NJBIZ - J&J Must Supply More Schizophrenia Drug Data to U.S.
NEW BRUNSWICK - Johnson & Johnson must supply more data to United States regulators before they can approve a once-monthly schizophrenia treatment to make up for declining sales of the company’s top -selling drug Risperdal.
The request from the Food and Drug Administration didn’t include a demand for additional studies, New Brunswick-based J&J said in a statement last week. The drug, paliperidone palmitate, is one of two monthly medicines J&J may promote as a successor to Risperdal. J&J is the world’s largest maker of health care products.
Related Results
RisperdalRisperdal approvalRisperdal okayRisperdal doseRisperdal cleared
Risperdal was approved 15 years ago and generated $1.52 billion in revenue in the first half of this year. Prescriptions for the once-a-day pill fell 78 percent from June 27, the week before Teva Pharmaceutical Industries Ltd. began selling its low-cost generic version, and Aug. 1, according to Bloomberg data.
“If you look at the market for these drugs in general, there is a real need for more convenient dosing for patients,” said Linda Bannister, an analyst with Edward Iones & Co. in St. Louis. Patients often fail to take daily pills, she said.
Paliperidone palmitate could generate $500 million in annual sales by 2012, Bannister estimated. The number could change depending on the prospects for J&J’s other slow-acting schizophrenia medicine, Risperdal Consta, and for products that competing companies are developing, she said. Eli Lilly & Co. is testing a long-lasting version of its once-a-day Zyprexa, according to Bannister.
NEWER RISPERDAL
Risperdal Consta, a newer version of Risperdal, is injected in the buttocks twice a month. Alkermes Inc., the Cambridge, Mass., company that developed Risperdal Consta for J&J, is working on a monthly formulation of the drug.
Whether J&J will put its marketing strength behind paliperidone, a reformulated Consta, or both depends on how Consta does in clinical studies to be completed next year, said Dominic Caruso, J&J’s chief financial officer, on a conference call with analysts last month.
Antipsychotics were the sixth best-selling class of medications worldwide in 2007. Risperdal, Bristol-Myers Squibb Co.’s Abilify and Zyprexa generated $20.7 billion in sales last year, according to IMS Health, a market research firm in Norwalk, Conn.
Paliperidone palmitate uses the same chemical ingredient as J&J’s Invega, a schizophrenia tablet taken once a day. The monthly dose of paliperidone, injected in the arm, is simpler for patients, J&J spokesman William Price said in an e-mail.
TEVA COPIES
Teva, of Petah Tikva, Israel, began selling copies of Risperdal in June, after the J&J drug lost U.S. patent protection. Risperdal sales in the U.S. fell 9 percent in the second quarter as customers began making room in their inventories for the generic pill, Caruso said on the call. Sales dropped 37 percent in other countries, where the generic brand was already on the market.
Paliperidone’s patent protections expire in 2013 in the U.S. and 2017 elsewhere, said Louise Mehrotra, J&J’s vice-president for investor relations. Consta’s patents expire in 2014, though the longer-acting formulation would have protection until 2017.
Copyright Journal Publications Inc. Sep 1, 2008
Provided by ProQuest Information and Learning Company. All rights Reserved
