ARTICLE | Product Development

Oral drugs and treatments for life-threatening diseases stand out among new product launches

An analysis of new drug launches in the pandemic environment

By Amanda Micklus, Senior Biopharma Analyst

October 3, 2020 12:06 AM UTC

Despite the challenge of introducing a drug to the market during the COVID-19 pandemic, sales of nearly all new product launches increased in 2Q20 versus 1Q, with drugs to treat life-threatening conditions and oral products performing better than drugs for non-life-threatening conditions and infused therapies.

The pandemic is changing the rulebook for how to successfully launch a therapy, as well as the characteristics of products that might predict a stronger or weaker launch.

The need for hospitals to limit exposure of patients to the virus prompted many centers to limit care for non-life-threatening diseases, suggesting that launches of new treatments for these indications could be at risk.

Route of administration (ROA) could also influence early commercial uptake during the pandemic, as oral, topical and subQ therapies can be shipped to patients, while infused products typically require them to travel to a physician’s office or specialized treatment center.

Both of those factors were apparent in an analysis by BioCentury of quarter-to-quarter growth of new drugs approved by FDA (NDAs and BLAs) from 1Q19 to 1Q20, with ROA emerging as a dominant differentiator.

The analysis identified 36 drugs for which sales were reported in at least the first and second quarters of 2020. Ex-U.S. sales were included for drugs approved in other markets, and some quarterly figures do not represent a full quarter if the product was launched mid-way.

2Q20 growth

Of the 36 drugs, 31 saw their sales increase from 1Q to 2Q, while five experienced a loss. The median increase was 45%.

Brukinsa zanubrutinib, a BTK inhibitor from BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160), was the top gainer in 2Q, with sales that increased from $717,000 to $7.0 million, or 872%. FDA approved Brukinsa in November 2019 for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and China’s NMPA followed with an approval in June 2020 for MCL and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL).

BeiGene pointed out in its earnings report that the impact of COVID-19 in China lessened in 2Q versus 1Q. Speaking at a joint BioCentury and McKinsey & Co. webinar in July 2020, CEO John Oyler commented on the industry’s swift adoption of remote technology, and noted that the majority of Brukinsa’s launch was conducted virtually (see “Biotechs Adapting to COVID-19”).

Manufacturers of four of the five drugs that saw losses in 2Q attributed the declines to COVID-19.

The steepest loss was postpartum depression product Zulresso brexanolone. Sage Therapeutics Inc. (NASDAQ:SAGE) reported sales of $1.1 million in 2Q, a 52% decrease from the $2.3 million in 1Q. The second quarter sales were also below those reported in 3Q and 4Q of 2019, which were $1.5 million and $2.0 million, respectively. However, Zulresso performed slightly ahead of the 2Q20 consensus forecast of $0.9 million.

Sage said a reduction in sales force and pauses in treatment at certified treatment centers during the pandemic contributed to the decrease.

Beating consensus

Actual sales were greater for 15 of the 18 new products’ consensus forecasts where estimates were available.

At $7.8 million, Jeuveau prabotulinumtoxinA-xvfs, an aesthetic product from Evolvus, beat the $1.9 million forecast by 311%, but was one of the five that saw a decline from 1Q to 2Q: 26% behind 1Q’s sales of $10.5 million. Evolvus noted that product revenue was impacted by COVID-19.

Mayzent siponimod from Novartis AG (NYSE:NVS; SIX:NOVN) and Evenity romosozumab-aqqg from Amgen Inc. (NASDAQ:AMGN) were the two pharma/big biotech products that failed to live up 2Q20 expectations, although both improved upon their 1Q20 sales. In their quarterly earnings reports, Novartis and Amgen both said COVID-19 had affected new patient starts.

Similarly, 2Q sales of Caplyta lumateperone from Intra-Cellular Therapies Inc. (NASDAQ:ITCI) beat its 1Q performance, by 115% ($0.9 million in 1Q versus $2.9 million in 2Q), but 2Q was off the $2.9 million forecast by 34%.

Launches of easy-to-administer drugs were stronger

Ease of delivery and administration likely helped fuel the launches of newly approved oral, topical, and subcutaneous drugs in the early months of the pandemic, as the difference in growth rates between new products that can be taken at home rather than in an office was striking.

For the 26 at-home therapies, the median increase in 2Q versus 1Q sales was 65%, compared with 18% for the 10 in-office medicines. All but one of the five products that showed a decline in sales from 1Q to 2Q were in-office products.

After Brukinsa, the second-biggest increase was for migraine therapy Nurtec rimegepant, an oral disintegrating tablet from Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN). Sales of the drug, which was the first oral CGRP inhibitor to make it to market, jumped 708% from $1.2 million to $9.7 million. Nurtec beat competing injectable CGRP inhibitors on number of prescriptions in its first six weeks of launch, and was likely helped by the ability of patients to describe their migraine symptoms via telemedicine visits, which have increased during the pandemic (see “Sizing Up Commercial Launches During Pandemic”). In its 2Q quarterly earnings report, Biohaven said that it shifted quickly to a virtual launch and prioritized virtual channels to engage with patients, physicians and pharmacies.

Another oral CGRP inhibitor, Ubrelvy ubrogepant, was approved in December 2019 and had 2Q20 sales of $22 million; AbbVie Inc. (NYSE:ABBV) did not report 1Q sales for the product so its growth could not be calculated.

Even though launches of oral therapies clearly did better, there were some strong 2Q increases among the injectables, led by Tepezza teprotumumab-trbw, approved in January 2020 as the first-ever treatment for adults with a rare thyroid eye disease. Developed by Horizon Therapeutics plc (NASDAQ:HZNP), Tepezza achieved $165.9 million in 2Q sales, a 606% increase over 1Q sales of $23.5 million. It also beat the 2Q consensus forecast of $68.7 million by 141%.

Pandemic conditions favor drugs for severe diseases

The median growth in sales from 1Q20 to 2Q20 was 52% for therapies that treat life-threatening conditions versus 45% for therapies for less severe diseases. The 36 products in the dataset were split 16 to 20 between the two groups, respectively.

Brukinsa, which saw the biggest percent gain in sales, and Reblozyl luspatercept-aamt from Bristol Myers Squibb Co. (NYSE:BMY), which was in the top five, are both approved for severe diseases. Reblozyl is indicated for anemia in adult beta thalassemia patients who require regular red blood cell transfusions, and grew 588% from $8 million in 1Q to $55 million in 2Q. FDA approved the drug in November 2019, EMA in June 2020, and Health Canada in September 2020.

None of the five drugs whose sales declined in 2Q over 1Q are approved for life-threatening diseases.

The pandemic is changing the rulebook for how to successfully launch a therapy, as well as the characteristics of products that might predict a stronger or weaker launch. ...

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