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2022-12-26| Special

GeneOnline’s Pick: Top 10 Industry News Stories in 2022

by Richard Chau
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2022 is a year full of changes and uncertainties in the international arena. In February, Russia launched an invasion of Ukraine, and the war has been raging on since then. Besides, as the global pandemic is gradually easing, countries are gradually progressing towards a return to normal. Apart from the Russo-Ukrainian war and the COVID-19 pandemic, there are a number of significant events that have shaken the global biotech and pharmaceutical industry throughout this year. As 2022 draws to a close, explore GeneOnline’s round-up of industry news stories that dominated the year.

1. How Did the Russian Invasion of Ukraine Affect Global Biopharma?

The war between Russia and Ukraine has lasted for more than 10 months since Russia invaded Ukraine on February 24, threatening international order and peace and triggering a wave of panic in the global biopharma industry. 

Several major pharmaceutical companies have taken action against Russian aggression following unprecedented sanctions on Russia. Pfizer ceased all planned investments and all future clinical trials in Russia, though it will keep providing needed medicines to the patients already enrolled. Other drugmakers declaring suspension or reduction of business activities in Russia include Abbott Laboratories, AbbVie, Bayer, Eli Lilly, Johnson & Johnson, and Novartis. Punitive actions range from pulling back from non-essential spending to suspending advertising and promotions to ceasing capital investment projects in the country. Many of these will also donate their profits from remaining businesses in Russia to support humanitarian relief in Ukraine.

Continue reading here.

 

2. President Biden’s Announced Effort to Renew Cancer Moonshot Initiative

On March 1, the US Food and Drug Administration (FDA) issued three guidelines to the industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced reignition of the Cancer Moonshot, highlighting new goals: to reduce the cancer death rate by half within 25 years and improve the lives of people with cancer and cancer survivors.

Firstly, the “Inclusion of Older Adults in Cancer Clinical Trials” recommends enrolling adults aged 65 years and older in early phase studies of cancer clinical trials to obtain information that better informs later phase studies. Secondly, the “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics” provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in-human cancer drugs. Thirdly, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients. 

Click here for more about the Cancer Moonshot.

 

3. Illumina to Pay BGI $333M Following Infringement Case

On May 6, a federal jury in Delaware, US found several Illumina DNA sequencing platforms violated two of the Chinese BGI Group Complete Genomics Inc’s patents. The jury also established that three of the Illumina rights Complete Genomics was accused of the breach were invalid, and should not have been issued in the first place. 

Complete Genomics, a BGI subsidiary, filed the suit in mid-2019, claiming that Illumina’s 2-channel sequencing system infringed patents for the technology which determines each DNA nucleotide from two signals. Both companies argue their exclusivity above technology, with Illumina claiming that it invented its 2-channel technology before the BGI patents and that BGI was unable to make 2-channel chemistry work until it copied Illumina’s technology.

BGI accused Illumina of infringing on several of its DNA sequencing platforms, including NovaSeq 6000, NextSeq 500/550/550x, 1000/2000 series, and MiniSeq. It also targeted Illumina’s library preparation kits and sequencing kits compatible with multiple platforms, saying that when used in combination with some systems, it will violate BGI’s rights.

Continue reading here.

 

4. Ultima Genomics Promises $100 Genome After Raising $600 Million

Ultima Genomics, a California-based startup, announced on May 31 that it is closer than ever to providing a low-cost, $100 genome after it came out of stealth funding with $600 million. Ultima is partnering with Sentieon, a bioinformatics developer, and Google DeepVariant, which uses deep learning to identify genetic variants in sequencing data to accelerate variant calling at larger scales. Ultima’s goal is to provide more cost-effective ways to aid in individualized diagnostics and disease risk predictions with its UG 100.

Ultima Genetics’ UG 100 project aims to solve this predicament and open up the world to large-scale, low-cost genetic sequencing to aid in drug discovery, disease risk prediction, and any number of other assets that are rapidly being developed throughout the industry. Ultima says its new genetic sequencing architecture will be available for $1/Gb. Ultima CEO Gilad Almogy says that $100 is only the starting point and that the company hopes to develop even cheaper versions in the future.

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5. Proposed demerger of the Consumer Healthcare business from GSK to form Haleon

Haleon, a joint venture between GlaxoSmithKline (GSK) and Pfizer established in July 2019, officially separated from GSK to form an independent company in July. Pfizer indicated that it would exit its 32% ownership interest in Haleon in a disciplined manner to focus on drug and vaccine development. 

Through the demerger, GSK also received approximately £7 billion in cash dividend income available for investment, and acquisition of future drugs to expand its own product portfolio. This also responded to the recent wave of investor calls to add more drug pipelines and would be able to increase the company’s annual sales by 5% and operating profit by 10% over the next five years.

Click here for more about the proposed demerger.

 

6. As Private Equity Sale Becomes Less Likely, Novartis May Gravitate Towards Sandoz Spinoff

Novartis’ desire to deal with Sandoz started in an October 2021 press release stating its intent to review the Sandoz division strategically. The Swiss pharmaceutical giant said it would consider all options, from retaining the business to separation and everything in between. Since then, Novartis has not formally indicated which direction it will go but says it will provide an update by the end of 2022.

Sandoz maintains that it continues to grow internationally, but its performance in the US has been in constant decline since the onset of the COVID-19 pandemic. The decline in US sales is the driving factor in Novartis’ potential to restructure or sell Sandoz. 

In addition to the Sandoz issue, Novartis reportedly intends to lay off 8,000 employees as part of a cost-saving restructuring of the company. A layoff that large accounts for 7.4% of Novartis’ workforce but could save the company up to $1 billion.

Continue reading here

 

7. CureVac Files mRNA Patent Lawsuit Against BioNTech in Germany + Moderna’s Lawsuit Against Pfizer/BioNTech

The research and development of vaccines for COVID-19 remain in the spotlight of the biotech industry in 2022, with exciting progress being made by pharmaceutical companies on their new vaccines. Meanwhile, however, two major lawsuits involving vaccine technology surfaced earlier this year. 

In July, CureVac sued BioNTech for alleged infringement of its mRNA technology rights. The Germany-based biotech company deemed its patents cover the engineering of mRNA molecules, including sequence modifications for increasing stability and enhancing protein expression, as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines. In response to CureVac’s action, BioNTech stressed that its work is original, and will vigorously defend it against all allegations of patent infringement. 

Besides, on August 26, Moderna filed a lawsuit against Pfizer and BioNTech in the United States and Germany. The foundation of Moderna’s lawsuit against Pfizer/BioNTech is the assertion that their COVID-19 vaccine, Comirnaty, infringes on Moderna’s patents for foundational mRNA technology. Although Pfizer did not release a public statement, BioNTech responded in a press release to Moderna’s lawsuit. The company adamantly rebuked Moderna’s claims, asserting that their work was original.

Click here for more about CureVac’s COVID vaccine lawsuit and here for Moderna’s lawsuit against Pfizer/BioNTech.

 

8. Amazon Care Scrapped, Making Room for New Telehealth Endeavors 

After three years of toying with its telehealth service, Amazon Care, the retail giant announced in late August through an email that it is closing the operation by December 31 this year. The announcement came just a month after Amazon announced its plans to acquire One Medical, a growing telehealth service, for $3.9 billion. The moves are another step in Amazon’s quest to reshape American healthcare.

In the email sent to Amazon Health Services, Neil Lindsay, the vice president of the operation, said the decision to close Amazon Care took months of consideration and thought about the company’s future healthcare plans. Lindsay said Amazon Care was not a long-term solution for enterprise customers.

Though Amazon dabbles in various healthcare areas, telehealth and hybrid care seem to be a primary focus for the company to bring in a new era of healthcare delivery. The acquisition of One Medical, a hybrid telehealth brand, in July might probably serve as the replacement for Amazon Care.

Continue reading here

 

9. The First Approved RSV Vaccine Worldwide Belongs to AstraZeneca and Sanofi 

On November 4, the European Commission (EC) became the first regulatory agency worldwide to approve a respiratory syncytial virus (RSV) vaccine. AstraZeneca and Sanofi’s Beyfortus (nirsevimab) won the honor of this historic approval, built on the basis of the pivotal MELODY efficacy trial. The trial demonstrated the vaccine’s efficacy and safety. 

RSV is a common virus that leads to infections of the lungs and respiratory tract which are typically mild. The virus is particularly risky for immunocompromised individuals in which infections might lead to pneumonia, hospitalization, or even death. 

Currently, several companies are working on RSV vaccine candidates, including GSK and Pfizer. Nevertheless, AstraZeneca and Sanofi managed to beat out the competition and their Beyfortus became the first RSV vaccine approved worldwide by any regulatory body.

Continue reading here

 

10. Rebyota Passes Through FDA To Become First Approved Fecal Microbiota Product 

On November 30, the US FDA approved Ferring Pharmaceuticals’ Rebyota (previously RBX2660), making it the first fecal microbiota product approved by the drug regulator. It is indicated for the prevention of the recurrence of Clostridiodes difficile infection (CDI) in patients aged 18 and older who have completed antibiotic treatment for recurrent CDI. Its application has been granted Fast Track, Breakthrough Therapy, and Orphan designations by the FDA. 

“As the first FDA-approved fecal microbiota product, the action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Continue reading here

 

Even though 2022 will soon come to an end, the global biotech industry never ceases to evolve. Looking ahead to 2023, the subsequent development of the Russo-Ukrainian war and the COVID-19 pandemic will continue to dominate global attention, while exciting or shocking news will continue to emerge in various areas such as M&A deals, clinical trials, approval of new drugs and therapies, as well as technological innovations. GeneOnline’s team will continue to provide in-depth coverage of global biotech events in the coming year to enable readers around the world to stay abreast of industry trends. Stay tuned for GeneOnline’s pick on Top 10 biotech M&A deals and Top 10 FDA-approved drugs. 

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