GSK HIV Drug Receives Priority Status In The U.S.

GSK HIV Drug Receives Priority Status In The U.S.
By Ian Wilson (Flickr) [<a href="">CC BY 2.0</a> or <a href="">CC BY 2.0</a>], <a href="">via Wikimedia Commons</a>

GlaxoSmithKline plc’s (NYSE:GSK) (LON:GSK) drug dolutegravir has been granted priority review status by the U.S. Food and Drug Administration. The HIV/AIDS drug is an integrase inhibitor which keeps the HIV virus from going into cells. The drug is owned by the joint venture ViiV Healthcare, and GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) is the largest shareholder.

GSK HIV Drug Receives Priority Status In The U.S.

Drugs receive priority status if U.S. officials believe they could greatly improve treatments that are currently being used. The FDA is expected to issue its decision on whether dolutegravir is approved for use by Aug. 17.

Nomad Capital: Looking For Businesses That Want To Get Better Every Day

Charlie MungerThe Nomad Investment Partnership had one of the best track records in the hedge fund industry during the first decade-and-a-half of this century. Q3 2020 hedge fund letters, conferences and more Run by Nicholas Sleep and Qais Zakaria between 2001 and 2013, the partnership yielded a total return of 921.1% after performance fees for investors Read More

Reuters reports that thus far the drug has shown positive results in clinical trials. The results have been so positive that GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) has redrawn its agreement with the Japanese drug maker Shionogi & Co Ltd (TYO:4507).

The new agreement gives Shionogi & Co Ltd (TYO:4507) a 10 percent stake in the joint venture in exchange for the company’s shared rights to the HIV/AIDS drug. As a result of that agreement, GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) owns 76.5 percent of the joint venture, while Pfizer Inc. (NYSE:PFE) owns 13.5 percent and Shinogi owns 10 percent.

Industry experts believe dolutegravir will become a strong competitor to Gilead Sciences’ HIV treatments, which are currently the most popular treatments for the disease. They believe the drug could bring billions of dollars in sales for GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) if it is approved and then distributed for treatments.

Meanwhile GlaxoSmithKline’s consumer healthcare division reported an 18 percent increase in net profits for its fourth quarter.

No posts to display