Market Place
India’s US$ 49 billion pharmaceutical industry has often been described as the ‘pharmacy to the world’, as it is the world’s largest exporter of generic drugs. But the country is having to contend with one scandal after another. After the deaths of scores of children, allegedly due to the consumption of cough syrups made by India’s Maiden Pharmaceuticals in October, there was news
of a similar crisis in Uzbekistan last December. The
culprit this time was Indian drugmaker Marion Biotech. In all, India-manufactured
cough syrups have been linked
to the deaths of around 89 children in the two
countries.Last week, yet another drug contamination case rocked the global
pharma industry. This time, the victims were the consumers in the United
States. The US Food and Drug
Administration (FDA) issued a warning against using an eye drop made by India-based Global Pharma Healthcare. FDA said the Artificial Tears eye drop manufactured by Global Pharma has a potential bacterial contamination and the company has violated current good manufacturing practices (cGMPs). Global Pharma’s plant is situated in Kancheepuram (near Chennai) in the state of Tamil Nadu.As of January 31, the Centers
for Disease Control and Prevention (CDC) had identified 55 patients in 12 states of the US with infections linked to the use of Artificial
Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss.Artificial tears are widely-used over-the-counter eye-drops used to lubricate dry eyes. In the US, the eye drop manufactured by Global Pharma is distributed by EzriCare LLC and Delsam Pharma.FDA has asked consumers not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.Eye drops with
antibiotic-resistant bacteria The CDC found the product contaminated with an extensively
drug-resistant strain of Pseudomonas
aeruginosa bacteria. This bacteria
is resistant to around 12 antibiotics, and was susceptible to only cefiderocol – an antibiotic that is used to treat complex infections.Pseudomonas bacterial infection is generally acquired at hospital settings, originating mostly in intensive-care units where patients are very sick.On February 2, Global Pharma issued a statement that it is voluntarily recalling all lots within expiry of their Artificial Tears eye drops distributed by EzriCare and Delsam Pharma, to the consumer level, due to possible contamination.The very next day, India’s federal and state drug regulators sent a team to Global Pharma’s contract manufacturing plant near Chennai. The manufacturer was instructed to stop manufacturing all products under the category of ophthalmic preparation until the completion of the investigation. The Tamil Nadu drugs controller collected many control samples of the same batches and sent them for investigation to a government lab in the state. The drugs controller also collected samples of raw materials used in making those batches.During the joint inspection it was found that Global Pharma had exported two consignments of 24 batches that were manufactured in 2021 and 2022. The drug inspectors could not find any clue to the possible contamination.FDA has also placed Global Pharma on import alert for providing inadequate
response to a records request and for not complying with cGMP requirements. The
import alert prevents these products from entering the US.Our viewIndia’s pharmaceutical sector has been growing at a fast clip, and the Indian Pharmaceutical Alliance expects it to reach a market size of US$ 130 billion by 2030. Over the last
decade, exports of pharmaceuticals from India have doubled to nearly US$ 25 billion per annum. And the US is a very important market for India — 29 percent of the country’s total drug exports go to the US.Though India’s drug industry has withstood several setbacks, including the Ranbaxy fraud and
innumerable quality and regulatory
compliance issues, three consecutive instances of contamination over the last four months — first in cough syrups (that had high levels of toxic substances ethylene glycol and diethylene glycol), and then in eye drops (with an antibiotic-resistant bacteria) — is a severe blow to India’s image as the ‘pharmacy to the world’.This year has begun with FDA issuing Form 483s to several big Indian
drugmakers, such as Lupin, Aurobindo Pharma, Sun Pharma and Intas.These three instances of deadly contamination are also particularly damning for India’s drug regulatory system. Last week, India’s health minister said the country will spend US$ 79.6 million to strengthen its drug
regulatory system. More than an increase in regulatory expenditure, Indian
drugmakers and regulators need to show a strong will to work towards regaining
its prestige, and emerge as a haven for safe (and affordable) drugs.
Impressions: 1403
https://www.pharmacompass.com/radio-compass-blog/after-cough-syrup-deaths-contaminated-eye-drops-haunt-indian-drug-industry
#PharmaFlow by PHARMACOMPASS
09 Feb 2023
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The US Food and Drug Administration’s (FDA) momentum of new drug approvals dropped marginally in 2019 — while 62 novel drugs were approved in 2018, 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 48 drugs while another six were approved by the Center for Biologics Evaluation and
Research (CBER).
Novartis dominated new drug approvals as CDER approved five of its new drugs across five different therapeutic areas. But then, it also made headlines when the FDA raised data accuracy issues over the Swiss drugmaker’s gene therapy — Zolgensma — which sent the company into a crisis
management mode.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The gene therapy drug
came into the fold of Novartis in April 2018 through the US$ 8.7 billion acquisition of Illinois-based AveXis Inc.
Zolgensma — the world’s most expensive drug — was approved as a one-time treatment for spinal muscular atrophy (SMA) in May 2019.
However, in March 2019, Novartis learnt of manipulation in the raw data derived
from a mice assay used at the time to test Zolgensma samples, but only alerted the FDA in June — about a month after the drug gained US approval.
Post that, Novartis came under fire from US lawmakers who said the company should have informed the regulators about the data irregularities before the drug’s approval in May, instead of waiting to conclude an internal investigation.
Novartis’ other approvals were brolucizumab (for treatment of macular
degeneration), siponimod (to treat multiple sclerosis), alpelisib (breast cancer), crizanlizumab (sickle
cell disease) and triclabendazole (fascioliasis, a tropical disease).
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Vertex’s Trikafta leads in estimated sales potential
At PharmaCompass,
we compiled the sales forecasts for the new drugs approved by the FDA in 2019. Vertex’s cystic fibrosis treatment — Trikafta — with expected sales of US$ 3.935 billion by 2024, leads our list.
Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor. Vertex already has three cystic fibrosis drugs on the market — Kalydeco (a standalone ivacaftor treatment), Symdeko (a combination of ivacaftor and tezacaftor) and Orkambi (which contains ivacaftor and lumacaftor).
Trikafta’s stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date.
Abbvie’s Humira, the top-selling drug in the world, is beginning to face generic competition in certain parts of the world and two new drug approvals in 2019 — Skyrizi (risankizumab for
plaque psoriasis) and Rinvoq (upadacitinib for rheumatoid arthritis) — are critical to AbbVie's plans to
grow beyond Humira. The two drugs are expected to contribute over US$ 5.5 billion by 2024 to AbbVie’s top-line.
In April, AstraZeneca struck a deal worth US$ 6.9 billion with Japanese drug major
Daiichi Sankyo, to jointly develop and commercialize the antibody drug conjugate cancer therapy —trastuzumab deruxtecan. The
breast cancer treatment won FDA approval in December and analysts forecast
sales of US$ 2.5 billion by 2024 with some believing that the drug could
achieve US$ 7 billion in peak sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The rise of new drugs from Asia
While Daiichi won the FDA nod for its cancer treatment — Turalio (pexidartinib) — new drugs from established Japanese drug makers like Shionogi, Kyowa Kirin and Eisai also bagged the American agency’s approval.
Shionogi’s novel antibiotic — Fetroja (cefiderocol) — got approved for complicated urinary tract infections while Kyowa won the nod for its Parkinson’s treatment — Nourianz (istradefylline). Eisai’s insomnia drug — Dayvigo (lemborexant) — was one of the last drugs approved in the year and is expected to generate sales of US$ 329 million.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
In 2019, the FDA also
approved new drugs from China and Korea. Zanubrutinib (branded
as Brukinsa) developed by Chinese biotech BeiGene won accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive and rare form of blood cancer.
This was followed, almost immediately, by news that the agency approved a new treatment for partial-onset seizures in adults. The drug — cenobamate — will be sold as Xcopri by SK Life Science,
the US subsidiary of the massive Korean conglomerate SK Group. Xcopri will
provide another therapeutic option to patients with epilepsy. This approval
marked the first time a Korean company independently took a compound from the
stage of discovery to FDA approval.
Xcopri is SK Life Science’s first commercial product and wraps a decade of quiet growth from SK Life Science, which has been developing its presence in the pharmaceutical industry.
The company plans to hire a salesforce to support the drug’s launch, which is expected to generate over US$ 1.5 billion in sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Sanofi’s controversial dengue vaccine, cast-off drug get approved
The FDA very narrowly approved Sanofi’s controversial dengue vaccine — Dengvaxia. The vaccine, which took 20 years to develop, got embroiled in a controversy when in 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus.
In Philippines, 800,000 school-age children had been vaccinated against dengue, the world’s fastest growing infectious disease.
The year 2019
had begun with Bristol-Myers Squibb (BMS) and Celgene announcing their US$ 74 billion mega-merger. As the firms worked through the year to get the merger approved, the FDA signed off on Celgene’s myelofibrosis drug Inrebic
(fedratinib).
Inrebic — the once-daily oral drug — is the first new treatment in nearly a decade approved to treat myelofibrosis. The story of Inrebic’s rise from the dead is a major success for Celgene,
which picked up the drug as a part of a US$ 1.1 billion acquisition of Impact
Biomedicines in January 2018. Before that, Inrebic had passed through multiple
hands.
Fedratinib was a flop
for Sanofi as patients began to develop a dangerous neurological
condition tied to vitamin B deficiency called Wernicke’s encephalopathy. As a result, the FDA put a clinical hold on it in 2013 and Sanofi ultimately shelved the effort.
Executives
at BMS have said the drug is among a group of potential blockbusters at
Celgene.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Our view
With over 40 companies from across the world getting new
drugs approved in 2019 across 17 therapeutic areas, the horizon for new drug
development across the globe continues to widen.
Although 2018 was a landmark year for approvals, given all
the development activity underway, the day is not far when this record too will get beaten. And
2020 could well witness that day!
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Impressions: 14509
https://www.pharmacompass.com/radio-compass-blog/novartis-leads-in-new-drug-approvals-vertex-s-cystic-fibrosis-med-holds-highest-sales-potential
#PharmaFlow by PHARMACOMPASS
31 Dec 2019
