Cymbalta

Under pressure, pharma collects new indications

Tracy Staton — Mon, 30 Jun 2008 09:32:24 -0400

If the pharma industry were in need of a poster child for indication-happy drug marketing, Cymbalta could be it. The Eli Lilly med is now "the Swiss army knife of drugs," the Indianapolis Star says. It has a half-dozen approved uses: depression, anxiety, maintenance treatment for depression, diabetic nerve pain, fibromyalgia, and in Europe, stress urinary incontinence.

There's reason behind this strategy. It works. On the market for just four years, Cymbalta racks up billions in sales for Lilly; in fact, it's Lilly's second-biggest seller. Given the fact that Lilly hasn't launched a new drug for humans in three years, growing existing meds has been crucial.

Lilly, of course, is far from alone. Dispirited by their limping pipelines and increasingly rigorous regulators, drug companies across the board have been looking for new uses for their already-approved drugs. Think Pfizer's Lyrica, for instance; it's approved for three different nervous system complaints, and the company plans to seek the OK for epilepsy treatment.

Understandably. But is this search for new indications eroding new-compound R&D? Some experts think so. Others say drugmakers would be remiss if they didn't look for new uses for old meds. One thing is certain: It's not about to stop anytime soon.

- read the story in the Indy Star

Lilly trumpets Cymbalta as arthritis med

Tracy Staton — Fri, 13 Jun 2008 11:18:40 -0400

Eli Lilly's Cymbalta might make the leap from psychiatric med to arthritis treatment. The company announced today that a study showed that 59 percent of patients saw their pain cut by 30 percent with Cymbalta, and 47 percent had a 50 percent reduction. That's compared with 45 percent and 29 percent on placebo, respectively. It wouldn't be Cymbalta's first painkilling indication; it's also approved for diabetic nerve pain. Report

Profits rise at Novartis, Merck, Lilly

Mon, 21 Apr 2008 06:59:58 -0400

Good financial results from three Pharma biggies should cheer up those market-watchers who moaned their way through much of last week. Sure, a couple of the profit leaps came at least in part from one-time gains. But increases are always better than the alternative. Here's the news:

Novartis reported an estimate-beating 6.8 percent increase in profits. Healthy sales of both Diovan and Gleevec helped, and so did the company's cost-cutting program. So did the weak dollar. But the real stars of the story were generic meds, over-the-counter products, animal drugs, and contact lenses; double-digit growth here offset a decline in brand-name drug sales. Profits rose to $2.32 billion on an 8.6 percent increase in revenue to $9.91 billion.
Merck also benefited from the weaker dollar, but its dramatic near-doubling in net income to $3.3 billion was mostly attributed to a one-time $1.4 billion gain on its limited partnership with AstraZeneca. Still, Merck's earnings excluding that item--89 cents--beat analysts' expectations of 86 cents. Revenues didn't meet the street's goals, however; analysts had projected $6.11 billion, but the company reported $5.82 billion. The 0.9 percent growth in sales included a four percentage-point boost off foreign exchange rates.
Eli Lilly's sales grew a striking 14 percent, with 8 percentage points of that coming from actual increases in sales volume; foreign exchange rates and price increases accounted for 5 percentage points and 1 percentage point, respectively. A big-gaining drug was Cymbalta, an antidepressant that posted 37 percent growth. Like Merck, Lilly reported a big one-time tax gain, posting net income of $1.06 billion, or 97 cents per share, compared with $508.7 million or 47 cents per share same quarter last year. Restructuring and acquisition costs depressed earnings last year, though; excluding items, the earnings per share gain was actually 9 cents, to 92 cents from 83 cents.

- get the Financial Times news on Novartis
- see the WSJ report
- read the Associated Press' news on Merck
- see the release on Lilly
- check out the Merck and Lilly numbers in the WSJ

Lilly predicts double-digit earnings growth

Thu, 06 Dec 2007 06:59:54 -0500

Here's one bright spot today: Eli Lilly predicts a big year in 2008, with 14 percent growth in net profits and seven billion-dollar-plus products. Higher sales of drugs for depression (Cymbalta), diabetes (Byetta and Humalog), cancer (Alimta), and ED (tadalafil) will account for much of that growth. Lilly also says it's hoping to launch pasugrel, its anti-clotting drug candidate designed to prevent recurrent heart attacks and strokes, in 2008.

In its latest forecast, the company also affirmed its 2007 expectations of $3.50 to $3.55 in earnings per share, excluding special charges. For 2008? It's predicting $3.85 to $4 per share, above analysts' previous expectations of $3.81 per share. The dark cloud in all this news, at least for Lilly's workforce, is that the earnings growth depends in part on increased productivity--and that includes an unspecified number job cuts.

- check out the release from Eli Lilly
- read the report from Dow Jones

ALSO: Take a look at Lilly's pipeline. Report

Related Articles:
Doubters see big obstacles for Lilly's Prasrugel. Report
In speech, Lilly CEO calls for drug monitoring. Report
Lilly CEO: Use IT to boost drug safety. Report

Lilly cited for"misleading" Cymbalta ads

Wed, 03 Oct 2007 06:59:54 -0400

While Eli Lilly's CEO was out lobbying for drug safety, the FDA was posting a letter on its website warning the drug maker to stop making "false and misleading" claims about its antidepressant Cymbalta.

At issue was a promotional mailing that left out some of the drug's most serious side effects and exaggerated its effectiveness at easing pain. (In addition to its approval for use in depression and anxiety, Cymbalta is approved for diabetic nerve pain.) The agency ordered Lilly to stop distributing the mailer--which was first used in 2005.

- check out the warning letter from the FDA

Related Article:
Lilly pursues new Cymbalta approval. Report

Lilly pursues new Cymbalta approval

Tue, 21 Aug 2007 06:59:57 -0400

What do you do with a booming antidepressant? Broaden its scope, of course. Eli Lilly has filed for FDA approval to sell Cymbalta as a fibromyalgia remedy. It's already marketed for use against general anxiety and nerve pain, in addition to depression.

Lilly announced its supplemental drug app with news of a study that found that fibromyalgia patients taking Cymbalta felt less pain than those taking placebo. The study subjects included patients with depression and those without. Already, Cymbalta has been a hot performer for Lilly this year. First-quarter sales of the drug were up almost 90 percent over the same period last year, to $41.8 million, and second quarter sales reached $519.5 million, at least in part because of an aggressive direct-to-consumer campaign begun last summer. If approved for fibromyalgia, Cymbalta would find a broad new market: an estimated 3 to 6 million Americans have the disease, according to the American College of Rheumatology.

- check out the release
- read the RTT News report

Related Articles:
Pfizer touts blockbuster drug for fibromyalgia. Report
Forest Labs reports Phase III failure for fibromyalgia drug. Report
FDA hands out two key regulatory approvals. Report