The financial terms of the agreement were not disclosed.
As per the agreement, Impax will acquire Ursodiol tablet and Lamotrigine orally disintegrating tablet. We note that the Abbreviated New Drug Application (ANDA) for Lamotrigine has been approved but the product is not marketed yet.
The acquisition will broaden Impax’s generics’ portfolio which includes generic Adderall XR, fenofibrate (generic to Lofibra) and oxymorphone HCI ER.
We note that Impax has been working actively on strengthening its generic products portfolio in recent times. In Apr 2014, Impax had launched the authorized generic version of Sanofi’s (SNY) Renvela, which will significantly boost the top line in 2014. Moreover, Impax is seeking approval for its pending ANDA for generic Renvela with the FDA.
Meanwhile, Impax is looking to get its late-stage candidate, Rytary, approved for the symptomatic treatment of Parkinson’s disease. The FDA accepted Impax’s re-submission of New Drug Application (:NDA) for Rytary in Apr 2014.
The FDA will inspect the manufacturing facilities involved in the production of Rytary. A response from the agency should be out by Oct 9, 2014. Impax also intends to file for EU approval for Rytary in the second half of 2014.
Impax currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the healthcare sector might consider Mallinckrodt plc (MNK), which carries a Zacks Rank #2 (Buy).
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