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    Home > Medical News > Latest Medical News > What is Pfizer still planning to return to the world's No. 1 mRNA vaccine?

    What is Pfizer still planning to return to the world's No. 1 mRNA vaccine?

    • Last Update: 2021-11-14
    • Source: Internet
    • Author: User
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    Pfizer is creating sales results that no pharmaceutical company can match
    .

    From the beginning of 2021, Pfizer has continuously raised its full-year revenue expectations, and the latest figures have swelled to US$81 billion to US$82 billion
    .

    On November 2, Pfizer announced its third quarter 2021 financial report
    .


    The financial report shows that Pfizer’s single-quarter sales reached 24.


    The biggest contributor deserves to be attributed to Pfizer's mRNA COVID-19 vaccine
    .


    In the third quarter, Pfizer’s vaccine segment had a total revenue of US$14.


    In contrast, Pfizer's other products in the field of vaccines are not outstanding
    .


    Sales of its best-selling Preliminary vaccine fell by 6% year-on-year to US$1.


    Excluding the revenue from the new crown vaccine, Pfizer’s sales in the third quarter were approximately US$11.
    117 billion, a year-on-year increase of 7%, and the gap with the world’s top 10 pharmaceutical companies has not widened
    .

    If nothing else, relying on the new crown vaccine, Pfizer will return Yiqi Juechen back to the world's number one throne, but aside this "dividend", what is left of Pfizer? Has the positive news of the vaccine overshadowed the unstable performance of Pfizer's other products to a certain extent? What is the layout of Pfizer, which is back to No.
    1? Perhaps it is more worthy of attention
    .

    01 New Crown "Bonus"

    01 New Crown "Bonus"

    On the same day that Pfizer announced its Q3 financial report, the vaccine consultants of the US CDC (Centers for Disease Control and Prevention) Advisory Committee voted unanimously to formally approve Pfizer's mRNA new crown vaccine Comirnaty for children 5 to 11 years old in the United States
    .

    Just a few days ago, the FDA has just granted the Comirnaty vaccine to children aged 5-11 to obtain the FDA’s Emergency Use Authorization (EUA)
    .


    This makes Pfizer the first COVID-19 vaccine available for 5-year-old children in the United States, leaving Moderna and Johnson & Johnson behind.


    Authorization brings more potential users to Pfizer
    .


    The CDC of the United States said in a statement that the move will expand the recommended range of vaccines to approximately 28 million children of this age in the United States


    Pfizer stated in the financial report that the rapid growth in sales of the new crown vaccine in the third quarter was due to the expansion of the vaccinated population
    .


    The global sales of Pfizer Comirnaty vaccine reached nearly 13 billion U.


    The ability to continuously expand the vaccinated population relies on the excellent clinical data of Comirnaty vaccine
    .


    In a phase II/III clinical trial involving about 4,500 children aged 5-11 years, the Comirnaty new crown vaccine showed good safety and a strong immune response, with an effective rate of 90.


    Based on this, the FDA has successively given the green light for its expansion of the applicable population this year: In August, the FDA fully approved the BLA of the Comirnaty vaccine; in September, the FDA approved the booster shot for specific populations; in October, the FDA granted it for 5-11 years old EUA of the crowd
    .

    In the financial report, Pfizer raised its full-year sales forecast for Comirnaty's new crown vaccine by 7% to approximately US$36 billion
    .

    In addition to vaccines, Pfizer is also developing two protease inhibitor drugs for COVID-19 treatment
    .


    According to the financial report, Phase II/III clinical trials of Pfizer's intravenous drug PF-07304814 and oral drug PF-07321332 have been launched, and relevant data are expected to be released in the fourth quarter of this year


    Although this year's new crown has brought huge "dividends" to Pfizer, Pfizer remains cautious about future expectations
    .
    In its financial report, Pfizer only predicts that in 2022, the signed contract sales will reach 29 billion U.
    S.
    dollars
    .
    Pfizer's chief financial officer stated that Frank D'Amelio said, "We will gradually update the data for 2022 based on the signed contract
    .
    " Pfizer has strengthened its revenue guidance for the new crown vaccine, and even adjusted it on a quarterly basis
    .
    He also emphasized that Pfizer has shortened the vaccine production time from 110 days to 30 days, "Productivity is not a challenge for us
    .
    "

    02 The road to a leader in gene therapy

    02 The road to a leader in gene therapy

    Pfizer's cautious attitude towards the future of the new crown vaccine has its own reasons
    .

    The results of the new crown vaccine are amazing, but how long can this income last? Apart from this drug, what Pfizer has left may be the crux of the problem
    .

    Take a look at Pfizer’s earnings report.
    The products that contributed the most to its revenue besides vaccines are apixaban (ELIQUIS) and pibacillil (IBRANCE)
    .

    Piperacillil is the world's first CDK4/6 inhibitor approved for listing.
    After its listing in 2015, its sales have increased year after year by virtue of its first-mover advantage.
    In 2019, its sales have reached 4.
    961 billion US dollars, with a growth rate of 20.
    47%
    .
    However, with the impact of latecomers such as Novartis, Eli Lilly and Absili, and generic drugs with expired patents, the growth has gradually slowed down, and the sales growth rate in 2020 is only 9%
    .
    In 2021, the sales of piperacillil in Q3 of 1.
    381 billion US dollars increased by only 1%
    .

    Pfizer’s other best-selling drug, Apixaban, has extended its patent expiration until 2026 after winning a key lawsuit and reaching a settlement agreement with its competitors in 2020
    .

    Apixaban's global sales in 2020 will reach 9.
    17 billion U.
    S.
    dollars, a year-on-year increase of 16%
    .
    As the common "star" product of Pfizer and BMS, the two companies split profits and losses equally, with Pfizer occupying the bulk of it.
    Revenue in 2020 was US$4.
    9 billion, an increase of 18% year-on-year
    .
    In Q3 of 2021, Pfizer announced that its apixaban continued to maintain rapid growth, with sales reaching 1.
    346 billion, an increase of 21% compared to the same period last year
    .

    Analysts predict that although Pfizer can withstand possible competition for the time being, the expiration of the patent in 2026 will cause Pfizer to lose $20 billion in sales
    .

    In the financial report, Pfizer also emphasized the future
    .

    Pfizer has updated the latest pipeline, including 94 projects under development, of which 27 are phase I projects, 29 are phase II projects, 29 are phase III projects, and 9 are in the registration phase
    .
    Pfizer also announced the latest developments in six key R&D pipeline products including the new crown vaccine, gene therapy pipeline, PDE4 inhibitor, TL1A inhibitor, IFN-β inhibitor and oral COVID-19 drugs
    .

    Of particular note is its layout in gene therapy
    .

    At the 2020 JP Morgan Conference, Pfizer CEO Albert Bourla stated that Pfizer is committed to becoming a leader in the field of gene therapy
    .

    Pfizer has been involved in the field of gene therapy since 2014.
    Through a series of cooperation and acquisitions, Pfizer has deployed hemophilia A, hemophilia B, Duchenne muscular dystrophy, amyotrophic lateral sclerosis, Wilson disease, and Friedrich.
    In many R&D fields such as ataxia, gene therapy has gradually become the key to Pfizer's R&D layout
    .

    In 2014, Pfizer announced that it would cooperate with Spark Therapeutics, a subsidiary of Roche, to develop the gene therapy SPK-9001 for hemophilia B;

    In 2016, it acquired the gene editing company Bamboo Therapeutics for US$600 million and became the first pharmaceutical giant to deploy new drug research and development in the DMD field;

    In 2017, it began to cooperate twice with the gene therapy company Sangamo Therapeutics for 475 million U.
    S.
    dollars and 200 million U.
    S.
    dollars for hemophilia A;

    In 2019, acquired 15% of the shares of Vivet Therapeutics, a cutting-edge gene therapy company, for US$630 million, and jointly developed VTX-801, a gene therapy for Wilson's disease;

    Just in October 2021, Pfizer has just announced that it will invest more than US$600 million in cooperation with Voyager Therapeutics to develop new AAV gene therapies to treat neurological and cardiovascular diseases
    .

    In this Q3 financial report, Pfizer announced the latest developments in the gene therapy pipeline for hemophilia and Duchenne muscular dystrophy.
    It specifically mentioned that VTX-801 was granted fast track status by the FDA
    .
    In addition, Pfizer has announced 12 preclinical gene therapy projects
    .

    However, progress has not been smooth sailing
    .
    Pfizer announced the extension of three clinical gene therapy projects in its Q3 financial report, including a clinical trial that was suspended due to safety considerations
    .

    03 Place a bet: looking for the next blockbuster

    Although the FDA will add more safety warnings to JAK inhibitors and restrict their use, Pfizer still believes in the importance of JAK inhibitors to suitable patients with inflammatory diseases
    .
    Pfizer CEO Albert Bourla said: "We are looking for multiple options to advance additional JAK inhibitor assets in our pipeline
    .
    "

    Perhaps to reverse the decline of tofacitinib, Pfizer has placed a heavy bet on JAK inhibitors-combining Xeljanz (tofacitinib citrate) and Cibinqo (abrocitinib) that has just been marketed
    .

    Tofacitib is the world's first JAK inhibitor to be marketed, with sales of US$610 million in the third quarter, a year-on-year decrease of 7%
    .
    Abrocitinib is a new generation of oral JAK1 inhibitor.
    In the head-to-head phase III JADE DARE study, every efficacy index evaluated beat Sanofi’s Dupixent
    .
    Dabituo expects full-year sales this year to reach 6 billion euros
    .

    At the same time, in order to control risks, Pfizer is getting some help to develop the next such drug candidate
    .

    In the third-quarter earnings call, Albert Bourla revealed to investors that the company has exclusively licensed its JAK1/TYK2 inhibitor brepocitinib to "a new company established in cooperation with a partner that is involved in advanced clinical trials of inflammation and immune drugs.
    There is a reliable record of development"
    .
    The names of the partners and the new company have not been disclosed yet
    .

    It is reported that the new company will also obtain Pfizer's TYK2 inhibitor PF-06826647 from the transaction and be responsible for all future development decisions
    .
    In return, Pfizer will retain 25% of these two assets and certain commercial rights outside the United States
    .

    brepocitinib is a dual JAK1/TYK2 inhibitor, currently in phase II development stage, for external and oral preparations, indications include hidradenitis suppurativa, ulcerative colitis, Crohn's disease, vitiligo, psoriatic arthritis , Alopecia areata, lupus, atopic dermatitis and psoriasis are very widespread
    .
    However, SVB Leerink analysts previously stated that Pfizer could hardly beat BMS's deucravacitinib's Phase II performance and was about two years behind BMS
    .

    Pfizer's development strategy in JAK inhibitor drugs is actually a development of the company's strategy
    .
    From Lipitor, from the joint development of the new crown vaccine in Q1 of last year, and the spin-off of upjohn in Q4, Pfizer is well aware of the importance of "transformative innovation"
    .
    As Pfizer wrote on the PPT, "New Pfizer, focusing on innovative Biopharma, is committed to finding First-in-class products
    .
    "

    And Pfizer's existing product structure and performance are also prompting him to do so
    .
    Pfizer’s financial report disclosed that more than one-third of the more than 40 kinds of commercial drugs with names showed negative growth, including the best-selling pneumococcal infection vaccine (Prevnar family(c), Prevnar family), tofacitib , And some even fell by 97% year-on-year
    .
    Secondly, these products of Pfizer lack blockbusters, except for the blockbuster prostate cancer drugs Xtandi (encortane, enzalutamide), Inlyta (Inlyta, axitinib), and Ena Xipu (Q3 sales of $283 million), and the newly launched rare disease drug Vyndaqel/Vyndamax (Q3 sales of $501 million)
    .
    There are not many new drugs in these blockbusters
    .

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