October 22, 2001 - Recent financial presentations to financial analysts by Glaxo SmithKline have put a definite end to the rumors that Dutasteride will not be coming out. In two separate presentations made to investors, Glaxo not only confirmed the expected approval date of their drug, but also made reference to Dutasteride's potential as a hair loss treatment.

John Coombe

In a presentation at the Merrill Lynch Global Pharmaceutical Investor Conference on September 25, 2001, John Coombe, Chief Financial Officer reiterated strategies for growth and discussed the drugs in the R&D pipeline, including Dutasteride.

In a second presentation less than a month later by Dr Placido Grino, VP Medical Affairs Latin America at Lehman Brothers, London on October 10, 2001, more specific information was given about Dutasteride. This included both the expected approval date of Dutasteride by the FDA, and its potential use as a hair loss treatment. According to the presentation, Glaxo expects to have FDA approval for Dutasteride as a BPH treatment in 2002.

Glaxo submitted a new drug application (NDA) in the 4th quarter of 2000 and a marketing approval application (MAA) was submitted in the 3rd quarter of 2001. Upon approval of the NDA expected sometime in November or December of 2001, Glaxo will then submit a supplemental new drug application (sNDA) that includes 2 year's worth of additional data following up the patients who have been using the drug.

If the FDA does approve it by the end of the year, Dutasteride will most likely become available by March of 2002 according to a source at Glaxo. This seems to tie in with the recent presentation, that states that the results of the BPH trials will be announced at the European Association of Urology meeting in February 2002. According to unconfirmed sources, Glaxo submitted data for a 0.5mg dose as well as a 2.5mg dose.

Once Dutasteride is approved for BPH anyone will be able to obtain the drug if their physician is willing to write them a prescription for it which is permitted by the FDA for 'off label' use. In addition it's almost a certainty that the drug will also be available via the internet from offshore drug sellers.

As far as Dutasteride being made available as a hair loss drug, we have seen some information that Glaxo is planning on submitting a NDA for use as a hair loss drug in 2002. However this cannot take place until Glaxo completes Phase 3 studies for hair loss. At this time we are unaware of any activity taking place that would indicate Phase 3 hair loss studies are underway. Most people believe that Glaxo will first see how people respond to Dutasteride as there is some concern about the sexual side effects based on Dutasteride's ability to suppress much more DHT than Finasteride. At this time there is insufficient information to determine if this will be a factor or not.