Glaxo set for big push into cancer medicine

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GSKGlaxoSmithKline Plc is preparing for a "renaissance" of its oncology business, led by Tykerb, a novel pill that is expected to win U.S. regulatory approval for breast cancer next month.

Oncology head Paolo Paoletti said Monday's launch of a Phase III study in head and neck cancer underlined Tykerb's potential in more tumor types, while four additional cancer medicines could win a marketing green light by 2010.

"We have five drugs that can be approved in the next few years," Paoletti said in an interview.

"If you compare that with the leaders in the field, Roche and Novartis, they have each had four drugs approved in 10 years.

"It's unprecedented ... the approval of Tykerb is just the beginning for us."

Aside from Tykerb, Glaxo has high hopes for pazopanib, a drug to starve tumors of blood supply; HuMax-CD20, a medicine for blood cancers recently licensed from Genmab; and two supportive care products, casopitant and eltrombopag.

All could be approved between 2007 and 2010.

Glaxo also has a therapeutic vaccine for lung cancer that will start final Phase III trials this year, as well as a clutch of earlier-stage products, including five or six drugs which will start human testing in the next 24 months, Paoletti said.

The tally does not include Cervarix, a vaccine against a sexually transmitted virus responsible for most cases of cervical cancer, which has had a delayed path to market but could be approved later this year.

CRUNCH DATE LOOMS FOR TYKERB

The U.S. Food and Drug Administration is due to deliver its verdict on Tykerb by March 13 and most industry analysts expect a positive decision.

The drug is seen as a key test of Glaxo's research and development machine, which was re-engineered at the start of the decade but has so far been slow to get new products to market.

It is unclear, though, how long it will take for Tykerb to generate sales that can move the dial at Glaxo, which had 2006 revenues of 23.2 billion pounds ($45.4 billion), since initial approval will only be for a sub-set of patients who have failed on other treatments.

Dresdner Kleinwort analysts believe Tykerb could still sell 700 million pounds by 2010, simply as a treatment for women with breast cancer who no longer respond to Roche and Genentech's rival product Herceptin.

But broker forecasts for 2010 sales range widely, between 90 million and 900 million pounds, with the more cautious analysts arguing that Tykerb will not hit the big time until it can demonstrate efficacy against Herceptin in early-stage cancer.

That won't happen until after 2010.

Paoletti declined to comment on sales prospects but said he expected strong interest in the product from oncologists and clear differentiation against Herceptin.

"Tykerb is not a 'me-too' drug, it has a completely different mechanism of action," he said.

"It is not an antibody -- it is the first dual-kinase inhibitor and it works within the cell. It is also the first targeted agent to show activity when another targeted agent has failed, which means it offers an incredible opportunity for an unmet medical need."

REPLACING CHEMOTHERAPY

Long-term, Tykerb could help replace toxic chemotherapy, he believes.

"The most interesting part from my perspective is that we will combine Tykerb with our VEGF inhibitor (pazopanib), which is also an oral drug, because we want to move the field forward, with the dream one day to displace chemotherapy," he said.

Glaxo believes it is particularly well-placed to take on rivals on this new frontier of cancer treatment, since Tykerb is a small-molecule medicine that is given as a tablet, while drugs such as Herceptin are antibodies that must be injected.

Copyright © 2007 Reuters

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