Friday Five – the pharma week in review (22 Feb)

Some much needed, albeit mixed, success in NASH

One week after a late-stage NASH setback (see Friday Five – the pharma week in review, 14 February), this week saw Intercept Pharmaceuticals confirm that its REGENERATE study of obeticholic acid met one of two primary endpoints.

Showing a fibrosis improvement with no worsening of NASH at a planned 18-month interim analysis should allow obeticholic acid to be submitted with regulators, said Intercept.

Even if approved, however, detailed results from REGENERATE cast some doubt on the commercial viability of obeticholic acid as a NASH therapy; confirming the opinion of numerous experts interviewed by FirstWord who view its mechanism of action as interesting, but expect superior drugs from the same class to emerge over time.

Analysis - ViewPoints: Intercept opens the door for FXR in NASH

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AstraZeneca returns to growth

AstraZeneca's fourth-quarter 2018 results - presented by the company late last week - delivered full-year underlying sales growth for the first time since Pascal Soriot's appointment as CEO seven years ago.

Soriot has overseen an impressive upturn in AstraZeneca's R&D fortunes and a number of recently launched products - such as the cancer therapies Tagrisso, Imfinzi and Lynparza - look set to drive continued revenue growth in the medium term.

Focus will increasingly shift, therefore, to what comes next - both in terms of new potential blockbusters from the R&D pipeline and AstraZeneca's over-arching strategy, which includes retirement of the MedImmune name as part of a research unit overhaul.

With a number of key executives having left the company, Soriot also needs to convince shareholders he is sticking around, describing rumours of his imminent departure as "fake news."

More here - ViewPoints: AstraZeneca returns to growth; can it stay the course?

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A David versus Goliath showdown nears in breast cancer

Little MacroGenics - a small US-based biotech - is taking on the might of Roche, announcing recently positive top-line data for its experimental breast cancer drug margetuximab; which it has indicated is superior to Herceptin in late-stage HER2-positive breast cancer.

FirstWord sat down this week with a leading breast cancer key opinion leader to discuss what additional benefit margetuximab needs to show when full data from MacroGenics' SOPHIA study reads out later this year, and the potential implications of moving the drug into earlier-stage head-to-head studies versus Herceptin.

More here - KOL Views Results: MacroGenics’ margetuximab has leading oncologist’s curiosity – but not his attention (yet)

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Johnson & Johnson's Spravato will be used with some caution, say prescribers

Recently backed by an FDA advisory committee for approval next month, Johnson & Johnson's Spravato (esketamine) - a potential new therapy for treatment-resistant depression - will likely be adopted conservatively by prescribers if it does reach the market, as now appears increasingly likely.

This is according to feedback from 100 US-based psychiatrists we snap-polled earlier this week.

More here - Physician Views Results: Psychiatrists outlook on esketamine mixed, though off-label ketamine use provides an interesting case study with potentially positive implications

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Pharma's fastest growing drug brands

With fourth-quarter earnings season winding down and the vast majority of large-cap pharmaceutical and biotechnology companies having reported their 2018 full-year results, we took a look at which drug brands have delivered the biggest incremental increase in 2018 global sales versus the prior year; and the key strategic narratives behind these performances.

Based on our analysis, 24 drug brands individually delivered incremental global sales growth of $500 million or greater between 2017 and 2018. Across these 24 drug brands, combined incremental sales growth in 2018 was $28.7 billion.

Oncology drug brands dominate pharma's list of the biggest growth drivers, comprising 10 of the 24 drug brands that individually delivered incremental growth of $500 million or more. Together, these 10 brands delivered combined incremental growth of $12 billion in 2018 versus 2017.  

Merck & Co.'s PD-1 inhibitor Keytruda was the fastest growing oncology brand and the fastest growing drug brand overall in 2018, delivering incremental sales growth of $3.4 billion over the prior year.

More here

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