The US Food and Drug Administration (FDA) recently released briefing documents ahead of the review by its Pulmonary-Allergy Drugs Advisory Committee of the New Drug Application (NDA) of Theravance/Glaxo’s /(GSK - Free Report) candidate FF/VI (furoate/vilanterol, proposed brand name: Breo Ellipta). The FDA panel is scheduled to review the NDA on Apr 17, 2013.
The companies are looking to get the candidate approved as a long-term, maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from chronic obstructive pulmonary disease (COPD). In the briefing documents posted on the FDA’s website, the reviewers stated that the overall safety data submitted in the NDA was consistent with similar drugs.
In its briefing documents, the FDA has asked the panel to analyze the risk-benefit profile of the candidate. We remind investors that the NDA was accepted for review by the FDA in Sep 2012. A final decision from the US regulatory body is expected by May 12, 2013. Although the FDA is not bound to accept the recommendation of the advisory panel it does pay heed when reviewing new drug applications.
We note that Glaxo and Theravance are also looking to get another COPD candidate approved. In Feb 2013, the FDA accepted the regulatory application of Glaxo/Theravance’s UMEC/VI (proposed trade name: Anoro). The companies are looking to get the candidate approved in the US as a once daily therapy for treating patients suffering from COPD. A decision from the US regulatory body on UMEC/VI’s NDA is expected by Dec 18, 2013.
We are positive on Theravance’s pipeline programs in collaboration with Glaxo. We note that Glaxo has a robust pipeline. A number of pipeline-related news is in fact expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo’s pipeline must deliver.
Glaxo, a large cap pharma stock, carries a Zacks Rank #4 (Sell), reflecting short-term pressure on the stock. Novartis (NVS - Free Report) appears to be more favorably placed in the large-cap pharma space with a Zacks Rank #2 (Buy).
Theravance, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Celgene Corporation (CELG - Free Report) is more favorably placed in the biopharma space carrying a Zacks Rank #2.