Friday Five - The pharma week in review (3 April 2020)

Mapping the COVID-19 impact on pharma

What impact will the COVID-19 pandemic have on the pharmaceutical industry?

Further trends (some companies have already confirmed delays to clinical study enrolment) will emerge over the coming weeks and months.

In the meantime, oncologists have suggested that virtual editions of key cancer meetings, such as ASCO, could result in the slower adoption of new therapies if the ability to discuss clinical data is compromised.

More significantly, perhaps, our poll of physicians indicates that many will give low priority (or make no priority at all) to engaging with pharma industry representatives amidst the pandemic.

Furthermore, this analysis provides insight on which physicians – by specialty – have seen the biggest increases and decreases in patient load in recent weeks.

______________

Amarin hit by patent ruling

Amarin was one of the first companies to announce a suspension of face-to-face meetings between its sales representatives and physicians last month. The upshot being that adoption of its drug Vascepa (icosapent ethyl) – touted as a potential blockbuster product in the cardiovascular market – will be slower in 2020 than previously anticipated.

The outlook for Amarin then worsened significantly this week, when a district court judge ruled that six patents on Vascepa – all due to expire in 2030 – are invalid. The decision prompted Amarin’s share price to fall as much as 70%.

If and when generic versions of Vascepa enter the US market remains unclear at this point, in part due to a lack of clarity on their regulatory progress and due to the strong likelihood that Amarin will appeal the decision. With Amarin previously touted as a potential acquisition target, any would-be suitors will be relieved to have passed up on this opportunity.

Analysis – ViewPoints: Soon to be plenty of fish in Amarin's sea

______________

Zeposia lands, but may struggle to take off 

Another new drug which may struggle to gain near term traction in part due to COVID-19 is Bristol Myers Squibb’s recently approved multiple sclerosis treatment Zeposia.  

Not only are conditions far from ideal to be launching a new product into an already crowded market, but Zeposia (ozanimod) is not notably differentiated from other oral S1P modulators such as Novartis’ Gilenya (fingolimod) and Mayzent (siponimod) franchises which are already available, a leading key opinion leader told FirstWord this week.

More here

He predicts that Zeposia could end up cornering approximately 5% of the market. 

______________

Akero adds to FGF confidence in NASH

Akero Therapeutics released its initial findings on liver fat reduction for FGF21 agonist AKR-001, with potential for best-in-class efficacy within the difficult indication- and in the face of an extensive competitive landscape focused on the potential of FGF agonism.

See ViewPoints: Akero sees strong start in NASH, with COVID complications ahead

However, the company has yet to demonstrate that its impressive reductions in liver fat correlate with improved histology. It's expecting to present that portion of the ongoing study in the second quarter- assuming it can continue to successfully collet liver biopsies from its enrolled patients, who may be sidelined by COVID-19. 

______________

COVID-19 therapeutics to test regulatory standards

While Gilead Sciences collected and rescinded an orphan drug designation from the FDA for remdesivir, some regulatory wheels were greased this week for hydroxychloroquine/chloroquine.

The malaria drug was granted an emergency use authorisation from the FDA, which should help ease any supply issues for the newly in-demand therapeutic- but doesn't do much to assuage concerns that the treatment might have little evidence to support its use.

See ViewPoints: Path cleared for chloroquine, while Gilead stays on the defensive

To read more Friday Five articles, click here.