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Sanofi plans to file JAK2 inhibitor after positive phase III

Aiming for approval in blood cancer myelofibrosis

Sanofi plans to file JAK2 inhibitor after positive phase III

Sanofi has started to prepare for regulatory filings of its blood cancer treatment SAR302503 following positive results in a pivotal study.

The drug – a selective Janus kinase-2 (JAK2) inhibitor – met its objective of reducing spleen volume in the JAKARTA trial of 289 patients with myelofibrosis, a haematological cancer characterised by abnormal blood cell production and scarring on the bone marrow.

In the trial, patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis were treated with either a once-daily dose of SAR302503 (400mg or 500mg) or placebo over 24 weeks.

The primary objective of treatment was a reduction in spleen volume of 35 per cent or more, with Sanofi indicating that significantly more patients on SAR302503 achieved that target compared to those on placebo.

"Patients with myelofibrosis in advanced stages are desperately ill and in need of treatments that will improve their outcomes," said Debasish Roychowdhury, head of Sanofi's oncology research unit.

"SAR302503 has moved from phase I to the completion of pivotal phase III studies in less than three years, and now we are planning regulatory filings with authorities to make this medicine available for patients," he added.

If approved, SAR302503 would compete in the market with Novartis and Incyte's Jakafi/ Jakavi (ruxolitinib), which has already been approved for marketing in around 30 countries and achieved sales of around $85m in the first quarter of the year.

Jakafi has been tipped to become a $1bn-plus product as the first real game-changer in myelofibrosis treatment in recent years, and Sanofi will have to differentiate its product with clinicians given its rival's head start.

Sanofi's product has more convenient dosing - once-daily versus twice-daily - and has a more selective mode of action as Jakafi affects both JAK1 and JAK2 receptors, although the clinical significance of this is not yet clear.

Sanofi seems to be targeting the drug to patients who are resistant or intolerant to Jakafi failures, and has a phase II trial ongoing in this population.

17th May 2013

From: Sales

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