COVID-19 Impact on Pemigatinib in the Healthcare Industry

The COVID-19 pandemic has influenced the whole planet with its major impacts on the economy and businesses across the globe. The COVID-19 spread worldwide in unprecedented ways due to its high infectious and contagious nature and lack of availability of its vaccine. As a result, the greatest medical challenge in the 21st century is yet to be faced by physicians worldwide. Though the emergence of the virus can be traced back to Asia, many European countries along with the U.S. have been struck massively by the pandemic. The virus has spread across all regions ranging from North America, Europe, Asia-Pacific, Middle East, and Africa up to South America. The COVID-19 has been declared as a pandemic by World Health Organization (WHO) due to its increased spread across the globe. After the declaration of the pandemic, various countries announced the complete lockdown such as India, China, and other Asian countries to decrease its spread. According to the latest situation report by World Health Organization (WHO) stated 175 million cases of Corona have been reported globally and 4 million patients are dead due to the coronavirus. On a slightly positive note, a total of 158 million people have recovered and a total of 2 million vaccine doses have been administered as well.
Pemigatinib is the first and only U.S. Food and Drug Administration (FDA) approved kinase inhibitor sold under the brand name ‘Pemazyre’. It is used for the treatment of adults with previously treated or unresectable locally advanced or metastatic bile duct cancer with fibroblast growth factor receptor 2 fusions or other rearrangements as detected by an FDA-approved test. Pemazyre was developed by Incyte and holds all the other rights for the development and commercialization of ‘Pemigatinib’ outside of the U.S.
Owing to the current COVID-19 pandemic, delays in data collection and validation caused related disruptions; mean that data from FIGHT-201, a clinical trial of Pemigatinib in patients with bladder cancer was not presented by the company due to the pandemic which was supposed to be presented at a medical conference in early 2021; however other clinical trials for Pemigatinib progressed as expected.
The FDA based its approval on an open-label study, which enrolled 107 patients. The drug went through various phases of clinical trials and showed a significant result in each phase.
The drug is made available as oral tablets with a recommended dosage of 13.5 mg once a day for 14 consecutive days.

IMPACT ON DEMAND
Since the pandemic, due to the lockdown imposed, the economic growth of the country is declining, and the manufacturing units for various items that are considered non-essential are shut down due to the non-availability of manpower. However, Pemigatinib faced no major impact on the commercial side of the business, and the manufacturer maintained a high level of engagement with healthcare providers and patients. All clinical trial programs were kept open, leaving enrollment decisions to patients and their caregivers.
FOR INSTANCE-
• Incyte in their financial report of performance from 2019-2020 stated that it is currently not possible to predict the long-term impact of COVID-19, but there has been no impact on the commercial side of the business, and Incyte currently has ample commercial and clinical supply of medicines to meet the demand of patients receiving Incyte’s approved medicines and those participating in clinical trials
• The company also stated that on the regulatory front, there was no impact on key timelines—as evidenced by the early FDA approvals announced for Pemazyre (Pemigatinib)
• The company is continuing to execute goals and is pleased to announce the FDA approval of Pemazyre (Pemigatinib)
However, the impact of the pandemic on the Pemigatinib market will be soon mitigated as different states/ countries allow medical clinics to reopen, services and once again being offered.

IMPACT ON PRICE
Due to the pandemic, the market is disturbed to a greater extent. The several establishments have to remain shut while others scale down or put on hold expansion plans as they tried to survive the unprecedented crisis.
Due to the impact of the Coronavirus, many large pharmaceutical companies have placed new trials on hold and numerous small, mid-size, and large enterprises have suspended ongoing ones, thereby demonstrating the magnitude of the disruption
There have been uncertainties in the past months due to the emergence of COVID-19. The sale of some companies experienced a downfall while others managed to stay afloat.
FOR INSTANCE-
• Incyte in its financial report 2020 published that there have been no major financial impacts in its performance for the twelve months ended 31 December 2020. The company experienced both positive and negative impacts of the pandemic, but overall operations and product demand remained very stable and strong
• Pemigatinib was launched first time in the market after its approval by FDA and performed very well. The sale of Pemigatinib was USD 26 million published in the annual report 2020.
However, the lockdown has put manufacturers and distributors in worry as the key materials for the product, especially raw material supply is hindered, and it will surely lead to change in price in nearby future.

IMPACT ON SUPPLY CHAIN
As the world came to a halt months due to the emergence of the pandemic, the supply chain couldn’t escape the impact. The government throughout the globe imposed total lockdown which led to supply chain disruptions. Consequently, the supply chain came to standstill due to the closure of borders. Supply of raw material was also affected, due to which the product was affected. Still, the companies managed to overcome the challenges and saw high growth.
The outsourcing services which are providing warehousing, storage, and other services face challenges too. They are dependent on the logistic and transportation of chemical compound raw material from the outsourced service to the researcher's desk. However, with the sudden shut down globally with the ban on travel this process gets disrupted. Still, the companies managed to overcome the challenges and saw high growth.
FOR INSTANCE-
• Incyte stated that the COVID-19 outbreak has not had any impact on the supply chain to date, and the company is working diligently to increase manufacturing efforts in response to the pandemic
• The company worked closely with distribution partners to monitor supply and ensure safeguards is in place and will work rapidly to make sure the patients continue to have access to medicines that have been prescribed
Hence, the supply chain of Pemigatinib didn’t face any impact due to the outbreak of COVID-19 as stated by the company. The companies have been faced with substantial business and operational disruptions, which have included everything from mitigating the effects of reduced supply to managing disruptions to logistics suppliers, and indeed hurdles in meeting their contractual obligations to customers.
The pandemic has forced the companies to rethink their supply chains and their stability and reliability for an uncertain future, including other externalities and government actions throughout the world, which have begun impacting supply chains, such as issues of sustainability

STRATEGIC INITIATIVES BY KEY PLAYERS
The careful management for bile duct cancer patients requires a priority, tailored approach during the pandemic. A crucial aspect of the strategic approach is the judicious consumption of fewer healthcare resources. Also, serious measures and rules should be followed to mitigate the pandemic.
At the individual company level, companies are now more focused on operational resilience and accelerating initiatives that enable more agility, and transparency through the greater deployment of analytical tools and automation. Companies are considering re-evaluating their strategies, risk tolerance, and overall footprint.
FOR INSTANCE-
• In April 2020, FDA approved Pemazyre, for the treatment of adults with previously treated, unresectable locally advanced or metastatic bile duct cancer
• In April 2020, Pemazyre (Pemigatinib), a fibroblast growth factor receptor (FGFR) inhibitor, also received orphan drug designation and breakthrough therapy designation
• Marketing authorization application (MAA) to launch Pemazyre in the European Union (EU) has been validated by the European Medicines Agency (EMA) and is currently under review
• In December 2018, Incyte entered into a research collaboration and licensing agreement with Innovent Biologics, Inc. Under the agreement, Innovent received the exclusive rights to Pemigatinib and clinical stage products in hematology and oncology indications in the mainland of China, Hong Kong, Macau, and Taiwan
However, to address the crisis all companies in this market are revisiting their financial trajectories and framing new strategies that will lead to bringing out solutions in the market resulting in increased business efficiency.

CONCLUSION
Like any other market and the financial system globally, COVID-19 has significantly impacted the global Pemigatinib market in various ways. However, not all aspects of the global Pemigatinib market have been impacted negatively.
To summarize, the price for Pemigatinib has not been affected. Pemigatinib costs USD 17,000 for each 21-day cycle of treatment of Pemigatinib. The supply chain of the market player has not been impacted negatively, and the manufacturers are taking the required measures to respond to the situation in effective ways. Moreover, key players have been taking significant strategic initiatives to improve their services during the pandemic.
However, healthcare industries and government bodies are exclusively concentrating on how they can make the effective and best contribution to control the spread of the virus and save lives. They are also ramping up the production of essential medicines to new levels and ensure that the speed doesn’t affect or destroy the quality of products.