtech’s vaccine to combat the Omicron variant of Covid-19 has been delayed by several weeks due to a delay in the data gathering process. Once the vaccine is ready, the company would assess whether it was still needed, Sahin said.
Astra to supply 1.7 million antibody doses to US: Drugmaker AstraZeneca has expanded its agreement with the US government to supply 1.7 million doses of its Covid-19 antibody treatment Evusheld for US$ 855 million. The FDA had authorized the treatment in December.
FDA approves Lilly’s new antibody drug: The FDA has issued an EUA for Eli Lilly’s antibody bebtelovimab to treat mild-to-moderate Covid-19 in patients above the age of 12 who are at a high risk of progressing to severe illness and who do not have access to alternative treatment options. The company has claimed that bebtelovimab can neutralize the Omicron variant of coronavirus.
Lilly has entered into an agreement with the US government to supply 600,000 doses of the drug for US$ 720 million.
Novartis India inks sales pact with Dr. Reddy’s; to lay off 400 employees
Novartis India has inked an exclusive sales and distribution pact with Dr. Reddy’s Laboratories to help broaden access to its meds. Under the arrangement, Dr. Reddy’s will have exclusive rights to promote and distribute Novartis’ Voveran range of pain relievers, the calcium range and Methergine (a medication used to treat severe bleeding from the uterus after childbirth) in India.
The deal will lead to 400 job cuts in India due to role redundancies. The company said it understands “the implications of this difficult decision” and is offering employees a severance package and outplacement services.
Ipsen sells consumer healthcare unit to Mayoly Spindler: French pharma company Ipsen has become the latest drugmaker to divest its global consumer health division as part of its reorganization drive. The Paris-headquartered company has held exclusive talks with Mayoly Spindler to divest its consumer health division. As part of the deal, Ipsen will receive about US$ 398 million (€350 million), including a contingent payment of US$ 57 million (€50 million).
Under the deal, Ipsen and Mayoly Spindler will combine their consumer healthcare divisions to create a global consumer healthcare platform. The deal is expected to close in the third quarter of 2022, Ipsen said.
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