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GSK looks ahead to surge of products in 2006

Published on 10/02/06 at 10:10am

GlaxoSmithKline has unveiled strong growth in sales and earnings in 2005, and is preparing for a series of key filings, approvals and launches in 2006.

Sales of the company's number one product Seretide/Advair were up nearly a quarter in 2005, while diabetes franchise Avandia/Avandamet rose 18%.  The company's vaccine business was another key contributor to overall growth of 8% in revenues.

Earnings per share shot up by 18% and chief executive Jean-Pierre Garnier said the fourth quarter had been a great finish to the year.

Looking ahead to the coming year, Garnier said: "Eight major assets are scheduled to enter phase III in 2006  this will double the number of late-stage development.

"I am also delighted that Cervarix, our cervical cancer vaccine, is expected to be filed for approval in Europe in the next few weeks and in the USA before the end of the year."

Garnier was quizzed about the company's interest in acquiring European biotech Serono or Pfizer's consumer health business - both currently for sale - but refused to be drawn.

"I cannot comment on specific deals," he said. "We keep an eye on what's for sale and we will take a look at everything. You have got to have the right opportunity at the right price. That's a rare combination."

Garnier indicated that the prospects for Cervarix were promising, but said the outlook for a new Cox-II inhibitor in its pipeline was not encouraging, with clinical trials failing to show any qualities to mark it out from existing drugs in the class.

GSK's 2006  - expected highlights

Launch of Avandaryl

The new diabetes treatment is the first to combine a glitazone ( rosiglitazone, brand name Avandia) with a sulfonylurea (glimepiride or Amaryl) and was launched in the US at the beginning of February.

EU approval is expected in the second quarter of 2006, and the drug is expected to boost sales of the franchise, already over $2 billion a year.

Launch of Rotarix

New two dose oral vaccine to prevent rotavirus gastroenteritis in infants, which kills half a million children every year in developing countries, and accounts for a third of hospital admissions from diarrhoea worldwide.

Rotarix is already approved in 31 markets and is expected to be launched in Europe in the second quarter.  The vaccine could be of huge benefit to public health around the world and earn the company up to $1.8 billion in peak sales.

Merck have received approval for a rival vaccine, Rotateq.

Tykerb filing

An innovative oral treatment for breast cancer, Tykerb is on course for regulatory filing in late 2006 / early 2007. The drug has been shown to be effective in treating patients with the HER2 form of the disease who have developed resistance to Roche's Herceptin.

The drug is also being studied in renal cancer, inflammatory breast cancer and brain metastases, with results due for publication in June.

Phase III developments

Eight major candidates will enter phase III this year, including denagliptin, a new DPP-IV inhibitor for type II diabetes, and brecanavr, a protease inhibitor treatment for HIV.

An extended release version of rosiglitazone (Avandia) is also entering studies for the treatment of Alzheimer's disease, while the drug is also being combined in one tablet with simvastatin to create a dual diabetes and high cholesterol treatment.

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