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Mylan Looking to Get Generic Version of Zytiga Approved

Zacks Equity Research
Updated

Mylan MYL has submitted an abbreviated new drug application (ANDA) to the FDA for the approval of its generic version of Johnson & Johnson’s JNJ blockbuster drug, Zytiga. Zytiga is indicated in combination with prednisone for the treatment of patients suffering from metastatic castration-resistant prostate cancer. As per IMS Health, for the 12 months ending Jun 30, 2015, the product generated U.S. sales of approximately $1.08 billion.

Mylan believes that it is the first company to file an ANDA for the generic version of Zytiga and should be entitled to 180 days of generic market exclusivity in the event of the FDA clearing the ANDA.

BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC have sued Mylan in connection with the filing of the ANDA.

The company’s generic unit has 268 ANDAs pending FDA approval. The ANDAs represent annual sales of $101.3 billion, according to data released by IMS Health. Mylan believes that 50 of these pending ANDAs are potential first-to-file opportunities. Data released by IMS Health further revealed that these 50 ANDAs represent annual branded sales of $33.4 billion for the 12 months ending Dec 31, 2014.

Meanwhile, the FDA has issued a warning letter to Mylan relating to its Agila Specialty Formulation Facility, Sterile Product Division and Onco Therapies Limited sites in India. The FDA warning letter is not expected to have a material impact on Mylan’s business or its previously announced full year earnings guidance. The company expects adjusted earnings per share in the range of $4.15 to $4.35. The Zacks Consensus Estimate of $4.20 is within the guided range.

Mylan carries a Zack Rank #3 (Hold). A couple of favorably ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Infinity Pharmaceuticals, Inc. INFI. While Valeant carries a Zacks Rank #1 (Strong Buy), Infinity Pharma holds a Zacks Rank #2 (Buy).

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VALEANT PHARMA (VRX): Free Stock Analysis Report
 
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MYLAN NV (MYL): Free Stock Analysis Report
 
INFINITY PHARMA (INFI): Free Stock Analysis Report
 
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