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By PharmaCompass
2019-09-26
Impressions: 3761
This week, Phispers brings you news on the drug pricing package unveiled by Democrats in the US, which is similar to the HHS plan, known as the International Pricing Index.
After concerns of a nitrosamine impurity in ranitidine, Sandoz recalled the drug from the US while GSK and Dr. Reddy’s halted worldwide supplies of Zantac.
In France, a landmark trial began this week that accuses French drugmaker Servier of knowingly marketing a weight loss pill that allegedly killed up to 2,000 people and left many injured for life.
The USFDA approved the oral version of Novo Nordisk’s diabetes drug — semaglutide.
And Novartis blamed AveXis’ Kaspar brothers of manipulating Zolgensma data.
NDMA concerns drive GSK, Dr Reddy’s to halt worldwide supplies, Sandoz recalls ranitidine from US
Last week, we had reported on how a nitrosamine impurity was back to haunt the world of pharmaceuticals, as the FDA had learnt that some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels
This week, the original branded maker of Zantac, GlaxoSmithKline Plc (GSK) halted global distribution of its ranitidine products and announced a recall of the drug in India and Hong Kong. In a statement to Bloomberg, GSK’s spokeswoman said that the recalled drugs are made by active ingredients sourced from two suppliers, Dr. Reddy’s and Saraca Laboratories in India.
A few days back, Dr Reddy’s announced it was halting worldwide supplies of its prescription and OTC drug products that contain ranitidine.
Similarly, Novartis’ Sandoz unit had announced it was halting worldwide distribution of its generic versions of Zantac. It also announced a recall from the United States of 14 lots of ranitidine capsules due to “an elevated amount” of NDMA.
The trigger for the NDMA concerns in ranitidine was a citizen petition filed on behalf of an online pharmacy — Valisure — on September 9, 2019. The petition states that while the FDA has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng, Valisure had detected NDMA in excess of 3,000,000 ng per tablet when it analyzed ranitidine products, likely due to an inherent instability of the ranitidine molecule. The molecule contains both a nitrite and a dimethylamine (“DMA”) group which is known to combine to form NDMA.
Valisure used the FDA recommended GC/MS headspace analysis method FY19-005-DPA8 for the determination of NDMA levels and following “the extreme nature of the results” it undertook “further scientific investigation to determine the origin of the NDMA.”
“Valisure’s tests suggest ranitidine can react with itself in standard analysis conditions (eg. GC/MS oven temperature of 130°C) at high efficiency to produce NDMA at levels well in excess of the permissible daily intake limit for this probable carcinogen.”
While the FDA has not identified the source of this impurity, Germany’s Federal Institute for Drugs and Medical Devices issued a statement informing patients about the withdrawal of ranitidine containing products produced by the API sourced from India’s Saraca Laboratories Limited. A similar statement has been issued by the Italian Drug Agency as well.
Valisure’s petition also tested other commonly used antacids for NDMA levels and detected elevated levels in another antacid containing nizatidine (sold under the brand name Axid).
Servier, French regulator being tried for ‘up to 2,000 deaths’ caused by weight loss drug
In France, a landmark trial over one of the country’s biggest healthcare scandals has begun after a weight-loss pill — Mediator — was believed to have killed up to 2,000 people and left many more injured for life. The drug was taken off the market in 2009.
French drug major Servier, the drug’s manufacturer, is accused of deceiving users over Mediator’s killer side effects. It is being tried for manslaughter and deceit. Servier has denied the charges, saying it did not lie about the side effects.
The trial will involve more than 2,600 plaintiffs and 21 defendants, and is expected to run over the course of six months. The French state drug regulator — the Agence National de Sécurité du Médicament — has also been accused of lenience and not acting to prevent patient deaths and injuries. The watchdog has said it would cooperate with the trial.
Based on a molecule called benfluorex, Mediator was first developed in 1976 as a lipopenic (a drug to lower fat levels in the blood). Later, it was prescribed to diabetic patients to help them lose weight. In time, its appetite-suppressant properties were recognized, and doctors began offering it as a weight-loss pill.
As many as 5 million people were given the drug between 1976 and 2009. Servier has been accused of profiting at least US$ 1.1 billion from the drug's sales.
“The trial comes as huge relief. Finally, we are to see the end of an intolerable scandal,” Irene Frachon, a pulmonologist credited with lifting the lid on the side effects of Mediator, told Reuters. Frachon's research revealed a clear pattern of heart valve problems and pulmonary damage among Mediator users and she had raised alarm back in 2007.
Servier has said it will continue to compensate victims and has paid nearly US$ 145 million (€132 million) to patients.
Novartis blames AveXis’ Kaspar brothers of manipulating Zolgensma data
Last month, Novartis had fired two top AveXis executives — Brian and Allan Kaspar — for their role in the Zolgensma data fiasco.
Incidentally, Brian Kaspar, the former chief scientific officer (CSO) of AveXis, had categorically denied any wrongdoing and had said he is “prepared to assert his rights and defend his conduct accordingly.”
This week, the Swiss drugmaker blamed the Kaspar brothers of manipulating data behind its US$ 2.1 million gene therapy Zolgensma, saying they either personally manipulated the data or pressured subordinates into doing so.
In its 59-page long response to a recent FDA Form 483 citation, the Novartis gene therapy unit said a whistleblower accused the two senior executives of doctoring raw data derived from a mice assay used at the time to test Zolgensma samples.
Zolgensma — the world’s most expensive drug — was approved as a one-time treatment for spinal muscular atrophy (SMA) in May this year.
AveXis had developed Zolgensma, and the company had been acquired by Novartis for US$ 8.7 billion last year.
Novartis has been under fire for its delay in reporting the data problems to the FDA, even after it confirmed the allegation internally in May. Last month, the FDA said Novartis could face civil or criminal penalties due to the data manipulation.
On August 13, after holding its investigation, Novartis had fired the Kaspar brothers. In its response to the regulators, Novartis also acknowledged that AveXis’s culture of quality was inadequate.
Democrats unveil drug pricing plan; Republicans say it’d be dead on arrival
In the US, even as Senator Chuck Grassley continues to push his drug pricing legislation in the Senate, House Speaker Nancy Pelosi unveiled her proposal to lower prescription drug prices on September 19. Pelosi’s plan is the Democratic caucus’ long-awaited drug pricing package.
At the heart of her plan is the idea that the Health and Human Services Secretary Alex Azar should select between 25 and 250 drugs annually and directly negotiate with manufacturers to establish a maximum price.
The second most powerful Republican in the US Senate, John Thune, said Pelosi’s plan would not survive in the Republican-dominated chamber, and called it “heavy-handed.” He said it would be “dead on arrival” if it passed the Democrat-led House of Representatives and went to the Senate.
President Donald Trump said he likes Grassley’s drug pricing bill very much, and added that it’s great to see Speaker Pelosi’s bill. “Let’s get it done in a bipartisan way,” Trump said on Twitter.
The Pelosi bill mirrors an HHS plan, known as the International Pricing Index (IPI). It recommends that the negotiations of HHS should be based on prices established in Australia, Canada, France, Germany, Japan and the UK. The pharmaceutical industry and Republicans fiercely oppose the IPI.
If manufacturers refuse to enter negotiations, the Pelosi bill would assess a tax on the manufacturer’s annual gross sales starting at 65 percent and increasing by 10 percent every quarter that the manufacturer is out of compliance (to a maximum of 95 percent).
The Pelosi plan would also penalize companies for raising the prices of drugs in Medicare Part B and D. “If a drug company has raised the price of a drug in Part B or D above the rate of inflation since 2016, they can either lower the price or be required to pay the entire price above inflation in a rebate back to the Treasury,” the summary said.
The bill also puts a cap on out-of-pocket costs for Medicare Part D beneficiaries at US$ 2,000 annually.
Meanwhile, industry groups are already opposing the Pelosi bill. Jim Greenwood, the President and CEO of the Biotechnology Innovation Organization (BIO), said in a statement: “It is deeply unfortunate House leaders have chosen an extreme approach that will make it harder to deliver meaningful reform for patients.”
If Pelosi’s proposal is accepted, cancer drugs Revlimid, Keytruda and Opdivo, along with diabetes treatments Januvia and insulin would likely be among the medicines subject to Medicare price negotiation. Blood thinners Eliquis and Xarelto and the eye drug Eylea would also probably be targets under the proposal.
Novo bags FDA
approval for new oral version of diabetes drug semaglutide
Last week, the US Food and Drug Administration (FDA) approved an oral version of Novo Nordisk’s diabetes drug — semaglutide. Novo is the world’s biggest producer of diabetes drugs. It already sells an injectable version of semaglutide under the brand name Ozempic at a cost of nearly US$ 800 per month in the US.
With this first-of-its-kind tablet version of its semaglutide drug, Novo aims to transform the market for diabetes drug. The new oral treatment, known as Rybelsus, stimulates insulin production in patients with type 2 diabetes and is meant to be taken once a day.
Even though over 70 percent of diabetes prescriptions in the United States are for oral treatments, they do not include the GLP-1 class that Novo specializes in. These GLP-1 drugs are viewed as highly effective medicines that stimulate insulin production.
“We have only worked with around 25 percent of the patients so far and we see it as a breakthrough because we can now also address the tablet-based market,” chief scientific officer Mads Krogsgaard Thomsen said.
Rybelsus’ competitors include Eli Lilly’s injectable Trulicity and Merck’s Januvia, an oral medication known chemically as sitagliptin. A study last year showed Novo’s Rybelsus was superior to Januvia in demonstrating reductions in both long-term blood sugar level and weight.
“We have a very strong position if you look at the leading tablet treatments in the market,” Thomsen said.
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