Lilly's antidepressant Cymbalta is priced at a 73% premium to Wyeth's Effexor XR .

[Editor's note: This story contains incorrect pricing information for Effexor XR. A ¹ corrected version of the story appeared in the Aug. 16 edition of the "The Pink Sheet".]

The average wholesale price for a 60 mg capsule of Cymbalta (duloxetine) is $3.56, compared to $2.06 for a 75 mg tablet of Effexor XR (venlafaxine).

Cymbalta was approved Aug. 3 for the treatment of major depressive disorder and will be available in pharmacies by the end of the month.

Effexor and Cymbalta are both selective serotonin and norepinephrine reuptake inhibitors.

Cymbalta is also priced above the leading brands in the selective serotonin reuptake inhibitor class, Pfizer's Zoloft (sertraline) and Forest's Lexapro (escitalopram).

A 60 mg capsule of Cymbalta is priced at a 24% premium to the recommended daily dose of Zoloft for MDD ($2.87 for a 50 mg tablet). Cymbalta 60 mg is 54% more than a 10 mg tablet of Lexapro ($2.31).

Lilly's premium pricing strategy is noteworthy because Cymbalta is one of the first major commercial launches in a large outpatient market since the passage of the Medicare drug benefit at the end of 2003.

As such, the pricing decision can be read as a gauge of how one company sees the dynamics of the new Part D benefit unfolding in 2006.

Cymbalta will be available in 20 mg, 30 mg and 60 mg capsules. The net wholesale price of the 20 mg dose will be $2.54 per capsule, Lilly says; the 30 mg and 60 mg dose will each carry a net wholesale price of $2.85 per capsule.

The flat pricing for the 30 mg and 60 mg doses will help Lilly encourage use of once-daily dosing.

According to Lilly, the 60 mg once-daily dose was most consistently effective in clinical trials. However, labeling describes three possible dosing regimens - 20 mg twice daily, 30 mg twice daily, and 60 mg once daily - in a neutral fashion.

However, the twice-daily regimens would be significantly more expensive (as well as less convenient).

Cymbalta gained FDA approval in time for Lilly to meet its projection of a late-summer launch. The company said it will have the supply chain "80% full" by the end of August (see ² Also see "Cymbalta Labeling Hints At Side Effect Claim; Lilly Will Test In Phase IV" - Pink Sheet, 9 August, 2004. ).

The application (NDA 21-427) took more than two and a half years to clear FDA. Lilly filed the NDA Nov. 12, 2001. It was deemed "approvable" in September 2002, pending resolution of manufacturing and labeling issues (³ Also see "Lilly Cymbalta Halted By GMP Issues; “Approvable” Letter Issued Sept. 13" - Pink Sheet, 23 September, 2002., p. 29). Lilly received a second approvable letter for Cymbalta a year later (⁴ 'The Pink Sheet' Oct. 6, 2003, In Brief).

In June, the user fee date was extended by three months after Lilly submitted additional data analyses to supplement its response to the approvable letter (⁵ 'The Pink Sheet' June 28, 2004, In Brief).

The late August launch date probably was not affected by the final user fee extension. When the product was expected to be approved in June, Lilly said it would not be able to launch until late summer because it needed to build up sufficient inventory of the product (⁶ Also see "Lilly GMPs Clear One Milestone; Cymbalta Launch Now Planned For Summer" - Pink Sheet, 3 November, 2003., p. 10).

Lilly said no supply issues remain, and described rollout challenges as logistical in nature.

Lilly also has an NDA pending for duloxetine for treatment of stress urinary incontinence, which the company hopes to market under the brand name Yentreve .

Lilly's dosing and pricing for Cymbalta appear to leave considerable flexibility for the company when it is ready to launch Yentreve.

While Lilly will attempt to establish the 60 mg once-daily dose as the standard for Cymbalta, Yentreve is expected to be approved in a twice-daily dose of 40 mg.

Lilly did not study Cymbalta for once-daily 40 mg dosing, so the company will not be setting a price for that dose with Cymbalta.

Using the 20 mg price (two pills taken twice daily), Lilly will be able to price Yentreve as high as $10 per day without encouraging patients to use Cymbalta off-label for SUI.

Lilly Cymbalta Launched At Premium Price; Once-Daily Dose Encouraged

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