Forest Escitalopram To Launch As Lexapro At Price Similar To Celexa

Forest plans to launch escitalopram at a price similar to or slightly lower than its predecessor antidepressant Celexa , Forest President & Chief Operating Officer Kenneth Goodman told a third quarter earnings call Jan. 15.

The company plans to sell escitalopram, the single-isomer formulation of Celexa (citalopram), under the trade name Lexapro, pending approval of the name by FDA, Goodman said.

"While we haven't finalized...the pricing of Lexapro, we do not expect it to be premium-priced over Celexa," Goodman said. "It may be [in] parity or slightly less then Celexa's pricing."

Forest increased Celexa's price by 4% in early October. The product is now available in bottles of 100 40 mg tablets for $234.48 AWP, according to Red Book data. Clinical trial data have demonstrated that Lexapro 10 mg has comparable efficacy to Celexa 40 mg, Forest said.

Current Celexa pricing represents about a 16% increase over its September 1998 launch price. Forest also sells the drug in 100-tablet bottles of 20 mg ($224.70) and 10 mg ($215.58). Peppermint-flavored citalopram hydrobromide oral solution (10 mg/5 mL) is available at $103.08 per 240 mL.

The choice of a tradename for escitalopram that does not use the "Cele" prefix may be an attempt to avoid further legal dispute with Pharmacia, which claimed that Celexa infringed on the Celebra / Celebrex tradename for its COX-2 inhibitor celecoxib. The lawsuit was recently settled; Forest's rights to the Celexa name were not affected.

Forest filed an sNDA for Lexapro in March and expects to receive an "approvable" letter by the end of January (¹ (Also see "Forest Expects “Approvable” Letter For Escitalopram In January" - Pink Sheet, 3 Dec, 2001.), p. 18).

Following labeling negotiations and submission of marketing materials to FDA's ad division, Forest anticipates approval and "launch of Lexapro for the treatment of depression around mid-calendar year," Goodman said.

A June launch would provide the company about two-and-a-half years to switch Celexa patients to the follow-on compound prior to generic competition expected in early 2005.

Celexa "inventory levels at the wholesaler level remain lean," Goodman noted. The SSRI's sales were $281 mil. for the quarter, up 48% over the year-ago quarter. Forest's net sales for the fiscal third quarter (ended Dec. 31) increased 30% to about $403 mil.

Forest was asked to comment on the potential for competition from Lilly's serotonin/norepinephrine reuptake inhibitor duloxetine, which has been submitted to FDA and is slated for launch in 2002.

"We still think that the market views the combination" serotonin and norepinephrine inhibitors "as a secondary therapy to SSRI therapy," Goodman told analysts.

He pointed out that Wyeth-Ayerst's serotonin/norepinephrine inhibitor Effexor (venlafaxine) "was around a long time before Celexa launched and, of course, we have simply blown right by them in terms of market share."

"We think duloxetine will receive, ultimately, the same kind of attention that Effexor does as sort of a second-line treatment," Goodman declared.

Forest hopes to position escitalopram based on its onset of action and safety claims. However, the onset of action data "will not be in the label because it is not there statistically in...the individual trials," Goodman told analysts.

While the three pivotal Lexapro trials each showed an onset of action of about one week, the studies were not powered to show statistical significance, Goodman explained. "Obviously, [the data] will become known to doctors by looking at the clinical studies themselves.

Goodman said Lexapro has had a positive reception from managed care, and he emphasized the large number of "managed care advisory boards and individual meetings we have already had...[reviewing] the clinical data."

Goodman noted that clinical trial discontinuation rates of patients taking escitalopram (5.9%) as compared to the 16% rate seen with Celexa "has played extremely well in the managed care advisory boards and in our medical advisory boards."