Alza Concerta Climbs To 15% Of ADHD Market With 170,000 Patients

Alza Concerta holds 15% of the attention deficit hyperactive disorder market, Senior VP-Sales & Marketing Dan Swisher told the company's annual analyst meeting in New York City Feb. 27.

"Week over week, we have done very good, strong, sustained growth such that we are at a 15% market share, or close to it, as of the week ending Feb. 16," Swisher said.

Since launch of the once-daily methylphenidate product in August, Concerta's market share has climbed steadily, Swisher indicated.

"At the end of the year we had 11.5% market share, better than any of us had actually expected....At January, our market share went up to 13%," he said. "Forty thousand physicians had actually written for Concerta, and we are currently benefiting over 170,000 patients."

Swisher attributed the growing market share to switches from methylphenidate immediate-release products (Novartis' Ritalin and generics), which are dosed twice or three times a day.

Some Concerta prescriptions are "from new patients, but some of it comes from switches," Swisher remarked. "Where it primarily comes from is the methylphenidate immediate-release," he added, "but we have also stolen share from some other products."

Concerta's entrance into the ADHD market has stalled the growth of Shire's Adderall (amphetamine), Swisher maintained. Before the Concerta launch, "Adderall was growing one percentage share point a month, and thereafter it completely stalled," he said.

"Most of the patients on methylphenidate immediate-release and [other ADHD drugs] that went to Concerta would otherwise have gone to Adderall," the exec continued. Shire reported in October that Adderall had a 32% market share of analeptics (¹ (Also see "Alza Concerta Marketing May Expand ADHD Market, Aid Adderall - Shire CEO" - Pink Sheet, 13 Nov, 2000.)).

Swisher also noted that Shire's development of a once-daily formulation of Adderall, Adderall LA, is facing challenges. Referring to Adderall LA Phase II data, Swisher said, "we were very pleased actually because the data showed an uneven onset depending on the dose. And to get the duration, they had to increase the dose significantly. As they did that, they saw more side effects. The biggest headache for them is going to be loss of appetite [and] suppression of potential weight loss."

Alza highlighted the positive response Concerta is receiving from managed care organizations.

"We have been very pleased with the speed at which managed care has reviewed our product and also with the favorable formulary placement that they have put Concerta on," Swisher said. "We really see managed care not as always an obstacle in this market."

"When we first were looking at this market, we thought pediatricians were going to be closed...but because of McNeil's relationship with them and reputation, they have been quick adopters," Swisher added.

Swisher suggested that Lilly's ADHD therapy under development, tomoxetine, will help expand the overall ADHD market, echoing comments Shire made at the time of Concerta's entry into the ADHD market.

"It will probably help expand the overall market because it will be good for patients who otherwise are unable or unwilling to take the current methylphenidate or Adderall," Swisher claimed. Tomoxetine is in Phase III with an NDA submission expected in late 2001 (² (Also see "Lilly Is Attentive To ADHD: Tomoxetine Into Phase III; 2001 NDA Planned" - Pink Sheet, 15 May, 2000.)).

Swisher called the overall ADHD market "very robust," with "close to 19 mil. scripts." The company's 2001 sales target for Concerta is $200 mil.

Alza is developing methylphenidate for cancer-related fatigue as a complementary therapy to Johnson & Johnson's Procrit (epoetin alfa). As with Concerta, Alza is using its OROS controlled-release osmotic delivery system for the oncology product. The company expects to have the results of Phase II studies and begin Phase III studies in 2001.

Swisher noted that cancer-related fatigue is a category created mainly by J&J through an aggressive direct-to-consumer advertising campaign. "The Procrit people are doing a great job in this category," he said. "They are getting out the message about cancer fatigue. Doctors are being increasingly aware and treating it, but the great opportunity is coming in with something complementary."