Market Place
Teva’s anti-competitive practices under EU scanner; FDA calls out Khloé Kardashian for making false claims
This week, Phispers brings you news of backlash over Biden administration’s plans to leverage the “full power” of its Defense Production Act to acquire more raw materials for the Pfizer-BioNTech vaccine. The world’s largest manufacturer of vaccines — Serum Institute of India — and the WHO have warned that such a move could lead to a shortage of vaccines.
Another warning was sent out by the US Congressional watchdog agency, Government Accountability Office (GAO), which said the backlog of FDA inspections could take years to complete.
The European Commission has opened a formal antitrust probe to find out if Israeli generic drug giant Teva has illegally delayed the market entry and uptake of medicines that compete with its largest selling drug, Copaxone.
Eli Lilly’s antibody cocktail received a shot in the arm when Phase 3 trial data showed that the bamlanivimab-etesevimab combo slashed the risk of hospitalization and death in patients suffering from severe Covid-19 disease by 87 percent as compared to a placebo.
Amgen has said it will acquire a clinical-stage biotechnology company — Five Prime Therapeutics — focused on developing immuno-oncology and targeted cancer therapies for around US$ 1.9 billion.
And the FDA has called out the Kardashians once again, after Khloé Kardashian’s promotional video for Biohaven Pharmaceuticals’ migraine drug made false claims about giving relief in only 15 minutes.
India’s SII raises red flag over US move to block exports of certain materials used in Covid shots
Serum Institute of India (SII), the largest vaccine manufacturer in the world by volume, has warned that there could be a shortage of vaccines due to America’s use of the Defense Production Act that will boost supplies needed to make Pfizer’s vaccine.
In January, the Biden administration said it would leverage the “full power” of the Defense Production Act to free up supplies for the production of coronavirus shots, including Pfizer-BioNTech’s messenger RNA vaccine, Comirnaty.
Adar Poonawalla, CEO of SII, said at a press conference held last week: “We’re talking about having free global access to vaccines but if we can’t get the raw materials out of the US – that’s going to be a serious limiting factor”. According to him, it is imperative to convince the US government that “there’s enough to go around”.
These concerns were echoed by the World Health Organization’s chief scientist, Soumya Swaminathan, who was a part of the press meet. Swaminathan warned of shortfalls of vials, glass, plastic and stoppers. Poonawalla had also brought up the issue before a World Bank panel.
“The Novavax vaccine, which we’re a major manufacturer for, needs these items from the US,” Poonawalla said. “If we’re talking about building capacity all over the world, the sharing of these critical raw materials is going to become a critical limiting factor – nobody has been able to address this so far.”
SII is producing shots on license for AstraZeneca and Novavax, and has so far dispatched 90 million doses of the AstraZeneca-Oxford vaccine to 51 countries in the past two months.
Evidently, the pandemic has given rise to vaccine nationalism. Last month, the European Union had hauled up British drugmaker AstraZeneca over reduced shot deliveries and placed temporary controls on exports of vaccines produced in the bloc. And this week, the Italian government garnered support of the EU to block AstraZeneca’s request to ship some 250,000 doses from its Anagni, Italy plant to Australia.
FDA inspection backlog could take years to clear, says GAO
Last week, we had carried news of how the drug industry has stepped up pressure on the US Food and Drug Administration (FDA) to solve the growing backlog of inspections. This week, the Government Accountability Office (GAO), a Congressional watchdog agency, has warned that the backlog of FDA inspections could take years to complete.
It’s been a year since the FDA halted a majority of foreign and domestic inspections due to the pandemic. According to a Reuters report, the FDA conducted more than 1,671 inspections of foreign and domestic drug manufacturing facilities in 2019. Last year, that number dropped by more than half, to 742.
In a new report, GAO Health Care Director Mary Denigan-Macauley said the agency needs to come up with a plan to address the looming inspections backlog and tackle some of its longstanding issues.
GAO’s report said: “If inspections continue to be postponed, the backlog of mandatory inspections this will create could both extend the maximum interval between inspections beyond FDA’s five-year policy and reduce the resources available in fiscal year 2022 for inspecting the other highest priority establishments identified by its model.”
“As it stands now, we remain very concerned that [FDA is] not going to have additional resources to be able to reduce that backlog, so perhaps they have to come up with a different way of looking at what they consider the most important ones to get done first,” GAO said.
From March to 1 October 2020, the agency conducted just three foreign and 52 domestic inspections, compared to hundreds of foreign and domestic inspections it would typically conduct over the same period.
Of late, the agency has restarted inspections in China and India, though the FDA “has not set a date for resuming routine foreign surveillance inspections in all countries.”
Teva’s anti-competitive practices over its multiple sclerosis drug under EU scanner
The European Commission has opened a formal antitrust investigation to assess whether Israeli generic drug giant Teva has illegally delayed the market entry and uptake of medicines that compete with its largest selling drug, Copaxone. The Commission will look into abuse of a dominant market position by Teva in breach of EU antitrust rules.
Copaxone is widely used to treat relapsing forms of multiple sclerosis and contains the active pharmaceutical ingredient (API) glatiramer acetate. In 2015, Teva’s basic patent covering this API had expired.
In 2019 and 2020, the European Commission had carried out unannounced inspections of Teva, and said that the drugmaker may have artificially extended the market exclusivity of Copaxone by strategically filing and withdrawing patents after the 2015 expiry of a basic patent of the key API used in the drug. The case assumes importance as over half a million Europeans need treatment for multiple sclerosis.
Teva, which has been fined twice in recent years for pay-for-delay deals, could face a sanction of up to 10 percent of its global turnover and an additional deterrent fine if found guilty of breaching EU rules. Margrethe Vestager, executive vice-president and in charge of competition policy for the European Commission, had said despite great efforts of the scientific community, humanity has not yet found a treatment for this disease, which remains incurable. “It is therefore paramount to preserve healthy competition in the market for available drugs that aim at slowing down the disease and improving patients’ quality of life. It is also important that companies compete to innovate so that new and affordable treatments can emerge,” she said.
Amgen buys Five Prime for US$ 1.9 billion for its gastric cancer drug in Phase 3 trials
Amgen has said it will acquire Five Prime Therapeutics, a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, for around US$ 1.9 billion. This acquisition adds Five Prime’s innovative pipeline to Amgen’s leading oncology portfolio.
Five Prime’s lead asset, bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody. The drug has shown positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer.
Through this acquisition, Amgen will get Five Prime’s earlier pipeline work as well, which includes one phase 1 CD80-Fc fusion asset and several other preclinical drugs.
“The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer,” said Robert Bradway, chairman and CEO at Amgen. This is the biggest buyout deal for Amgen after it acquired Onyx Pharma in 2013.
Eli Lilly’s antibody combo for Covid cuts hospitalization, deaths by 87% in phase 3 study
Last month, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate Covid-19 in patients over 12 years of age and at least 40 kilograms in weight. The EUA includes treatment for those who are 65 years of age and older or who have certain chronic medical conditions.
This week, the antibody cocktail from Eli Lilly received a shot in the arm when Phase 3 trial data showed how the bamlanivimab-etesevimab duo slashed the risk of hospitalization and death by an impressive 87 percent as compared to a placebo. Investigators tested a combination of 700 mg of bamlanivimab and 1400 mg of etesevimab in a trial comprising 769 patients.
It's the starkest reduction in hospitalizations and deaths for a Covid-19 therapeutic seen so far, and in a “fairly sizable” sample size, Janelle Sabo Eli Lilly’s Covid-19 therapeutics platform leader said.
After bagging FDA’s EUA, Lilly has also signed a supply deal with the US government covering 100,000 doses for US$ 210 million. The doses will be delivered before March-end. The US government has the option to purchase another 1.1 million doses through November 25.
FDA calls out Khloé Kardashian for making false claims in Biohaven’s migraine drug video
The Office of Prescription Drug Promotion (OPDP) under the US Food and Drug Administration (FDA) has raised concerns that Khloé Kardashian’s promotional video for Biohaven Pharmaceuticals’ migraine drug has made false claims about giving relief in only 15 minutes.
In a letter, FDA’s OPDP has said that in reality, clinical work to support the drug, known as Nurtec ODT, began measuring how it works two hours after dosing.
“Claims that Nurtec ODT provides relief in 15-30 minutes are not supported by the clinical trial data,” the FDA said in its letter. Biohaven has 15 working days to respond to the FDA.
The promotional video claims that Nurtec ODT is more effective than other migraine drugs and is, in fact, a “game-changer.” The FDA says these comparative claims are misleading since Biohaven has not demonstrated that Nurtec ODT is clinically superior to or more effective than any other prescription and over-the-counter drug.
“Biohaven is working closely with the FDA to evaluate their comments and respond,” the company said in an SEC filing.
This isn’t the first time the Kardashians have run into trouble with the agency over their promotions of drugs. Back in 2015, Kim Kardashian had promoted Duchesnay’s morning sickness drug Diclegis on Instagram and the FDA had slammed the company with a warning letter for not disclosing enough risk information in the post.
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