Amar Narayanan

Gilead Continues To Shine, But Watch The Competition

Your article has several factual errors. Just a couple of them...

1. Atripla is still not approved for use in the EU. The approval you seem to be referring to came from the Committee for Medicinal Products for Human Use of the European Medicines Agency. This is only a preliminary approval. The final approval from the European Commission is yet to be obtained, though it is widely expected to come through by end of the year.

2. There is no real competition for GILD's HIV franchise. The Viread-Truvada-Atripla franchise is best-in-class. There is another ten years for patent expiration on the tenofovir molecule used in these drugs.

This franchise remains the dominant method of therapy in the developed world. 65% of all treated patients in the US are put on either Atripla/Truvada/Viread... 80% of new patients in the US receive Atripla/Truvada. With a 10% annual growth in diagnosis in the US and with many of the 250,000 undiagnosed HIV positive Americans soon to begin treatment (following Center For Disease Control & Prevention's recommendation of mandatory HIV testing for patients in 13-64 age group), this number is only likely to grow.

As regards competition, Merck recently got an approval for an integrase inhibitor, Isentress. Gilead plans to counter this with Phase III trials of its own integrase inhibitor, GS9137 or Elvitagravir, in 2008.



Despite the errors in your analysis, I share your bullish sentiment. The story here is mostly HIV. Other products such as Letairis, Darusentan, Viread for Hep-B and Aztreonam Lysine are only poor cousins of the HIV franchise.

Cheers,
Amar