Roche cancer and osteoporosis drugs get EU nod

ZURICH - Medicines for lung cancer and osteoporosis developed by Roche Holding AG have received positive recommendations from a panel of EU doctors, paving the way for their launch in Europe.

Roche said on Monday that Tarceva, one of a new class of drugs for cancer patients, had been given a positive opinion by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of non-small-cell lung cancer.

"This decision is proof of the impressive survival benefit that Tarceva offers patients with late stage lung cancer," William Burns, chief executive of Roche's pharmaceuticals division, said in a statement.

The drug's recommended approval covers patients with advanced or metastatic forms of non-small-cell lung cancer, the most common form of the disease, and for whom other treatment options have failed.

Tarceva was co-developed by Roche, Genentech, the US biotech firm in which Roche has a majority stake, and OSI Pharmaceuticals Inc. It targets EGFR, epidermal growth factor receptor, to block tumour cell growth.

It was approved for use in the United States in November and Switzerland in March. Roche has also filed for approval of Tarceva in the United States in advanced pancreatic cancer.

Prospects for the drug were given a boost earlier this month after the US Food and Drug Administration (FDA) restricted access to a rival cancer drug Iressa, made by AstraZeneca on the grounds it did not help patients live longer.

Tarceva has already been shown to work better than Iressa and analysts have said the drug could generate annual sales of some $1.6 billion by 2009.

Roche certificates were last trading 0.2 per cent higher at 159 Swiss francs, in a weaker Swiss market. The stock has gained 21 per cent this year, thanks in part to the sales potential of a portfolio of cancer drugs which Roche has built up through its partnership with Genentech.

In a separate statement, Roche said the once-a-month osteoporosis drug Bonviva, or Boniva in the US market, which it co-promotes with Britain's GlaxoSmithKline, had also been recommended for approval by the CHMP.

Official EU approval usually follows within 90 days after the CHMP gives a positive recommendation, suggesting an approval for both drugs before the end of September, slightly ahead of expectations in Tarceva's case.

Once-monthly Bonviva was approved in the US in March and is the first ever oral once-a-month single tablet for any disease.

Analysts expect the drug to be popular with patients who find current treatments inconvenient due to the fact they need to be taken daily, in the morning, on an empty stomach and patients must remain upright for 30 to 45 minutes.

"This is particularly important as almost two thirds of patients stop taking their oesteoporosis treatment within a year, foregoing the bone building benefits these drugs can provide over time," Lombard Odier Darier Hentsch analysts said.

A daily version of the pill was first approved by the Food and Drug Administration in 2003 but was never launched as they explored a more convenient dosage for the brittle-bone drug.

Bonviva/Boniva is part of a popular class of the drugs known as bisphosphonates that aim to treat post-menopausal women with osteoporosis, a market which has annual multibillion-dollar sales potential.

Bonviva/Boniva will compete with Merck & Co Inc.'s Fosamax and Sanofi-Aventis SA/Procter & Gamble Co's Actonel.

Analysts have forecast sales for the drug of more than US$750 ($1077.12) million by 2009. However, some have said that the market may be underestimating the potential for the drug, which could benefit from Glaxo's marketing clout.

Roche and Glaxo are also seeking US approval for an intravenous form of Bonviva/Boniva to be given once every three months.

- REUTERS