Bristol, Lilly Race to Sell Teen Antipsychotic Drug

(May 23, 2007) -- (Bloomberg) -- Bristol-Myers Squibb Co. said it will seek U.S. approval to market its Abilify antipsychotic for schizophrenia in teens. Separately, Eli Lilly & Co. said regulators delayed clearing its Zyprexa for the same use.

The company comments came as the two drugmakers reported separate study results at a medical meeting in San Diego today. Abilify worked in teens without causing significant weight gain or sexual dysfunction, one study said. Zyprexa had double the risk of weight gain in adolescents than in adults in a different study reported at the meeting.

No drugs are currently approved in the U.S. to treat schizophrenia in teens. The medications made by Bristol-Myers and Lilly are competing with Johnson & Johnson's Risperdal to be the first. The J&J drug may be cleared for teen schizophrenia and bipolar disorder by June, the company said today. Drugmakers sold more than $15 billion in antipsychotic drugs last year, according to data compiled by Bloomberg.

``There's no gold standard for treating schizophrenia in teens and the first company to get FDA approval for this will have a bit of an edge in this very crowded market of atypical antipsychotics,'' said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in a telephone interview.

Atypical antipsychotic drugs are newer drugs with fewer side effects. Their use in children has risen sharply recently, prompting concern among doctors and parents because the drugs cause weight gain and trigger diabetes and aren't approved for use in children. Lilly is being sued by attorneys general of Utah and Montana for inappropriately marketing Zyprexa to children with psychiatric condition.

Time to Analyze Data

Lilly said today it received a so-called approvable letter for Zyprexa from the FDA on April 30. Approvable letters typically are used by the agency to tell drugmakers what's needed for marketing clearance. The FDA wanted more time to analyze data on the drug, and discuss its prescribing guidelines, the Indianapolis-based company said today.

The company said it didn't release information about the letter when it was received because it wasn't required to do so under securities laws. The company is seeking approval of Zyprexa for both schizophrenia and bipolar disorder in teens.

``We are one step closer to being able to provide an answer an unmet medical need and make sure clinicians have more information to make a difficult treatment decision about this patient population,'' said Carole Puls, a Lilly spokeswoman, in a telephone interview today.

Schizophrenia causes distorted thinking, hallucinations and an inability to feel normal emotions. Approximately 1 in 100 people have the disorder, and a third of them develop it in adolescence, said Robert Findling, the author of the Abilify study and professor of psychiatry at Case Western Reserve University in Cleveland, Ohio.

Effectiveness

Abilify was found in a study to be safe and effective in teens from age 13 to 17 at doses of 10 milligrams and 30 milligrams, with 85 percent of patients remaining on the drug through six weeks. Zyprexa was found to be effective in treating schizophrenia and bipolar disorder in 13 to 18 year olds.

``Most kids right now are being treated with atypical antipsychotics even though the drugs aren't approved for this use,'' Findling said in a telephone interview today. ``FDA approval would give physicians a sense of confidence about the scientific data of this use and also give parents some reassurance.''

Bristol-Myers spokesman Jeffrey Macdonald said the Abilify data, presented at a meeting of the American Psychiatric Association, would be used to seek U.S. regulatory approval of the drug for treating teens.

He declined to comment on how soon the company would file an application with the Food and Drug Administration.

Dec. 21 Request

J&J asked the FDA to approve Risperdal for schizophrenia and bipolar disorder in teens on Dec. 21, company spokesman Srikant Ramaswami said today in a telephone interview. Regulators typically take six months to review pediatric medicines, he said.

In the Zyprexa study of 454 patients, children between 13 and 18 were more than twice as likely to have significant weight gain as adults taking the drug with 65 percent of adolescents gaining 7 percent or more of their weight compared with 36 percent in adults.

``Head to head trials of these drugs haven't been done yet to know which one will be most appropriate for which adolescent patient or why,'' Findling said. ``Right now, the drugs are prescribed off-label, and I'm not sure how many physicians will change their prescribing habits based on one getting FDA approval specifically for adolescents.''

Weight Gain in Kids

Children may have had more weight gain because the adults have already gained weight from taking other antipsychotic medications, many of which also cause weight gain, Lilly medical officer Sara Corya said.

Zyprexa also caused a greater increase in prolactin in teens than adults. That may be related to the adolescents changing hormones, she said. High levels of prolactin have been linked to an increase in sexual dysfunction, studies have found.

U.S. regulators wanted more time to analyze the data and discuss the drug's prescribing information, Corya said. She didn't have a timeline for when a decision will be reach. There are no ongoing studies of the drug in children, she said.

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Sales of Abilify climbed 41 percent to $1.3 billion last year. Its biggest rivals are Eli Lilly & Co.'s Zyprexa, which generated $4.4 billion, and Johnson & Johnson's Risperdal, with sales of $4.2 billion.

Lilly has struggled to increase Zyprexa sales in the past two years because of negative publicity about the drug's weight gain, analysts have said.

By: Lisa Rapaport and Shannon Pettypiece
Source: Bloomberg.com

Last updated: 05/07

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