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By PharmaCompass
2022-06-02
Impressions: 986
In Phispers this week, the world’s largest vaccine maker by sales – GSK – picked up Boston-based biopharma Affinivax for US$ 3.3 billion to challenge Pfizer in the pneumococcal vaccine segment. GSK has also confirmed that Pfizer plans to sell its 32 percent stake in Haleon, a consumer health joint venture of the two drug behemoths, after the business lists as an independent company on London Stock Exchange next month.
In approvals, Roche’s spinal muscular atrophy (SMA) drug Evrysdi has scored an expanded approval in the US to treat infants younger than two months old. The US Food and Drug Administration (FDA) has also granted an add-on approval to Novartis’ Kymriah to treat adults with relapsed or refractory follicular lymphoma. And BMS’ Opdivo has received twin FDA approvals – Opdivo plus Yervoy and Opdivo plus chemotherapy — as first-line therapies for newly diagnosed adults with advanced esophageal squamous cell carcinoma (ECSS).
The FDA granted breakthrough status to Sanofi’s hemophilia drug — efanesoctocog alfa. Sanofi and Regeneron’s blockbuster drug Dupixent has been granted a priority review for prurigo nodularis (PN), a chronic skin disorder.
The US regulator has withdrawn its approval granted to TG Therapeutics’ cancer drug Ukoniq (umbralisib) in February last year to treat two specific types of lymphoma, citing increased death risk. It has also put a break on a Sanofi trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment.
In frauds-related news, a longtime Kadmon consultant was arrested last week for allegedly using insider knowledge regarding Sanofi’s US$ 1.9 billion takeover of Kadmon to make illegal profits of over US$ 400,000. A former AstraZeneca employee has also been charged with insider trading.
And, Moderna’s CEO Stéphane Bancel said he plans to give away the bulk of his fortune to charity.
GSK snaps up Affinivax in US$ 3.3 billion deal; to challenge Pfizer's pneumococcal jabs
GSK – the world’s largest vaccine maker by sales – is planning to fight it out for a share of the pneumococcal vaccine market by acquiring Boston-based biopharma Affinivax for a potential US$ 3.3 billion. Under the deal, GSK will pay the privately-held pharma US$ 2.1 billion upfront and up to US$ 1.2 billion in potential development milestones.
With this deal, GSK will gain control of Affinivax’s 24-valent pneumococcal vaccine candidate. GSK believes that the vaccine candidate will help it challenge market leader Pfizer’s blockbuster Prevnar range of vaccines, including the latest 20-strain shot. The British pharma already has an approved pneumococcal vaccine, Synflorix, but it has failed to challenge Pfizer’s vaccines.
ViiV to make HIV shot available in low-income countries: GSK’s ViiV Healthcare said it is in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to broaden access to its latest HIV prevention med – Apretude (cabotegravir) – in low- and middle-income countries. ViiV said it hopes to finalize a licensing agreement in the coming months.
Pfizer to sell its stake in Haleon, its consumer health JV with GSK, post its LSE listing
GSK has confirmed that Pfizer plans to sell its 32 percent stake in Haleon after the business lists as an independent company in July. GSK is spinning off Haleon, its consumer health JV with Pfizer that is known for its Sensodyne toothpaste and Advil painkillers, as the British drugmaker plans to focus on vaccines and prescription drugs. GSK owns a 68 percent stake in Haleon.
GSK will complete the split from Haleon next month, with a listing for the new company on the London Stock Exchange set for July 18. A listing on the New York Stock Exchange will follow shortly. Previously, Pfizer had indicated it wants to sell its stake in Haleon but GSK had said in February that the US pharma giant would retain its stake post floatation. A Pfizer spokesperson said on Wednesday that the US company had always intended to sell its Haleon stake over time.
FDA withdraws TG Therapeutics’ cancer drug approval citing increased death risk
The FDA has withdrawn TG Therapeutics' cancer drug Ukoniq (umbralisib) to treat two specific types of lymphoma — marginal zone lymphoma and follicular lymphoma — citing safety concerns.
Approved in February 2021, Ukoniq was billed as a potentially safer treatment for lymphoma.
Updated findings from an ongoing trial of the drug show an increased risk of death in patients, and FDA said the risks of treatment with Ukoniq outweigh its benefits. “Health care professionals should stop prescribing Ukoniq and switch patients to alternative treatments,” FDA statement said.
Meanwhile, the FDA has extended the PDUFA date for TG Therapeutics’ drug candidate ublituximab, developed as a treatment for patients with relapsing forms of multiple sclerosis or RMS, by three months to December 28 of this year. The pharma said the FDA needs the time to review a submission provided by the company in response to an FDA information request.
Roche’s spinal muscular atrophy drug bags FDA nod to treat newborns
Roche’s spinal muscular atrophy drug Evrysdi has scored an expanded approval in the US to treat infants younger than two months old. The add-on approval permits doctors to use the oral drug in babies whose disorder is identified through newborn screening tests. Evrysdi has also become the first SMA drug to receive a nod for administering the med to infants at home.
The FDA’s approval is based on a phase 2 study on about 25 infants with confirmed SMA who weren’t showing any symptoms. Of the six babies evaluable for efficacy, all are now able to sit after one year of treatment. Four of them can stand and three can walk.
Evrysdi was first approved in 2020 to treat infants above two months and adults. It became the third SMA drug to gain approval in the US, after Novartis' gene therapy Zolgensma and Biogen’s drug Spinraza.
Sanofi’s Dupixent gets priority review for skin disease: Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) recently bagged an FDA approval to treat eosinophilic esophagitis (EoE) – becoming the first and only medicine to treat the condition. Now, the FDA has granted it priority review for prurigo nodularis (PN). If approved, Dupixent will become the first medicine to treat the condition in the US. PN is a chronic skin disease that causes extreme itching and inflammatory skin rashes and lesions on various parts of the body.
UK health agency confirms community spread of monkeypox
The UK Health Security Agency (UKHSA) has said that monkeypox is spreading from person to person in England. “The current outbreak is the first time that the virus has been passed from person to person in England where travel links to an endemic country have not been identified,” the agency said. Monkeypox is said to be endemic in west and central Africa.
According to the UKHSA, most cases in the UK — 132 — are in London, while 111 cases are known to be in gay, bisexual, or other men who have sex with men (GBMSM). Only two cases are in women. Monkeypox is usually a mild viral disease understood to spread through close contact.
Bavarian Nordic increases guidance yet again: With the spread of monkeypox, Bavarian Nordic — a company that manufactures a smallpox vaccine known as Jynneos — continues to receive orders from around the world. The drugmaker has increased its 2022 guidance yet again — it is now predicting US$ 200 million to US$ 229 million in revenue this year (between Danish Krone 1.4 billion and 1.6 billion). Last week, the company had pegged its 2022 revenues at US$ 186 million to US$ 215 million (Danish Krone 1.3 billion to 1.5 billion).
Novartis' Kymriah bags FDA nod in follicular lymphoma; to challenge Gilead’s Yescarta
Novartis’ Kymriah has received an add-on FDA nod as a treatment for adults with relapsed or refractory follicular lymphoma, pitching it as a rival to Gilead Sciences' Yescarta. Follicular lymphoma is the second most prevalent type of lymphoma.
This is the third FDA approval for Kymriah (tisagenlecleucel), which is also the only CAR-T cell therapy allowed for use in both pediatric and adult patients. The US nod for Kymriah comes weeks after the European Commission authorized it for the same indication in the EU.
BMS' Opdivo receives twin FDA nods: Bristol Myers Squibb’s Opdivo (nivolumab) has received twin FDA approvals. It can now be used in combination with another immuno-oncology drug Yervoy (ipilimumab) as a first-line therapy for (newly diagnosed) adults with advanced esophageal squamous cell carcinoma (ECSS). The drug has also bagged approval for use along with chemotherapy for the same condition. Both the approvals cover patients regardless of their tumors' PD-L1 expression levels.
Sanofi’s Hemlibra rival bags FDA’s breakthrough status
The FDA granted breakthrough status to Sanofi’s hemophilia drug — efanesoctocog alfa. Sanofi is pushing the therapy toward market as a potential rival to Roche’s blockbuster Hemlibra.
The regulator based the decision on data from the phase 3 XTEND-1 study, which showed the drug helped prevent bleeds in people with severe hemophilia A over a 52-week period. Sanofi is developing efanesoctocog alfa along with its partner Sobi.
OTC drug trial paused: The FDA has paused a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment. Sanofi said the hold is related to the design of the trial protocol. Cialis (tadalafil) was first approved by the European Medicines Agency in 2002 and by the FDA in 2003 as a prescription-only therapy. The treatment raked in billions for Eli Lilly before patents expired in the US and generic competition ate into the market share. In 2014, Sanofi received the license to sell Cialis as a non-prescription drug in the US, Europe, Canada and Australia.
RhoVac’s cancer vaccine fails trial: Swedish biotech RhoVac’s attempts to develop the first antigen vaccine for prostate cancer has hit a dead end in a phase 2 trial, forcing it to initiate cost cutting measures. The vaccine candidate – RV001 (onilcamotide) – failed to stop progression of prostate cancer compared to placebo in patients who showed signs of cancer recurrence. The drug had received a fast-track designation from the FDA in November 2020.
Consultant arrested for insider trading ahead of Sanofi’s acquisition of Kadmon
In September 2021, Sanofi had acquired American biopharma Kadmon Holdings for US$ 1.9 billion. And last week, a longtime Kadmon consultant was arrested for allegedly using insider knowledge of the deal to make illegal profits of over US$ 400,000.
In its complaint, the US Securities and Exchange Commission (SEC) has accused California-based executive compensation consultant Frank Glassner with insider trading, slapping him with two securities fraud charges that carry maximum prison sentences of 20 and 25 years, respectively. The US Attorney’s Office for the Southern District of New York has also filed criminal charges against Glassner.
Former Astra employee charged with insider trading: The SEC has charged a former AstraZeneca employee with involvement in insider trading while working at the pharma.
In early March 2019, the then global head of corporate affairs for Astra’s oncology division, Hugues Pierre Joublin, learnt that his company was in talks with Daiichi Sankyo for global development and commercialization rights for Enhertu. He used this knowledge to buy shares of Daiichi and sold them once the deal was announced, thereby making illicit profits.
Moderna CEO Stéphane Bancel pledges to donate bulk of his US$ 4 billion fortune
Recently, Moderna CEO Stéphane Bancel said his wife Brenda and he will donate all the after-tax proceeds from their original Moderna stock options — worth around US$ 355 million — to charity over the next one year. Bancel had received the stock option in 2013 after he became the CEO of the company.
Now, the billionaire has told Bloomberg that he plans to give away the bulk of his fortune to charity. Bancel said he is interested in charitable efforts in areas such as healthcare and global food security. The Moderna CEO holds a 5.4 percent stake in the biotech that is worth about US$ 4.1 billion, according to Bloomberg.
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