Market Place
Phillip Morris acquires two drug firms; Pfizer, WHO remain at loggerheads over booster shots
This week, Phispers brings you lots of news from the US, the world’s largest pharmaceutical market. The US Food and Drug Administration (FDA) had approved Biogen’s Alzheimer’s drug — aducanumab — last month. But now, lawmakers are raising concerns about Biogen’s “atypical” approval process.
The US President Joe Biden issued an executive order last week to promote competition in several sectors, including drugs, wherein the aim is to combat high prescription drug prices and price gouging.
A district court in the US dismissed claims by consumers against ranitidine (Zantac) over nitrosamine impurities. The drug had been withdrawn last year.
The stand-off between Pfizer and the WHO over a booster dose of its Covid-19 jab for the vaccinated population intensified last week. The US government has come forth to say that vaccinated Americans don’t need a third dose, as of now. The FDA has put a new warning regarding a rare neurological disorder on J&J’s Covid-19 vaccine factsheet.
The other major news of the week is tobacco group Philip Morris’ entry into the pharmaceutical industry through the acquisition of two drug companies —Vectura for US$ 1.44 billion and Fertin Pharma for US$ 820 million.
In M&A news, Novo Nordisk is buying US drug developer Prothena Corp’s experimental heart therapy — PRX004 — in a deal that could be worth up to US$ 1.23 billion. And Biogen is paying US$ 125 million upfront for Chinese biotech InnoCare’s BTK inhibitor, orelabrutinib.
Tobacco group Phillip Morris acquires two drug companies to change image
Tobacco group Philip Morris International is acquiring Vectura for US$ 1.44 billion (GBP 1.05 billion) and Fertin Pharma for US$ 820 million in a bid to change its image. In June, there was news that Philip Morris was reviewing the two companies.
Phillip Morris has set a target to generate more than 50 percent of its revenue from smoke-free products and at least US$ 1 billion from products beyond nicotine by 2025 as part of its “evolution into a broader healthcare and wellness company”. Other tobacco companies, like British American Tobacco and Altria, have also moved towards e-cigarettes, cannabis and tobacco-heating products but with varying degrees of success.
Vectura makes approved inhaled medicines and associated devices to treat respiratory illnesses such as asthma. Philip Morris aims to produce a range of over-the-counter and prescription-based respiratory therapies with the help of Vectura’s expertise.
Philip Morris has also entered into an agreement to acquire Fertin Pharma, a developer and manufacturer of innovative pharmaceutical and well-being products based on oral and intra-oral delivery systems, for an enterprise value of US$ 820 million (Danish Krone 5.1 billion). Fertin Pharma is a privately-held company with more than 850 employees and operations in Denmark, Canada, and India.
US lawmakers probe Biogen over its recently approved Alzheimer’s drug
Last month, we brought you news that the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s controversial Alzheimer’s drug — aducanumab — the first treatment to attack a likely cause of Alzheimer’s disease.
However, the approval proved to be a controversial one since experts are of the view that there is not enough evidence that aducanumab — which will go by the brand name Aduhelm — can address cognitive symptoms. And now, there is news that the FDA’s acting commissioner, Janet Woodcock, is taking the unusual step of asking for a federal investigation of doctors within the FDA who met with Biogen executives before the medicine’s recent approval.
According to a Wall Street Journal story, the FDA reviewers met people from Biogen and collaborated with the company to prepare a joint review document presented to an FDA panel of outside advisers at a public meeting in 2020.
Days after Woodcock’s request, two high-ranking Congressional Democrats are learnt to be seeking answers to several concerns over Aduhelm, which comes at a lofty annual list price of US$ 56,000. In their letter, the lawmakers told Biogen that they are concerned about reports of the company’s “atypical” approval process and a secret campaign, dubbed “Project Onyx.”
In a JAMA Network publication, the FDA highlighted that two randomized, double-blind placebo-controlled, phase 3 studies on aducanumab (301 and 302), which included 1,647 and 1,638 participants, provided conflicting results. “Although evidence from the aducanumab program was suggestive of clinical benefit—strongly so in study 302 with support from study 103—we concluded, as did the FDA’s Peripheral and Central Nervous System Advisory Committee, that the clinical trial data were not adequate on their own to convincingly demonstrate a clinical benefit in reducing clinical decline in patients with Alzheimer disease,” the medical journal said.
Meanwhile, according to a Reuters report, the US government has started a review process for national Medicare coverage of Aduhelm. The Centers for Medicare & Medicaid Services (CMS) expects to give a proposed decision within six months and a final decision within nine months.
Biden issues new order targeting drug prices; revisits drug imports from Canada
The US President Joe Biden issued an executive order last week that aims at promoting competition in the US marketplace across several sectors. In particular, it calls on the Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) to advance several policies that are already planned or underway, including some policies pursued by the previous administration.
Biden has also directed the HHS to “issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging.”
“Americans are paying too much for prescription drugs and healthcare services — far more than the prices paid in other countries,” the executive order said.
One such policy includes revisiting prescription drug importation from Canada, where prices are cheaper than in the US. Other provisions of the order directed at the FDA include continuing to clarify and improve the approval framework for generics and biosimilars; clarifying standards for the approval of interchangeable biologics; supporting education and communication initiatives for biosimilars; and to continue clarifying requirements and procedures related to the review and submission of biologics license applications (BLAs).
The HHS and the FDA are also instructed to “continue to promote generic drug and biosimilar competition,” as laid out in the FDA’s 2017 and 2018 competition plans for drugs and biologics.
Booster dose: Pfizer, WHO at loggerheads; US govt says vaccinated Americans don’t need it
Amid rising fears of a surge in the Delta variant, triggered by a sharp increase in Covid cases in the US, Pfizer recently said it was seeking authorization for a third dose of its vaccine, to be delivered as booster shots to the vaccinated population in the US. However, the World Health Organization (WHO) insisted there was not enough evidence to show that third doses are needed.
Tedros Adhanom Ghebreyesus, director general of the WHO said some countries are ordering millions of booster doses before others have vaccinated health workers and the most vulnerable.
“We are making conscious choices right now not to protect those in need,” he said, adding that the global gap in Covid-19 vaccine supply is hugely uneven and inequitable. The WHO chief said companies like Pfizer should instead direct their doses to Covax, the vaccine-sharing program mainly for middle-income and poorer countries.
However, Anthony Fauci, chief medical adviser to US President Joe Biden, said on Sunday that he did not rule out the possibility of recommending a third shot. Post that, there was news that Pfizer is slated to meet top US government health officials over the booster shot.
After meeting Pfizer executives on Monday, US officials reiterated that Americans who have been fully vaccinated do not need to get a booster shot at this time. A government spokesperson said HHS officials will continue to discuss when and if booster shots will be needed in the future.
Jay Butler, deputy director at the US Centers for Disease Control and Prevention (CDC) said a third dose could potentially come with even greater risks. Butler said he has not seen any evidence of waning immunity to Covid-19 among US residents who received shots in December or January. He also said the existing shots provide significant protection against the Delta variant of Covid-19.
Meanwhile, the controversy surrounding the need for a booster shot is likely to continue for some time. According to a story published in Politico, Biden administration health officials believe the most vulnerable Americans will eventually need booster shots, but are debating how quickly that should happen.
US district court dismisses claims against ranitidine over nitrosamine impurities
In April 2020, the US Food and Drug Administration had asked for the withdrawal of all prescription and over-the-counter (OTC) ranitidine drugs from the market. The agency had determined that ranitidine, the active ingredient of GlaxoSmithKline’s Zantac, had shown to transform over time into a cancer-causing agent, N-nitrosodimethylamine (NDMA). Over the last few years, Zantac, which was approved in 1983, and other OTC and generic drugs containing ranitidine have been pulled from shelves in the US.
However, this year, two studies examining the potential for nitrosamine formation from ranitidine had allayed concerns. And now, a US district court judge in southern Florida has dismissed the claims against Zantac.
In an amended master personal injury complaint, thousands of people who say they’ve developed various cancers after taking Zantac (ranitidine) accused the manufacturers of 17 counts and a multitude of state-specific sub-counts — including negligence and failure to warn through the FDA.
The judge dismissed all claims against the generic and store-brand defendants in the master complaints “without leave to amend.”
M&A update: Novo Nordisk to buy Prothena’s heart drug in US$ 1.2 billion deal
Novo Nordisk is acquiring US drug developer Prothena Corp’s experimental heart therapy — PRX004 — in a deal that could be worth up to US$ 1.23 billion. The acquisition is in line with Novo’s strategy to diversify its core insulin portfolio that has been facing tough competition.
Under the agreement, Prothena will receive US$ 100 million in upfront and near-term clinical milestone payments for PRX004, currently in a mid-stage trial.
In December, Prothena had reported positive data from an early-stage trial of PRX004 to treat hereditary ATTR amyloidosis, a life-threatening genetic disease that affects the heart, nerves and other organs.
Novo Nordisk said it will focus on developing PRX004 for ATTR cardiomyopathy, a potentially fatal form of the disease characterized by a build-up of amyloid deposits in cardiac tissue.
Biogen buys InnoCare’s MS drug: Biogen is paying US$ 125 million upfront for Chinese biotech InnoCare’s orelabrutinib, a drug being studied in a phase 2 trial for relapsing-remitting multiple sclerosis (RRMS). Apart from the upfront payment of US$ 125 million, InnoCare also stands to gain US$ 812.5 million should the therapy gain approval, along with a percentage of sales.
FDA adds new warning regarding rare nerve disorder to J&J’s Covid vaccine factsheet
This week, the US Food and Drug Administration (FDA) added a warning to the factsheet for Johnson & Johnson’s Covid-19 vaccine to include an increased risk of a rare neurological disorder in the six weeks after inoculation.
In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being “very low.” Yet, it said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.
After the United States added a warning label to J&J’s one shot vaccine, the European Medicines Agency (EMA) also said it was analyzing data on rare cases of a nerve disorder reported among recipients of the Covid-19 vaccine.
Around 12.8 million people have received J&J’s one-dose vaccine in the US. The FDA said 100 preliminary reports of GBS in the vaccine recipients include 95 serious cases that required hospitalization and one reported death. J&J said in a statement that it was in discussions with regulators about the cases of GBS.
Guillain-Barre syndrome is already a known sequel to viral infections in general, and has also shown up as a response to vaccination. Most people fully recover from this autoimmune disorder.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
