Will GSK’s Dolutegravir Ultimately Supplant Merck’s Isentress®, In 2013?


Merck’s Isentress® holds an enviable position at the moment, in the market for HIV therapies — at over $18,000 a year (administed twice a day), it is the only true integrase inhibitor presently on the market. And by all accounts, it works.

Earlier today, Glaxo (with its Japanese Chinese partner) reported very encouraging top-line results in a late Phase III trial for its dolutegravir candidate. It need only be taken once a day, and it is showing results equal to Isentress in treatment naive patients.

Glaxo’s spokesperson said it is still possible that FDA will accept it for an NDA filing in 2012. That could mark a 2013 approval, and some serious erosion to the Merck blockbuster’s market dominance. Stay tuned, but here is the Wall Street Journal on it all — do go read; here’s a bit:

. . . .”This marks an important milestone for the development of dolutegravir and the Shionogi-ViiV Healthcare joint venture. We look forward to completing further Phase III studies in a variety of clinical settings in order to fully understand the potential clinical benefit for a range of HIV patient populations,” said Tsutae Nagata, Shionogi’s chief medical officer.

Full results of the Spring-2 study will be presented at an upcoming scientific meeting. It is the first of four Phase III studies on dolutegravir due to be reported this year which are designed to support regulatory filing of the experimental product and are keenly watched by experts and investors, as the full picture of the efficacy and safety of dolutegravir has not been conclusively determined.

“The anticipated timing of the remaining registration studies means we could potentially file dolutegravir in 2012,” a Glaxo spokesman said. . . .

As I say — do stay tuned. Merck may well open off on the NYSE tomorrow.

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