Mature assets keep on giving – marketed upgrades and downgrades

It has been a rocky period for Gilead Sciences and things look set to get rockier: the company's HIV drug Stribild and Solvadi/Harvoni hepatitis C franchise saw the biggest analyst downgrades of the past 12 months.

The biggest upgrades, surprisingly, went to two drugs that have been around the block: Celgene’s Revlimid and AbbVie’s Humira. And there were differing fortunes for two cancer-targeting antibodies: Bristol-Myers Squibb’s dominance of the checkpoint inhibitor market is forecast to continue with Opdivo, but forecasts for Roche’s Kadcyla are shrinking (see tables below).

Revlimid revs up

Celgene’s multiple myeloma drug Revlimid might be an oldie, but it is a goodie. Its forecasts have no doubt been boosted by the recent approval of several new multiple myeloma agents, most of which are given alongside a Revlimid backbone. 

Five biggest upgrades to marketed products over the past 12 months
Product Company Therapy subcategory 2020 sales ($bn) Change ($bn)
Revlimid Celgene Other cytostatics 10.18 +2.17
Humira AbbVie Other anti-rheumatics 15.92 +2.0
Cosentyx Novartis Other dermatologicals 2.78 +1.68
Opdivo Bristol-Myers Squibb Anti-neoplastic MAbs 8.36 +1.55
Prevnar 13 Pfizer Vaccines 6.90 +1.36

New indications could also expand Revlimid’s reach, and the drug is in phase III trials for various diseases including follicular lymphoma, where it is being studied in combination with Rituxan.

However, the good times might not last, with myeloma drugs recently attracting the attention of a US pricing crusader, the Institute for Clinical and Economic Review, or ICER (Therapy focus – Multiple myeloma pricing set to feel the heat, February 1, 2016). 

ICER previously targeted Solvadi/Harvoni, and it cannot be a coincidence that Merck & Co’s rival hep C drug Zepatier is priced at a level recommended by the institute. Increasing competition, pricing pushback and a dwindling pool of eligible patients are hitting Gilead’s franchise hard.

Stribild suffers in HIV rebuild

But it was another Gilead product, the HIV drug Stribild, which had the biggest chunk knocked off its forecast. However, it is not bad news overall for the company as its next-generation HIV medications should pick up the slack.

Five biggest downgrades to marketed products over the past 12 months
Product Company Therapy subcategory 2020 sales ($bn) Change ($bn)
Stribild Gilead Sciences HIV antiviral 3.16 (1.61)
Sovaldi/Harvoni franchise Gilead Sciences Hep-C antiviral 10.88 (1.60)
Kadcyla Roche Anti-neoplastic MAbs 1.62 (1.21)
Remicade Merck & Co* Other anti-rheumatics 0.8 (1.01)
Zytiga Johnson & Johnson Hormone therapies 1.90 (0.95)
Note: *Merck markets Remicade in Europe, Russia and Turkey

Gilead’s new HIV drug, Genvoya, replaces the tenofovir disoproxil fumarate (TDF) component in Stribild with tenofovir alafenamide (TAF). Because TAF enters cells more efficiently than TDF, it can be given at a lower dose, which could reduce side-effects: TAF has shown improvements in bone mineral density and renal measures versus TDF. Gilead is also working on other TAF-containing regimens.

No Humira biosimilar backlash – yet

Meanwhile, AbbVie’s rheumatoid arthritis stalwart Humira continues to do well, with analysts seemingly untroubled by the impending threat from biosimilars. Chief executive Rick Gonzalez is keeping faith with the company’s patents, which he says should keep cheaper copies off the market until 2022 (Read my lips: no Humira biosimilars until 2022, November 2, 2015). 

But his promise should soon be tested: last month the FDA accepted for review the first biosimilar Humira candidate, Amgen’s ABP501, and a decision is expected in September. More clarity on biosimilars could mean future downgrades for Humira.

Biosimilar competition from Celltrion’s Remsima has already hit European sales of a rival product, Remicade – it is marketed there by Merck & Co. And the cheaper version could soon be coming to the US, with the FDA recently releasing positive briefing documents ahead of an advisory committee meeting.

The news hurt the share price of several companies including Johnson & Johnson, which developed Remicade, AbbVie and Amgen, which markets Enbrel. US approval of Remsima would clearly be bad news for all the anti-TNF drugs, not just Remicade.

New kids on the block

The third and fourth-largest upgrades went to products released more recently: Novartis’s psoriasis drug Cosentyx and Bristol’s cancer immunotherapy Opdivo. The former had a stronger launch than expected last year – a rare bright spot for Novartis, which is dealing with disappointing sales of its heart failure drug Entresto, among other issues.

Opdivo continues to lead the PD-1 inhibitor market in spite of an ongoing challenge from Merck & Co’s Keytruda. But while Leerink analysts believe that Bristol will stay on top in immuno-oncology for at least the next few years, Jefferies points to incoming competition from the likes of Roche’s atezolizumab, expected to be one of the year’s biggest launches (As sector pain continues Roche leads the blockbuster charge, January 26, 2016). 

Roche needs something to look forward to. Its breast cancer drug Kadcyla once again featured in the top five downgrades after its hopes of expanding it into the first-line metastatic breast cancer setting were dashed with the failure of the Marianne trial.

Roche, along with Gilead, will be hoping that new contenders can make up for the shortfall.

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow @medtech_ma on Twitter

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