The US Food and Drug Administration (FDA) has ordered Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) to pull its generic version of antidepressant Wellbutrin, Budeprion, after finding that the 300-milligram dosage was not therapeutically equivalent to the brand drug. Teva Pharmaceuticals USA Inc. markets Budeprion, which is manufactured by Impax Laboratories Inc. (Nasdaq: IPXL), and they have stopped shipments.
Budeprion has been sold in the US for six years. The FDA said that it started receiving reports from patients who were experiencing reduced efficacy after being switched from Wellbutrin to its generic counterparts, and that the problems appear to be associated with the Impax/Teva product.
The FDA instructed Teva and Impax to carry out a study to verify the claims, but they could not recruit enough patients. The FDA therefore carried out its own study, and found that the Impax/Teva version was not as effective as brand Wellbutrin, which is produced by GlaxoSmithKline plc (NYSE; LSE: GSK).
UBS believes that the decision will not have a material effect on Teva, because Budeprion had $9 million in sales in 2011.
Teva said that its priority was patients, and that it aimed to provide the highest quality medications. "Upon receipt of the FDA notice, Teva immediately halted shipments of the product. The updated FDA guidelines relate to the product's biological level of similarity with the brand drug, and do not relate to any safety problems with its use," Teva told "Globes" in response.
In addition to its regular generic business, Teva develops biosimilars (generic biological drugs). In this field, the company has suffered delays in one of the flagship products. Teva and its Swiss partner Lonza AG (SWX: LONN) are developing a biosimilar of Rituxan, a brand drug made by Roche AG (SWX: ROG) for the treatment of certain cancers and arthritis, which had $5.5 billion in sales in 2011, including $1 billion in sales for treatment of arthritis.
A clinical trial in Europe of Teva's biosimilar for the treatment of arthritis has been postponed, and it is not clear when it will be resumed. A corresponding trial in the US is in the early stages, and Teva is reportedly considering conducting a later phase trial under US and EU protocols.
Published by Globes [online], Israel business news - www.globes-online.com - on October 4, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012