Valeant Pharmaceuticals International, Inc.'s
) 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
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
Actavis also settled its patent litigation with
) 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
Actavis currently holds a Zacks Rank #3 (Hold).
) currently looks attractive with a Zacks Rank #2 (Buy).
ACTAVIS INC (ACT): Free Stock Analysis Report
ASTRAZENECA PLC (AZN): Free Stock Analysis
MYLAN INC (MYL): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.