U.S. Becomes Country with Highest COVID-19 Cases; Pfizer, Eli Lilly, and Other Pharma Companies Significantly Impacted

According to data released by Johns Hopkins University in the United States on the 26th, as of 18:00 Eastern Time on the 26th (06:00 Beijing Time on the 27th), the number of confirmed COVID-19 cases in the United States reached 82,404, making it the country with the highest number of confirmed cases globally. According to the World Health Organization’s daily epidemiological report, as of 10:00 Central European Time on the 26th (17:00 Beijing Time on the 26th), the number of confirmed COVID-19 cases outside China increased by 49,106 from the previous day, reaching 380,723. Affected by the COVID-19 pandemic, global pharmaceutical companies have also suffered significant impacts.

The COVID-19 Pandemic and Delays in Clinical Trials

It has been reported that, due to the impact of COVID-19, Pfizer has suspended many new and ongoing clinical trials. Pfizer’s current plan is to postpone patient enrollment in trials by three weeks. Pfizer also stated that COVID-19 would have a significant impact on the company’s operations.

Eli Lilly’s clinical trials have also been affected. Tim Garnett, Chief Medical Officer at Eli Lilly, stated that the company has repurposed its laboratories to conduct diagnostic testing for patients and is investigating potential treatments. To alleviate the burden on healthcare institutions and enable physicians to focus more efforts on combating COVID-19, Eli Lilly has postponed most new studies and suspended the enrollment of new patients or volunteers in most ongoing trials.

Compared with Pfizer and Eli Lilly, Bristol-Myers Squibb has adopted relatively moderate measures, stating that its existing websites will continue to recruit new subjects at the appropriate time.

It is reported that, due to the impact of COVID-19, an estimated 315 studies are expected to be delayed. These studies, originally scheduled to expire by the end of this year, involve 172,104 participants and represent a potential financial impact of up to $20 billion.

COVID-19 Patients Prioritized? SMA Patients Face Delayed Treatment

Biogen’s nusinersen sodium injection (Spinraza), used to treat spinal muscular atrophy (SMA), has seen treatment plans for some SMA patients delayed due to hospitals prioritizing the care of COVID-19 patients, raising concerns among SMA patients that they may not receive effective treatment.

Image source: Biogen official website

Spinraza is the first drug approved globally for the treatment of spinal muscular atrophy (SMA), with an annual treatment cost of $750,000. In 2019, Spinraza generated $2.097 billion in sales revenue, representing a 22% year-over-year increase. However, Spinraza faced competition from Novartis’s Zolgensma, the world’s first gene therapy for SMA, which was launched in May 2019 and brought in $361 million for Novartis within just six months. Furthermore, the COVID-19 pandemic has prevented SMA patients from receiving Spinraza treatment, significantly impacting Biogen.

# COVID-19 Impact Delays Multiple Corporate Mergers

On the morning of March 26 local time, Pfizer and Mylan announced that, due to the impact of the COVID-19 public health emergency and delays in relevant regulatory review processes, the transaction between Mylan and Upjohn, a subsidiary of Pfizer, is expected to be completed in the second half of 2020. Mylan’s shareholders’ meeting has also been rescheduled from April 27 to June 30.

On July 29 last year, Pfizer announced the complete spin-off of its off-patent drug business, Upjohn, to merge with generic drug giant Mylan. Industry experts believe that the combined entity is expected to generate annual sales exceeding $20 billion, and this transaction could reshape the competitive landscape of the global off-patent and generic drug markets.

Mylan stated that although the merger plan has been delayed, the terms of the transaction are not expected to change, and Mylan, Pfizer, and Upjohn have made significant progress in their preparatory work.

Image source: Pfizer official website

Pfizer and Mylan were not the only companies to postpone their merger plans due to the COVID-19 public health emergency; AbbVie, which recently gained widespread attention for waiving the patent rights to its HIV combination drug Kaletra, also saw its planned acquisition of Allergan delayed.

Last June, AbbVie announced that it would acquire Allergan for approximately $63 billion. Earlier this month, the deal received approval from the European Union, but regulators required the divestiture of brazikumab prior to the merger. AbbVie stated that the merger was expected to close in May, following the final review of drug sales by the U.S. Federal Trade Commission (FTC); however, the merger timeline may be delayed due to the impact of COVID-19.

FDA Emergency Authorization

Due to the COVID-19 pandemic, hospitals in many parts of the United States experienced shortages of medical equipment. In response, the FDA issued an Emergency Use Authorization for ventilators.

To date, the FDA has issued 16 emergency authorizations to alleviate shortages of inspection equipment and medical devices caused by COVID-19, and has collaborated with more than 190 test developers to develop procedures and products for testing the virus.

References:

1、Should Biogen's Spinraza for SMA be delayed amid COVID-19? No, say these parents

2、MYLAN AND PFIZER PROVIDE UPDATE REGARDING PROPOSED COMBINATION OF MYLAN AND UPJOHN

3、COVID-19 prompts Pfizer to stop enrollment in most studies

4. Clinical Trials and the CDMO Industry Hit the Pause Button

5、FDA authorizes CPAP machines and more as emergency ventilator alternatives

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