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2024-01-15| Special

GeneOnline’s Pick – Top 10 Global Industry News Stories in 2023 (Part 2)

by Richard Chau
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Following the previous article on the top biotech industry news in 2023, GeneOnline’s editorial team will now delve deeper into another five perspectives, delivering a comprehensive review of the pivotal industry events in the global biotech industry.

Related article: GeneOnline’s Pick: Top 10 Global Industry News Stories in 2023 (Part 1) 

6. Nobel Prize Awarded to Scientists Responsible for mRNA Breakthrough

The 2023 Nobel Prize in Physiology or Medicine was shared by Hungarian-born Katalin Kariko and Drew Weissman from the United States for their “discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19”. Their groundbreaking discovery in 2005 showed that replacing uridine with pseudouridine can render mRNA non-immunogenic, avoiding strong inflammatory responses in the body, and thus enhancing protein expression. 

The duo already won the Tang Prize in Biopharmaceutical Science in 2022 for their mRNA vaccine-related research, which was further recognized by the Nobel Committee in 2023, culminating in winning the prestigious prize in medical sciences.

mRNA technology has not only led to the creation of COVID-19 vaccines that have helped the world weather the pandemic years, but its broader application in the post-COVID era is also promising. One example is vaccines that can train the immune system to fight against tumors. Innovative mRNA technologies have allowed researchers to develop cancer vaccines that target multiple antigens on tumor cells, possibly making them more vulnerable to vaccine-induced immune responses, thereby suppressing the development of cancer.

Related article: Vaccine Development Has No Limits, the Application Direction of mRNA After the Nobel Prize 

As a pioneer in mRNA technology, Moderna is also actively developing personalized cancer vaccines following its significant success in the COVID-19 vaccine market. In February 2023, the company’s therapeutic portfolio, developed in collaboration with Merck (known as MSD outside of the U.S. and Canada), was granted breakthrough therapy designation by the FDA. The combination featured Moderna’s mRNA cancer vaccine, mRNA-4157/V940, and the immune checkpoint inhibitor Keytruda, MSD’s lead product. Phase 2 clinical trials showed that combining the two significantly reduced the risk of disease recurrence or death in melanoma patients following complete surgical resection. In late July, the two companies announced the initiation of Phase 3 clinical trial, and in mid-December, they began another Phase 3 trial to test the efficacy and safety of an mRNA cancer vaccine paired with Keytruda for the treatment of non-small cell lung cancer (Stage II to IIIB).

Related article: Moderna’s Cancer Vaccine to Enter Phase 3 Trials This Year

7. Pfizer and Novavax Announce Downsizing as COVID Vaccine Revenue Slumps

As the global COVID-19 Pandemic subsides, the demand for COVID-19 Pandemic vaccines and medicines has declined significantly, dealing a significant blow to the revenues of certain biopharma companies. Owing to strategic adjustments and cost-saving considerations, pharma companies such as Novavax and Pfizer, which originally enjoyed significant profits from COVID-19 vaccines, have announced large-scale downsizing plans in 2023 to regroup after the impact. Novavax, for example, reported revenues of US$81 million in Q1 2023, down 88% from $704 million in the same period in 2022. To address this, Novavax announced in May that it plans to lay off up to 25% of its workforce (about 500 employees) to make room for future growth initiatives. In fact, Novavax saw a similar revenue drop in Q3 as well, and the company indicated in November that further downsizing may be possible, but the number of jobs and types of positions involved have yet to be announced.

Related article: Novavax, Takeda, and BMS To Cut Employees This Year

Pfizer’s overall revenue in 2023 also fell sharply due to the decline in sales of COVID-19 vaccines and medications, and its stock price declined by about 44% from the beginning of January 2023 (as of December 29, 2023). For example, in Q3, its revenue amounted to $13.23 billion, a decrease of $9.4 billion (down 42% year-over-year) from the same period in 2022, and it reported a net loss of $2.38 billion. 

In a bid to reverse the trend, Pfizer announced in mid-October that it would implement an “Enterprise-Wide Cost Realignment Program” aimed at saving $3.5 billion by the end of 2024 (with an initial $1 billion in savings in 2023). Since the program was announced, the company has made four announcements between late October and mid-November of job cuts or plant closures in the U.S., U.K. and Ireland, affecting at least 800 employees. With another $2.5 billion in savings on the horizon, Pfizer could likely launch its next round of downsizing in 2024.

8. First FDA Full Approval for Alzheimer’s Drug in 20 Years

Leqembi (lecanemab-irmb), a new Alzheimer’s disease drug jointly developed by Eisai and Biogen, received accelerated approval from the U.S. FDA in early January, and the drug was subsequently launched in the U.S. market. Six months later, the FDA further upgraded the accelerated approval to regular approval on July 6, marking the first time in 20 years that the U.S. regulatory agency has granted such status to a drug for the treatment of Alzheimer’s Disease. 

Leqembi can be administered every two weeks by intravenous injection in a clinic or doctor’s office, and it is estimated that approximately 1.5 million people in the U.S. will be eligible to use the drug. Additionally, following Leqembi’s full FDA approval, the drug is also covered by Medicare.

Nevertheless, Leqembi may still face many challenges. Firstly, patients could spend as much as $90,000 per year on the drug. Despite 80% Medicare coverage, patients will still need to pay about $18,000 out-of-pocket. Coupled with the fact that the number of Alzheimer’s patients is increasing with the aging of the population, this expense can be a significant burden on both the patients themselves and the Medicare system as a whole. In addition, the risk of serious adverse events such as brain swelling (edema) or brain hemorrhage as a result of taking Leqembi should not be overlooked.

Related article: FDA Granted Eisai and Biogen’s New Alzheimer’s Drug a Traditional Approval, Making Medicare Coverage Possible 

9. Biotech Industry Joins Forces to Combat the Global Threat of Infectious Diseases

According to the World Health Organization (WHO), tuberculosis (TB) ranked as the world’s second-deadliest infectious disease in both 2021 and 2022 (slightly behind COVID-19). However, since the only available vaccine against TB, the Bacille Calmette-Guérin (BCG) vaccine, was first introduced in 1921, the vaccine development has been stalled for more than 100 years. Besides, BCG has limited protection against TB outside of infants and young children. 

Fortunately, the world could finally see the light at the end of the tunnel in 2023, when the Wellcome Trust and the Bill & Melinda Gates Foundation announced a combined $550 million funding initiative to expedite the progress of TB vaccine candidate M72/AS01E (M72), through its Phase 3 clinical trial. If M72 is ultimately proven effective and approved, it will not only be the first new TB vaccine in more than a century, but it also holds the promise of paving the way for affordable and accessible TB vaccines for adults and adolescents.

Related article: The Gates Foundation and Wellcome Join Forces to Fund Late-Stage Tuberculosis Vaccine

Apart from tuberculosis, infections caused by antibiotic-resistant bacteria also pose a major threat to public health globally. Some experts even express concerns over the dire situation of running out of medicines for certain diseases if the prescription and use of antibiotics are not carefully controlled, or if the development of new antibiotics fails to keep pace with bacterial evolution. 

To highlight the threat of antimicrobial resistance (AMR) to global health, the AMR Action Fund, Pfizer, MSD, and Shionogi co-funded an ambitious documentary-style film, produced by the BBC Storyworks Commercial Productions, which premiered globally on YouTube on September 5 and is now available on YouTube. Featuring testimonials from survivors of serious drug-resistant bacterial infections, as well as scientists and academics dedicated to the study of bacterial resistance, the documentary tells the story of how doctors, patients, and researchers can work together to address this health crisis and aim to promote the proper use of antibiotics.

Related article: World Premiere of Documentary-style Film on the Battle Against Antibiotic Resistance 

10. Antibody-drug Conjugate (ADC) – A Pharma Breakout Star of 2023

Antibody-drug conjugates (ADCs) took center stage at two of the world’s leading oncology conferences in 2023 – the ASCO and ESMO Annual Meetings – with a host of important clinical research findings reported for a wide range of solid tumors, including breast cancer, non-small cell lung cancer, ovarian cancer, pancreatic cancer, bladder cancer, and many others. 

One notable example was ENHERTU (trastuzumab deruxtecan), jointly developed by Daiichi Sankyo and AstraZeneca (AZ). The drug is currently used to treat unresectable or metastatic HER2-positive breast cancer and non-small cell lung cancer. Interim results from a Phase 2 clinical trial, DESTINY-PanTumor-02, presented at ASCO 2023, showed that ENHERTU demonstrated clinically meaningful and durable responses in gynecologic cancers such as cervical, endometrial, and ovarian cancers. Also, data from the Phase 2 DESTINY-PanTumor01 trial presented in ESMO 2023 suggested that the drug could be effective in other HER2-positive solid tumors. These results indicate that ENHERTU may become the first FDA-approved ADC anticancer drug with a tumor-agnostic indication, and its development in the coming year is still promising.

In terms of market trends, many major pharma companies have recognized the promising prospects of ADCs, and have joined the market competition or strengthened their pipelines through large-scale acquisitions or collaborations. Take Daiichi Sankyo as an example, the Japanese drugmaker reached a partnership agreement with Merck (known as MSD outside the US and Canada) in late October to jointly promote the development and commercialization of three new ADC drugs globally (excluding Japan), with a total value of $22 billion for upfront payments ($1.5 billion for each drug), payments for sales milestones (up to $5.5 billion for each drug), and other expenses.

Related article: Merck Joins Forces with Daiichi Sankyo in $5.5 Billion Deal to Develop Cancer Drugs

Besides, AbbVie and Bristol Myers Squibb also made big moves in the ADC drug development business in the second half of the year. The former announced the acquisition of ImmunoGen on November 30 to bring its major ADC product ELAHERE under its umbrella, which involved a total equity value of approximately $10.1 billion, and was one of the four $10 billion-plus buyouts of the year. The latter announced on December 11 that it had signed an exclusive license and collaboration agreement with SystImmune for a total value of $8.4 billion, under which the two companies will co-develop a first-in-class bispecific ADC targeting both EGFR and HER3.

Related article: AbbVie Invests $10.1 Billion in ImmunoGen, Targeting the Ovarian Cancer Landscape

Concluding Remarks

Looking ahead to 2024, the impact of international politico-economic affairs (e.g. Israeli-Palestinian conflict, the Russo-Ukrainian war, U.S. drug price controversies, etc.) on the global biotech industry will undoubtedly attract much attention. Meanwhile, the development of hot trending issues like technological innovations (e.g. medical AI and ADC drugs), M&A and fundraising deals, new drug discovery, and patent cliffs will also remain in the spotlight. GeneOnline will continue to offer insightful coverage of global biotech stories in 2024, helping readers keep abreast of market trends.

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