India reports steep rise in API prices; US$ 26 billion settlement announced to resolve opioid lawsuits

India reports steep rise in API prices; US$ 26 billion settlement announced to resolve opioid lawsuits

By PharmaCompass

2021-07-22Impressions: 2756

India reports steep rise in API prices; US$ 26 billion settlement announced to resolve opioid lawsuits

In Phispers this week, we bring you news that a group of state attorneys general in the US has unveiled a landmark US$ 26 billion settlement with major American drug companies that have been accused of fueling the opioid epidemic.

The USFDA has granted priority review status to the BLA of Pfizer’s two-dose mRNA vaccine for Covid-19. Britain’s competition regulator has fined over 10 firms US$ 360 million for overcharging the National Health Service (NHS) for a steroid whose price rose 10,000 percent in less than eight years.

For the first time since March 2020, the FDAs inspections of US-based biopharma sites have returned to normal. However, overseas inspections continue to remain affected by the pandemic.

Facing over 25,000 lawsuits pertaining to its talcum products, Johnson & Johnson is exploring the possibility of creating a new business to absorb the liabilities associated with the litigations and then seek bankruptcy protections. J&J has estimated its talc liabilities to be around US$ 3.9 billion.

The USFDA has allowed Pfizer to market its anti-smoking drug with elevated levels of a cancer-causing impurity. German biotech company BioNTech acquired Kite Pharmas oncology R&D platform and Maryland plant to expand it cell therapy production network.

India has reported a steep rise in API prices due to high import costs and supply disruptions from China. And Italian drugmaker Leadiant has been fined US$ 23.59 million by the Dutch competition regulator for increasing the price of a drug, used to treat a rare metabolic disorder, by over 6,000 percent.


India reports steep rise in API prices due to high import costs, supply disruptions from China

India, which is just about emerging out of a deadly second wave of Covid-19, is now battling with a steep rise in the cost of active pharmaceutical ingredients (API). In certain cases, the price rise is as high as 139 percent since the pre-pandemic levels, says a report published in The Economic Times.

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Nearly 70 percent of Indias APIs are imported from China, and the dependence is as high as 90 percent for antibiotics like cephalosporins, azithromycin and penicillin.“The overall increase, averaging nearly 50 percent in the wake of high-priced imports and supply disruptions from China, have raised doubts on the availability of drugs and could lead to shortages, particularly of those that are key in Covid therapy,” says the ET report.

This rise in API prices is hurting the industry. The prices of drugs such as paracetamol, meropenem and metformin, have increased 139 percent, 127 percent and 124 percent respectively. In India, these drugs are under price control, compelling companies to absorb the higher costs. Moreover, packaging and freight costs have also jumped manifold, ranging from 100 percent for packaging materials, and between 233 percent and 360 percent for shipping freight rates from China.


US state attorneys reach landmark US$ 26 billion opioid settlement with drug companies

In the US, a group of state attorneys general has unveiled a landmark US$ 26 billion settlement with major American drug companies that have been accused of fueling the opioid epidemic in the country. However, the deal requires support from thousands of local governments, says a Reuters report.

If it gets the required support, this will be the second-largest cash settlement in United States history, after the US$ 246 billion tobacco agreement in 1998, says an Al Jazeera news report.

Under the settlement proposal, the three largest US drug distributors – McKesson, Cardinal Health and AmerisourceBergen – are expected to pay US$ 21 billion together, while Johnson & Johnson is expected to pay US$ 5 billion.

Theres not enough money in the world frankly to address the pain and suffering,” said Connecticut attorney general William Tong. He said the money raised through this settlement will help where help is needed”. The money is expected to be used on addiction treatment, family support, education and other social programs.

To receive the full payout, the agreement needs support from at least 48 states, 98 percent of litigating local governments and 97 percent of the jurisdictions that have yet to sue. Over 3,000 lawsuits related to the opioid health crisis, mostly by state and local governments, have been filed, and the settlement’s ultimate payout depends on the number of localities that agree to drop their lawsuits.


FDA grants priority review status to Pfizer vaccine’s full approval application

The US Food and Drug Administration (FDA) has granted priority review status to Pfizer-BioNTech’s application for a full approval, known as a biologics license application (BLA), of their Covid-19 vaccine.

A full approval for the Pfizer vaccine could help bolster the US vaccination effort, as many people are reluctant to receive the vaccine under its emergency use authorization (EUA) status. Over 85 million Americans have been fully vaccinated with Pfizer’s vaccine.

The FDA will review the BLA of the vaccine in people 16 years and older by January, the companies said. However, the approval may happen earlier, FDA’s acting commissioner Janet Woodcock said on Twitter. According to a CNN news report, a decision on full approval is likely to come within two months.

In a letter to The New York Times, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, wrote that the review of applications for full approval of Covid-19 vaccines is “one of the highest priorities” at the FDA, but it requires the evaluation of

extensive manufacturing and clinical information.

Pfizer and BioNTech began the BLA process in May and have completed the submission. Moderna has begun submitting data for the BLA of its Covid vaccine, and Johnson & Johnson is also expected to seek a full FDA approval soon. All three vaccines currently being administered in the US have the FDA’s EUA.

Moderna’s scrip joins S&P 500 index: After the significant success of its Covid-19 vaccine, Moderna Inc’s scrip joined the S&P 500 index this week, replacing Alexion Pharmaceuticals. The company’s stock is up nearly 175 percent this year, leading to Modernas market valuation of more than US$ 115 billion. The vaccine is expected to generate revenues of more than US$ 19 billion in 2021, as compared to only US$ 803.4 million in 2020.


FDA’s domestic inspections return to normal; overseas inspections still affected

For the first time since March 2020, the FDAs inspections of US-based biopharma sites have returned to normal, FDA acting commissioner Janet Woodcock said.

Im pleased to say that as of this month, weve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.

The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic. Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends. Unlike other inspections, these are planned in advance.

FDA estimates that roughly 14 percent of the 15,514 domestic surveillance inspections still to be conducted in FY21 will be achievable in the Base-Case scenario,” an FDA report from May this year said. About 3,229 of those 15,514 inspections are related to human and animal drugs.

However, the agency is still struggling with foreign inspections, which are difficult to conduct during the pandemic. The FDA has successfully conducted only about 30 foreign inspections that were mission critical.


British regulator fines over 10 drug firms US$ 360 million for overcharging NHS

The Competition and Markets Authority (CMA), Britains competition regulator, has fined over 10 drug firms US$ 360 million (£260 million) for overcharging the National Health Service (NHS) for a steroid whose price rose from £0.70 (US$0.96) to £88 (US$ 120.6) a pack in less than eight years. According to the CMA, NHS paid over 10,000 percent more for single packs of 10 mg and 20 mg hydrocortisone tablets in 2016, as compared to the price it was paying in 2008.

Hydrocortisone is used to treat conditions where adrenal glands do not make sufficient hormones, including the life-threatening Addisons disease. The CMA’s probe found that Auden Mckenzie and Actavis UK (now known as Accord-UK) charged the NHS excessively high prices for hydrocortisone tablets for almost a decade.

The CMA said the companies broke competition rules. Before April 2008, the NHS was spending about £500,000 (US$ 685,177) annually on hydrocortisone tablets. By 2016, that cost rose to more than £80 million (US$ 109.63 million), the CMA said.

The CMA has fined Actavis UK, Auden Mckenzie, Allergan, Accord Healthcare, Intas, Waymade Plc, Amdipharm, Advanz Pharma and some entities of private-equity group Cinven. Auden and Actavis UK together will pay £221.1 million (US$ 302.98 million). The CMA said that in addition to its fines, the NHS will also be able to seek damages.


J&J may create new company to absorb US$ 3.9 billion worth of talc liabilities

Johnson & Johnson is experiencing tough times. Apart from the US$ 5 billion payout towards the opioid settlement, it is also facing liabilities worth US$ 3.9 billion due to talcum powder lawsuits.

The company is facing over 25,000 lawsuits that allege that its talcum products cause cancer. The company is looking for ways to mitigate the extremely large costs involving these lawsuits. According to news reports, J&J is exploring the possibility of creating a new business to absorb the liabilities associated with the litigation and then seek bankruptcy protections. Earlier this year, J&J had estimated that its talc liabilities are worth around US$ 3.9 billion.

According to a Reuters report, splitting a company up for the purpose of claiming bankruptcy, also referred to as the Texas Two-Step, isnt a new strategy. In 2017, a paper towel manufacturer pursued this legal approach to address its asbestos lawsuits.

However, the company is yet to decide if the plan is feasible. “Johnson & Johnson Consumer Inc. has not decided on any particular course of action in this litigation other than to continue to defend the safety of talc and litigate these cases in the tort system, as the pending trials demonstrate,” the company said in a statement.

Last month, the US Supreme Court had rejected J&J’s appeal of a US$ 2.11 billion verdict for women who developed ovarian cancer. Even after that loss, the company now faces around 28,900 talc lawsuits.

To make matters worse for J&J, the FDA is also investigating how a cancer-causing chemical ended up in J&J sunscreens, after the company said it had done internal testing and found low levels of benzene in some.


FDA allows Pfizer to market anti-smoking drug with elevated levels of carcinogenic impurity

Last week, the FDA said it will temporarily allow manufacturers to distribute the anti-smoking drug varenicline with elevated levels of an impurity that can cause cancer. In June, Pfizer had halted distribution of Chantix (branded varenicline) and recalled a number of lots after finding elevated levels of nitrosamines in the pills.

The regulator said the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline. Therefore, the FDA will temporarily allow some manufacturers to distribute varenicline containing impurities above its intake limit of 37 nanograms per day, but below an interim limit of 185 nanograms per day, until the impurity can be eliminated or reduced to acceptable levels.

The nitrosamine impurity, called N-nitroso-varenicline, may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication, the FDA said.

Meanwhile, Pfizer expanded its voluntary recall of varenicline (Chantix) to 12 lots to the consumer level last week, the FDA website said.


BioNTech acquires Kite Pharma’s oncology R&D platform and Maryland plant

BioNTech is acquiring a production site and a research and development platform from Kite Pharma, a subsidiary of US biotech company Gilead. BioNTech is buying a solid tumor neoantigen T-cell receptor therapy (TCR-Ts) R&D platform and a manufacturing plant in Gaithersburg city in the state of Maryland from Kite Pharma.

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

The German biotech company is making a one-time payment of an undisclosed amount to buy the R&D platform and the Maryland plant. The sale is expected to close by the end of this month and will bolster BioNTechs cell therapy production network. BioNTech will use the Kite plant to support supply for its US clinical trials, the company said in a statement.

T-cell receptors (TCRs) are a class of compounds that make it easier for the bodys immune cells to identify and destroy cancer cells, while TCR-Ts detect targets both inside and outside the cancer cells. Kite Pharma is a big player in the CAR T-cell therapy space with FDA-approved drugs like Tecartus and Yescarta that are used to treat mantle cell lymphoma and follicular lymphoma, respectively.


Italian drugmaker fined for raising price of drug by 6,000 percent

Italian drugmaker Leadiant has been fined US$ 23.59 million (nearly €20 million) by the Dutch competition regulator for increasing the price of a drug used to treat a rare metabolic disorder (cerebrotendinous xanthomatosis) by more than 6,000 percent. The Netherlands Authority for Consumers and Markets said it would fine Leadiant US$ 23.11 million (19.6 million) for repeatedly increasing the price of the drug Chenodeoxycholic acid (CDCA) since it acquired the patent in 2008.

When Leadiant purchased the rights to the treatment for the rare disorder, the medication sold for US$ 54.25 (46) for 100 capsules. In 2009, the company released the same drug under a new name, raising the price to US$ 1,044 (885) for 100 capsules. In 2019, Leadiant obtained the exclusive rights to sell the drug and the price increased to a whopping US$ 16,513 (14,000) for 100 capsules — a 6,645.65 percent increase over the price it was ten years earlier.

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