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By PharmaCompass
2022-04-14
Impressions: 2053
This week in Phispers, there is news that Novartis is planning to lay off thousands of staffers as part of its major organizational shake-up.
Pfizer has appointed David Denton, who comes with a track record of M&As, as the new chief financial officer. The drugmaker is planning to utilize Denton’s dealmaking expertise for new buyouts and deals. Its Covid-19 vaccine competitor – Moderna – has also appointed a new CFO, Jorge Gomez.
In Covid news, Moderna has recalled a batch of its Covid-19 vaccine – Spikevax – after a vial was found contaminated by a foreign body. The batch containing 764,900 doses was manufactured by its Spanish contract manufacturer Rovi and was distributed for use in Europe.
In regulatory news, FDA lifted a partial clinical hold on five cancer studies evaluating Gilead’s US$ 5 billion cancer drug candidate – magrolimab – in combination with azacitidine. And FDA’s Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Bausch Health for a “misleading” video and a webpage promoting its Duobrii plaque psoriasis cream.
Despite a months-long review and a pressure campaign from various quarters, Medicare’s decision-making body – CMS – remained firm in its decision to cover Biogen’s Alzheimer’s drug Aduhelm (aducanumab) for patients enrolled in clinical trials.
In M&A news, British pharma GlaxoSmithKline is planning to boost its cancer drug pipeline by acquiring California-based biopharma Sierra Oncology for US$ 1.9 billion. And San Diego-based Halozyme Therapeutics has acquired auto-injector specialist Antares Pharma in a US$ 960 million all-cash deal.
Novartis plans thousands of layoffs as part of global restructuring
Last week, Swiss pharma giant Novartis announced a major organizational makeover, merging its pharmaceuticals and oncology units into an innovative medicines (IM) unit.
This week, Swiss newspaper Tages-Anzeiger reported that Novartis will cut thousands of jobs as part of the reorganization. Over 100 employees may be laid off at the company’s Swiss sites in Rotkreuz and Basel, the paper reported, citing unnamed company sources.
A Novartis spokesperson said efficiencies will come through leaner structures and will “inevitably lead to roles being impacted,” but did not specify how many employees will be affected.
The shake-up announced by the Swiss pharma is aimed at simplifying its organizational structure, saving at least US$ 1 billion by 2024 and ensuring a four percent sales growth in constant currency through 2026. Novartis expects the new structure to be in place and operational by the end of this year.
Pfizer signals big M&A plans by appointing dealmaker David Denton as new finance officer
Pharma giant Pfizer has signalled its intention of using its Covid-19 bounty for new buyouts and deals by appointing David Denton as the new Chief Financial Officer (CFO). He is replacing company veteran Frank D’Amelio.
Denton, who is currently the CFO at home improvement giant Lowe’s, has a track record of big M&A from his tenure at health solutions company CVS. At CVS, he had led the company’s US$ 69 billion takeover of health insurance giant Aetna in 2018. He also led the merger of pharmacy benefit manager Caremark with CVS in a deal worth US$ 26.5 billion in 2006.
The New York-based drugmaker is planning to use Denton’s dealmaking experience to achieve its goal of adding US$ 25 billion of risk-adjusted revenues to its 2030 top line that Pfizer CEO Albert Bourla announced in February. Denton will be a member of Pfizer’s Executive Leadership Team and report to Bourla. He will join Pfizer on May 2.
Moderna appoints new CFO: Just hours after Pfizer appointed Denton as the CFO, its Covid-19 vaccine competitor Moderna named Jorge Gomez as the successor of David Meline to the CFO’s post.
Gomez has been serving as the finance chief of dental products maker Dentsply Sirona since August 2019. He was also with drug distributor Cardinal Health for over a decade in several roles. Meline, who has chosen to retire, will remain with Moderna as a consultant as Gomez transitions to the role of CFO. Gomez will take charge on May 9.
Meline will receive US$ 42 million – the current value of his 270,000 stock options that were awarded to him when he joined the drugmaker in July 2020.
‘Foreign substance’ found in vial forces Moderna to recall Covid-19 vaccines in Europe
Last week, Moderna announced a recall of a batch of its massively successful Covid-19 vaccine – Spikevax – after a vial was found contaminated by a foreign body. The recalled batch contains 764,900 doses manufactured by its Spanish contract manufacturer Rovi. The vaccines were distributed in Norway, Poland, Portugal, Spain and Sweden in January.
The Cambridge, Massachusetts-based drugmaker said the contamination was found in only one vial, but it recalled the whole batch out of “caution.” The drugmaker said it did not believe the contamination posed a risk to other vials in the lot. Moderna said it is working closely with health authorities as it runs its investigation.
This is not the first time that Moderna is facing contamination issues with vaccines made by its CDMO partner Rovi. Last year, Moderna’s Japanese vaccine partner Takeda had halted the use of 1.63 million Spikevax doses after three lots manufactured by Rovi were found to be contain stainless steel particles.
Viatris’ Mylan recalls one lot of insulin glargine injection over missing labels: Mylan Pharmaceuticals, a Viatris company, has announced a voluntary recall of one lot of insulin glargine injection, an interchangeable biosimilar to Sanofi’s diabetes medicine Lantus.
Mylan said missing labels on some vials is the reason behind the recall. The missing labels could pose a risk to patients taking more than one type of insulin, the drugmaker added. The affected lot containing cartons of 10-ml Semglee vials was manufactured by India-based Biocon.
This is the second time this year that Mylan has initiated a recall over fears of missing labels. Back in January, it had recalled one lot of non-interchangeable Semglee over missing labels on certain prefilled pens. The company said the recall doesn’t extend to branded, interchangeable Semglee.
Viatris was formed in late 2020 through the merger of Mylan and Pfizer’s Upjohn.
Japan cancels 40 million Astra vaccine shots: Japan has announced plans to cancel the purchase of around 40 million AstraZeneca Covid-19 shots that it had agreed to buy last year. The contract allowed the government to cancel a portion of the supply if it was unneeded, a health ministry official said. The cancelled lot is a third of the 120 million shots that the country had originally agreed upon. About 200,000 doses of AstraZeneca’s Covid-19 vaccine have been supplied to local governments in Japan.
FDA puts on hold Covaxin clinical trials in US: Days after the World Health Organization suspended the supply of Bharat Biotech’s Covid-19 vaccine – Covaxin – through United Nations procurement agencies, the FDA followed up with a clinical hold on the vaccine’s US trials.
Bharat Biotech’s partner Ocugen said the agency has placed a hold on the shot’s phase 2/3 study. Ocugen is co-developing the vaccine in the US and Canada. The WHO had found non-compliance of good manufacturing practices (GMP) at the drugmaker’s manufacturing facility in Hyderabad, India, during an inspection between March 14 and 22.
FDA lifts partial clinical hold on Gilead’s US$ 5 billion blood cancer drug
In January, the US Food and Drug Administration (FDA) had placed a partial clinical hold on five cancer studies evaluating Gilead’s US$ 5 billion cancer drug candidate – magrolimab – in combination with azacitidine. The partial clinical hold was placed due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms (SUSARS).
This week, the FDA lifted its partial clinical hold on trials testing the blood cancer drug combination after reviewing the safety data from each trial, the drugmaker said.
Following the FDA’s decision, Gilead will resume enrollment in three phase 3 studies in certain blood cancers – myelodysplastic syndrome and acute myeloid leukemia – as well as two earlier-stage trials. Other trials in lymphoma and multiple myeloma will remain on hold.
Gilead got access to magrolimab when it acquired clinical-stage immuno-oncology company Forty Seven for US$ 4.9 billion in 2020.
GSK to buy US biopharma Sierra Oncology for US$ 1.9 billion to boost cancer drug pipeline
British pharma GlaxoSmithKline is planning to boost its cancer drug pipeline by acquiring American drug developer Sierra Oncology for US$ 1.9 billion. The deal will help GSK fend off pressure from activist shareholder Elliott, which has been asking the drugmaker to shore up its drug pipeline.
The California-based biopharma focuses on targeted therapies for the treatment of rare forms of cancer. It plans to apply for US marketing approval of its experimental drug momelotinib, which is being developed to treat anaemic patients with a type of bone marrow cancer called myelofibrosis, in this quarter.
As per the deal, Sierra’s shareholders will receive US$ 55 per share of common stock in cash – a 39 percent premium over Tuesday’s closing price. The acquisition is expected to close in the third quarter.
Jazz signs US$ 1.26 billion deal with Werewolf: Dublin-based Jazz Pharmaceuticals has signed a licensing deal with Werewolf Therapeutics to acquire the global rights of its investigational cancer therapy, WTX-613.
The Massachusetts-based pharma will receive US$ 15 million upfront from Jazz as part of the deal. It will receive up to US$ 1.26 billion in potential development and regulatory milestone fees along with royalties. WTX-613 is currently in preclinical development.
Pfizer buys ReViral for potential US$ 525 million: Pfizer has acquired London-based ReViral in a deal worth up to US$ 525 million, which includes milestone payments. The takeover will give the New York-based drugmaker access to ReViral’s experimental drugs against the respiratory syncytial virus (RSV), a common respiratory illness that can be potentially life-threatening for infants. ReViral has four RSV therapies in its pipeline, with its lead product candidate sisunatovir and another treatment currently in mid-stage studies.
Halozyme Therapeutics acquires Antares Pharma for US$ 960 million
San Diego-based Halozyme Therapeutics, best known for its under-the-skin drug delivery platform, has acquired auto-injector specialist Antares Pharma in a US$ 960 million all-cash deal. Halozyme has agreed to pay US$ 5.60 per share to Antares, which specializes in injectable medications and offers a range of testosterone replacement therapy.
Antares’ auto-injector technologies are behind several marketed products, including the Vibex device used in Teva’s generic EpiPen and generic Forteo as well as newly FDA-approved Tlando, the first oral testosterone product without titration requirement. Halozyme’s Enhanze drug delivery technology is utilized in J&J’s multiple myeloma therapy Darzalex Faspro and Roche’s Phesgo. Halozyme plans to combine the two technologies to produce a rapid subcutaneous drug delivery system that will allow for a large volume of administration up to 5mL.
Last year, Antares’ revenue increased by 23 percent to US$ 184 million.
US Medicare body sticks to narrow coverage decision for Biogen’s Alzheimer’s drug Aduhelm
In January, the US Centers for Medicare and Medicaid Services (CMS), the health agency that runs Medicare, had proposed to cover Biogen’s Aduhelm (aducanumab), along with the entire class of drugs for Alzheimer’s disease and dementia, for patients enrolled in clinical trials.
Last week, despite a months-long review and a pressure campaign from pharma, patient advocacy groups and legislators, CMS remained firm in its narrow national coverage decision for the entire class of drugs to treat amyloid plaques, if they receive approval under the FDA’s accelerated pathway.
The agency, however, broadened the list of eligible trials to cover Alzheimer’s therapies when administered in FDA drug trials conducted by the National Institutes of Health. The CMS said it will also cover any drug more broadly in approved settings if it secures a traditional FDA approval.
The decision will come into effect immediately, CMS said, adding that it can modify it in the future based on trial data.
Biogen and other drugmakers have hinted that they might take Medicare to court over the decision.
Meanwhile, Eisai and Eli Lilly – which are carrying out clinical trials of their Alzheimer’s drugs – said they still plan to seek accelerated FDA approval for their therapies. Roche is not seeking an accelerated FDA review for its late-stage plaque-targeting antibody, gantenerumab.
FDA sends letter to Bausch for ‘misleading’ video promoting Duobrii plaque psoriasis cream
The FDA’s Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Bausch Health for a “misleading” video and a webpage promoting its Duobrii plaque psoriasis cream.
The video had been aired on a talk show on Lifetime TV and is still posted on the show’s website tagged with an August 2020 date.
“Bausch appears to be promoting Duobrii without presenting the serious risks and efficacy of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP,” says the untitled letter dated March 31.
The letter also mentions that the agency had “expressed similar concerns” over the drug’s marketing in February 2020. A Bausch spokesperson claimed that it did not receive a letter from the FDA in 2020.
The company said it is working on a response to the FDA’s untitled letter.
Warns two websites for illegally selling ADHD drug Adderall: The FDA and the US Drug Enforcement Administration have jointly issued warning letters to two websites – Kubapharm.com and Premiumlightssupplier.com – for illegally selling Adderall, a treatment for attention deficit hyperactivity disorder (ADHD), without a prescription.
According to the FDA, Adderall has a high abuse potential and “should only be used under the supervision of a licensed healthcare professional.” The FDA said the websites selling Adderall without a prescription pose a risk to consumers as the products may be counterfeit, contaminated, expired or harmful.
The warning letters were issued on March 30. The websites have 15 business days to reply, informing the agencies about the steps being taken.
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