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Oncology has long been the king of pharmaceuticals, at least in terms of R&D spending and revenue, but many other therapeutic areas are hotbeds of competition.
Immunology is a particularly attractive field, with drugs that can target multiple indications, broadening patient reach. This therapeutic area has produced a number of blockbuster products, including Humira and Stelara. One-fifth of the 50 best-selling drugs last year.
Vaccines have not always been a particularly profitable business for the pharmaceutical industry, but the huge profits generated by COVID-19 have increased their potential value in times of need. But even outside the context of a pandemic, many vaccination gaps remain. The NIH has found that RSV infection is the most common cause of death in the U.S., according to the National Institutes of Health. 14,000 deaths each year For Americans aged 65 and older, the growing competition in the RSV disease field suggests that infection prevention can still be a major win-win.
Here are three signs of increased competition among pharmaceutical companies:
Biologics compete for position in COPD treatment space
Sanofi and Regeneron’s blockbuster anti-inflammatory drug Dupixent is doing well. Sales of the drug, which was approved by the FDA last year for five indications, including atopic dermatitis and asthma, rose by 1.2%. It rose 33% last year More than $11 billion.
The companies are currently waiting to hear from the FDA regarding possible approval for the treatment of patients with type 2 COPD. With the expanded indication, Dupixent would become the first biologic to be approved for the treatment of COPD. $20 billion record That could happen in 10 years, analysts say.
But companies may not be able to dominate the market for long.
Earlier this week, AstraZeneca and Amgen released data from a Phase 2a clinical trial of an asthma treatment. TedSpir in COPDAlthough TedSpire did not meet the trial’s primary endpoint, the biologic showed potential efficacy in certain COPD patient populations, and if these results hold up in other trials, Planned Phase 3 Trials,Tezspire is, Sales: $653 million A study conducted by the two companies last year found it may be more effective than Dupixent for these patients.
The FDA was scheduled to decide the fate of Dupixent for COPD on June 27, but during the company’s first-quarter earnings call, Regeneron CEO Len Schleifer said the FDA was requesting additional information on patient subgroups, which could delay the decision by up to three months.
Three-way RSV showdown
GSK and Pfizer have been competing against each other in the RSV vaccine arena since both companies won landmark approvals for their vaccines last year. The FDA gave first-ever approval to GSK’s RSV vaccine, Alexi, in early May. A few weeks later, Pfizer’s Avrisvo also received regulatory approval.
So far, GSK’s vaccine has performed well in the market, exceeding the blockbuster threshold in its first year. Sales: $1.5 billionPfizer’s vaccine could generate $890 million in revenue in 2023. GSK has a slight edge this year: the company reported revenue of about $227 million in 2023. Arexvy’s first quarter salesMeanwhile, Pfizer Abrisvo made $145 million. In terms of worldwide revenue.
To keep up the momentum, the companies are studying their RSV vaccines in younger populations (both vaccines are approved for adults over 60) and seeking to broaden their market reach, but even if they do, increased competition from Moderna could make the fight against RSV more complicated.
The FDA was scheduled to make a decision on Moderna’s RSV vaccine, mRNA-1345, on May 12. However, just days before the scheduled decision, the company filed a lawsuit against the FDA. The judgement was postponed It has been postponed until late May due to “administrative constraints.”
Moderna hopes that if its vaccine is approved, its prefilled syringes, which make it easier to administer, will give it an advantage over Pfizer Inc. and GlaxoSmithKline Plc. The company also expects the CDC to find its vaccine comparable to rivals, which could help spur interest in the new mRNA vaccines.
Once released, analysts estimate that the Moderna vaccine will be around $166.7 million This year, according to Reuters.
Big Pharma Competition in Ulcerative Colitis
Eli Lilly’s Omvo became the first IL-23 inhibitor to hit the ulcerative colitis market last October, and big pharma rivals are already eager to follow suit.
Earlier this week, Johnson & Johnson announced positive results from a Phase 3 UC trial of its IL-23 drug Tremfya, which is indicated for plaque psoriasis and active psoriatic arthritis.
J&J filed for BLAs for UC and Crohn’s disease in March. The latest study results show that the drug It was effective As maintenance therapy.
The study also suggested Tremfya may be slightly more effective than Skyrizi, a drug AbbVie hopes to develop for UC. Published test results The company approved the blockbuster drug as a maintenance treatment for UC last year and has applied for an expanded indication.
