This week, Phispers brings you news on M&As, Covid
vaccines, lawsuits, regulations and more. Pfizer is expected to cross US$ 100
billion in revenues next year, all thanks to its Covid-19 vaccine developed in
partnership with BioNTech and its antiviral drug Paxlovid. The New
York-headquartered drug behemoth also acquired immuno-oncology firm Trillium
for US$ 2.2 billion.
In the first jury verdict on the opioid epidemic in the US, a federal jury said pharmacy chain operators — CVS Health, Walgreens Boots and Walmart — contributed substantially to the crises that led to opioid overdoses and deaths in two Ohio counties.
In a recent update, the US Food and Drug
Administration (FDA) has suggested that
drugmakers consider using certain antioxidants or excipients, such as sodium
carbonate and ascorbic acid, in their drug
products to inhibit the formation of nitrosamine impurities.
Meanwhile, all adults in America can now take a booster dose of Pfizer or Moderna’s Covid-19 vaccine since the FDA has expanded the
emergency use authorizations (EUAs) for both the mRNA shots.
Despite pushback from the activist investors of
Acceleron, Merck completed its US$ 11.5
billion acquisition of the biotech.
AstraZeneca formally unveiled its
R&D campus in Cambridge, UK, built at a cost of US$ 1.34 billion (£1 billion). The
drugmaker announced positive results for its Covid antibody cocktail as the
therapy offered 83
percent protection over six months in a clinical trial.
In M&A news, Novo Nordisk bought Dicerna for US$
3.3 billion, and there was news that Sweden-based investment group EQT and the
Struengmann family of Germany were considering a joint move to buy Sandoz, the
generic drugs division of Novartis, for US$ 21.6 billion. And
GSK is foraying into non-alcoholic
steatohepatitis (NASH) by signing a US$ 1 billion asset pact with Arrowhead
Pharmaceuticals.
Novo Nordisk buys Dicerna for US$ 3.3 billion; Novartis may have a buyer for Sandoz
The week saw several M&A deals. First, Novo Nordisk agreed to buy Dicerna Pharmaceuticals for US$ 3.3 billion in
cash. Dicerna specializes in therapeutics that counteract disease-causing
genes.
The diabetes player has been looking for new approaches to
drug development. Like many of its rivals, such as Amgen, Regeneron
and Novartis, Novo is
betting on RNA interference (RNAi) technology, where genes that contribute to disease
are silenced or rendered ineffective.
In 2019, Novo had entered into a research collaboration with Dicerna to
pursue several clinical candidates for disorders, including chronic liver
disease, non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and
rare diseases. The transaction, which will mainly be financed by debt, is
expected to close in the fourth quarter of 2021.
Buyer for Sandoz: In October-end,
there was news that Novartis had commenced strategic review of its generic drugs division — Sandoz. This
week, German newspaper Handelsblatt has
reported that Sweden-based investment group EQT and the Struengmann family of
Germany are considering a joint move to purchase the
generics outfit for US$ 21.6
billion,
The price would make it the largest pharma deal of the year. EQT and
Struengmann, who provided the investment power behind BioNTech, have
attracted interest from other private equity investors to join the group, the
report said.
Neurocrine in US$ 2.6 billion biobucks deal with
Sosei: Neurocrine Biosciences and Sosei Heptares are joining hands for a
range of early- to mid-stage neuro assets. The deal gives Neurocrine rights to a “broad portfolio” of drugs discovered by Sosei Heptares.
Neurocrine is paying US$ 100
million upfront and up to US$ 2.6
billion in various
milestone payments. Additionally, Sosei is eligible to receive royalties on
future sales of any products that result from the collaboration.
Earlier this year, AbbVie had returned the rights to the drugs to Sosei Heptares. These drugs have yet to reach human testing. The most advanced of them — a potential treatment for schizophrenia — is expected to enter a mid-stage clinical trial in 2022.
GSK in pact with Arrowhead for NASH therapy: GlaxoSmithKline is foraying into non-alcoholic
steatohepatitis (NASH), a fatty liver condition, by signing a US$ 1 billion
asset pact with Arrowhead Pharmaceuticals. Under the pact, Arrowhead said it would get an upfront payment of US$ 120
million and is eligible for additional milestone payments, including up to US$
190 million at first commercial sale of the product, and up to US$ 590 million
in sales-related milestone payments.
The deal centers around Arrowhead’s
experimental early clinical-stage RNAi therapy ARO-HSD, which is targeting
HSD17B13, a member of the hydroxysteroid dehydrogenase family involved in the
metabolism of hormones, fatty acids and bile acids, with the focus on NASH.
NASH affects millions of Americans, a large chunk of them being obese or
those with type 2 diabetes. It
causes a build-up of fat in the liver which can eventually lead to scarring
and, in some cases, severe liver damage, liver failure and even death.
FDA suggests alternative approaches to assess nitrosamine
risk
The US Food and Drug Administration (FDA) has suggested that drugmakers
consider using certain antioxidants or excipients, such as sodium carbonate and ascorbic acid, in their drug products to inhibit the formation of nitrosamine impurities.
These approaches were outlined in a recent update on possible mitigation
strategies to reduce the risk of nitrosamine impurities in drug products.
“These nitrosamine drug substance-related impurities (NDSRIs) are a class of nitrosamines sharing structural similarity to the API. NDSRIs can be generated during manufacturing or during the shelf-life storage period of the drug product,” FDA said. The agency expects manufacturers to ascertain the presence of nitrosamines, including NDSRIs, using the three-step mitigation strategy described in the agency’s guidance.
The update is meant to complement FDA’s guidance issued
in September 2020 on controlling the risk of nitrosamine in drug products.
The first of these possible mitigation strategies is derived from
reports showing that commonly used antioxidants, such as ascorbic acid (vitamin
C) or alpha-tocopherol (vitamin E), inhibit the formation of nitrosamines based
on data from human gastric fluid in vitro studies.
Another approach proposed by the FDA calls for using excipients such as
sodium carbonate to “modify
the micro-environment to neutral or basic pH.” According to the FDA, this should inhibit the
formation of NDSRIs. The agency has said that regardless of the approach taken,
“each manufacturer
should determine the potential benefit from and demonstrate the suitability of
any reformulation approach.”
Pfizer likely to cross US$ 100 billion in 2022 revenues,
thanks to Covid drug, vaccine
Analysts have predicted that Pfizer’s
revenue could reach US$ 101.3 billion in 2022, all thanks to the Covid-19
vaccine it has developed along with BioNTech and
its antiviral drug — Paxlovid — that has shown impressive results in clinical trials.
Paxlovid could contribute US$ 24.2 billion in 2022 revenue, SVB Leerink
analyst Geoffrey Porges said in a note. The contribution of its Covid vaccine could
be around US$ 29.7 billion.
Revenues upwards of US$ 100 billion are unheard of in the pharma
industry. Johnson & Johnson, the world’s largest
biopharma company by revenue for years, recorded revenue to the tune of US$ 82.6 billion
in 2020. Pfizer’s own
revenue in 2018 was US$ 53.7 billion,
before it separated its consumer health franchise into a joint venture with
GlaxoSmithKline in 2019.
Acquires Trillium for US$ 2.2 billion: Pfizer has completed its acquisition of Trillium Therapeutics, a Canadian clinical-stage immuno-oncology company,
for an aggregate purchase price of approximately US$ 2.22 billion.
In September 2020, Pfizer had invested US$ 25 million in Trillium. Pfizer’s key interest is in Trillium’s two lead molecules — TTI-622 and TTI-621. These are novel SIRPα-Fc fusion proteins that
are currently in phase 1b/2 development across several indications, with a
focus on hematological malignancies. Both molecules are also being tested to
evaluate clinical potential in solid tumors.
Pharmacy chains in US helped fuel opioid epidemic,
says federal jury
In the first jury verdict in an opioid case, this week a federal jury in the US found that pharmacy chain operators — CVS Health Corp, Walgreens Boots Alliance Inc and Walmart Inc — had substantially contributed to the crisis of opioid overdoses and deaths in two Ohio counties.
After six days of deliberations, jurors in Cleveland federal court
concluded that the actions of pharmacy chains helped create a “public
nuisance” that resulted in an oversupply of addictive pain pills and the diversion of those opioids to the black market.
Mark Lanier, a lawyer for Ohio’s Lake and Trumbull counties, called the verdict a “landmark decision,” and said it paved the way for the counties to seek more than US$ 1 billion each from the companies in redressal.
CVS, Walgreens and Walmart said they would appeal the verdict, and said
it ran contrary to the facts. They said the verdict misapplied the public
nuisance law to hold them liable under a legal theory that courts in California
and Oklahoma have recently rejected in similar cases.
Over 3,300 opioid lawsuits have been filed in the US against drug
manufacturers, distributors, and pharmacies. According to US officials, by
2019, the crisis had led to nearly 500,000 opioid
overdose deaths over two decades.
All adults in America can take booster dose of Pfizer, Moderna’s Covid-19 vaccine
Last week, the US Food and Drug Administration (FDA)
simultaneously expanded emergency use
authorizations (EUAs) for both mRNA vaccines so that they can be used as
boosters in adults
(people aged 18 years
and above). Given
the recent rise in infections, the move allows millions of
Americans to get additional protection against the virus.
On Friday, the director of the Centers for Disease Control and
Prevention (CDC), Rochelle Walensky, signed off on the expanded eligibility
after the FDA broadened its authorization of booster doses to all adults who
had received their second shot of either the Pfizer-BioNTech or Moderna
vaccine at least six months before. Those who received the single-dose Johnson & Johnson vaccine are also eligible for a booster dose of any
of the vaccines after two months.
Meanwhile, Pfizer said this week that its Covid-19 vaccine provided strong long-term protection
against the coronavirus in a late-stage study conducted among
adolescents aged 12 to 15 year.
“The updated findings from the companies’ pivotal phase 3 trial show that a two-dose series of the Pfizer-BioNTech Covid-19 vaccine (30-µg per dose) was 100 percent effective against Covid-19, measured seven days through over four months after the second dose,” Pfizer said in a statement.
The vaccine was authorized for emergency use in people aged 12-15 years
by the FDA in May and granted full approval for use in people aged 16 and above
in August.
Merck completes acquisition of Acceleron; bags EMA’s authorization for molnupiravir
Merck completed its much talked about acquisition of Acceleron Pharma, making it the biggest biotech merger of the year.
The US$ 11.5 billion deal to acquire the biotech and its lead pulmonary arterial hypertension drug — sotatercept — had received enough pushback from Acceleron’s activist investors over the last few months.
Meanwhile, the European Medicines Agency (EMA) said last week that Merck’s antiviral molnupiravir can now be used to treat adults
with Covid-19 who do not require supplemental oxygen and who are at increased
risk of developing severe disease.
EMA’s authorization is based on data showing the drug reduced the chance that a newly diagnosed Covid-19 patient would be hospitalized or die by 50 percent.
The pill, known commercially in Europe as Lagevrio, has not yet been
authorized in the US. The drug has to be taken twice a day for five days, and
the EMA said it should be administered as soon as possible after diagnosis of
Covid, and within five days of the start of symptoms.
AstraZeneca finally unveils its US$ 1.34 billion
R&D campus in Cambridge
AstraZeneca formally unveiled its R&D
campus in Cambridge, UK, built at a cost of US$ 1.34 billion (£1 billion). This swanky new facility spanning 19,000 square meters will boast of a suite of robotics, high-throughput screening and AI-driven technology, and will house 2,200 research scientists. This week’s grand opening had Prince Charles as the guest of honor.
Pascal Soriot had
initiated the R&D centre in 2013,
when he had taken over as the CEO of the drug behemoth. When AstraZeneca first
announced its plans to build the new global R&D hub and corporate
headquarters, the budget was US$ 500 million and the target was to move-in by
2016. From precision medicines to next-gen treatments, the company has high
hopes for the site.
Reports positive results for its Covid antibody
cocktail: Last week, AstraZeneca
announced that its antibody cocktail offered 83 percent
protection over six months. The data gives hope of additional protection to
people who do not respond well to vaccines, such as cancer patients.
After six months of the treatment
being administered, no severe cases of Covid-19
or deaths from the virus had been recorded among patients who had been given
the antibody cocktail. In the placebo group, five participants contracted
severe Covid-19 within six months of the start of the trial, and there were two
Covid-related deaths.
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