Urogen won its first US approval this week, for a treatment for a rare form of urothelial cancer, but executives could be forgiven for feeling pangs of regret at the timing. The small developer faces making its debut in an incredibly tough market, largely locked down by the coronavirus pandemic.
Urogen is preparing for a “virtual launch” and insists that this can still be carried out successfully: Jelmyto will arrive on June 1. The company is certainly not alone in braving uncertain territories, and Evaluate Vantage has identified 16 products launched in the past couple of months that the sellside believes hold significant revenue potential – sales that are now at risk.
None will escape disruption, though the pandemic will hurt some launches more than others. Jelmyto, for example, treats low-grade upper tract urothelial cancer, an orphan disease that afflicts only 6,000-7,000 patients a year, so a targeted marketing campaign to specialists that Urogen no doubt already has in its sights could probably still have an impact.
Treatment of cancer and other life-threatening illnesses is continuing throughout the pandemic, another advantage of sorts for companies with this focus. However, the cancellation of medical conferences will be a big blow to those hoping to roll out a medicine to a captive physician audience.
And treating a rare disease is certainly no shield; Bluebird Bio, which released its beta-thalassemia gene therapy in Germany in January, said earlier this month that it now expected the first patients not to be dosed until later in the year. It also warned that the pandemic would hinder its ability to launch in other European markets.
Feeling most pain?
Launches targeting the primary care market are thought particularly vulnerable to the global shutdown. Aside from the widespread disruptions to healthcare systems, sales teams will be physically unable to reach front-line physicians.
In this category Biohaven looks particularly exposed. The company launched its migraine treatment Nurtec ODT in March, and presumably its marketing team has been grounded. Esperion’s cholesterol-lowering drug Nexletol also arrived on US pharmacy shelves at the end of last month; the company has resorted to setting up telephone lines and email addresses, and asking physicians to get in touch with questions.
Aimmune’s peanut allergy treatment was another March debut, and in a further hindrance to uptake Palforzia needs to be administered in-office by allergists. Like Biohaven and Esperion, Aimmune is due to report first-quarter earnings in May, at which point the lockdown's ramifications on these launches will be revealed.
Investors should be braced for disappointing numbers, and the hope has to be that the results will reflect delays rather than permanent commercial setbacks. Big drug developers are also being affected: Bristol-Myers Squibb, on receiving approval for its new multiple sclerosis treatment Zeposia in March, said it would hold off a launch.
Bristol’s motivation was presumably to give a product entering a highly competitive market the best start possible. Smaller companies, however, which typically will have invested heavily ahead of a launch, will be less willing or able simply to hit the pause button. For those with a closer eye on cash flow this will be a very difficult time.
Note: with projected sales of $76m in 2024, according to EvaluatePharma’s consensus, Urogen’s Jelmyto falls just outside the $100m threshold selected as a cut-off for the analysis below.
|Hitting the market or hitting the skids? 2020's biggest drug approvals so far|
|Product||Company||Status||2020e sales ($m)||2024e sales ($m)|
|Enhertu||Daiichi Sankyo/Astrazeneca||January US launch||219||2,738|
|Palforzia||Aimmune||March US launch||46||1,150|
|Caplyta||Intracellular Therapeutics||March US launch||51||974|
|Zeposia (ozanimod)||Bristol-Myers Squibb||US approved March, launch delayed||52||966|
|Nurtec ODT/rimegepant*||Biohaven||March US launch||
|Zynteglo||Bluebird Bio||EU approved but initial treatments delayed||23||888|
|Nexletol||Esperion||March US launch||42||716|
|Ayvakit||Blueprint Medicines||January US launch||12||705|
|Tepezza||Horizon Therapeutics||February US launch||37||606|
|Tazverik||Epizyme||February US launch||29||566|
|Sarclisa (isatuximab)||Sanofi||March US launch||50||516|
|Vyepti||Lundbeck||April US launch||41||470|
|Reyvow||Lilly||February US launch||70||304|
|Ubrelvy||Allergan||January US launch||25||302|
|Amzeeq||Menlo Pharmaceuticals||January US launch||37||174|
|Barhemsys||Acacia Pharma||US launched planned H2 2020||1||102|
|*Forecasts include use in preventative setting, for which the drug is not yet approved. Source: EvaluatePharma.|
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