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AbbVie

Published on 24/02/14 at 04:18pm
The company was split into two separate entities in 2013

In 2013 the company formerly known as Abbott split into two new and separate firms - one holding on to the Abbott name, the other taking AbbVie as its new insignia.

AbbVie has become the new pharma division, headed-up by its former pharma business leader Richard Gonzalez, and it predominately focusses on patented medicines.

The remainder of the business has retained the Abbott name and includes the branded generic pharmaceuticals division, devices, diagnostics, and nutritionals businesses.

AbbVie’s biggest earner remains the rheumatoid arthritis treatment Humira (adalimumab). The company’s full year results for 2013 show that - as expected - Humira drove AbbVie’s growth in its first year as a standalone company, accounting for $10.7 billion of the company’s $18.8 billion turnover.

In the fourth quarter last year the company brought in revenue of $5.1 billion (down 1%), with sales of Humira growing 13% worldwide and 18% in the US. AbbVie’s overall turnover rose 2.2% in 2013, although it dropped 2.4% in the US year-on-year.

Chief among the poor performers was out-of-patent TriCor/Trilipix (fenofibrate), which plummeted 72% to $303 million, while sales of HIV treatment Kaletra (lopinavir/ritonavir) dropped 5% year-on-year to $962 million, and prostate cancer drug Lupron (leuprolide acetate) fell 2% to $785 million.

But despite these losses Humira is still a strong workhorse for the firm. However, AbbVie cannot afford to rest on its laurels and needs a blockbuster to replace Humira whose US patent expires in December 2016.

So the firm is now hoping its batch of new hepatitis C treatments will fit the bill in the shape of its three-pronged hep C regimen which is likely to transform treatment of the disease.

AbbVie’s drugs have produced cure rates well above 90% in clinical trials, without the need to be taken with older standard drugs that cause harsh side effects and must be taken for longer periods.

It is expected that the drugs will be launched this year - earlier than the original 2015 launch date, on the strength of new data.

Analysts believe that AbbVie’s drugs could capture peak annual sales of $2.8 billion, even if they only claim a 10-13% share of the hepatitis C market.

And the share may well be this small as it is up against a formidable rival in the shape of Gilead’s new treatment Sovaldi (sofosbuvir). Both drug regimens have shown strong results in cutting treatment time, raising ‘cure’ rates measured by ‘sustained viral response’ (SVR) and making treatment simpler for patients.

Sovaldi launched in the US in December, and hit EU markets in January. Gilead’s drug has a convenient once-daily regimen and will prove tough competition for AbbVie’s drugs.

Stellar sales revenues are expected for AbbVie’s offerings and Sovaldi - analysts predict Gilead’s drug will rocket to $5 billion sales by 2015.

Both AbbVie’s treatment and Sovaldi have achieved SVR rates above 90%, making them significantly more effective than existing treatments in virtually eliminating the virus.

Key to the appeal of AbbVie’s regimen is that it promises to eliminate the need for interferon in genotype 1 patients. This is one step further than Sovaldi, which currently can only be used without interferon in patients who cannot tolerate or take interferon, or who are awaiting a liver transplant.

The FDA has designated AbbVie’s regimen a ‘breakthrough therapy’ and the firm is set to submit its data with regulators in the second quarter of this year.

AbbVie’s treatment involves taking four pills a day. In addition to protease inhibition, the regimen includes an NS5A inhibitor in ABT-267 and a non-nucleoside NS5B inhibitor in ABT-333. The three different mechanisms of action combine to interrupt the HCV replication with the aim of optimising SVR rates across different patient populations.

View Abbott's pipeline here. Please note the company's disclosure of pipeline details is limited.

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