OSI / Roche / Genentech: European approval would confirm Tarceva's lead

An EMEA committee has recommended approval of Tarceva in an advanced non-small cell lung cancer (NSCLC) indication. If granted, the approval should make Tarceva the leading drug of its kind in the lung cancer market, as well as strengthening OSI, Genentech and Roche's positions in oncology.

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OSI / Genentech / Roche: Tarceva triumphs again

The results of a phase II study have suggested that OSI Pharmaceuticals, Genentech and Roche's Tarceva may be particularly beneficial in elderly patients with previously untreated lung cancer. These results may increase off-label first-line use of the drug in such patients, although Tarceva's high price may hinder uptake in this setting.

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Onyx/Bayer: to pursue development of Nexavar despite study failure

The addition of Nexavar to the second-line chemotherapy combination of carboplatin and paclitaxel for melanoma has failed to improve progression-free survival. Given the commercial potential associated with melanoma, the companies are likely to pursue the development of Nexavar and evaluate the drug in a more treatment-naive melanoma patient population, where more encouraging data may be possible.

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Novuspharma: lymphoma drug well positioned for success

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Novuspharma: lending a hand to Micromet

Novuspharma has agreed to co-develop Micromet's MT201, the only fully human antibody in development that targets the Ep-CAM molecule. The companies plan to begin phase II trials for the drug, across a wide range of cancers. Novuspharma's expertise and experience in oncology will aid MT201's development, but the companies will also need an experienced marketing partner.

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Novo Nordisk/Dr Reddy's: cancer fears freeze diabetes drug

Novo Nordisk has suspended human trials of ragaglitazar, after discovering tumors in rodents that had been fed the experimental drug. The possible loss of ragaglitazar, which had been forecast peak annual sales of $1.78 billion, is Novo Nordisk's third setback this year. It also hits the drug's originator Dr Reddy's hard.

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Noven: Mesafem emerges as potential alternative to HRT

Recently announced results suggest that Noven's non-hormonal therapy Mesafem is effective in relieving vasomotor symptoms associated with the menopause. However, Datamonitor believes that Mesafem will have to demonstrate equivalent or superior efficacy to hormonal replacement therapy if it is to overcome the challenges in this underserved market.

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Novelos Therapeutics: fast track presents new opportunities

Having received marketing approval in Russia and performed well in phase I/II trials, Novelos Therapeutics' NOV-002 has now been granted FDA fast track designation in lung cancer. This means a new drug application submission can occur on a rolling basis, which should speed up the approval process. However, Novelos should secure an experienced marketing partner to maximize on NOV-002's potential.

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Novartis: market experience will help Tasigna

Following the approval of Bristol-Myers Squibb's Sprycel in the US in June 2006 and EU in November 2006, Novartis has completed regulatory submissions for Gleevec follow-up Tasigna with both the FDA and EMEA. Despite Sprycel's first-to-market status, Novartis is well placed in the CML market via its experience with Gleevec to meet this challenge.

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Novartis: heeding the shift in the cancer treatment paradigm

Based on positive clinical trial data, Novartis has filed for marketing approval for Gleevec in both the US and Europe in four rare tumor types. Although these niche indications have little commercial potential in themselves, the filings suggest that Gleevec is set not only to maintain its blockbuster status but also to heed a shift in the cancer treatment paradigm, towards targeted therapies.

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