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Sosei begins phase III pain spray study in EU

Japan-headquartered biotech Sosei wins EU approval to begin a phase III clinical trial programme for its fentanyl sublingual spray for breakthrough pain in cancer

Japan-headquartered biotech Sosei has received approval to begin a phase III clinical trial programme for its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of breakthrough pain in cancer.

The UK Medicines and Healthcare products Regulatory Agency's (MHRA) clinical trial authorisation (CTA) covers two multi-centre phase III efficacy studies followed by an open label safety study.

Patient enrolment in the UK is expected to commence before the end of 2007. Applications have been made in other EU countries and further patient recruitment will be initiated as soon as approval is received from the relevant local regulatory body.

The CTA is Sosei's first in a major EU country will also trigger the receipt of a project milestone payment under the AD 923 Licence Agreement signed with UK-based Mundipharma back in June 2006.

Per the agreement, Sosei is responsible for developing and registering AD 923 and Mundipharma is charged with the manufacture, marketing and sales within the licensed territories. Sosei could receive up to GBP 17.5m (USD 36.1m), including upfront and milestone payments and double-digit royalties on product sales.

Sosei has, however, retained the option to co-promote AD 923 in the UK and Germany. A joint committee will be established to oversee all activities covered under the agreement.

Sosei is still evaluating its options for commercialisation of AD 923 in North America and Japan, which could include the option to conduct its own sales or co-promotion in these territories.

A key growth strategy for Sosei will be to gain initial approval for cancer breakthrough pain and then drive sales in additional indications through off-label use or regulatory approval.

According to a Datamonitor report, a relative lack of treatments for breathrough pain and further key patent expiries within the next ten years could see the market more than double in value from 2005 to reach USD 2.5bn in 2016.

30th September 2008

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