ViiV Healthcare’s Single-Pill HIV Drug Triumeq Cleared by FDA

Zacks

GlaxoSmithKline (GSK) announced that ViiV Healthcare’s Triumeq (a fixed-dose combination of Tivicay, abacavir and lamivudine) has been cleared by the FDA for the treatment of HIV-1 infection.

ViiV Healthcare is also looking to get the HIV drug approved in the EU and has submitted a Marketing Authorisation Application to the European Medicines Agency. The Committee for Medicinal Products for Human Use has already rendered a positive opinion on the drug. The drug will most likely gain EU approval in the third quarter of 2014.

We note that ViiV Healthcare, a company focused on the treatment of HIV, was established by Glaxo and Pfizer (PFE) in 2009. After certain amendments in Oct 2012, Shionogi joined as a shareholder.

Our Take

We are pleased with the approval of Triumeq in the U.S. The single-pill regimen of Triumeq will reduce the pill-burden on patients and improve convenience and compliance. It is also a step forward for Tivicay, having been approved last year as an add-on therapy to other antiretroviral agents.

ViiV Healthcare has been working on developing Tivicay-based therapies. In Jun 2014, ViiV Healthcare entered into an agreement with Janssen R&D Ireland Ltd., a subsidiary of Johnson & Johnson (JNJ), for the development and commercialization of a single tablet combination of Tivicay and Johnson & Johnson’s Edurant.

Glaxo is a Zacks Rank #5 (Strong Sell) stock. A better-ranked stock in the health care sector is Allergan (AGN) carrying a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.

Be the first to comment

Leave a Reply