Theravance Inc. (THRX) announced that its supplemental new drug application (sNDA) for Breo Ellipta is scheduled to be reviewed by the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee on Mar 19, 2015.
We note that Theravance and partner GlaxoSmithKline (GSK) are seeking to expand the label of Breo Ellipta in the U.S. for the once-daily treatment of asthma in patients aged 12 years and above. A final response from the FDA is expected by Apr 30, 2015.
We note that Breo Ellipta is already approved in the U.S. as a long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. The drug is also approved for the reduction of exacerbations in COPD patients.
Another approved respiratory product under Theravance’s partnership with Glaxo is Anoro Ellipta. The drug is approved for the treatment of COPD.
We note that Theravance receives and recognizes royalties on sales of these two respiratory products under an agreement with Glaxo entered into in Nov 2002.
We remind investors that Theravance had split into two independent, listed companies last year. While Theravance, Inc., a royalty management company, deals with products/candidates under the Glaxo partnership, Theravance Biopharma (TBPH) focuses on the discovery, development and commercialization of small-molecule therapies targeted across a number of therapeutic areas including bacterial infections, central nervous system/pain, respiratory disease and gastrointestinal motility dysfunction.
Theravance currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is Ophthotech Corp. (OPHT) 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
Be the first to comment