Pipeline updates are eagerly awaited by investors in the biotech/pharma space. An insight into late-stage candidates (including regulatory approval) targeting lucrative markets often influence their investment decisions on a particular stock.
Last week, GlaxoSmithKline (GSK) received some good news on the pipeline front with the European Commission (EC) approving ViiV Healthcare’s Triumeq (a fixed-dose combination of Tivicay, abacavir and lamivudine) for the treatment of HIV-1 infection in patients above 12 years and weighing at least 40kg.
However, before Triumeq can be prescribed to any HIV-infected patient, screening for the presence of a genetic marker, the HLA-B*5701 allele, is recommended. Patients with this genetic marker are at high risk of experiencing a hypersensitivity reaction to abacavir, a component of Triumeq.
The approval by the EC did not come as a surprise as the Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion on the approval of Triumeq in June.
Last month, Triumeq also received FDA approval. ViiV Healthcare is looking to get the drug approved in several other countries including Australia, Brazil and Canada.
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 EU. The single-pill regimen of Triumeq will reduce the pill burden on patients and improve convenience and compliance.
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