Glaxo Challenges Herceptin

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Glaxo to challenge Herceptin at top cancer meeting

Wed May 24, 2006 9:28 AM ET

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By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) hopes to grab the headlines at the world's top cancer meeting early next month with a barrage of data, including key trial results for a new breast cancer pill challenging blockbuster Herceptin.

Until now, cancer has been a small area for Europe's biggest drugmaker, accounting for around 1 billion pounds ($1.88 billion) or 5 percent of group sales, mostly due to anti-nausea drug Zofran, which is given to chemotherapy patients.

But with Tykerb for breast cancer, cervical cancer vaccine Cervarix and platelet-booster eltrombopag all potentially set for launch in 2007, that is about to change.

The June 2-6 annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta will let Glaxo showcase this central plank of its large, but still risky, new drug pipeline.

Glaxo said on Tuesday it would have a bumper 34 data presentations at ASCO, including 13 on Tykerb, a dual-action targeted cancer therapy that analysts say has the long-term potential to be a multibillion-dollar seller.

"It's a very important presence, showing we are starting to become an important player in oncology," Paulo Paoletti, Glaxo's head of cancer drug development, told Reuters.

With cancer now the fast-growing section of the pharmaceutical market -- and one of the most profitable -- ASCO has become a key event for investors as well as doctors.

In addition to its three main new drug hopes, Glaxo will also present clinical findings on therapeutic lung cancer vaccine MAGE-3, an experimental anti-angiogenesis drug called pazopanib and a successor to Zofran known as casopitant.

TYKERB VS HERCEPTIN

Paoletti believes most attention at ASCO will center on Tykerb, which, as a pill, is more convenient than Roche Holding AG's (ROG.VX: Quote, Profile, Research) and Genentech Inc's (DNA.N: Quote, Profile, Research) $1.8 billion-a-year seller Herceptin, which must be injected.

Late-breaking data from a Phase III of Tykerb in women with Herceptin-resistant advanced breast cancer will be shown in a special session on June 3.

Enrolment into the trial was stopped ahead of schedule last month because women given Tykerb plus oral chemotherapy Xeloda did so much better than those on Xeloda alone.

Physicians will learn at ASCO just how big the benefits were, with analysts expecting a greater than 50 percent improvement in extending the time to disease progression.

Glaxo is also expected to report Phase II results showing Tykerb can reach tumors that have spread to the brain -- a problem for 30-40 percent of women with the aggressive HER2 form of the disease whose cancer recurs, according to Paoletti.

Because Herceptin is a large antibody drug, it cannot cross the blood-brain barrier in the same way.

Glaxo still has a fight on its hands, however, since Roche/Genentech are developing combination treatments that could rival Tykerb, while proving Tykerb's value in the big early-stage, or adjuvant, setting will still take several years.

But ASCO could cement confidence in the drug following earlier delays in its development, industry analysts believe.

Progress on MAGE-3 is viewed by analysts as the other key piece of news for Glaxo at the meeting, with results of a Phase II study due to be presented on June 4.

Chief Executive Jean-Pierre Garnier said last month the trial would show the vaccine could effectively prime the body's immune system to attack lung cancer cells.

Data updates on Cervarix and eltrombopag are expected to be confirmatory, rather than ground-breaking.

Taken together, analysts at Sanford Bernstein said in a recent note that success in oncology could increase Glaxo's revenues by as much as 7.5 billion pounds in 2012.

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