Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has received final FDA approval for its generic version of Risperdal, and has begun shipping its products.
Petah Tikva-based Teva announced that the US Food and Drug Administration (FDA) has granted final approval for Teva's abbreviated new drug application (ANDA) to market its generic version of Janssen's antipsychotic agent Risperdal (Risperidone) tablets, in dosages ranging from 0.25 mg to 4 mg. Shipment of these products has commenced.
Risperdal is used as a treatment for schizophrenia and some symptoms of autism. The drug is made by Johnson & Johnson (NYSE: JNJ) unit Janssen.
As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
The brand products had annual sales of approximately $2.6 billion in the United States for the twelve months that ended March 31, 2008, based on IMS sales data.
Lehman Brothers analyst Richard Silver reiterated his "Overweight" rating on Teva. He cited the generic Risperdal approval, with its 180-day exclusivity period, as a key factor to his near-term positive view. He also looked ahead to the third quarter's potential release of results from Phase 3 Copaxone 40mg study. Copaxone is currently produced in a lower 20mg dose.
Leader Capital Markets analyst Yoav Burgan had predicted that Risperdal could add $0.10-0.15 to Teva's earnings per share for 2008. Shares in Teva rose 1.3% in Nasdaq trading yesterday to $45.80, giving it a market cap of $35.36 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on July 1, 2008
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