Alza/McNeil Concerta 420-Rep Sales Force Will Target Peak October Season

Alza and McNeil Consumer Healthcare are preparing a combined sales force of 420 reps to detail Alza's once-daily methylphenidate treatment Concerta for pediatric attention deficit/hyperactivity disorder.

"We are delighted to be partnering with McNeil...one of the most respected pediatric sales forces in the pharmaceutical industry," Alza said April 18.

The launch of Concerta (methylphenidate OROS) is expected in late summer, just prior to the peak season for methylphenidate (Novartis' Ritalin and generics) use during the beginning of the school year and first parent-teacher conferences in October, Alza Group VP Sam Saks, MD, said in a briefing on the company's first quarter 2000 results.

"We plan to be launching in conjunction with McNeil....It's very important that we get the word out by that timeframe," Saks said.

The McNeil sales force will use its expertise in marketing to pediatric and primary care physicians, while the Alza sales force will concentrate on psychiatrists and neurologists.

Alza is building a 120-rep sales force that would target 13,300 psychiatrists, 2,800 neurologists and 3,700 child psychiatrists who currently write prescriptions for ADHD, Alza said. Alza sees Concerta as a stepping stone to creating a specialty central nervous system business.

McNeil will provide 110 reps to detail the once-daily osmotic controlled-release methylphenidate product to pediatricians and 190 reps to primary care physicians. McNeil reps already detail pediatric drugs like Children's Tylenol, Children's Motrin as well as Ocuflox (ofloxacin ophthalmic solution) and Floxin Otic (ofloxacin otic) for a broader population.

McNeil is also understood to be planning a consumer awareness program for Concerta.

The use of psychoactive drugs like methylphenidate in children has increasingly come under White House scrutiny. A March 20 meeting between First Lady Hillary Clinton and HHS Secretary Shalala highlighted the need for proper diagnosis, treatment and monitoring of children with emotional and behavioral conditions.

The White House meeting followed a Journal of the American Medical Association article, which reported that 12.3% of children ages two to four years are currently prescribed stimulants while only 3%-5% of school age children have ADHD (¹ (Also see "FDA Pediatric Cmte. To Discuss Psychotropic Drug Protocols For Preschoolers" - Pink Sheet, 27 Mar, 2000.)).

Alza and McNeil are working on a Concerta educational campaign for physicians. "Coming soon" ads are also in the works.

The user fee deadline for FDA action on Concerta is in July, when the company expects to gain approval for two doses of the product, 18 mg and 36 mg. Alza is planning to file for approval of a 54 mg dose after initial approval. The company estimates that the ADHD market is valued at $700 mil.

As part of the NDA, Alza submitted studies showing that naive patients and those already on immediate/ sustained-release methylphenidate could be switched successfully to Concerta, Saks said.

Concerta's three-phase release formulation is designed for a rapid onset, a sustained effect, then a drop off in the late afternoon when school closes, for a total of 12 hours, the company explained. Ritalin is a sustained-release formulation that acts for eight hours.

Concerta's three-phase profile is best suited for ADHD in school kids, the company contended. "We think a two-pulse profile would be sub-optimal," Saks said. Alza maintained that with a two-pulse profile the drug fluctuates in the bloodstream in crests and troughs.

In addition to methylphenidate, current ADHD treatments include Shire's ADHD once-daily amphetamine product Adderall. Other ADHD therapies in development include Lilly's tomoxetine and Celgene's Attenade, a chirally-pure version of dl-methylphenidate. The firm plans to file an NDA for Attenade later this year.

Concerta sales are included in Alza's $450 mil. sales estimate for fiscal 2000, Saks said. Net sales increased by 13% to $109 mil. in the first quarter over last year's quarter. Sales of products marketed by Alza rose by 17% to $80 mil. in the quarter.