from the WSJ--Glaxo seeking UK approval for Tykerb(lapatinib)

[Lani]

for our European her2support members:.
Glaxo Seeks Approval
To Sell Cancer Drug Tykerb
Associated Press
October 9, 2006 3:48 p.m.
LONDON -- GlaxoSmithKline PLC said Monday it is seeking regulatory approval to sell its breast cancer drug Tykerb -- one of the most promising high earners in its pipeline of new medicines -- in Europe.



Glaxo has already lodged an application with the U.S. Food and Drug Administration to approve Tykerb. The FDA last month gave the drug so-called "fast track" status, which may lead to quicker approval.

Glaxo is applying to the European Medicines Agency to market the pill in Europe in combination with Roche Holding AG's chemotherapy treatment Xeloda, for the treatment of advanced breast cancer in women who have received other therapies.

The company said it hopes to launch Tykerb, also known as lapatinib ditosylate, in both markets next year, but declined to comment on its sales prospects. The drug is one of the most promising in Glaxo's pipeline -- analysts say it could bring in revenue of more than $1 billion each year.

"A few people have been skeptical about Tykerb because they saw a limited market, but oncologists will vote with their prescribing pen when they see good data," said Mike Ward, an analyst at Nomura Code.

Ward added that the drug's use was likely to widen to earlier stages of breast cancer, increasing its sales prospects.

The findings of an international study on the drug presented earlier this year to the American Society of Clinical Oncology found that it delayed the growth of advanced breast cancer in women who had stopped responding to rival Roche Holding AG's drug Herceptin and were out of treatment options.

Patients who received Tykerb plus the chemotherapy drug Xeloda had no growth of their tumors for 8 1/2 months. That compares to 4 1/2 months for those given only Xeloda, according to the team led by Charles Geyer Jr. of Allegheny General Hospital in Pittsburgh.

Tykerb is a pill taken daily while Herceptin is given intravenously every month. Glaxo said that there are more than 360,000 new cases of breast-cancer diagnosed every year in Europe.

"We hope that lapatinib [Tykerb] will offer these patients a much needed effective alternative treatment," Paolo Paoletti, senior vice president of Glaxo's oncology medicine development center, said in a statement.

Glaxo said it aims to have filed for approval to sell Tykerb in Australia, Canada and a number of countries in Asia, Latin America and the Middle East by the end of the year.

Copyright © 2006 Associated Press

[Sandy H]

This is wonderful for our sisters out of the country. I myself would like to see everyone have access to this drug that is working wonders for myself. Looks like its being worked on. I realize not everyone will get the response I have had but they should have the chance of giving it a try. Great news. Sandy

[Christine MH-UK]

Since GSK is seeking a license for the whole of the Europe Union, not just the UK. Since her2support attracts people from all over the European Union, maybe the title needs a correction.

I am glad to see that things are moving so fast on the approval.

Lani, how do you find the time to post so much? You are amazing.

Take care,

Christine

[Lani]

substitution of UK in title instead of EU due to jetlag on my part (9hr time difference and 20+hours of travelling)! Departed EU via UK! Terrible mess at Heathrow (bomb scare occurred during my time at LHR, just in next terminal) must have been on my mind. Am not sure if I can edit the title or just the content.???

[tousled1]

When I lived in Europe I found that a lot of drugs that were by prescription only in the US were sold off the shelf in Europe. Perhaps they will get Tykerb approved there before it is approved in the US.

[Lani]

you even had to have a prescription for aspirin! The pharmacists' lobby is very strong there. From what I understand the price of tykerb, I doubt it will be available over the counter as the pharmacists will not keep it in stock (inventory would be too expensive).

I may be wrong, but this is my take on it.

Now in Russia, you may be able to get anything for a price...but it might also be a fake!