Impax Laboratories, Inc.
) announced that it has started shipping the authorized generic
) 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). The company is
looking for commercialization partners for Rytary outside the
We expect investor focus to remain on further updates from the
company especially on the Hayward manufacturing facility.
Impax carries a Zacks Rank #2 (Buy). Some better-ranked stocks
in the health care sector include
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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