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Mylan’s Recent Commercial and Product Developments

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Mylan’s recent developments

Mylan’s (MYL) recent developments include commercial as well as product developments. Let’s take a look at those developments.

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Commercial developments

Recent commercial developments for Mylan include the following:

  • completed acquisition of the Cold-EEZE brand from ProPhase Labs (PRPH) on January 9, 2017
  • completed acquisition of Meda AB (MEDAA) on August 2, 2016
  • completed acquisition of the topicals-focused business (generic and specialty products) from Renaissance Acquisition Holdings on June 15, 2016

Product developments

Below are some of Mylan’s recent product developments:

  • On December 29, 2016, Mylan received approval from the FDA (U.S. Food and Drug Administration) and launched a generic version of Concerta, a product of Johnson & Johnson’s (JNJ) subsidiary Janssen, for the treatment of attention-deficit/hyperactivity disorder.
  • On December 29, 2016, Mylan launched a generic version of Pfizer’s (PFE) Cerebyx Injection for the treatment of severe seizures.
  • On December 28, 2016, Mylan launched a generic version of Zovia tablets used to prevent pregnancy in women.
  • On December 16, 2016, Mylan launched a generic version of the EpiPen Auto-Injector at a wholesale acquisition cost (or WAC) of $300 for a pack of two auto-injectors.

Below are a few of Mylan’s other product developments:

  • On November 8, 2016, Mylan, in collaboration with Biocon, submitted a BLA (Biologics License Application) to the FDA (U.S. Food and Drug Administration) for a biosimilar of the drug trastuzumab for the treatment of HER2+ breast and gastric cancer. Trastuzumab is the international non-proprietary name for Genentech’s Herceptin.
  • On November 3, 2016, Mylan and Biocon announced that the European Medicines Agency had accepted for review the Marketing Authorization Application for insulin glargine.
  • On November 2, 2016, Momenta Pharmaceuticals (MNTA) and Mylan announced the initiation of a Phase 1 clinical study to compare the safety, immunogenicity, and pharmacokinetics of the drug M834, a proposed biosimilar of Bristol-Myers Squibb’s (BMY) Orencia.

Mylan has more than 250 ANDAs (Abbreviated New Drug Applications) pending FDA approval.

To avoid risk, you can consider ETFs such as the iShares US Pharmaceuticals ETF (IHE), which holds 3.6% of its total assets in Mylan.

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