Forest expects its anti-depressant Lexapro (escitalopram) to lead the selective serotonin reuptake inhibitor market by 2005.

"When we project out into [late 2004 and early 2005], we expect Lexapro to be the market leader by far, we expect its share to be continuing to grow," Forest Chief Operating Officer Kenneth Goodman said during an April 22 earnings call.

The company noted that its market projections apply only to the SSRI portion of the overall anti-depressant market, which also includes serotonin/norepinephrine reuptake inhibitors such as Wyeth's Effexor (venlafaxine). Forest maintained, however, that leadership in the SSRI category is essentially de facto leadership in the anti-depressant market as SSRIs make up the bulk of anti-depressant scripts.

Lilly, which dominated the SSRI category before Prozac (fluoxetine) went generic, will attempt to change the market share split between SSRIs and SNRIs with the approval of its SNRI Cymbalta (duloxetine). Cymbalta approval is expected later this year.

According to IMS Health data, Lexapro currently has 11.3% of new SSRI scripts as of the week ending April 11. Pfizer's Zoloft (sertraline) has 20.5% while GlaxoSmithKline's Paxil (paroxetine) line, which includes Paxil CR , has 20.1%. Forest's first generation product Celexa (citalopram) has 12.1% of new scripts, giving the company a market leading total of 23.4%.

In addition to increasing Lexapro's script share in the depression market, the company is seeking to expand the agent's label to include other indications in order to ensure its growth. Lexapro was approved for the treatment of depression in August (¹ Also see "Forest Lexapro Approval Includes Label Claim Of Greater Potency Than Celexa" - Pink Sheet, 19 August, 2002., p. 3).

Forest's first label expansion for Lexapro will be an indication for general anxiety disorder. The company plans to "re-launch" the agent for GAD within a year, following supplemental approval.

"This indication is a significant additional opportunity for Lexapro as we continue to believe that Lexapro will clearly establish itself as the category leader in the SSRI market," Goodman said. "We have very compelling clinical data in this indication and see strong market growth within the anxiety indications, and therefore a significant role for Lexapro in this market," he added.

The Lexapro sNDA was submitted in November 2002, making the user fee date in September. Forest's estimate of re-launch in early 2004 suggests the company has considered the potential of an "approvable" letter.

The GAD market is a large untapped resource for Forest's SSRI franchise, Goodman said. "The anxiety disorders portion of the SSRI marketplace...is a little bit over $4 bil. It is a very significant part of the market, probably one third of the total market."

"Celexa had about 7% of its business that came from that proportion of the market as compared to something like Paxil, which...probably is the leading share in that marketplace [and] has something like a 24% share of its business coming from that market."

Other sNDA filings planned for Lexapro include panic disorder "in the very near term" and social anxiety disorder "late in the fiscal year" (² Also see "Tidbits From The SG Cowen Health Care Conference" - Pink Sheet, 31 March, 2003., p. 30).

Forest will ramp up its selling, general and administrative spending over the course of the year in preparation for the re-launch of Lexapro. "We will invest heavily behind...what we consider to be a true re-launch of the product," Goodman said. The company plans to maintain its $198 mil. SG&A "run rate" from the previous quarter during the next two quarters; Forest will then increase its SG&A spend next winter and spring.

Analysts pressed Goodman about whether or not the company would be "flexible" in its spend levels, particularly in light of potential competition from Cymbalta and the potential entrance of generic Paxil.

Acknowledging that Cymbalta will be "the major new competitive entrant in the marketplace," he said that "our spending levels are certainly able to be flexed and are partly dependent on the competitive landscape."

However, given that Cymbalta is expected to be approved toward the end of the year, Goodman does not "see a great deal of pressure to increase" the company's support of Lexapro.

"Essentially, we're trying to maximize, and feel we have maximized, the appropriate level of effort for the number of doctors we have to reach and call on. That won't necessarily change with somebody else in the market place," Goodman added.

The COO also said that Forest has no plans to decrease its SG&A spend. "I certainly don't anticipate reducing it because we think it's having the desired effect."

Although Forest also expects to bolster Lexapro's market position by taking share from its predecessor product Celexa, Goodman told investors that Forest will not change its current detailing strategy. "We do not detail against Celexa, per se; we are not attempting to convert Celexa, per se. We are, and continue to be, of the belief that that conversion is taking place naturally and is accelerating naturally."

"The end game...is how much Celexa business will be left at a point where we think the generics will enter the market late in '04, early in '05. If we felt that we needed to accelerate the conversion, then of course we could detail specifically head to head against Celexa," Goodman added.

The exec noted that Forest hopes "that [Celexa] would be down to perhaps 15% or so of what it originally was or what it once was, which was about $1.5 bil. in sales," at the time of a generic entrance to the market. Forest expects the remaining 15% of patients to be "chronic controlled" Celexa users.

However, Goodman downplayed the impact of the future loss of Celexa exclusivity by touting the company's product portfolio and pipeline, focusing on the potential of the angiotensin II receptor antagonist Benicar (olmesartan) and the pending Alzheimer's product memantine (see ³ Also see "Forest Counting On Memantine, Benicar, To Bolster Growth Post-Celexa " - Pink Sheet, 28 April, 2003.).

Forest expects that generic Celexa will enter the market "no earlier than the latter part of 2004 into 2005." Although the product loses exclusivity Jan. 17, 2004, branded Celexa's life may be extended because FDA will have to "come to terms with managing some place between eight and 15 ANDAs all at the same time, none with exclusivity or advance review priority," Goodman said.

Forest will be presenting a head-to-head study comparing Lexapro to Effexor at the American Psychiatric Association conference in San Francisco the week of May 18. The company will also present a recently completed head-to-head study of Lexapro versus Paxil in GAD at the European College of Neuro-Psycho Pharmacology in mid-September.

Lexapro sales for the quarter were $142 mil. The product had total sales of $244.7 mil. for the fiscal year ending March 31.

Forest Expects Lexapro To Lead Market By ’05; Will Re-Launch In GAD In ’04

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