Abbott Laboratories is reporting a 44% year-over-year leap in net income during the first quarter. The results were propelled by Humira, which has begun its expected march to overtaking Lipitor as the world’s top-selling drug. The strong quarter prompted the company to raise its ongoing earnings-per-share outlook for 2012, during which it plans to spin off its drug development units.

Abbott recorded net income of $1.24 billion on group sales that increased 4.6%, to $9.457 billion. About half, or $4.072 billion, came from its proprietary pharmaceuticals unit. The unit saw sales rise 8.3% over Q1 2011, led by Humira, which racked up $1.934 billion in sales, up 17.4% from the first quarter of 2011. Humira’s sales were almost six times those of Abbott’s next best-selling drug Trilipix/TriCor at $329 million.

Humira is approved for a variety of indications including RA, Crohn disease, and psoriasis, with Abbott studying additional indications for the drug. Abbott has initiated two Phase III trials to evaluate Humira in patients with moderate-to-severe hidradenitis suppurativa, a skin condition for which no treatments have been approved. “Substantial research and development and selling support has been and continues to be dedicated to maximizing the worldwide potential of Humira,” Abbott states.

In that report, Abbott forecasted “low double-digit growth for worldwide Humira sales in 2012.” One likely driver of increased sales for the drug this year is in Europe, where it obtained approval in moderate-to-severe ulcerative colitis in April. The sanction marks the drug’s seventh indication in the EU. Humira is the first and only self-injectable biologic therapy available for UC patients in Europe.

Humira’s 2012 sales are also helped by the absence of patent expirations like those affecting the top-selling drugs of 2011. Last week a consensus of analyst forecasts compiled by Thomson Reuters Pharma projected that neither Pfizer’s anticholesterol drug Lipitor nor blood thinner Plavix, marketed by Sanofi and Bristol-Myers Squibb, will crack the top 10 sales list.

Lipitor’s U.S. patent expired in November, while Q1 2012 is the last full quarter of patent protection for Plavix, which is expected to face several cheaper generic competitors after it goes off patent next month. Last year, Lipitor sales fell $1.156 billion, or 10%, to about $9.6 billion, while Plavix sales were about $9.8 billion after combining $7.087 billion, up 6% from 2010 (BMS), plus €2.04 billion, down 2.1% from ‘10 ($2.679 billion) (Sanofi).

Humira is expected to retain its market-leading position through 2016, though EvaluatePhrama last year lowered its projection to $9.7 billion from $10.1 billion forecast in 2010 by EvaluatePharma. Reuters last week forecast $11.75 billion. All those numbers still fall short, however, of the almost $13 billion achieved by Lipitor at its peak in 2006. And the only condition for which a new $13 million drug is even foreseen in the future is Alzheimer disease, though Reuters has reported that expectations for an effective treatment remain low, despite ongoing late-stage clinical trials of drug candidates from Pfizer, Eli Lilly, and Johnson & Johnson.

In explaining its strong proprietary pharma sales, Abbott also cited several other strong drug franchises including the testosterone replacement gel AndroGel, the digestion aid Creon, the advanced prostate cancer drug Lupron, and the thyroid medicine Synthroid. AndroGel sales zoomed 23.6% in Q1 to $241 million; while sales of Creon rose 10% to $146 million; Synthroid sales increased 9.1% to $155 million; and Lupron, 8%, to $199 million.

The company’s strong start this year has enabled it to raise its EPS forecast for this year, to between $5.00 and $5.10 per share, from between $4.95 and $5.05, according to Miles D. White, Abbott’s chairman and CEO.

The strong Q1 results come as Abbott continues to plan a spinoff of its proprietary pharmaceuticals and biologics into an $18 billion-a-year drug development company to be called AbbVie. Its chairman and CEO will be Richard A. Gonzalez, currently evp, global pharmaceuticals for the current Abbott. The surviving company, which White will run and which will continue to be called Abbott, would focus on diagnostics, devices, nutrition, and branded generics businesses. “We remain focused on the process of separating Abbott into two leading health care companies, which remains on track to be completed by the end of the year,” White remarks.

To read the story from Reuters, click here.

To read the story from EvaluatePharma, click here.

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