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GlaxoSmithKline JV wins FDA OK on HIV blockbuster dolutegravir

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The FDA has stamped an OK on GlaxoSmithKline's HIV drug dolutegravir--to be sold as Tivicay. The approval marks another key advance for Glaxo ($GSK) on the regulatory front this year, providing a blockbuster candidate that analysts believe should do very well in competing against Gilead's ($GILD) rival therapies.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

The FDA issued the approval following a priority review.

The once-daily treatment is an integrase inhibitor, blocking the virus from entering cells to spur AIDS. Pushing hard on the late-stage development, GSK redrew the market share for this drug last fall. GSK, the majority owner of the ViiV joint venture, gave up a portion of its equity to Shionogi in exchange for control of the drug. Pfizer ($PFE) also gave up equity as the partners carved out a 10% stake in the venture for the Japanese pharma company.

GSK is clearly pumped about dolutegravir's commercial potential. In a head-to-head study that reported out a bit more than a year ago, the treatment blocked all signs of the virus in 88% of patients after 48 weeks of treatment, compared to 81% for Gilead's Atripla. The data persuaded JPMorgan to raise the chances of regulatory success to a certainty, flagging a new drug worth close to $5 billion a year in potential sales.

GSK and Pfizer set up ViiV more than three years ago, with both committing HIV/AIDS assets and splitting ownership 85% and 15%. After the deal with Shionogi went through, Glaxo owned 76.5% of the joint venture, with Pfizer at 13.5%. Shionogi's 10% will be augmented now with a double-digit royalty stream for the HIV treatment.

This is GlaxoSmithKline's fourth new drug approval so far this year--a major step for a company which has gone through some lean years on the R&D side. The pharma giant has been boasting that its four-year-old R&D restructuring effort is finally paying dividends.

- here's the press release

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