Cancer drug approval clears way for 150 jobs boost

THE US Food and Drug Administration last night cleared the way for production of a new drug which will lead to the creation of 150 new jobs in Cork.

GlaxoSmithKline, which plans to introduce five new treatments this year, won US approval to sell the drug Tykerb for breast cancer.

The drug will now be manufactured at the company’s Cork plant.

The company already employs between 600 and 700 in Cork.

The production of the new drug will result in a €150 million investment in the Currabinny factory and Glaxo has already secured planning permission for the expansion of the plant.

Yesterday, the US regulator approved the once-daily pill in combination with Roche Holding’s Xeloda for treatment of advanced breast cancer in women who carry the HER-2 gene and don’t respond to Roche’s Herceptin drug.

HER-2 positive breast cancer is a more aggressive form of the disease.

Tykerb belongs to a class of drugs known as dual-kinase inhibitors, which impede the growth of tumour cells.

Tykerb is one of the medicines Glaxo is relying on to help counter slowing growth in sales of its top-selling asthma drug Advair and the loss of patent protection on other products.

The company is also seeking a bigger share of the €26.5bn global cancer market dominated by Roche and Genentech. The Glaxo pill may rival Herceptin, which is given in monthly infusions and brought in €2.4bn for Roche in the fourth quarter of 2006.

“The data to date is very promising,” analyst Gbola Amusa of Sanford C Bernstein in London said in a telephone interview.

“Oncologists and breast cancer specialists we’ve spoken to would say these are some of the most promising data sets they have seen.” A late-stage trial of 324 women given Tykerb and Xeloda found it took 8.4 months until their advanced or metastatic breast cancer progressed, compared with 4.4 months in women given Xeloda alone, a US researcher told the American Society of Clinical Oncology in June.

Mr Amusa estimated Tykerb will bring in $258m (€195.5m) for Glaxo in the US by 2010 and $1.1bn (€833m) by 2015.

Glaxo, the world’s second largest drug maker after Pfizer had sales of €33.94bn in 2006, about half of which came from the US.

The drug maker applied to sell Tykerb in the US in September and was awarded a ‘fast-track review’ from the FDA in November.

An application filed with the European Medicines Agency has been pending since October.

Breast cancer is the most common cancer in women, affecting about one million women a year worldwide, according to the World Health Organisation.

An estimated 212,920 new cases of the disease were diagnosed in the US in 2006, according to the American Cancer Society, a patient advocacy group.

About 8,000 to 10,000 women die from the HER-2 positive form of breast cancer each year, the FDA said in a statement.

More than 360,000 new cases of breast cancer are diagnosed in Europe every year, Glaxo says.

In a separate statement, Glaxo said it will offer Tykerb for free to low-income Americans without health insurance.

Patients enrolled in the Medicare plan for the elderly and disabled may be eligible if they spend $600 (€455) a year on other drugs, Glaxo said.