Market Place
Pfizer rejigs into three businesses; Cancer causing impurity in China-made API leads to major EU drug recall
This week in Phispers, we bring you news on Pfizer reorganizing itself into three businesses — Innovative Medicines, Established Medicines and Consumer Healthcare. EMA recently reviewed medicines containing valsartan, an API supplied by Zhejiang Huahai of China, and detected a dangerous amount of a carcinogen — nitrosodimethylamine — in it. This has led to massive recalls across Europe of drugs containing valsartan. Takeda is selling off its ancestral headquarters in Osaka to fund the US$ 62 billion acquisition of Shire. A tax incentive lured Teva to shift its US headquarters from Pennsylvania to New Jersey. Meanwhile, the Trump administration halted Obamacare payments. And in France, drugmaker Sanofi had to shutdown a plant due to release of dangerous pollutants.
Pfizer to reorganize itself
into three businesses; creates new hospital drugs business
The biggest news of the week came in yesterday as America’s largest drug maker Pfizer Inc said it will organize itself into three businesses — Innovative Medicines (a science-based drugs business and a new hospital business unit); Established Medicines (an off-patent branded and generic business operating with substantial autonomy within Pfizer); and Consumer Healthcare business.
This new reorganization will come into effect at the beginning of the company’s 2019 fiscal year.
“This new structure represents a natural evolution of these businesses given the ongoing strength of our in-market products and our late-stage pipeline and the expected significant reduction in the impact of patent protection losses post-2020 following the loss of exclusivity for Lyrica in the US which is expected to occur in or after December 2018,” chairman and CEO of Pfizer, Ian Read, said in a statement.
The Innovative Medicines business will include all of the current Pfizer Innovative Health business units as well as a new Hospital Medicines business unit that will commercialize Pfizer’s global portfolio of sterile injectable and anti-infective medicines, allowing for better focus and customer centricity. Pfizer will also incorporate its biosimilar portfolio into its Oncology and Inflammation & Immunology business units.
The Established Medicines business will include the majority of Pfizer’s off-patent solid oral dose legacy brands, including Lyrica, Lipitor, Norvasc and Viagra, and certain generic medicines. This business will operate across the world.
The Consumer Healthcare (PCH) business will include all of Pfizer’s over-the-counter medicines. It will continue to operate relatively autonomously with dedicated manufacturing and regulatory capabilities.
Cancerous
impurity in China-made valsartan API leads to recalls across Europe
Last week, the European Medicines Agency (EMA) reviewed medicines containing the active pharmaceutical ingredient (API) valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China. The reason behind the review was the impurity — nitrosodimethylamine (or NDMA) — detected by the company in their valsartan API.
Zhejiang Huahai supplies the API to most major manufacturers producing valsartan medicines available in the EU.
NDMA is classified as a probable human carcinogen. NDMA can occur in drinking-water through the degradation of dimethylhydrazine (a component of rocket fuel) as well as from several other industrial processes. It is also a contaminant of certain pesticides.
The presence of NDMA was unexpected and is thought to be related to changes in the way the API was manufactured.
EMA’s review will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them and measures that can be taken to reduce or eliminate the impurity from the future batches produced by the company. As a precaution, the review will also consider whether other valsartan medicines may be affected.
While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai. Alerts and recalls are being undertaken by all major regulatory authorities in countries such as the UK, France, Spain, Portugal, Germany, Finland, Ireland, Bahrain, Bulgaria, Italy and Taiwan.
Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.
Takeda to sell old
HQ to fund Shire acquisition; shifts into new global HQ in Tokyo
Takeda Pharmaceutical plans to sell its headquarters in Osaka to bolster its finances ahead of the planned acquisition of Irish drugmaker Shire for over US$ 62 billion (7 trillion yen). Takeda hopes to find buyers for this ancestral property by the end of the year through a bidding process which is likely to be held by October.
The building housing the headquarters — the Takeda Midosuji Building — stands on the same site where Takeda was founded 237 years ago. The company expects to raise around US$ 535 million (60 billion yen) from the sale of this property, which will also include other properties in the area.
The acquisition of Shire threatens to hit Takeda’s finances. The sell-off is part of Takeda’s larger game-plan to focus on the drugs business by selling off assets that are not important to drug-making. Takeda has begun divesting nonessential properties. In April 2017, it sold an office building in Tokyo’s Shinagawa Ward. In December 2017, it agreed to sell two buildings, including its former Tokyo headquarters, to Osaka department store operator Takashimaya.
Meanwhile, the company shifted into its new global headquarters in Tokyo last week. The global headquarters had been completed in March this year, and provides “an environment that support diverse work-styles and enhances the connectivity of colleagues from around the world and promotes creativity in work,” a Takeda statement had said.
The Shire deal will radically transform Takeda, making it the ninth largest global drugmaker by revenue. After purchasing Shire, Takeda’s interest-bearing debt is expected to be about US$ 35.97 billion (4 trillion yen), four times the level at the end of March.
If Takeda is able to integrate Shire successfully, nearly half of the revenue of the combined entity will come from the lucrative US market, while sales from Japan will shrink to 19 percent of the total from 34 percent.
Lured by US$ 40
million tax break, Teva moves its US HQ to New Jersey
It’s not just Takeda that is shifting its headquarters. Israeli generic drug giant Teva too is planning to shift its US headquarters from Pennsylvania to New Jersey. The decision follows approval of a 10-year, US$ 40 million tax incentive plan designed to woo Teva from its longtime base of Pennsylvania. The plan required Teva to preserve 1,000 New Jersey jobs to reap the credits.
According to New Jersey Governor Phil Murphy, Teva will be moving its US home base to Parsippany-Troy Hills from North Wales, Pennsylvania.
The decision is a win-win. Teva, which is in the middle of a US$ 3 billion cost-cutting effort being implemented by its CEO Kåre Schultz, will be able to consolidate some of its operations in a central location. For the US, the switch will transfer and create a total of 843 jobs in the state, while 232 workers at the Parsippany-Troy Hills location—which will expand to nearly 350,000 square feet—will keep their positions.
It’s not clear how many Pennsylvania workers will lose their jobs on account of the move. Teva has already cut some jobs in Pennsylvania. In January, the drugmaker pink-slipped 65 employees across three buildings in Horsham and North Wales, Pennsylvania, 96 across sites in Fraser and Great Valley, and 47 more in West Chester.
Trump administration
halts Obamacare payments; forces Pfizer to rollback drug price hike
The US President Donald Trump was up in arms against drugmakers last week. He entered into a Twitter war with Pfizer and also halted billions of dollars in payments to health insurers under the Obamacare healthcare law, quoting a recent federal court ruling that prevents the money from being disbursed.
The Centers for Medicare and Medicaid Services, which administers programs under the Affordable Care Act, said the action affects US$ 10.4 billion in risk adjustment payments. About 20 million Americans have received health insurance coverage through the program.
The Trump administration has used its regulatory powers to undermine Obamacare after the Republican-controlled Congress last year failed to repeal and replace the law.
“We were disappointed by the court’s recent ruling. As a result of this litigation, billions of dollars in risk adjustment payments and collections are now on hold,” CMS Administrator Seema Verma said in a statement. The CMS statement said the agency has asked the New Mexico court to reconsider its decision and expressed hope for a prompt resolution of the issue.
Meanwhile, President Trump tried to shame Pfizer over Twitter for hiking prices and later got the US-based drug giant to roll back the drug price hikes it had brought into effect on July 1. In May, Trump had said industry players were planning “massive” price reductions.
In his earlier tweets, Trump had said Pfizer and others “should be ashamed that they have raised drug prices for no reason”.
Pfizer, on the other hand, said the roll back is temporary.
“Just talked with Pfizer CEO and @SecAzar on our drug pricing blueprint,” Trump tweeted on July 10. “Pfizer is rolling back price hikes, so American patients don’t pay more. We applaud Pfizer for this decision and hope other companies do the same. Great news for the American people!”
Pfizer, on the other hand, had defended the price hikes through tweets posted by its spokesperson, who had said the company markets more than 400 drugs and vaccines, and recently modified prices on about 10 percent of its portfolio, including some price reductions. “List prices don't typically reflect what patients or insurers pay,” she added.
According to the spokesperson, net prices grew 0 percent in the first quarter “due to the growing amount of rebates paid back to stakeholders in the biopharmaceutical supply chain.”
Sanofi shuts down plant in France due to dangerous
emissions
French drugmaker Sanofi said they have stopped production at their plant in the French Pyrenees following complaints that the factory has been “sending astronomical quantities of pollutants into the air.”
The Mourenx-based plant, which produces the epilepsy treatment valproate, was allegedly emitting the widely used solvent bromopropane, which can cause respiratory and skin infections as well as cancer.
Complaints against Sanofi had been filed by an environmental body representing 3,000 local associations — known as French Nature Environnement (FNE). The body was demanding an immediate shut down of the plant. The FNE alleged the emissions at the plant situated in the French commune of Mourenx were 7,000 times above the limit permitted by France.
The French government said it was monitoring the situation to ensure that Sanofi had taken steps to prevent excessive pollution before it allows the plant to re-open.
The government has given three months to Sanofi to return to the limits of emission of toxic discharges.
Representatives from Sanofi stated: “Sanofi Chemical has decided from today to stop production at its Mourenx site and to carry out the announced technical improvements needed to return to normal.”
The Mourenx plant is authorized to release five volatile organic compounds (bromopropane, toluene, isopropanol, valonitrile and propene) into the air in the overall limit of 110 mg / m3. However, “it actually emits 770,000 mg /m3, or 7,000 times more than the allowed standard,” FNE said in a statement.
Though Sanofi admitted there was “a problem of exceeding the threshold for the vapor waste of solvents,” it said the local population had not been exposed to levels higher than those laid down by regulation.
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