COVID-19 Challenges for Product Launch Timelines and Activities

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Diagnostic; Health Care; Consulting; Medical Device; Clinical Research; Laboratories


Companies Profiled:
AMAG Pharmaceuticals; Almirall; Alkermes; Amicus Therapeutics; Ascend Therapeutics; Asklepion Pharmaceuticals; LLC; Aspen Pharmacare; Astellas; Avadel Pharmaceuticals; Biofrontera; Bracco Diagnostics Inc.; Catalyst Pharmaceuticals; Celyad; Deciphera Pharmaceuticals; Eisai; FerGene; Ferring Pharmaceuticals; Kyowa Kirin; Merck; Milestone Pharmaceuticals; Mirador Global LP; Mission Bio; Nobio; Novartis; Novo Nordisk; Osmotica Pharmaceuticals; QED Therapeutics; Roche; Sanofi; Santhera Pharmaceuticals; Scilex Pharmaceuticals; Inc.; Servier; Shionogi Inc.; Sunovion; Supernus; Takeda Pharmaceuticals; TerSera Therapeutics; TG Therapeutics; Vifor Pharma; Visioneering Technologies Inc.; Zosano Pharma

Study Snapshot

Best Practices, LLC engaged 56 leaders at 41 life sciences companies in this research. Half of the research participants serve at the director/ head level.

Key topics covered in this report include:

• Product Launch Timelines, Delays, & Decision Making
• Product Launch Activities Affected by COVID-19
• Approaches to Overcome COVID-19 Impact on Launch Activities

• Launch Timelines and Scale have changed in the face of COVID-19:

• 1/3 of launches originally set for Q2, 2020 are now delayed, 1/3 of companies are proceeding with a soft launch in the quarter.


• Q3, 2020 launches: 50% are maintaining same timeline at full scale, 50% are proceeding with a soft launch.


• Biopharma leaders anticipate launches to be affected by COVID-19 for 6-7 more months, with some changes permanent.

Sr. No.	Topic	Slide No.
I.	Overview & Key Actions	pgs. 3-7
	Universe of Learning	pg. 4
	Key Actions	pg. 5
	Key Perspectives in Launch Reality of 2020	pg. 6
	Key Data Insights From Launch Leaders	pg. 7
II.	Product Launch Timelines, Delays, & Decision Making	pg. 8
III.	Bristol-Myers Squibb’s ZEPOSIA: A Well-Differentiated Product Overcame Delays	pg.16
IV.	Immunomedics’s TRODELVY: Shifting Resources to Capitalize On Opportunity	pg. 23
V.	Product Launch Activities Affected by COVID-19, Approaches to Overcome Impact	pg. 33
VI.	Biogen’s VUMERITY: Supporting Robust Access and Engagement Activities	pg. 45
VII.	Esperion’s NEXLETOL and NEXLIZET: Shifting Launch Activities to Digital Outreach	pg. 52
VIII.	Participant Demographics	pg. 59
IX.	About Best Practices, LLC	pg. 62

• Biopharma product launch timelines and decisions in 2020
• Q2, 2020 product launch timelines and decisions in detail
• Q3, 2020 product launch timelines and decisions in detail
• Q4, 2020 product launch timelines and decisions in detail
• Biopharma product launch timelines and decisions for 2021
• Q1, 2021 product launch timelines and decisions in detail
• Types of information prioritized by benchmark organizations to make timeline decisions for their Q4, 2020 and Q1, 2021 product launches

• Zeposia launch timeline
• Approval rejection of Celgene’s ozanimod by FDA
• Bristol-Myers Squibb’s acquisition of Celgene
• Zeposia’s delayed launch and continued engagement with the neurology community during COVID-19
• Ozanimod’s FDA approval under the brand name ‘Zeposia’ for the treatment of relapsing forms of multiple sclerosis (RMS)
• Zeposia’s commercial launch

• Trodelvy launch timeline
• Initial rejection from the FDA
• Change in launch plans due to COVID-19
• Advance FDA drug approval for Trodelvy as a third-line treatment for metastatic triple-negative breast cancer
• First treatment and drug supply post approval
• Manufacturing and commercialization support
• Driving brand awareness and engagement during the pandemic
• COVID-19 challenges
• Changes in sales teams

• Anticipated duration of COVID-19 impact on product launches
• COVID-19 impact on HCP and thought leader focused launch activities
• Percentage of previously expected face-to-face engagements related to the new product converted to digital ones by benchmark organizations
• Interview narratives on overcoming limitations
• COVID-19 impact on payer and patient focused launch activities
• Interview narratives around payer and patient focused launch activities
• Impact on internal drivers of launch activities
• Interview narratives on the investment approaches to be taken across the launch timeline
• Launch staffing adjustments in response to COVID-19
• Most highly impacted forms of launch activities
• Relative impact of COVID-19 situation across core commercial and medical pre-launch and launch areas

• Vumerity’s timeline from drug approval to performance during the early COVID months
• Vumerity’s FDA approval for the treatment of relapsing forms of multiple sclerosis (MS)
• Drug backlash due to high price
• Q1 sales result
• Impact of COVID-19 on Vumerity sales
• Vumerity’s market recovery

• Esperion’s launch of two new products during the pandemic – A brief timeline
• FDA approval of Esperion’s NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe)
• Launch strategy during the pandemic
• NEXLIZET’s preponed launch at the peak of pandemic due to doctors’ overwhelming response and capable supply chain
• NEXLIZET availability and field team training
• Activities leading to Esperion achieving the highest revenues of all time