Navigation Links
Sosei Announces Start of AD 923 Phase III Studies in Europe
Date:2/11/2008

TOKYO, Japan, February 12 /PRNewswire-FirstCall/ -- Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), a biopharmaceutical company, today announces that it has commenced Phase III studies for its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain.

The trial is a multi-centre, randomised, double-blind, double-dummy, crossover study to evaluate the safety and efficacy of AD 923 against an active comparator (morphine sulphate immediate release (MSIR)) for the treatment of breakthrough pain in patients with malignancies. The primary endpoint is the well established summary of pain intensity difference (SPID) measure over the first 30 minutes from initial dosing.

Overall, the European Phase III programme will involve some 300 patients in two studies, involving an active comparator, across 10 European countries. These will then be followed by a single combined open label study to assess the long term effectiveness, safety and tolerability of AD 923.

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 is currently evaluating its commercialisation options for the un-partnered territories.

Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that we are able to announce the start of Phase III studies. AD 923 has been optimised to meet the well recognised need for a safe and effective method of delivering fentanyl for the rapid relief of breakthrough pain in malignant and also non-malignant conditions."

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 http://www.sosei.com

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. The recent European Pain in Cancer Survey (EPIC) results reveal that cancer related pain is widespread in Europe, with one in two (56%) cancer patients enduring moderate to severe pain (n=5,084). The second, detailed phase of the survey reveals that cancer breakthrough pain or inadequate pain relief is a common problem for many patients - 63% of patients in Europe prescribed analgesia, report that they are affected by breakthrough pain (n=441). It also highlights that breakthrough pain can be a frequent occurrence - 26% experiencing it at least once a day (n=279). For further information please visit http://www.epicsurvey.com.

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.


'/>"/>
SOURCE Sosei Group Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Sosei and Vectura Announce Start of Phase II Studies of QVA149 for the Treatment of COPD
2. Sosei Announces Update on Phase I Trials for SD118
3. Sosei Announces Approval to Start AD 923 Phase III Studies in Europe
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... ... 05, 2016 , ... The event is being held on April 7, 2016 ... Minn. Triumph Over Parkinson’s will fund nearly $100,000 for research for the care and ... Parkinson’s disease and is the architect of this informative event to raise awareness and ...
(Date:2/5/2016)... ... February 05, 2016 , ... Looking for a last-minute ... at the tips of your toes. Foot massage, whether administered by a professional masseuse ... and relaxation. The American Board of Multiple Specialties in Podiatry (ABMSP) has ...
(Date:2/5/2016)... ... 2016 , ... The Lymphoma Research Foundation (LRF) – the ... the lymphoma community through a comprehensive series of education programs, outreach initiatives and ... Event at the La Gorce Country Club in Miami Beach on March 15, ...
(Date:2/5/2016)... Grants Pass, OR (PRWEB) , ... February 05, 2016 , ... ... though, with modern technology, such water may be safer than regular municipal or well ... water advocate and radio host Sharon Kleyne, could go a long way toward increasing ...
(Date:2/5/2016)... ... February 05, 2016 , ... Boar’s Head Brand®, one ... time for this weekend’s Big Game. Take the stress out of your party preparation ... your guests happy at every stage of the game. , “The key to hosting ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... 4, 2016  Edwards Lifesciences Corporation (NYSE: EW ... heart disease and critical care monitoring, announced today that ... agreement with Morgan Stanley & Co. LLC to repurchase ... part of the Company,s previously authorized program to repurchase ... --> --> ...
(Date:2/4/2016)... Wegener Polyangiitis - Pipeline Review, H2 ... Polyangiitis - Pipeline Review, H2 2015, provides an ... This report provides comprehensive information on the therapeutic ... at various stages, therapeutics assessment by drug target, ... and molecule type, along with latest updates, and ...
(Date:2/4/2016)... Feb. 4, 2016  Omnicell, Inc. (NASDAQ: OMCL ), ... to healthcare systems, today announced results for its fiscal ... --> --> GAAP results: Revenue ... up $5.1 million or 4.1% from the third quarter ... the fourth quarter of 2014. Revenue for the year ...
Breaking Medicine Technology: