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DATA COMPILATION #PharmaFlow

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Top Pharma Companies & Drugs in 2021: Covid vaccines, pills cause churn in list
Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a year when the industry was busy developing vaccines and therapies so that the world could recover from the Covid-19 pandemic. And this resulted in many drugmakers raking in billions of dollars in sales. As a result, the top company of 2020 in terms of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after spinning off its generic business, moved up to the number one slot. The year proved to be a good one for pharmaceutical companies. Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in their revenue. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) Pfizer’s Comirnaty steals the show The company that reaped the maximum gains from its Covid vaccine was Pfizer. Comirnaty (tozinameran) was the top selling pharmaceutical product of 2021, posting global revenues of US$ 36.8 billion. This messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021.  In 2020, Pfizer was at number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has become the fastest-selling drug in the history of the pharmaceutical industry. Back in December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna. Analysts expect both Pfizer-BioNTech and Moderna to sell even more vaccines in 2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and is unlikely to be eradicated in the near future, creating a need for booster shots. Second, the younger age groups are still to get vaccinated. Along with Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion in 2022 revenues. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) AbbVie moves up, sans Covid product; Roche slips to number five With no Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi. Roche emerged as a big loser in 2021, as several copycats of its blockbuster drugs hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its immunosuppressive effects. Like Roche, Novartis also slipped last year. It fell from number two in 2020 to the number four slot in 2021. Essentially, Novartis is struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last year for US$ 20.7 billion. It plans to use that sum for acquisitions in order to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring plan that includes layoffs of thousands of employees. Before the pandemic, Merck’s Keytruda was touted as the drug that would overtake Humira at the top in 2024. The checkpoint inhibitor has continued to grow impressively, adding new indications and treatment lines. Keytruda is now used in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as the fourth largest selling drug of 2022. Overall though, Merck slipped from number six to the number eight slot. This was due to the fact that Merck had spun out its women’s health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter. View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) BMS moves up with Eliquis, Revlimid; J&J lands at number three Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in 2026. BMS posted US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5 billion reported in 2020. In immuno-oncology, Opdivo brought in US$ 7.52 billion in sales, while Yervoy drew in sales of US$ 2 billion (an increase of 20 percent). J&J’s pharma division brought in US$ 52.1 billion in revenues last year, an increase of 14 percent over its revenues of US$ 45.6 billion posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021, helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in sales.  View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) GSK bags approval for shingles vaccine; Takeda suffers setbacks GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026.  GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines. Sanofi managed to retain its ninth slot, even as its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$ 41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference. AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021.  AstraZeneca wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year. Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year, helping its revenues grow by 11 percent.  View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available) Our view If anything, the pandemic has taught us that change is the only constant. It has also taught us that products can become blockbusters in a matter of a few months. The industry landscape continues to change. On the one hand, we are seeing people scrambling to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and Regeneron’s REGEN-COV (casirivimab and imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization granted to GSK and Vir Biotechnology’s antibody therapy this month, citing data that suggested it was unlikely to be effective against the dominant Omicron sub-variant. And last week, there was news that demand for Pfizer’s antiviral pill Paxlovid has remained unexpectedly low. The supply of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by around 90 percent in a clinical trial, has far outstripped demand in many countries like the US, the UK and South Korea. Though Pfizer is hopeful of crossing US$ 100 billion in revenue this year, much depends on how the pandemic pans out and what new research has to say about the novel coronavirus. A lot will change once the pandemic becomes endemic. The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax will continue to perform well. But two years down the line, our charts could look very different.  

Impressions: 8254

https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2021-covid-vaccines-pills-cause-churn-in-list

#PharmaFlow by PHARMACOMPASS
28 Apr 2022

STOCK RECAP #PipelineProspector

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Pipeline Prospector Feb 2020: Coronavirus Developments & Deal Updates
In February, PharmaCompass and SCORR Marketing had announced the launch of the Pipeline Prospector, a free-access database of global drug development deals and updates designed for executives in the drug development industry. While our recap of January had focused on the major deals announced in the pharma and biotech world, February was dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19).  Although the industry is striving to make antiviral medicines available in months and a vaccine available by next year that can effectively target the infection caused by the novel coronavirus, since the end of January we have seen some of the biopharma industry’s biggest names as well as small startups announce steps they are undertaking to combat the disease. Access the Pipeline Prospector Dashboard for All Deals & Development Updates  Fujifilm, Zhejiang Hisun Pharmaceutical’s Favipiravir The Chinese National Medical Products Administration also approved the clinical trial to test the influenza drug Favipiravir, manufactured by Zhejiang Hisun Pharmaceutical, for pneumonia caused by the new coronavirus in an upcoming clinical trial being conducted in Shenzhen.  Favipiravir is a RdRP (RNA-dependent RNA polymerase) inhibitor which works as a broad spectrum antiviral agent that has been approved in Japan for novel or re-emergent influenza and it has also been used to treat Ebola patients in Guinea. On February 22, Japan’s Health Minister Katsunobu Kato said his ministry would recommend favipiravir (sold as Avigan in Japan), developed by Fujifilm-owned Toyama Chemical, for use as a coronavirus treatment after test dosages appeared effective in mild and asymptomatic cases in at least two medical institutions. Access the Pipeline Prospector Dashboard for All Deals & Development Updates This week, the director of China’s National Center of Biotechnology Development announced that a clinical trial completed in China has demonstrated that favipiravir has good clinical efficacy against Covid-19. However, South Korean health authorities announced they will not use the Japanese anti-influenza medication for treatment of Covid-19 due to doubts over its efficacy and potential side effects. Gilead’s remdesivir Gilead Sciences Inc announced it had started two late-stage studies with its experimental antiviral drug — remdesivir — to test it in patients with severe and moderate cases of the illness caused by the coronavirus. Remdesivir, Gilead’s experimental anti-viral treatment, had shown some positive results in a patient in the US with worsening symptoms of a confirmed Covid-19 infection. Remdesivir appeared effective as a throat swab tested negative for the virus just a few days after receiving the infusion, and no adverse events were reported. However, a paper subsequently published, without peer review, revealed that some hospitalized patients showed signs of worsening in the second week after illness onset. Wall Street analysts in a note to investors wrote that they “see a less than 50/50 possibility that the drug is ultimately proven effective”. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Remdesivir is an investigational antiviral drug that was being developed to combat the Ebola virus, and is not currently approved for any indication globally. However, some patients with Covid-19 have received intravenous remdesivir for compassionate use outside of a clinical trial setting. In China, multiple clinical trials of investigational therapeutics have been implemented, including two controlled, randomized Phase III trials which are underway at the China-Japan Friendship Hospital. Gilead said these two new studies expand the drug’s research that are under way in China’s Hubei province led by the China-Japan Friendship Hospital and in the United States led by the National Institute of Allergy and Infectious Diseases. While results from such studies are bound to take months, the virology institute in Wuhan has applied for a patent on this experimental Gilead drug.  Access the Pipeline Prospector Dashboard for All Deals & Development Updates 80-year-old malaria drug chloroquine Chinese scientists also reported that remdesivir and chloroquine, an 80-year-old malaria drug, were found to be highly effective in laboratory settings to thwart the novel coronavirus. There are several trials underway at Chinese facilities, some in combination with other agents like remdesivir. While the virology institute in Wuhan said the two drugs’ efficacies on humans required further clinical tests, no company has currently announced an active development program for this age-old treatment against Covid-19. Chloroquine, which has been taken for many decades as an antimalarial, has a number of common side effects which include muscle problems, loss of appetite and diarrhea. Some of its more serious side effects include problems with vision, muscle damage, seizures etc. Although Chloroquine features on the WHO’s List of Essential Medicines, its efficacy and safety against the novel coronavirus will need to be established as it is possible to do more harm with a rushed treatment. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Roche’s tocilizumab China approved Swiss drugmaker Roche’s Actemra (tocilizumab), a biologic drug approved in 2010 in the United States for rheumatoid arthritis (RA), for patients who develop severe complications from Covid-19. Tocilizumab suppresses overreactions of the immune system and helps inhibit a deadly medical condition called a cytokine storm — an overproduction of immune cells that damage healthy tissues -- which is also one of the main causes of death for critically ill Covid-19 patients.  Last month, the Red Cross Society of China donated more than 30,000 injection solutions to help patients in Wuhan and around 270 severely ill patients were being treated with tocilizumab. Access the Pipeline Prospector Dashboard for All Deals & Development Updates In February, Israel-based Enlivex Therapeutics Limited, a clinical-stage immunotherapy company, announced it is initiating a plan to increase its manufacturing capacity of Allocetra, an experimental therapy being investigated for treatment of patients with organ failure associated with sepsis, a syndrome whose lethal pathophysiology (cytokine storm followed by organ failure) is similar to that of the coronavirus (Covid-19). Enlivex had announced its plan to initiate two clinical studies this year: (i) a Phase II/III clinical trial for sepsis later in the year; and (ii) a Phase II/III for the prevention of GvHD (graft versus host disease) in patients who undergo bone-marrow transplantations. The manufacturing capacity of Allocetra was initially planned to match the expected recruitment rate of patients in those two clinical trials. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Vaccines February also saw companies like Sanofi and Johnson & Johnson (J&J) announce they were joining forces with a US Health and Human Services Department — BARDA (Biomedical Advanced Research and Development Authority) — to develop vaccines for Covid-19.  Sanofi will be investigating an advanced pre-clinical SARS vaccine it was working on in the early 2000s as a potential treatment for the novel coronavirus. Sanofi SA and its partner Regeneron Pharmaceuticals Inc also announced that they had started a clinical trial of their rheumatoid arthritis drug Kevzara as another potential treatment option. On February 24, Moderna, a Massachusetts-headquartered biotechnology firm, confirmed the shipment of its first batch of mRNA-1273 in a planned Phase I open-label, dose-ranging trial study, to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273, given 28 days apart, across three doses in healthy adults in the United States. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI agreed to fund the manufacturing of a 2019-nCoV vaccine that uses Moderna’s proprietary messenger RNA (mRNA) platform and this week Moderna announced that the first patient had been dosed with the vaccine. Access the Pipeline Prospector Dashboard for All Deals & Development Updates GlaxoSmithKline and CEPI also said they would work to accelerate the creation of a vaccine. The project will rely on GSK’s adjuvant system, designed to enhance the body’s immune response and create a stronger and longer lasting protection against the infection. However, developing a preventive and confirming that it is safe and useful in humans could take 12 to 18 months. US-based biotech company Inovio Pharmaceuticals and its partner Beijing Advaccine Biotechnology announced they were developing a ‘DNA vaccine’ called INO-4800. This nucleic acid-based vaccine is currently in preclinical trials and involves directly injecting genetic material into a person to trigger a strong immune response. Other companies which announced they would be working on vaccines for the novel coronavirus were Applied DNA Sciences, ImmunoPrecise Antibodies and Codagenix. Other developments There are several other known antiviral drugs under evaluation in China, such as oseltamivir (better known as Tamiflu), AbbVie Inc’s HIV combination therapy lopinavir and ritonavir (sold as brand drug Kaletra) and Johnson & Johnson’s darunavir (sold under brand name Prezista). Meanwhile, Johnson and Johnson has revealed that there is no evidence to support the use of darunavir for the treatment of COVID-19. With multiple clinical trials underway it remains to be seen if all these are desperate long shots or if they can become effective treatments against this novel coronavirus. Innovation Pharmaceuticals announced it was exploring Brilacidin as a potential treatment for Covid-19. According to the company, Brilacidin has already demonstrated widespread antibacterial, anti-inflammatory and immunomodulatory properties in multiple FDA clinical trials. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Bioxytran announced it is exploring partnering with international drug companies to develop its lead product BXT-25, originally formulated to treat hypoxia, to circulate oxygen in the bodies of patients suffering from the later stages of Covid-19. According to the company, most late-stage coronavirus patients develop acute respiratory distress syndrome (ARDS), characterized by low blood oxygen levels due to fluid build up. They also asserted that the only treatment for ARDS is oxygen therapy along with ventilator support. A drug candidate developed by APEIRON Biologics named APN01 is being tested in China in a phase one pilot trial as a treatment for Covid-19 coordinated by Angalpharma and dMed Pharmaceutical. The APN01 drug candidate, formulated to treat lung and respiratory distress syndromes, builds on a previous discovery that ACE2 protein is the key receptor for the SARS virus.  Academic institutions have also been active as Emory University’s non-profit biotechnology company, Drug Innovation Ventures at Emory (DRIVE), launched a GoFundMe campaign to raise money for testing its antiviral drug candidate – EIDD-2801 — which has shown potential therapeutic effects against Covid-19.  Our view Covid-19, which was first detected in December in Wuhan, China, has already sickened more than 200,000 people worldwide and killed over 9,000. The exponential growth rate of the infections with limited breakthrough treatments in sight indicate a long development road ahead for the industry. The novel coronavirus has a mortality rate that ranges between 1 to 4 percent, which pales in comparison to the Ebola virus that killed 50 percent of the people infected by it. In fact, 53 percent of the people who took one of the lead treatments against Covid-19 -- Gilead’s remdesivir — had died during the Ebola study. On the other hand, Merck & Co won FDA approval for its Ebola vaccine last year but the company isn’t currently working on developing a vaccine against this novel coronavirus. Merck’s reasoning is that if the virus is as bad as everyone fears it to be, then almost everyone will need to be immunized. However, as everyone does not get seriously ill, giving a vaccine to healthy people requires a comprehensive safety assessment which will be a long process. Access the Pipeline Prospector Dashboard for All Deals & Development Updates As Julie Gerberding, who was director of the Centers for Disease Control and Prevention during the SARS outbreak and is now Merck’s chief patient officer, told Bloomberg: “We have never made a vaccine for the world.” The focus on drug development is constantly evolving and the Pipeline Prospector, our free access database of global drug development deals and development updates, is designed to provide the insights necessary for professionals to drive their business forward. Email us at support@pipelineprospector.com to learn more. Access the Pipeline Prospector Dashboard for All Deals & Development Updates  

Impressions: 5566

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2020-coronavirus-developments-deal-updates

#Phispers by PHARMACOMPASS
19 Mar 2020

NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20241008521376/en

BUSINESSWIRE
09 Oct 2024

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-9-2024-25441.pdf

FDA
09 Oct 2024

https://www.fiercepharma.com/manufacturing/gilead-recalls-one-lot-its-covid-19-drug-due-presence-glass-shards

FIERCE PHARMA
26 Sep 2024

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due

FDA
23 Sep 2024

https://www.accesswire.com/viewarticle.aspx?id=883753&lang=en

ACCESSWIRE
01 Jul 2024

https://www.businesswire.com/news/home/20240304530607/en

BUSINESSWIRE
05 Mar 2024