Impax said Tuesday that the purchase — covering solid oral, inhalable, injectable and topical dosage forms — includes a group of 15 currently marketed generic products; one approved generic product and two approved strengths of a currently marketed product, which have not yet launched; one pipeline generic product and one pipeline strength of a currently marketed product, which are pending Food and Drug Administration approval; and one generic product under development.
The acquisition also includes the full commercial rights to Impax’s pending ANDA for the generic equivalent to Concerta (methylphenidate hydrochloride), a product previously partnered with Teva.
Impax is buying the products as Teva continues to divest assets to gain Federal Trade Commission clearance for its acquisition of Allergan’s generics business. The Impax transaction is pending customary closing conditions, including the FTC’s approval of Impax as buyer of the generic assets and Teva’s completion of the Allergan generics acquisition.
“The anticipated acquisition of these currently marketed and pipeline products fits with our strategic priorities of maximizing our generic platform, optimizing R&D and accelerating business development to create long term growth,” stated Fred Wilkinson, president and chief executive officer of Impax. “Through this transaction, we will be expanding our portfolio of difficult-to-manufacture or limited-competition products and maximizing utilization of our existing manufacturing facilities in Hayward, Calif., and Taiwan.
“The acquisition of full commercial rights to generic Concerta provides an additional opportunity to add another valuable near-term launch and accentuates the strength of our internal R&D program,” he added.
Impax said the acquired marketed generic products generated about $150 million in net sales. Citing figures from IMS Health, Impax said the pending and development pipeline programs are estimated to have U.S. brand and generic sales of approximately $3.1 billion for the 12 months ended in March.
“The anticipated addition of 15 marketed products from the transaction is currently expected to add approximately $80 million of revenue in the second half of 2016 and is expected to offset the revenue decline from recent competition on our diclofenac sodium gel and metaxalone products,” according to Wilkinson. “However, the anticipated product portfolio from the transaction is currently expected to add approximately $50 million to our 2016 EBITDA, expand our gross margins by several hundred basis points and provide a boost to our EPS, which is currently expected to increase by at least 20% over the prior year.”