TOKYO, Japan, March 5 /PRNewswire-FirstCall/ -- Sosei Group Corporation , a biopharmaceutical company, today announces that AD 923, a novel sublingual fentanyl spray for the treatment of cancer breakthrough pain, has entered into a Phase I comparative pharmacokinetic study in the USA under an IND regulatory submission.
The trial is a single centre, open-label, single dose, cross-over study to investigate the comparative pharmacokinetics of AD923 against intravenous and oral transmucosal formulations of fentanyl in 24 healthy human volunteers.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that we have been able to announce the progression of the AD 923 development programme into the USA. There is a major requirement for a simple and manageable method of providing immediate-release fentanyl for the rapid relief of breakthrough pain which AD 923 has been optimised to deliver."
Notes for Editors:
About Sosei
Sosei Group Corporation is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.
For further information about Sosei, please visit www.sosei.com
About AD 923
AD 923 is an optimised, sublingual formulation of the strong opioid analgesic fentanyl. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosage. Sosei has concluded a range of studies that confirm the potential of this novel product.
In June 2006, Sosei entered into an agreement with Mundipharma International Corporation Limited for the development and commercialisation of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei are currently evaluating its commercialisation options for the un-partnered territories.
About Cancer Breakthrough Pain
Cancer breakthrough pain is characterised by temporary exacerbations of moderate to severe pain in cancer patients that "breakthrough" their around-the-clock opioid treatments. Each episode may be spontaneous or incidental to an activity. It is estimated that the condition is prevalent in approximately 60% of cancer pain patients across Europe, the US and Japan, representing a total population size of 2.3 million. Most current treatments for cancer breakthrough pain are considered sub-optimal. The market seeks products which have a rapid onset of action and are easy to use. The current worldwide market for cancer breakthrough pain drug treatment is estimated to be worth $1.5bn and represents a growing market opportunity.
Sosei Group CorporationCONTACT: Sosei Group Corporation: Ichiban-cho FS Bldg., 8 Ichiban-cho,Chiyoda-ku, Tokyo 102-0082 Japan, Hiroki Maekawa, Representative ExecutiveOfficer, E-mail: hmaekawa@sosei.com Tel: +81-3-5210-3399 Fax:+81-3-5210-3291; Sosei R&D Ltd.: Chesterford Research Park, Saffron Walden,CB10 1XL England, John Daffurn, SVP Corporate Development, E-mail:daffurnj@sosei.com Tel: +44-(0)1799-532-350 Fax: +44-(0)1799-532-351;Financial Dynamics Tel: +44-(0)207-831-3113, Julia Phillips; The TroutGroup: Thomas Fechtner Tel: +1-646-378-2915; Brandon Lewis Tel:+1-646-378-2931
