GlaxoSmithKline (GSK) recently announced that it does not intend to seek approval for the use of Avodart (dutasteride) for the reduction of the risk of prostate cancer. The company said that it will withdraw its regulatory applications for the indication across the world.
Moreover, Glaxo intends to work with regulatory agencies on removing the prostate cancer risk reduction indication from the product’s label in countries where it is approved for this indication. Dutasteride is also approved in more than 90 countries for the treatment of benign prostatic hyperplasia (BPH). Besides this, the product is approved in a few countries for the reduction of the risk of acute urinary retention (AUR) and BPH-related surgery.
Decision Based on Feedback from Regulatory Agencies
Earlier this year, the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) for Glaxo’s marketing application for expanding Avodart’s label. The CRL did not come as a surprise as, in Dec 2010, the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted 14-2 against the label expansion. There were 2 abstentions in the voting process.
The panel had expressed concerns about the occurrence of more aggressive tumors in patients taking Avodart compared to patients on placebo (29 versus 19). Similar concerns were raised in Feb 2011 by Sweden, the reference member state in Europe. Based on these concerns, the company decided to withdraw its regulatory applications across the world for the indication.
Avodart sales came in at $975 million sales in 2010, up 17.9%. Glaxo said that Avodart continues to have a favorable risk/benefit profile for the BPH indication.
Neutral on Glaxo
We currently have a Neutral recommendation on Glaxo, which is supported by a Zacks #3 Rank (short-term “Hold” rating). The company’s diversified base and presence in different geographical areas should help support revenue growth. Meanwhile, Glaxo’s restructuring initiative should help offset the impact of increasing generic competition in the next few years.
While we remain concerned about growth with several products scheduled to go off patent in the next few years, we are pleased with the company’s progress with its late-stage pipeline. We expect Glaxo to drive growth through acquisitions and further partnering arrangements. The company’s HIV partnership with Pfizer (PFE) and the Steifel acquisition are the beginning of a trend which we expect to continue going forward.
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
Zacks Investment Research