Forest Lexapro Strategy Changes: Reps Encouraging Switches From Celexa

Forest is restructuring its sales representative compensation program to encourage switches from the company's antidepressant Celexa to the follow-on selective serotonin reuptake inhibitor Lexapro .

In a change from previously stated plans, Forest will "move into a more active phase" of converting scripts to Lexapro, including instituting "a change in the compensation programs which would probably make it somewhat more attractive for our sales force to look more towards converting Celexa business than it has in the past," President Ken Goodman said July 15.

In April, Forest told investors it did not intend to actively detail against Celexa, saying that any patient conversion to Lexapro would take place "naturally" (¹ (Also see "Forest Expects Lexapro To Lead Market By ’05; Will Re-Launch In GAD In ’04" - Pink Sheet, 28 Apr, 2003.), p. 35).

Forest now expects to become "somewhat more aggressive in conversion and in compensation to the sales force" to encourage switches to Lexapro (escitalopram), Goodman said.

The change in strategy may better protect Forest's SSRI market share through some shake-ups in the antidepressant market, including the entry of Celexa (citalopram) generics and the pending launch of Lilly's Cymbalta (duloxetine). The serotonin norepinephrine reuptake inhibitor has been delayed by manufacturing issues (² 'The Pink Sheet' June 16, 2003, In Brief).

Prior to expected generic citalopram entry in January, Forest hopes to reduce Celexa annual sales to the $300 mil. to $500 mil. range, Goodman said. Celexa sales for fiscal year 2003 were $1.45 bil. (ended March 31), and sales for the fiscal first quarter were $284.7 mil.

Forest is predicting "many" Celexa generics, although the timing for such competition is uncertain. "We expect...multiple filings to take place in January," Goodman said. The quickest FDA reviews have been seven months, "and generally they've been more like 12 to 18 months," he noted.

Despite what Forest is predicting will be a "significant" Cymbalta launch, it does not expect to lose Lexapro market share to Lilly. "We don't expect share losses," Goodman said. "It will create a little bit more noise in the category. It may or may not have some impact on our growth rate at the time that they come out."

In addition to encouraging switches from Celexa, Forest is using "competitive" data in its Lexapro sales pitches. The sales force began using the results from two head-to-head studies against Wyeth's Effexor (venlafaxine) in the last week.

Both studies "show that we achieve at least comparable remission rates to Effexor with significantly less side effects," Goodman said. "And of course, Effexor is promoted primarily based on its efficacy and its ability to get patients into remission. So we think that's very strong data for us."

Forest will also use the comparative data against Cymbalta. "We have some pretty impressive data right now...and we think that's going to be pretty important for the Cymbalta launch as well," he said. "Market research still says that [Cymbalta] will be viewed by many doctors as a second-line product and perhaps will take a significant amount of its share away from Effexor."

The company is continuing to project 8% growth for its total SSRI prescriptions for the balance of 2003, assuming a Cymbalta launch "around the end of the year," Goodman said. Lilly has said it expects Cymbalta to launch in the fourth quarter.

Forest's total SSRI prescription market share increased to 22.85% at the end of June from 21.75% at the end of March. Total franchise sales, however, were down $9.2 mil. from the fiscal fourth quarter due to a wholesaler inventory buy-out.

According to IMS data, inventory for Forest's SSRI franchise dropped to 7.6 days in June from its March level of 11.2 days. The workdown resulted in approximately $30 mil. in reduced sales this quarter, Goodman told investors.

The bulk of the reduction came from Celexa. "The reduction in Lexapro was about one day, and the reduction in Celexa was almost five days," he noted.

Goodman characterized the drop as the result of a general economic slowdown. "It seems as though most of the markets in the IMS categorization have slowed, and therefore it would seem to be more of a general economic situation, perhaps, than it is one that is specific to the SSRI category."

"And of course the wholesalers are also trying to sort of guess what the range of the decline in Celexa is going to be versus the pick-up in Lexapro, so that also has some impact on their ability to...control the product."

Lexapro had a price increase of about 4% in the second quarter, narrowing the price differential between Celexa and Lexapro from 12% to 8%, Goodman said. "We always take our price increases mid-quarter to try to avoid the possibility of any wholesaler buying or stocking," he noted.

Expanding Lexapro's label is another core strategy for the antidepressant. In addition to the Effexor studies, Forest has "completed studies versus [Pfizer's] Zoloft and [GlaxoSmithKline's] Paxil in connection with our generalized anxiety disorder launch," Goodman said.

The user fee deadline for the GAD sNDA is Sept. 22; Forest is planning an early 2004 "re-launch" of the product. An indication for panic disorder has a user fee date in early March 2004, and an sNDA for social anxiety disorder should be filed in the "next several months."

Forest is increasing the size of its sales force by 450 to 600 reps in conjunction with the expanded Lexapro labeling. The reps were initially tapped for the lercanidipine and memantine launches, both of which have been delayed to the 2004-2005 timeframe (³ (Also see "Forest Adding 600 Sales Reps For Memantine, Lercanidipine Launches" - Pink Sheet, 21 Oct, 2002.), p. 23).

The expanded sales team will also assist Forest's European partner Sankyo in launching the Benicar /hydrochlorothiazide combination product Benicar HCT , which was approved in June as second-line treatment for hypertension.

Memantine will be reviewed by FDA's Peripheral and Central Nervous System Drugs Advisory Committee for moderate to severe Alzheimer's disease on Sept. 24 (⁴ 'The Pink Sheet' July 14, 2003, In Brief). The user fee date is Oct. 19, at which time Forest expects to receive an "approvable" letter ("The Pink Sheet" April 28, 2003, p. 33).

Memantine failed to reach statistical significance compared to placebo in mild to moderate Alzheimer's patients taking a concomitant acetycholinesterase inhibitor. Another Phase III study in the treatment of neuropathic pain also failed to meet its endpoints (⁵ 'The Pink Sheet' May 12, 2003, In Brief).