Abbott's HDL cholesterol-raising medication Niaspan (niacin) will compete favorably against Merck's Cordaptive (niacin/laropiprant), currently under review by FDA, based on its safety record and efficacy, despite the flushing side effect, VP-Investor Relations John Thomas said during Abbott's first quarter sales and earnings call April 16.

In a healthy first quarter for Abbott, in which worldwide pharmaceutical sales grew 14.3 percent, sales of Niaspan jumped 24.2 percent to $176 million, fueled by the launch of a new film-coated tablet last year that offers a dosing benefit and which the company has said reduces incidence of flushing (¹ Also see "New Niaspan Tablets Gain FDA Approval" - Pink Sheet, 6 April, 2007.).

Abbott also launched Simcor in the first quarter, a fixed-dose combination of extended-release Niaspan with simvastatin (Merck's Zocor and generics) to lower LDL cholesterol while raising HDL cholesterol in patients with complex lipid disease (² Also see "Abbott’s Simcor Wins FDA Nod" - Pink Sheet, 15 February, 2008.).

Sales of Simcor in the quarter were close to $20 million, Thomas said, on track to meet the full-year forecast of $100 million.

"Niaspan is the only prescription therapy capable of increasing HDL 25 percent to 35 percent on average with proven cardiovascular outcomes," Thomas stated. "It's a safe, effective and very well-know therapy." While the temporary flushing side effect associated with Niaspan is a nuisance, it is greatly reduced when Niaspan is taken with aspirin, he added, pointing out that in pivotal studies, only 6 percent of patients discontinued treatment due to flushing. Similar results were seen in studies evaluating Simcor.

The data stack up against rates of discontinuation seen with Merck's Cordaptive, which adds a new chemical entity to address a nuisance side effect rather than a safety issue, Thomas asserted.

FDA action is anticipated on Merck's NDA for Cordaptive in the second quarter (³ Also see "Merck’s Lipid-Lowering Combo Cordaptive Could Clear FDA In Mid-2008" - Pink Sheet, 29 August, 2007.).

Sales of Humira surged 53.7 percent to $878 million in the first quarter following approval of two new indications for plaque psoriasis and juvenile arthritis. Sales of the tumor necrosis factor inhibitor are expected to reach $4 billion in 2008, Abbot reported, with the biologic capturing a majority of all patients new to anti-TNF therapy in a market that continues to grow double digits.

Consolidated sales increased 13.8 percent to $6.8 billion in the period, including a favorable 5.5 percent benefit from currency exchange. Growth was driven by international markets, where sales increased 23.6 percent to $3.72 billion. In the U.S., sales increased 3.7 percent to $3.04 billion, with the sluggish growth reflecting the entry of generic competition for the antibacterial Omnicef (cefdinir) in May 2007. Net earnings increased 34.5 percent to $937.9 million.

Abbott expects to drive growth during the remainder of the year through new launches including the introduction of the next-generation fenofibrate TriLipix , extended release Vicodin CR , and the drug-eluting stent Xience V , all of which are under review at FDA.

Abbott and its TAP joint venture partner Takeda announced in March that they will dissolve TAP, splitting the assets. Abbott will receive full U.S. ownership of the prostate cancer treatment Lupron and future cash payments from Takeda (⁴ Also see "Takeda Buys Abbott’s Stake In TAP Joint Venture" - Pink Sheet, 19 March, 2008.).

Following the deal's close, expected in the second quarter, Abbott will add approximately $400 million of Lupron sales to the top line for the remainder of the year. Annual sales of Lupron are about $600 million, the firm said.

-Jessica Merrill (j.merrill@elsevier.com)

Abbott Won’t Shrink From Competitor Merck’s Cordaptive

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