US Approval

Holder of Zydena patent in United States, North America, Mexico, and Russia: Dong-A PharmTech is a new drug development company that holds the patent for Zydena (Udenafil: erectile dysfunction treatment) in four regions (e.g., North America, Mexico, Russia).

  1. Upfront payments from licensing out Zydena to local pharmaceutical firms (e.g.,Warner Chilcot, Nycomed);
  2. commission income from milestone payments and running royalties from sales. 2010 OR came in at KRW24.4bn (up 32%YoY), OP at KRW17.5bn (up 35%YoY), and NP at KRW16.4bn (up 42%YoY). Global erectile dysfunction treatment market estimated at USD410mn (18% CAGR): The global market for erectile dysfunction treatments grew at a CAGR of 18% in 2005-10 and reached USD410mn in 2010. Major products include Viagra (46% of the total market), Cialis (40%), and Levitra (14%). Avanafil will be available in the US market sometime late 2012.  Of note, long-acting products such as Cialis are growing rapidly, bolstered by increasing popularity among users and developments in the methods of daily usage. Zydena to hit US market in 2013: Dong-A PharmTech plans to finish Phase III clinical trials for Zydena in 2012 and apply to the US FDA for new drug approval. Upon attaining approval, the company will be able to launch Zydena in the US in 2013.

Zydena’s share of the US market looks set to expand in view of the following:

  • generics for Viagra will not be launched in the US before 2019, when Viagra’s patent expires;
  • Zydena is a long-acting drug like Cialis but is more cost competitive than Cialis.
  • Application for approval to fuel profit recovery in 2012:
  • income following the application of Zydena for FDA approval and royalty income from Russia.