Impax Laboratories, Inc. (IPXL) announced that it has started shipping the authorized generic version of Sanofi’s (SNY) Renvela (800 mg) under its settlement agreement with the latter. The drug is approved for the control of serum phosphorus in patients suffering from chronic kidney disease (:CKD) and dependent on dialysis.
We note that Impax’s settlement agreement with Sanofi allows it to sell generic versions of two other products − Renagel and Renvela (for oral suspension) starting on Sep 16, 2014, pending U.S. Food and Drug Administration (:FDA) approval for its abbreviated new drug applications (ANDAs) for these products.
Meanwhile, Impax is looking to get its ANDA for generic Renvela approved by the FDA. Approval would allow the company to launch its generic version later this year.
The launch of the authorized generic version of Renvela is an important event for Impax. Renvela’s U.S. sales were about $907 million in the 12 months ended Feb 2014, as per IMS Health.
Impax expects the sale of authorized generic Renvela to generate net profits of approximately $50 million−$70 million in 2014.
Meanwhile, Impax’s Rytary is under FDA review for the symptomatic treatment of Parkinson's disease (PD.TO). The company is looking for commercialization partners for Rytary outside the U.S.
We expect investor focus to remain on further updates from the company especially on the Hayward manufacturing facility.