Actavis, Inc. (ACT), and Valeant Pharmaceuticals International, Inc.’s (VRX) Medicis Pharmaceutical Corporation recently entered into settlement agreements regarding a couple of Abbreviated New Drug Applications (ANDAs) filed by Actavis.
Actavis had filed ANDAs seeking US Food and Drug Administration (:FDA) approval for its generic versions of Valeant’s Ziana and Zyclara.
According to the terms of the settlement agreements, Actavis can now launch its generic versions of Ziana and Zyclara in Jul 2016 and on Jan 1, 2019, respectively. Actavis may, however, launch its product earlier under certain circumstances. While Ziana is approved for the topical treatment of acne vulgaris in patients 12 years or older, Zyclara is prescribed for the treatment of actinic keratosis on the full face or balding scalp in adults with a normal immune function.
Although detailed financial terms were not available, the companies said that Valeant will be entitled to a share of the economics from the generic products sold by Actavis under these agreements.
This is the second deal to be signed by Actavis and Valeant this month. Earlier, the company had entered into an agreement whereby Actavis will exclusively market and distribute an authorized generic of Valeant's Zovirax ointment.
Actavis also gained exclusive rights to co-promote Zovirax cream to obstetricians and gynecologists in the US by using its existing Specialty Brands sales and marketing structure.
In return, Valeant gained exclusive right to co-promote Actavis’ Cordran Tape in the US, which is indicated for treating inflammation and itching caused by skin allergic reactions, eczema and psoriasis. Valeant will co-promote the drug using its dermatalogy sales and marketing structure for a co-promotion fee on sales.
Actavis also settled its patent litigation with AstraZeneca (AZN) regarding Crestor tablets (5, 10, 20 and 40 mg). Crestor is slated to lose exclusivity in the US on Jul 8, 2016 (including pediatric exclusivity). As per the terms of the agreement, Actavis may launch its generic version of Crestor 67 days before Crestor loses exclusivity on paying 39% of net sales to AstraZeneca.
Actavis currently holds a Zacks Rank #3 (Hold). Mylan (MYL) currently looks attractive with a Zacks Rank #2 (Buy).
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