AbbVie sticking to HCV sales forecasts

AbbVie’s combination hepatitis C virus (HCV) therapy Viekira Pak racked up sales of $231 million in its first quarter on the market, setting it on course for blockbuster revenues for the full-year but missing some analyst expectations.

The therapy – sold as Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) in Europe – was always going to struggle to make the same sort of impact as rival HCV therapies Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) from Gilead Sciences.

However, the first-quarter performance suggests AbbVie may have a harder time catching up with the competition than envisaged, despite undercutting Gilead on price.

Sovaldi and Harvoni collectively had sales of more than $12 billion last year on the back of pent-up demand for more effective alternatives to injectable interferon-based therapy for HCV, with Harvoni making more than $2 billion in its first quarter on sale.

AbbVie’s management is still suggesting Viekira Pak should make annualised sales of around $3 billion before the end of the year, with analysts seemingly divided as to whether this is now likely.

Credit Suisse analyst Vamil Divan asked whether AbbVie’s management would still feel confident with that guidance based on first-quarter performance.

AbbVie chief executive Richard Gonzalez is, however, adamant that the drug is performing at least as well as expected, particularly outside the US, and told investors yesterday: “We are pleased with the pace of our progress internationally which is tracking ahead of our planning assumptions – this will lead to a higher level of international sales this year than we originally expected.”

Meanwhile, he said that in the US “many of our contracts have start dates in the April and May timeframe and we expect those to begin to ramp in the second and third quarters and build for the remainder of the year.”

The company reported better-than-expected first quarter results overall as sales of its mega-blockbuster Humira (adalimumab) for rheumatoid arthritis, psoriasis and Crohn’s disease – among other indications – leaped 18 per cent to $3.11 billion in the quarter. Group first-quarter sales climbed more than 10 per cent to $5 billion, in line with analyst estimates.

Humira is facing the loss of some patents from next year, and the threat of biosimilar competition with Amgen discussing a possible 2017 launch for its copycat version, although AbbVie insists its intellectual property for the drug extends into the next decade.

The drug’s continued growth and resilience despite increasing competition in the immunotherapy sector is encouraging but does not lessen the need for AbbVie to bring forward additional products quickly.

The company agreed a deal to acquire Pharmacyclics for $21 billion last month, adding a new portfolio of cancer drugs including blockbuster-in-waiting Imbruvica (ibrutinib).

HCV prospects after Viekira

There was further good news for AbbVie’s HCV programme after the Japanese authorities awarded priority review status to a two-agent regimen – based on ritonavir-boosted paritaprevir and ombitasvir – that was filed for approval there in February.

Earlier this month the company also reported preliminary results from a phase IIb study of its next-generation protease inhibitor ABT‐493 and follow-up NS5A inhibitor ABT-530, and it expects to advance these into phase III later this year.

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